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Uncontrolled BP linked to one-third of ED visits for CVD

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A look at the top cardiovascular disease (CVD) diagnoses in U.S. emergency departments (EDs) suggests that many heart-related emergencies are due to poorly controlled high blood pressure.

In a study of more than 20 million ED visits, about one-third of CVD-related ED visits in the United States were for hypertension-related conditions.

Overall, 13% of ED visits, representing more than 2.7 million individuals, were for essential hypertension.

Dr. Mamas A. Mamas


The fact that these visits rarely led to an inpatient admission (< 3%) or death (< 0.1%) suggests they were “mostly related to the management of hypertension,” lead author Mamas A. Mamas, MD, Keele University, Staffordshire, England, said in a news release.

The study was published online in the Journal of the American Heart Association.
 

Nationwide sample

The researchers studied more than 20.6 million ED encounters in adults with a primary CVD diagnosis using data from the Nationwide Emergency Department Sample between 2016 and 2018.

In the sample, 49% were women, and the median age was 67 years. Men had poorer overall baseline cardiometabolic profiles, but women had higher rates of obesity, hypertension, and cerebrovascular disease. The majority had Medicare or Medicaid insurance.

In women, essential hypertension was the most common reason for an ED visit (16%), followed by hypertensive heart or kidney disease (14%) and atrial fibrillation (AF)/flutter (10%).

In men, the top three reasons were hypertensive heart or kidney disease (15%), essential hypertension (11%), and acute myocardial infarction (AMI, 11%).

On presentation, women were significantly more likely to have essential hypertension, hypertensive crisis, AF/flutter, supraventricular tachycardia, pulmonary embolism, or ischemic stroke, while men were more likely to have AMI, or cardiac arrest.

“Previous studies have shown sex differences in patterns of CVD among hospitalized patients,” Dr. Mamas noted. “However, examining CVD encounters in the ED provides a more complete picture of the cardiovascular healthcare needs of men and women, as it captures encounters prior to hospitalization.”

He noted that previous studies of CVD emergency visits are limited to suspected MI visits. “Therefore, this analysis of 15 CVD conditions helps to better understand the full spectrum of acute CVD needs, including sex disparities in hospitalization and risk of death,” Dr. Mamas said.
 

Sex differences in outcomes

The study found that outcomes from the emergency CVD visits were slightly different for men and women.

Overall, women were less likely than were men to die (3.3% vs. 4.3%) or be hospitalized (49.1% vs. 52.3%) after an ED visit for CVD. The difference may be due to women’s generally lower-risk diagnoses, Dr. Mamas said, but there could be an underestimation of deaths in women.

In logistic regression models adjusted for baseline covariates, women with intracranial hemorrhage (ICH) had a higher risk of being admitted to hospital or dying compared with men with ICH.

Men were more likely to die if they presented with hypertensive heart or kidney disease, AF/flutter, AMI or cardiac arrest, the researchers found. 

“We did not track deaths outside of the hospital setting,” Dr. Mamas pointed out. Given past evidence that women are more likely to be inappropriately discharged from the ED, and strong evidence for the systemic undertreatment of women, further study is warranted to track outcomes beyond the ED visit,” he added.

The researchers called for further research into understanding the underlying factors driving the differences in CVD patterns and outcomes between men and women.

Reached for comment, Maryann McLaughlin, MD, a cardiologist at Mount Sinai Hospital, New York, said: “Hypertension is a silent killer” and this study “reiterates that people need to get their blood pressure checked more regularly.

“In the very least, if they do present to the hospital as not feeling well or whatever it is, and they are identified as having high blood pressure, that’s an important opportunity to really teach them about hypertension and have them follow-up with it,” Dr. McLaughlin told this news organization. 

The study was supported by Health Data Research UK. Dr. Keele and Dr. McLaughlin have reported no relevant financial relationships.

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

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A look at the top cardiovascular disease (CVD) diagnoses in U.S. emergency departments (EDs) suggests that many heart-related emergencies are due to poorly controlled high blood pressure.

In a study of more than 20 million ED visits, about one-third of CVD-related ED visits in the United States were for hypertension-related conditions.

Overall, 13% of ED visits, representing more than 2.7 million individuals, were for essential hypertension.

Dr. Mamas A. Mamas


The fact that these visits rarely led to an inpatient admission (< 3%) or death (< 0.1%) suggests they were “mostly related to the management of hypertension,” lead author Mamas A. Mamas, MD, Keele University, Staffordshire, England, said in a news release.

The study was published online in the Journal of the American Heart Association.
 

Nationwide sample

The researchers studied more than 20.6 million ED encounters in adults with a primary CVD diagnosis using data from the Nationwide Emergency Department Sample between 2016 and 2018.

In the sample, 49% were women, and the median age was 67 years. Men had poorer overall baseline cardiometabolic profiles, but women had higher rates of obesity, hypertension, and cerebrovascular disease. The majority had Medicare or Medicaid insurance.

In women, essential hypertension was the most common reason for an ED visit (16%), followed by hypertensive heart or kidney disease (14%) and atrial fibrillation (AF)/flutter (10%).

In men, the top three reasons were hypertensive heart or kidney disease (15%), essential hypertension (11%), and acute myocardial infarction (AMI, 11%).

On presentation, women were significantly more likely to have essential hypertension, hypertensive crisis, AF/flutter, supraventricular tachycardia, pulmonary embolism, or ischemic stroke, while men were more likely to have AMI, or cardiac arrest.

“Previous studies have shown sex differences in patterns of CVD among hospitalized patients,” Dr. Mamas noted. “However, examining CVD encounters in the ED provides a more complete picture of the cardiovascular healthcare needs of men and women, as it captures encounters prior to hospitalization.”

He noted that previous studies of CVD emergency visits are limited to suspected MI visits. “Therefore, this analysis of 15 CVD conditions helps to better understand the full spectrum of acute CVD needs, including sex disparities in hospitalization and risk of death,” Dr. Mamas said.
 

Sex differences in outcomes

The study found that outcomes from the emergency CVD visits were slightly different for men and women.

Overall, women were less likely than were men to die (3.3% vs. 4.3%) or be hospitalized (49.1% vs. 52.3%) after an ED visit for CVD. The difference may be due to women’s generally lower-risk diagnoses, Dr. Mamas said, but there could be an underestimation of deaths in women.

In logistic regression models adjusted for baseline covariates, women with intracranial hemorrhage (ICH) had a higher risk of being admitted to hospital or dying compared with men with ICH.

Men were more likely to die if they presented with hypertensive heart or kidney disease, AF/flutter, AMI or cardiac arrest, the researchers found. 

“We did not track deaths outside of the hospital setting,” Dr. Mamas pointed out. Given past evidence that women are more likely to be inappropriately discharged from the ED, and strong evidence for the systemic undertreatment of women, further study is warranted to track outcomes beyond the ED visit,” he added.

The researchers called for further research into understanding the underlying factors driving the differences in CVD patterns and outcomes between men and women.

Reached for comment, Maryann McLaughlin, MD, a cardiologist at Mount Sinai Hospital, New York, said: “Hypertension is a silent killer” and this study “reiterates that people need to get their blood pressure checked more regularly.

“In the very least, if they do present to the hospital as not feeling well or whatever it is, and they are identified as having high blood pressure, that’s an important opportunity to really teach them about hypertension and have them follow-up with it,” Dr. McLaughlin told this news organization. 

The study was supported by Health Data Research UK. Dr. Keele and Dr. McLaughlin have reported no relevant financial relationships.

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

A look at the top cardiovascular disease (CVD) diagnoses in U.S. emergency departments (EDs) suggests that many heart-related emergencies are due to poorly controlled high blood pressure.

In a study of more than 20 million ED visits, about one-third of CVD-related ED visits in the United States were for hypertension-related conditions.

Overall, 13% of ED visits, representing more than 2.7 million individuals, were for essential hypertension.

Dr. Mamas A. Mamas


The fact that these visits rarely led to an inpatient admission (< 3%) or death (< 0.1%) suggests they were “mostly related to the management of hypertension,” lead author Mamas A. Mamas, MD, Keele University, Staffordshire, England, said in a news release.

The study was published online in the Journal of the American Heart Association.
 

Nationwide sample

The researchers studied more than 20.6 million ED encounters in adults with a primary CVD diagnosis using data from the Nationwide Emergency Department Sample between 2016 and 2018.

In the sample, 49% were women, and the median age was 67 years. Men had poorer overall baseline cardiometabolic profiles, but women had higher rates of obesity, hypertension, and cerebrovascular disease. The majority had Medicare or Medicaid insurance.

In women, essential hypertension was the most common reason for an ED visit (16%), followed by hypertensive heart or kidney disease (14%) and atrial fibrillation (AF)/flutter (10%).

In men, the top three reasons were hypertensive heart or kidney disease (15%), essential hypertension (11%), and acute myocardial infarction (AMI, 11%).

On presentation, women were significantly more likely to have essential hypertension, hypertensive crisis, AF/flutter, supraventricular tachycardia, pulmonary embolism, or ischemic stroke, while men were more likely to have AMI, or cardiac arrest.

“Previous studies have shown sex differences in patterns of CVD among hospitalized patients,” Dr. Mamas noted. “However, examining CVD encounters in the ED provides a more complete picture of the cardiovascular healthcare needs of men and women, as it captures encounters prior to hospitalization.”

He noted that previous studies of CVD emergency visits are limited to suspected MI visits. “Therefore, this analysis of 15 CVD conditions helps to better understand the full spectrum of acute CVD needs, including sex disparities in hospitalization and risk of death,” Dr. Mamas said.
 

Sex differences in outcomes

The study found that outcomes from the emergency CVD visits were slightly different for men and women.

Overall, women were less likely than were men to die (3.3% vs. 4.3%) or be hospitalized (49.1% vs. 52.3%) after an ED visit for CVD. The difference may be due to women’s generally lower-risk diagnoses, Dr. Mamas said, but there could be an underestimation of deaths in women.

In logistic regression models adjusted for baseline covariates, women with intracranial hemorrhage (ICH) had a higher risk of being admitted to hospital or dying compared with men with ICH.

Men were more likely to die if they presented with hypertensive heart or kidney disease, AF/flutter, AMI or cardiac arrest, the researchers found. 

“We did not track deaths outside of the hospital setting,” Dr. Mamas pointed out. Given past evidence that women are more likely to be inappropriately discharged from the ED, and strong evidence for the systemic undertreatment of women, further study is warranted to track outcomes beyond the ED visit,” he added.

The researchers called for further research into understanding the underlying factors driving the differences in CVD patterns and outcomes between men and women.

Reached for comment, Maryann McLaughlin, MD, a cardiologist at Mount Sinai Hospital, New York, said: “Hypertension is a silent killer” and this study “reiterates that people need to get their blood pressure checked more regularly.

“In the very least, if they do present to the hospital as not feeling well or whatever it is, and they are identified as having high blood pressure, that’s an important opportunity to really teach them about hypertension and have them follow-up with it,” Dr. McLaughlin told this news organization. 

The study was supported by Health Data Research UK. Dr. Keele and Dr. McLaughlin have reported no relevant financial relationships.

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

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Commentary: IBS and comorbid conditions, October 2022

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Mon, 10/17/2022 - 14:48
APN Kametas scans the journals, so you don’t have to!

Marita Kametas, MSN, FNP-BC, CMSRN, COCN
Three studies this month highlight the increased incidence of irritable bowel syndrome (IBS) in the setting of other chronic diseases, specifically diseases with an effect on the abdomen and pelvis:

  • Fairbrass et al: Natural history and impact of IBS-type symptoms in inflammatory bowel disease during 6 years of longitudinal follow-up
  • Nabi et al: Endometriosis and IBS — a systematic review and meta-analyses
  • Wang et al: Factors related to IBS and differences among subtypes — a cross-sectional study in the UK Biobank

Combined diseases can make assessment and treatment very difficult for clinicians. Having a thorough understanding of the pathophysiology and phenotype of each of these diseases is imperative to ensuring that they are managed to the standard of care. When these diseases are in remission and abdominal symptoms persist, it begs the question what is the cause? IBS should always be in the differential diagnosis. The dynamic relationship between the varying presentations of IBS and co-occurring conditions can greatly affect the patient's quality of life and experience with the healthcare system. Thus, it is vital to implement an interdisciplinary approach in order to comprehensively care for the patient and build a therapeutic relationship with the patient. Establishing short-term and long-term goals through shared decision-making will create a foundation of trust and allow for improved patient experience.

Author and Disclosure Information

Marita Kametas, MSN,  FNP-BC, CMSRN, COCN, Advanced Practice Nurse, Department of Digestive Diseases, The University of Chicago Medicine, Chicage, Illinois

APN Kametas is an active member of the Abbvie Speakers’ Bureau

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Marita Kametas, MSN,  FNP-BC, CMSRN, COCN, Advanced Practice Nurse, Department of Digestive Diseases, The University of Chicago Medicine, Chicage, Illinois

APN Kametas is an active member of the Abbvie Speakers’ Bureau

Author and Disclosure Information

Marita Kametas, MSN,  FNP-BC, CMSRN, COCN, Advanced Practice Nurse, Department of Digestive Diseases, The University of Chicago Medicine, Chicage, Illinois

APN Kametas is an active member of the Abbvie Speakers’ Bureau

APN Kametas scans the journals, so you don’t have to!
APN Kametas scans the journals, so you don’t have to!

Marita Kametas, MSN, FNP-BC, CMSRN, COCN
Three studies this month highlight the increased incidence of irritable bowel syndrome (IBS) in the setting of other chronic diseases, specifically diseases with an effect on the abdomen and pelvis:

  • Fairbrass et al: Natural history and impact of IBS-type symptoms in inflammatory bowel disease during 6 years of longitudinal follow-up
  • Nabi et al: Endometriosis and IBS — a systematic review and meta-analyses
  • Wang et al: Factors related to IBS and differences among subtypes — a cross-sectional study in the UK Biobank

Combined diseases can make assessment and treatment very difficult for clinicians. Having a thorough understanding of the pathophysiology and phenotype of each of these diseases is imperative to ensuring that they are managed to the standard of care. When these diseases are in remission and abdominal symptoms persist, it begs the question what is the cause? IBS should always be in the differential diagnosis. The dynamic relationship between the varying presentations of IBS and co-occurring conditions can greatly affect the patient's quality of life and experience with the healthcare system. Thus, it is vital to implement an interdisciplinary approach in order to comprehensively care for the patient and build a therapeutic relationship with the patient. Establishing short-term and long-term goals through shared decision-making will create a foundation of trust and allow for improved patient experience.

