A headline recently caught my eye about flying cars close to being a reality. Since this is pretty much the dream of everyone who grew up watching “The Jetsons,” I paused to read it.

Of course, it wasn’t quite what I hoped. Battery-powered short-range helicopter services to fly people to airports – to alleviate traffic congestion – have received Food and Drug Administration approval for testing.

In other words, they are still years away, I’m not going to be at the controls, and I won’t be taking them to my office anytime soon. (Granted, it’s only 5 minutes from my house, but wouldn’t you rather fly?)

Maybe it’s hyperbole, maybe clickbait, maybe just an enthusiastic writer, or a little of each.

On a similar note, a recent article titled, “A tiny patch may someday do your patients’ lab work,” about patches with microneedles to measure interstitial fluid, got my attention.

It certainly sounds promising, and more reasonable than the Theranos scam. This has interesting potential as a way to track lab values without repeated needle sticks.

But “someday” is the key word here. The technology is promising. For some conditions it certainly has the potential to improve patient care without frequent lab trips and blood draws.

But the point is ... it ain’t here yet. At the end of the article it says it may be available for some things within 2 years, with more indications over the next decade.

I’m not knocking the technology. That’s great news. But I’m seeing patients today. If I can’t offer it to them now, it doesn’t matter to me.

Maybe I’m a skeptic, but I’ve seen too many initially promising treatments or tests go nowhere when they move into large-scale trials. A lot of things seem like great ideas that don’t work out.

I think the microneedle patch probably has a future for certain conditions, and when it gets here it will be great for those who need it. But that won’t be tomorrow, or even 2024.

But, as with someday flying to work, I’m not holding my breath for it, either.

Dr. Block has a solo neurology practice in Scottsdale, Ariz.

A headline recently caught my eye about flying cars close to being a reality. Since this is pretty much the dream of everyone who grew up watching “The Jetsons,” I paused to read it.

Of course, it wasn’t quite what I hoped. Battery-powered short-range helicopter services to fly people to airports – to alleviate traffic congestion – have received Food and Drug Administration approval for testing.

In other words, they are still years away, I’m not going to be at the controls, and I won’t be taking them to my office anytime soon. (Granted, it’s only 5 minutes from my house, but wouldn’t you rather fly?)

Maybe it’s hyperbole, maybe clickbait, maybe just an enthusiastic writer, or a little of each.

On a similar note, a recent article titled, “A tiny patch may someday do your patients’ lab work,” about patches with microneedles to measure interstitial fluid, got my attention.

It certainly sounds promising, and more reasonable than the Theranos scam. This has interesting potential as a way to track lab values without repeated needle sticks.

But “someday” is the key word here. The technology is promising. For some conditions it certainly has the potential to improve patient care without frequent lab trips and blood draws.

But the point is ... it ain’t here yet. At the end of the article it says it may be available for some things within 2 years, with more indications over the next decade.

I’m not knocking the technology. That’s great news. But I’m seeing patients today. If I can’t offer it to them now, it doesn’t matter to me.

Maybe I’m a skeptic, but I’ve seen too many initially promising treatments or tests go nowhere when they move into large-scale trials. A lot of things seem like great ideas that don’t work out.

I think the microneedle patch probably has a future for certain conditions, and when it gets here it will be great for those who need it. But that won’t be tomorrow, or even 2024.

But, as with someday flying to work, I’m not holding my breath for it, either.

Dr. Block has a solo neurology practice in Scottsdale, Ariz.

A headline recently caught my eye about flying cars close to being a reality. Since this is pretty much the dream of everyone who grew up watching “The Jetsons,” I paused to read it.

Of course, it wasn’t quite what I hoped. Battery-powered short-range helicopter services to fly people to airports – to alleviate traffic congestion – have received Food and Drug Administration approval for testing.

In other words, they are still years away, I’m not going to be at the controls, and I won’t be taking them to my office anytime soon. (Granted, it’s only 5 minutes from my house, but wouldn’t you rather fly?)

Maybe it’s hyperbole, maybe clickbait, maybe just an enthusiastic writer, or a little of each.

On a similar note, a recent article titled, “A tiny patch may someday do your patients’ lab work,” about patches with microneedles to measure interstitial fluid, got my attention.

It certainly sounds promising, and more reasonable than the Theranos scam. This has interesting potential as a way to track lab values without repeated needle sticks.

But “someday” is the key word here. The technology is promising. For some conditions it certainly has the potential to improve patient care without frequent lab trips and blood draws.

But the point is ... it ain’t here yet. At the end of the article it says it may be available for some things within 2 years, with more indications over the next decade.

I’m not knocking the technology. That’s great news. But I’m seeing patients today. If I can’t offer it to them now, it doesn’t matter to me.

Maybe I’m a skeptic, but I’ve seen too many initially promising treatments or tests go nowhere when they move into large-scale trials. A lot of things seem like great ideas that don’t work out.

I think the microneedle patch probably has a future for certain conditions, and when it gets here it will be great for those who need it. But that won’t be tomorrow, or even 2024.

But, as with someday flying to work, I’m not holding my breath for it, either.

Dr. Block has a solo neurology practice in Scottsdale, Ariz.

Investigators have developed and validated a new risk calculator to help predict death by suicide in the 6-12 months after an episode of nonfatal self-harm, new research shows.

A study led by Seena Fazel, MBChB, MD, University of Oxford, England, suggests the Oxford Suicide Assessment Tool for Self-harm (OxSATS) may help guide treatment decisions and target resources to those most in need, the researchers note.

“Many tools use only simple high/low categories, whereas OxSATS includes probability scores, which align more closely with risk calculators in cardiovascular medicine, such as the Framingham Risk Score, and prognostic models in cancer medicine, which provide 5-year survival probabilities. This potentially allows OxSATS to inform clinical decision-making more directly,” Dr. Fazel told this news organization.

The findings were published online in BMJ Mental Health.
 

Targeted tool

Self-harm is associated with a 1-year risk of suicide that is 20 times higher than that of the general population. Given that about 16 million people self-harm annually, the impact at a population level is potentially quite large, the researchers note.

Current structured approaches to gauge suicide risk among those who have engaged in self-harm are based on tools developed for other purposes and symptom checklists. “Their poor to moderate performance is therefore not unexpected,” Dr. Fazel told this news organization.

In contrast, OxSATS was specifically developed to predict suicide mortality after self-harm.

Dr. Fazel’s group evaluated data on 53,172 Swedish individuals aged 10 years and older who sought emergency medical care after episodes of self-harm.

The development cohort included 37,523 individuals. Of these, 391 died by suicide within 12 months. The validation cohort included 15,649 individuals; of these people, 178 died by suicide within 12 months.

The final OxSATS model includes 11 predictors related to age and sex, as well as variables related to substance misuse, mental health, and treatment and history of self-harm.

“The performance of the model in external validation was good, with c-index at 6 and 12 months of 0.77,” the researchers note.

Using a cutoff threshold of 1%, the OxSATS correctly identified 68% of those who died by suicide within 6 months, while 71% of those who didn’t die were correctly classified as being at low risk. The figures for risk prediction at 12 months were 82% and 54%, respectively.

The OxSATS has been made into a simple online tool with probability scores for suicide at 6 and 12 months after an episode of self-harm, but without linkage to interventions. A tool on its own is unlikely to improve outcomes, said Dr. Fazel.

“However,” he added, “it can improve consistency in the assessment process, especially in busy clinical settings where people from different professional backgrounds and experience undertake such assessments. It can also highlight the role of modifiable risk factors and provide an opportunity to transparently discuss risk with patients and their carers.”
 

Valuable work

Reached for comment, Igor Galynker, MD, PhD, professor of psychiatry at the Icahn School of Medicine at Mount Sinai, New York, said that this is a “very solid study with a very large sample size and solid statistical analysis.”

Another strength of the research is the outcome of suicide death versus suicide attempt or suicidal ideation. “In that respect, it is a valuable paper,” Dr. Galynker, who directs the Mount Sinai Beth Israel Suicide Research Laboratory, told this news organization.

He noted that there are no new risk factors in the model. Rather, the model contains the typical risk factors for suicide, which include male sex, substance misuse, past suicide attempt, and psychiatric diagnosis.

“The strongest risk factor in the model is self-harm by hanging, strangulation, or suffocation, which has been shown before and is therefore unsurprising,” said Dr. Galynker.

In general, the risk factors included in the model are often part of administrative tools for suicide risk assessment, said Dr. Galynker, but the OxSATS “seems easier to use because it has 11 items only.”

Broadly speaking, individuals with mental illness and past suicide attempt, past self-harm, alcohol use, and other risk factors “should be treated proactively with suicide prevention measures,” he told this news organization.

As previously reported, Dr. Galynker and colleagues have developed the Abbreviated Suicide Crisis Syndrome Checklist (A-SCS-C), a novel tool to help identify which suicidal patients who present to the emergency department should be admitted to hospital and which patients can be safely discharged.

Funding for the study was provided by Wellcome Trust and the Swedish Research Council. Dr. Fazel and Dr. Galynker have no relevant disclosures.

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

Investigators have developed and validated a new risk calculator to help predict death by suicide in the 6-12 months after an episode of nonfatal self-harm, new research shows.

A study led by Seena Fazel, MBChB, MD, University of Oxford, England, suggests the Oxford Suicide Assessment Tool for Self-harm (OxSATS) may help guide treatment decisions and target resources to those most in need, the researchers note.

“Many tools use only simple high/low categories, whereas OxSATS includes probability scores, which align more closely with risk calculators in cardiovascular medicine, such as the Framingham Risk Score, and prognostic models in cancer medicine, which provide 5-year survival probabilities. This potentially allows OxSATS to inform clinical decision-making more directly,” Dr. Fazel told this news organization.

The findings were published online in BMJ Mental Health.
 

Targeted tool

Self-harm is associated with a 1-year risk of suicide that is 20 times higher than that of the general population. Given that about 16 million people self-harm annually, the impact at a population level is potentially quite large, the researchers note.

Current structured approaches to gauge suicide risk among those who have engaged in self-harm are based on tools developed for other purposes and symptom checklists. “Their poor to moderate performance is therefore not unexpected,” Dr. Fazel told this news organization.

In contrast, OxSATS was specifically developed to predict suicide mortality after self-harm.

Dr. Fazel’s group evaluated data on 53,172 Swedish individuals aged 10 years and older who sought emergency medical care after episodes of self-harm.

The development cohort included 37,523 individuals. Of these, 391 died by suicide within 12 months. The validation cohort included 15,649 individuals; of these people, 178 died by suicide within 12 months.

The final OxSATS model includes 11 predictors related to age and sex, as well as variables related to substance misuse, mental health, and treatment and history of self-harm.

“The performance of the model in external validation was good, with c-index at 6 and 12 months of 0.77,” the researchers note.

Using a cutoff threshold of 1%, the OxSATS correctly identified 68% of those who died by suicide within 6 months, while 71% of those who didn’t die were correctly classified as being at low risk. The figures for risk prediction at 12 months were 82% and 54%, respectively.

The OxSATS has been made into a simple online tool with probability scores for suicide at 6 and 12 months after an episode of self-harm, but without linkage to interventions. A tool on its own is unlikely to improve outcomes, said Dr. Fazel.

“However,” he added, “it can improve consistency in the assessment process, especially in busy clinical settings where people from different professional backgrounds and experience undertake such assessments. It can also highlight the role of modifiable risk factors and provide an opportunity to transparently discuss risk with patients and their carers.”
 

Valuable work

Reached for comment, Igor Galynker, MD, PhD, professor of psychiatry at the Icahn School of Medicine at Mount Sinai, New York, said that this is a “very solid study with a very large sample size and solid statistical analysis.”

Another strength of the research is the outcome of suicide death versus suicide attempt or suicidal ideation. “In that respect, it is a valuable paper,” Dr. Galynker, who directs the Mount Sinai Beth Israel Suicide Research Laboratory, told this news organization.

He noted that there are no new risk factors in the model. Rather, the model contains the typical risk factors for suicide, which include male sex, substance misuse, past suicide attempt, and psychiatric diagnosis.

“The strongest risk factor in the model is self-harm by hanging, strangulation, or suffocation, which has been shown before and is therefore unsurprising,” said Dr. Galynker.

In general, the risk factors included in the model are often part of administrative tools for suicide risk assessment, said Dr. Galynker, but the OxSATS “seems easier to use because it has 11 items only.”

Broadly speaking, individuals with mental illness and past suicide attempt, past self-harm, alcohol use, and other risk factors “should be treated proactively with suicide prevention measures,” he told this news organization.

As previously reported, Dr. Galynker and colleagues have developed the Abbreviated Suicide Crisis Syndrome Checklist (A-SCS-C), a novel tool to help identify which suicidal patients who present to the emergency department should be admitted to hospital and which patients can be safely discharged.

