ILLUSTRATIVE CASE

A 64-year-old overweight White man with a history of hypertension, hyperlipidemia, and HF with an ejection fraction (EF) of 40% presents for primary care follow-up after a recent inpatient admission for worsened HF symptoms. At baseline, he is comfortable at rest but becomes dyspneic upon walking to another room within his home. He is already taking a mineralocorticoid receptor antagonist, a high-intensity statin, a beta-blocker, and an angiotensin-converting enzyme (ACE) inhibitor. What other medication should be considered to minimize his cardiovascular (CV)risk?

An estimated 1% to 2% of the world’s adult population has HF.² Although the exact prevalence is difficult to quantify due to variations in definitions and diagnostic methods, the American Heart Association (AHA) estimated that 6.2 million Americans had HF between 2013 and 2016.³ Prevalence increases with age, with an annual incidence of approximately 35 per 1000 by age 85.⁴ Due to the significant morbidity and mortality associated with HF, advancements in treatment are needed.

SGLT2 inhibitors work within the proximal tubule of the kidneys, resulting in increased glucose and sodium excretion with secondary osmotic diuresis and therefore a modest reduction in serum glucose.^1,2,5,6 SGLT2 inhibitors are classically prescribed for hyperglycemia treatment in type 2 diabetes. However, preliminary data suggest that this class of medication also positively impacts cardiac function. The diuresis and natriuresis effects of SGLT2 inhibitors appear to optimize cardiac output and subsequent oxygen consumption through a reduction of afterload and preload.^1,2,5,6 Further, SGLT2 inhibitors may decrease inflammatory pathways and lead to a secondary reduction of cardiac remodeling via a reduction and modulation of inflammatory pathways. This reduction and modulation may also be associated with a reduction in development, and possibly a reversal, of hypertrophic cardiomyopathy, cardiac fibrosis, and atherosclerosis.^5,6 Some of the previously reported adverse effects of SGLT2 inhibitors include urinary tract infection, acute kidney injury, lower extremity amputation, bone fracture, and diabetic ketoacidosis.²

In several studies of patients with type 2 diabetes, SGLT2 inhibitors have shown benefit in reducing CV disease–related death and hospitalization for HF.^1,2,5,6 A recent expert consensus from the American College of Cardiology (ACC) states that SGLT2 therapy should be considered for any patient with type 2 diabetes who also has established atherosclerotic CV disease, HF (a clinical syndrome as defined in ACC/AHA guidelines), or diabetic kidney disease, or who is at a high risk for atherosclerotic CV disease (ie, has signs of end-organ damage, such as left ventricular hypertrophy or retinopathy, or multiple risk factors such as advanced age, smoking, hypertension, and family history).^7,8

Dapagliflozin demonstrated decreased HF exacerbations and CV deaths, improved patient-reported HF symptoms, and lower allcause mortality in patients both with and without diabetes.

Additionally, a 2019 randomized controlled trial (RCT) by Nassif et al showed that, compared to placebo, dapagliflozin significantly improved both patient-reported HF symptoms and cardiac natriuretic peptide levels over 12 weeks in patients with and without diabetes.⁹ In September 2020, ­UpToDate added SGLT2 inhibitors as an option for patients with continued symptoms of HF despite use of appropriate primary agents and mineralocorticoid receptor antagonists, whether or not they have type 2 diabetes; this update was based on 2 studies, 1 of which is reviewed here.¹⁰

STUDY SUMMARY

Dapagliflozin demonstrated better CV outcomes than placebo

The Dapagliflozin and Prevention of Adverse Outcomes in Heart Failure (DAPA-HF) study is an RCT that compared dapagliflozin to placebo among 4744 patients ages 18 years and older who had HF with an EF ≤ 40% and NYHA class II, III, or IV symptoms. The study included patients with (41.8%) and without diabetes. Most patients were male (76.2%-77%), White (70%), and European (44.7%-46.1%).

Patients were randomized to receive either dapagliflozin 10 mg/d or a matching placebo in addition to standard HF therapy (including an ACE inhibitor, angiotensin receptor blocker, or sacubitril-valsartan plus a beta-blocker unless contraindicated; mineralocorticoid antagonist use was encouraged). Follow-up occurred at 14 days, 60 days, 4 months, and then every 4 months, for an average of about 18 months. Patients with diabetes continued to use their glucose-lowering therapies, with dose adjustments, as needed.

Continue to: The primary outcome...

The primary outcome was a composite of worsening HF (hospitalization or urgent visit requiring intravenous HF therapy) or death from a CV cause. Secondary outcomes included a composite of hospitalization for HF or CV death; total number of hospitalizations for HF (including repeat admissions) and CV death; a change in Kansas City Cardiomyopathy Questionnaire symptom score; a composite of worsening renal function including a sustained (≥ 28 d) decline in the estimated glomerular filtration rate (eGFR) of ≥ 50%, end-stage renal disease (defined as sustained eGFR of < 15 mL/min/1.73 m², sustained dialysis, or renal transplantation), or renal death; and death from any cause.

The primary outcome of worsening HF or death from CV causes occurred in 386 of 2373 patients (16.3%) in the dapagliflozin group and in 502 of 2371 patients (21.2%) in the placebo group (hazard ratio [HR] = 0.74; 95% CI, 0.65-0.85; P < .001). The composite score of hospitalizations for HF plus death from a CV cause was lower in the dapagliflozin group compared to the placebo group (HR = 0.75; 95% CI, 0.65-0.85; P < .001).

Integration of SGLT2 inhibitors into a patient’s medication regimen may require dose adjustments of other medications.

A total of 276 patients (11.6%) in the dapagliflozin group and 329 patients (13.9%) in the placebo group died from any cause (HR = 0.83; 95% CI, 0.71-0.97). More patients in the dapagliflozin group than in the placebo group had an improvement in symptom score (58.3% vs 50.9%; odds ratio = 1.15; 95% CI, 1.08-1.23; P < .001). Renal composite outcome did not differ between the 2 treatment groups. Potential adverse effects included volume depletion, renal adverse event, and major hypoglycemia, which occurred at the same rate in the treatment and placebo groups. There was no difference in outcomes or adverse effects between patients with and without diabetes.¹

WHAT'S NEW

Evidence supports dapagliflozin use in a new patient population

The DAPA-HF study compared dapagliflozin to placebo in HF patients both with and without diabetes and demonstrated decreased HF exacerbations and CV deaths, improved ­patient-reported HF symptoms, and lower all-cause mortality in the treatment group. This study supports use of dapagliflozin in a new patient population—those with HF—rather than solely in patients with diabetes, as the drug was originally marketed.

CAVEATS

Specific study population may limit generalizability

The DAPA-HF study included mostly male, White, European patients followed for an average of 18.2 months as part of initial Phase III studies funded by AstraZeneca (the pharmaceutical company that developed dapagliflozin). Given the potential conflict due to funding, all statistical results were verified by an independent academic group, and analyses were completed with an intention-to-treat model. The outlined benefits described here were only studied in a population of patients with reduced EF (≤ 40%), so the impact remains unclear for patients with preserved EF. Safety and benefits beyond 24 months were not studied in this RCT; therefore long-term data are still unknown.

Continue to: CHALLENGES TO IMPLEMENTATION

Adding an SGLT2 inhibitor may be cost prohibitive for some patients

An SGLT2 inhibitor costs, on average, $500 to $600 for a 30-day supply, which may be prohibitive for some patients.¹¹ Integration of SGLT2 inhibitors into a patient’s medication regimen may require dose adjustments of other medications, particularly glucose-lowering therapies, and the optimal prioritization of medications is not yet known.

ACKNOWLEDGEMENT

The PURLs Surveillance System was supported in part by Grant Number UL1RR024999 from the National Center for Research Resources, a Clinical Translational Science Award to the University of Chicago. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Center for Research Resources or the National Institutes of Health.

ILLUSTRATIVE CASE

A 64-year-old overweight White man with a history of hypertension, hyperlipidemia, and HF with an ejection fraction (EF) of 40% presents for primary care follow-up after a recent inpatient admission for worsened HF symptoms. At baseline, he is comfortable at rest but becomes dyspneic upon walking to another room within his home. He is already taking a mineralocorticoid receptor antagonist, a high-intensity statin, a beta-blocker, and an angiotensin-converting enzyme (ACE) inhibitor. What other medication should be considered to minimize his cardiovascular (CV)risk?

An estimated 1% to 2% of the world’s adult population has HF.² Although the exact prevalence is difficult to quantify due to variations in definitions and diagnostic methods, the American Heart Association (AHA) estimated that 6.2 million Americans had HF between 2013 and 2016.³ Prevalence increases with age, with an annual incidence of approximately 35 per 1000 by age 85.⁴ Due to the significant morbidity and mortality associated with HF, advancements in treatment are needed.

SGLT2 inhibitors work within the proximal tubule of the kidneys, resulting in increased glucose and sodium excretion with secondary osmotic diuresis and therefore a modest reduction in serum glucose.^1,2,5,6 SGLT2 inhibitors are classically prescribed for hyperglycemia treatment in type 2 diabetes. However, preliminary data suggest that this class of medication also positively impacts cardiac function. The diuresis and natriuresis effects of SGLT2 inhibitors appear to optimize cardiac output and subsequent oxygen consumption through a reduction of afterload and preload.^1,2,5,6 Further, SGLT2 inhibitors may decrease inflammatory pathways and lead to a secondary reduction of cardiac remodeling via a reduction and modulation of inflammatory pathways. This reduction and modulation may also be associated with a reduction in development, and possibly a reversal, of hypertrophic cardiomyopathy, cardiac fibrosis, and atherosclerosis.^5,6 Some of the previously reported adverse effects of SGLT2 inhibitors include urinary tract infection, acute kidney injury, lower extremity amputation, bone fracture, and diabetic ketoacidosis.²

In several studies of patients with type 2 diabetes, SGLT2 inhibitors have shown benefit in reducing CV disease–related death and hospitalization for HF.^1,2,5,6 A recent expert consensus from the American College of Cardiology (ACC) states that SGLT2 therapy should be considered for any patient with type 2 diabetes who also has established atherosclerotic CV disease, HF (a clinical syndrome as defined in ACC/AHA guidelines), or diabetic kidney disease, or who is at a high risk for atherosclerotic CV disease (ie, has signs of end-organ damage, such as left ventricular hypertrophy or retinopathy, or multiple risk factors such as advanced age, smoking, hypertension, and family history).^7,8

Dapagliflozin demonstrated decreased HF exacerbations and CV deaths, improved patient-reported HF symptoms, and lower allcause mortality in patients both with and without diabetes.

Additionally, a 2019 randomized controlled trial (RCT) by Nassif et al showed that, compared to placebo, dapagliflozin significantly improved both patient-reported HF symptoms and cardiac natriuretic peptide levels over 12 weeks in patients with and without diabetes.⁹ In September 2020, ­UpToDate added SGLT2 inhibitors as an option for patients with continued symptoms of HF despite use of appropriate primary agents and mineralocorticoid receptor antagonists, whether or not they have type 2 diabetes; this update was based on 2 studies, 1 of which is reviewed here.¹⁰

STUDY SUMMARY

Dapagliflozin demonstrated better CV outcomes than placebo

The Dapagliflozin and Prevention of Adverse Outcomes in Heart Failure (DAPA-HF) study is an RCT that compared dapagliflozin to placebo among 4744 patients ages 18 years and older who had HF with an EF ≤ 40% and NYHA class II, III, or IV symptoms. The study included patients with (41.8%) and without diabetes. Most patients were male (76.2%-77%), White (70%), and European (44.7%-46.1%).

Patients were randomized to receive either dapagliflozin 10 mg/d or a matching placebo in addition to standard HF therapy (including an ACE inhibitor, angiotensin receptor blocker, or sacubitril-valsartan plus a beta-blocker unless contraindicated; mineralocorticoid antagonist use was encouraged). Follow-up occurred at 14 days, 60 days, 4 months, and then every 4 months, for an average of about 18 months. Patients with diabetes continued to use their glucose-lowering therapies, with dose adjustments, as needed.

Continue to: The primary outcome...

The primary outcome was a composite of worsening HF (hospitalization or urgent visit requiring intravenous HF therapy) or death from a CV cause. Secondary outcomes included a composite of hospitalization for HF or CV death; total number of hospitalizations for HF (including repeat admissions) and CV death; a change in Kansas City Cardiomyopathy Questionnaire symptom score; a composite of worsening renal function including a sustained (≥ 28 d) decline in the estimated glomerular filtration rate (eGFR) of ≥ 50%, end-stage renal disease (defined as sustained eGFR of < 15 mL/min/1.73 m², sustained dialysis, or renal transplantation), or renal death; and death from any cause.

The primary outcome of worsening HF or death from CV causes occurred in 386 of 2373 patients (16.3%) in the dapagliflozin group and in 502 of 2371 patients (21.2%) in the placebo group (hazard ratio [HR] = 0.74; 95% CI, 0.65-0.85; P < .001). The composite score of hospitalizations for HF plus death from a CV cause was lower in the dapagliflozin group compared to the placebo group (HR = 0.75; 95% CI, 0.65-0.85; P < .001).

Integration of SGLT2 inhibitors into a patient’s medication regimen may require dose adjustments of other medications.

A total of 276 patients (11.6%) in the dapagliflozin group and 329 patients (13.9%) in the placebo group died from any cause (HR = 0.83; 95% CI, 0.71-0.97). More patients in the dapagliflozin group than in the placebo group had an improvement in symptom score (58.3% vs 50.9%; odds ratio = 1.15; 95% CI, 1.08-1.23; P < .001). Renal composite outcome did not differ between the 2 treatment groups. Potential adverse effects included volume depletion, renal adverse event, and major hypoglycemia, which occurred at the same rate in the treatment and placebo groups. There was no difference in outcomes or adverse effects between patients with and without diabetes.¹

WHAT'S NEW

Evidence supports dapagliflozin use in a new patient population

The DAPA-HF study compared dapagliflozin to placebo in HF patients both with and without diabetes and demonstrated decreased HF exacerbations and CV deaths, improved ­patient-reported HF symptoms, and lower all-cause mortality in the treatment group. This study supports use of dapagliflozin in a new patient population—those with HF—rather than solely in patients with diabetes, as the drug was originally marketed.

CAVEATS

Specific study population may limit generalizability

The DAPA-HF study included mostly male, White, European patients followed for an average of 18.2 months as part of initial Phase III studies funded by AstraZeneca (the pharmaceutical company that developed dapagliflozin). Given the potential conflict due to funding, all statistical results were verified by an independent academic group, and analyses were completed with an intention-to-treat model. The outlined benefits described here were only studied in a population of patients with reduced EF (≤ 40%), so the impact remains unclear for patients with preserved EF. Safety and benefits beyond 24 months were not studied in this RCT; therefore long-term data are still unknown.

Continue to: CHALLENGES TO IMPLEMENTATION

Adding an SGLT2 inhibitor may be cost prohibitive for some patients

An SGLT2 inhibitor costs, on average, $500 to $600 for a 30-day supply, which may be prohibitive for some patients.¹¹ Integration of SGLT2 inhibitors into a patient’s medication regimen may require dose adjustments of other medications, particularly glucose-lowering therapies, and the optimal prioritization of medications is not yet known.

ACKNOWLEDGEMENT

The PURLs Surveillance System was supported in part by Grant Number UL1RR024999 from the National Center for Research Resources, a Clinical Translational Science Award to the University of Chicago. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Center for Research Resources or the National Institutes of Health.

ILLUSTRATIVE CASE

A 64-year-old overweight White man with a history of hypertension, hyperlipidemia, and HF with an ejection fraction (EF) of 40% presents for primary care follow-up after a recent inpatient admission for worsened HF symptoms. At baseline, he is comfortable at rest but becomes dyspneic upon walking to another room within his home. He is already taking a mineralocorticoid receptor antagonist, a high-intensity statin, a beta-blocker, and an angiotensin-converting enzyme (ACE) inhibitor. What other medication should be considered to minimize his cardiovascular (CV)risk?

An estimated 1% to 2% of the world’s adult population has HF.² Although the exact prevalence is difficult to quantify due to variations in definitions and diagnostic methods, the American Heart Association (AHA) estimated that 6.2 million Americans had HF between 2013 and 2016.³ Prevalence increases with age, with an annual incidence of approximately 35 per 1000 by age 85.⁴ Due to the significant morbidity and mortality associated with HF, advancements in treatment are needed.

SGLT2 inhibitors work within the proximal tubule of the kidneys, resulting in increased glucose and sodium excretion with secondary osmotic diuresis and therefore a modest reduction in serum glucose.^1,2,5,6 SGLT2 inhibitors are classically prescribed for hyperglycemia treatment in type 2 diabetes. However, preliminary data suggest that this class of medication also positively impacts cardiac function. The diuresis and natriuresis effects of SGLT2 inhibitors appear to optimize cardiac output and subsequent oxygen consumption through a reduction of afterload and preload.^1,2,5,6 Further, SGLT2 inhibitors may decrease inflammatory pathways and lead to a secondary reduction of cardiac remodeling via a reduction and modulation of inflammatory pathways. This reduction and modulation may also be associated with a reduction in development, and possibly a reversal, of hypertrophic cardiomyopathy, cardiac fibrosis, and atherosclerosis.^5,6 Some of the previously reported adverse effects of SGLT2 inhibitors include urinary tract infection, acute kidney injury, lower extremity amputation, bone fracture, and diabetic ketoacidosis.²

In several studies of patients with type 2 diabetes, SGLT2 inhibitors have shown benefit in reducing CV disease–related death and hospitalization for HF.^1,2,5,6 A recent expert consensus from the American College of Cardiology (ACC) states that SGLT2 therapy should be considered for any patient with type 2 diabetes who also has established atherosclerotic CV disease, HF (a clinical syndrome as defined in ACC/AHA guidelines), or diabetic kidney disease, or who is at a high risk for atherosclerotic CV disease (ie, has signs of end-organ damage, such as left ventricular hypertrophy or retinopathy, or multiple risk factors such as advanced age, smoking, hypertension, and family history).^7,8

Dapagliflozin demonstrated decreased HF exacerbations and CV deaths, improved patient-reported HF symptoms, and lower allcause mortality in patients both with and without diabetes.

Additionally, a 2019 randomized controlled trial (RCT) by Nassif et al showed that, compared to placebo, dapagliflozin significantly improved both patient-reported HF symptoms and cardiac natriuretic peptide levels over 12 weeks in patients with and without diabetes.⁹ In September 2020, ­UpToDate added SGLT2 inhibitors as an option for patients with continued symptoms of HF despite use of appropriate primary agents and mineralocorticoid receptor antagonists, whether or not they have type 2 diabetes; this update was based on 2 studies, 1 of which is reviewed here.¹⁰

STUDY SUMMARY

Dapagliflozin demonstrated better CV outcomes than placebo

The Dapagliflozin and Prevention of Adverse Outcomes in Heart Failure (DAPA-HF) study is an RCT that compared dapagliflozin to placebo among 4744 patients ages 18 years and older who had HF with an EF ≤ 40% and NYHA class II, III, or IV symptoms. The study included patients with (41.8%) and without diabetes. Most patients were male (76.2%-77%), White (70%), and European (44.7%-46.1%).

Patients were randomized to receive either dapagliflozin 10 mg/d or a matching placebo in addition to standard HF therapy (including an ACE inhibitor, angiotensin receptor blocker, or sacubitril-valsartan plus a beta-blocker unless contraindicated; mineralocorticoid antagonist use was encouraged). Follow-up occurred at 14 days, 60 days, 4 months, and then every 4 months, for an average of about 18 months. Patients with diabetes continued to use their glucose-lowering therapies, with dose adjustments, as needed.

Continue to: The primary outcome...

The primary outcome was a composite of worsening HF (hospitalization or urgent visit requiring intravenous HF therapy) or death from a CV cause. Secondary outcomes included a composite of hospitalization for HF or CV death; total number of hospitalizations for HF (including repeat admissions) and CV death; a change in Kansas City Cardiomyopathy Questionnaire symptom score; a composite of worsening renal function including a sustained (≥ 28 d) decline in the estimated glomerular filtration rate (eGFR) of ≥ 50%, end-stage renal disease (defined as sustained eGFR of < 15 mL/min/1.73 m², sustained dialysis, or renal transplantation), or renal death; and death from any cause.

The primary outcome of worsening HF or death from CV causes occurred in 386 of 2373 patients (16.3%) in the dapagliflozin group and in 502 of 2371 patients (21.2%) in the placebo group (hazard ratio [HR] = 0.74; 95% CI, 0.65-0.85; P < .001). The composite score of hospitalizations for HF plus death from a CV cause was lower in the dapagliflozin group compared to the placebo group (HR = 0.75; 95% CI, 0.65-0.85; P < .001).