Marita Kametas, MSN, FNP-BC, CMSRN, COCN
Three studies this month highlight the increased incidence of irritable bowel syndrome (IBS) in the setting of other chronic diseases, specifically diseases with an effect on the abdomen and pelvis:

  • Fairbrass et al: Natural history and impact of IBS-type symptoms in inflammatory bowel disease during 6 years of longitudinal follow-up
  • Nabi et al: Endometriosis and IBS — a systematic review and meta-analyses
  • Wang et al: Factors related to IBS and differences among subtypes — a cross-sectional study in the UK Biobank

Combined diseases can make assessment and treatment very difficult for clinicians. Having a thorough understanding of the pathophysiology and phenotype of each of these diseases is imperative to ensuring that they are managed to the standard of care. When these diseases are in remission and abdominal symptoms persist, it begs the question what is the cause? IBS should always be in the differential diagnosis. The dynamic relationship between the varying presentations of IBS and co-occurring conditions can greatly affect the patient's quality of life and experience with the healthcare system. Thus, it is vital to implement an interdisciplinary approach in order to comprehensively care for the patient and build a therapeutic relationship with the patient. Establishing short-term and long-term goals through shared decision-making will create a foundation of trust and allow for improved patient experience.

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Presence of community health workers linked with better results in patients with T2D

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Tue, 09/27/2022 - 16:14

Adding community health workers (CHW) to a primary care setting was linked with improved type 2 diabetes management in a safety-net population, new research indicates.

The researchers, led by Robert L. Ferrer, MD, MPH, with the department of family and community medicine at the University of Texas Health Science Center, San Antonio, enrolled 986 people in a Latino, inner-city cohort in primary care in San Antonio. Patients had uncontrolled type 2 diabetes and psychosocial risk factors. The study was published in Annals of Family Medicine.

The primary outcome measured was whether patients progressed through three stages of self-care: outreach (meeting face to face with a community health care worker), stabilization (collaborating with community health care workers to address life circumstances), and a third stage the researchers called “self-care generativity” (being able to manage blood sugar levels at home). The intervention lasted up to 12 weeks and had a 4-year follow-up.

Of participating patients, the researchers reported, 27% remained in outreach, 41% progressed to stabilization, 32% achieved self-care generativity status.

Coauthor Carlos Roberto Jaén, MD, PhD, also from the UT Health Science Center at San Antonio, said in an interview, “I don’t know any other intervention for diabetes that has 32% of participants having this kind of effect 4 years later.”

Dr. Jaén added that the study is unusual in that it had a 4-year follow-up and showed positive effects throughout that period, as most CHW studies have followed patients only up to one year.

The positive results over the 4 years after a short intervention “is a testimony of the power of intervention,” he said.

A1c drops with more progress in the intervention

The secondary outcome was change in hemoglobin A1c and need for urgent care or emergency department or hospital care.

Study participants who worked with a CHW – regardless of which group they were in at the end of the intervention – collectively saw a 2% drop in blood sugar.

Over a similar time period to when the study was conducted, the researchers analyzed 27,000 A1c measurements of patients with type 2 diabetes in a comparator group. For these patients, who did not receive the study intervention but were part of the same practice as those who received the intervention, the researchers observed a reduction in A1c levels of 0.05%.

Among the study participants, for those who remained in outreach, hospital visits were 6% higher than for those who advanced to the level of self-care generativity, but this difference was not statistically significant. Hospital visits were 90% higher for those who achieved stabilization versus those who remained in outreach (P = .014) The average count of emergency department visits was 74% higher for those who achieved stabilization versus those who achieved self-care generativity, and 31% higher in the group remaining at outreach versus those who reached the highest level of self-care.
 

Advantages of community workers

In San Antonio, the authors noted, type 2 diabetes prevalence is high: 15.5% of its 1.6 million residents have been diagnosed with the disease.

The CHWs built trust with patients and helped them set goals, navigate the health system and connect to community resources. They worked with behavioral health clinicians, nurse care managers, and medical assistants toward population management.

“Community health workers’ detailed understanding of patients’ circumstances help to tailor their care rather than apply fixed interventions,” the authors wrote.

Ricardo Correa, MD, director of the endocrinology, diabetes, and metabolism fellowship program in the University of Arizona, Phoenix, who was not involved with the study, said in an interview he was not surprised by the positive results.

He described the difference when CHWs get involved with type 2 diabetes care, particularly in the Latino community.

“They understand the culture, not just the language,” he said. “They have the trust of the community.”

It’s different when a provider not from the community tells a person with type 2 diabetes he or she needs to eat healthier or exercise more, he said.

The CHW can understand, for instance, that the nearest fresh market may be two towns away and open only on Saturdays and the parks are not safe for exercise outside at certain times of the day. Then they can help the patient find a sustainable solution.

“Community workers also won’t be looking at your immigration status,” something important to many in the Latino community, he explained.

Though this study looked at type 2 diabetes management, community health workers are also effective in other areas, he explained, such as increasing COVID-19 vaccinations, also do them being trustworthy and understanding.
 

 

 

Other study strengths

The group of people with type 2 diabetes they studied has the highest rates of poverty – “the poorest of the poor” – and the highest rates of diabetes-related amputations in San Antonio, Dr. Jaén said.

The intervention “is more focused on what people want to do, less so on the disease,” he explained. People are asked what goals they want to achieve and how the care team can help.

“It becomes an alliance between the community health worker and the patient,” he continued.

Others interested in implementing a program should know that building that relationship takes time and takes a broad multidisciplinary team working together, he said. “We would not necessarily see these effects in 6 months. You have to use a larger perspective.”

The researchers include with this study under the first-page tab “more online” access to tools, including resources for training, for others who want to implement such a program.

The study authors and Dr. Correa reported no relevant financial relationships.

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Adding community health workers (CHW) to a primary care setting was linked with improved type 2 diabetes management in a safety-net population, new research indicates.

The researchers, led by Robert L. Ferrer, MD, MPH, with the department of family and community medicine at the University of Texas Health Science Center, San Antonio, enrolled 986 people in a Latino, inner-city cohort in primary care in San Antonio. Patients had uncontrolled type 2 diabetes and psychosocial risk factors. The study was published in Annals of Family Medicine.

The primary outcome measured was whether patients progressed through three stages of self-care: outreach (meeting face to face with a community health care worker), stabilization (collaborating with community health care workers to address life circumstances), and a third stage the researchers called “self-care generativity” (being able to manage blood sugar levels at home). The intervention lasted up to 12 weeks and had a 4-year follow-up.

Of participating patients, the researchers reported, 27% remained in outreach, 41% progressed to stabilization, 32% achieved self-care generativity status.

Coauthor Carlos Roberto Jaén, MD, PhD, also from the UT Health Science Center at San Antonio, said in an interview, “I don’t know any other intervention for diabetes that has 32% of participants having this kind of effect 4 years later.”

Dr. Jaén added that the study is unusual in that it had a 4-year follow-up and showed positive effects throughout that period, as most CHW studies have followed patients only up to one year.

The positive results over the 4 years after a short intervention “is a testimony of the power of intervention,” he said.

A1c drops with more progress in the intervention

The secondary outcome was change in hemoglobin A1c and need for urgent care or emergency department or hospital care.

Study participants who worked with a CHW – regardless of which group they were in at the end of the intervention – collectively saw a 2% drop in blood sugar.

Over a similar time period to when the study was conducted, the researchers analyzed 27,000 A1c measurements of patients with type 2 diabetes in a comparator group. For these patients, who did not receive the study intervention but were part of the same practice as those who received the intervention, the researchers observed a reduction in A1c levels of 0.05%.

Among the study participants, for those who remained in outreach, hospital visits were 6% higher than for those who advanced to the level of self-care generativity, but this difference was not statistically significant. Hospital visits were 90% higher for those who achieved stabilization versus those who remained in outreach (P = .014) The average count of emergency department visits was 74% higher for those who achieved stabilization versus those who achieved self-care generativity, and 31% higher in the group remaining at outreach versus those who reached the highest level of self-care.
 

Advantages of community workers

In San Antonio, the authors noted, type 2 diabetes prevalence is high: 15.5% of its 1.6 million residents have been diagnosed with the disease.

The CHWs built trust with patients and helped them set goals, navigate the health system and connect to community resources. They worked with behavioral health clinicians, nurse care managers, and medical assistants toward population management.

“Community health workers’ detailed understanding of patients’ circumstances help to tailor their care rather than apply fixed interventions,” the authors wrote.

Ricardo Correa, MD, director of the endocrinology, diabetes, and metabolism fellowship program in the University of Arizona, Phoenix, who was not involved with the study, said in an interview he was not surprised by the positive results.

He described the difference when CHWs get involved with type 2 diabetes care, particularly in the Latino community.

“They understand the culture, not just the language,” he said. “They have the trust of the community.”

It’s different when a provider not from the community tells a person with type 2 diabetes he or she needs to eat healthier or exercise more, he said.

The CHW can understand, for instance, that the nearest fresh market may be two towns away and open only on Saturdays and the parks are not safe for exercise outside at certain times of the day. Then they can help the patient find a sustainable solution.

“Community workers also won’t be looking at your immigration status,” something important to many in the Latino community, he explained.

Though this study looked at type 2 diabetes management, community health workers are also effective in other areas, he explained, such as increasing COVID-19 vaccinations, also do them being trustworthy and understanding.
 

 

 

Other study strengths

The group of people with type 2 diabetes they studied has the highest rates of poverty – “the poorest of the poor” – and the highest rates of diabetes-related amputations in San Antonio, Dr. Jaén said.

The intervention “is more focused on what people want to do, less so on the disease,” he explained. People are asked what goals they want to achieve and how the care team can help.

“It becomes an alliance between the community health worker and the patient,” he continued.

Others interested in implementing a program should know that building that relationship takes time and takes a broad multidisciplinary team working together, he said. “We would not necessarily see these effects in 6 months. You have to use a larger perspective.”

The researchers include with this study under the first-page tab “more online” access to tools, including resources for training, for others who want to implement such a program.

The study authors and Dr. Correa reported no relevant financial relationships.

Adding community health workers (CHW) to a primary care setting was linked with improved type 2 diabetes management in a safety-net population, new research indicates.

The researchers, led by Robert L. Ferrer, MD, MPH, with the department of family and community medicine at the University of Texas Health Science Center, San Antonio, enrolled 986 people in a Latino, inner-city cohort in primary care in San Antonio. Patients had uncontrolled type 2 diabetes and psychosocial risk factors. The study was published in Annals of Family Medicine.

The primary outcome measured was whether patients progressed through three stages of self-care: outreach (meeting face to face with a community health care worker), stabilization (collaborating with community health care workers to address life circumstances), and a third stage the researchers called “self-care generativity” (being able to manage blood sugar levels at home). The intervention lasted up to 12 weeks and had a 4-year follow-up.

Of participating patients, the researchers reported, 27% remained in outreach, 41% progressed to stabilization, 32% achieved self-care generativity status.

Coauthor Carlos Roberto Jaén, MD, PhD, also from the UT Health Science Center at San Antonio, said in an interview, “I don’t know any other intervention for diabetes that has 32% of participants having this kind of effect 4 years later.”

Dr. Jaén added that the study is unusual in that it had a 4-year follow-up and showed positive effects throughout that period, as most CHW studies have followed patients only up to one year.

The positive results over the 4 years after a short intervention “is a testimony of the power of intervention,” he said.

A1c drops with more progress in the intervention

The secondary outcome was change in hemoglobin A1c and need for urgent care or emergency department or hospital care.

Study participants who worked with a CHW – regardless of which group they were in at the end of the intervention – collectively saw a 2% drop in blood sugar.

Over a similar time period to when the study was conducted, the researchers analyzed 27,000 A1c measurements of patients with type 2 diabetes in a comparator group. For these patients, who did not receive the study intervention but were part of the same practice as those who received the intervention, the researchers observed a reduction in A1c levels of 0.05%.

Among the study participants, for those who remained in outreach, hospital visits were 6% higher than for those who advanced to the level of self-care generativity, but this difference was not statistically significant. Hospital visits were 90% higher for those who achieved stabilization versus those who remained in outreach (P = .014) The average count of emergency department visits was 74% higher for those who achieved stabilization versus those who achieved self-care generativity, and 31% higher in the group remaining at outreach versus those who reached the highest level of self-care.
 

Advantages of community workers

In San Antonio, the authors noted, type 2 diabetes prevalence is high: 15.5% of its 1.6 million residents have been diagnosed with the disease.

The CHWs built trust with patients and helped them set goals, navigate the health system and connect to community resources. They worked with behavioral health clinicians, nurse care managers, and medical assistants toward population management.

“Community health workers’ detailed understanding of patients’ circumstances help to tailor their care rather than apply fixed interventions,” the authors wrote.

Ricardo Correa, MD, director of the endocrinology, diabetes, and metabolism fellowship program in the University of Arizona, Phoenix, who was not involved with the study, said in an interview he was not surprised by the positive results.

He described the difference when CHWs get involved with type 2 diabetes care, particularly in the Latino community.

“They understand the culture, not just the language,” he said. “They have the trust of the community.”

It’s different when a provider not from the community tells a person with type 2 diabetes he or she needs to eat healthier or exercise more, he said.

The CHW can understand, for instance, that the nearest fresh market may be two towns away and open only on Saturdays and the parks are not safe for exercise outside at certain times of the day. Then they can help the patient find a sustainable solution.

“Community workers also won’t be looking at your immigration status,” something important to many in the Latino community, he explained.

Though this study looked at type 2 diabetes management, community health workers are also effective in other areas, he explained, such as increasing COVID-19 vaccinations, also do them being trustworthy and understanding.
 

 

 

Other study strengths

The group of people with type 2 diabetes they studied has the highest rates of poverty – “the poorest of the poor” – and the highest rates of diabetes-related amputations in San Antonio, Dr. Jaén said.

The intervention “is more focused on what people want to do, less so on the disease,” he explained. People are asked what goals they want to achieve and how the care team can help.

“It becomes an alliance between the community health worker and the patient,” he continued.

Others interested in implementing a program should know that building that relationship takes time and takes a broad multidisciplinary team working together, he said. “We would not necessarily see these effects in 6 months. You have to use a larger perspective.”

The researchers include with this study under the first-page tab “more online” access to tools, including resources for training, for others who want to implement such a program.

The study authors and Dr. Correa reported no relevant financial relationships.

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Psoriasis, psoriatic arthritis insurance coverage remains restrictive

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Tue, 02/07/2023 - 16:38

Insurance coverage for specialty drugs to treat psoriasis and psoriatic arthritis varies extensively among insurance companies and often restricts coverage beyond the drug labels, according to a review of data from commercial health plans in the United States.