Funding for the study was provided by Wellcome Trust and the Swedish Research Council. Dr. Fazel and Dr. Galynker have no relevant disclosures.

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

Investigators have developed and validated a new risk calculator to help predict death by suicide in the 6-12 months after an episode of nonfatal self-harm, new research shows.

A study led by Seena Fazel, MBChB, MD, University of Oxford, England, suggests the Oxford Suicide Assessment Tool for Self-harm (OxSATS) may help guide treatment decisions and target resources to those most in need, the researchers note.

“Many tools use only simple high/low categories, whereas OxSATS includes probability scores, which align more closely with risk calculators in cardiovascular medicine, such as the Framingham Risk Score, and prognostic models in cancer medicine, which provide 5-year survival probabilities. This potentially allows OxSATS to inform clinical decision-making more directly,” Dr. Fazel told this news organization.

The findings were published online in BMJ Mental Health.
 

Targeted tool

Self-harm is associated with a 1-year risk of suicide that is 20 times higher than that of the general population. Given that about 16 million people self-harm annually, the impact at a population level is potentially quite large, the researchers note.

Current structured approaches to gauge suicide risk among those who have engaged in self-harm are based on tools developed for other purposes and symptom checklists. “Their poor to moderate performance is therefore not unexpected,” Dr. Fazel told this news organization.

In contrast, OxSATS was specifically developed to predict suicide mortality after self-harm.

Dr. Fazel’s group evaluated data on 53,172 Swedish individuals aged 10 years and older who sought emergency medical care after episodes of self-harm.

The development cohort included 37,523 individuals. Of these, 391 died by suicide within 12 months. The validation cohort included 15,649 individuals; of these people, 178 died by suicide within 12 months.

The final OxSATS model includes 11 predictors related to age and sex, as well as variables related to substance misuse, mental health, and treatment and history of self-harm.

“The performance of the model in external validation was good, with c-index at 6 and 12 months of 0.77,” the researchers note.

Using a cutoff threshold of 1%, the OxSATS correctly identified 68% of those who died by suicide within 6 months, while 71% of those who didn’t die were correctly classified as being at low risk. The figures for risk prediction at 12 months were 82% and 54%, respectively.

The OxSATS has been made into a simple online tool with probability scores for suicide at 6 and 12 months after an episode of self-harm, but without linkage to interventions. A tool on its own is unlikely to improve outcomes, said Dr. Fazel.

“However,” he added, “it can improve consistency in the assessment process, especially in busy clinical settings where people from different professional backgrounds and experience undertake such assessments. It can also highlight the role of modifiable risk factors and provide an opportunity to transparently discuss risk with patients and their carers.”
 

Valuable work

Reached for comment, Igor Galynker, MD, PhD, professor of psychiatry at the Icahn School of Medicine at Mount Sinai, New York, said that this is a “very solid study with a very large sample size and solid statistical analysis.”

Another strength of the research is the outcome of suicide death versus suicide attempt or suicidal ideation. “In that respect, it is a valuable paper,” Dr. Galynker, who directs the Mount Sinai Beth Israel Suicide Research Laboratory, told this news organization.

He noted that there are no new risk factors in the model. Rather, the model contains the typical risk factors for suicide, which include male sex, substance misuse, past suicide attempt, and psychiatric diagnosis.

“The strongest risk factor in the model is self-harm by hanging, strangulation, or suffocation, which has been shown before and is therefore unsurprising,” said Dr. Galynker.

In general, the risk factors included in the model are often part of administrative tools for suicide risk assessment, said Dr. Galynker, but the OxSATS “seems easier to use because it has 11 items only.”

Broadly speaking, individuals with mental illness and past suicide attempt, past self-harm, alcohol use, and other risk factors “should be treated proactively with suicide prevention measures,” he told this news organization.

As previously reported, Dr. Galynker and colleagues have developed the Abbreviated Suicide Crisis Syndrome Checklist (A-SCS-C), a novel tool to help identify which suicidal patients who present to the emergency department should be admitted to hospital and which patients can be safely discharged.

Funding for the study was provided by Wellcome Trust and the Swedish Research Council. Dr. Fazel and Dr. Galynker have no relevant disclosures.

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

Topline

Glucagon-like peptide-1 receptor agonist (GLP-1 RA) use lowers the risk for death, cardiovascular disease, decompensated cirrhosis, and liver failure in adults with type 2 diabetes (T2D) and compensated liver cirrhosis, new observational data show.

Methodology

• Population-based cohort study using data from the National Health Insurance Research Database of Taiwan.
• Propensity-score matching was used to construct 467 matched pairs of GLP-1 RA users and nonusers (mean age, 57) with T2D and compensated liver cirrhosis.
• All-cause mortality, cardiovascular events, decompensated cirrhosis, and other key outcomes were compared using multivariable-adjusted Cox proportional hazards models.

Takeaway

• During mean follow-up of about 3 years, rates of death per 1,000 person-years were 27.5 in GLP-1 RA users versus 55.9 in nonusers.
• GLP-1 RA users had a significantly lower risk for mortality (adjusted hazard ratio [aHR], 0.47), cardiovascular events (aHR, 0.6), decompensated cirrhosis (aHR, 0.7), hepatic encephalopathy (aHR, 0.59), and liver failure (aHR, 0.54).
• A longer cumulative duration of GLP-1 RA use was associated with lower risk for these outcomes compared with no use.

In practice

“GLP-1 RAs may be a treatment option for diabetes patients with liver cirrhosis. However, additional studies are needed to confirm our results and to explore the mechanisms of GLP-1 RAs, cirrhotic decompensation and hepatic encephalopathy,” the researchers concluded.

Study details

The study was led by Fu-Shun Yen, Dr Yen’s Clinic, Taoyuan, Taiwan. It was published online June 16, 2023, in Clinical Gastroenterology and Hepatology. Funding was provided in part by the Taiwan Ministry of Health and Welfare Clinical Trial Center, China Medical University Hospital, Taipei Veterans General Hospital, and the Ministry of Science and Technology.

Limitations 

Limitations of the study include a lack of complete information on family history, diet, body weight, and physical activity, as well as biochemical tests, hemoglobin A1c, pathology, and imaging findings that could potentially influence the results.

Disclosures

The authors disclosed no relevant financial relationships.
 

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

Topline

Glucagon-like peptide-1 receptor agonist (GLP-1 RA) use lowers the risk for death, cardiovascular disease, decompensated cirrhosis, and liver failure in adults with type 2 diabetes (T2D) and compensated liver cirrhosis, new observational data show.

Methodology

• Population-based cohort study using data from the National Health Insurance Research Database of Taiwan.
• Propensity-score matching was used to construct 467 matched pairs of GLP-1 RA users and nonusers (mean age, 57) with T2D and compensated liver cirrhosis.
• All-cause mortality, cardiovascular events, decompensated cirrhosis, and other key outcomes were compared using multivariable-adjusted Cox proportional hazards models.

Takeaway

• During mean follow-up of about 3 years, rates of death per 1,000 person-years were 27.5 in GLP-1 RA users versus 55.9 in nonusers.
• GLP-1 RA users had a significantly lower risk for mortality (adjusted hazard ratio [aHR], 0.47), cardiovascular events (aHR, 0.6), decompensated cirrhosis (aHR, 0.7), hepatic encephalopathy (aHR, 0.59), and liver failure (aHR, 0.54).
• A longer cumulative duration of GLP-1 RA use was associated with lower risk for these outcomes compared with no use.

In practice

“GLP-1 RAs may be a treatment option for diabetes patients with liver cirrhosis. However, additional studies are needed to confirm our results and to explore the mechanisms of GLP-1 RAs, cirrhotic decompensation and hepatic encephalopathy,” the researchers concluded.

Study details

The study was led by Fu-Shun Yen, Dr Yen’s Clinic, Taoyuan, Taiwan. It was published online June 16, 2023, in Clinical Gastroenterology and Hepatology. Funding was provided in part by the Taiwan Ministry of Health and Welfare Clinical Trial Center, China Medical University Hospital, Taipei Veterans General Hospital, and the Ministry of Science and Technology.

Limitations 

Limitations of the study include a lack of complete information on family history, diet, body weight, and physical activity, as well as biochemical tests, hemoglobin A1c, pathology, and imaging findings that could potentially influence the results.

Disclosures

The authors disclosed no relevant financial relationships.
 

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

Topline

Glucagon-like peptide-1 receptor agonist (GLP-1 RA) use lowers the risk for death, cardiovascular disease, decompensated cirrhosis, and liver failure in adults with type 2 diabetes (T2D) and compensated liver cirrhosis, new observational data show.

Methodology

• Population-based cohort study using data from the National Health Insurance Research Database of Taiwan.
• Propensity-score matching was used to construct 467 matched pairs of GLP-1 RA users and nonusers (mean age, 57) with T2D and compensated liver cirrhosis.
• All-cause mortality, cardiovascular events, decompensated cirrhosis, and other key outcomes were compared using multivariable-adjusted Cox proportional hazards models.

Takeaway

• During mean follow-up of about 3 years, rates of death per 1,000 person-years were 27.5 in GLP-1 RA users versus 55.9 in nonusers.
• GLP-1 RA users had a significantly lower risk for mortality (adjusted hazard ratio [aHR], 0.47), cardiovascular events (aHR, 0.6), decompensated cirrhosis (aHR, 0.7), hepatic encephalopathy (aHR, 0.59), and liver failure (aHR, 0.54).
• A longer cumulative duration of GLP-1 RA use was associated with lower risk for these outcomes compared with no use.

In practice

“GLP-1 RAs may be a treatment option for diabetes patients with liver cirrhosis. However, additional studies are needed to confirm our results and to explore the mechanisms of GLP-1 RAs, cirrhotic decompensation and hepatic encephalopathy,” the researchers concluded.

Study details

The study was led by Fu-Shun Yen, Dr Yen’s Clinic, Taoyuan, Taiwan. It was published online June 16, 2023, in Clinical Gastroenterology and Hepatology. Funding was provided in part by the Taiwan Ministry of Health and Welfare Clinical Trial Center, China Medical University Hospital, Taipei Veterans General Hospital, and the Ministry of Science and Technology.

Limitations 

Limitations of the study include a lack of complete information on family history, diet, body weight, and physical activity, as well as biochemical tests, hemoglobin A1c, pathology, and imaging findings that could potentially influence the results.

Disclosures

The authors disclosed no relevant financial relationships.
 

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

“I’ve been hit in the head by a walking stick,” a primary care receptionist reported.

“A mother came in and was screaming and swearing at me because she couldn’t get an appointment for her daughters,” another receptionist reported.

“I’ve had people throw a bag of syringes at me because we don’t accept syringes,” said another.

Reports such as these are part of the literature supporting a review that finds patient aggression against receptionists is a serious safety concern for primary care offices and affects delivery of health care.

The review was published online in the BMJ’s Family Medicine and Community Health journal.

“Receptionists in general practice deserve evidence-based measures to improve their working conditions and well-being,” say the authors, led by Fiona Willer, PhD, of the Centre for Community Health and Wellbeing at the University of Queensland, Brisbane, Australia.

Though the study looked primarily at European and Australian practices, physicians in the United States say the incidences are familiar.
 

Cause often lack of access

Dr. Willer and colleagues point out that the root cause of patient regression is typically related to operational factors, such as inefficient scheduling or lack of access to the medical providers.

“However, reception staff are placed in the unenviable position of having to deal with the aftermath of the poor function of these systems without having the status or autonomy to overhaul them,” the authors note.

Authors analyzed 20 studies on aggression against receptionists.

Among the findings:

• All studies reported that patient hostility and verbal abuse of receptionists “was a frequent, routine, and relatively unavoidable occurrence in general practice.”
• Nine studies reported acts of physical violence toward receptionists, with all reporting that physical abuse occurred much less frequently than verbal abuse.
• Some acts were very severe, including being hit, shaken, held at gunpoint, stalked, and threatened with a razorblade.

The studies also discussed ways to prevent potential aggression or react to it, including:

• Regular staff training for managing patient aggression.
• Designing clinics with “safe rooms” and “cool down” spaces.
• Providing clear acrylic shields between receptionists and patients.
• Developing formal policy/procedure/protocol/action guides relating to management of patients.
•  

Behavior can interrupt health care delivery

Carrie Janiski, DO, regional medical director at Golden Valley Health Centers in California, who was not part of the review, said she has seen the aggressive behavior the authors document in her practice’s lobby, “including yelling, name-calling, and threatening language or physical behavior.”

The instances disrupt health care delivery to the patient, who is often in crisis, and all patients and staff in the clinic, she said.

“The patient needs help and the aggressive way they are seeking it could cause harm to others or prevent them from receiving all the help they need,” she said.

She says in practices she has worked in, some effective mitigation strategies have included open-access scheduling, increased walk-in availability for appointments, de-escalation training for front-line staff, and office and exam room layout designed for safety.