Integration of SGLT2 inhibitors into a patient’s medication regimen may require dose adjustments of other medications.

A total of 276 patients (11.6%) in the dapagliflozin group and 329 patients (13.9%) in the placebo group died from any cause (HR = 0.83; 95% CI, 0.71-0.97). More patients in the dapagliflozin group than in the placebo group had an improvement in symptom score (58.3% vs 50.9%; odds ratio = 1.15; 95% CI, 1.08-1.23; P < .001). Renal composite outcome did not differ between the 2 treatment groups. Potential adverse effects included volume depletion, renal adverse event, and major hypoglycemia, which occurred at the same rate in the treatment and placebo groups. There was no difference in outcomes or adverse effects between patients with and without diabetes.¹

WHAT'S NEW

Evidence supports dapagliflozin use in a new patient population

The DAPA-HF study compared dapagliflozin to placebo in HF patients both with and without diabetes and demonstrated decreased HF exacerbations and CV deaths, improved ­patient-reported HF symptoms, and lower all-cause mortality in the treatment group. This study supports use of dapagliflozin in a new patient population—those with HF—rather than solely in patients with diabetes, as the drug was originally marketed.

CAVEATS

Specific study population may limit generalizability

The DAPA-HF study included mostly male, White, European patients followed for an average of 18.2 months as part of initial Phase III studies funded by AstraZeneca (the pharmaceutical company that developed dapagliflozin). Given the potential conflict due to funding, all statistical results were verified by an independent academic group, and analyses were completed with an intention-to-treat model. The outlined benefits described here were only studied in a population of patients with reduced EF (≤ 40%), so the impact remains unclear for patients with preserved EF. Safety and benefits beyond 24 months were not studied in this RCT; therefore long-term data are still unknown.

Continue to: CHALLENGES TO IMPLEMENTATION

Adding an SGLT2 inhibitor may be cost prohibitive for some patients

An SGLT2 inhibitor costs, on average, $500 to $600 for a 30-day supply, which may be prohibitive for some patients.¹¹ Integration of SGLT2 inhibitors into a patient’s medication regimen may require dose adjustments of other medications, particularly glucose-lowering therapies, and the optimal prioritization of medications is not yet known.

ACKNOWLEDGEMENT

The PURLs Surveillance System was supported in part by Grant Number UL1RR024999 from the National Center for Research Resources, a Clinical Translational Science Award to the University of Chicago. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Center for Research Resources or the National Institutes of Health.

Some adults who have an intellectual or other developmental disability (IDD) require extensive subspecialty care; many, however, depend primarily on their family physician for the bulk of their health care. With that reliance in mind, this article provides (1) an overview of important services that family physicians can provide for their adult patients with IDD and (2) pragmatic clinical suggestions for tailoring that care. Note: We highlight only some high-impact areas of clinical focus; refer to the 2018 Canadian consensus guidelines for a comprehensive approach to optimizing primary care for this population.¹

CASE

Laura S, a 24-year-old woman with Down syndrome, is visiting your clinic with her mother to establish care. Ms. S has several medical comorbidities, including type 2 diabetes, hyperlipidemia, repaired congenital heart disease, schizoaffective disorder, and hypothyroidism. She is under the care of multiple specialists, including a cardiologist and an endocrinologist. Her medications include the atypical antipsychotic risperidone, which was prescribed for her through the services of a community mental health center.

Ms. S is due for multiple preventive health screenings. She indicates that she feels nervous today talking about these screenings with a new physician.

First step in care: Proficiency in the lexicon of IDD

Three core concepts of IDD are impairment, disability, and handicap. According to the World Health Organization²:

• impairment “is any loss or abnormality of psychological, physiological, or anatomical structure or function.”
• disability “is any restriction or lack (resulting from an impairment) of ability to perform an activity in the manner or within the range considered normal for a human being.”
• handicap therefore “represents socialization of an impairment or disability, and as such it reflects the consequences for the individual—cultural, social, economic, and environmental—that stem from the presence of impairment and disability.”

Essential transition: Pediatric to adult health care

Health care transition (HCT) is the planned process of transferring care from a pediatric to an adult-based health care setting,³ comprising 3 phases:

• preparation
• transfer from pediatric to adult care
• integration into adult-based care.

Two critical components of a smooth HCT include initiating the transition early in adolescence and providing transition-support resources, which are often lacking, even in large, integrated health systems.⁴ Got Transition, created by the National Alliance to Advance Adolescent Health, outlines core elements of an organized HCT process (www.gottransition.org) specific to young adults with IDD, including young adults with autism spectrum disorder.^5,6 

Even young people who are served by a family physician and who intend to remain in that family practice as they age into adulthood require HCT services that include⁶:

• assessment of readiness to transition to adult care
• update of the medical history
• assessment and promotion of self-care skills
• consent discussions and optimized participation in decision-making
• transition of specialty care from pediatric to adult specialists.

Continue to: For an ideal HCT...

For an ideal health care transition, full engagement of the patient, the medical home, and the patient’s family (including the primary caregiver or guardian) is critical.

For an ideal HCT, full engagement of the patient, the medical home (physicians, nursing staff, and care coordinators), and the patient’s family (including the primary caregiver or guardian) is critical. In addition to preventive care visits and management of chronic disease, additional domains that require explicit attention in transitioning young people with IDD include health insurance, transportation, employment, and postsecondary education.

Young people who have special health care needs and receive high-quality HCT demonstrate improvements in adherence to care, disease-specific measures, quality of life, self-care skills, satisfaction with care, and health care utilization.⁷TABLE 1³ lists resources identified by Berens and colleagues that are helpful in facilitating the transition.

Teach and practice disability etiquette

Societal prejudice harms people with IDD—leading to self-deprecation, alienation from the larger community, and isolation from others with IDD.⁸ To promote acceptance and inclusivity in residential communities, the workplace, recreational venues, and clinical settings, disability etiquette should be utilized—a set of guidelines on how to interact with patients with IDD. These include speaking to the patient directly, using clear language in an adult voice, and avoiding stereotypes about people with disabilities.⁹ The entire health care team, including all front-facing staff (receptionists and care and financial coordinators) and clinical staff (physicians, nurses, medical assistants), need to be educated in, and practice, disability etiquette.

Preparing for in-person visits. Pre-­visit preparation, ideally by means of dialogue between health care staff and the patient or caregiver (or both), typically by telephone and in advance of the scheduled visit, is often critical for a successful first face-to-face encounter. (See “Pre-visit telephone questionnaire and script for a new adult patient with IDD,” page 287, which we developed for use in our office practice.) Outcomes of the pre-visit preparation should include identifying:

• words or actions that can trigger anxiety or panic
• de-escalation techniques, such as specific calming words and actions
• strategies for optimal communication, physical access, and physical examination.

Initial appointments should focus on building trust and rapport with the health care team and desensitizing the patient to the clinical environment.¹⁰ Examination techniques used with pediatric patients can be applied to this population: for example, demonstrating an examination maneuver first on the parent or caregiver; beginning the examination with the least invasive or anxiety-­provoking components; and stating what you plan to do next—before you do it.

Continue to: Systematic health checks provide great value

A health check is a systematic and comprehensive health assessment that is provided annually to adults with IDD, and includes:

• specific review of signs and symptoms of health conditions that often co-­occur in adults with IDD (TABLE 2Calibri¹¹)
• screening for changes in adaptive functioning and secondary disability
• lifestyle counseling
• medication review and counseling
• immunization update
• discussion of caregiver concerns.

Successful implementation of preventive health screening tests for a patient with IDD often requires ingenuity and creativity to allay fears and anxieties.

Regarding the last point: Many caregivers are the aging parents of the adult patient with IDD—people who have their own emerging health and support needs. You should initiate conversations about advanced planning for the needs of patients, which often involves engaging siblings and other family members to assume a greater role in caregiving.¹²

Benefits of the health check. A systematic review of 38 studies, comprising more than 5000 patients with IDD, found that health checks increased the detection of serious conditions, improved screening for sensory impairments, and increased the immunization rate.¹³ Although many patients with IDD generally understand the need for a periodic health examination, you can enhance their experience by better explaining the rationale for the health check; scheduling sufficient time for the appointment, based on the individual clinical situation; and discussing the value of laboratory testing and referrals to specialists.¹⁴

Tailoring preventive care

Many of the preventive services recommendations typically utilized by family physicians, such as guidelines from the US Preventive Services Task Force, have been developed for the general population at average risk of conditions of interest.¹⁵ Adults with IDD, depending on the cause of their developmental disability and their behavioral risk profile, might be at significantly higher (or lower) risk of cancer, heart disease, or other conditions than the general population. To address these differences, preventive care guidelines tailored to patients with certain developmental disabilities have been created, including guidelines specific to adults with Down syndrome, fragile X syndrome, Prader-Willi syndrome, Smith-Magenis syndrome, and 22q11.2 deletion (DiGeorge) syndrome.¹⁶

Clarifying the molecular genetic etiology of many developmental disabilities has led to more precise understandings about physical and behavioral health issues associated with specific developmental disabilities. For that reason, patients without a known cause for their IDD might benefit from referral to a geneticist—even in early or middle adulthood. Variables generally associated with a higher likelihood of an abnormal genetic test result include¹⁷:

• a family history of developmental disability
• a congenital malformation or dysmorphic features
• a dual diagnosis of developmental disability and co-occurring mental illness
• hypotonia
• severe or profound IDD.

Continue to: Successful implementation of preventive health screening tests...

Successful implementation of preventive health screening tests often requires ingenuity and the collective creativity of the patient, family members, staff, and family physician to allay fears and anxieties. Examples: Women who have been advised to undergo screening mammography might feel less anxious by undergoing tandem screening with their sister or mother, and colorectal cancer screening might be more easily accomplished using a fecal DNA test rather than by colonoscopy. Procedural desensitization strategies and preventive care instructional materials targeting people with IDD are posted on YouTube (for example, the “DD CARES Best Practices” series [see www.youtube.com/watch?v=EPJy4zvg4io]) and other websites.

Management of chronic disease

Evidence of health disparities in patients with IDD includes suboptimal management of chronic diseases, such as diabetes¹⁸ and hypertension,¹⁹ despite contact with a primary care physician. Nonadherence to a medication regimen might be more common in patients who live with their family or in a residential setting where there is a lower degree of supervision—that is, compared to a residence that maintains 24-hour staffing with daily nursing care and supervision. For a patient who is not so closely supervised, reviewing the medication refill history with the pharmacy, or using the so-called brown-bag technique of counting pill bottles brought to appointments, can ensure medication adherence.

CASE

As you interview Ms. S, you note that she is shy, avoids eye contact, and appears generally anxious. You calm her by noticing and complimenting her jewelry and fingernail polish. Ms. S smiles and talks about her favorite polish colors.

Evaluation of suspected mental and behavioral health issues begins with assessment for medical conditions that might be causing pain and distress or stereotypies.

Her mother reports that, when Ms. S is stressed, she talks to herself alone in her bedroom. However, you do not observe evidence of schizoaffective disorder, and begin to wonder whether she needs to be taking risperidone.

Essentials of mental health care

It is estimated that one-third of adults with IDD have significant mental and behavioral health care needs.²⁰ Patients with IDD suffer the same psychiatric disorders as the general population; some also engage in problematic behaviors, such as self-injurious actions, physical or verbal aggression (or both), property destruction, and resistance to caregiving assistance.

Continue to: Mental and behavioral health problems...

Mental and behavioral health problems can have a profound impact on the quality of life of patients with IDD, their peers, and their family and other caregivers. If untreated, these problems can lead to premature institutionalization, loss of employment or desired program participation, fractured social relationships, and caregiver withdrawal and burnout.

Initial evaluation of suspected mental and behavioral health problems begins with careful assessment for medical conditions that might be causing pain and distress, stereotypies, and other problematic behaviors. Common sources of pain and discomfort include dental and other oral disease, dysphagia, gastroesophageal reflux disease, gastritis, constipation, allergic disease, headache, musculoskeletal pathology, lower urinary tract disease, and gynecologic disorders.¹¹ Identification and optimal treatment of medical conditions might not eliminate problematic behaviors but often decrease their frequency and intensity.

Psychoactive medications are prescribed for many patients with IDD. Many have behavioral adverse effects, such as akathisia, aggression, and disinhibition—leading to a prescribing cascade of psychoactive medication polypharmacy and escalating dosages.²¹ Antipsychotic medications are often initiated without a careful diagnosis, explicit outcome targets, or adequate clinical monitoring for effectiveness; in addition, they often lead to insulin resistance, metabolic syndrome, and massive weight gain.²¹ Even a family physician who is not the prescriber can perform an important advocacy role by critically reviewing psychoactive medications, documenting adverse effects, insisting on a clear therapeutic target, and calling for discontinuation of medications that appear to be ineffective.

Evaluation of mental and behavioral health problems requires a developmental perspective to interpret specific, observable behaviors with a proper clinical lens. For example, many patients with IDD engage in self-talk (soliloquizing) as a means of processing the world around them. This practice might escalate during a time of physical or psychological stress, and the unwary clinician might misinterpret this behavior as psychotic, leading to inappropriate prescribing of antipsychotic medication. Other psychotoform behaviors that, superficially, mimic but are typically not truly psychotic, include talk with or about imaginary friends and repetitive retelling of sometimes elaborate or grandiose tales or assertions. The failure of clinicians to recognize developmentally determined expressions of distress often leads to a misdiagnosis of schizophrenia or other psychotic illness and, consequently, inappropriate psychopharmacotherapy. 

Family physicians, familiar with the use of psychiatric scales for diagnosis and treatment monitoring, should use similar scales that have been developed specifically for patients with IDD (TABLE 3¹¹). In addition, a psychiatric diagnosis manual, the Diagnostic Manual—Intellectual Disability 2, specific to people with IDD (and analogous to the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition) provides modification of diagnostic criteria to account for patients who have difficulty articulating their internal emotional state and inner thoughts.²²

Continue to: Problematic behaviors

Problematic behaviors that are not features of a bona fide psychiatric disorder are often best understood through functional behavioral analysis, which examines antecedents and consequences of problematic behaviors and identifies their predictable outcomes, such as gaining attention, avoiding a task, or securing a desired item. Rather than being given a prescription for psychoactive medication, many adult patients with IDD and problematic behaviors might be best served by having you order consultation with a certified behavior analyst. The analyst will conduct an evaluation and, along with family or residential staff and the patient, craft a behavioral support plan to address core drivers of the undesired behavior. Behavioral support plans might be enriched by multidisciplinary input from a speech and language pathologist, habilitation professionals, occupational and physical therapists, a neuropsychologist, and others.²³

Antipsychotic medications are often initiated without a careful diagnosis. In addition, they often lead to insulin resistance, metabolic syndrome, and massive weight gain.

Resources to help you address the physical, mental, and behavioral health problems of these patients are available online through Vanderbilt Kennedy Center’s “Toolkit for primary care providers” (https://iddtoolkit.vkcsites.org).

CASE

During your examination, you review Ms. S’s vital signs, including body mass index (BMI). You calculate that she is morbidly obese—BMI, 37—in the setting of a known comorbidity, diabetes.

Ms. S tells you that she is interested in having a healthy lifestyle, but feels frustrated because she does not know how to make the necessary changes. You discuss with her how some medications, including risperidone, can promote weight gain, and that it is important for her mental health provider to carefully reassess whether she needs to continue the drug.

Weight management in a patient population that tends to be sedentary

Patients with IDD are more likely to live a sedentary lifestyle. Compared to adults who do not have IDD, adults with IDD—especially women and patients with Down syndrome—are reported to have a higher prevalence of obesity.²⁴

Continue to: As in the general population...

Similarly, undesired weight loss demands careful evaluation and management because such loss can reflect a medically significant condition, such as gastroesophageal reflux, constipation, dysphagia, neglect, and cancer.²⁷

Boosting the amount and effectiveness of physical activity

Young people with IDD participate in physical activity less often than their neurotypical peers; as a result, they tend to be less fit and have a higher prevalence of obesity.²⁸ Based on a meta-analysis, interventions that focus on sport and movement skills training, such as soccer, basketball, and ball-throwing programs, might be more effective than general physical activity programs.²⁸ In addition to year-round sports training and athletic competitions, Special Olympics conducts vital health screenings of athletes and supports community-based initiatives that address bias against patients with IDD, promote inclusion, and foster social relationships (www.specialolympics.org/our-work/inclusive-health?locale=en).

Success in weight management involves multidisciplinary treatment, including nutritional support, physical activity, behavioral changes, and close follow-up.

Emphasize regular activity. In adulthood, fewer than 10% of patients with IDD exercise regularly.²¹ According to the second edition of Physical Activity Guidelines for Americans,²⁹ “all adults, with or without a disability, should get at least 150 minutes of aerobic physical activity a week. Activities can be broken down into smaller amounts, such as about 25 minutes a day every day.”³⁰ Supplementation with muscle-strengthening activities (eg, yoga, weight training, and resistance-band training) provides further health benefit, such as improvement in posture and prevention of future injury.³¹ An ideal exercise program proposed by Tyler and Baker is based on a daily, “3-2-1” schedule (ie, of every hour of activity, 30 minutes should be of aerobic exercise; 20 minutes, of strength building; and 10 minutes, of flexibility).¹¹ By participating in any type of physical activity, there is potential for considerable health benefit in reducing psychosocial stressors, improving mental health, counteracting metabolic syndromes, and, ultimately, reducing morbidity and mortality related to physical inactivity.

CASE

With permission from Ms. S, you send your progress notes by fax to her mental health provider at the community mental health center and request a call to discuss her case—in particular, to examine potential alternatives to risperidone. With Ms. S’s input, you also co-create an exercise prescription that includes a daily 20-minute walking program with her mother.

At the follow-up visit that is scheduled in 3 months, you anticipate adding a resistance component and balance activity to the exercise prescription to enrich Ms. S’s physical activity regimen.

CORRESPONDENCE
Carl V. Tyler Jr., MD, 14601 Detroit Avenue, Lakewood, OH, 44107; [email protected]

Some adults who have an intellectual or other developmental disability (IDD) require extensive subspecialty care; many, however, depend primarily on their family physician for the bulk of their health care. With that reliance in mind, this article provides (1) an overview of important services that family physicians can provide for their adult patients with IDD and (2) pragmatic clinical suggestions for tailoring that care. Note: We highlight only some high-impact areas of clinical focus; refer to the 2018 Canadian consensus guidelines for a comprehensive approach to optimizing primary care for this population.¹

CASE

Laura S, a 24-year-old woman with Down syndrome, is visiting your clinic with her mother to establish care. Ms. S has several medical comorbidities, including type 2 diabetes, hyperlipidemia, repaired congenital heart disease, schizoaffective disorder, and hypothyroidism. She is under the care of multiple specialists, including a cardiologist and an endocrinologist. Her medications include the atypical antipsychotic risperidone, which was prescribed for her through the services of a community mental health center.

Ms. S is due for multiple preventive health screenings. She indicates that she feels nervous today talking about these screenings with a new physician.

First step in care: Proficiency in the lexicon of IDD

Three core concepts of IDD are impairment, disability, and handicap. According to the World Health Organization²:

• impairment “is any loss or abnormality of psychological, physiological, or anatomical structure or function.”
• disability “is any restriction or lack (resulting from an impairment) of ability to perform an activity in the manner or within the range considered normal for a human being.”
• handicap therefore “represents socialization of an impairment or disability, and as such it reflects the consequences for the individual—cultural, social, economic, and environmental—that stem from the presence of impairment and disability.”

Essential transition: Pediatric to adult health care

Health care transition (HCT) is the planned process of transferring care from a pediatric to an adult-based health care setting,³ comprising 3 phases:

• preparation
• transfer from pediatric to adult care
• integration into adult-based care.

Two critical components of a smooth HCT include initiating the transition early in adolescence and providing transition-support resources, which are often lacking, even in large, integrated health systems.⁴ Got Transition, created by the National Alliance to Advance Adolescent Health, outlines core elements of an organized HCT process (www.gottransition.org) specific to young adults with IDD, including young adults with autism spectrum disorder.^5,6 

Even young people who are served by a family physician and who intend to remain in that family practice as they age into adulthood require HCT services that include⁶:

• assessment of readiness to transition to adult care
• update of the medical history
• assessment and promotion of self-care skills
• consent discussions and optimized participation in decision-making
• transition of specialty care from pediatric to adult specialists.

Continue to: For an ideal HCT...

For an ideal health care transition, full engagement of the patient, the medical home, and the patient’s family (including the primary caregiver or guardian) is critical.