Although specialty medications have demonstrated effectiveness for psoriasis and psoriatic arthritis, data on insurance coverage for these indications are limited and costs are often a barrier to treatment, Christine Learned, of Tufts Medical Center, Boston, and colleagues wrote.

Catalin205/Thinkstock

In a study published in the Journal of Psoriasis and Psoriatic Arthritis, the researchers used the Tufts Medical Center Specialty Drug Evidence and Coverage database, which includes information on 158 specialty drugs covered by 17 U.S. commercial health plans, to review data on a total of 11 medications indicated for psoriasis (etanercept, adalimumab, certolizumab pegol, secukinumab, ixekizumab, brodalumab, ustekinumab, guselkumab, tildrakizumab, risankizumab, and apremilast) and 11 indicated for psoriatic arthritis (etanercept, adalimumab, certolizumab pegol, golimumab, secukinumab, ixekizumab, ustekinumab, guselkumab, tofacitinib, apremilast, and abatacept) at the time of the study.

Overall, an average of 78.6% and 66.8% of insurance plans were more restrictive than the Food and Drug Association label in coverage of specialty medications for psoriasis and psoriatic arthritis, respectively.

Disease severity affected insurance coverage for psoriasis. The percentage of plans with a body surface area requirement for specialty medications ranged from 11% for apremilast to 39% for tildrakizumab, adalimumab, and certolizumab pegol. The percentage of plans with exceptions for special body locations affected by psoriasis ranged from 6% for risankizumab and brodalumab to 39% for certolizumab pegol. In addition, 6% of plans had Psoriasis Area and Severity Index requirements for etanercept and ixekizumab, and 11% had PASI requirements for adalimumab, certolizumab pegol, and tildrakizumab.

The percentage of plans with prescriber restrictions for both psoriasis and psoriatic arthritis ranged from 33% to 50%.

All 11 medications for psoriatic arthritis were approved as first-line treatments by at least one plan, compared with 3 the 11 medications with indications for psoriasis. However, medications for both psoriasis and psoriatic arthritis were approved mainly as second-line therapies.

Study designs may impact insurance coverage, as randomized, controlled trials are often used as the basis for coverage decisions for psoriasis, while coverage for psoriatic arthritis is more often based on clinical guidelines, the researchers explained.

“Our analysis confirms that variability exists for the indications of psoriasis and psoriatic arthritis,” they wrote.

The comorbidities associated with psoriasis are not always considered in insurance coverage, and coverage complications may contribute to the persistent undertreatment of many patients with psoriasis, the researchers added.

“Insurance restrictions may blunt provider and patient autonomy in selection of specialty medications and have the potential to diminish a provider’s ability to tailor regimens so as to optimize outcomes while minimizing risks,” they emphasized.

The study findings were limited by the inclusion only of publicly available policy information; therefore, some plans’ restrictions may have been missed in the analysis, the researchers said.

The results suggest that patients should review their insurance coverage of specialty drugs when choosing a health plan, and clinicians should factor in a patient’s plan a likely drug access when considering treatment options, they concluded.

The study received no outside funding. Ms. Learned had no relevant financial conflicts to disclose, but two coauthors reported financial relationships with pharmaceutical companies that manufacturer drugs for psoriasis and psoriatic arthritis.

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Insurance coverage for specialty drugs to treat psoriasis and psoriatic arthritis varies extensively among insurance companies and often restricts coverage beyond the drug labels, according to a review of data from commercial health plans in the United States.

Although specialty medications have demonstrated effectiveness for psoriasis and psoriatic arthritis, data on insurance coverage for these indications are limited and costs are often a barrier to treatment, Christine Learned, of Tufts Medical Center, Boston, and colleagues wrote.

Catalin205/Thinkstock

In a study published in the Journal of Psoriasis and Psoriatic Arthritis, the researchers used the Tufts Medical Center Specialty Drug Evidence and Coverage database, which includes information on 158 specialty drugs covered by 17 U.S. commercial health plans, to review data on a total of 11 medications indicated for psoriasis (etanercept, adalimumab, certolizumab pegol, secukinumab, ixekizumab, brodalumab, ustekinumab, guselkumab, tildrakizumab, risankizumab, and apremilast) and 11 indicated for psoriatic arthritis (etanercept, adalimumab, certolizumab pegol, golimumab, secukinumab, ixekizumab, ustekinumab, guselkumab, tofacitinib, apremilast, and abatacept) at the time of the study.

Overall, an average of 78.6% and 66.8% of insurance plans were more restrictive than the Food and Drug Association label in coverage of specialty medications for psoriasis and psoriatic arthritis, respectively.

Disease severity affected insurance coverage for psoriasis. The percentage of plans with a body surface area requirement for specialty medications ranged from 11% for apremilast to 39% for tildrakizumab, adalimumab, and certolizumab pegol. The percentage of plans with exceptions for special body locations affected by psoriasis ranged from 6% for risankizumab and brodalumab to 39% for certolizumab pegol. In addition, 6% of plans had Psoriasis Area and Severity Index requirements for etanercept and ixekizumab, and 11% had PASI requirements for adalimumab, certolizumab pegol, and tildrakizumab.

The percentage of plans with prescriber restrictions for both psoriasis and psoriatic arthritis ranged from 33% to 50%.

All 11 medications for psoriatic arthritis were approved as first-line treatments by at least one plan, compared with 3 the 11 medications with indications for psoriasis. However, medications for both psoriasis and psoriatic arthritis were approved mainly as second-line therapies.

Study designs may impact insurance coverage, as randomized, controlled trials are often used as the basis for coverage decisions for psoriasis, while coverage for psoriatic arthritis is more often based on clinical guidelines, the researchers explained.

“Our analysis confirms that variability exists for the indications of psoriasis and psoriatic arthritis,” they wrote.

The comorbidities associated with psoriasis are not always considered in insurance coverage, and coverage complications may contribute to the persistent undertreatment of many patients with psoriasis, the researchers added.

“Insurance restrictions may blunt provider and patient autonomy in selection of specialty medications and have the potential to diminish a provider’s ability to tailor regimens so as to optimize outcomes while minimizing risks,” they emphasized.

The study findings were limited by the inclusion only of publicly available policy information; therefore, some plans’ restrictions may have been missed in the analysis, the researchers said.

The results suggest that patients should review their insurance coverage of specialty drugs when choosing a health plan, and clinicians should factor in a patient’s plan a likely drug access when considering treatment options, they concluded.

The study received no outside funding. Ms. Learned had no relevant financial conflicts to disclose, but two coauthors reported financial relationships with pharmaceutical companies that manufacturer drugs for psoriasis and psoriatic arthritis.

Insurance coverage for specialty drugs to treat psoriasis and psoriatic arthritis varies extensively among insurance companies and often restricts coverage beyond the drug labels, according to a review of data from commercial health plans in the United States.

Although specialty medications have demonstrated effectiveness for psoriasis and psoriatic arthritis, data on insurance coverage for these indications are limited and costs are often a barrier to treatment, Christine Learned, of Tufts Medical Center, Boston, and colleagues wrote.

Catalin205/Thinkstock

In a study published in the Journal of Psoriasis and Psoriatic Arthritis, the researchers used the Tufts Medical Center Specialty Drug Evidence and Coverage database, which includes information on 158 specialty drugs covered by 17 U.S. commercial health plans, to review data on a total of 11 medications indicated for psoriasis (etanercept, adalimumab, certolizumab pegol, secukinumab, ixekizumab, brodalumab, ustekinumab, guselkumab, tildrakizumab, risankizumab, and apremilast) and 11 indicated for psoriatic arthritis (etanercept, adalimumab, certolizumab pegol, golimumab, secukinumab, ixekizumab, ustekinumab, guselkumab, tofacitinib, apremilast, and abatacept) at the time of the study.

Overall, an average of 78.6% and 66.8% of insurance plans were more restrictive than the Food and Drug Association label in coverage of specialty medications for psoriasis and psoriatic arthritis, respectively.

Disease severity affected insurance coverage for psoriasis. The percentage of plans with a body surface area requirement for specialty medications ranged from 11% for apremilast to 39% for tildrakizumab, adalimumab, and certolizumab pegol. The percentage of plans with exceptions for special body locations affected by psoriasis ranged from 6% for risankizumab and brodalumab to 39% for certolizumab pegol. In addition, 6% of plans had Psoriasis Area and Severity Index requirements for etanercept and ixekizumab, and 11% had PASI requirements for adalimumab, certolizumab pegol, and tildrakizumab.

The percentage of plans with prescriber restrictions for both psoriasis and psoriatic arthritis ranged from 33% to 50%.

All 11 medications for psoriatic arthritis were approved as first-line treatments by at least one plan, compared with 3 the 11 medications with indications for psoriasis. However, medications for both psoriasis and psoriatic arthritis were approved mainly as second-line therapies.

Study designs may impact insurance coverage, as randomized, controlled trials are often used as the basis for coverage decisions for psoriasis, while coverage for psoriatic arthritis is more often based on clinical guidelines, the researchers explained.

“Our analysis confirms that variability exists for the indications of psoriasis and psoriatic arthritis,” they wrote.

The comorbidities associated with psoriasis are not always considered in insurance coverage, and coverage complications may contribute to the persistent undertreatment of many patients with psoriasis, the researchers added.

“Insurance restrictions may blunt provider and patient autonomy in selection of specialty medications and have the potential to diminish a provider’s ability to tailor regimens so as to optimize outcomes while minimizing risks,” they emphasized.

The study findings were limited by the inclusion only of publicly available policy information; therefore, some plans’ restrictions may have been missed in the analysis, the researchers said.

The results suggest that patients should review their insurance coverage of specialty drugs when choosing a health plan, and clinicians should factor in a patient’s plan a likely drug access when considering treatment options, they concluded.

The study received no outside funding. Ms. Learned had no relevant financial conflicts to disclose, but two coauthors reported financial relationships with pharmaceutical companies that manufacturer drugs for psoriasis and psoriatic arthritis.

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Minorities hit especially hard by overdose deaths during COVID

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Mon, 09/26/2022 - 11:19

Drug overdose deaths rose significantly during the COVID-19 pandemic, but more so among Blacks and Native American and Alaska Native people.

The results underscore the “urgency of expanding prevention, treatment, and harm reduction interventions tailored to specific populations, especially American Indian or Alaska Native and Black populations, given long-standing structural racism and inequities in accessing these services,” the researchers note.

The study was published online in JAMA Network Open.
 

‘Urgent need’ for education

From February 2020 to August 2021, drug overdose deaths in the United States rose 37%, and these deaths were largely due to synthetic opioids other than methadone – primarily fentanyl or analogs – and methamphetamine.

Yet, data are lacking regarding racial and ethnic disparities in overdose death rates.

To investigate, Beth Han, MD, PhD, with the National Institute on Drug Abuse, and colleagues analyzed federal drug overdose death data for individuals aged 15-34 and 35-64 from March 2018 to August 2021.

Among individuals aged 15-34, from March 2018 to August 2021, overdose death rates involving any drug, fentanyl, and methamphetamine with or without fentanyl, increased overall.

For the 6 months from March to August 2021, non-Hispanic Native American or Alaska Native men had the highest rates overall involving any drug, fentanyl, and methamphetamine without fentanyl, with rates of 42.0, 30.2, and 6.0 per 100,000, respectively.

The highest rates (per 100,000) of drug overdose deaths involving methamphetamine with fentanyl were for Native American or Alaska Native men (9.2) and women (8.0) and non-Hispanic White men (6.7).

Among people aged 35-64, from March to August 2021, overall drug overdose rates (per 100,000) were highest among non-Hispanic Black men (61.2) and Native American or Alaska Native men (60.0), and fentanyl-involved death rates were highest among Black men (43.3).

Rates involving methamphetamine with fentanyl were highest among Native American or Alaska Native men (12.6) and women (9.4) and White men (9.5).

Rates involving methamphetamine without fentanyl were highest among Native American or Alaska Native men (22.9).

The researchers note the findings highlight the “urgent need” for education on dangers of methamphetamine and fentanyl.

Expanding access to naloxone, fentanyl test strips, and treatments for substance use disorders to disproportionately affected populations is also critical to help curb disparities in drug overdose deaths, they add.

Limitations of the study are that overdose deaths may be underestimated because of the use of 2021 provisional data and that racial or ethnic identification may be misclassified, especially for Native American or Alaska Native people.

This study was sponsored by the National Institute on Drug Abuse of the National Institutes of Health and the Centers for Disease Control and Prevention. The authors report no relevant disclosures.

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

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Drug overdose deaths rose significantly during the COVID-19 pandemic, but more so among Blacks and Native American and Alaska Native people.

The results underscore the “urgency of expanding prevention, treatment, and harm reduction interventions tailored to specific populations, especially American Indian or Alaska Native and Black populations, given long-standing structural racism and inequities in accessing these services,” the researchers note.

The study was published online in JAMA Network Open.
 

‘Urgent need’ for education

From February 2020 to August 2021, drug overdose deaths in the United States rose 37%, and these deaths were largely due to synthetic opioids other than methadone – primarily fentanyl or analogs – and methamphetamine.

Yet, data are lacking regarding racial and ethnic disparities in overdose death rates.

To investigate, Beth Han, MD, PhD, with the National Institute on Drug Abuse, and colleagues analyzed federal drug overdose death data for individuals aged 15-34 and 35-64 from March 2018 to August 2021.

Among individuals aged 15-34, from March 2018 to August 2021, overdose death rates involving any drug, fentanyl, and methamphetamine with or without fentanyl, increased overall.

For the 6 months from March to August 2021, non-Hispanic Native American or Alaska Native men had the highest rates overall involving any drug, fentanyl, and methamphetamine without fentanyl, with rates of 42.0, 30.2, and 6.0 per 100,000, respectively.

The highest rates (per 100,000) of drug overdose deaths involving methamphetamine with fentanyl were for Native American or Alaska Native men (9.2) and women (8.0) and non-Hispanic White men (6.7).

Among people aged 35-64, from March to August 2021, overall drug overdose rates (per 100,000) were highest among non-Hispanic Black men (61.2) and Native American or Alaska Native men (60.0), and fentanyl-involved death rates were highest among Black men (43.3).

Rates involving methamphetamine with fentanyl were highest among Native American or Alaska Native men (12.6) and women (9.4) and White men (9.5).

Rates involving methamphetamine without fentanyl were highest among Native American or Alaska Native men (22.9).

The researchers note the findings highlight the “urgent need” for education on dangers of methamphetamine and fentanyl.