She added that incident review is important and should include a process for patient dismissal from the practice.

Dustin Arnold, DO, an internal medicine specialist and chief medical officer at UnityPoint Health-St. Luke’s Hospital, Cedar Rapids, IA, said he agrees with the authors on the urgency for action.

“This is an urgent concern for practices across the country. Your receptionist is the face of your practice, and you should invest in them,” said Dr. Arnold, who was not part of the review.

He said he has seen “verbal abuse and generalized incivility” from patients against receptionists in practices where he has worked.

He said the measure the authors list that he thinks is most effective is staff de-escalation training.

“However, the best preventative measure is for the physician to be on time and minimize cancellation of appointments,” he said. “These are the two primary triggers of a patient becoming disruptive.”

He said his practice has installed a panic button at the front desk and built an alert into the electronic health record indicating that a patient has shown disruptive behavior in the past.

The authors conclude: “Staff training and protocols to manage patient aggression and ongoing structured staff support should be considered essential in general practice. Evidence-based strategies to prevent, manage, and mitigate the harms of patient aggression towards general practice reception staff are urgently needed.”

The authors and Dr. Janiski and Dr. Arnold declared no relevant financial relationships.

[email protected]

“I’ve been hit in the head by a walking stick,” a primary care receptionist reported.

“A mother came in and was screaming and swearing at me because she couldn’t get an appointment for her daughters,” another receptionist reported.

“I’ve had people throw a bag of syringes at me because we don’t accept syringes,” said another.

Reports such as these are part of the literature supporting a review that finds patient aggression against receptionists is a serious safety concern for primary care offices and affects delivery of health care.

The review was published online in the BMJ’s Family Medicine and Community Health journal.

“Receptionists in general practice deserve evidence-based measures to improve their working conditions and well-being,” say the authors, led by Fiona Willer, PhD, of the Centre for Community Health and Wellbeing at the University of Queensland, Brisbane, Australia.

Though the study looked primarily at European and Australian practices, physicians in the United States say the incidences are familiar.
 

Cause often lack of access

Dr. Willer and colleagues point out that the root cause of patient regression is typically related to operational factors, such as inefficient scheduling or lack of access to the medical providers.

“However, reception staff are placed in the unenviable position of having to deal with the aftermath of the poor function of these systems without having the status or autonomy to overhaul them,” the authors note.

Authors analyzed 20 studies on aggression against receptionists.

Among the findings:

• All studies reported that patient hostility and verbal abuse of receptionists “was a frequent, routine, and relatively unavoidable occurrence in general practice.”
• Nine studies reported acts of physical violence toward receptionists, with all reporting that physical abuse occurred much less frequently than verbal abuse.
• Some acts were very severe, including being hit, shaken, held at gunpoint, stalked, and threatened with a razorblade.

The studies also discussed ways to prevent potential aggression or react to it, including:

• Regular staff training for managing patient aggression.
• Designing clinics with “safe rooms” and “cool down” spaces.
• Providing clear acrylic shields between receptionists and patients.
• Developing formal policy/procedure/protocol/action guides relating to management of patients.
•  

Behavior can interrupt health care delivery

Carrie Janiski, DO, regional medical director at Golden Valley Health Centers in California, who was not part of the review, said she has seen the aggressive behavior the authors document in her practice’s lobby, “including yelling, name-calling, and threatening language or physical behavior.”

The instances disrupt health care delivery to the patient, who is often in crisis, and all patients and staff in the clinic, she said.

“The patient needs help and the aggressive way they are seeking it could cause harm to others or prevent them from receiving all the help they need,” she said.

She says in practices she has worked in, some effective mitigation strategies have included open-access scheduling, increased walk-in availability for appointments, de-escalation training for front-line staff, and office and exam room layout designed for safety.

She added that incident review is important and should include a process for patient dismissal from the practice.

Dustin Arnold, DO, an internal medicine specialist and chief medical officer at UnityPoint Health-St. Luke’s Hospital, Cedar Rapids, IA, said he agrees with the authors on the urgency for action.

“This is an urgent concern for practices across the country. Your receptionist is the face of your practice, and you should invest in them,” said Dr. Arnold, who was not part of the review.

He said he has seen “verbal abuse and generalized incivility” from patients against receptionists in practices where he has worked.

He said the measure the authors list that he thinks is most effective is staff de-escalation training.

“However, the best preventative measure is for the physician to be on time and minimize cancellation of appointments,” he said. “These are the two primary triggers of a patient becoming disruptive.”

He said his practice has installed a panic button at the front desk and built an alert into the electronic health record indicating that a patient has shown disruptive behavior in the past.

The authors conclude: “Staff training and protocols to manage patient aggression and ongoing structured staff support should be considered essential in general practice. Evidence-based strategies to prevent, manage, and mitigate the harms of patient aggression towards general practice reception staff are urgently needed.”

The authors and Dr. Janiski and Dr. Arnold declared no relevant financial relationships.

[email protected]

“I’ve been hit in the head by a walking stick,” a primary care receptionist reported.

“A mother came in and was screaming and swearing at me because she couldn’t get an appointment for her daughters,” another receptionist reported.

“I’ve had people throw a bag of syringes at me because we don’t accept syringes,” said another.

Reports such as these are part of the literature supporting a review that finds patient aggression against receptionists is a serious safety concern for primary care offices and affects delivery of health care.

The review was published online in the BMJ’s Family Medicine and Community Health journal.

“Receptionists in general practice deserve evidence-based measures to improve their working conditions and well-being,” say the authors, led by Fiona Willer, PhD, of the Centre for Community Health and Wellbeing at the University of Queensland, Brisbane, Australia.

Though the study looked primarily at European and Australian practices, physicians in the United States say the incidences are familiar.
 

Cause often lack of access

Dr. Willer and colleagues point out that the root cause of patient regression is typically related to operational factors, such as inefficient scheduling or lack of access to the medical providers.

“However, reception staff are placed in the unenviable position of having to deal with the aftermath of the poor function of these systems without having the status or autonomy to overhaul them,” the authors note.

Authors analyzed 20 studies on aggression against receptionists.

Among the findings:

• All studies reported that patient hostility and verbal abuse of receptionists “was a frequent, routine, and relatively unavoidable occurrence in general practice.”
• Nine studies reported acts of physical violence toward receptionists, with all reporting that physical abuse occurred much less frequently than verbal abuse.
• Some acts were very severe, including being hit, shaken, held at gunpoint, stalked, and threatened with a razorblade.

The studies also discussed ways to prevent potential aggression or react to it, including:

• Regular staff training for managing patient aggression.
• Designing clinics with “safe rooms” and “cool down” spaces.
• Providing clear acrylic shields between receptionists and patients.
• Developing formal policy/procedure/protocol/action guides relating to management of patients.
•  

Behavior can interrupt health care delivery

Carrie Janiski, DO, regional medical director at Golden Valley Health Centers in California, who was not part of the review, said she has seen the aggressive behavior the authors document in her practice’s lobby, “including yelling, name-calling, and threatening language or physical behavior.”

The instances disrupt health care delivery to the patient, who is often in crisis, and all patients and staff in the clinic, she said.

“The patient needs help and the aggressive way they are seeking it could cause harm to others or prevent them from receiving all the help they need,” she said.

She says in practices she has worked in, some effective mitigation strategies have included open-access scheduling, increased walk-in availability for appointments, de-escalation training for front-line staff, and office and exam room layout designed for safety.

She added that incident review is important and should include a process for patient dismissal from the practice.

Dustin Arnold, DO, an internal medicine specialist and chief medical officer at UnityPoint Health-St. Luke’s Hospital, Cedar Rapids, IA, said he agrees with the authors on the urgency for action.

“This is an urgent concern for practices across the country. Your receptionist is the face of your practice, and you should invest in them,” said Dr. Arnold, who was not part of the review.

He said he has seen “verbal abuse and generalized incivility” from patients against receptionists in practices where he has worked.

He said the measure the authors list that he thinks is most effective is staff de-escalation training.

“However, the best preventative measure is for the physician to be on time and minimize cancellation of appointments,” he said. “These are the two primary triggers of a patient becoming disruptive.”

He said his practice has installed a panic button at the front desk and built an alert into the electronic health record indicating that a patient has shown disruptive behavior in the past.

The authors conclude: “Staff training and protocols to manage patient aggression and ongoing structured staff support should be considered essential in general practice. Evidence-based strategies to prevent, manage, and mitigate the harms of patient aggression towards general practice reception staff are urgently needed.”

The authors and Dr. Janiski and Dr. Arnold declared no relevant financial relationships.

[email protected]

Calcitonin gene-related peptide (CGRP) antagonist medications have revolutionized migraine therapy since being introduced in 2018. The initial preventive trials for monoclonal antibodies (mAb) excluded older adults, with a cutoff in all studies at age 65 years. Long-term safety studies have not revealed signals for concern related to vascular or other adverse events. The study by Muñoz-Vendrell and colleagues investigated the efficacy of CGRP mAb in treatment-refractory older adults.

This was an observational retrospective study in participants older than 65 years that had previously used three or more prior migraine preventives unsuccessfully. The primary endpoints were reduction in monthly migraine days after 6 months of treatment and the presence of adverse effects. Secondary endpoints were reductions in headache and acute medication frequency as well as improvement in patient reported outcomes.

A total of 162 participants were followed at 18 different headache centers throughout Spain. All patients had at least 8 headache days per month and had been treated unsuccessfully with three prior medications for migraine prevention, one of which was botulinum toxin. The median age was 68 years, and over 80% had chronic migraine. The reduction in mean headache days was 10 days per month; 72% continued to use their CGRP mAb after using it for 6 months. Participants were compared relative to medication overuse but no significant differences were found between those who overused medication and others.

This study highlights the efficacy of CGRP medications in those outside of the initially studied population. Other preventive medications may be contraindicated in this population, but CGRP antagonists do appear to be safe and effective options for older adults.

Opiate medications are typically considered inappropriate as an acute treatment for migraine. Even infrequent use of opiate medications has been shown to be associated with worse migraine outcomes, specifically higher frequency and a higher likelihood to convert from episodic to chronic migraine. Van Welie and colleagues performed a cross-sectional questionnaire-based study assessing levels of opioid use in patients with migraine.

Participants were selected from the Leiden Headache Center and fit the diagnostic criteria of migraine. They were given an e-questionnaire to determine their use of these opiates: buprenorphine, fentanyl, hydromorphone, morphine, oxycodone, tapentadol, and tramadol (codeine was not included in this list). Patients were separately divided between chronic and episodic migraine groups. The primary outcome was assessing for current acute treatment of migraine with an opiate; secondary outcomes were association of chronicity of migraine and likelihood of medication overuse with opiate use.

Only approximately 1.8% of participants reported that they currently use an opiate for acute migraine treatment; 12.5% reported that they previously have used an opiate and 25.7% reported using an opiate for another pain condition. Tramadol was the most commonly used opiate medication, followed by oxycodone and morphine; 2.4% of patients reported that their opiate use was not prescribed by their doctor. Primary care doctors were the most common prescribers of the opiate medications; 16% of the time, patients were told that it was a preventive treatment for migraine. Opiate use was more frequent in patients with a diagnosis of chronic migraine, and the duration of use was greater.

Opiate medications remain a poor acute choice of treatment for migraine, and this study shows a correlation between higher opiate use and chronic migraine. There are many other acute medications now available for migraine, many of them migraine-specific treatments, such as triptans, gepants, and ditans. This research again shows that opiates should be avoided if at all possible for migraine.

Patients with medication overuse headache are more likely to be treatment-refractory, and the addition of acute medications often can be less effective if they remain on the overused medication. There has been a long-standing debate whether it is best to wean medications first or start a preventive initially when faced with medication overuse. The CGRP antagonists may be one of the better preventive options in this situation, and one mAb (fremenezumab) reported positive data in a small medication overuse trial. The study by Guerzoni and colleagues investigated the effectiveness of galcanezumab in chronic migraine with medication overuse.

This was a prospective trial conducted at the University Hospital of Modena. A total of 78 patients with a diagnosis of chronic migraine and medication overuse were enrolled for 15 months, with follow-up every 3 months. At each follow-up appointment, they completed a questionnaire asking them details about: mean migraine days per month, mean number of painkillers taken per month, mean days per month taking a painkiller, average migraine severity, and the Headache Impact Test (HIT-6) and Migraine Disability Assessment (MIDAS) questions. Patients were given the standard-dosing regimen of glacanezumab for migraine and were not blinded; this was an open-label study.

The mean migraine days per month were significantly reduced after 3, 6, 9, and 12 months. The amount of painkillers used per month and days of painkillers per month both reduced significantly as well. Migraine-related disability on HIT-6 and MIDAS were all reduced significantly as well. The most significant improvement long-term was noted in patients who improved the most during the initial 3 months of treatment.