For an ideal HCT, full engagement of the patient, the medical home (physicians, nursing staff, and care coordinators), and the patient’s family (including the primary caregiver or guardian) is critical. In addition to preventive care visits and management of chronic disease, additional domains that require explicit attention in transitioning young people with IDD include health insurance, transportation, employment, and postsecondary education.

Young people who have special health care needs and receive high-quality HCT demonstrate improvements in adherence to care, disease-specific measures, quality of life, self-care skills, satisfaction with care, and health care utilization.⁷TABLE 1³ lists resources identified by Berens and colleagues that are helpful in facilitating the transition.

Teach and practice disability etiquette

Societal prejudice harms people with IDD—leading to self-deprecation, alienation from the larger community, and isolation from others with IDD.⁸ To promote acceptance and inclusivity in residential communities, the workplace, recreational venues, and clinical settings, disability etiquette should be utilized—a set of guidelines on how to interact with patients with IDD. These include speaking to the patient directly, using clear language in an adult voice, and avoiding stereotypes about people with disabilities.⁹ The entire health care team, including all front-facing staff (receptionists and care and financial coordinators) and clinical staff (physicians, nurses, medical assistants), need to be educated in, and practice, disability etiquette.

Preparing for in-person visits. Pre-­visit preparation, ideally by means of dialogue between health care staff and the patient or caregiver (or both), typically by telephone and in advance of the scheduled visit, is often critical for a successful first face-to-face encounter. (See “Pre-visit telephone questionnaire and script for a new adult patient with IDD,” page 287, which we developed for use in our office practice.) Outcomes of the pre-visit preparation should include identifying:

• words or actions that can trigger anxiety or panic
• de-escalation techniques, such as specific calming words and actions
• strategies for optimal communication, physical access, and physical examination.

Initial appointments should focus on building trust and rapport with the health care team and desensitizing the patient to the clinical environment.¹⁰ Examination techniques used with pediatric patients can be applied to this population: for example, demonstrating an examination maneuver first on the parent or caregiver; beginning the examination with the least invasive or anxiety-­provoking components; and stating what you plan to do next—before you do it.

Continue to: Systematic health checks provide great value

A health check is a systematic and comprehensive health assessment that is provided annually to adults with IDD, and includes:

• specific review of signs and symptoms of health conditions that often co-­occur in adults with IDD (TABLE 2Calibri¹¹)
• screening for changes in adaptive functioning and secondary disability
• lifestyle counseling
• medication review and counseling
• immunization update
• discussion of caregiver concerns.

Successful implementation of preventive health screening tests for a patient with IDD often requires ingenuity and creativity to allay fears and anxieties.

Regarding the last point: Many caregivers are the aging parents of the adult patient with IDD—people who have their own emerging health and support needs. You should initiate conversations about advanced planning for the needs of patients, which often involves engaging siblings and other family members to assume a greater role in caregiving.¹²

Benefits of the health check. A systematic review of 38 studies, comprising more than 5000 patients with IDD, found that health checks increased the detection of serious conditions, improved screening for sensory impairments, and increased the immunization rate.¹³ Although many patients with IDD generally understand the need for a periodic health examination, you can enhance their experience by better explaining the rationale for the health check; scheduling sufficient time for the appointment, based on the individual clinical situation; and discussing the value of laboratory testing and referrals to specialists.¹⁴

Tailoring preventive care

Many of the preventive services recommendations typically utilized by family physicians, such as guidelines from the US Preventive Services Task Force, have been developed for the general population at average risk of conditions of interest.¹⁵ Adults with IDD, depending on the cause of their developmental disability and their behavioral risk profile, might be at significantly higher (or lower) risk of cancer, heart disease, or other conditions than the general population. To address these differences, preventive care guidelines tailored to patients with certain developmental disabilities have been created, including guidelines specific to adults with Down syndrome, fragile X syndrome, Prader-Willi syndrome, Smith-Magenis syndrome, and 22q11.2 deletion (DiGeorge) syndrome.¹⁶

Clarifying the molecular genetic etiology of many developmental disabilities has led to more precise understandings about physical and behavioral health issues associated with specific developmental disabilities. For that reason, patients without a known cause for their IDD might benefit from referral to a geneticist—even in early or middle adulthood. Variables generally associated with a higher likelihood of an abnormal genetic test result include¹⁷:

• a family history of developmental disability
• a congenital malformation or dysmorphic features
• a dual diagnosis of developmental disability and co-occurring mental illness
• hypotonia
• severe or profound IDD.

Continue to: Successful implementation of preventive health screening tests...

Successful implementation of preventive health screening tests often requires ingenuity and the collective creativity of the patient, family members, staff, and family physician to allay fears and anxieties. Examples: Women who have been advised to undergo screening mammography might feel less anxious by undergoing tandem screening with their sister or mother, and colorectal cancer screening might be more easily accomplished using a fecal DNA test rather than by colonoscopy. Procedural desensitization strategies and preventive care instructional materials targeting people with IDD are posted on YouTube (for example, the “DD CARES Best Practices” series [see www.youtube.com/watch?v=EPJy4zvg4io]) and other websites.

Management of chronic disease

Evidence of health disparities in patients with IDD includes suboptimal management of chronic diseases, such as diabetes¹⁸ and hypertension,¹⁹ despite contact with a primary care physician. Nonadherence to a medication regimen might be more common in patients who live with their family or in a residential setting where there is a lower degree of supervision—that is, compared to a residence that maintains 24-hour staffing with daily nursing care and supervision. For a patient who is not so closely supervised, reviewing the medication refill history with the pharmacy, or using the so-called brown-bag technique of counting pill bottles brought to appointments, can ensure medication adherence.

CASE

As you interview Ms. S, you note that she is shy, avoids eye contact, and appears generally anxious. You calm her by noticing and complimenting her jewelry and fingernail polish. Ms. S smiles and talks about her favorite polish colors.

Evaluation of suspected mental and behavioral health issues begins with assessment for medical conditions that might be causing pain and distress or stereotypies.

Her mother reports that, when Ms. S is stressed, she talks to herself alone in her bedroom. However, you do not observe evidence of schizoaffective disorder, and begin to wonder whether she needs to be taking risperidone.

Essentials of mental health care

It is estimated that one-third of adults with IDD have significant mental and behavioral health care needs.²⁰ Patients with IDD suffer the same psychiatric disorders as the general population; some also engage in problematic behaviors, such as self-injurious actions, physical or verbal aggression (or both), property destruction, and resistance to caregiving assistance.

Continue to: Mental and behavioral health problems...

Mental and behavioral health problems can have a profound impact on the quality of life of patients with IDD, their peers, and their family and other caregivers. If untreated, these problems can lead to premature institutionalization, loss of employment or desired program participation, fractured social relationships, and caregiver withdrawal and burnout.

Initial evaluation of suspected mental and behavioral health problems begins with careful assessment for medical conditions that might be causing pain and distress, stereotypies, and other problematic behaviors. Common sources of pain and discomfort include dental and other oral disease, dysphagia, gastroesophageal reflux disease, gastritis, constipation, allergic disease, headache, musculoskeletal pathology, lower urinary tract disease, and gynecologic disorders.¹¹ Identification and optimal treatment of medical conditions might not eliminate problematic behaviors but often decrease their frequency and intensity.

Psychoactive medications are prescribed for many patients with IDD. Many have behavioral adverse effects, such as akathisia, aggression, and disinhibition—leading to a prescribing cascade of psychoactive medication polypharmacy and escalating dosages.²¹ Antipsychotic medications are often initiated without a careful diagnosis, explicit outcome targets, or adequate clinical monitoring for effectiveness; in addition, they often lead to insulin resistance, metabolic syndrome, and massive weight gain.²¹ Even a family physician who is not the prescriber can perform an important advocacy role by critically reviewing psychoactive medications, documenting adverse effects, insisting on a clear therapeutic target, and calling for discontinuation of medications that appear to be ineffective.

Evaluation of mental and behavioral health problems requires a developmental perspective to interpret specific, observable behaviors with a proper clinical lens. For example, many patients with IDD engage in self-talk (soliloquizing) as a means of processing the world around them. This practice might escalate during a time of physical or psychological stress, and the unwary clinician might misinterpret this behavior as psychotic, leading to inappropriate prescribing of antipsychotic medication. Other psychotoform behaviors that, superficially, mimic but are typically not truly psychotic, include talk with or about imaginary friends and repetitive retelling of sometimes elaborate or grandiose tales or assertions. The failure of clinicians to recognize developmentally determined expressions of distress often leads to a misdiagnosis of schizophrenia or other psychotic illness and, consequently, inappropriate psychopharmacotherapy. 

Family physicians, familiar with the use of psychiatric scales for diagnosis and treatment monitoring, should use similar scales that have been developed specifically for patients with IDD (TABLE 3¹¹). In addition, a psychiatric diagnosis manual, the Diagnostic Manual—Intellectual Disability 2, specific to people with IDD (and analogous to the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition) provides modification of diagnostic criteria to account for patients who have difficulty articulating their internal emotional state and inner thoughts.²²

Continue to: Problematic behaviors

Problematic behaviors that are not features of a bona fide psychiatric disorder are often best understood through functional behavioral analysis, which examines antecedents and consequences of problematic behaviors and identifies their predictable outcomes, such as gaining attention, avoiding a task, or securing a desired item. Rather than being given a prescription for psychoactive medication, many adult patients with IDD and problematic behaviors might be best served by having you order consultation with a certified behavior analyst. The analyst will conduct an evaluation and, along with family or residential staff and the patient, craft a behavioral support plan to address core drivers of the undesired behavior. Behavioral support plans might be enriched by multidisciplinary input from a speech and language pathologist, habilitation professionals, occupational and physical therapists, a neuropsychologist, and others.²³

Antipsychotic medications are often initiated without a careful diagnosis. In addition, they often lead to insulin resistance, metabolic syndrome, and massive weight gain.

Resources to help you address the physical, mental, and behavioral health problems of these patients are available online through Vanderbilt Kennedy Center’s “Toolkit for primary care providers” (https://iddtoolkit.vkcsites.org).

CASE

During your examination, you review Ms. S’s vital signs, including body mass index (BMI). You calculate that she is morbidly obese—BMI, 37—in the setting of a known comorbidity, diabetes.

Ms. S tells you that she is interested in having a healthy lifestyle, but feels frustrated because she does not know how to make the necessary changes. You discuss with her how some medications, including risperidone, can promote weight gain, and that it is important for her mental health provider to carefully reassess whether she needs to continue the drug.

Weight management in a patient population that tends to be sedentary

Patients with IDD are more likely to live a sedentary lifestyle. Compared to adults who do not have IDD, adults with IDD—especially women and patients with Down syndrome—are reported to have a higher prevalence of obesity.²⁴

Continue to: As in the general population...

Similarly, undesired weight loss demands careful evaluation and management because such loss can reflect a medically significant condition, such as gastroesophageal reflux, constipation, dysphagia, neglect, and cancer.²⁷

Boosting the amount and effectiveness of physical activity

Young people with IDD participate in physical activity less often than their neurotypical peers; as a result, they tend to be less fit and have a higher prevalence of obesity.²⁸ Based on a meta-analysis, interventions that focus on sport and movement skills training, such as soccer, basketball, and ball-throwing programs, might be more effective than general physical activity programs.²⁸ In addition to year-round sports training and athletic competitions, Special Olympics conducts vital health screenings of athletes and supports community-based initiatives that address bias against patients with IDD, promote inclusion, and foster social relationships (www.specialolympics.org/our-work/inclusive-health?locale=en).

Success in weight management involves multidisciplinary treatment, including nutritional support, physical activity, behavioral changes, and close follow-up.

Emphasize regular activity. In adulthood, fewer than 10% of patients with IDD exercise regularly.²¹ According to the second edition of Physical Activity Guidelines for Americans,²⁹ “all adults, with or without a disability, should get at least 150 minutes of aerobic physical activity a week. Activities can be broken down into smaller amounts, such as about 25 minutes a day every day.”³⁰ Supplementation with muscle-strengthening activities (eg, yoga, weight training, and resistance-band training) provides further health benefit, such as improvement in posture and prevention of future injury.³¹ An ideal exercise program proposed by Tyler and Baker is based on a daily, “3-2-1” schedule (ie, of every hour of activity, 30 minutes should be of aerobic exercise; 20 minutes, of strength building; and 10 minutes, of flexibility).¹¹ By participating in any type of physical activity, there is potential for considerable health benefit in reducing psychosocial stressors, improving mental health, counteracting metabolic syndromes, and, ultimately, reducing morbidity and mortality related to physical inactivity.

CASE

With permission from Ms. S, you send your progress notes by fax to her mental health provider at the community mental health center and request a call to discuss her case—in particular, to examine potential alternatives to risperidone. With Ms. S’s input, you also co-create an exercise prescription that includes a daily 20-minute walking program with her mother.

At the follow-up visit that is scheduled in 3 months, you anticipate adding a resistance component and balance activity to the exercise prescription to enrich Ms. S’s physical activity regimen.

CORRESPONDENCE
Carl V. Tyler Jr., MD, 14601 Detroit Avenue, Lakewood, OH, 44107; [email protected]

Some adults who have an intellectual or other developmental disability (IDD) require extensive subspecialty care; many, however, depend primarily on their family physician for the bulk of their health care. With that reliance in mind, this article provides (1) an overview of important services that family physicians can provide for their adult patients with IDD and (2) pragmatic clinical suggestions for tailoring that care. Note: We highlight only some high-impact areas of clinical focus; refer to the 2018 Canadian consensus guidelines for a comprehensive approach to optimizing primary care for this population.¹

CASE

Laura S, a 24-year-old woman with Down syndrome, is visiting your clinic with her mother to establish care. Ms. S has several medical comorbidities, including type 2 diabetes, hyperlipidemia, repaired congenital heart disease, schizoaffective disorder, and hypothyroidism. She is under the care of multiple specialists, including a cardiologist and an endocrinologist. Her medications include the atypical antipsychotic risperidone, which was prescribed for her through the services of a community mental health center.

Ms. S is due for multiple preventive health screenings. She indicates that she feels nervous today talking about these screenings with a new physician.

First step in care: Proficiency in the lexicon of IDD

Three core concepts of IDD are impairment, disability, and handicap. According to the World Health Organization²:

• impairment “is any loss or abnormality of psychological, physiological, or anatomical structure or function.”
• disability “is any restriction or lack (resulting from an impairment) of ability to perform an activity in the manner or within the range considered normal for a human being.”
• handicap therefore “represents socialization of an impairment or disability, and as such it reflects the consequences for the individual—cultural, social, economic, and environmental—that stem from the presence of impairment and disability.”

Essential transition: Pediatric to adult health care

Health care transition (HCT) is the planned process of transferring care from a pediatric to an adult-based health care setting,³ comprising 3 phases:

• preparation
• transfer from pediatric to adult care
• integration into adult-based care.

Two critical components of a smooth HCT include initiating the transition early in adolescence and providing transition-support resources, which are often lacking, even in large, integrated health systems.⁴ Got Transition, created by the National Alliance to Advance Adolescent Health, outlines core elements of an organized HCT process (www.gottransition.org) specific to young adults with IDD, including young adults with autism spectrum disorder.^5,6 

Even young people who are served by a family physician and who intend to remain in that family practice as they age into adulthood require HCT services that include⁶:

• assessment of readiness to transition to adult care
• update of the medical history
• assessment and promotion of self-care skills
• consent discussions and optimized participation in decision-making
• transition of specialty care from pediatric to adult specialists.

Continue to: For an ideal HCT...

For an ideal health care transition, full engagement of the patient, the medical home, and the patient’s family (including the primary caregiver or guardian) is critical.

For an ideal HCT, full engagement of the patient, the medical home (physicians, nursing staff, and care coordinators), and the patient’s family (including the primary caregiver or guardian) is critical. In addition to preventive care visits and management of chronic disease, additional domains that require explicit attention in transitioning young people with IDD include health insurance, transportation, employment, and postsecondary education.

Young people who have special health care needs and receive high-quality HCT demonstrate improvements in adherence to care, disease-specific measures, quality of life, self-care skills, satisfaction with care, and health care utilization.⁷TABLE 1³ lists resources identified by Berens and colleagues that are helpful in facilitating the transition.

Teach and practice disability etiquette

Societal prejudice harms people with IDD—leading to self-deprecation, alienation from the larger community, and isolation from others with IDD.⁸ To promote acceptance and inclusivity in residential communities, the workplace, recreational venues, and clinical settings, disability etiquette should be utilized—a set of guidelines on how to interact with patients with IDD. These include speaking to the patient directly, using clear language in an adult voice, and avoiding stereotypes about people with disabilities.⁹ The entire health care team, including all front-facing staff (receptionists and care and financial coordinators) and clinical staff (physicians, nurses, medical assistants), need to be educated in, and practice, disability etiquette.

Preparing for in-person visits. Pre-­visit preparation, ideally by means of dialogue between health care staff and the patient or caregiver (or both), typically by telephone and in advance of the scheduled visit, is often critical for a successful first face-to-face encounter. (See “Pre-visit telephone questionnaire and script for a new adult patient with IDD,” page 287, which we developed for use in our office practice.) Outcomes of the pre-visit preparation should include identifying:

• words or actions that can trigger anxiety or panic
• de-escalation techniques, such as specific calming words and actions
• strategies for optimal communication, physical access, and physical examination.

Initial appointments should focus on building trust and rapport with the health care team and desensitizing the patient to the clinical environment.¹⁰ Examination techniques used with pediatric patients can be applied to this population: for example, demonstrating an examination maneuver first on the parent or caregiver; beginning the examination with the least invasive or anxiety-­provoking components; and stating what you plan to do next—before you do it.

Continue to: Systematic health checks provide great value

A health check is a systematic and comprehensive health assessment that is provided annually to adults with IDD, and includes:

• specific review of signs and symptoms of health conditions that often co-­occur in adults with IDD (TABLE 2Calibri¹¹)
• screening for changes in adaptive functioning and secondary disability
• lifestyle counseling
• medication review and counseling
• immunization update
• discussion of caregiver concerns.

Successful implementation of preventive health screening tests for a patient with IDD often requires ingenuity and creativity to allay fears and anxieties.

Regarding the last point: Many caregivers are the aging parents of the adult patient with IDD—people who have their own emerging health and support needs. You should initiate conversations about advanced planning for the needs of patients, which often involves engaging siblings and other family members to assume a greater role in caregiving.¹²

Benefits of the health check. A systematic review of 38 studies, comprising more than 5000 patients with IDD, found that health checks increased the detection of serious conditions, improved screening for sensory impairments, and increased the immunization rate.¹³ Although many patients with IDD generally understand the need for a periodic health examination, you can enhance their experience by better explaining the rationale for the health check; scheduling sufficient time for the appointment, based on the individual clinical situation; and discussing the value of laboratory testing and referrals to specialists.¹⁴

Tailoring preventive care

Many of the preventive services recommendations typically utilized by family physicians, such as guidelines from the US Preventive Services Task Force, have been developed for the general population at average risk of conditions of interest.¹⁵ Adults with IDD, depending on the cause of their developmental disability and their behavioral risk profile, might be at significantly higher (or lower) risk of cancer, heart disease, or other conditions than the general population. To address these differences, preventive care guidelines tailored to patients with certain developmental disabilities have been created, including guidelines specific to adults with Down syndrome, fragile X syndrome, Prader-Willi syndrome, Smith-Magenis syndrome, and 22q11.2 deletion (DiGeorge) syndrome.¹⁶

Clarifying the molecular genetic etiology of many developmental disabilities has led to more precise understandings about physical and behavioral health issues associated with specific developmental disabilities. For that reason, patients without a known cause for their IDD might benefit from referral to a geneticist—even in early or middle adulthood. Variables generally associated with a higher likelihood of an abnormal genetic test result include¹⁷:

• a family history of developmental disability
• a congenital malformation or dysmorphic features
• a dual diagnosis of developmental disability and co-occurring mental illness
• hypotonia
• severe or profound IDD.

Continue to: Successful implementation of preventive health screening tests...

Successful implementation of preventive health screening tests often requires ingenuity and the collective creativity of the patient, family members, staff, and family physician to allay fears and anxieties. Examples: Women who have been advised to undergo screening mammography might feel less anxious by undergoing tandem screening with their sister or mother, and colorectal cancer screening might be more easily accomplished using a fecal DNA test rather than by colonoscopy. Procedural desensitization strategies and preventive care instructional materials targeting people with IDD are posted on YouTube (for example, the “DD CARES Best Practices” series [see www.youtube.com/watch?v=EPJy4zvg4io]) and other websites.