Expanding access to naloxone, fentanyl test strips, and treatments for substance use disorders to disproportionately affected populations is also critical to help curb disparities in drug overdose deaths, they add.

Limitations of the study are that overdose deaths may be underestimated because of the use of 2021 provisional data and that racial or ethnic identification may be misclassified, especially for Native American or Alaska Native people.

This study was sponsored by the National Institute on Drug Abuse of the National Institutes of Health and the Centers for Disease Control and Prevention. The authors report no relevant disclosures.

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

Drug overdose deaths rose significantly during the COVID-19 pandemic, but more so among Blacks and Native American and Alaska Native people.

The results underscore the “urgency of expanding prevention, treatment, and harm reduction interventions tailored to specific populations, especially American Indian or Alaska Native and Black populations, given long-standing structural racism and inequities in accessing these services,” the researchers note.

The study was published online in JAMA Network Open.
 

‘Urgent need’ for education

From February 2020 to August 2021, drug overdose deaths in the United States rose 37%, and these deaths were largely due to synthetic opioids other than methadone – primarily fentanyl or analogs – and methamphetamine.

Yet, data are lacking regarding racial and ethnic disparities in overdose death rates.

To investigate, Beth Han, MD, PhD, with the National Institute on Drug Abuse, and colleagues analyzed federal drug overdose death data for individuals aged 15-34 and 35-64 from March 2018 to August 2021.

Among individuals aged 15-34, from March 2018 to August 2021, overdose death rates involving any drug, fentanyl, and methamphetamine with or without fentanyl, increased overall.

For the 6 months from March to August 2021, non-Hispanic Native American or Alaska Native men had the highest rates overall involving any drug, fentanyl, and methamphetamine without fentanyl, with rates of 42.0, 30.2, and 6.0 per 100,000, respectively.

The highest rates (per 100,000) of drug overdose deaths involving methamphetamine with fentanyl were for Native American or Alaska Native men (9.2) and women (8.0) and non-Hispanic White men (6.7).

Among people aged 35-64, from March to August 2021, overall drug overdose rates (per 100,000) were highest among non-Hispanic Black men (61.2) and Native American or Alaska Native men (60.0), and fentanyl-involved death rates were highest among Black men (43.3).

Rates involving methamphetamine with fentanyl were highest among Native American or Alaska Native men (12.6) and women (9.4) and White men (9.5).

Rates involving methamphetamine without fentanyl were highest among Native American or Alaska Native men (22.9).

The researchers note the findings highlight the “urgent need” for education on dangers of methamphetamine and fentanyl.

Expanding access to naloxone, fentanyl test strips, and treatments for substance use disorders to disproportionately affected populations is also critical to help curb disparities in drug overdose deaths, they add.

Limitations of the study are that overdose deaths may be underestimated because of the use of 2021 provisional data and that racial or ethnic identification may be misclassified, especially for Native American or Alaska Native people.

This study was sponsored by the National Institute on Drug Abuse of the National Institutes of Health and the Centers for Disease Control and Prevention. The authors report no relevant disclosures.

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

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Desperate long COVID patients turn to unproven alternative therapies

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Wed, 09/28/2022 - 18:45

Entrepreneur Maya McNulty, 49, was one of the first victims of the COVID-19 pandemic. The Schenectady, N.Y., businesswoman spent 2 months in the hospital after catching the disease in March 2020. That September, she was diagnosed with long COVID.

“Even a simple task such as unloading the dishwasher became a major challenge,” she says.

Over the next several months, Ms. McNulty saw a range of specialists, including neurologists, pulmonologists, and cardiologists. She had months of physical therapy and respiratory therapy to help regain strength and lung function. While many of the doctors she saw were sympathetic to what she was going through, not all were.

“I saw one neurologist who told me to my face that she didn’t believe in long COVID,” she recalls. “It was particularly astonishing since the hospital they were affiliated with had a long COVID clinic.”

Ms. McNulty began to connect with other patients with long COVID through a support group she created at the end of 2020 on the social media app Clubhouse. They exchanged ideas and stories about what had helped one another, which led her to try, over the next year, a plant-based diet, Chinese medicine, and vitamin C supplements, among other treatments.

She also acted on unscientific reports she found online and did her own research, which led her to discover claims that some asthma patients with chronic coughing responded well to halotherapy, or dry salt therapy, during which patients inhale micro-particles of salt into their lungs to reduce inflammation, widen airways, and thin mucus. She’s been doing this procedure at a clinic near her home for over a year and credits it with helping with her chronic cough, especially as she recovers from her second bout of COVID-19.

It’s not cheap – a single half-hour session can cost up to $50 and isn’t covered by insurance. There’s also no good research to suggest that it can help with long COVID, according to the Cleveland Clinic.

Ms. McNulty understands that but says many people who live with long COVID turn to these treatments out of a sense of desperation.

“When it comes to this condition, we kind of have to be our own advocates. People are so desperate and feel so gaslit by doctors who don’t believe in their symptoms that they play Russian roulette with their body,” she says. “Most just want some hope and a way to relieve pain.”

Across the country, 16 million Americans have long COVID, according to the Brookings Institution’s analysis of a 2022 Census Bureau report. The report also estimated that up to a quarter of them have such debilitating symptoms that they are no longer able to work. While long COVID centers may offer therapies to help relieve symptoms, “there are no evidence-based established treatments for long COVID at this point,” says Andrew Schamess, MD, a professor of internal medicine at Ohio State Wexner Medical Center, who runs its Post-COVID Recovery Program. “You can’t blame patients for looking for alternative remedies to help them. Unfortunately, there are also a lot of people out to make a buck who are selling unproven and disproven therapies.”
 

 

 

Sniffing out the snake oil

With few evidence-based treatments for long COVID, patients with debilitating symptoms can be tempted by unproven options. One that has gotten a lot of attention is hyperbaric oxygen. This therapy has traditionally been used to treat divers who have decompression sickness, or “the bends.” It’s also being touted by some clinics as an effective treatment for long COVID.

A very small trial of 73 patients with long COVID, published in the journal Scientific Reports, found that those treated in a high-pressure oxygen system 5 days a week for 2 months showed improvements in brain fog, pain, energy, sleep, anxiety, and depression, compared with similar patients who got sham treatments. But larger studies are needed to show how well it works, notes Dr. Schamess.

“It’s very expensive – roughly $120 per session – and there just isn’t the evidence there to support its use,” he says.

In addition, the therapy itself carries risks, such as ear and sinus pain, middle ear injury, temporary vision changes, and, very rarely, lung collapse, according to the U.S. Food and Drug Administration.

One “particularly troubling” treatment being offered, says Kathleen Bell, MD, chair of the department of physical medicine and rehabilitation at the University of Texas Southwestern Medical Center, is stem cell therapy. This therapy is still in its infancy, but it’s being marketed by some clinics as a way to prevent COVID-19 and also treat long-haul symptoms.

The FDA has issued advisories that there are no products approved to treat long COVID and recommends against their use, except in a clinical trial.

“There’s absolutely no regulation – you don’t know what you’re getting, and there’s no research to suggest this therapy even works,” says Dr. Bell. It’s also prohibitively expensive – one Cayman Islands–based company advertises its treatment for as much as $25,000.

Patients with long COVID are even traveling as far as Cyprus, Germany, and Switzerland for a procedure known as blood washing, in which large needles are inserted into veins to filter blood and remove lipids and inflammatory proteins, the British Medical Journal reported in July. Some patients are also prescribed blood thinners to remove microscopic blood clots that may contribute to long COVID. But this treatment is also expensive, with many people paying $10,000-$15,000 out of pocket, and there’s no published evidence to suggest it works, according to the BMJ.

It can be particularly hard to discern what may work and what’s unproven, since many primary care providers are themselves unfamiliar with even traditional long COVID treatments, Dr. Bell says.
 

Sorting through supplements

Yufang Lin, MD, an integrative specialist at the Cleveland Clinic, says many patients with long COVID enter her office with bags of supplements.

“There’s no data on them, and in large quantities, they may even be harmful,” she says.

Instead, she works closely with the Cleveland Clinic’s long COVID center to do a thorough workup of each patient, which often includes screening for certain nutritional deficiencies.

“Anecdotally, we do see many patients with long COVID who are deficient in these vitamins and minerals,” says Dr. Lin. “If someone is low, we will suggest the appropriate supplement. Otherwise, we work with them to institute some dietary changes.”

This usually involves a plant-based, anti-inflammatory eating pattern such as the Mediterranean diet, which is rich in fruits, vegetables, whole grains, nuts, fatty fish, and healthy fats such as olive oil and avocados.

Other supplements some doctors recommend for patients with long COVID are meant to treat inflammation, Dr. Bell says, although there’s not good evidence they work. One is the antioxidant coenzyme Q10.

But a small preprint study published in The Lancet, of 121 patients with long COVID who took 500 milligrams a day of coenzyme Q10 for 6 weeks saw no differences in recovery, compared with those who took a placebo. Because the study is still a preprint, it has not been peer-reviewed.

Another is probiotics. A small study, published in the journal Infectious Diseases Diagnosis & Treatment, found that a blend of five lactobacillus probiotics, along with a prebiotic called inulin, taken for 30 days, helped with long-term COVID symptoms such as coughing and fatigue. But larger studies need to be done to support their use.

One that may have more promise is omega-3 fatty acids. Like many other supplements, these may help with long COVID by easing inflammation, says Steven Flanagan, MD, a rehabilitation medicine specialist at NYU Langone who works with long COVID patients. Researchers at the Mount Sinai School of Medicine, New York, are studying whether a supplement can help patients who have lost their sense of taste or smell after an infection, but results aren’t yet available.

Among the few alternatives that have been shown to help patients are mindfulness-based therapies – in particular, mindfulness-based forms of exercise such as tai chi and qi gong may be helpful, as they combine a gentle workout with stress reduction.

“Both incorporate meditation, which helps not only to relieve some of the anxiety associated with long COVID but allows patients to redirect their thought process so that they can cope with symptoms better,” says Dr. Flanagan.

A 2022 study, published in BMJ Open, found that these two activities reduced inflammatory markers and improved respiratory muscle strength and function in patients recovering from COVID-19.

“I recommend these activities to all my long COVID patients, as it’s inexpensive and easy to find classes to do either at home or in their community,” he says. “Even if it doesn’t improve their long COVID symptoms, it has other benefits such as increased strength and flexibility that can boost their overall health.”

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

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Entrepreneur Maya McNulty, 49, was one of the first victims of the COVID-19 pandemic. The Schenectady, N.Y., businesswoman spent 2 months in the hospital after catching the disease in March 2020. That September, she was diagnosed with long COVID.

“Even a simple task such as unloading the dishwasher became a major challenge,” she says.

Over the next several months, Ms. McNulty saw a range of specialists, including neurologists, pulmonologists, and cardiologists. She had months of physical therapy and respiratory therapy to help regain strength and lung function. While many of the doctors she saw were sympathetic to what she was going through, not all were.

“I saw one neurologist who told me to my face that she didn’t believe in long COVID,” she recalls. “It was particularly astonishing since the hospital they were affiliated with had a long COVID clinic.”

Ms. McNulty began to connect with other patients with long COVID through a support group she created at the end of 2020 on the social media app Clubhouse. They exchanged ideas and stories about what had helped one another, which led her to try, over the next year, a plant-based diet, Chinese medicine, and vitamin C supplements, among other treatments.

She also acted on unscientific reports she found online and did her own research, which led her to discover claims that some asthma patients with chronic coughing responded well to halotherapy, or dry salt therapy, during which patients inhale micro-particles of salt into their lungs to reduce inflammation, widen airways, and thin mucus. She’s been doing this procedure at a clinic near her home for over a year and credits it with helping with her chronic cough, especially as she recovers from her second bout of COVID-19.

It’s not cheap – a single half-hour session can cost up to $50 and isn’t covered by insurance. There’s also no good research to suggest that it can help with long COVID, according to the Cleveland Clinic.

Ms. McNulty understands that but says many people who live with long COVID turn to these treatments out of a sense of desperation.

“When it comes to this condition, we kind of have to be our own advocates. People are so desperate and feel so gaslit by doctors who don’t believe in their symptoms that they play Russian roulette with their body,” she says. “Most just want some hope and a way to relieve pain.”

Across the country, 16 million Americans have long COVID, according to the Brookings Institution’s analysis of a 2022 Census Bureau report. The report also estimated that up to a quarter of them have such debilitating symptoms that they are no longer able to work. While long COVID centers may offer therapies to help relieve symptoms, “there are no evidence-based established treatments for long COVID at this point,” says Andrew Schamess, MD, a professor of internal medicine at Ohio State Wexner Medical Center, who runs its Post-COVID Recovery Program. “You can’t blame patients for looking for alternative remedies to help them. Unfortunately, there are also a lot of people out to make a buck who are selling unproven and disproven therapies.”
 

 

 

Sniffing out the snake oil

With few evidence-based treatments for long COVID, patients with debilitating symptoms can be tempted by unproven options. One that has gotten a lot of attention is hyperbaric oxygen. This therapy has traditionally been used to treat divers who have decompression sickness, or “the bends.” It’s also being touted by some clinics as an effective treatment for long COVID.

A very small trial of 73 patients with long COVID, published in the journal Scientific Reports, found that those treated in a high-pressure oxygen system 5 days a week for 2 months showed improvements in brain fog, pain, energy, sleep, anxiety, and depression, compared with similar patients who got sham treatments. But larger studies are needed to show how well it works, notes Dr. Schamess.

“It’s very expensive – roughly $120 per session – and there just isn’t the evidence there to support its use,” he says.

In addition, the therapy itself carries risks, such as ear and sinus pain, middle ear injury, temporary vision changes, and, very rarely, lung collapse, according to the U.S. Food and Drug Administration.

One “particularly troubling” treatment being offered, says Kathleen Bell, MD, chair of the department of physical medicine and rehabilitation at the University of Texas Southwestern Medical Center, is stem cell therapy. This therapy is still in its infancy, but it’s being marketed by some clinics as a way to prevent COVID-19 and also treat long-haul symptoms.

The FDA has issued advisories that there are no products approved to treat long COVID and recommends against their use, except in a clinical trial.

“There’s absolutely no regulation – you don’t know what you’re getting, and there’s no research to suggest this therapy even works,” says Dr. Bell. It’s also prohibitively expensive – one Cayman Islands–based company advertises its treatment for as much as $25,000.

Patients with long COVID are even traveling as far as Cyprus, Germany, and Switzerland for a procedure known as blood washing, in which large needles are inserted into veins to filter blood and remove lipids and inflammatory proteins, the British Medical Journal reported in July. Some patients are also prescribed blood thinners to remove microscopic blood clots that may contribute to long COVID. But this treatment is also expensive, with many people paying $10,000-$15,000 out of pocket, and there’s no published evidence to suggest it works, according to the BMJ.