The debate regarding the best treatment for patients with medication overuse will continue, but this study highlights the effectiveness of CGRP mAb use in this population. Patients were able to decrease the use of acute medications without a strict wean off of their previous medication. Ideally, a similar study should also be done for additional mAb and oral CGRP antagonists.

Calcitonin gene-related peptide (CGRP) antagonist medications have revolutionized migraine therapy since being introduced in 2018. The initial preventive trials for monoclonal antibodies (mAb) excluded older adults, with a cutoff in all studies at age 65 years. Long-term safety studies have not revealed signals for concern related to vascular or other adverse events. The study by Muñoz-Vendrell and colleagues investigated the efficacy of CGRP mAb in treatment-refractory older adults.

This was an observational retrospective study in participants older than 65 years that had previously used three or more prior migraine preventives unsuccessfully. The primary endpoints were reduction in monthly migraine days after 6 months of treatment and the presence of adverse effects. Secondary endpoints were reductions in headache and acute medication frequency as well as improvement in patient reported outcomes.

A total of 162 participants were followed at 18 different headache centers throughout Spain. All patients had at least 8 headache days per month and had been treated unsuccessfully with three prior medications for migraine prevention, one of which was botulinum toxin. The median age was 68 years, and over 80% had chronic migraine. The reduction in mean headache days was 10 days per month; 72% continued to use their CGRP mAb after using it for 6 months. Participants were compared relative to medication overuse but no significant differences were found between those who overused medication and others.

This study highlights the efficacy of CGRP medications in those outside of the initially studied population. Other preventive medications may be contraindicated in this population, but CGRP antagonists do appear to be safe and effective options for older adults.

Opiate medications are typically considered inappropriate as an acute treatment for migraine. Even infrequent use of opiate medications has been shown to be associated with worse migraine outcomes, specifically higher frequency and a higher likelihood to convert from episodic to chronic migraine. Van Welie and colleagues performed a cross-sectional questionnaire-based study assessing levels of opioid use in patients with migraine.

Participants were selected from the Leiden Headache Center and fit the diagnostic criteria of migraine. They were given an e-questionnaire to determine their use of these opiates: buprenorphine, fentanyl, hydromorphone, morphine, oxycodone, tapentadol, and tramadol (codeine was not included in this list). Patients were separately divided between chronic and episodic migraine groups. The primary outcome was assessing for current acute treatment of migraine with an opiate; secondary outcomes were association of chronicity of migraine and likelihood of medication overuse with opiate use.

Only approximately 1.8% of participants reported that they currently use an opiate for acute migraine treatment; 12.5% reported that they previously have used an opiate and 25.7% reported using an opiate for another pain condition. Tramadol was the most commonly used opiate medication, followed by oxycodone and morphine; 2.4% of patients reported that their opiate use was not prescribed by their doctor. Primary care doctors were the most common prescribers of the opiate medications; 16% of the time, patients were told that it was a preventive treatment for migraine. Opiate use was more frequent in patients with a diagnosis of chronic migraine, and the duration of use was greater.

Opiate medications remain a poor acute choice of treatment for migraine, and this study shows a correlation between higher opiate use and chronic migraine. There are many other acute medications now available for migraine, many of them migraine-specific treatments, such as triptans, gepants, and ditans. This research again shows that opiates should be avoided if at all possible for migraine.

Patients with medication overuse headache are more likely to be treatment-refractory, and the addition of acute medications often can be less effective if they remain on the overused medication. There has been a long-standing debate whether it is best to wean medications first or start a preventive initially when faced with medication overuse. The CGRP antagonists may be one of the better preventive options in this situation, and one mAb (fremenezumab) reported positive data in a small medication overuse trial. The study by Guerzoni and colleagues investigated the effectiveness of galcanezumab in chronic migraine with medication overuse.

This was a prospective trial conducted at the University Hospital of Modena. A total of 78 patients with a diagnosis of chronic migraine and medication overuse were enrolled for 15 months, with follow-up every 3 months. At each follow-up appointment, they completed a questionnaire asking them details about: mean migraine days per month, mean number of painkillers taken per month, mean days per month taking a painkiller, average migraine severity, and the Headache Impact Test (HIT-6) and Migraine Disability Assessment (MIDAS) questions. Patients were given the standard-dosing regimen of glacanezumab for migraine and were not blinded; this was an open-label study.

The mean migraine days per month were significantly reduced after 3, 6, 9, and 12 months. The amount of painkillers used per month and days of painkillers per month both reduced significantly as well. Migraine-related disability on HIT-6 and MIDAS were all reduced significantly as well. The most significant improvement long-term was noted in patients who improved the most during the initial 3 months of treatment.

The debate regarding the best treatment for patients with medication overuse will continue, but this study highlights the effectiveness of CGRP mAb use in this population. Patients were able to decrease the use of acute medications without a strict wean off of their previous medication. Ideally, a similar study should also be done for additional mAb and oral CGRP antagonists.

Calcitonin gene-related peptide (CGRP) antagonist medications have revolutionized migraine therapy since being introduced in 2018. The initial preventive trials for monoclonal antibodies (mAb) excluded older adults, with a cutoff in all studies at age 65 years. Long-term safety studies have not revealed signals for concern related to vascular or other adverse events. The study by Muñoz-Vendrell and colleagues investigated the efficacy of CGRP mAb in treatment-refractory older adults.

This was an observational retrospective study in participants older than 65 years that had previously used three or more prior migraine preventives unsuccessfully. The primary endpoints were reduction in monthly migraine days after 6 months of treatment and the presence of adverse effects. Secondary endpoints were reductions in headache and acute medication frequency as well as improvement in patient reported outcomes.

A total of 162 participants were followed at 18 different headache centers throughout Spain. All patients had at least 8 headache days per month and had been treated unsuccessfully with three prior medications for migraine prevention, one of which was botulinum toxin. The median age was 68 years, and over 80% had chronic migraine. The reduction in mean headache days was 10 days per month; 72% continued to use their CGRP mAb after using it for 6 months. Participants were compared relative to medication overuse but no significant differences were found between those who overused medication and others.

This study highlights the efficacy of CGRP medications in those outside of the initially studied population. Other preventive medications may be contraindicated in this population, but CGRP antagonists do appear to be safe and effective options for older adults.

Opiate medications are typically considered inappropriate as an acute treatment for migraine. Even infrequent use of opiate medications has been shown to be associated with worse migraine outcomes, specifically higher frequency and a higher likelihood to convert from episodic to chronic migraine. Van Welie and colleagues performed a cross-sectional questionnaire-based study assessing levels of opioid use in patients with migraine.

Participants were selected from the Leiden Headache Center and fit the diagnostic criteria of migraine. They were given an e-questionnaire to determine their use of these opiates: buprenorphine, fentanyl, hydromorphone, morphine, oxycodone, tapentadol, and tramadol (codeine was not included in this list). Patients were separately divided between chronic and episodic migraine groups. The primary outcome was assessing for current acute treatment of migraine with an opiate; secondary outcomes were association of chronicity of migraine and likelihood of medication overuse with opiate use.

Only approximately 1.8% of participants reported that they currently use an opiate for acute migraine treatment; 12.5% reported that they previously have used an opiate and 25.7% reported using an opiate for another pain condition. Tramadol was the most commonly used opiate medication, followed by oxycodone and morphine; 2.4% of patients reported that their opiate use was not prescribed by their doctor. Primary care doctors were the most common prescribers of the opiate medications; 16% of the time, patients were told that it was a preventive treatment for migraine. Opiate use was more frequent in patients with a diagnosis of chronic migraine, and the duration of use was greater.

Opiate medications remain a poor acute choice of treatment for migraine, and this study shows a correlation between higher opiate use and chronic migraine. There are many other acute medications now available for migraine, many of them migraine-specific treatments, such as triptans, gepants, and ditans. This research again shows that opiates should be avoided if at all possible for migraine.

Patients with medication overuse headache are more likely to be treatment-refractory, and the addition of acute medications often can be less effective if they remain on the overused medication. There has been a long-standing debate whether it is best to wean medications first or start a preventive initially when faced with medication overuse. The CGRP antagonists may be one of the better preventive options in this situation, and one mAb (fremenezumab) reported positive data in a small medication overuse trial. The study by Guerzoni and colleagues investigated the effectiveness of galcanezumab in chronic migraine with medication overuse.

This was a prospective trial conducted at the University Hospital of Modena. A total of 78 patients with a diagnosis of chronic migraine and medication overuse were enrolled for 15 months, with follow-up every 3 months. At each follow-up appointment, they completed a questionnaire asking them details about: mean migraine days per month, mean number of painkillers taken per month, mean days per month taking a painkiller, average migraine severity, and the Headache Impact Test (HIT-6) and Migraine Disability Assessment (MIDAS) questions. Patients were given the standard-dosing regimen of glacanezumab for migraine and were not blinded; this was an open-label study.

The mean migraine days per month were significantly reduced after 3, 6, 9, and 12 months. The amount of painkillers used per month and days of painkillers per month both reduced significantly as well. Migraine-related disability on HIT-6 and MIDAS were all reduced significantly as well. The most significant improvement long-term was noted in patients who improved the most during the initial 3 months of treatment.

The debate regarding the best treatment for patients with medication overuse will continue, but this study highlights the effectiveness of CGRP mAb use in this population. Patients were able to decrease the use of acute medications without a strict wean off of their previous medication. Ideally, a similar study should also be done for additional mAb and oral CGRP antagonists.

SAN DIEGO – An assessment of people with diabetes before Ramadan is vital so they can learn whether it is safe for them to fast, and if it is, how to do so without jeopardizing their health.

“With correct advice and support” from knowledgeable health care professionals “most people with type 2 diabetes can fast safely during Ramadan,” Mohamed Hassanein, MBChB, said at the annual scientific sessions of the American Diabetes Association.

One of the most authoritative guidelines on how people with diabetes can safely fast during Ramadan has come from a collaboration between the International Diabetes Federation and the Diabetes & Ramadan International Alliance, an organization chaired by Dr. Hassanein. The groups issued a revised practical guide in 2021 for Ramadan fasting for people with diabetes, an update of the first edition released in 2016. Dr. Hassanein was lead author of the 2016 guidelines and edited the 2021 revision.

The 2021 guidelines also led to an update of a risk stratification app available for free from the DAR. The app provides risk stratification for people with diabetes and helps them access educational material to guide them through their fasts.

Although the latest guidelines address fasting for people with type 1 or type 2 diabetes, far more people with type 2 diabetes are at risk from fasting, and not only because of the higher prevalence of type 2 diabetes.

Results from a global survey of Muslims with diabetes in 2020 showed that 30% of those with type 1 diabetes did not do any fasting during Ramadan, but the percentage of those abstaining from fasting dropped to 16% among Muslims with type 2 diabetes, Dr. Hassanein explained. (Survey results in 2013 from about 38,000 Muslims in 39 countries showed a median of 7% of all adults did no fasting during Ramadan.)
 

Risk assessment by app

Currently, the DAR app is available in Arabic, English, French, and Urdu (the primary language of Pakistan), with more languages being added soon, said Dr. Hassanein, an endocrinologist at Dubai Hospital and professor at Mohammed Bin-Rashid University of Medicine & Health Sciences in Dubai, United Arab Emirates.

The app and screening protocol divides people with diabetes into low-, moderate-, and high-risk subgroups, and those at high risk are advised to refrain from fasting.

But the many other people with diabetes who potentially could fast still face risks for hypoglycemia, hyperglycemia (from overindulgent break-fast meals), diabetic ketoacidosis, dehydration, and thrombosis. Individual risk for these adverse events depends on many factors, including age, duration of diabetes, diabetes type, treatments received, history of hypoglycemia, and diabetes complications.

Dr. Hassanein and colleagues documented the high rate of complications from fasting in a 2020 survey of more than 5,800 Muslims with type 2 diabetes from 20 countries. The results showed that 72% of survey participants had to interrupt their 30 days of daily fasting for at least 1 day because of a diabetes-related event, and an additional 28% had diabetes-triggered interruptions that totaled more than 7 days. About 7% required hospitalization or an emergency department visit, and 16% developed at least one episode of daytime hypoglycemia.
 

Endorsement from Islamic clerics

The recommended risk assessment, and resulting exemptions from fasting, have been endorsed by the Mofty of Egypt, a group of religious scholars who issue legal opinions interpreting Islamic law.

The Mofty agreed that fasting should be interrupted for cases of hypoglycemia with blood glucose less than 70 mg/dL, hyperglycemia with blood glucose greater than 300 mg/dL, symptoms of hypo- or hyperglycemia, or symptoms of acute illness. The Mofty also endorsed that although fasting is obligatory for low-risk adults with diabetes and preferred for those with moderate-risk diabetes, the latter group may consider not fasting out of concern for their safety or to take prescribed medications. People at high risk were deemed by the Mofty as individuals who should not fast because of the potential for harm.