Management of chronic disease

Evidence of health disparities in patients with IDD includes suboptimal management of chronic diseases, such as diabetes¹⁸ and hypertension,¹⁹ despite contact with a primary care physician. Nonadherence to a medication regimen might be more common in patients who live with their family or in a residential setting where there is a lower degree of supervision—that is, compared to a residence that maintains 24-hour staffing with daily nursing care and supervision. For a patient who is not so closely supervised, reviewing the medication refill history with the pharmacy, or using the so-called brown-bag technique of counting pill bottles brought to appointments, can ensure medication adherence.

CASE

As you interview Ms. S, you note that she is shy, avoids eye contact, and appears generally anxious. You calm her by noticing and complimenting her jewelry and fingernail polish. Ms. S smiles and talks about her favorite polish colors.

Evaluation of suspected mental and behavioral health issues begins with assessment for medical conditions that might be causing pain and distress or stereotypies.

Her mother reports that, when Ms. S is stressed, she talks to herself alone in her bedroom. However, you do not observe evidence of schizoaffective disorder, and begin to wonder whether she needs to be taking risperidone.

Essentials of mental health care

It is estimated that one-third of adults with IDD have significant mental and behavioral health care needs.²⁰ Patients with IDD suffer the same psychiatric disorders as the general population; some also engage in problematic behaviors, such as self-injurious actions, physical or verbal aggression (or both), property destruction, and resistance to caregiving assistance.

Continue to: Mental and behavioral health problems...

Mental and behavioral health problems can have a profound impact on the quality of life of patients with IDD, their peers, and their family and other caregivers. If untreated, these problems can lead to premature institutionalization, loss of employment or desired program participation, fractured social relationships, and caregiver withdrawal and burnout.

Initial evaluation of suspected mental and behavioral health problems begins with careful assessment for medical conditions that might be causing pain and distress, stereotypies, and other problematic behaviors. Common sources of pain and discomfort include dental and other oral disease, dysphagia, gastroesophageal reflux disease, gastritis, constipation, allergic disease, headache, musculoskeletal pathology, lower urinary tract disease, and gynecologic disorders.¹¹ Identification and optimal treatment of medical conditions might not eliminate problematic behaviors but often decrease their frequency and intensity.

Psychoactive medications are prescribed for many patients with IDD. Many have behavioral adverse effects, such as akathisia, aggression, and disinhibition—leading to a prescribing cascade of psychoactive medication polypharmacy and escalating dosages.²¹ Antipsychotic medications are often initiated without a careful diagnosis, explicit outcome targets, or adequate clinical monitoring for effectiveness; in addition, they often lead to insulin resistance, metabolic syndrome, and massive weight gain.²¹ Even a family physician who is not the prescriber can perform an important advocacy role by critically reviewing psychoactive medications, documenting adverse effects, insisting on a clear therapeutic target, and calling for discontinuation of medications that appear to be ineffective.

Evaluation of mental and behavioral health problems requires a developmental perspective to interpret specific, observable behaviors with a proper clinical lens. For example, many patients with IDD engage in self-talk (soliloquizing) as a means of processing the world around them. This practice might escalate during a time of physical or psychological stress, and the unwary clinician might misinterpret this behavior as psychotic, leading to inappropriate prescribing of antipsychotic medication. Other psychotoform behaviors that, superficially, mimic but are typically not truly psychotic, include talk with or about imaginary friends and repetitive retelling of sometimes elaborate or grandiose tales or assertions. The failure of clinicians to recognize developmentally determined expressions of distress often leads to a misdiagnosis of schizophrenia or other psychotic illness and, consequently, inappropriate psychopharmacotherapy. 

Family physicians, familiar with the use of psychiatric scales for diagnosis and treatment monitoring, should use similar scales that have been developed specifically for patients with IDD (TABLE 3¹¹). In addition, a psychiatric diagnosis manual, the Diagnostic Manual—Intellectual Disability 2, specific to people with IDD (and analogous to the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition) provides modification of diagnostic criteria to account for patients who have difficulty articulating their internal emotional state and inner thoughts.²²

Continue to: Problematic behaviors

Problematic behaviors that are not features of a bona fide psychiatric disorder are often best understood through functional behavioral analysis, which examines antecedents and consequences of problematic behaviors and identifies their predictable outcomes, such as gaining attention, avoiding a task, or securing a desired item. Rather than being given a prescription for psychoactive medication, many adult patients with IDD and problematic behaviors might be best served by having you order consultation with a certified behavior analyst. The analyst will conduct an evaluation and, along with family or residential staff and the patient, craft a behavioral support plan to address core drivers of the undesired behavior. Behavioral support plans might be enriched by multidisciplinary input from a speech and language pathologist, habilitation professionals, occupational and physical therapists, a neuropsychologist, and others.²³

Antipsychotic medications are often initiated without a careful diagnosis. In addition, they often lead to insulin resistance, metabolic syndrome, and massive weight gain.

Resources to help you address the physical, mental, and behavioral health problems of these patients are available online through Vanderbilt Kennedy Center’s “Toolkit for primary care providers” (https://iddtoolkit.vkcsites.org).

CASE

During your examination, you review Ms. S’s vital signs, including body mass index (BMI). You calculate that she is morbidly obese—BMI, 37—in the setting of a known comorbidity, diabetes.

Ms. S tells you that she is interested in having a healthy lifestyle, but feels frustrated because she does not know how to make the necessary changes. You discuss with her how some medications, including risperidone, can promote weight gain, and that it is important for her mental health provider to carefully reassess whether she needs to continue the drug.

Weight management in a patient population that tends to be sedentary

Patients with IDD are more likely to live a sedentary lifestyle. Compared to adults who do not have IDD, adults with IDD—especially women and patients with Down syndrome—are reported to have a higher prevalence of obesity.²⁴

Continue to: As in the general population...

Similarly, undesired weight loss demands careful evaluation and management because such loss can reflect a medically significant condition, such as gastroesophageal reflux, constipation, dysphagia, neglect, and cancer.²⁷

Boosting the amount and effectiveness of physical activity

Young people with IDD participate in physical activity less often than their neurotypical peers; as a result, they tend to be less fit and have a higher prevalence of obesity.²⁸ Based on a meta-analysis, interventions that focus on sport and movement skills training, such as soccer, basketball, and ball-throwing programs, might be more effective than general physical activity programs.²⁸ In addition to year-round sports training and athletic competitions, Special Olympics conducts vital health screenings of athletes and supports community-based initiatives that address bias against patients with IDD, promote inclusion, and foster social relationships (www.specialolympics.org/our-work/inclusive-health?locale=en).

Success in weight management involves multidisciplinary treatment, including nutritional support, physical activity, behavioral changes, and close follow-up.

Emphasize regular activity. In adulthood, fewer than 10% of patients with IDD exercise regularly.²¹ According to the second edition of Physical Activity Guidelines for Americans,²⁹ “all adults, with or without a disability, should get at least 150 minutes of aerobic physical activity a week. Activities can be broken down into smaller amounts, such as about 25 minutes a day every day.”³⁰ Supplementation with muscle-strengthening activities (eg, yoga, weight training, and resistance-band training) provides further health benefit, such as improvement in posture and prevention of future injury.³¹ An ideal exercise program proposed by Tyler and Baker is based on a daily, “3-2-1” schedule (ie, of every hour of activity, 30 minutes should be of aerobic exercise; 20 minutes, of strength building; and 10 minutes, of flexibility).¹¹ By participating in any type of physical activity, there is potential for considerable health benefit in reducing psychosocial stressors, improving mental health, counteracting metabolic syndromes, and, ultimately, reducing morbidity and mortality related to physical inactivity.

CASE

With permission from Ms. S, you send your progress notes by fax to her mental health provider at the community mental health center and request a call to discuss her case—in particular, to examine potential alternatives to risperidone. With Ms. S’s input, you also co-create an exercise prescription that includes a daily 20-minute walking program with her mother.

At the follow-up visit that is scheduled in 3 months, you anticipate adding a resistance component and balance activity to the exercise prescription to enrich Ms. S’s physical activity regimen.

CORRESPONDENCE
Carl V. Tyler Jr., MD, 14601 Detroit Avenue, Lakewood, OH, 44107; [email protected]

Headache was the most common adverse event (AE) people experienced in 72 weeks of taking the once-daily investigational two-drug HIV treatment islatravir (ISL; Merck) plus doravirine (DOR; Merck), and those AEs were short-lived and mild, according to a safety analysis presented at the International AIDS Society (IAS) Conference 2021.

That finding, combined with other data showing few changes in metabolic markers, is potentially good news for people living with HIV, inasmuch as two-drug regimens generally have fewer side effects than traditional three- or four-drug regimens, said Jean-Michel Molina, MD, PhD, of Sant-Louis and Lariboisière Hospitals, Paris, who previously presented efficacy data on the combination at the HIV Glasgow 2020 Virtual Conference.

“At this point, it’s encouraging,” Dr. Molina told this news organization. “Safety is good, efficacy seems good. But the data are limited, and it’s too early to tell.”

If it makes it to the clinic, IS/DOR would be the fourth two-drug regimen approved for HIV treatment, following the U.S. Food and Drug Administration approval of dolutegravir/lamivudine (Dovato), dolutegravir/rilpivirine (Juluca), and the monthly injectable cabotegravir long-acting/rilpivirine long-acting (Cabenuva).

DOR, a non-nucleoside reverse transcriptase inhibitor (NNRTI), is currently approved and is part of the three-drug single-pill regimen Delstrigo (doravirine/lamivudine/tenofovir disoproxil fumarate, DOR/3TC/TDF, Merck). ISL is still under development for treatment and prevention. Dr. Molina had previously presented data showing that 81.1% of people living with HIV maintained undetectable viral loads (defined as <50 copies/mL) compared to 80.6% of people who continued treatment with DOR/3TC/TDF. Data on ISL/DOR versus DOR/3TC/TDF for people new to HIV treatment were published May 14 in The Lancet HIV.

The ISL/DOR trial was designed to assess the safety of three doses of ISL with 100 mg of DOR – 0.25 mg, 0.75 mg, and 2.25 mg – as a daily treatment. The investigators randomly assigned 29, 30, and 31 participants, respectively, to each of the dual-therapy arms and 31 people to the DOR/3TC/TDF arm after a 24-week lead-in course of DOR/3TC/TDF. At week 60, everyone in the two-drug arms received 0.75 mg of ISL with DOR.

At HIV Glasgow, Dr. Molina didn’t present details about the safety profile of the two-drug combination. Douglas Cunningham, DO, a primary care provider at Pueblo Family Physicians, Phoenix, presented such data at IAS 2021. What he showed was that over the first 96 weeks of the trial, there were a total of 118 AEs among the 90 participants in the ISL plus DOR arms and 42 among the 31 participants in the three-drug regimen arm, but there were only seven drug-related AEs for people in the ISL plus DOR arm, and all of those occurred during the first 48 weeks. There were none from weeks 48 to 96.

In total, there were no drug-related serious AEs for ISL/DOR; there was one in the DOR/3TC/TDF arm. The most common AE was headache, which occurred in a total of 10 participants in the ISL/DOR arms. There were nine cases of vitamin D deficiency, eight cases of nausea, seven cases of arthralgia, diarrhea, sinus pain, and vomiting, and six cases each of anxiety and rash. Four people experienced pain in their extremities.

In the three-drug combination arm, side effects were far fewer – just 18 occurred in at least 10% of participants. The most common AE among people on the three-drug combination was diarrhea, which occurred in six participants. Nausea occurred in three; vomiting and headache in two; and there was one instance each of vitamin D deficiency, arthralgia, sinus pain, rash, and pain in extremities.

“The majority of these events were mild, transient, and not related to study drug,” Dr. Cunningham said.

Three ISL/DOR participants experienced an increase in fasting triglyceride level of >500-1,000 mg/dL, and six patients experienced grade 4 changes in creatine kinase level of ≥20 IU/L. Dr. Cunningham said that all but one of the cases of an increase in creatinine level were the result of physical exertion by the participants, and all of those changes were found to have resolved at future visits. The bottom line is that the two-drug combination was safe.

“In the islatravir and doravirine arm, there were no serious drug related serious AEs and no discontinuations due to drug-related AEs from week 48 to week 96,” said Dr. Cunningham. “Islatravir in combination with doravirine was generally well tolerated through week 96 with few drug-related AEs.”

Still, the value of this combination is unclear for Laura Waters, MD, consulting physician in HIV and sexual health at Central and Northwest London NHS Trust. She pointed out that the data are preliminary and that islatravir hasn’t yet been shown to lessen the chances of development of treatment-resistant mutations – a big deal for two-drug regimens, inasmuch as early attempts at using only two drugs resulted in incomplete suppression of the virus and resistance. Merck is planning a study of the combination in heavily pretreated individuals.

Merck presented data at IAS on another NNRTI, the investigational MK-8507, in combination with islatravir. MK-8507 has the potential to be used weekly instead of daily. Dr. Waters said she suspects that this trial is just a proof of concept of islatravir in combination with an NNRTI. Merck has signed an agreement with Gilead Sciences to co-develop islatravir with long-acting lenacapravir. Additionally, the two-drug combination of dolutegravir and lamivudine has been very successful.

“I’d be surprised if they developed islatravir/doravirine as a usable combo,” she said. “It’s just too soon to say. My personal view is that people are a bit too overoptimistic about it.”

The study was funded by Merck. Dr. Molina has received grants from Gilead Sciences, Merck, ViiV Healthcare, and Sanofi. Dr. Waters has received speaker or advisory fees during the past 2 years from Gilead Sciences, ViiV Healthcare, Merck, Janssen, Theratech, Sipla, and Mylan.

A version of this article first appeared on Medscape.com.

Headache was the most common adverse event (AE) people experienced in 72 weeks of taking the once-daily investigational two-drug HIV treatment islatravir (ISL; Merck) plus doravirine (DOR; Merck), and those AEs were short-lived and mild, according to a safety analysis presented at the International AIDS Society (IAS) Conference 2021.

That finding, combined with other data showing few changes in metabolic markers, is potentially good news for people living with HIV, inasmuch as two-drug regimens generally have fewer side effects than traditional three- or four-drug regimens, said Jean-Michel Molina, MD, PhD, of Sant-Louis and Lariboisière Hospitals, Paris, who previously presented efficacy data on the combination at the HIV Glasgow 2020 Virtual Conference.

“At this point, it’s encouraging,” Dr. Molina told this news organization. “Safety is good, efficacy seems good. But the data are limited, and it’s too early to tell.”

If it makes it to the clinic, IS/DOR would be the fourth two-drug regimen approved for HIV treatment, following the U.S. Food and Drug Administration approval of dolutegravir/lamivudine (Dovato), dolutegravir/rilpivirine (Juluca), and the monthly injectable cabotegravir long-acting/rilpivirine long-acting (Cabenuva).

DOR, a non-nucleoside reverse transcriptase inhibitor (NNRTI), is currently approved and is part of the three-drug single-pill regimen Delstrigo (doravirine/lamivudine/tenofovir disoproxil fumarate, DOR/3TC/TDF, Merck). ISL is still under development for treatment and prevention. Dr. Molina had previously presented data showing that 81.1% of people living with HIV maintained undetectable viral loads (defined as <50 copies/mL) compared to 80.6% of people who continued treatment with DOR/3TC/TDF. Data on ISL/DOR versus DOR/3TC/TDF for people new to HIV treatment were published May 14 in The Lancet HIV.

The ISL/DOR trial was designed to assess the safety of three doses of ISL with 100 mg of DOR – 0.25 mg, 0.75 mg, and 2.25 mg – as a daily treatment. The investigators randomly assigned 29, 30, and 31 participants, respectively, to each of the dual-therapy arms and 31 people to the DOR/3TC/TDF arm after a 24-week lead-in course of DOR/3TC/TDF. At week 60, everyone in the two-drug arms received 0.75 mg of ISL with DOR.

At HIV Glasgow, Dr. Molina didn’t present details about the safety profile of the two-drug combination. Douglas Cunningham, DO, a primary care provider at Pueblo Family Physicians, Phoenix, presented such data at IAS 2021. What he showed was that over the first 96 weeks of the trial, there were a total of 118 AEs among the 90 participants in the ISL plus DOR arms and 42 among the 31 participants in the three-drug regimen arm, but there were only seven drug-related AEs for people in the ISL plus DOR arm, and all of those occurred during the first 48 weeks. There were none from weeks 48 to 96.

In total, there were no drug-related serious AEs for ISL/DOR; there was one in the DOR/3TC/TDF arm. The most common AE was headache, which occurred in a total of 10 participants in the ISL/DOR arms. There were nine cases of vitamin D deficiency, eight cases of nausea, seven cases of arthralgia, diarrhea, sinus pain, and vomiting, and six cases each of anxiety and rash. Four people experienced pain in their extremities.

In the three-drug combination arm, side effects were far fewer – just 18 occurred in at least 10% of participants. The most common AE among people on the three-drug combination was diarrhea, which occurred in six participants. Nausea occurred in three; vomiting and headache in two; and there was one instance each of vitamin D deficiency, arthralgia, sinus pain, rash, and pain in extremities.

“The majority of these events were mild, transient, and not related to study drug,” Dr. Cunningham said.

Three ISL/DOR participants experienced an increase in fasting triglyceride level of >500-1,000 mg/dL, and six patients experienced grade 4 changes in creatine kinase level of ≥20 IU/L. Dr. Cunningham said that all but one of the cases of an increase in creatinine level were the result of physical exertion by the participants, and all of those changes were found to have resolved at future visits. The bottom line is that the two-drug combination was safe.

“In the islatravir and doravirine arm, there were no serious drug related serious AEs and no discontinuations due to drug-related AEs from week 48 to week 96,” said Dr. Cunningham. “Islatravir in combination with doravirine was generally well tolerated through week 96 with few drug-related AEs.”

Still, the value of this combination is unclear for Laura Waters, MD, consulting physician in HIV and sexual health at Central and Northwest London NHS Trust. She pointed out that the data are preliminary and that islatravir hasn’t yet been shown to lessen the chances of development of treatment-resistant mutations – a big deal for two-drug regimens, inasmuch as early attempts at using only two drugs resulted in incomplete suppression of the virus and resistance. Merck is planning a study of the combination in heavily pretreated individuals.

Merck presented data at IAS on another NNRTI, the investigational MK-8507, in combination with islatravir. MK-8507 has the potential to be used weekly instead of daily. Dr. Waters said she suspects that this trial is just a proof of concept of islatravir in combination with an NNRTI. Merck has signed an agreement with Gilead Sciences to co-develop islatravir with long-acting lenacapravir. Additionally, the two-drug combination of dolutegravir and lamivudine has been very successful.

“I’d be surprised if they developed islatravir/doravirine as a usable combo,” she said. “It’s just too soon to say. My personal view is that people are a bit too overoptimistic about it.”

The study was funded by Merck. Dr. Molina has received grants from Gilead Sciences, Merck, ViiV Healthcare, and Sanofi. Dr. Waters has received speaker or advisory fees during the past 2 years from Gilead Sciences, ViiV Healthcare, Merck, Janssen, Theratech, Sipla, and Mylan.

A version of this article first appeared on Medscape.com.

Headache was the most common adverse event (AE) people experienced in 72 weeks of taking the once-daily investigational two-drug HIV treatment islatravir (ISL; Merck) plus doravirine (DOR; Merck), and those AEs were short-lived and mild, according to a safety analysis presented at the International AIDS Society (IAS) Conference 2021.

That finding, combined with other data showing few changes in metabolic markers, is potentially good news for people living with HIV, inasmuch as two-drug regimens generally have fewer side effects than traditional three- or four-drug regimens, said Jean-Michel Molina, MD, PhD, of Sant-Louis and Lariboisière Hospitals, Paris, who previously presented efficacy data on the combination at the HIV Glasgow 2020 Virtual Conference.

“At this point, it’s encouraging,” Dr. Molina told this news organization. “Safety is good, efficacy seems good. But the data are limited, and it’s too early to tell.”

If it makes it to the clinic, IS/DOR would be the fourth two-drug regimen approved for HIV treatment, following the U.S. Food and Drug Administration approval of dolutegravir/lamivudine (Dovato), dolutegravir/rilpivirine (Juluca), and the monthly injectable cabotegravir long-acting/rilpivirine long-acting (Cabenuva).

DOR, a non-nucleoside reverse transcriptase inhibitor (NNRTI), is currently approved and is part of the three-drug single-pill regimen Delstrigo (doravirine/lamivudine/tenofovir disoproxil fumarate, DOR/3TC/TDF, Merck). ISL is still under development for treatment and prevention. Dr. Molina had previously presented data showing that 81.1% of people living with HIV maintained undetectable viral loads (defined as <50 copies/mL) compared to 80.6% of people who continued treatment with DOR/3TC/TDF. Data on ISL/DOR versus DOR/3TC/TDF for people new to HIV treatment were published May 14 in The Lancet HIV.