It can be particularly hard to discern what may work and what’s unproven, since many primary care providers are themselves unfamiliar with even traditional long COVID treatments, Dr. Bell says.
 

Sorting through supplements

Yufang Lin, MD, an integrative specialist at the Cleveland Clinic, says many patients with long COVID enter her office with bags of supplements.

“There’s no data on them, and in large quantities, they may even be harmful,” she says.

Instead, she works closely with the Cleveland Clinic’s long COVID center to do a thorough workup of each patient, which often includes screening for certain nutritional deficiencies.

“Anecdotally, we do see many patients with long COVID who are deficient in these vitamins and minerals,” says Dr. Lin. “If someone is low, we will suggest the appropriate supplement. Otherwise, we work with them to institute some dietary changes.”

This usually involves a plant-based, anti-inflammatory eating pattern such as the Mediterranean diet, which is rich in fruits, vegetables, whole grains, nuts, fatty fish, and healthy fats such as olive oil and avocados.

Other supplements some doctors recommend for patients with long COVID are meant to treat inflammation, Dr. Bell says, although there’s not good evidence they work. One is the antioxidant coenzyme Q10.

But a small preprint study published in The Lancet, of 121 patients with long COVID who took 500 milligrams a day of coenzyme Q10 for 6 weeks saw no differences in recovery, compared with those who took a placebo. Because the study is still a preprint, it has not been peer-reviewed.

Another is probiotics. A small study, published in the journal Infectious Diseases Diagnosis & Treatment, found that a blend of five lactobacillus probiotics, along with a prebiotic called inulin, taken for 30 days, helped with long-term COVID symptoms such as coughing and fatigue. But larger studies need to be done to support their use.

One that may have more promise is omega-3 fatty acids. Like many other supplements, these may help with long COVID by easing inflammation, says Steven Flanagan, MD, a rehabilitation medicine specialist at NYU Langone who works with long COVID patients. Researchers at the Mount Sinai School of Medicine, New York, are studying whether a supplement can help patients who have lost their sense of taste or smell after an infection, but results aren’t yet available.

Among the few alternatives that have been shown to help patients are mindfulness-based therapies – in particular, mindfulness-based forms of exercise such as tai chi and qi gong may be helpful, as they combine a gentle workout with stress reduction.

“Both incorporate meditation, which helps not only to relieve some of the anxiety associated with long COVID but allows patients to redirect their thought process so that they can cope with symptoms better,” says Dr. Flanagan.

A 2022 study, published in BMJ Open, found that these two activities reduced inflammatory markers and improved respiratory muscle strength and function in patients recovering from COVID-19.

“I recommend these activities to all my long COVID patients, as it’s inexpensive and easy to find classes to do either at home or in their community,” he says. “Even if it doesn’t improve their long COVID symptoms, it has other benefits such as increased strength and flexibility that can boost their overall health.”

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

Entrepreneur Maya McNulty, 49, was one of the first victims of the COVID-19 pandemic. The Schenectady, N.Y., businesswoman spent 2 months in the hospital after catching the disease in March 2020. That September, she was diagnosed with long COVID.

“Even a simple task such as unloading the dishwasher became a major challenge,” she says.

Over the next several months, Ms. McNulty saw a range of specialists, including neurologists, pulmonologists, and cardiologists. She had months of physical therapy and respiratory therapy to help regain strength and lung function. While many of the doctors she saw were sympathetic to what she was going through, not all were.

“I saw one neurologist who told me to my face that she didn’t believe in long COVID,” she recalls. “It was particularly astonishing since the hospital they were affiliated with had a long COVID clinic.”

Ms. McNulty began to connect with other patients with long COVID through a support group she created at the end of 2020 on the social media app Clubhouse. They exchanged ideas and stories about what had helped one another, which led her to try, over the next year, a plant-based diet, Chinese medicine, and vitamin C supplements, among other treatments.

She also acted on unscientific reports she found online and did her own research, which led her to discover claims that some asthma patients with chronic coughing responded well to halotherapy, or dry salt therapy, during which patients inhale micro-particles of salt into their lungs to reduce inflammation, widen airways, and thin mucus. She’s been doing this procedure at a clinic near her home for over a year and credits it with helping with her chronic cough, especially as she recovers from her second bout of COVID-19.

It’s not cheap – a single half-hour session can cost up to $50 and isn’t covered by insurance. There’s also no good research to suggest that it can help with long COVID, according to the Cleveland Clinic.

Ms. McNulty understands that but says many people who live with long COVID turn to these treatments out of a sense of desperation.

“When it comes to this condition, we kind of have to be our own advocates. People are so desperate and feel so gaslit by doctors who don’t believe in their symptoms that they play Russian roulette with their body,” she says. “Most just want some hope and a way to relieve pain.”

Across the country, 16 million Americans have long COVID, according to the Brookings Institution’s analysis of a 2022 Census Bureau report. The report also estimated that up to a quarter of them have such debilitating symptoms that they are no longer able to work. While long COVID centers may offer therapies to help relieve symptoms, “there are no evidence-based established treatments for long COVID at this point,” says Andrew Schamess, MD, a professor of internal medicine at Ohio State Wexner Medical Center, who runs its Post-COVID Recovery Program. “You can’t blame patients for looking for alternative remedies to help them. Unfortunately, there are also a lot of people out to make a buck who are selling unproven and disproven therapies.”
 

 

 

Sniffing out the snake oil

With few evidence-based treatments for long COVID, patients with debilitating symptoms can be tempted by unproven options. One that has gotten a lot of attention is hyperbaric oxygen. This therapy has traditionally been used to treat divers who have decompression sickness, or “the bends.” It’s also being touted by some clinics as an effective treatment for long COVID.

A very small trial of 73 patients with long COVID, published in the journal Scientific Reports, found that those treated in a high-pressure oxygen system 5 days a week for 2 months showed improvements in brain fog, pain, energy, sleep, anxiety, and depression, compared with similar patients who got sham treatments. But larger studies are needed to show how well it works, notes Dr. Schamess.

“It’s very expensive – roughly $120 per session – and there just isn’t the evidence there to support its use,” he says.

In addition, the therapy itself carries risks, such as ear and sinus pain, middle ear injury, temporary vision changes, and, very rarely, lung collapse, according to the U.S. Food and Drug Administration.

One “particularly troubling” treatment being offered, says Kathleen Bell, MD, chair of the department of physical medicine and rehabilitation at the University of Texas Southwestern Medical Center, is stem cell therapy. This therapy is still in its infancy, but it’s being marketed by some clinics as a way to prevent COVID-19 and also treat long-haul symptoms.

The FDA has issued advisories that there are no products approved to treat long COVID and recommends against their use, except in a clinical trial.

“There’s absolutely no regulation – you don’t know what you’re getting, and there’s no research to suggest this therapy even works,” says Dr. Bell. It’s also prohibitively expensive – one Cayman Islands–based company advertises its treatment for as much as $25,000.

Patients with long COVID are even traveling as far as Cyprus, Germany, and Switzerland for a procedure known as blood washing, in which large needles are inserted into veins to filter blood and remove lipids and inflammatory proteins, the British Medical Journal reported in July. Some patients are also prescribed blood thinners to remove microscopic blood clots that may contribute to long COVID. But this treatment is also expensive, with many people paying $10,000-$15,000 out of pocket, and there’s no published evidence to suggest it works, according to the BMJ.

It can be particularly hard to discern what may work and what’s unproven, since many primary care providers are themselves unfamiliar with even traditional long COVID treatments, Dr. Bell says.
 

Sorting through supplements

Yufang Lin, MD, an integrative specialist at the Cleveland Clinic, says many patients with long COVID enter her office with bags of supplements.

“There’s no data on them, and in large quantities, they may even be harmful,” she says.

Instead, she works closely with the Cleveland Clinic’s long COVID center to do a thorough workup of each patient, which often includes screening for certain nutritional deficiencies.

“Anecdotally, we do see many patients with long COVID who are deficient in these vitamins and minerals,” says Dr. Lin. “If someone is low, we will suggest the appropriate supplement. Otherwise, we work with them to institute some dietary changes.”

This usually involves a plant-based, anti-inflammatory eating pattern such as the Mediterranean diet, which is rich in fruits, vegetables, whole grains, nuts, fatty fish, and healthy fats such as olive oil and avocados.

Other supplements some doctors recommend for patients with long COVID are meant to treat inflammation, Dr. Bell says, although there’s not good evidence they work. One is the antioxidant coenzyme Q10.

But a small preprint study published in The Lancet, of 121 patients with long COVID who took 500 milligrams a day of coenzyme Q10 for 6 weeks saw no differences in recovery, compared with those who took a placebo. Because the study is still a preprint, it has not been peer-reviewed.

Another is probiotics. A small study, published in the journal Infectious Diseases Diagnosis & Treatment, found that a blend of five lactobacillus probiotics, along with a prebiotic called inulin, taken for 30 days, helped with long-term COVID symptoms such as coughing and fatigue. But larger studies need to be done to support their use.

One that may have more promise is omega-3 fatty acids. Like many other supplements, these may help with long COVID by easing inflammation, says Steven Flanagan, MD, a rehabilitation medicine specialist at NYU Langone who works with long COVID patients. Researchers at the Mount Sinai School of Medicine, New York, are studying whether a supplement can help patients who have lost their sense of taste or smell after an infection, but results aren’t yet available.

Among the few alternatives that have been shown to help patients are mindfulness-based therapies – in particular, mindfulness-based forms of exercise such as tai chi and qi gong may be helpful, as they combine a gentle workout with stress reduction.

“Both incorporate meditation, which helps not only to relieve some of the anxiety associated with long COVID but allows patients to redirect their thought process so that they can cope with symptoms better,” says Dr. Flanagan.

A 2022 study, published in BMJ Open, found that these two activities reduced inflammatory markers and improved respiratory muscle strength and function in patients recovering from COVID-19.

“I recommend these activities to all my long COVID patients, as it’s inexpensive and easy to find classes to do either at home or in their community,” he says. “Even if it doesn’t improve their long COVID symptoms, it has other benefits such as increased strength and flexibility that can boost their overall health.”

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

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Early age at hysterectomy ups type 2 diabetes risk

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Thu, 12/15/2022 - 14:24

Data from a large French cohort study suggest that women who have a hysterectomy before 40-45 years of age may be at particular risk of subsequently developing type 2 diabetes.

A 20% increase in the risk for incident diabetes was found comparing women of all ages who had and had not had a hysterectomy (P = .0003).

This risk jumped to a 52% increase when only women below the age of 45 were considered (P < .0001) and was still 38% higher if only women under 40 years were analyzed (P = .005).

Dr. Fabrice Bonnet
Dr. Fabrice Bonnet

Our findings clearly show that hysterectomy is a risk marker for diabetes,” Fabrice Bonnet, MD, PhD, of Centre Hospitalier Universitaire (CHU) de Rennes (France), said at the annual meeting of the European Association for the Study of Diabetes.

Importantly, this risk appears to occur “independently of any hormonal therapy, any reproductive factors, physical activity, and diet,” Dr. Bonnet added.
 

Findings challenged

“I would like to challenge your findings,” said Peter Nilsson, MD, PhD, a professor at Lund (Sweden) University, during the postpresentation discussion period.

“Could there be a detection bias?” queried Dr. Nilsson. “If you undergo surgery like this, there will be several postoperative visits to a physician and there’s a higher likelihood of somebody taking blood samples and detecting diabetes.

“So, if this is true, it could mean that postoperative controls of goiter or thyroid surgery would bring the same findings,” Dr. Nilsson suggested.

“It is an epidemiological cohort of woman followed for a long time,” Dr. Bonnet responded. “So of course, there probably was more blood testing than in the usual population, but we did not observe the association for another type of surgery and type 2 diabetes.”

Clarifying further, Dr. Bonnet said that they had looked at thyroid surgery but not any other types of abdominal surgery.
 

Assessing the risk of incident diabetes

Hysterectomy is a common surgery among women – more than 400,000 are estimated to be performed every year in the United States, and 80,000 in France, with a rising rate in developing countries, Dr. Bonnet said in an interview.

“We don’t know exactly why that is, but it could have long-term consequences in terms of metabolic effects and the incidence of diabetes,” he said.

Prior research has linked having a hysterectomy with an increased rate of hypertension and cardiovascular risk, and there have also been a few studies linking it to diabetes.

“Our aim was to analyze the relationship between the past history of hysterectomies and the risk of incident diabetes; and specifically, we assessed the influence of age,” Dr. Bonnet said.

To do so, data on more than 83,000 women who had participated in The French E3N Prospective Cohort Study (E3N) were obtained. This large epidemiologic study is the French component of the long-running EPIC study.

For inclusion in the analysis, women had to have no diabetes at baseline, to have had their uterus, ovaries, or both removed for benign gynecologic reasons, and to have had their surgeries performed before any diagnosis of diabetes had been made. A diagnosis of diabetes was identified through the women’s responses to self-report questionnaires and prescriptions for antidiabetic medications.

In all, 2,672 women were found to have developed diabetes during the 16-year follow-up period.

The hazard ratio for the risk of diabetes in women who had and had not had a hysterectomy was 1.30 (95% confidence interval, 1.17-1.43; P < .0001), taking age into account and stratifying for birth generation.

The association held, when there was adjustment for other factors such as smoking status, physical activity, history of diabetes, weight, and adherence to a Mediterranean diet (HR 1.27; 95% CI 1.02-1.05; P = .02).

And, after adjustment for age at menarche, menopausal status, age at which menopause was reached, oral contraceptive and hormone therapy use, and the number of pregnancies, the risk for type 2 diabetes was still apparent in those who had undergoing a hysterectomy (HR, 1.20; 95% CI, 1.09-1.33; P = .0003).
 

 

 

Risk increased with oophorectomy

“Women who had both hysterectomy with bilateral oophorectomy had the highest rates of incident diabetes, as compared to women without hysterectomy and no oophorectomy,” said Dr. Bonnet (HR, 1.26; 95% CI, 1.11-1.42; P = .0003).

“This suggests preserving ovarian function is of importance,” he added. “Try to keep the ovaries in place, so just have hysterectomy alone,” he suggested might be the advice to fellow clinicians.

“So, identifying women at higher risk could be followed by a prevention program,” he suggested. “We do this for women who have gestational diabetes,” but for women who have had a hysterectomy, “we didn’t pay attention to this until now.”
 