Other notable 2020 survey findings included pre-Ramadan education being received by just 43% of the respondents, and no self-monitoring of blood glucose performed by about a quarter of the respondents.

The 2021 guidelines also include treatment recommendations, such as avoiding older, longer-acting sulfonylurea agents in people with type 2 diabetes. And having people achieve stable, guideline-directed dosages of sodium-glucose cotransporter 2 (SGLT2) inhibitors and glucagonlike peptide-1 (GLP-1) agonists before Ramadan starts, rather than trying to initiate these agents during Ramadan. The guidelines also recommend reducing usual insulin doses when fasting during Ramadan.

Despite summarizing findings from several observational studies and surveys, research to date on how to optimize the safety of diabetes management during Ramadan fasting “is all very basic,” Dr. Hassanein said in an interview.

“We need more randomized clinical trials. We need more [data and evidence] for every single aspect” of management, he added.

The 2021 Diabetes and Ramadan Practical Guidelines were supported by an educational grant from Sanofi and Servier. Dr. Hassanein has reported being a speaker on behalf of Abbott, AstraZeneca, Boehringer Ingelheim, Lilly, Novo Nordisk, Sanofi, and Servier.

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

SAN DIEGO – An assessment of people with diabetes before Ramadan is vital so they can learn whether it is safe for them to fast, and if it is, how to do so without jeopardizing their health.

“With correct advice and support” from knowledgeable health care professionals “most people with type 2 diabetes can fast safely during Ramadan,” Mohamed Hassanein, MBChB, said at the annual scientific sessions of the American Diabetes Association.

One of the most authoritative guidelines on how people with diabetes can safely fast during Ramadan has come from a collaboration between the International Diabetes Federation and the Diabetes & Ramadan International Alliance, an organization chaired by Dr. Hassanein. The groups issued a revised practical guide in 2021 for Ramadan fasting for people with diabetes, an update of the first edition released in 2016. Dr. Hassanein was lead author of the 2016 guidelines and edited the 2021 revision.

The 2021 guidelines also led to an update of a risk stratification app available for free from the DAR. The app provides risk stratification for people with diabetes and helps them access educational material to guide them through their fasts.

Although the latest guidelines address fasting for people with type 1 or type 2 diabetes, far more people with type 2 diabetes are at risk from fasting, and not only because of the higher prevalence of type 2 diabetes.

Results from a global survey of Muslims with diabetes in 2020 showed that 30% of those with type 1 diabetes did not do any fasting during Ramadan, but the percentage of those abstaining from fasting dropped to 16% among Muslims with type 2 diabetes, Dr. Hassanein explained. (Survey results in 2013 from about 38,000 Muslims in 39 countries showed a median of 7% of all adults did no fasting during Ramadan.)
 

Risk assessment by app

Currently, the DAR app is available in Arabic, English, French, and Urdu (the primary language of Pakistan), with more languages being added soon, said Dr. Hassanein, an endocrinologist at Dubai Hospital and professor at Mohammed Bin-Rashid University of Medicine & Health Sciences in Dubai, United Arab Emirates.

The app and screening protocol divides people with diabetes into low-, moderate-, and high-risk subgroups, and those at high risk are advised to refrain from fasting.

But the many other people with diabetes who potentially could fast still face risks for hypoglycemia, hyperglycemia (from overindulgent break-fast meals), diabetic ketoacidosis, dehydration, and thrombosis. Individual risk for these adverse events depends on many factors, including age, duration of diabetes, diabetes type, treatments received, history of hypoglycemia, and diabetes complications.

Dr. Hassanein and colleagues documented the high rate of complications from fasting in a 2020 survey of more than 5,800 Muslims with type 2 diabetes from 20 countries. The results showed that 72% of survey participants had to interrupt their 30 days of daily fasting for at least 1 day because of a diabetes-related event, and an additional 28% had diabetes-triggered interruptions that totaled more than 7 days. About 7% required hospitalization or an emergency department visit, and 16% developed at least one episode of daytime hypoglycemia.
 

Endorsement from Islamic clerics

The recommended risk assessment, and resulting exemptions from fasting, have been endorsed by the Mofty of Egypt, a group of religious scholars who issue legal opinions interpreting Islamic law.

The Mofty agreed that fasting should be interrupted for cases of hypoglycemia with blood glucose less than 70 mg/dL, hyperglycemia with blood glucose greater than 300 mg/dL, symptoms of hypo- or hyperglycemia, or symptoms of acute illness. The Mofty also endorsed that although fasting is obligatory for low-risk adults with diabetes and preferred for those with moderate-risk diabetes, the latter group may consider not fasting out of concern for their safety or to take prescribed medications. People at high risk were deemed by the Mofty as individuals who should not fast because of the potential for harm.

Other notable 2020 survey findings included pre-Ramadan education being received by just 43% of the respondents, and no self-monitoring of blood glucose performed by about a quarter of the respondents.

The 2021 guidelines also include treatment recommendations, such as avoiding older, longer-acting sulfonylurea agents in people with type 2 diabetes. And having people achieve stable, guideline-directed dosages of sodium-glucose cotransporter 2 (SGLT2) inhibitors and glucagonlike peptide-1 (GLP-1) agonists before Ramadan starts, rather than trying to initiate these agents during Ramadan. The guidelines also recommend reducing usual insulin doses when fasting during Ramadan.

Despite summarizing findings from several observational studies and surveys, research to date on how to optimize the safety of diabetes management during Ramadan fasting “is all very basic,” Dr. Hassanein said in an interview.

“We need more randomized clinical trials. We need more [data and evidence] for every single aspect” of management, he added.

The 2021 Diabetes and Ramadan Practical Guidelines were supported by an educational grant from Sanofi and Servier. Dr. Hassanein has reported being a speaker on behalf of Abbott, AstraZeneca, Boehringer Ingelheim, Lilly, Novo Nordisk, Sanofi, and Servier.

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

SAN DIEGO – An assessment of people with diabetes before Ramadan is vital so they can learn whether it is safe for them to fast, and if it is, how to do so without jeopardizing their health.

“With correct advice and support” from knowledgeable health care professionals “most people with type 2 diabetes can fast safely during Ramadan,” Mohamed Hassanein, MBChB, said at the annual scientific sessions of the American Diabetes Association.

One of the most authoritative guidelines on how people with diabetes can safely fast during Ramadan has come from a collaboration between the International Diabetes Federation and the Diabetes & Ramadan International Alliance, an organization chaired by Dr. Hassanein. The groups issued a revised practical guide in 2021 for Ramadan fasting for people with diabetes, an update of the first edition released in 2016. Dr. Hassanein was lead author of the 2016 guidelines and edited the 2021 revision.

The 2021 guidelines also led to an update of a risk stratification app available for free from the DAR. The app provides risk stratification for people with diabetes and helps them access educational material to guide them through their fasts.

Although the latest guidelines address fasting for people with type 1 or type 2 diabetes, far more people with type 2 diabetes are at risk from fasting, and not only because of the higher prevalence of type 2 diabetes.

Results from a global survey of Muslims with diabetes in 2020 showed that 30% of those with type 1 diabetes did not do any fasting during Ramadan, but the percentage of those abstaining from fasting dropped to 16% among Muslims with type 2 diabetes, Dr. Hassanein explained. (Survey results in 2013 from about 38,000 Muslims in 39 countries showed a median of 7% of all adults did no fasting during Ramadan.)
 

Risk assessment by app

Currently, the DAR app is available in Arabic, English, French, and Urdu (the primary language of Pakistan), with more languages being added soon, said Dr. Hassanein, an endocrinologist at Dubai Hospital and professor at Mohammed Bin-Rashid University of Medicine & Health Sciences in Dubai, United Arab Emirates.

The app and screening protocol divides people with diabetes into low-, moderate-, and high-risk subgroups, and those at high risk are advised to refrain from fasting.

But the many other people with diabetes who potentially could fast still face risks for hypoglycemia, hyperglycemia (from overindulgent break-fast meals), diabetic ketoacidosis, dehydration, and thrombosis. Individual risk for these adverse events depends on many factors, including age, duration of diabetes, diabetes type, treatments received, history of hypoglycemia, and diabetes complications.

Dr. Hassanein and colleagues documented the high rate of complications from fasting in a 2020 survey of more than 5,800 Muslims with type 2 diabetes from 20 countries. The results showed that 72% of survey participants had to interrupt their 30 days of daily fasting for at least 1 day because of a diabetes-related event, and an additional 28% had diabetes-triggered interruptions that totaled more than 7 days. About 7% required hospitalization or an emergency department visit, and 16% developed at least one episode of daytime hypoglycemia.
 

Endorsement from Islamic clerics

The recommended risk assessment, and resulting exemptions from fasting, have been endorsed by the Mofty of Egypt, a group of religious scholars who issue legal opinions interpreting Islamic law.

The Mofty agreed that fasting should be interrupted for cases of hypoglycemia with blood glucose less than 70 mg/dL, hyperglycemia with blood glucose greater than 300 mg/dL, symptoms of hypo- or hyperglycemia, or symptoms of acute illness. The Mofty also endorsed that although fasting is obligatory for low-risk adults with diabetes and preferred for those with moderate-risk diabetes, the latter group may consider not fasting out of concern for their safety or to take prescribed medications. People at high risk were deemed by the Mofty as individuals who should not fast because of the potential for harm.

Other notable 2020 survey findings included pre-Ramadan education being received by just 43% of the respondents, and no self-monitoring of blood glucose performed by about a quarter of the respondents.

The 2021 guidelines also include treatment recommendations, such as avoiding older, longer-acting sulfonylurea agents in people with type 2 diabetes. And having people achieve stable, guideline-directed dosages of sodium-glucose cotransporter 2 (SGLT2) inhibitors and glucagonlike peptide-1 (GLP-1) agonists before Ramadan starts, rather than trying to initiate these agents during Ramadan. The guidelines also recommend reducing usual insulin doses when fasting during Ramadan.

Despite summarizing findings from several observational studies and surveys, research to date on how to optimize the safety of diabetes management during Ramadan fasting “is all very basic,” Dr. Hassanein said in an interview.

“We need more randomized clinical trials. We need more [data and evidence] for every single aspect” of management, he added.

The 2021 Diabetes and Ramadan Practical Guidelines were supported by an educational grant from Sanofi and Servier. Dr. Hassanein has reported being a speaker on behalf of Abbott, AstraZeneca, Boehringer Ingelheim, Lilly, Novo Nordisk, Sanofi, and Servier.

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

The advent of subcutaneously injectable glucagonlike peptide–1 (GLP-1) receptor agonists for the management of type 2 diabetes during 2005 was arguably one of the greatest therapeutic advances for the condition since metformin.

I was an early advocate of the class, given its potent glucose-lowering efficacy, secondary benefits of significant weight reduction, and a low risk for hypoglycemia (if not used alongside sulfonylureas or insulin).

During 2016, the first cardiovascular outcomes trial for a GLP-1 agonist, in the form of the LEADER study, was reported. These trials were mandated by the Food and Drug Administration in the aftermath of the rosiglitazone debacle in which the type 2 diabetes drug had its use restricted because of cardiovascular events attributed to it in a meta-analysis. These events weren’t seen in a subsequent trial, and the FDA’s restrictions were later lifted.

LEADER examined the once-daily GLP-1 agonist liraglutide and showed that, in addition to its glucose-lowering effects, liraglutide brought cardiovascular benefits to the table. Moreover, during 2019, the REWIND trial, the cardiovascular outcome trial for once-weekly subcutaneous dulaglutide, revealed the same cardiovascular benefits but also demonstrated a lower incidence of macroalbuminuria, albeit with no significant improvements in hard renal endpoints such as estimated glomerular filtration decline or rates of dialysis.

Despite these compelling benefits, the uptake of GLP-1 agonists has always been slower than that of other compelling agents such as the sodium-glucose cotransporter 2 inhibitors, mainly because the latter are oral drugs, while GLP-1 agonists were initially injectable medications. This difference has proven to be a barrier for patients and clinicians alike.

However, in 2019, oral semaglutide, in doses of 7 mg and 14 mg, was approved by the FDA as the first (and still only) commercially available oral GLP-1 agonist to improve glycemic control in adults with type 2 diabetes. This approval was hailed as a “game changer” at the time. The treatment had no proven cardiovascular benefits, only lack of cardiovascular harm in PIONEER 6. The SOUL cardiovascular outcome trial for oral semaglutide in doses of 7 mg and 14 mg is due to be completed during 2024. But semaglutide certainly had compelling glucose-lowering efficacy and secondary benefits of significant weight loss similar to those of its injectable counterparts.

Cardiovascular benefits of injectable semaglutide for type 2 diabetes were demonstrated in the SUSTAIN-6 trial in 2016, and the U.S. label for Ozempic was amended accordingly in 2020.