The ISL/DOR trial was designed to assess the safety of three doses of ISL with 100 mg of DOR – 0.25 mg, 0.75 mg, and 2.25 mg – as a daily treatment. The investigators randomly assigned 29, 30, and 31 participants, respectively, to each of the dual-therapy arms and 31 people to the DOR/3TC/TDF arm after a 24-week lead-in course of DOR/3TC/TDF. At week 60, everyone in the two-drug arms received 0.75 mg of ISL with DOR.

At HIV Glasgow, Dr. Molina didn’t present details about the safety profile of the two-drug combination. Douglas Cunningham, DO, a primary care provider at Pueblo Family Physicians, Phoenix, presented such data at IAS 2021. What he showed was that over the first 96 weeks of the trial, there were a total of 118 AEs among the 90 participants in the ISL plus DOR arms and 42 among the 31 participants in the three-drug regimen arm, but there were only seven drug-related AEs for people in the ISL plus DOR arm, and all of those occurred during the first 48 weeks. There were none from weeks 48 to 96.

In total, there were no drug-related serious AEs for ISL/DOR; there was one in the DOR/3TC/TDF arm. The most common AE was headache, which occurred in a total of 10 participants in the ISL/DOR arms. There were nine cases of vitamin D deficiency, eight cases of nausea, seven cases of arthralgia, diarrhea, sinus pain, and vomiting, and six cases each of anxiety and rash. Four people experienced pain in their extremities.

In the three-drug combination arm, side effects were far fewer – just 18 occurred in at least 10% of participants. The most common AE among people on the three-drug combination was diarrhea, which occurred in six participants. Nausea occurred in three; vomiting and headache in two; and there was one instance each of vitamin D deficiency, arthralgia, sinus pain, rash, and pain in extremities.

“The majority of these events were mild, transient, and not related to study drug,” Dr. Cunningham said.

Three ISL/DOR participants experienced an increase in fasting triglyceride level of >500-1,000 mg/dL, and six patients experienced grade 4 changes in creatine kinase level of ≥20 IU/L. Dr. Cunningham said that all but one of the cases of an increase in creatinine level were the result of physical exertion by the participants, and all of those changes were found to have resolved at future visits. The bottom line is that the two-drug combination was safe.

“In the islatravir and doravirine arm, there were no serious drug related serious AEs and no discontinuations due to drug-related AEs from week 48 to week 96,” said Dr. Cunningham. “Islatravir in combination with doravirine was generally well tolerated through week 96 with few drug-related AEs.”

Still, the value of this combination is unclear for Laura Waters, MD, consulting physician in HIV and sexual health at Central and Northwest London NHS Trust. She pointed out that the data are preliminary and that islatravir hasn’t yet been shown to lessen the chances of development of treatment-resistant mutations – a big deal for two-drug regimens, inasmuch as early attempts at using only two drugs resulted in incomplete suppression of the virus and resistance. Merck is planning a study of the combination in heavily pretreated individuals.

Merck presented data at IAS on another NNRTI, the investigational MK-8507, in combination with islatravir. MK-8507 has the potential to be used weekly instead of daily. Dr. Waters said she suspects that this trial is just a proof of concept of islatravir in combination with an NNRTI. Merck has signed an agreement with Gilead Sciences to co-develop islatravir with long-acting lenacapravir. Additionally, the two-drug combination of dolutegravir and lamivudine has been very successful.

“I’d be surprised if they developed islatravir/doravirine as a usable combo,” she said. “It’s just too soon to say. My personal view is that people are a bit too overoptimistic about it.”

The study was funded by Merck. Dr. Molina has received grants from Gilead Sciences, Merck, ViiV Healthcare, and Sanofi. Dr. Waters has received speaker or advisory fees during the past 2 years from Gilead Sciences, ViiV Healthcare, Merck, Janssen, Theratech, Sipla, and Mylan.

A version of this article first appeared on Medscape.com.

HIV increases the risk for severe COVID-19 by 6% and the risk of dying of COVID-19 in the hospital by 30%, according to a report from the World Health Organization on COVID-19 outcomes among people living with HIV. The study primarily included people from South Africa but also some data from other parts of the world, including the United States.

However, the report, presented at the 11th IAS Conference on HIV Science (IAS 2021), couldn’t answer some crucial questions clinicians have been wondering about since the COVID-19 pandemic began. For example, was the increase in COVID risk a result of the presence of HIV or because of the immune compromise caused by untreated HIV?

The report didn’t include data on viral load or CD counts, both used to evaluate the health of a person’s immune system. On effective treatment, people living with HIV have a lifespan close to their HIV-negative peers. And effective treatment causes undetectable viral loads which, when maintained for 6 months or more, eliminates transmission of HIV to sexual partners.

What’s clear is that in people with HIV, as in people without HIV, older people, men, and people with diabetes, hypertension, or obesity had the worst outcomes and were most likely to die from COVID-19.

For David Malebranche, MD, MPH, an internal medicine doctor who provides primary care for people in Atlanta, and who was not involved in the study, the WHO study didn’t add anything new. He already recommends the COVID-19 vaccine for all of his patients, HIV-positive or not.

“We don’t have any information from this about the T-cell counts [or] the rates of viral suppression, which I think is tremendously important,” he told this news organization. “To bypass that and not include that in any of the discussion puts the results in a questionable place for me.”

The results come from the WHO Clinical Platform, which culls data from WHO member country surveillance as well as manual case reports from all over the world. By April 29, data on 268,412 people hospitalized with COVID-19 from 37 countries were reported to the platform. Of those, 22,640 people are from the U.S.

A total of 15,522 participants worldwide were living with HIV, 664 in the United States. All U.S. cases were reported from the New York City Health and Hospitals system, Henry Ford Hospital in Detroit, and BronxCare Health System in New York City. Almost all of the remaining participants lived in South Africa – 14,682 of the 15,522, or 94.5%.

Of the 15,522 people living with HIV in the overall group, 37.1% of participants were male, and their median age was 45 years. More than 1 in 3 (36.2%) were admitted with severe or critical COVID-19, and nearly one quarter – 23.1% – with a known outcome died. More than half had one or more chronic conditions, including those that themselves are associated with worse COVID-19 outcomes, such as hypertension (in 33.2% of the participants), diabetes (22.7%), and BMIs above 30 (16.9%). In addition, 8.9% were smokers, 6.6% had chronic pulmonary disease, and 4.3% had chronic heart disease.

After adjusting for those chronic conditions, age, and sex, people living with HIV had a 6% higher rate of severe or critical COVID-19 illness. When investigators adjusted the analysis additionally to differentiate outcomes based on not just the presence of comorbid conditions but the number of them a person had, that increased risk rose to 13%. HIV itself is a comorbid condition, though it wasn’t counted as one in this adjusted analysis.

It didn’t matter whether researchers looked at risk for severe outcomes or deaths after removing the significant co-occurring conditions or if they looked at number of chronic illnesses (aside from HIV), said Silvia Bertagnolio, MD, medical officer at the World Health Organization and co-author of the analysis.

“Both models show almost identical [adjusted odds ratios], meaning that HIV was independently significantly associated with severe/critical presentation,” she told this news organization.

As for death, the analysis showed that, overall, people living with HIV were 30% more likely to die of COVID-19 compared with those not living with HIV. And while this held true even when they adjusted the data for comorbidities, people with HIV were more likely to die if they were over age 65 (risk increased by 82%), male (risk increased by 21%), had diabetes (risk increased by 50%), or had hypertension (risk increased by 26%).

When they broke down the data by WHO region – Africa, Europe, the Americas – investigators found that the increased risk for death held true in Africa. But there were not enough data from the other regions to model mortality risk. What’s more, when they broke the data down by country and excluded South Africa, they found that the elevated risk for death in people living with HIV did not reach statistical significance. Dr. Bertagnolio said she suspects that the small sample sizes from other regions made it impossible to detect a difference, but one could still be present.

One thing conspicuously absent from the analysis was information on viral load, CD4 T-cell count, progression of HIV to AIDS, and whether individuals were in HIV care. The first three factors were not reported in the platform, and the fourth was available for 60% of participants but was not included in the analysis. Dr. Bertagnolio pointed out that, for those 60% of participants, 91.8% were on antiretroviral treatment (ART).

“The majority of patients come from South Africa, and we know that in South Africa, over 90% of people receiving ART are virologically suppressed,” she told this news organization. “So we could speculate that this effect persists despite the use of ART, in a population likely to be virally suppressed, although we cannot assess this with certainty through the data set we had.”

A much smaller study of 749 people living with HIV and diagnosed with SARS-CoV-2, also presented at the conference, found that detectable HIV viral load was significantly associated with a slightly higher risk of severe outcomes (P < .039), but CD4 counts less than 200 cells/mm³ was not (P = .15).

And although both Dr. Bertagnolio and conference organizers presented this data as proof that HIV increases the risk for poor COVID-19 outcomes, Dr. Malebranche isn’t so sure. He estimates that only about half his patients have received the COVID-19 vaccine. But this study is unlikely to make him forcefully recommend a COVID-19 vaccination with young, otherwise healthy, and undetectable people in his care who express particular concern about long-term effects of the vaccine. He also manages a lot of people with HIV who have undetectable viral loads and CD4 counts of up to 1,200 but are older, with diabetes, obesity, and high blood pressure. Those are the people he will target with stronger messages regarding the vaccine.

“The young patients who are healthy, virally suppressed, and doing well may very much argue with me, ‘I’m not going to push it,’ but I will bring it up on the next visit,” he said. The analysis “just helps reinforce in me that I need to have these conversations and be a little bit more persuasive to my older patients with comorbid conditions.”

Dr. Bertagnolio has disclosed no relevant financial relationships. Dr. Malebranche serves on the pre-exposure prophylaxis (PrEP) speakers bureau for Gilead Sciences and has consulted and advised for ViiV Healthcare. This study was funded by the World Health Organization.

A version of this article first appeared on Medscape.com.

HIV increases the risk for severe COVID-19 by 6% and the risk of dying of COVID-19 in the hospital by 30%, according to a report from the World Health Organization on COVID-19 outcomes among people living with HIV. The study primarily included people from South Africa but also some data from other parts of the world, including the United States.

However, the report, presented at the 11th IAS Conference on HIV Science (IAS 2021), couldn’t answer some crucial questions clinicians have been wondering about since the COVID-19 pandemic began. For example, was the increase in COVID risk a result of the presence of HIV or because of the immune compromise caused by untreated HIV?

The report didn’t include data on viral load or CD counts, both used to evaluate the health of a person’s immune system. On effective treatment, people living with HIV have a lifespan close to their HIV-negative peers. And effective treatment causes undetectable viral loads which, when maintained for 6 months or more, eliminates transmission of HIV to sexual partners.

What’s clear is that in people with HIV, as in people without HIV, older people, men, and people with diabetes, hypertension, or obesity had the worst outcomes and were most likely to die from COVID-19.

For David Malebranche, MD, MPH, an internal medicine doctor who provides primary care for people in Atlanta, and who was not involved in the study, the WHO study didn’t add anything new. He already recommends the COVID-19 vaccine for all of his patients, HIV-positive or not.

“We don’t have any information from this about the T-cell counts [or] the rates of viral suppression, which I think is tremendously important,” he told this news organization. “To bypass that and not include that in any of the discussion puts the results in a questionable place for me.”

The results come from the WHO Clinical Platform, which culls data from WHO member country surveillance as well as manual case reports from all over the world. By April 29, data on 268,412 people hospitalized with COVID-19 from 37 countries were reported to the platform. Of those, 22,640 people are from the U.S.

A total of 15,522 participants worldwide were living with HIV, 664 in the United States. All U.S. cases were reported from the New York City Health and Hospitals system, Henry Ford Hospital in Detroit, and BronxCare Health System in New York City. Almost all of the remaining participants lived in South Africa – 14,682 of the 15,522, or 94.5%.

Of the 15,522 people living with HIV in the overall group, 37.1% of participants were male, and their median age was 45 years. More than 1 in 3 (36.2%) were admitted with severe or critical COVID-19, and nearly one quarter – 23.1% – with a known outcome died. More than half had one or more chronic conditions, including those that themselves are associated with worse COVID-19 outcomes, such as hypertension (in 33.2% of the participants), diabetes (22.7%), and BMIs above 30 (16.9%). In addition, 8.9% were smokers, 6.6% had chronic pulmonary disease, and 4.3% had chronic heart disease.

After adjusting for those chronic conditions, age, and sex, people living with HIV had a 6% higher rate of severe or critical COVID-19 illness. When investigators adjusted the analysis additionally to differentiate outcomes based on not just the presence of comorbid conditions but the number of them a person had, that increased risk rose to 13%. HIV itself is a comorbid condition, though it wasn’t counted as one in this adjusted analysis.

It didn’t matter whether researchers looked at risk for severe outcomes or deaths after removing the significant co-occurring conditions or if they looked at number of chronic illnesses (aside from HIV), said Silvia Bertagnolio, MD, medical officer at the World Health Organization and co-author of the analysis.

“Both models show almost identical [adjusted odds ratios], meaning that HIV was independently significantly associated with severe/critical presentation,” she told this news organization.

As for death, the analysis showed that, overall, people living with HIV were 30% more likely to die of COVID-19 compared with those not living with HIV. And while this held true even when they adjusted the data for comorbidities, people with HIV were more likely to die if they were over age 65 (risk increased by 82%), male (risk increased by 21%), had diabetes (risk increased by 50%), or had hypertension (risk increased by 26%).

When they broke down the data by WHO region – Africa, Europe, the Americas – investigators found that the increased risk for death held true in Africa. But there were not enough data from the other regions to model mortality risk. What’s more, when they broke the data down by country and excluded South Africa, they found that the elevated risk for death in people living with HIV did not reach statistical significance. Dr. Bertagnolio said she suspects that the small sample sizes from other regions made it impossible to detect a difference, but one could still be present.

One thing conspicuously absent from the analysis was information on viral load, CD4 T-cell count, progression of HIV to AIDS, and whether individuals were in HIV care. The first three factors were not reported in the platform, and the fourth was available for 60% of participants but was not included in the analysis. Dr. Bertagnolio pointed out that, for those 60% of participants, 91.8% were on antiretroviral treatment (ART).

“The majority of patients come from South Africa, and we know that in South Africa, over 90% of people receiving ART are virologically suppressed,” she told this news organization. “So we could speculate that this effect persists despite the use of ART, in a population likely to be virally suppressed, although we cannot assess this with certainty through the data set we had.”

A much smaller study of 749 people living with HIV and diagnosed with SARS-CoV-2, also presented at the conference, found that detectable HIV viral load was significantly associated with a slightly higher risk of severe outcomes (P < .039), but CD4 counts less than 200 cells/mm³ was not (P = .15).

And although both Dr. Bertagnolio and conference organizers presented this data as proof that HIV increases the risk for poor COVID-19 outcomes, Dr. Malebranche isn’t so sure. He estimates that only about half his patients have received the COVID-19 vaccine. But this study is unlikely to make him forcefully recommend a COVID-19 vaccination with young, otherwise healthy, and undetectable people in his care who express particular concern about long-term effects of the vaccine. He also manages a lot of people with HIV who have undetectable viral loads and CD4 counts of up to 1,200 but are older, with diabetes, obesity, and high blood pressure. Those are the people he will target with stronger messages regarding the vaccine.

“The young patients who are healthy, virally suppressed, and doing well may very much argue with me, ‘I’m not going to push it,’ but I will bring it up on the next visit,” he said. The analysis “just helps reinforce in me that I need to have these conversations and be a little bit more persuasive to my older patients with comorbid conditions.”

Dr. Bertagnolio has disclosed no relevant financial relationships. Dr. Malebranche serves on the pre-exposure prophylaxis (PrEP) speakers bureau for Gilead Sciences and has consulted and advised for ViiV Healthcare. This study was funded by the World Health Organization.

A version of this article first appeared on Medscape.com.

HIV increases the risk for severe COVID-19 by 6% and the risk of dying of COVID-19 in the hospital by 30%, according to a report from the World Health Organization on COVID-19 outcomes among people living with HIV. The study primarily included people from South Africa but also some data from other parts of the world, including the United States.

However, the report, presented at the 11th IAS Conference on HIV Science (IAS 2021), couldn’t answer some crucial questions clinicians have been wondering about since the COVID-19 pandemic began. For example, was the increase in COVID risk a result of the presence of HIV or because of the immune compromise caused by untreated HIV?

The report didn’t include data on viral load or CD counts, both used to evaluate the health of a person’s immune system. On effective treatment, people living with HIV have a lifespan close to their HIV-negative peers. And effective treatment causes undetectable viral loads which, when maintained for 6 months or more, eliminates transmission of HIV to sexual partners.

What’s clear is that in people with HIV, as in people without HIV, older people, men, and people with diabetes, hypertension, or obesity had the worst outcomes and were most likely to die from COVID-19.

For David Malebranche, MD, MPH, an internal medicine doctor who provides primary care for people in Atlanta, and who was not involved in the study, the WHO study didn’t add anything new. He already recommends the COVID-19 vaccine for all of his patients, HIV-positive or not.

“We don’t have any information from this about the T-cell counts [or] the rates of viral suppression, which I think is tremendously important,” he told this news organization. “To bypass that and not include that in any of the discussion puts the results in a questionable place for me.”

The results come from the WHO Clinical Platform, which culls data from WHO member country surveillance as well as manual case reports from all over the world. By April 29, data on 268,412 people hospitalized with COVID-19 from 37 countries were reported to the platform. Of those, 22,640 people are from the U.S.

A total of 15,522 participants worldwide were living with HIV, 664 in the United States. All U.S. cases were reported from the New York City Health and Hospitals system, Henry Ford Hospital in Detroit, and BronxCare Health System in New York City. Almost all of the remaining participants lived in South Africa – 14,682 of the 15,522, or 94.5%.

Of the 15,522 people living with HIV in the overall group, 37.1% of participants were male, and their median age was 45 years. More than 1 in 3 (36.2%) were admitted with severe or critical COVID-19, and nearly one quarter – 23.1% – with a known outcome died. More than half had one or more chronic conditions, including those that themselves are associated with worse COVID-19 outcomes, such as hypertension (in 33.2% of the participants), diabetes (22.7%), and BMIs above 30 (16.9%). In addition, 8.9% were smokers, 6.6% had chronic pulmonary disease, and 4.3% had chronic heart disease.

After adjusting for those chronic conditions, age, and sex, people living with HIV had a 6% higher rate of severe or critical COVID-19 illness. When investigators adjusted the analysis additionally to differentiate outcomes based on not just the presence of comorbid conditions but the number of them a person had, that increased risk rose to 13%. HIV itself is a comorbid condition, though it wasn’t counted as one in this adjusted analysis.

It didn’t matter whether researchers looked at risk for severe outcomes or deaths after removing the significant co-occurring conditions or if they looked at number of chronic illnesses (aside from HIV), said Silvia Bertagnolio, MD, medical officer at the World Health Organization and co-author of the analysis.

“Both models show almost identical [adjusted odds ratios], meaning that HIV was independently significantly associated with severe/critical presentation,” she told this news organization.

As for death, the analysis showed that, overall, people living with HIV were 30% more likely to die of COVID-19 compared with those not living with HIV. And while this held true even when they adjusted the data for comorbidities, people with HIV were more likely to die if they were over age 65 (risk increased by 82%), male (risk increased by 21%), had diabetes (risk increased by 50%), or had hypertension (risk increased by 26%).

When they broke down the data by WHO region – Africa, Europe, the Americas – investigators found that the increased risk for death held true in Africa. But there were not enough data from the other regions to model mortality risk. What’s more, when they broke the data down by country and excluded South Africa, they found that the elevated risk for death in people living with HIV did not reach statistical significance. Dr. Bertagnolio said she suspects that the small sample sizes from other regions made it impossible to detect a difference, but one could still be present.

One thing conspicuously absent from the analysis was information on viral load, CD4 T-cell count, progression of HIV to AIDS, and whether individuals were in HIV care. The first three factors were not reported in the platform, and the fourth was available for 60% of participants but was not included in the analysis. Dr. Bertagnolio pointed out that, for those 60% of participants, 91.8% were on antiretroviral treatment (ART).

“The majority of patients come from South Africa, and we know that in South Africa, over 90% of people receiving ART are virologically suppressed,” she told this news organization. “So we could speculate that this effect persists despite the use of ART, in a population likely to be virally suppressed, although we cannot assess this with certainty through the data set we had.”