No increased risk for endometriosis

While hysterectomy appears to up the risk for diabetes, having endometriosis does not. In a separate analysis of data from the E3N cohort, no effect was seen despite the association between endometriosis and other cardiometabolic risk factors.

The HR for incident type 2 diabetes comparing women with and without endometriosis was 10.06 in a fully adjusted statistical model (95% CI, 0.87-1.29). While there was an increase in the risk for diabetes if a woman had endometriosis and had also had a hysterectomy, this was not significant (HR, 1.22; 95% CI, 0.96-1.54).

The E3N study was sponsored by the French Institute for Health and Research. Dr. Bonnet and Dr. Nilsson had no relevant conflicts of interest to disclose.

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Data from a large French cohort study suggest that women who have a hysterectomy before 40-45 years of age may be at particular risk of subsequently developing type 2 diabetes.

A 20% increase in the risk for incident diabetes was found comparing women of all ages who had and had not had a hysterectomy (P = .0003).

This risk jumped to a 52% increase when only women below the age of 45 were considered (P < .0001) and was still 38% higher if only women under 40 years were analyzed (P = .005).

Dr. Fabrice Bonnet
Dr. Fabrice Bonnet

Our findings clearly show that hysterectomy is a risk marker for diabetes,” Fabrice Bonnet, MD, PhD, of Centre Hospitalier Universitaire (CHU) de Rennes (France), said at the annual meeting of the European Association for the Study of Diabetes.

Importantly, this risk appears to occur “independently of any hormonal therapy, any reproductive factors, physical activity, and diet,” Dr. Bonnet added.
 

Findings challenged

“I would like to challenge your findings,” said Peter Nilsson, MD, PhD, a professor at Lund (Sweden) University, during the postpresentation discussion period.

“Could there be a detection bias?” queried Dr. Nilsson. “If you undergo surgery like this, there will be several postoperative visits to a physician and there’s a higher likelihood of somebody taking blood samples and detecting diabetes.

“So, if this is true, it could mean that postoperative controls of goiter or thyroid surgery would bring the same findings,” Dr. Nilsson suggested.

“It is an epidemiological cohort of woman followed for a long time,” Dr. Bonnet responded. “So of course, there probably was more blood testing than in the usual population, but we did not observe the association for another type of surgery and type 2 diabetes.”

Clarifying further, Dr. Bonnet said that they had looked at thyroid surgery but not any other types of abdominal surgery.
 

Assessing the risk of incident diabetes

Hysterectomy is a common surgery among women – more than 400,000 are estimated to be performed every year in the United States, and 80,000 in France, with a rising rate in developing countries, Dr. Bonnet said in an interview.

“We don’t know exactly why that is, but it could have long-term consequences in terms of metabolic effects and the incidence of diabetes,” he said.

Prior research has linked having a hysterectomy with an increased rate of hypertension and cardiovascular risk, and there have also been a few studies linking it to diabetes.

“Our aim was to analyze the relationship between the past history of hysterectomies and the risk of incident diabetes; and specifically, we assessed the influence of age,” Dr. Bonnet said.

To do so, data on more than 83,000 women who had participated in The French E3N Prospective Cohort Study (E3N) were obtained. This large epidemiologic study is the French component of the long-running EPIC study.

For inclusion in the analysis, women had to have no diabetes at baseline, to have had their uterus, ovaries, or both removed for benign gynecologic reasons, and to have had their surgeries performed before any diagnosis of diabetes had been made. A diagnosis of diabetes was identified through the women’s responses to self-report questionnaires and prescriptions for antidiabetic medications.

In all, 2,672 women were found to have developed diabetes during the 16-year follow-up period.

The hazard ratio for the risk of diabetes in women who had and had not had a hysterectomy was 1.30 (95% confidence interval, 1.17-1.43; P < .0001), taking age into account and stratifying for birth generation.

The association held, when there was adjustment for other factors such as smoking status, physical activity, history of diabetes, weight, and adherence to a Mediterranean diet (HR 1.27; 95% CI 1.02-1.05; P = .02).

And, after adjustment for age at menarche, menopausal status, age at which menopause was reached, oral contraceptive and hormone therapy use, and the number of pregnancies, the risk for type 2 diabetes was still apparent in those who had undergoing a hysterectomy (HR, 1.20; 95% CI, 1.09-1.33; P = .0003).
 

 

 

Risk increased with oophorectomy

“Women who had both hysterectomy with bilateral oophorectomy had the highest rates of incident diabetes, as compared to women without hysterectomy and no oophorectomy,” said Dr. Bonnet (HR, 1.26; 95% CI, 1.11-1.42; P = .0003).

“This suggests preserving ovarian function is of importance,” he added. “Try to keep the ovaries in place, so just have hysterectomy alone,” he suggested might be the advice to fellow clinicians.

“So, identifying women at higher risk could be followed by a prevention program,” he suggested. “We do this for women who have gestational diabetes,” but for women who have had a hysterectomy, “we didn’t pay attention to this until now.”
 

No increased risk for endometriosis

While hysterectomy appears to up the risk for diabetes, having endometriosis does not. In a separate analysis of data from the E3N cohort, no effect was seen despite the association between endometriosis and other cardiometabolic risk factors.

The HR for incident type 2 diabetes comparing women with and without endometriosis was 10.06 in a fully adjusted statistical model (95% CI, 0.87-1.29). While there was an increase in the risk for diabetes if a woman had endometriosis and had also had a hysterectomy, this was not significant (HR, 1.22; 95% CI, 0.96-1.54).

The E3N study was sponsored by the French Institute for Health and Research. Dr. Bonnet and Dr. Nilsson had no relevant conflicts of interest to disclose.

Data from a large French cohort study suggest that women who have a hysterectomy before 40-45 years of age may be at particular risk of subsequently developing type 2 diabetes.

A 20% increase in the risk for incident diabetes was found comparing women of all ages who had and had not had a hysterectomy (P = .0003).

This risk jumped to a 52% increase when only women below the age of 45 were considered (P < .0001) and was still 38% higher if only women under 40 years were analyzed (P = .005).

Dr. Fabrice Bonnet
Dr. Fabrice Bonnet

Our findings clearly show that hysterectomy is a risk marker for diabetes,” Fabrice Bonnet, MD, PhD, of Centre Hospitalier Universitaire (CHU) de Rennes (France), said at the annual meeting of the European Association for the Study of Diabetes.

Importantly, this risk appears to occur “independently of any hormonal therapy, any reproductive factors, physical activity, and diet,” Dr. Bonnet added.
 

Findings challenged

“I would like to challenge your findings,” said Peter Nilsson, MD, PhD, a professor at Lund (Sweden) University, during the postpresentation discussion period.

“Could there be a detection bias?” queried Dr. Nilsson. “If you undergo surgery like this, there will be several postoperative visits to a physician and there’s a higher likelihood of somebody taking blood samples and detecting diabetes.

“So, if this is true, it could mean that postoperative controls of goiter or thyroid surgery would bring the same findings,” Dr. Nilsson suggested.

“It is an epidemiological cohort of woman followed for a long time,” Dr. Bonnet responded. “So of course, there probably was more blood testing than in the usual population, but we did not observe the association for another type of surgery and type 2 diabetes.”

Clarifying further, Dr. Bonnet said that they had looked at thyroid surgery but not any other types of abdominal surgery.
 

Assessing the risk of incident diabetes

Hysterectomy is a common surgery among women – more than 400,000 are estimated to be performed every year in the United States, and 80,000 in France, with a rising rate in developing countries, Dr. Bonnet said in an interview.

“We don’t know exactly why that is, but it could have long-term consequences in terms of metabolic effects and the incidence of diabetes,” he said.

Prior research has linked having a hysterectomy with an increased rate of hypertension and cardiovascular risk, and there have also been a few studies linking it to diabetes.

“Our aim was to analyze the relationship between the past history of hysterectomies and the risk of incident diabetes; and specifically, we assessed the influence of age,” Dr. Bonnet said.

To do so, data on more than 83,000 women who had participated in The French E3N Prospective Cohort Study (E3N) were obtained. This large epidemiologic study is the French component of the long-running EPIC study.

For inclusion in the analysis, women had to have no diabetes at baseline, to have had their uterus, ovaries, or both removed for benign gynecologic reasons, and to have had their surgeries performed before any diagnosis of diabetes had been made. A diagnosis of diabetes was identified through the women’s responses to self-report questionnaires and prescriptions for antidiabetic medications.

In all, 2,672 women were found to have developed diabetes during the 16-year follow-up period.

The hazard ratio for the risk of diabetes in women who had and had not had a hysterectomy was 1.30 (95% confidence interval, 1.17-1.43; P < .0001), taking age into account and stratifying for birth generation.

The association held, when there was adjustment for other factors such as smoking status, physical activity, history of diabetes, weight, and adherence to a Mediterranean diet (HR 1.27; 95% CI 1.02-1.05; P = .02).

And, after adjustment for age at menarche, menopausal status, age at which menopause was reached, oral contraceptive and hormone therapy use, and the number of pregnancies, the risk for type 2 diabetes was still apparent in those who had undergoing a hysterectomy (HR, 1.20; 95% CI, 1.09-1.33; P = .0003).
 

 

 

Risk increased with oophorectomy

“Women who had both hysterectomy with bilateral oophorectomy had the highest rates of incident diabetes, as compared to women without hysterectomy and no oophorectomy,” said Dr. Bonnet (HR, 1.26; 95% CI, 1.11-1.42; P = .0003).

“This suggests preserving ovarian function is of importance,” he added. “Try to keep the ovaries in place, so just have hysterectomy alone,” he suggested might be the advice to fellow clinicians.

“So, identifying women at higher risk could be followed by a prevention program,” he suggested. “We do this for women who have gestational diabetes,” but for women who have had a hysterectomy, “we didn’t pay attention to this until now.”
 

No increased risk for endometriosis

While hysterectomy appears to up the risk for diabetes, having endometriosis does not. In a separate analysis of data from the E3N cohort, no effect was seen despite the association between endometriosis and other cardiometabolic risk factors.

The HR for incident type 2 diabetes comparing women with and without endometriosis was 10.06 in a fully adjusted statistical model (95% CI, 0.87-1.29). While there was an increase in the risk for diabetes if a woman had endometriosis and had also had a hysterectomy, this was not significant (HR, 1.22; 95% CI, 0.96-1.54).

The E3N study was sponsored by the French Institute for Health and Research. Dr. Bonnet and Dr. Nilsson had no relevant conflicts of interest to disclose.

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A switch to B/F/TAF keeps HIV suppressed, even with M184V/I mutation

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Wed, 09/28/2022 - 17:14

People with suppressed HIV and the M184V/I viral mutation who switch medications to combined bictegravir, emtricitabine, and tenofovir alafenamide (B/F/TAF) appear to maintain viral suppression, reports an industry-sponsored analysis.

“M184V/I was detected in 10% of virologically suppressed clinical trial participants at study baseline. Switching to B/F/TAF demonstrated durable efficacy in maintaining viral suppression, including in those with preexisting M184V/I,” write senior study author Kirsten L. White, PhD, of Gilead Sciences, in Foster City, Calif., and colleagues in AIDS .

“Similarly high rates of virologic suppression were maintained in B/F/TAF-treated participants with or without preexisting M184V/I for at least 1 year with no emergent resistance,” they write.

Clinicians use the single-tablet B/F/TAF combination as an initial HIV therapy and as an approved replacement regimen when switching therapies in certain virologically suppressed people with HIV, the authors write.

Dr. White and her colleagues analyzed pooled data from 2,286 adult and 100 child participants in six randomized clinical trials investigating the safety and efficacy of switching to B/F/TAF in virologically suppressed (HIV-1 RNA < 50 copies/mL for 3 or 6 months) people with HIV. At screening, participants were on three-drug antiretroviral regimens.

Overall, 2,034 participants switched treatment regimens to B/F/TAF and had follow-up HIV-1 RNA data. Of these, 1,825 had baseline genotypic data, and preexisting M184V/I was detected in 182 (10%) of them.

All studies had postbaseline visits at weeks 4 and 12, and every 12 weeks thereafter, with B/F/TAF treatment lasting a median of 72 weeks. Plasma HIV-1 RNA levels were measured, and efficacy was assessed for all patients who switched to B/F/TAF.

The researchers assessed preexisting drug resistance by historical genotypes, baseline proviral DNA genotyping, or both, and they determined virologic outcomes by last available on-treatment HIV-1 RNA. They used stepwise selection in a multivariate logistic regression model to identify potential risk factors for M184V/I.
 

Virologic suppression well maintained

At the final on-treatment visit, 98% (179/182) of participants with preexisting M184V/I and 99% (2012/2034) of all B/F/TAF-treated participants had HIV-1 RNA less than 50 copies/mL, with no treatment-emergent resistance to B/F/TAF.

Factors linked with preexisting M184V/I in adults included being Black or Hispanic/Latinx, having baseline CD4+ cell count less than 500 cells/mL, advanced HIV disease, longer antiretroviral therapy, more prior third agents, and other resistance.

These results are important, Jana K. Dickter, MD, associate clinical professor in the division of infectious diseases at City of Hope in Duarte, Calif., told this news organization in an email.

“This study supports the use of B/F/TAF as a first-line agent for people living with HIV who carry the M184V/I resistance mutation,” added Dr. Dickter, who was not involved in the study. “This combination is recommended as an initial regimen by the U.S. Department of Health & Human Services.”
 

Easy to administer, well tolerated, and potent

Barbara Gripshover, MD, professor at Case Western Reserve University, Cleveland, and medical director of the special immunology unit of the Cleveland Medical Center, explained that “M184V/I is a common resistance mutation in patients who’ve had prior virologic failure on a lamivudine- or emtricitabine-containing regimen.”

“This study shows that, even in the presence of the M184V/I, switching virally suppressed persons to B/F/TAF provides continued durable virologic suppression,” Dr. Gripshover, who also was not involved in the study, said in an email.

Clinicians may comfortably switch patients to this regimen without fear of virologic failure, she added.

“Fixed-dose B/F/TAF, a potent, well-tolerated, single-tablet regimen, is a good switch option for persons on older regimens that contain either more pills, less tolerable agents, or ‘boosting’ agents that block cytochrome 3A4,” she noted. “Having a potent backbone agent is key.

“This is a good regimen due to its simplicity, tolerability, and potency,” Dr. Gripshover said, “and many patients exposed to older regimens may harbor archived M184V/I.

“The large number of subjects who had prior M184V/I and remained suppressed is convincing to me that B/F/TAF is durably effective in the presence of FTC resistance,” she concluded.