Again, I was an early adopter of oral semaglutide, and it has been great for my patients with type 2 diabetes to have the option of a noninjectable GLP-1 agonist. However, it is not without its drawbacks: Oral semaglutide must be taken on an empty stomach, at least 30 minutes before any other food, drink, or medication, and with no more than 120 mL water to maximize absorption and bioavailability.

I am of South Asian origin and have a strong family history of type 2 diabetes. If I develop type 2 diabetes in the future and require treatment escalation to a GLP-1 agonist, I will most likely opt for a weekly injectable, as it would best fit my lifestyle. But having choices of preparation has been a huge advantage in helping my patients best individualize their therapies.

I attended the recent American Diabetes Association congress in San Diego, which had two interesting oral GLP-1 agonist sessions on the program.

The first discussed the efficacy and safety of a new daily oral nonpeptide GLP-1 agonist, orforglipron, for weight reduction in adults with obesity. The phase 2 results were impressive, with clinically significant reductions in weight and cardiometabolic parameters, and a reassuring safety profile similar to that of the injectable GLP-1 agonists.

Notably, because orforglipron is a nonpeptide, it can be taken without any food, water, or medication restrictions. This indeed could turn out to be a real game changer by simplifying the complex administration of oral semaglutide, which no doubt has hampered compliance.

In fact, an Association of British Clinical Diabetologists real-world audit (also presented at the ADA Congress as a poster) of oral semaglutide use for type 2 diabetes found clinically significant hemoglobin A1c and weight reductions, but perhaps less than expected when compared with the clinical trial program, which could be a sign of poor adherence.

A phase 3 trial of orforglipron is underway (ATTAIN-2), exploring its efficacy and safety in adults with obesity or overweight and type 2 diabetes, but it is not due to be completed until 2027.

I also attended the session presenting the results of the OASIS 1 and PIONEER-PLUS trials of higher-dose oral semaglutide.

OASIS 1 explored the efficacy and safety of high-dose oral semaglutide, 50 mg once daily, for the treatment of adults with overweight or obesity without type 2 diabetes. The investigators found clinically significant reductions in body weight of around 15%-17% from baseline, compared with placebo. This result was similar to the weight loss observed in the STEP 1 trial of 2.4 mg weekly subcutaneous injectable semaglutide in adults with obesity (a much lower dose is needed when GLP-1 agonists are given as injectables because the oral forms are not very bioavailable). The side-effect profile was also similar.

PIONEER PLUS explored the efficacy and safety of high-dose oral semaglutide 25 mg and 50 mg in adults with inadequately controlled type 2 diabetes. Patients treated with 50 mg oral semaglutide had around a 2% reduction in A1c and an 8-kg (18-lb) reduction in weight from baseline. It is well known that people with obesity and type 2 diabetes lose less weight than those with obesity alone, so this result was impressive. Again, the safety profile was similar to that of the wider class, with predictably high levels of gastrointestinal side effects.

So, the future appears very bright for oral GLP-1 agonists. I hope that future developments bring the class to an even wider demographic and perhaps reduce some of the global inequities in managing type 2 diabetes and obesity. It should be easier (and cheaper) to mass-produce and distribute an oral medication, compared with an injectable one.

However, it should be noted that, in the United Kingdom, the National Health Service tariff cost of oral semaglutide (at usual doses for type 2 diabetes) remains similar to that of injectable semaglutide (at doses for type 2 diabetes rather than obesity). And notably, the U.K. National Institute for Health and Care Excellence, which decides whether new drugs will be funded on the NHS, has recently delayed its decision on approving tirzepatide, a dual GLP-1 and GIP agonist, for type 2 diabetes, citing the requirement for further evidence for its clinical and cost-effectiveness. This is not uncommon for NICE, and I fully expect tirzepatide to gain NICE approval on resubmission later in 2023.

One solution to contain costs might be a phased approach to the management of obesity, with initial stages using highly efficacious obesity drugs such as tirzepatide, injectable semaglutide, or high-dose oral semaglutide, and then transitioning to lower-efficacy and cheaper obesity drugs for weight maintenance.

On this note, a generic version of liraglutide (a once-daily injectable GLP-1 agonist) will be available during 2024. Moreover, it will be interesting to see the cost of orforglipron, assuming that it is approved, when it becomes commercially available in a few years, given that a nonpeptide agent should be cheaper to produce than a peptide-like semaglutide.

This phased approach is analogous to the treatment of rheumatoid arthritis, where potent targeted biologic therapy is often used early on to achieve remission of rheumatoid arthritis, followed by a switch to a conventional disease-modifying antirheumatic drug for maintenance therapy, for reasons of long-term safety and health economics.

Using this approach for obesity management might help the sustainability of health care systems.

Dr. Fernando is a general practitioner near Edinburgh. He reported receiving speaker fees from Eli Lilly and Novo Nordisk.

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

The advent of subcutaneously injectable glucagonlike peptide–1 (GLP-1) receptor agonists for the management of type 2 diabetes during 2005 was arguably one of the greatest therapeutic advances for the condition since metformin.

I was an early advocate of the class, given its potent glucose-lowering efficacy, secondary benefits of significant weight reduction, and a low risk for hypoglycemia (if not used alongside sulfonylureas or insulin).

During 2016, the first cardiovascular outcomes trial for a GLP-1 agonist, in the form of the LEADER study, was reported. These trials were mandated by the Food and Drug Administration in the aftermath of the rosiglitazone debacle in which the type 2 diabetes drug had its use restricted because of cardiovascular events attributed to it in a meta-analysis. These events weren’t seen in a subsequent trial, and the FDA’s restrictions were later lifted.

LEADER examined the once-daily GLP-1 agonist liraglutide and showed that, in addition to its glucose-lowering effects, liraglutide brought cardiovascular benefits to the table. Moreover, during 2019, the REWIND trial, the cardiovascular outcome trial for once-weekly subcutaneous dulaglutide, revealed the same cardiovascular benefits but also demonstrated a lower incidence of macroalbuminuria, albeit with no significant improvements in hard renal endpoints such as estimated glomerular filtration decline or rates of dialysis.

Despite these compelling benefits, the uptake of GLP-1 agonists has always been slower than that of other compelling agents such as the sodium-glucose cotransporter 2 inhibitors, mainly because the latter are oral drugs, while GLP-1 agonists were initially injectable medications. This difference has proven to be a barrier for patients and clinicians alike.

However, in 2019, oral semaglutide, in doses of 7 mg and 14 mg, was approved by the FDA as the first (and still only) commercially available oral GLP-1 agonist to improve glycemic control in adults with type 2 diabetes. This approval was hailed as a “game changer” at the time. The treatment had no proven cardiovascular benefits, only lack of cardiovascular harm in PIONEER 6. The SOUL cardiovascular outcome trial for oral semaglutide in doses of 7 mg and 14 mg is due to be completed during 2024. But semaglutide certainly had compelling glucose-lowering efficacy and secondary benefits of significant weight loss similar to those of its injectable counterparts.

Cardiovascular benefits of injectable semaglutide for type 2 diabetes were demonstrated in the SUSTAIN-6 trial in 2016, and the U.S. label for Ozempic was amended accordingly in 2020.

Again, I was an early adopter of oral semaglutide, and it has been great for my patients with type 2 diabetes to have the option of a noninjectable GLP-1 agonist. However, it is not without its drawbacks: Oral semaglutide must be taken on an empty stomach, at least 30 minutes before any other food, drink, or medication, and with no more than 120 mL water to maximize absorption and bioavailability.

I am of South Asian origin and have a strong family history of type 2 diabetes. If I develop type 2 diabetes in the future and require treatment escalation to a GLP-1 agonist, I will most likely opt for a weekly injectable, as it would best fit my lifestyle. But having choices of preparation has been a huge advantage in helping my patients best individualize their therapies.

I attended the recent American Diabetes Association congress in San Diego, which had two interesting oral GLP-1 agonist sessions on the program.

The first discussed the efficacy and safety of a new daily oral nonpeptide GLP-1 agonist, orforglipron, for weight reduction in adults with obesity. The phase 2 results were impressive, with clinically significant reductions in weight and cardiometabolic parameters, and a reassuring safety profile similar to that of the injectable GLP-1 agonists.

Notably, because orforglipron is a nonpeptide, it can be taken without any food, water, or medication restrictions. This indeed could turn out to be a real game changer by simplifying the complex administration of oral semaglutide, which no doubt has hampered compliance.

In fact, an Association of British Clinical Diabetologists real-world audit (also presented at the ADA Congress as a poster) of oral semaglutide use for type 2 diabetes found clinically significant hemoglobin A1c and weight reductions, but perhaps less than expected when compared with the clinical trial program, which could be a sign of poor adherence.

A phase 3 trial of orforglipron is underway (ATTAIN-2), exploring its efficacy and safety in adults with obesity or overweight and type 2 diabetes, but it is not due to be completed until 2027.

I also attended the session presenting the results of the OASIS 1 and PIONEER-PLUS trials of higher-dose oral semaglutide.

OASIS 1 explored the efficacy and safety of high-dose oral semaglutide, 50 mg once daily, for the treatment of adults with overweight or obesity without type 2 diabetes. The investigators found clinically significant reductions in body weight of around 15%-17% from baseline, compared with placebo. This result was similar to the weight loss observed in the STEP 1 trial of 2.4 mg weekly subcutaneous injectable semaglutide in adults with obesity (a much lower dose is needed when GLP-1 agonists are given as injectables because the oral forms are not very bioavailable). The side-effect profile was also similar.

PIONEER PLUS explored the efficacy and safety of high-dose oral semaglutide 25 mg and 50 mg in adults with inadequately controlled type 2 diabetes. Patients treated with 50 mg oral semaglutide had around a 2% reduction in A1c and an 8-kg (18-lb) reduction in weight from baseline. It is well known that people with obesity and type 2 diabetes lose less weight than those with obesity alone, so this result was impressive. Again, the safety profile was similar to that of the wider class, with predictably high levels of gastrointestinal side effects.

So, the future appears very bright for oral GLP-1 agonists. I hope that future developments bring the class to an even wider demographic and perhaps reduce some of the global inequities in managing type 2 diabetes and obesity. It should be easier (and cheaper) to mass-produce and distribute an oral medication, compared with an injectable one.

However, it should be noted that, in the United Kingdom, the National Health Service tariff cost of oral semaglutide (at usual doses for type 2 diabetes) remains similar to that of injectable semaglutide (at doses for type 2 diabetes rather than obesity). And notably, the U.K. National Institute for Health and Care Excellence, which decides whether new drugs will be funded on the NHS, has recently delayed its decision on approving tirzepatide, a dual GLP-1 and GIP agonist, for type 2 diabetes, citing the requirement for further evidence for its clinical and cost-effectiveness. This is not uncommon for NICE, and I fully expect tirzepatide to gain NICE approval on resubmission later in 2023.

One solution to contain costs might be a phased approach to the management of obesity, with initial stages using highly efficacious obesity drugs such as tirzepatide, injectable semaglutide, or high-dose oral semaglutide, and then transitioning to lower-efficacy and cheaper obesity drugs for weight maintenance.

On this note, a generic version of liraglutide (a once-daily injectable GLP-1 agonist) will be available during 2024. Moreover, it will be interesting to see the cost of orforglipron, assuming that it is approved, when it becomes commercially available in a few years, given that a nonpeptide agent should be cheaper to produce than a peptide-like semaglutide.

This phased approach is analogous to the treatment of rheumatoid arthritis, where potent targeted biologic therapy is often used early on to achieve remission of rheumatoid arthritis, followed by a switch to a conventional disease-modifying antirheumatic drug for maintenance therapy, for reasons of long-term safety and health economics.

Using this approach for obesity management might help the sustainability of health care systems.

Dr. Fernando is a general practitioner near Edinburgh. He reported receiving speaker fees from Eli Lilly and Novo Nordisk.

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

The advent of subcutaneously injectable glucagonlike peptide–1 (GLP-1) receptor agonists for the management of type 2 diabetes during 2005 was arguably one of the greatest therapeutic advances for the condition since metformin.

I was an early advocate of the class, given its potent glucose-lowering efficacy, secondary benefits of significant weight reduction, and a low risk for hypoglycemia (if not used alongside sulfonylureas or insulin).

During 2016, the first cardiovascular outcomes trial for a GLP-1 agonist, in the form of the LEADER study, was reported. These trials were mandated by the Food and Drug Administration in the aftermath of the rosiglitazone debacle in which the type 2 diabetes drug had its use restricted because of cardiovascular events attributed to it in a meta-analysis. These events weren’t seen in a subsequent trial, and the FDA’s restrictions were later lifted.

LEADER examined the once-daily GLP-1 agonist liraglutide and showed that, in addition to its glucose-lowering effects, liraglutide brought cardiovascular benefits to the table. Moreover, during 2019, the REWIND trial, the cardiovascular outcome trial for once-weekly subcutaneous dulaglutide, revealed the same cardiovascular benefits but also demonstrated a lower incidence of macroalbuminuria, albeit with no significant improvements in hard renal endpoints such as estimated glomerular filtration decline or rates of dialysis.