A much smaller study of 749 people living with HIV and diagnosed with SARS-CoV-2, also presented at the conference, found that detectable HIV viral load was significantly associated with a slightly higher risk of severe outcomes (P < .039), but CD4 counts less than 200 cells/mm³ was not (P = .15).

And although both Dr. Bertagnolio and conference organizers presented this data as proof that HIV increases the risk for poor COVID-19 outcomes, Dr. Malebranche isn’t so sure. He estimates that only about half his patients have received the COVID-19 vaccine. But this study is unlikely to make him forcefully recommend a COVID-19 vaccination with young, otherwise healthy, and undetectable people in his care who express particular concern about long-term effects of the vaccine. He also manages a lot of people with HIV who have undetectable viral loads and CD4 counts of up to 1,200 but are older, with diabetes, obesity, and high blood pressure. Those are the people he will target with stronger messages regarding the vaccine.

“The young patients who are healthy, virally suppressed, and doing well may very much argue with me, ‘I’m not going to push it,’ but I will bring it up on the next visit,” he said. The analysis “just helps reinforce in me that I need to have these conversations and be a little bit more persuasive to my older patients with comorbid conditions.”

Dr. Bertagnolio has disclosed no relevant financial relationships. Dr. Malebranche serves on the pre-exposure prophylaxis (PrEP) speakers bureau for Gilead Sciences and has consulted and advised for ViiV Healthcare. This study was funded by the World Health Organization.

A version of this article first appeared on Medscape.com.

The Food and Drug Administration has approved a new version of asparaginase for use in children and adults who have developed hypersensitivity to asparaginase derived from Escherichia coli.

The new product is Jazz Pharmaceutical’s Rylaze (asparaginase erwinia chrysanthemi [recombinant]-rywn), and it is approved for use in the treatment of acute lymphoblastic leukemia and lymphoblastic lymphoma.

Asparaginase, an enzyme that helps kill blood cancer cells, is a key component of chemotherapy for both conditions.

The problem is that about 20% of patients become allergic to the standard option, asparaginase derived from Escherichia coli.

The only alternative until now has been Erwinaze (also distributed by Jazz Pharmaceuticals), which, like Rylaze, is derived from Erwinia chrysanthemi, a plant pathogen related to Escherichia coli.

However, Erwinaze has been bedeviled by manufacturing problems and has been in short supply since 2016.

The situation has been “extremely disconcerting to patients, families and providers,” and the hope is that Rylaze will “provide a consistently sourced alternative,” Gregory Reaman, MD, the FDA’s associate director of pediatric oncology, said in a press release.

Rylaze will hit the U.S. market in mid-July. Jazz has been a distributor of Erwinaze as well, but it released its last batch in May, according to a spokesperson.

The key difference between the two products is that the asparaginase in Erwinaze is derived directly from Erwinia chrysanthemi, whereas the asparaginase in Rylaze is a recombinant product produced by different bacteria that have been genetically altered with Erwinia chrysanthemi DNA.

The approval for Rylaze was based on a study involving 102 patients (median age, 10 years) who developed hypersensitivity to Escherichia coli–derived enzyme or “silent inactivation” from neutralizing antibodies. In the study, almost 94% of patients achieved asparaginase target activity levels at the approved dosage of 25 mg/m² IM every 48 hours. The study is ongoing, and investigators are currently evaluating intravenous dosing.

The most common side effects are hypersensitivity reactions, blood clots, hemorrhage, and pancreatic and liver toxicity. There is also a risk for fetal harm, so labeling advises women to use effective nonhormonal contraception during treatment and for 3 months afterward.
 

A version of this article first appeared on Medscape.com.

The Food and Drug Administration has approved a new version of asparaginase for use in children and adults who have developed hypersensitivity to asparaginase derived from Escherichia coli.

The new product is Jazz Pharmaceutical’s Rylaze (asparaginase erwinia chrysanthemi [recombinant]-rywn), and it is approved for use in the treatment of acute lymphoblastic leukemia and lymphoblastic lymphoma.

Asparaginase, an enzyme that helps kill blood cancer cells, is a key component of chemotherapy for both conditions.

The problem is that about 20% of patients become allergic to the standard option, asparaginase derived from Escherichia coli.

The only alternative until now has been Erwinaze (also distributed by Jazz Pharmaceuticals), which, like Rylaze, is derived from Erwinia chrysanthemi, a plant pathogen related to Escherichia coli.

However, Erwinaze has been bedeviled by manufacturing problems and has been in short supply since 2016.

The situation has been “extremely disconcerting to patients, families and providers,” and the hope is that Rylaze will “provide a consistently sourced alternative,” Gregory Reaman, MD, the FDA’s associate director of pediatric oncology, said in a press release.

Rylaze will hit the U.S. market in mid-July. Jazz has been a distributor of Erwinaze as well, but it released its last batch in May, according to a spokesperson.

The key difference between the two products is that the asparaginase in Erwinaze is derived directly from Erwinia chrysanthemi, whereas the asparaginase in Rylaze is a recombinant product produced by different bacteria that have been genetically altered with Erwinia chrysanthemi DNA.

The approval for Rylaze was based on a study involving 102 patients (median age, 10 years) who developed hypersensitivity to Escherichia coli–derived enzyme or “silent inactivation” from neutralizing antibodies. In the study, almost 94% of patients achieved asparaginase target activity levels at the approved dosage of 25 mg/m² IM every 48 hours. The study is ongoing, and investigators are currently evaluating intravenous dosing.

The most common side effects are hypersensitivity reactions, blood clots, hemorrhage, and pancreatic and liver toxicity. There is also a risk for fetal harm, so labeling advises women to use effective nonhormonal contraception during treatment and for 3 months afterward.
 

A version of this article first appeared on Medscape.com.

The Food and Drug Administration has approved a new version of asparaginase for use in children and adults who have developed hypersensitivity to asparaginase derived from Escherichia coli.

The new product is Jazz Pharmaceutical’s Rylaze (asparaginase erwinia chrysanthemi [recombinant]-rywn), and it is approved for use in the treatment of acute lymphoblastic leukemia and lymphoblastic lymphoma.

Asparaginase, an enzyme that helps kill blood cancer cells, is a key component of chemotherapy for both conditions.

The problem is that about 20% of patients become allergic to the standard option, asparaginase derived from Escherichia coli.

The only alternative until now has been Erwinaze (also distributed by Jazz Pharmaceuticals), which, like Rylaze, is derived from Erwinia chrysanthemi, a plant pathogen related to Escherichia coli.

However, Erwinaze has been bedeviled by manufacturing problems and has been in short supply since 2016.

The situation has been “extremely disconcerting to patients, families and providers,” and the hope is that Rylaze will “provide a consistently sourced alternative,” Gregory Reaman, MD, the FDA’s associate director of pediatric oncology, said in a press release.

Rylaze will hit the U.S. market in mid-July. Jazz has been a distributor of Erwinaze as well, but it released its last batch in May, according to a spokesperson.

The key difference between the two products is that the asparaginase in Erwinaze is derived directly from Erwinia chrysanthemi, whereas the asparaginase in Rylaze is a recombinant product produced by different bacteria that have been genetically altered with Erwinia chrysanthemi DNA.

The approval for Rylaze was based on a study involving 102 patients (median age, 10 years) who developed hypersensitivity to Escherichia coli–derived enzyme or “silent inactivation” from neutralizing antibodies. In the study, almost 94% of patients achieved asparaginase target activity levels at the approved dosage of 25 mg/m² IM every 48 hours. The study is ongoing, and investigators are currently evaluating intravenous dosing.

The most common side effects are hypersensitivity reactions, blood clots, hemorrhage, and pancreatic and liver toxicity. There is also a risk for fetal harm, so labeling advises women to use effective nonhormonal contraception during treatment and for 3 months afterward.
 

A version of this article first appeared on Medscape.com.

The amount of prescription drugs given to children in the United States decreased by 27.1% between April and December 2020, compared with the same period in 2019, based on data from a national database.

Overall, dispensing of prescription drugs to all patients in the United States decreased in the wake of COVID-19 but has since rebounded, wrote Kao-Ping Chua, MD, of the University of Michigan, Ann Arbor, and colleagues. “However, whether these same trends occurred for children is unknown.”

In a study published in Pediatrics, the researchers used the IQVIA National Prescription Audit, a database that contains monthly dispensing details from 92% of retail pharmacies in the United States. They compared changes in the dispensing of prescriptions with children aged 0-19 years during 2018-2020.

In the April 2020–December 2020 time period, prescriptions for children aged 1-2 years, 3-9 years, and 10-19 years decreased by 48.7%, 40.6%, and 16.8%, respectively, compared with the same time period in 2019.

The overall dispensing total for children from April 2020 to December 2020 was 160,630,406, representing a 27.1% reduction, compared with the 220,284,613 total from April 2019 to December 2019.

By drug class, prescriptions for antibiotics, ADHD medications, and antidepressants decreased by 55.6%, 11.8%, and 0.1%, respectively, in comparing the two time periods. Prescriptions for drug classes used typically for acute infections decreased by 51.3%, and those used for chronic diseases decreased by 17.4%.

From January 2018 to February 2020, a median of 25,744,758 prescriptions were dispensed to children aged 0-19 years each month. The total prescriptions decreased from 25,684,219 in March 2020 to 16,742,568 in April 2020, increased to 19,657,289 in October 2020, and decreased again to 15,821,914 during December 2020.

In a subgroup analysis, the decline in prescriptions was greater in children aged 0-9 years, compared with those aged 10-19 years. “Because young children have a higher rate of antibiotic use than older children, declines in antibiotic dispensing might affect overall dispensing totals to a greater degree in young children,” the researchers said.

The study findings were limited by several factors including the lack of information on clinical outcomes, disease severity, and details of new versus ongoing prescriptions, as well as the possible heterogeneity in indications within drug classes, and lack of data from small pharmacies, the researchers noted. However, the results were strengthened by the use of a national all-payer database that including most prescriptions dispensed in the United States, and the use of objective measurements of prescribing practices rather than self-reports.

Despite concerns for the decreased dispensing of chronic disease drugs to children during the pandemic, “declines in dispensing of infection-related drugs, such as antitussives and antibiotics, may be welcome developments,” the researchers said. “These declines reveal that substantial reductions in prescribing of these drugs are possible,” and ongoing monitoring is needed to follow whether the reductions continue long term.
 

COVID precautions contributed to prescription declines

The mask-wearing and social distancing imposed by the COVID-19 pandemic has contributed to reduced rates of other illnesses, Karalyn Kinsella, MD, a pediatrician in private practice in Cheshire, Conn., said in an interview.

“On the surface, with masks and social isolation, we have seen a drastic reduction in infectious disease,” she said. Fewer infections mean a reduced need for prescriptions to treat them. However, Dr. Kinsella expects the situation to change as more venues and activities open. “I expect that, as things continue to open, we will continue to see more infectious disease,” which will likely lead to more prescription drug use.

Part of the study data were provided through the IQVIA Institute’s Human Data Science Research Collaborative. Lead author Dr. Chua was supported by a career development award from the National Institute on Drug Abuse, but had no financial conflicts to disclose. Dr. Kinsella had no financial conflicts to disclose, but serves as a member of the Pediatric News editorial advisory board.

The amount of prescription drugs given to children in the United States decreased by 27.1% between April and December 2020, compared with the same period in 2019, based on data from a national database.

Overall, dispensing of prescription drugs to all patients in the United States decreased in the wake of COVID-19 but has since rebounded, wrote Kao-Ping Chua, MD, of the University of Michigan, Ann Arbor, and colleagues. “However, whether these same trends occurred for children is unknown.”

In a study published in Pediatrics, the researchers used the IQVIA National Prescription Audit, a database that contains monthly dispensing details from 92% of retail pharmacies in the United States. They compared changes in the dispensing of prescriptions with children aged 0-19 years during 2018-2020.

In the April 2020–December 2020 time period, prescriptions for children aged 1-2 years, 3-9 years, and 10-19 years decreased by 48.7%, 40.6%, and 16.8%, respectively, compared with the same time period in 2019.

The overall dispensing total for children from April 2020 to December 2020 was 160,630,406, representing a 27.1% reduction, compared with the 220,284,613 total from April 2019 to December 2019.

By drug class, prescriptions for antibiotics, ADHD medications, and antidepressants decreased by 55.6%, 11.8%, and 0.1%, respectively, in comparing the two time periods. Prescriptions for drug classes used typically for acute infections decreased by 51.3%, and those used for chronic diseases decreased by 17.4%.

From January 2018 to February 2020, a median of 25,744,758 prescriptions were dispensed to children aged 0-19 years each month. The total prescriptions decreased from 25,684,219 in March 2020 to 16,742,568 in April 2020, increased to 19,657,289 in October 2020, and decreased again to 15,821,914 during December 2020.

In a subgroup analysis, the decline in prescriptions was greater in children aged 0-9 years, compared with those aged 10-19 years. “Because young children have a higher rate of antibiotic use than older children, declines in antibiotic dispensing might affect overall dispensing totals to a greater degree in young children,” the researchers said.

The study findings were limited by several factors including the lack of information on clinical outcomes, disease severity, and details of new versus ongoing prescriptions, as well as the possible heterogeneity in indications within drug classes, and lack of data from small pharmacies, the researchers noted. However, the results were strengthened by the use of a national all-payer database that including most prescriptions dispensed in the United States, and the use of objective measurements of prescribing practices rather than self-reports.

Despite concerns for the decreased dispensing of chronic disease drugs to children during the pandemic, “declines in dispensing of infection-related drugs, such as antitussives and antibiotics, may be welcome developments,” the researchers said. “These declines reveal that substantial reductions in prescribing of these drugs are possible,” and ongoing monitoring is needed to follow whether the reductions continue long term.
 

COVID precautions contributed to prescription declines

The mask-wearing and social distancing imposed by the COVID-19 pandemic has contributed to reduced rates of other illnesses, Karalyn Kinsella, MD, a pediatrician in private practice in Cheshire, Conn., said in an interview.

“On the surface, with masks and social isolation, we have seen a drastic reduction in infectious disease,” she said. Fewer infections mean a reduced need for prescriptions to treat them. However, Dr. Kinsella expects the situation to change as more venues and activities open. “I expect that, as things continue to open, we will continue to see more infectious disease,” which will likely lead to more prescription drug use.

Part of the study data were provided through the IQVIA Institute’s Human Data Science Research Collaborative. Lead author Dr. Chua was supported by a career development award from the National Institute on Drug Abuse, but had no financial conflicts to disclose. Dr. Kinsella had no financial conflicts to disclose, but serves as a member of the Pediatric News editorial advisory board.

The amount of prescription drugs given to children in the United States decreased by 27.1% between April and December 2020, compared with the same period in 2019, based on data from a national database.

Overall, dispensing of prescription drugs to all patients in the United States decreased in the wake of COVID-19 but has since rebounded, wrote Kao-Ping Chua, MD, of the University of Michigan, Ann Arbor, and colleagues. “However, whether these same trends occurred for children is unknown.”

In a study published in Pediatrics, the researchers used the IQVIA National Prescription Audit, a database that contains monthly dispensing details from 92% of retail pharmacies in the United States. They compared changes in the dispensing of prescriptions with children aged 0-19 years during 2018-2020.

In the April 2020–December 2020 time period, prescriptions for children aged 1-2 years, 3-9 years, and 10-19 years decreased by 48.7%, 40.6%, and 16.8%, respectively, compared with the same time period in 2019.

The overall dispensing total for children from April 2020 to December 2020 was 160,630,406, representing a 27.1% reduction, compared with the 220,284,613 total from April 2019 to December 2019.

By drug class, prescriptions for antibiotics, ADHD medications, and antidepressants decreased by 55.6%, 11.8%, and 0.1%, respectively, in comparing the two time periods. Prescriptions for drug classes used typically for acute infections decreased by 51.3%, and those used for chronic diseases decreased by 17.4%.

From January 2018 to February 2020, a median of 25,744,758 prescriptions were dispensed to children aged 0-19 years each month. The total prescriptions decreased from 25,684,219 in March 2020 to 16,742,568 in April 2020, increased to 19,657,289 in October 2020, and decreased again to 15,821,914 during December 2020.

In a subgroup analysis, the decline in prescriptions was greater in children aged 0-9 years, compared with those aged 10-19 years. “Because young children have a higher rate of antibiotic use than older children, declines in antibiotic dispensing might affect overall dispensing totals to a greater degree in young children,” the researchers said.

The study findings were limited by several factors including the lack of information on clinical outcomes, disease severity, and details of new versus ongoing prescriptions, as well as the possible heterogeneity in indications within drug classes, and lack of data from small pharmacies, the researchers noted. However, the results were strengthened by the use of a national all-payer database that including most prescriptions dispensed in the United States, and the use of objective measurements of prescribing practices rather than self-reports.

Despite concerns for the decreased dispensing of chronic disease drugs to children during the pandemic, “declines in dispensing of infection-related drugs, such as antitussives and antibiotics, may be welcome developments,” the researchers said. “These declines reveal that substantial reductions in prescribing of these drugs are possible,” and ongoing monitoring is needed to follow whether the reductions continue long term.
 

COVID precautions contributed to prescription declines

The mask-wearing and social distancing imposed by the COVID-19 pandemic has contributed to reduced rates of other illnesses, Karalyn Kinsella, MD, a pediatrician in private practice in Cheshire, Conn., said in an interview.

“On the surface, with masks and social isolation, we have seen a drastic reduction in infectious disease,” she said. Fewer infections mean a reduced need for prescriptions to treat them. However, Dr. Kinsella expects the situation to change as more venues and activities open. “I expect that, as things continue to open, we will continue to see more infectious disease,” which will likely lead to more prescription drug use.

Part of the study data were provided through the IQVIA Institute’s Human Data Science Research Collaborative. Lead author Dr. Chua was supported by a career development award from the National Institute on Drug Abuse, but had no financial conflicts to disclose. Dr. Kinsella had no financial conflicts to disclose, but serves as a member of the Pediatric News editorial advisory board.

Coronary angiography and percutaneous coronary interventions (PCI) can be performed successfully after transcatheter aortic valve replacement in most cases, according to data drawn from an international registry that has collected more than 400 such cases.

Overall, reaccess coronary angiography was successful in about 99% of cases with type of prosthesis identified as the most important variable in predicting success, according to a multicenter investigating team led by Won-Keun Kim, MD, director of structural heart disease, Kerckhoff Heart Center, Bad Nauheim, Germany.

By type of prosthesis, Dr. Kim was referring to long versus short stent-frame prostheses (SFP). In the case of angiography of the right coronary artery, for example, success was achieved in 99.6% of those with a short SFP and 95.9% of those with a long SFP (P = .005).

The study was published online in JACC: Cardiovascular Interventions.

Based on these and previous data, “prosthetic choice will be the main decisive factor that affects coronary reaccess, and this decision is in the hands of the TAVR operator,” said Dr. Kim in an interview.

This does not preclude use of a long SFP in TAVR. For patients with increased likelihood of eventually requiring a coronary intervention after TAVR, such as those undergoing the procedure at a relatively young age, a short device appears to be preferable, but Dr. Kim emphasized that it is not the only consideration.

When performing TAVR, “the highest priority is to accomplish a safe procedure with a good immediate outcome,” he said, pointing out that angiographic reaccess and PCI are successfully achieved in most patients whether fitted with a short or long SFP.

“If for any reason I assume that the immediate outcome [after TAVR] might be better using a long SFP, I would not hesitate to use a long SFP,” said Dr. Kim, giving such examples as a need for resheathing or precise positioning.
 

Coronary reaccess has low relative priority

“Coronary reaccess is an important issue and there is an increasing awareness of this, but it has a lower priority” than optimizing TAVR success,” Dr. Kim explained.

The analysis of coronary angiographic reaccess was based on 449 TAVR patients from 25 sites who required reaccess angiography. The indication in most cases was an acute coronary syndrome, mostly non–ST-elevation myocardial infarction (STEMI, 79%). Of the remaining patients, about half had STEMIs and half had other acute cardiovascular situations. The median time interval from TAVR to need for coronary angiography was 311 days.

In all but 2.7%, diagnostic catheterization was performed initially. It was successful in 98.3% of the procedures in the right coronary artery, 99.3% of the left coronary artery, and 97.3% overall.

Of the 60% who underwent PCI, 9% were considered unsuccessful. The reasons included lack of reflow in eight cases and coronary access issues in six cases. A variety of other issues accounted for the remaining seven cases.