The study was supported by Gilead Sciences. Dr. White and 11 coauthors are employees and stock shareholders of Gilead, and three other coauthors report relevant financial relationships with Gilead and other pharmaceutical companies. One coauthor as well as Dr. Dickter and Dr. Gripshover report no relevant financial relationships.

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

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People with suppressed HIV and the M184V/I viral mutation who switch medications to combined bictegravir, emtricitabine, and tenofovir alafenamide (B/F/TAF) appear to maintain viral suppression, reports an industry-sponsored analysis.

“M184V/I was detected in 10% of virologically suppressed clinical trial participants at study baseline. Switching to B/F/TAF demonstrated durable efficacy in maintaining viral suppression, including in those with preexisting M184V/I,” write senior study author Kirsten L. White, PhD, of Gilead Sciences, in Foster City, Calif., and colleagues in AIDS .

“Similarly high rates of virologic suppression were maintained in B/F/TAF-treated participants with or without preexisting M184V/I for at least 1 year with no emergent resistance,” they write.

Clinicians use the single-tablet B/F/TAF combination as an initial HIV therapy and as an approved replacement regimen when switching therapies in certain virologically suppressed people with HIV, the authors write.

Dr. White and her colleagues analyzed pooled data from 2,286 adult and 100 child participants in six randomized clinical trials investigating the safety and efficacy of switching to B/F/TAF in virologically suppressed (HIV-1 RNA < 50 copies/mL for 3 or 6 months) people with HIV. At screening, participants were on three-drug antiretroviral regimens.

Overall, 2,034 participants switched treatment regimens to B/F/TAF and had follow-up HIV-1 RNA data. Of these, 1,825 had baseline genotypic data, and preexisting M184V/I was detected in 182 (10%) of them.

All studies had postbaseline visits at weeks 4 and 12, and every 12 weeks thereafter, with B/F/TAF treatment lasting a median of 72 weeks. Plasma HIV-1 RNA levels were measured, and efficacy was assessed for all patients who switched to B/F/TAF.

The researchers assessed preexisting drug resistance by historical genotypes, baseline proviral DNA genotyping, or both, and they determined virologic outcomes by last available on-treatment HIV-1 RNA. They used stepwise selection in a multivariate logistic regression model to identify potential risk factors for M184V/I.
 

Virologic suppression well maintained

At the final on-treatment visit, 98% (179/182) of participants with preexisting M184V/I and 99% (2012/2034) of all B/F/TAF-treated participants had HIV-1 RNA less than 50 copies/mL, with no treatment-emergent resistance to B/F/TAF.

Factors linked with preexisting M184V/I in adults included being Black or Hispanic/Latinx, having baseline CD4+ cell count less than 500 cells/mL, advanced HIV disease, longer antiretroviral therapy, more prior third agents, and other resistance.

These results are important, Jana K. Dickter, MD, associate clinical professor in the division of infectious diseases at City of Hope in Duarte, Calif., told this news organization in an email.

“This study supports the use of B/F/TAF as a first-line agent for people living with HIV who carry the M184V/I resistance mutation,” added Dr. Dickter, who was not involved in the study. “This combination is recommended as an initial regimen by the U.S. Department of Health & Human Services.”
 

Easy to administer, well tolerated, and potent

Barbara Gripshover, MD, professor at Case Western Reserve University, Cleveland, and medical director of the special immunology unit of the Cleveland Medical Center, explained that “M184V/I is a common resistance mutation in patients who’ve had prior virologic failure on a lamivudine- or emtricitabine-containing regimen.”

“This study shows that, even in the presence of the M184V/I, switching virally suppressed persons to B/F/TAF provides continued durable virologic suppression,” Dr. Gripshover, who also was not involved in the study, said in an email.

Clinicians may comfortably switch patients to this regimen without fear of virologic failure, she added.

“Fixed-dose B/F/TAF, a potent, well-tolerated, single-tablet regimen, is a good switch option for persons on older regimens that contain either more pills, less tolerable agents, or ‘boosting’ agents that block cytochrome 3A4,” she noted. “Having a potent backbone agent is key.

“This is a good regimen due to its simplicity, tolerability, and potency,” Dr. Gripshover said, “and many patients exposed to older regimens may harbor archived M184V/I.

“The large number of subjects who had prior M184V/I and remained suppressed is convincing to me that B/F/TAF is durably effective in the presence of FTC resistance,” she concluded.

The study was supported by Gilead Sciences. Dr. White and 11 coauthors are employees and stock shareholders of Gilead, and three other coauthors report relevant financial relationships with Gilead and other pharmaceutical companies. One coauthor as well as Dr. Dickter and Dr. Gripshover report no relevant financial relationships.

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

People with suppressed HIV and the M184V/I viral mutation who switch medications to combined bictegravir, emtricitabine, and tenofovir alafenamide (B/F/TAF) appear to maintain viral suppression, reports an industry-sponsored analysis.

“M184V/I was detected in 10% of virologically suppressed clinical trial participants at study baseline. Switching to B/F/TAF demonstrated durable efficacy in maintaining viral suppression, including in those with preexisting M184V/I,” write senior study author Kirsten L. White, PhD, of Gilead Sciences, in Foster City, Calif., and colleagues in AIDS .

“Similarly high rates of virologic suppression were maintained in B/F/TAF-treated participants with or without preexisting M184V/I for at least 1 year with no emergent resistance,” they write.

Clinicians use the single-tablet B/F/TAF combination as an initial HIV therapy and as an approved replacement regimen when switching therapies in certain virologically suppressed people with HIV, the authors write.

Dr. White and her colleagues analyzed pooled data from 2,286 adult and 100 child participants in six randomized clinical trials investigating the safety and efficacy of switching to B/F/TAF in virologically suppressed (HIV-1 RNA < 50 copies/mL for 3 or 6 months) people with HIV. At screening, participants were on three-drug antiretroviral regimens.

Overall, 2,034 participants switched treatment regimens to B/F/TAF and had follow-up HIV-1 RNA data. Of these, 1,825 had baseline genotypic data, and preexisting M184V/I was detected in 182 (10%) of them.

All studies had postbaseline visits at weeks 4 and 12, and every 12 weeks thereafter, with B/F/TAF treatment lasting a median of 72 weeks. Plasma HIV-1 RNA levels were measured, and efficacy was assessed for all patients who switched to B/F/TAF.

The researchers assessed preexisting drug resistance by historical genotypes, baseline proviral DNA genotyping, or both, and they determined virologic outcomes by last available on-treatment HIV-1 RNA. They used stepwise selection in a multivariate logistic regression model to identify potential risk factors for M184V/I.
 

Virologic suppression well maintained

At the final on-treatment visit, 98% (179/182) of participants with preexisting M184V/I and 99% (2012/2034) of all B/F/TAF-treated participants had HIV-1 RNA less than 50 copies/mL, with no treatment-emergent resistance to B/F/TAF.

Factors linked with preexisting M184V/I in adults included being Black or Hispanic/Latinx, having baseline CD4+ cell count less than 500 cells/mL, advanced HIV disease, longer antiretroviral therapy, more prior third agents, and other resistance.

These results are important, Jana K. Dickter, MD, associate clinical professor in the division of infectious diseases at City of Hope in Duarte, Calif., told this news organization in an email.

“This study supports the use of B/F/TAF as a first-line agent for people living with HIV who carry the M184V/I resistance mutation,” added Dr. Dickter, who was not involved in the study. “This combination is recommended as an initial regimen by the U.S. Department of Health & Human Services.”
 

Easy to administer, well tolerated, and potent

Barbara Gripshover, MD, professor at Case Western Reserve University, Cleveland, and medical director of the special immunology unit of the Cleveland Medical Center, explained that “M184V/I is a common resistance mutation in patients who’ve had prior virologic failure on a lamivudine- or emtricitabine-containing regimen.”

“This study shows that, even in the presence of the M184V/I, switching virally suppressed persons to B/F/TAF provides continued durable virologic suppression,” Dr. Gripshover, who also was not involved in the study, said in an email.

Clinicians may comfortably switch patients to this regimen without fear of virologic failure, she added.

“Fixed-dose B/F/TAF, a potent, well-tolerated, single-tablet regimen, is a good switch option for persons on older regimens that contain either more pills, less tolerable agents, or ‘boosting’ agents that block cytochrome 3A4,” she noted. “Having a potent backbone agent is key.

“This is a good regimen due to its simplicity, tolerability, and potency,” Dr. Gripshover said, “and many patients exposed to older regimens may harbor archived M184V/I.

“The large number of subjects who had prior M184V/I and remained suppressed is convincing to me that B/F/TAF is durably effective in the presence of FTC resistance,” she concluded.

The study was supported by Gilead Sciences. Dr. White and 11 coauthors are employees and stock shareholders of Gilead, and three other coauthors report relevant financial relationships with Gilead and other pharmaceutical companies. One coauthor as well as Dr. Dickter and Dr. Gripshover report no relevant financial relationships.

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

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Limiting antibiotic overprescription in pandemics: New guidelines

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Changed
Wed, 09/28/2022 - 18:09

A statement by the Society for Healthcare Epidemiology of America, published online in Infection Control & Hospital Epidemiology, offers health care providers guidelines on how to prevent inappropriate antibiotic use in future pandemics and to avoid some of the negative scenarios that have been seen with COVID-19.

According to the U.S. Centers of Disease Control and Prevention, the COVID-19 pandemic brought an alarming increase in antimicrobial resistance in hospitals, with infections and deaths caused by resistant bacteria and fungi going up by 15%. For some pathogens, such as the Carbapenem-resistant Acinetobacter, that number is now as high as 78%.

The culprit might be the widespread antibiotic overprescription during the current pandemic. A 2022 meta-analysis revealed that in high-income countries, 58% of patients with COVID-19 were given antibiotics, whereas in lower- and middle-income countries, 89% of patients were put on such drugs. Some hospitals in Europe and the United States reported similarly elevated numbers, sometimes approaching 100%.

“We’ve lost control,” Natasha Pettit, PharmD, pharmacy director at University of Chicago Medicine, told this news organization. Dr. Pettit was not involved in the SHEA study. “Even if CDC didn’t come out with that data, I can tell you right now more of my time is spent trying to figure out how to manage these multi-drug–resistant infections, and we are running out of options for these patients,”

“Dealing with uncertainty, exhaustion, [and] critical illness in often young, otherwise healthy patients meant doctors wanted to do something for their patients,” said Tamar Barlam, MD, an infectious diseases expert at the Boston Medical Center who led the development of the SHEA white paper, in an interview.

That something often was a prescription for antibiotics, even without a clear indication that they were actually needed. A British study revealed that in times of pandemic uncertainty, clinicians often reached for antibiotics “just in case” and referred to conservative prescribing as “bravery.”

Studies have shown, however, that bacterial co-infections in COVID-19 are rare. A 2020 meta-analysis of 24 studies concluded that only 3.5% of patients had a bacterial co-infection on presentation, and 14.3% had a secondary infection. Similar patterns had previously been observed in other viral outbreaks. Research on MERS-CoV, for example, documented only 1% of patients with a bacterial co-infection on admission. During the 2009 H1N1 influenza pandemic, that number was 12% of non–ICU hospitalized patients.

Yet, according to Dr. Pettit, even when such data became available, it didn’t necessarily change prescribing patterns. “Information was coming at us so quickly, I think the providers didn’t have a moment to see the data, to understand what it meant for their prescribing. Having external guidance earlier on would have been hugely helpful,” she told this news organization.

That’s where the newly published SHEA statement comes in: It outlines recommendations on when to prescribe antibiotics during a respiratory viral pandemic, what tests to order, and when to de-escalate or discontinue the treatment. These recommendations include, for instance, advice to not trust inflammatory markers as reliable indicators of bacterial or fungal infection and to not use procalcitonin routinely to aid in the decision to initiate antibiotics.

According to Dr. Barlam, one of the crucial lessons here is that if clinicians see patients with symptoms that are consistent with the current pandemic, they should trust their own impressions and avoid reaching for antimicrobials “just in case.”

Another important lesson is that antibiotic stewardship programs have a huge role to play during pandemics. They should not only monitor prescribing but also compile new information on bacterial co-infections as it gets released and make sure it reaches the clinicians in a clear form.

Evidence suggests that such programs and guidelines do work to limit unnecessary antibiotic use. In one medical center in Chicago, for example, before recommendations on when to initiate and discontinue antimicrobials were released, over 74% of COVID-19 patients received antibiotics. After guidelines were put in place, the use of such drugs fell to 42%.

Dr. Pettit believes, however, that it’s important not to leave each medical center to its own devices. “Hindsight is always twenty-twenty,” she said, “but I think it would be great that, if we start hearing about a pathogen that might lead to another pandemic, we should have a mechanism in place to call together an expert body to get guidance for how antimicrobial stewardship programs should get involved.”

One of the authors of the SHEA statement, Susan Seo, reports an investigator-initiated Merck grant on cost-effectiveness of letermovir in hematopoietic stem cell transplant patients. Another author, Graeme Forrest, reports a clinical study grant from Regeneron for inpatient monoclonals against SARS-CoV-2. All other authors report no conflicts of interest. The study was independently supported.

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

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A statement by the Society for Healthcare Epidemiology of America, published online in Infection Control & Hospital Epidemiology, offers health care providers guidelines on how to prevent inappropriate antibiotic use in future pandemics and to avoid some of the negative scenarios that have been seen with COVID-19.

According to the U.S. Centers of Disease Control and Prevention, the COVID-19 pandemic brought an alarming increase in antimicrobial resistance in hospitals, with infections and deaths caused by resistant bacteria and fungi going up by 15%. For some pathogens, such as the Carbapenem-resistant Acinetobacter, that number is now as high as 78%.

The culprit might be the widespread antibiotic overprescription during the current pandemic. A 2022 meta-analysis revealed that in high-income countries, 58% of patients with COVID-19 were given antibiotics, whereas in lower- and middle-income countries, 89% of patients were put on such drugs. Some hospitals in Europe and the United States reported similarly elevated numbers, sometimes approaching 100%.

“We’ve lost control,” Natasha Pettit, PharmD, pharmacy director at University of Chicago Medicine, told this news organization. Dr. Pettit was not involved in the SHEA study. “Even if CDC didn’t come out with that data, I can tell you right now more of my time is spent trying to figure out how to manage these multi-drug–resistant infections, and we are running out of options for these patients,”

“Dealing with uncertainty, exhaustion, [and] critical illness in often young, otherwise healthy patients meant doctors wanted to do something for their patients,” said Tamar Barlam, MD, an infectious diseases expert at the Boston Medical Center who led the development of the SHEA white paper, in an interview.

That something often was a prescription for antibiotics, even without a clear indication that they were actually needed. A British study revealed that in times of pandemic uncertainty, clinicians often reached for antibiotics “just in case” and referred to conservative prescribing as “bravery.”