Despite these compelling benefits, the uptake of GLP-1 agonists has always been slower than that of other compelling agents such as the sodium-glucose cotransporter 2 inhibitors, mainly because the latter are oral drugs, while GLP-1 agonists were initially injectable medications. This difference has proven to be a barrier for patients and clinicians alike.

However, in 2019, oral semaglutide, in doses of 7 mg and 14 mg, was approved by the FDA as the first (and still only) commercially available oral GLP-1 agonist to improve glycemic control in adults with type 2 diabetes. This approval was hailed as a “game changer” at the time. The treatment had no proven cardiovascular benefits, only lack of cardiovascular harm in PIONEER 6. The SOUL cardiovascular outcome trial for oral semaglutide in doses of 7 mg and 14 mg is due to be completed during 2024. But semaglutide certainly had compelling glucose-lowering efficacy and secondary benefits of significant weight loss similar to those of its injectable counterparts.

Cardiovascular benefits of injectable semaglutide for type 2 diabetes were demonstrated in the SUSTAIN-6 trial in 2016, and the U.S. label for Ozempic was amended accordingly in 2020.

Again, I was an early adopter of oral semaglutide, and it has been great for my patients with type 2 diabetes to have the option of a noninjectable GLP-1 agonist. However, it is not without its drawbacks: Oral semaglutide must be taken on an empty stomach, at least 30 minutes before any other food, drink, or medication, and with no more than 120 mL water to maximize absorption and bioavailability.

I am of South Asian origin and have a strong family history of type 2 diabetes. If I develop type 2 diabetes in the future and require treatment escalation to a GLP-1 agonist, I will most likely opt for a weekly injectable, as it would best fit my lifestyle. But having choices of preparation has been a huge advantage in helping my patients best individualize their therapies.

I attended the recent American Diabetes Association congress in San Diego, which had two interesting oral GLP-1 agonist sessions on the program.

The first discussed the efficacy and safety of a new daily oral nonpeptide GLP-1 agonist, orforglipron, for weight reduction in adults with obesity. The phase 2 results were impressive, with clinically significant reductions in weight and cardiometabolic parameters, and a reassuring safety profile similar to that of the injectable GLP-1 agonists.

Notably, because orforglipron is a nonpeptide, it can be taken without any food, water, or medication restrictions. This indeed could turn out to be a real game changer by simplifying the complex administration of oral semaglutide, which no doubt has hampered compliance.

In fact, an Association of British Clinical Diabetologists real-world audit (also presented at the ADA Congress as a poster) of oral semaglutide use for type 2 diabetes found clinically significant hemoglobin A1c and weight reductions, but perhaps less than expected when compared with the clinical trial program, which could be a sign of poor adherence.

A phase 3 trial of orforglipron is underway (ATTAIN-2), exploring its efficacy and safety in adults with obesity or overweight and type 2 diabetes, but it is not due to be completed until 2027.

I also attended the session presenting the results of the OASIS 1 and PIONEER-PLUS trials of higher-dose oral semaglutide.

OASIS 1 explored the efficacy and safety of high-dose oral semaglutide, 50 mg once daily, for the treatment of adults with overweight or obesity without type 2 diabetes. The investigators found clinically significant reductions in body weight of around 15%-17% from baseline, compared with placebo. This result was similar to the weight loss observed in the STEP 1 trial of 2.4 mg weekly subcutaneous injectable semaglutide in adults with obesity (a much lower dose is needed when GLP-1 agonists are given as injectables because the oral forms are not very bioavailable). The side-effect profile was also similar.

PIONEER PLUS explored the efficacy and safety of high-dose oral semaglutide 25 mg and 50 mg in adults with inadequately controlled type 2 diabetes. Patients treated with 50 mg oral semaglutide had around a 2% reduction in A1c and an 8-kg (18-lb) reduction in weight from baseline. It is well known that people with obesity and type 2 diabetes lose less weight than those with obesity alone, so this result was impressive. Again, the safety profile was similar to that of the wider class, with predictably high levels of gastrointestinal side effects.

So, the future appears very bright for oral GLP-1 agonists. I hope that future developments bring the class to an even wider demographic and perhaps reduce some of the global inequities in managing type 2 diabetes and obesity. It should be easier (and cheaper) to mass-produce and distribute an oral medication, compared with an injectable one.

However, it should be noted that, in the United Kingdom, the National Health Service tariff cost of oral semaglutide (at usual doses for type 2 diabetes) remains similar to that of injectable semaglutide (at doses for type 2 diabetes rather than obesity). And notably, the U.K. National Institute for Health and Care Excellence, which decides whether new drugs will be funded on the NHS, has recently delayed its decision on approving tirzepatide, a dual GLP-1 and GIP agonist, for type 2 diabetes, citing the requirement for further evidence for its clinical and cost-effectiveness. This is not uncommon for NICE, and I fully expect tirzepatide to gain NICE approval on resubmission later in 2023.

One solution to contain costs might be a phased approach to the management of obesity, with initial stages using highly efficacious obesity drugs such as tirzepatide, injectable semaglutide, or high-dose oral semaglutide, and then transitioning to lower-efficacy and cheaper obesity drugs for weight maintenance.

On this note, a generic version of liraglutide (a once-daily injectable GLP-1 agonist) will be available during 2024. Moreover, it will be interesting to see the cost of orforglipron, assuming that it is approved, when it becomes commercially available in a few years, given that a nonpeptide agent should be cheaper to produce than a peptide-like semaglutide.

This phased approach is analogous to the treatment of rheumatoid arthritis, where potent targeted biologic therapy is often used early on to achieve remission of rheumatoid arthritis, followed by a switch to a conventional disease-modifying antirheumatic drug for maintenance therapy, for reasons of long-term safety and health economics.

Using this approach for obesity management might help the sustainability of health care systems.

Dr. Fernando is a general practitioner near Edinburgh. He reported receiving speaker fees from Eli Lilly and Novo Nordisk.

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

TOPLINE:

High-dose vitamin D supplementation may prevent atrial fibrillation (AFib) in healthy elderly men and women, a post hoc analysis from a randomized trial conducted in Finland suggests.

METHODOLOGY:

• Observational studies have suggested that vitamin D deficiency is associated with increased risk for AFib, but few randomized trials have looked at the effect of vitamin D supplementation on AFib incidence in healthy people.
• The study, a post hoc analysis from a trial that explored the effects of vitamin D3 supplementation on incidence of cardiovascular diseases and cancer, included 2,495 vitamin D–sufficient healthy older adults, mean age 68.2 years, of whom 43% were women.
• Participants had been randomized to one of three groups in which they received vitamin D3 at either 1,600 IU/day or 3,200 IU/day, or placebo.
• Serum 25(OH)D3 concentrations were measured and data on incident AFib were gathered from national health records.

TAKEAWAY:

• Atrial fibrillation was diagnosed in 190 participants.
• Over a follow-up averaging 4.1 years, risk for incident AFib was reduced by 27% for participants who received the 1,600 IU/day dose, compared with placebo; hazard ratio, 0.73 (95% confidence interval, 0.52-1.02; P = .07), and by 32% for those in the 3,200 IU/day arm; HR, 0.68 (95% CI, 0.48-0.96; P = .03).
• The incident-AFib risk was reduced by 30% in a comparison of the two vitamin D groups combined versus the placebo group; HR, 0.70 (95% CI, 0.53-0.94; P = .02).
• After exclusion of 122 participants who reported being on antiarrhythmic medications at baseline, the 1,600 IU/day group showed a significant 27% reduction in risk for AF (95% CI, 4%-58%; P = .03) and the 3,200 IU/day group a nonsignificant 30% (95% CI, 5%-53%; P = .08) reduction in risk.

IN PRACTICE:

High-dose vitamin D3 supplementation may reduce incidence of AFib in a generally healthy, largely vitamin D–sufficient elderly population, the authors proposed. Additional controlled trials are needed, especially in diverse populations.

STUDY DETAILS:

The study was conducted by Jyrki K. Virtanen, PhD, University of Eastern Finland, Institute of Public Health and Clinical Nutrition, Kuopio, and colleagues. It was published in the American Heart Journal.

LIMITATIONS:

Atrial fibrillation was not prespecified as a primary outcome, and the results differ from those of other randomized controlled trials. Information on type of AFib (whether paroxysmal or nonparoxysmal, for example) wasn’t available nor were participants’ history of AFib. All participants were White and from Finland, limiting generalizability of the results.

DISCLOSURES:

The study was supported by the Academy of Finland, University of Eastern Finland, the Juho Vainio Foundation, Medicinska Understödsföreningen Liv och Hälsa, Finnish Foundation for Cardiovascular Research, Finnish Diabetes Research Foundation, and the Finnish Cultural Foundation. One coauthor disclosed receiving grants from the National Institutes of Health and Mars Edge. Another coauthor disclosed receipt of a grant from Orion. The other authors disclosed no relevant financial relationships.

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

TOPLINE:

High-dose vitamin D supplementation may prevent atrial fibrillation (AFib) in healthy elderly men and women, a post hoc analysis from a randomized trial conducted in Finland suggests.

METHODOLOGY:

• Observational studies have suggested that vitamin D deficiency is associated with increased risk for AFib, but few randomized trials have looked at the effect of vitamin D supplementation on AFib incidence in healthy people.
• The study, a post hoc analysis from a trial that explored the effects of vitamin D3 supplementation on incidence of cardiovascular diseases and cancer, included 2,495 vitamin D–sufficient healthy older adults, mean age 68.2 years, of whom 43% were women.
• Participants had been randomized to one of three groups in which they received vitamin D3 at either 1,600 IU/day or 3,200 IU/day, or placebo.
• Serum 25(OH)D3 concentrations were measured and data on incident AFib were gathered from national health records.

TAKEAWAY:

• Atrial fibrillation was diagnosed in 190 participants.
• Over a follow-up averaging 4.1 years, risk for incident AFib was reduced by 27% for participants who received the 1,600 IU/day dose, compared with placebo; hazard ratio, 0.73 (95% confidence interval, 0.52-1.02; P = .07), and by 32% for those in the 3,200 IU/day arm; HR, 0.68 (95% CI, 0.48-0.96; P = .03).
• The incident-AFib risk was reduced by 30% in a comparison of the two vitamin D groups combined versus the placebo group; HR, 0.70 (95% CI, 0.53-0.94; P = .02).
• After exclusion of 122 participants who reported being on antiarrhythmic medications at baseline, the 1,600 IU/day group showed a significant 27% reduction in risk for AF (95% CI, 4%-58%; P = .03) and the 3,200 IU/day group a nonsignificant 30% (95% CI, 5%-53%; P = .08) reduction in risk.

IN PRACTICE:

High-dose vitamin D3 supplementation may reduce incidence of AFib in a generally healthy, largely vitamin D–sufficient elderly population, the authors proposed. Additional controlled trials are needed, especially in diverse populations.

STUDY DETAILS:

The study was conducted by Jyrki K. Virtanen, PhD, University of Eastern Finland, Institute of Public Health and Clinical Nutrition, Kuopio, and colleagues. It was published in the American Heart Journal.

LIMITATIONS:

Atrial fibrillation was not prespecified as a primary outcome, and the results differ from those of other randomized controlled trials. Information on type of AFib (whether paroxysmal or nonparoxysmal, for example) wasn’t available nor were participants’ history of AFib. All participants were White and from Finland, limiting generalizability of the results.

DISCLOSURES:

The study was supported by the Academy of Finland, University of Eastern Finland, the Juho Vainio Foundation, Medicinska Understödsföreningen Liv och Hälsa, Finnish Foundation for Cardiovascular Research, Finnish Diabetes Research Foundation, and the Finnish Cultural Foundation. One coauthor disclosed receiving grants from the National Institutes of Health and Mars Edge. Another coauthor disclosed receipt of a grant from Orion. The other authors disclosed no relevant financial relationships.

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

TOPLINE:

High-dose vitamin D supplementation may prevent atrial fibrillation (AFib) in healthy elderly men and women, a post hoc analysis from a randomized trial conducted in Finland suggests.

METHODOLOGY:

• Observational studies have suggested that vitamin D deficiency is associated with increased risk for AFib, but few randomized trials have looked at the effect of vitamin D supplementation on AFib incidence in healthy people.
• The study, a post hoc analysis from a trial that explored the effects of vitamin D3 supplementation on incidence of cardiovascular diseases and cancer, included 2,495 vitamin D–sufficient healthy older adults, mean age 68.2 years, of whom 43% were women.
• Participants had been randomized to one of three groups in which they received vitamin D3 at either 1,600 IU/day or 3,200 IU/day, or placebo.
• Serum 25(OH)D3 concentrations were measured and data on incident AFib were gathered from national health records.