Technical success was achieved in 91.4% of native arteries. In the six cases in which engagement of the culprit vessel with a guiding catheter failed, three were converted to urgent coronary bypass grafting and three died in the hospital. Neither selective versus unselective guiding-catheter engagement nor long versus short SFP related to PCI success, but PCI was performed less commonly in the native coronary arteries of TAVR patients with a long rather than short SFP (49% vs. 57%).

The 30-day all-cause mortality in this series was 12.2%. The independent predictors were a history of diabetes and the occurrence of cardiogenic shock. In the PCI subgroup, these factors plus PCI success predicted 30-day mortality.
 

Strategies to improve reaccess not resolved

When performing TAVR, other factors that might influence subsequent PCI success includes commissural alignment and positioning, according to Dr. Kim. But he cautioned that there are a number of potential controversies when weighing how to improve chances of post-TAVR angiographic reaccess without compromising the success of valve replacement.

“Lower positioning facilitates coronary access, but unfortunately will increase rates of conduction disturbances,” he noted.

Overall, one of the main messages from this analysis is that “the fear of impaired coronary access [after TAVR] may well be disproportionate to the reality,” according to Neal S. Kleiman, MD, an interventional cardiologist at Houston Methodist DeBakey Heart and Vascular Center. Dr. Kleiman wrote an editorial on the registry findings in the same issue of JACC: Cardiovascular Interventions).

Yet, he agreed that the issue of angiographic reaccess after TAVR cannot be ignored. Although reaccess after TAVR has so far been “surprisingly rare,” Dr. Kleiman expects cases to increase as more younger patients undergo TAVR. He suggested that interventionalists will need consider this issue when performing TAVR, a point he reemphasized in an interview.

“It is still a concern when recommending TAVR to a patient and still poses challenges to device manufacturers,” said Dr. Kleiman, suggesting that “a new set of skills” will be required to perform TAVR that will optimize subsequent angiographic access and PCI.

Dr. Kim agreed. Ultimately, other challenges, such as PCI performed after TAVR-in-TAVR placement, are likely to further complicate this issue, but he, too, is looking to new devices to minimize the problems.

“It would be desirable to modify the design, especially of long SFPs, to improve access for PCI, and there are ongoing efforts of the manufacturers to achieve this,” Dr. Kim said.

Dr. Kim reported financial relationships with Abbot, Boston Scientific, Edwards Lifesciences, Medtronic, and Meril Lifesciences. Dr. Kleiman reported financial relationships with Abbott, Boston Scientific, Edwards Lifesciences, and Medtronic.

Coronary angiography and percutaneous coronary interventions (PCI) can be performed successfully after transcatheter aortic valve replacement in most cases, according to data drawn from an international registry that has collected more than 400 such cases.

Overall, reaccess coronary angiography was successful in about 99% of cases with type of prosthesis identified as the most important variable in predicting success, according to a multicenter investigating team led by Won-Keun Kim, MD, director of structural heart disease, Kerckhoff Heart Center, Bad Nauheim, Germany.

By type of prosthesis, Dr. Kim was referring to long versus short stent-frame prostheses (SFP). In the case of angiography of the right coronary artery, for example, success was achieved in 99.6% of those with a short SFP and 95.9% of those with a long SFP (P = .005).

The study was published online in JACC: Cardiovascular Interventions.

Based on these and previous data, “prosthetic choice will be the main decisive factor that affects coronary reaccess, and this decision is in the hands of the TAVR operator,” said Dr. Kim in an interview.

This does not preclude use of a long SFP in TAVR. For patients with increased likelihood of eventually requiring a coronary intervention after TAVR, such as those undergoing the procedure at a relatively young age, a short device appears to be preferable, but Dr. Kim emphasized that it is not the only consideration.

When performing TAVR, “the highest priority is to accomplish a safe procedure with a good immediate outcome,” he said, pointing out that angiographic reaccess and PCI are successfully achieved in most patients whether fitted with a short or long SFP.

“If for any reason I assume that the immediate outcome [after TAVR] might be better using a long SFP, I would not hesitate to use a long SFP,” said Dr. Kim, giving such examples as a need for resheathing or precise positioning.
 

Coronary reaccess has low relative priority

“Coronary reaccess is an important issue and there is an increasing awareness of this, but it has a lower priority” than optimizing TAVR success,” Dr. Kim explained.

The analysis of coronary angiographic reaccess was based on 449 TAVR patients from 25 sites who required reaccess angiography. The indication in most cases was an acute coronary syndrome, mostly non–ST-elevation myocardial infarction (STEMI, 79%). Of the remaining patients, about half had STEMIs and half had other acute cardiovascular situations. The median time interval from TAVR to need for coronary angiography was 311 days.

In all but 2.7%, diagnostic catheterization was performed initially. It was successful in 98.3% of the procedures in the right coronary artery, 99.3% of the left coronary artery, and 97.3% overall.

Of the 60% who underwent PCI, 9% were considered unsuccessful. The reasons included lack of reflow in eight cases and coronary access issues in six cases. A variety of other issues accounted for the remaining seven cases.

Technical success was achieved in 91.4% of native arteries. In the six cases in which engagement of the culprit vessel with a guiding catheter failed, three were converted to urgent coronary bypass grafting and three died in the hospital. Neither selective versus unselective guiding-catheter engagement nor long versus short SFP related to PCI success, but PCI was performed less commonly in the native coronary arteries of TAVR patients with a long rather than short SFP (49% vs. 57%).

The 30-day all-cause mortality in this series was 12.2%. The independent predictors were a history of diabetes and the occurrence of cardiogenic shock. In the PCI subgroup, these factors plus PCI success predicted 30-day mortality.
 

Strategies to improve reaccess not resolved

When performing TAVR, other factors that might influence subsequent PCI success includes commissural alignment and positioning, according to Dr. Kim. But he cautioned that there are a number of potential controversies when weighing how to improve chances of post-TAVR angiographic reaccess without compromising the success of valve replacement.

“Lower positioning facilitates coronary access, but unfortunately will increase rates of conduction disturbances,” he noted.

Overall, one of the main messages from this analysis is that “the fear of impaired coronary access [after TAVR] may well be disproportionate to the reality,” according to Neal S. Kleiman, MD, an interventional cardiologist at Houston Methodist DeBakey Heart and Vascular Center. Dr. Kleiman wrote an editorial on the registry findings in the same issue of JACC: Cardiovascular Interventions).

Yet, he agreed that the issue of angiographic reaccess after TAVR cannot be ignored. Although reaccess after TAVR has so far been “surprisingly rare,” Dr. Kleiman expects cases to increase as more younger patients undergo TAVR. He suggested that interventionalists will need consider this issue when performing TAVR, a point he reemphasized in an interview.

“It is still a concern when recommending TAVR to a patient and still poses challenges to device manufacturers,” said Dr. Kleiman, suggesting that “a new set of skills” will be required to perform TAVR that will optimize subsequent angiographic access and PCI.

Dr. Kim agreed. Ultimately, other challenges, such as PCI performed after TAVR-in-TAVR placement, are likely to further complicate this issue, but he, too, is looking to new devices to minimize the problems.

“It would be desirable to modify the design, especially of long SFPs, to improve access for PCI, and there are ongoing efforts of the manufacturers to achieve this,” Dr. Kim said.

Dr. Kim reported financial relationships with Abbot, Boston Scientific, Edwards Lifesciences, Medtronic, and Meril Lifesciences. Dr. Kleiman reported financial relationships with Abbott, Boston Scientific, Edwards Lifesciences, and Medtronic.

Coronary angiography and percutaneous coronary interventions (PCI) can be performed successfully after transcatheter aortic valve replacement in most cases, according to data drawn from an international registry that has collected more than 400 such cases.

Overall, reaccess coronary angiography was successful in about 99% of cases with type of prosthesis identified as the most important variable in predicting success, according to a multicenter investigating team led by Won-Keun Kim, MD, director of structural heart disease, Kerckhoff Heart Center, Bad Nauheim, Germany.

By type of prosthesis, Dr. Kim was referring to long versus short stent-frame prostheses (SFP). In the case of angiography of the right coronary artery, for example, success was achieved in 99.6% of those with a short SFP and 95.9% of those with a long SFP (P = .005).

The study was published online in JACC: Cardiovascular Interventions.

Based on these and previous data, “prosthetic choice will be the main decisive factor that affects coronary reaccess, and this decision is in the hands of the TAVR operator,” said Dr. Kim in an interview.

This does not preclude use of a long SFP in TAVR. For patients with increased likelihood of eventually requiring a coronary intervention after TAVR, such as those undergoing the procedure at a relatively young age, a short device appears to be preferable, but Dr. Kim emphasized that it is not the only consideration.

When performing TAVR, “the highest priority is to accomplish a safe procedure with a good immediate outcome,” he said, pointing out that angiographic reaccess and PCI are successfully achieved in most patients whether fitted with a short or long SFP.

“If for any reason I assume that the immediate outcome [after TAVR] might be better using a long SFP, I would not hesitate to use a long SFP,” said Dr. Kim, giving such examples as a need for resheathing or precise positioning.
 

Coronary reaccess has low relative priority

“Coronary reaccess is an important issue and there is an increasing awareness of this, but it has a lower priority” than optimizing TAVR success,” Dr. Kim explained.

The analysis of coronary angiographic reaccess was based on 449 TAVR patients from 25 sites who required reaccess angiography. The indication in most cases was an acute coronary syndrome, mostly non–ST-elevation myocardial infarction (STEMI, 79%). Of the remaining patients, about half had STEMIs and half had other acute cardiovascular situations. The median time interval from TAVR to need for coronary angiography was 311 days.

In all but 2.7%, diagnostic catheterization was performed initially. It was successful in 98.3% of the procedures in the right coronary artery, 99.3% of the left coronary artery, and 97.3% overall.

Of the 60% who underwent PCI, 9% were considered unsuccessful. The reasons included lack of reflow in eight cases and coronary access issues in six cases. A variety of other issues accounted for the remaining seven cases.

Technical success was achieved in 91.4% of native arteries. In the six cases in which engagement of the culprit vessel with a guiding catheter failed, three were converted to urgent coronary bypass grafting and three died in the hospital. Neither selective versus unselective guiding-catheter engagement nor long versus short SFP related to PCI success, but PCI was performed less commonly in the native coronary arteries of TAVR patients with a long rather than short SFP (49% vs. 57%).

The 30-day all-cause mortality in this series was 12.2%. The independent predictors were a history of diabetes and the occurrence of cardiogenic shock. In the PCI subgroup, these factors plus PCI success predicted 30-day mortality.
 

Strategies to improve reaccess not resolved

When performing TAVR, other factors that might influence subsequent PCI success includes commissural alignment and positioning, according to Dr. Kim. But he cautioned that there are a number of potential controversies when weighing how to improve chances of post-TAVR angiographic reaccess without compromising the success of valve replacement.

“Lower positioning facilitates coronary access, but unfortunately will increase rates of conduction disturbances,” he noted.

Overall, one of the main messages from this analysis is that “the fear of impaired coronary access [after TAVR] may well be disproportionate to the reality,” according to Neal S. Kleiman, MD, an interventional cardiologist at Houston Methodist DeBakey Heart and Vascular Center. Dr. Kleiman wrote an editorial on the registry findings in the same issue of JACC: Cardiovascular Interventions).

Yet, he agreed that the issue of angiographic reaccess after TAVR cannot be ignored. Although reaccess after TAVR has so far been “surprisingly rare,” Dr. Kleiman expects cases to increase as more younger patients undergo TAVR. He suggested that interventionalists will need consider this issue when performing TAVR, a point he reemphasized in an interview.

“It is still a concern when recommending TAVR to a patient and still poses challenges to device manufacturers,” said Dr. Kleiman, suggesting that “a new set of skills” will be required to perform TAVR that will optimize subsequent angiographic access and PCI.

Dr. Kim agreed. Ultimately, other challenges, such as PCI performed after TAVR-in-TAVR placement, are likely to further complicate this issue, but he, too, is looking to new devices to minimize the problems.

“It would be desirable to modify the design, especially of long SFPs, to improve access for PCI, and there are ongoing efforts of the manufacturers to achieve this,” Dr. Kim said.

Dr. Kim reported financial relationships with Abbot, Boston Scientific, Edwards Lifesciences, Medtronic, and Meril Lifesciences. Dr. Kleiman reported financial relationships with Abbott, Boston Scientific, Edwards Lifesciences, and Medtronic.

Background: Atrial fibrillation (Afib) is the most common arrhythmia requiring treatment in the ED. There is a paucity of literature regarding the management of acute (onset < 48 h) atrial fibrillation in this setting and no conclusive evidence exists regarding the superiority of pharmacologic vs. electrical cardioversion.

The “drug-shock” group achieved and maintained sinus rhythm in 96% of cases, compared to 92% in the “placebo-shock” group (statistically insignificant difference). The procainamide infusion alone achieved and maintained sinus rhythm in 52% of recipients, who thereby avoided the need for procedural sedation and monitoring. Notably, only 2% of patients in the study required admission to the hospital. Pad placement was equally efficacious in the AL or AP positions. The most common adverse event observed was transient hypotension during infusion of procainamide. No strokes were observed in either arm. Follow-up ECGs obtained 14 days later showed that 95% of patients remained in sinus rhythm.

Bottom line: Pharmacologic cardioversion with procainamide infusion and/or electrical cardioversion is a safe and efficacious initial management strategy for acute atrial fibrillation, and all but eliminates the need for hospital admission.

Citation: Stiell IG et al. Electrical versus pharmacological cardioversion for emergency department patients with acute atrial fibrillation (RAFF2): a partial factorial randomized trial. Lancet. 2020 Feb 1;395(10221):339-49.

Dr. Lawson is assistant professor of medicine, section of hospital medicine, at the University of Virginia School of Medicine, Charlottesville.

Background: Atrial fibrillation (Afib) is the most common arrhythmia requiring treatment in the ED. There is a paucity of literature regarding the management of acute (onset < 48 h) atrial fibrillation in this setting and no conclusive evidence exists regarding the superiority of pharmacologic vs. electrical cardioversion.

The “drug-shock” group achieved and maintained sinus rhythm in 96% of cases, compared to 92% in the “placebo-shock” group (statistically insignificant difference). The procainamide infusion alone achieved and maintained sinus rhythm in 52% of recipients, who thereby avoided the need for procedural sedation and monitoring. Notably, only 2% of patients in the study required admission to the hospital. Pad placement was equally efficacious in the AL or AP positions. The most common adverse event observed was transient hypotension during infusion of procainamide. No strokes were observed in either arm. Follow-up ECGs obtained 14 days later showed that 95% of patients remained in sinus rhythm.

Bottom line: Pharmacologic cardioversion with procainamide infusion and/or electrical cardioversion is a safe and efficacious initial management strategy for acute atrial fibrillation, and all but eliminates the need for hospital admission.

Citation: Stiell IG et al. Electrical versus pharmacological cardioversion for emergency department patients with acute atrial fibrillation (RAFF2): a partial factorial randomized trial. Lancet. 2020 Feb 1;395(10221):339-49.

Dr. Lawson is assistant professor of medicine, section of hospital medicine, at the University of Virginia School of Medicine, Charlottesville.

Background: Atrial fibrillation (Afib) is the most common arrhythmia requiring treatment in the ED. There is a paucity of literature regarding the management of acute (onset < 48 h) atrial fibrillation in this setting and no conclusive evidence exists regarding the superiority of pharmacologic vs. electrical cardioversion.

The “drug-shock” group achieved and maintained sinus rhythm in 96% of cases, compared to 92% in the “placebo-shock” group (statistically insignificant difference). The procainamide infusion alone achieved and maintained sinus rhythm in 52% of recipients, who thereby avoided the need for procedural sedation and monitoring. Notably, only 2% of patients in the study required admission to the hospital. Pad placement was equally efficacious in the AL or AP positions. The most common adverse event observed was transient hypotension during infusion of procainamide. No strokes were observed in either arm. Follow-up ECGs obtained 14 days later showed that 95% of patients remained in sinus rhythm.

Bottom line: Pharmacologic cardioversion with procainamide infusion and/or electrical cardioversion is a safe and efficacious initial management strategy for acute atrial fibrillation, and all but eliminates the need for hospital admission.

Citation: Stiell IG et al. Electrical versus pharmacological cardioversion for emergency department patients with acute atrial fibrillation (RAFF2): a partial factorial randomized trial. Lancet. 2020 Feb 1;395(10221):339-49.

Dr. Lawson is assistant professor of medicine, section of hospital medicine, at the University of Virginia School of Medicine, Charlottesville.

For me, vacation planning brings with it a bit of anxiety and stress – particularly as we navigate the many uncertainties around COVID-19.

Courtesy Danielle M. Scott

Not only must my husband and I think about our own safety, we also have to make sure that our beloved dog, Samson, gets the proper care while we are away.

My husband adopted Samson, an 11-year-old mixed-breed rescue, when he was just a year old. He’s an important part of our family.

So, when booking our hotel room and flights, we also had to find someone we trust to care for Samson in our absence. Family members are not always an option, so we often rely on pet-sitting apps. We looked through profile after profile, contacted sitters, and interrogated them as if we were looking for care for a tiny human.

Eventually, we found a service that allows owners to use a mobile app that provides updates about how their pets are faring. While we were away, the sitter sent daily photos and videos of Samson that put our minds at ease.

As a registered nurse who works in an ICU, my own anxiety about leaving Samson reminded me about my patients’ reservations about leaving their pets during hospitalizations. Many of them share the same kinds of anxieties when they are separated from their beloved pets. Hospital visits are rarely planned. I have cared for patients who expressed concerns about their pets being home alone and needing to coordinate pet care. In some cases – to alleviate those patients’ anxieties – I have helped them contact friends and family members to assist with care.
 

Pets’ popularity grows in U.S.

According to the 2019-2020 National Pet Owners Survey, about 67% of U.S. households own a pet – which translates to about 84.9 million homes. During the height of COVID, Americans also acquired a greater number of smaller pets.¹ In addition, when social restrictions increased, the demand for dog adoptions and the desire to serve as foster owners rose significantly.² Last Chance Animal Rescue of Waldorf, Md., reportedly saw the adoption of dogs rise from 30%-40% in 2020. Another animal rescue operation, Lucky Dog, of Arlington, Va., in 2020 helped about 3,385 pets find adoption, up from about 1,800 in 2019.³ About two-thirds of all American households and roughly half of elderly individuals own pets.⁴

I am not surprised by those numbers. In my nursing practice, I face many stress-related factors, such as alternating day and night shifts, 12-hour shifts, strenuous physical work, and the psychological strain of attending to ill and dying patients. Interacting with Samson helps relieve that stress. The motion of petting Samson helps calm my heart rate and decreases my anxiety. In addition, Samson makes me smile – and excites almost all the people I interact with while he’s around. Of course, I’m not objective, but I view Samson’s impact on people as a symbol of the power of animal-assisted therapy (AAT).

AAT, defined as “the positive interaction between an animal and a patient within a therapeutic framework,”has proven to be an effective intervention for adults with intellectual disabilities who experience anxiety in an observational study.⁵ The intervention also has helped reduce cortisol levels in a study of nurses in physical medicine, internal medicine, and long-term care.⁶ Since most patient hospital stays are unplanned, there is a need to introduce AAT into hospital care. This would lessen anxiety in patients concerning their pets’ welfare.

We know that long-term hospital stays often cause adverse psychosocial effects on patients. Such stays can result in “hospitalization syndrome,” which is characterized by a gradual loss of cognition and orientation, an unwillingness to maintain contact with others or to engage in group therapy, and a loss of interest in their surroundings.⁷ The common causes for this syndrome are infection, medication, isolation, response to surgery, and dehydration. A consequence can be a permanent change in cognitive function or psychological impairment. However, my experience of practicing nursing for years has led me to discover that pets as an external stimulus can prevent the syndrome’s onset. This is because a large percentage of hospitalized patients have pets, and contact with a pet reminds them of home and the memories they share at home.

Introducing animal therapy into health care facilities could boost patients’ mental health – and ease their anxiety – by acting as a bridge between their present circumstances and the lives they have outside the establishment.
 

References

1. American Pet Owners Association. Will the COVID Pet Spike Last? State of the industry presentation. 2021 Mar 24.

2. Morgan L et al. Humanit Soc Sci Comm. 2020 Nov 24;7(144). doi: 10.1057/S41599-020-00649-x.

3. Hedgpeth D. So many pets have been adopted during the pandemic that shelters are running out. Washington Post. 2021 Jan 6.