Studies have shown, however, that bacterial co-infections in COVID-19 are rare. A 2020 meta-analysis of 24 studies concluded that only 3.5% of patients had a bacterial co-infection on presentation, and 14.3% had a secondary infection. Similar patterns had previously been observed in other viral outbreaks. Research on MERS-CoV, for example, documented only 1% of patients with a bacterial co-infection on admission. During the 2009 H1N1 influenza pandemic, that number was 12% of non–ICU hospitalized patients.

Yet, according to Dr. Pettit, even when such data became available, it didn’t necessarily change prescribing patterns. “Information was coming at us so quickly, I think the providers didn’t have a moment to see the data, to understand what it meant for their prescribing. Having external guidance earlier on would have been hugely helpful,” she told this news organization.

That’s where the newly published SHEA statement comes in: It outlines recommendations on when to prescribe antibiotics during a respiratory viral pandemic, what tests to order, and when to de-escalate or discontinue the treatment. These recommendations include, for instance, advice to not trust inflammatory markers as reliable indicators of bacterial or fungal infection and to not use procalcitonin routinely to aid in the decision to initiate antibiotics.

According to Dr. Barlam, one of the crucial lessons here is that if clinicians see patients with symptoms that are consistent with the current pandemic, they should trust their own impressions and avoid reaching for antimicrobials “just in case.”

Another important lesson is that antibiotic stewardship programs have a huge role to play during pandemics. They should not only monitor prescribing but also compile new information on bacterial co-infections as it gets released and make sure it reaches the clinicians in a clear form.

Evidence suggests that such programs and guidelines do work to limit unnecessary antibiotic use. In one medical center in Chicago, for example, before recommendations on when to initiate and discontinue antimicrobials were released, over 74% of COVID-19 patients received antibiotics. After guidelines were put in place, the use of such drugs fell to 42%.

Dr. Pettit believes, however, that it’s important not to leave each medical center to its own devices. “Hindsight is always twenty-twenty,” she said, “but I think it would be great that, if we start hearing about a pathogen that might lead to another pandemic, we should have a mechanism in place to call together an expert body to get guidance for how antimicrobial stewardship programs should get involved.”

One of the authors of the SHEA statement, Susan Seo, reports an investigator-initiated Merck grant on cost-effectiveness of letermovir in hematopoietic stem cell transplant patients. Another author, Graeme Forrest, reports a clinical study grant from Regeneron for inpatient monoclonals against SARS-CoV-2. All other authors report no conflicts of interest. The study was independently supported.

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

A statement by the Society for Healthcare Epidemiology of America, published online in Infection Control & Hospital Epidemiology, offers health care providers guidelines on how to prevent inappropriate antibiotic use in future pandemics and to avoid some of the negative scenarios that have been seen with COVID-19.

According to the U.S. Centers of Disease Control and Prevention, the COVID-19 pandemic brought an alarming increase in antimicrobial resistance in hospitals, with infections and deaths caused by resistant bacteria and fungi going up by 15%. For some pathogens, such as the Carbapenem-resistant Acinetobacter, that number is now as high as 78%.

The culprit might be the widespread antibiotic overprescription during the current pandemic. A 2022 meta-analysis revealed that in high-income countries, 58% of patients with COVID-19 were given antibiotics, whereas in lower- and middle-income countries, 89% of patients were put on such drugs. Some hospitals in Europe and the United States reported similarly elevated numbers, sometimes approaching 100%.

“We’ve lost control,” Natasha Pettit, PharmD, pharmacy director at University of Chicago Medicine, told this news organization. Dr. Pettit was not involved in the SHEA study. “Even if CDC didn’t come out with that data, I can tell you right now more of my time is spent trying to figure out how to manage these multi-drug–resistant infections, and we are running out of options for these patients,”

“Dealing with uncertainty, exhaustion, [and] critical illness in often young, otherwise healthy patients meant doctors wanted to do something for their patients,” said Tamar Barlam, MD, an infectious diseases expert at the Boston Medical Center who led the development of the SHEA white paper, in an interview.

That something often was a prescription for antibiotics, even without a clear indication that they were actually needed. A British study revealed that in times of pandemic uncertainty, clinicians often reached for antibiotics “just in case” and referred to conservative prescribing as “bravery.”

Studies have shown, however, that bacterial co-infections in COVID-19 are rare. A 2020 meta-analysis of 24 studies concluded that only 3.5% of patients had a bacterial co-infection on presentation, and 14.3% had a secondary infection. Similar patterns had previously been observed in other viral outbreaks. Research on MERS-CoV, for example, documented only 1% of patients with a bacterial co-infection on admission. During the 2009 H1N1 influenza pandemic, that number was 12% of non–ICU hospitalized patients.

Yet, according to Dr. Pettit, even when such data became available, it didn’t necessarily change prescribing patterns. “Information was coming at us so quickly, I think the providers didn’t have a moment to see the data, to understand what it meant for their prescribing. Having external guidance earlier on would have been hugely helpful,” she told this news organization.

That’s where the newly published SHEA statement comes in: It outlines recommendations on when to prescribe antibiotics during a respiratory viral pandemic, what tests to order, and when to de-escalate or discontinue the treatment. These recommendations include, for instance, advice to not trust inflammatory markers as reliable indicators of bacterial or fungal infection and to not use procalcitonin routinely to aid in the decision to initiate antibiotics.

According to Dr. Barlam, one of the crucial lessons here is that if clinicians see patients with symptoms that are consistent with the current pandemic, they should trust their own impressions and avoid reaching for antimicrobials “just in case.”

Another important lesson is that antibiotic stewardship programs have a huge role to play during pandemics. They should not only monitor prescribing but also compile new information on bacterial co-infections as it gets released and make sure it reaches the clinicians in a clear form.

Evidence suggests that such programs and guidelines do work to limit unnecessary antibiotic use. In one medical center in Chicago, for example, before recommendations on when to initiate and discontinue antimicrobials were released, over 74% of COVID-19 patients received antibiotics. After guidelines were put in place, the use of such drugs fell to 42%.

Dr. Pettit believes, however, that it’s important not to leave each medical center to its own devices. “Hindsight is always twenty-twenty,” she said, “but I think it would be great that, if we start hearing about a pathogen that might lead to another pandemic, we should have a mechanism in place to call together an expert body to get guidance for how antimicrobial stewardship programs should get involved.”

One of the authors of the SHEA statement, Susan Seo, reports an investigator-initiated Merck grant on cost-effectiveness of letermovir in hematopoietic stem cell transplant patients. Another author, Graeme Forrest, reports a clinical study grant from Regeneron for inpatient monoclonals against SARS-CoV-2. All other authors report no conflicts of interest. The study was independently supported.

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

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Type 1 diabetes complication risk rises with A1c, duration

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Changed
Fri, 09/23/2022 - 08:49

Long-term A1c from the time of type 1 diabetes diagnosis strongly predicts the development of severe retinopathy and nephropathy, new data suggest.

“[Weighted] HbA1c followed from diagnosis is a very strong biomarker for pan-retinal laser-treated diabetic retinopathy (PDR) and nephropathy, [and] the prevalence of both is still increasing 32 years after diagnosis,” say Hans J. Arnqvist, MD, and colleagues in their study published online Sept. 12 in Diabetes Care.

The results are from a 32-year follow-up of 447 patients from time of diagnosis of type 1 diabetes at age 0-34 in the Vascular Diabetic Complications in Southeast Sweden study.

“To avoid PDR and macroalbuminuria in patients with type 1 diabetes, A1c less than 7.0% (53 mmol/mol) and as normal as possible should be recommended when achievable without severe hypoglycemia and with good quality of life,” stress Dr. Arnqvist, department of endocrinology, Linköping University (Sweden), and coauthors.

At the time of the 20- to 24-year VISS follow-up, severe eye complications, defined as PDR, or nephropathy, defined as macroalbuminuria, were not present in participants with a long-term weighted mean A1c less than 7.6% (60 mmol/mol), they write.
 

Is explanation an increase in glycemic burden with diabetes duration?

By years 32-36, the prevalence of PDR had risen from 14% to 27%, and macroalbuminuria from 4% to 8%, with prevalence strongly correlated with A1c levels. At the same time, the threshold for the appearance of those severe complications dropped, with the lowest A1c values for appearance of PDR decreasing from 7.6% to 7.3% and for macroalbuminuria from 8.4% to 8.1%.

“A possible explanation for the lowered threshold for development of severe microangiopathy is the increase in ‘glycemic burden’ with diabetes duration,” the authors speculate.

In all A1c categories above 6.7% (> 50 mmol/mol), the cumulative proportion with PDR and/or macroproteinuria continued to increase up to at least 32 years of diabetes duration.

At the highest A1c quintile, greater than 9.5% (> 80mmol/mol), 75% had developed PDR and 44.2% had macroalbuminuria.

These findings align with guidelines from both the International Society for Pediatric and Adolescent Diabetes, which recommend A1c less than 7% (53 mmol/mol) as a treatment goal, and the UK National Institute for Health and Care Excellence, which advises a target A1c of 6.5% (48 mmol/mol) or lower in children and adults with type 1 diabetes.

The American Diabetes Association recommends individualized A1c targets ranging from 6.5% to 8.0%.

The study was supported by Barndiabetesfonden (Swedish Children’s Diabetes Foundation) and Region Ostergotlands Stiftelsefonder. The authors reported no further disclosures.

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

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Long-term A1c from the time of type 1 diabetes diagnosis strongly predicts the development of severe retinopathy and nephropathy, new data suggest.

“[Weighted] HbA1c followed from diagnosis is a very strong biomarker for pan-retinal laser-treated diabetic retinopathy (PDR) and nephropathy, [and] the prevalence of both is still increasing 32 years after diagnosis,” say Hans J. Arnqvist, MD, and colleagues in their study published online Sept. 12 in Diabetes Care.

The results are from a 32-year follow-up of 447 patients from time of diagnosis of type 1 diabetes at age 0-34 in the Vascular Diabetic Complications in Southeast Sweden study.

“To avoid PDR and macroalbuminuria in patients with type 1 diabetes, A1c less than 7.0% (53 mmol/mol) and as normal as possible should be recommended when achievable without severe hypoglycemia and with good quality of life,” stress Dr. Arnqvist, department of endocrinology, Linköping University (Sweden), and coauthors.

At the time of the 20- to 24-year VISS follow-up, severe eye complications, defined as PDR, or nephropathy, defined as macroalbuminuria, were not present in participants with a long-term weighted mean A1c less than 7.6% (60 mmol/mol), they write.
 

Is explanation an increase in glycemic burden with diabetes duration?

By years 32-36, the prevalence of PDR had risen from 14% to 27%, and macroalbuminuria from 4% to 8%, with prevalence strongly correlated with A1c levels. At the same time, the threshold for the appearance of those severe complications dropped, with the lowest A1c values for appearance of PDR decreasing from 7.6% to 7.3% and for macroalbuminuria from 8.4% to 8.1%.

“A possible explanation for the lowered threshold for development of severe microangiopathy is the increase in ‘glycemic burden’ with diabetes duration,” the authors speculate.

In all A1c categories above 6.7% (> 50 mmol/mol), the cumulative proportion with PDR and/or macroproteinuria continued to increase up to at least 32 years of diabetes duration.

At the highest A1c quintile, greater than 9.5% (> 80mmol/mol), 75% had developed PDR and 44.2% had macroalbuminuria.

These findings align with guidelines from both the International Society for Pediatric and Adolescent Diabetes, which recommend A1c less than 7% (53 mmol/mol) as a treatment goal, and the UK National Institute for Health and Care Excellence, which advises a target A1c of 6.5% (48 mmol/mol) or lower in children and adults with type 1 diabetes.

The American Diabetes Association recommends individualized A1c targets ranging from 6.5% to 8.0%.

The study was supported by Barndiabetesfonden (Swedish Children’s Diabetes Foundation) and Region Ostergotlands Stiftelsefonder. The authors reported no further disclosures.

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

Long-term A1c from the time of type 1 diabetes diagnosis strongly predicts the development of severe retinopathy and nephropathy, new data suggest.

“[Weighted] HbA1c followed from diagnosis is a very strong biomarker for pan-retinal laser-treated diabetic retinopathy (PDR) and nephropathy, [and] the prevalence of both is still increasing 32 years after diagnosis,” say Hans J. Arnqvist, MD, and colleagues in their study published online Sept. 12 in Diabetes Care.

The results are from a 32-year follow-up of 447 patients from time of diagnosis of type 1 diabetes at age 0-34 in the Vascular Diabetic Complications in Southeast Sweden study.

“To avoid PDR and macroalbuminuria in patients with type 1 diabetes, A1c less than 7.0% (53 mmol/mol) and as normal as possible should be recommended when achievable without severe hypoglycemia and with good quality of life,” stress Dr. Arnqvist, department of endocrinology, Linköping University (Sweden), and coauthors.

At the time of the 20- to 24-year VISS follow-up, severe eye complications, defined as PDR, or nephropathy, defined as macroalbuminuria, were not present in participants with a long-term weighted mean A1c less than 7.6% (60 mmol/mol), they write.
 

Is explanation an increase in glycemic burden with diabetes duration?

By years 32-36, the prevalence of PDR had risen from 14% to 27%, and macroalbuminuria from 4% to 8%, with prevalence strongly correlated with A1c levels. At the same time, the threshold for the appearance of those severe complications dropped, with the lowest A1c values for appearance of PDR decreasing from 7.6% to 7.3% and for macroalbuminuria from 8.4% to 8.1%.

“A possible explanation for the lowered threshold for development of severe microangiopathy is the increase in ‘glycemic burden’ with diabetes duration,” the authors speculate.

In all A1c categories above 6.7% (> 50 mmol/mol), the cumulative proportion with PDR and/or macroproteinuria continued to increase up to at least 32 years of diabetes duration.

At the highest A1c quintile, greater than 9.5% (> 80mmol/mol), 75% had developed PDR and 44.2% had macroalbuminuria.

These findings align with guidelines from both the International Society for Pediatric and Adolescent Diabetes, which recommend A1c less than 7% (53 mmol/mol) as a treatment goal, and the UK National Institute for Health and Care Excellence, which advises a target A1c of 6.5% (48 mmol/mol) or lower in children and adults with type 1 diabetes.

The American Diabetes Association recommends individualized A1c targets ranging from 6.5% to 8.0%.

The study was supported by Barndiabetesfonden (Swedish Children’s Diabetes Foundation) and Region Ostergotlands Stiftelsefonder. The authors reported no further disclosures.

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

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