4. Cherniack EP and Cherniack AR. Curr Gerontol Geriatr Res. 2014. doi: 10.1155/2014/623203.

5. Giuliani F and Jacquemettaz M. Eur J Integ Med. 2017 Sep;14;13-9.

6. Machová K et al. Int J Environ Res and Public Health. 2019 Oct;16(19):3670.

7. Machová K et al. Int J Environ Res Public Health. 2012 Apr;16(8):1362.

Ms. Scott is a registered nurse specializing in critical care and also has experience in nursing leadership. She has 8 years of experience in cardiothoracic ICUs. Ms. Scott received a bachelor of science in nursing degree from Queens University of Charlotte (N.C.), and a master of business administration in health care administration from the University of North Alabama, Florence. She has no conflicts of interest.

For me, vacation planning brings with it a bit of anxiety and stress – particularly as we navigate the many uncertainties around COVID-19.

Courtesy Danielle M. Scott

Not only must my husband and I think about our own safety, we also have to make sure that our beloved dog, Samson, gets the proper care while we are away.

My husband adopted Samson, an 11-year-old mixed-breed rescue, when he was just a year old. He’s an important part of our family.

So, when booking our hotel room and flights, we also had to find someone we trust to care for Samson in our absence. Family members are not always an option, so we often rely on pet-sitting apps. We looked through profile after profile, contacted sitters, and interrogated them as if we were looking for care for a tiny human.

Eventually, we found a service that allows owners to use a mobile app that provides updates about how their pets are faring. While we were away, the sitter sent daily photos and videos of Samson that put our minds at ease.

As a registered nurse who works in an ICU, my own anxiety about leaving Samson reminded me about my patients’ reservations about leaving their pets during hospitalizations. Many of them share the same kinds of anxieties when they are separated from their beloved pets. Hospital visits are rarely planned. I have cared for patients who expressed concerns about their pets being home alone and needing to coordinate pet care. In some cases – to alleviate those patients’ anxieties – I have helped them contact friends and family members to assist with care.
 

Pets’ popularity grows in U.S.

According to the 2019-2020 National Pet Owners Survey, about 67% of U.S. households own a pet – which translates to about 84.9 million homes. During the height of COVID, Americans also acquired a greater number of smaller pets.¹ In addition, when social restrictions increased, the demand for dog adoptions and the desire to serve as foster owners rose significantly.² Last Chance Animal Rescue of Waldorf, Md., reportedly saw the adoption of dogs rise from 30%-40% in 2020. Another animal rescue operation, Lucky Dog, of Arlington, Va., in 2020 helped about 3,385 pets find adoption, up from about 1,800 in 2019.³ About two-thirds of all American households and roughly half of elderly individuals own pets.⁴

I am not surprised by those numbers. In my nursing practice, I face many stress-related factors, such as alternating day and night shifts, 12-hour shifts, strenuous physical work, and the psychological strain of attending to ill and dying patients. Interacting with Samson helps relieve that stress. The motion of petting Samson helps calm my heart rate and decreases my anxiety. In addition, Samson makes me smile – and excites almost all the people I interact with while he’s around. Of course, I’m not objective, but I view Samson’s impact on people as a symbol of the power of animal-assisted therapy (AAT).

AAT, defined as “the positive interaction between an animal and a patient within a therapeutic framework,”has proven to be an effective intervention for adults with intellectual disabilities who experience anxiety in an observational study.⁵ The intervention also has helped reduce cortisol levels in a study of nurses in physical medicine, internal medicine, and long-term care.⁶ Since most patient hospital stays are unplanned, there is a need to introduce AAT into hospital care. This would lessen anxiety in patients concerning their pets’ welfare.

We know that long-term hospital stays often cause adverse psychosocial effects on patients. Such stays can result in “hospitalization syndrome,” which is characterized by a gradual loss of cognition and orientation, an unwillingness to maintain contact with others or to engage in group therapy, and a loss of interest in their surroundings.⁷ The common causes for this syndrome are infection, medication, isolation, response to surgery, and dehydration. A consequence can be a permanent change in cognitive function or psychological impairment. However, my experience of practicing nursing for years has led me to discover that pets as an external stimulus can prevent the syndrome’s onset. This is because a large percentage of hospitalized patients have pets, and contact with a pet reminds them of home and the memories they share at home.

Introducing animal therapy into health care facilities could boost patients’ mental health – and ease their anxiety – by acting as a bridge between their present circumstances and the lives they have outside the establishment.
 

References

1. American Pet Owners Association. Will the COVID Pet Spike Last? State of the industry presentation. 2021 Mar 24.

2. Morgan L et al. Humanit Soc Sci Comm. 2020 Nov 24;7(144). doi: 10.1057/S41599-020-00649-x.

3. Hedgpeth D. So many pets have been adopted during the pandemic that shelters are running out. Washington Post. 2021 Jan 6.

4. Cherniack EP and Cherniack AR. Curr Gerontol Geriatr Res. 2014. doi: 10.1155/2014/623203.

5. Giuliani F and Jacquemettaz M. Eur J Integ Med. 2017 Sep;14;13-9.

6. Machová K et al. Int J Environ Res and Public Health. 2019 Oct;16(19):3670.

7. Machová K et al. Int J Environ Res Public Health. 2012 Apr;16(8):1362.

Ms. Scott is a registered nurse specializing in critical care and also has experience in nursing leadership. She has 8 years of experience in cardiothoracic ICUs. Ms. Scott received a bachelor of science in nursing degree from Queens University of Charlotte (N.C.), and a master of business administration in health care administration from the University of North Alabama, Florence. She has no conflicts of interest.

For me, vacation planning brings with it a bit of anxiety and stress – particularly as we navigate the many uncertainties around COVID-19.

Courtesy Danielle M. Scott

Not only must my husband and I think about our own safety, we also have to make sure that our beloved dog, Samson, gets the proper care while we are away.

My husband adopted Samson, an 11-year-old mixed-breed rescue, when he was just a year old. He’s an important part of our family.

So, when booking our hotel room and flights, we also had to find someone we trust to care for Samson in our absence. Family members are not always an option, so we often rely on pet-sitting apps. We looked through profile after profile, contacted sitters, and interrogated them as if we were looking for care for a tiny human.

Eventually, we found a service that allows owners to use a mobile app that provides updates about how their pets are faring. While we were away, the sitter sent daily photos and videos of Samson that put our minds at ease.

As a registered nurse who works in an ICU, my own anxiety about leaving Samson reminded me about my patients’ reservations about leaving their pets during hospitalizations. Many of them share the same kinds of anxieties when they are separated from their beloved pets. Hospital visits are rarely planned. I have cared for patients who expressed concerns about their pets being home alone and needing to coordinate pet care. In some cases – to alleviate those patients’ anxieties – I have helped them contact friends and family members to assist with care.
 

Pets’ popularity grows in U.S.

According to the 2019-2020 National Pet Owners Survey, about 67% of U.S. households own a pet – which translates to about 84.9 million homes. During the height of COVID, Americans also acquired a greater number of smaller pets.¹ In addition, when social restrictions increased, the demand for dog adoptions and the desire to serve as foster owners rose significantly.² Last Chance Animal Rescue of Waldorf, Md., reportedly saw the adoption of dogs rise from 30%-40% in 2020. Another animal rescue operation, Lucky Dog, of Arlington, Va., in 2020 helped about 3,385 pets find adoption, up from about 1,800 in 2019.³ About two-thirds of all American households and roughly half of elderly individuals own pets.⁴

I am not surprised by those numbers. In my nursing practice, I face many stress-related factors, such as alternating day and night shifts, 12-hour shifts, strenuous physical work, and the psychological strain of attending to ill and dying patients. Interacting with Samson helps relieve that stress. The motion of petting Samson helps calm my heart rate and decreases my anxiety. In addition, Samson makes me smile – and excites almost all the people I interact with while he’s around. Of course, I’m not objective, but I view Samson’s impact on people as a symbol of the power of animal-assisted therapy (AAT).

AAT, defined as “the positive interaction between an animal and a patient within a therapeutic framework,”has proven to be an effective intervention for adults with intellectual disabilities who experience anxiety in an observational study.⁵ The intervention also has helped reduce cortisol levels in a study of nurses in physical medicine, internal medicine, and long-term care.⁶ Since most patient hospital stays are unplanned, there is a need to introduce AAT into hospital care. This would lessen anxiety in patients concerning their pets’ welfare.

We know that long-term hospital stays often cause adverse psychosocial effects on patients. Such stays can result in “hospitalization syndrome,” which is characterized by a gradual loss of cognition and orientation, an unwillingness to maintain contact with others or to engage in group therapy, and a loss of interest in their surroundings.⁷ The common causes for this syndrome are infection, medication, isolation, response to surgery, and dehydration. A consequence can be a permanent change in cognitive function or psychological impairment. However, my experience of practicing nursing for years has led me to discover that pets as an external stimulus can prevent the syndrome’s onset. This is because a large percentage of hospitalized patients have pets, and contact with a pet reminds them of home and the memories they share at home.

Introducing animal therapy into health care facilities could boost patients’ mental health – and ease their anxiety – by acting as a bridge between their present circumstances and the lives they have outside the establishment.
 

References

1. American Pet Owners Association. Will the COVID Pet Spike Last? State of the industry presentation. 2021 Mar 24.

2. Morgan L et al. Humanit Soc Sci Comm. 2020 Nov 24;7(144). doi: 10.1057/S41599-020-00649-x.

3. Hedgpeth D. So many pets have been adopted during the pandemic that shelters are running out. Washington Post. 2021 Jan 6.

4. Cherniack EP and Cherniack AR. Curr Gerontol Geriatr Res. 2014. doi: 10.1155/2014/623203.

5. Giuliani F and Jacquemettaz M. Eur J Integ Med. 2017 Sep;14;13-9.

6. Machová K et al. Int J Environ Res and Public Health. 2019 Oct;16(19):3670.

7. Machová K et al. Int J Environ Res Public Health. 2012 Apr;16(8):1362.

Ms. Scott is a registered nurse specializing in critical care and also has experience in nursing leadership. She has 8 years of experience in cardiothoracic ICUs. Ms. Scott received a bachelor of science in nursing degree from Queens University of Charlotte (N.C.), and a master of business administration in health care administration from the University of North Alabama, Florence. She has no conflicts of interest.

Patients with rheumatoid arthritis currently being treated with low doses of oral glucocorticoids (GCs) had a 59% increased risk of sustaining a vertebral fracture when compared with past users, results of a retrospective cohort study have shown.

izusek/Getty Images

Although the overall risk of an osteoporotic fracture was not increased when comparing current and past GC users, with a hazard ratio of 1.14 (95% confidence interval, 0.98-1.33), the HR for sustaining a spinal fracture was 1.59 (95% CI, 1.11-2.29).

“Clinicians should be aware that, even in RA patients who receive low daily glucocorticoid doses, the risk of clinical vertebral fracture is increased,” Shahab Abtahi, MD, of Maastricht (the Netherlands) University and coauthors reported in Rheumatology.

This is important considering around a quarter of RA patients are treated with GCs in the United Kingdom in accordance with European recommendations, they observed.

Conflicting randomized and observational findings on whether or not osteoporotic fractures might be linked to the use of low-dose GCs prompted Dr. Abtahi and associates to see if there were any signals in real-world data. To do so, they used data one of the world’s largest primary care databases – the Clinical Practice Research Datalink (CPRD), which consists of anonymized patient data from a network of primary care practices across the United Kingdom.

Altogether, the records of more than 15,000 patients with RA aged 50 years and older who were held in the CRPD between 1997 and 2017 were pulled for analysis, and just half (n = 7,039) were receiving or had received GC therapy. Low-dose GC therapy was defined as a prednisolone equivalent dose (PED) of 7.5 mg or less per day.

The use of low-dose GCs use during three key time periods was considered: within the past 6 months (current users), within the past 7-12 months (recent users), and within the past year (past users).

The analyses involved time-dependent Cox proportional-hazards models to look for associations between GC use and all types of osteoporotic fracture, including the risk for incident hip, vertebral, humeral, forearm, pelvis, and rib fractures. They were adjusted for various lifestyle parameters, comorbidities, and the use of other medications.

“Current GC use was further broken down into subcategories based on average daily and cumulative dose,” Dr. Abtahi observed. As might be expected, doses even lower than 7.5 mg or less PED did not increase the chance of any osteoporotic fracture but there was an increased risk for some types with higher average daily doses, notably at the hip and pelvis, as well as the spine.

“Low-dose oral GC therapy was associated with an increased risk of clinical vertebral fracture, while the risk of other individual OP fracture sites was not increased,” said the team, adding that the main results remained unchanged regardless of short- or long-term use.

“We know that vertebral fracture risk is markedly increased in RA, and it is well known that GC therapy in particular affects trabecular bone, which is abundantly present in lumbar vertebrae,” Dr. Abtahi wrote.

“Therefore, we can hypothesize that the beneficial effect of low-dose GC therapy on suppressing the background inflammation of RA could probably be enough to offset its negative effect on bone synthesis in most fracture sites but not in vertebrae,” they suggested.

One of the limitations of the study is that the researchers lacked data on the disease activity of the patients or if they were being treated with biologic therapy. This means that confounding by disease severity might be an issue with only those with higher disease activity being treated with GCs and thus were at higher risk for fractures.

“Another limitation was a potential misclassification of exposure with oral GCs, as we had only prescribing information from CPRD, which is roughly two steps behind actual drug use by patients,” the researchers conceded. The average duration of GC use was estimated at 3.7 years, which is an indication of actual use.

A detection bias may also be involved with regard to vertebral fractures, with complaints of back pain maybe being discussed more often when prescribing GCs, leading to more referrals for possible fracture assessment.

Dr. Abtahi and a fellow coauthor disclosed receiving research and other funding from several pharmaceutical companies unrelated to this study. All other coauthors had no conflicts of interest.

Patients with rheumatoid arthritis currently being treated with low doses of oral glucocorticoids (GCs) had a 59% increased risk of sustaining a vertebral fracture when compared with past users, results of a retrospective cohort study have shown.

izusek/Getty Images

Although the overall risk of an osteoporotic fracture was not increased when comparing current and past GC users, with a hazard ratio of 1.14 (95% confidence interval, 0.98-1.33), the HR for sustaining a spinal fracture was 1.59 (95% CI, 1.11-2.29).

“Clinicians should be aware that, even in RA patients who receive low daily glucocorticoid doses, the risk of clinical vertebral fracture is increased,” Shahab Abtahi, MD, of Maastricht (the Netherlands) University and coauthors reported in Rheumatology.

This is important considering around a quarter of RA patients are treated with GCs in the United Kingdom in accordance with European recommendations, they observed.

Conflicting randomized and observational findings on whether or not osteoporotic fractures might be linked to the use of low-dose GCs prompted Dr. Abtahi and associates to see if there were any signals in real-world data. To do so, they used data one of the world’s largest primary care databases – the Clinical Practice Research Datalink (CPRD), which consists of anonymized patient data from a network of primary care practices across the United Kingdom.

Altogether, the records of more than 15,000 patients with RA aged 50 years and older who were held in the CRPD between 1997 and 2017 were pulled for analysis, and just half (n = 7,039) were receiving or had received GC therapy. Low-dose GC therapy was defined as a prednisolone equivalent dose (PED) of 7.5 mg or less per day.

The use of low-dose GCs use during three key time periods was considered: within the past 6 months (current users), within the past 7-12 months (recent users), and within the past year (past users).

The analyses involved time-dependent Cox proportional-hazards models to look for associations between GC use and all types of osteoporotic fracture, including the risk for incident hip, vertebral, humeral, forearm, pelvis, and rib fractures. They were adjusted for various lifestyle parameters, comorbidities, and the use of other medications.

“Current GC use was further broken down into subcategories based on average daily and cumulative dose,” Dr. Abtahi observed. As might be expected, doses even lower than 7.5 mg or less PED did not increase the chance of any osteoporotic fracture but there was an increased risk for some types with higher average daily doses, notably at the hip and pelvis, as well as the spine.

“Low-dose oral GC therapy was associated with an increased risk of clinical vertebral fracture, while the risk of other individual OP fracture sites was not increased,” said the team, adding that the main results remained unchanged regardless of short- or long-term use.

“We know that vertebral fracture risk is markedly increased in RA, and it is well known that GC therapy in particular affects trabecular bone, which is abundantly present in lumbar vertebrae,” Dr. Abtahi wrote.

“Therefore, we can hypothesize that the beneficial effect of low-dose GC therapy on suppressing the background inflammation of RA could probably be enough to offset its negative effect on bone synthesis in most fracture sites but not in vertebrae,” they suggested.

One of the limitations of the study is that the researchers lacked data on the disease activity of the patients or if they were being treated with biologic therapy. This means that confounding by disease severity might be an issue with only those with higher disease activity being treated with GCs and thus were at higher risk for fractures.

“Another limitation was a potential misclassification of exposure with oral GCs, as we had only prescribing information from CPRD, which is roughly two steps behind actual drug use by patients,” the researchers conceded. The average duration of GC use was estimated at 3.7 years, which is an indication of actual use.

A detection bias may also be involved with regard to vertebral fractures, with complaints of back pain maybe being discussed more often when prescribing GCs, leading to more referrals for possible fracture assessment.

Dr. Abtahi and a fellow coauthor disclosed receiving research and other funding from several pharmaceutical companies unrelated to this study. All other coauthors had no conflicts of interest.

Patients with rheumatoid arthritis currently being treated with low doses of oral glucocorticoids (GCs) had a 59% increased risk of sustaining a vertebral fracture when compared with past users, results of a retrospective cohort study have shown.

izusek/Getty Images

Although the overall risk of an osteoporotic fracture was not increased when comparing current and past GC users, with a hazard ratio of 1.14 (95% confidence interval, 0.98-1.33), the HR for sustaining a spinal fracture was 1.59 (95% CI, 1.11-2.29).

“Clinicians should be aware that, even in RA patients who receive low daily glucocorticoid doses, the risk of clinical vertebral fracture is increased,” Shahab Abtahi, MD, of Maastricht (the Netherlands) University and coauthors reported in Rheumatology.

This is important considering around a quarter of RA patients are treated with GCs in the United Kingdom in accordance with European recommendations, they observed.

Conflicting randomized and observational findings on whether or not osteoporotic fractures might be linked to the use of low-dose GCs prompted Dr. Abtahi and associates to see if there were any signals in real-world data. To do so, they used data one of the world’s largest primary care databases – the Clinical Practice Research Datalink (CPRD), which consists of anonymized patient data from a network of primary care practices across the United Kingdom.

Altogether, the records of more than 15,000 patients with RA aged 50 years and older who were held in the CRPD between 1997 and 2017 were pulled for analysis, and just half (n = 7,039) were receiving or had received GC therapy. Low-dose GC therapy was defined as a prednisolone equivalent dose (PED) of 7.5 mg or less per day.

The use of low-dose GCs use during three key time periods was considered: within the past 6 months (current users), within the past 7-12 months (recent users), and within the past year (past users).

The analyses involved time-dependent Cox proportional-hazards models to look for associations between GC use and all types of osteoporotic fracture, including the risk for incident hip, vertebral, humeral, forearm, pelvis, and rib fractures. They were adjusted for various lifestyle parameters, comorbidities, and the use of other medications.

“Current GC use was further broken down into subcategories based on average daily and cumulative dose,” Dr. Abtahi observed. As might be expected, doses even lower than 7.5 mg or less PED did not increase the chance of any osteoporotic fracture but there was an increased risk for some types with higher average daily doses, notably at the hip and pelvis, as well as the spine.

“Low-dose oral GC therapy was associated with an increased risk of clinical vertebral fracture, while the risk of other individual OP fracture sites was not increased,” said the team, adding that the main results remained unchanged regardless of short- or long-term use.

“We know that vertebral fracture risk is markedly increased in RA, and it is well known that GC therapy in particular affects trabecular bone, which is abundantly present in lumbar vertebrae,” Dr. Abtahi wrote.

“Therefore, we can hypothesize that the beneficial effect of low-dose GC therapy on suppressing the background inflammation of RA could probably be enough to offset its negative effect on bone synthesis in most fracture sites but not in vertebrae,” they suggested.

One of the limitations of the study is that the researchers lacked data on the disease activity of the patients or if they were being treated with biologic therapy. This means that confounding by disease severity might be an issue with only those with higher disease activity being treated with GCs and thus were at higher risk for fractures.

“Another limitation was a potential misclassification of exposure with oral GCs, as we had only prescribing information from CPRD, which is roughly two steps behind actual drug use by patients,” the researchers conceded. The average duration of GC use was estimated at 3.7 years, which is an indication of actual use.

A detection bias may also be involved with regard to vertebral fractures, with complaints of back pain maybe being discussed more often when prescribing GCs, leading to more referrals for possible fracture assessment.

Dr. Abtahi and a fellow coauthor disclosed receiving research and other funding from several pharmaceutical companies unrelated to this study. All other coauthors had no conflicts of interest.