TAKEAWAY:

• Atrial fibrillation was diagnosed in 190 participants.
• Over a follow-up averaging 4.1 years, risk for incident AFib was reduced by 27% for participants who received the 1,600 IU/day dose, compared with placebo; hazard ratio, 0.73 (95% confidence interval, 0.52-1.02; P = .07), and by 32% for those in the 3,200 IU/day arm; HR, 0.68 (95% CI, 0.48-0.96; P = .03).
• The incident-AFib risk was reduced by 30% in a comparison of the two vitamin D groups combined versus the placebo group; HR, 0.70 (95% CI, 0.53-0.94; P = .02).
• After exclusion of 122 participants who reported being on antiarrhythmic medications at baseline, the 1,600 IU/day group showed a significant 27% reduction in risk for AF (95% CI, 4%-58%; P = .03) and the 3,200 IU/day group a nonsignificant 30% (95% CI, 5%-53%; P = .08) reduction in risk.

IN PRACTICE:

High-dose vitamin D3 supplementation may reduce incidence of AFib in a generally healthy, largely vitamin D–sufficient elderly population, the authors proposed. Additional controlled trials are needed, especially in diverse populations.

STUDY DETAILS:

The study was conducted by Jyrki K. Virtanen, PhD, University of Eastern Finland, Institute of Public Health and Clinical Nutrition, Kuopio, and colleagues. It was published in the American Heart Journal.

LIMITATIONS:

Atrial fibrillation was not prespecified as a primary outcome, and the results differ from those of other randomized controlled trials. Information on type of AFib (whether paroxysmal or nonparoxysmal, for example) wasn’t available nor were participants’ history of AFib. All participants were White and from Finland, limiting generalizability of the results.

DISCLOSURES:

The study was supported by the Academy of Finland, University of Eastern Finland, the Juho Vainio Foundation, Medicinska Understödsföreningen Liv och Hälsa, Finnish Foundation for Cardiovascular Research, Finnish Diabetes Research Foundation, and the Finnish Cultural Foundation. One coauthor disclosed receiving grants from the National Institutes of Health and Mars Edge. Another coauthor disclosed receipt of a grant from Orion. The other authors disclosed no relevant financial relationships.

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

SAN DIEGO – Prescribing optimal medical therapy for people with both type 2 diabetes and cardiovascular disease can and should improve, speakers urged at the annual scientific sessions of the American Diabetes Association.

A symposium there focused on the recent randomized, controlled COORDINATE-Diabetes trial, which investigated a multipronged educational intervention in 43 U.S. cardiology clinics aimed at improving prescribing of guideline-recommended treatments for people with both type 2 diabetes and cardiovascular disease. Compared with clinics that were randomly assigned to offer usual care, the intervention significantly increased recommended prescribing of high-intensity statins, angiotensin-converting enzyme inhibitors or angiotensin receptor blockers (ARBs), and sodium-glucose cotransporter 2 (SGLT2) inhibitors and/or glucagonlike peptide 1 receptor agonists (GLP-1 agonists).

COORDINATE-Diabetes was aimed at cardiologists, who typically see these patients more often than do endocrinologists. However, the results are relevant to all health care providers involved in the care of those with type 2 diabetes, speakers argued at the ADA symposium.

“This is a cardiology study. I think it’s safe to say that not too many of you in the room are cardiologists. So why would you care about the results of the COORDINATE study?” said Ildiko Lingvay, MD, of the University of Texas Southwestern Medical Center, Dallas.

Dr. Lingvay went on to outline reasons that the COORDINATE findings apply to endocrinologists and primary care clinicians, as well as cardiologists. For one, a study from her institution that was presented at a recent internal medicine meeting showed that, among more than 10,000 patients with type 2 diabetes and cardiovascular disease, heart failure, and/or chronic kidney disease, the proportion of patients who were prescribed the appropriate guideline-indicated medications was 20.1% for those seen in primary care, 24.8% in endocrinology, 20.3% in cardiology, and 18.3% in nephrology.

“So, we [endocrinologists are] not that much better [than other specialties]” at prescribing, she noted.

Mikhail N. Kosiborod, MD, in independent commentary called the COORDINATE trial and other similar initiatives “the beginning of care transformation.”

The COORDINATE-Diabetes results were originally presented in March at the joint scientific sessions of the American College of Cardiology and the World Heart Federation. The study was simultaneously published in JAMA.
 

‘They’ve shown we can do better’

Asked to comment, Robert H. Eckel, MD, said in an interview, “I look at COORDINATE as a wake-up call to the need for multispecialty approaches to people with type 2 diabetes and cardiovascular disease. ... I think it’s a step in the door.”

Dr. Eckel, who has long advocated for a new “cardiometabolic” physician subspecialty, noted that COORDINATE-Diabetes “stopped short of training health care providers in the science and medicine of cardio-renal-metabolic disease.”

Nonetheless, regarding the efforts toward a more coordinated system of care, Dr. Eckel said, “I support the concept, unequivocally.” He is associated with the division of endocrinology, metabolism, and diabetes, University of Colorado at Denver, Aurora.

But the cost-effectiveness of the intervention “requires time to assess,” he added. “We don’t know anything yet other than [that] managing drug administration to meet goals that relate to outcomes in people with diabetes can be accomplished. They’ve shown that we can do better.”
 

Why should you care about a cardiology study?

In COORDINATE-Diabetes, 20 of the centers were randomly assigned to provide five interventions: assess local barriers, develop care pathways, coordinate care, educate clinicians, report data back to the clinics, and provide tools for the 459 participants. The other 23 clinics, with 590 participants, were randomly assigned to provide usual care per practice guidelines.

The primary outcome was the proportion of participants that prescribed all three groups of the recommended therapies at 6-12 months after enrollment; 37.9% prescribed the intervention, and 14.5% provided usual care, a significant 23% difference (P < .001). The rate of prescriptions of each of the three individual drug groups was also significantly higher with the intervention. No differences were seen in cardiovascular risk factors or outcomes.

Dr. Lingvay pointed out that the interventions tested in COORDINATE – such as fact sheets and medication passports for patients, system audits and feedback, and provider grand rounds – can be extrapolated to any specialist setting.

She added that the long-held model of team-based care means that “everyone involved in the care of these patients is responsible for ensuring best practices are followed.” Part of that, she said, is helping other specialists prescribe the same medications and communicate across the team.

For all specialists, she recommends using the resources available on the COORDINATE website.
 

‘It’s not a silver bullet; additional solutions are needed’

In his commentary, Dr. Kosiborod, executive director of the Cardiometabolic Center Alliance, noted, “The treatments studied in COORDINATE represent the biggest advances in a generation when it comes to improving outcomes in this population. ... We’re living in a renaissance age with the number of tools we have available. ... It’s getting better every day.”

Moreover, all the relevant professional society guidelines now recommend GLP-1 agonists and SGLT2 inhibitors. “And yet, when we look, less than 1 in 10 patients with type 2 diabetes and atherosclerotic cardiovascular disease are getting appropriate recommended care. One of the lessons of COORDINATE is that this needs to change if we’re really going to improve our patients’ lives.”

The barriers aren’t simply financial, Dr. Kosiborod said. He pointed to two studies that show that even reducing out-of-pocket costs resulted in only modest increases in adherence.

Educational gaps on the part of both clinicians and patients also factor in, as do misaligned incentives.

“Clinicians get paid for how many things they do, not necessarily how well they do them. Everyone wants to do the right thing, but ultimately, incentives do matter,” he emphasized.

While the COORDINATE-Diabetes interventions addressed several of the barriers, two-thirds of the participants still did not receive optimal therapy.

“It’s not a silver bullet. ... Additional solutions are needed,” Dr. Kosiborod observed.
 

Transformation occurs ‘when the status quo is no longer acceptable’

Enter his institution, the Cardiometabolic Center Alliance, part of Saint Luke’s Mid-America Heart Institute. The nonprofit system, which currently has 16 subscribing clinics around the country, offers patient-centered “team-based, coordinated, comprehensive care” for people with both type 2 diabetes and cardiovascular disease.

The model is led by preventive cardiology in collaboration with endocrinology and primary care. Support staff includes advance practice providers, nurse navigators, certified diabetes educators, dietitians, and pharmacists. Individualized treatment plans aim for “aggressive secondary risk reduction,” Dr. Kosiborod noted.

Six-month data from the Cardiometabolic Center Alliance show an increase from 28.2% at baseline to 67.1% (P < .0001) in prescribing of a four-agent guideline-directed medical therapy “bundle,” including the three from COORDINATE-Diabetes plus an antiplatelet or anticoagulant agent. Dr. Kosiborod presented these data during the ADA meeting in a poster.

Remaining questions involve sustainability, scalability, and system transformation, which require buy-in from multiple stakeholders, he noted.

He contends that it can be done. A prior example of “rapid and lasting care transformation” occurred in November 2006 with the launch of the “Door to Balloon (D2B) Alliance for Quality,” which dramatically increased the proportion of patients who received primary angioplasty within 90 minutes at hospitals around the United States. From January 2005 to September 2010, those proportions rose from 27.3% to 70.4%.

“Patients were coming into the emergency department with myocardial infarctions and waiting for hours before the interventional cardiologist came. The community said we needed a nationwide quality improvement initiative. ... Almost every hospital in the country changed their systems of care. It was a huge national effort. ... When we no longer consider the status quo acceptable, we can actually make something very special happen very quickly.”

After the session, Dr. Kosiborod said in an interview that the Cardiometabolic Center Alliance is now gathering data to make the financial case for the approach.

“We’re trying to develop a model that tells the admins which patients will save money, because, of course, if you can create a financial incentive, it only makes it go faster. ... We want to synchronize it in the best way possible.”

Dr. Lingvay has receiving nonfinancial support and grants from Novo Nordisk, personal fees or nonfinancial support from Sanofi, Lilly, Boehringer Ingelheim, Merck/Pfizer, Mylan, AstraZeneca, Johnson & Johnson, Intercept, Target Pharma, Zealand, Shionogi, Carmot, Structure, Bayer, Mediflix, WebMD, GI Dynamics, Intarcia Therapeutics, Mannkind, Novartis, Structure Therapeutics, and Valeritas. Dr. Kosiborod is a consultant for Alnylam Pharmaceuticals, Amgen, Applied Therapeutics, AstraZeneca, Bayer, Boehringer Ingelheim, Cytokinetics, Dexcom, Eli Lilly, ESPERION Therapeutics, Janssen Pharmaceuticals, Lexicon Pharmaceuticals, Merck, Novo Nordisk, Pharmacosmos, Pfizer, Sanofi, Vifor Pharma Management, and Youngene Therapeutics. He also receives research support from AstraZeneca and Boehringer Ingelheim. Dr. Eckel serves on consulting/advisory boards for Amgen, Arrowhead, Better, Ionis, Kowa, Lexicon, Novo Nordisk, Precision BioSciences, The Healthy Aging Company, Tolmar, and Weight Watchers.

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

SAN DIEGO – Prescribing optimal medical therapy for people with both type 2 diabetes and cardiovascular disease can and should improve, speakers urged at the annual scientific sessions of the American Diabetes Association.

A symposium there focused on the recent randomized, controlled COORDINATE-Diabetes trial, which investigated a multipronged educational intervention in 43 U.S. cardiology clinics aimed at improving prescribing of guideline-recommended treatments for people with both type 2 diabetes and cardiovascular disease. Compared with clinics that were randomly assigned to offer usual care, the intervention significantly increased recommended prescribing of high-intensity statins, angiotensin-converting enzyme inhibitors or angiotensin receptor blockers (ARBs), and sodium-glucose cotransporter 2 (SGLT2) inhibitors and/or glucagonlike peptide 1 receptor agonists (GLP-1 agonists).

COORDINATE-Diabetes was aimed at cardiologists, who typically see these patients more often than do endocrinologists. However, the results are relevant to all health care providers involved in the care of those with type 2 diabetes, speakers argued at the ADA symposium.

“This is a cardiology study. I think it’s safe to say that not too many of you in the room are cardiologists. So why would you care about the results of the COORDINATE study?” said Ildiko Lingvay, MD, of the University of Texas Southwestern Medical Center, Dallas.

Dr. Lingvay went on to outline reasons that the COORDINATE findings apply to endocrinologists and primary care clinicians, as well as cardiologists. For one, a study from her institution that was presented at a recent internal medicine meeting showed that, among more than 10,000 patients with type 2 diabetes and cardiovascular disease, heart failure, and/or chronic kidney disease, the proportion of patients who were prescribed the appropriate guideline-indicated medications was 20.1% for those seen in primary care, 24.8% in endocrinology, 20.3% in cardiology, and 18.3% in nephrology.

“So, we [endocrinologists are] not that much better [than other specialties]” at prescribing, she noted.

Mikhail N. Kosiborod, MD, in independent commentary called the COORDINATE trial and other similar initiatives “the beginning of care transformation.”

The COORDINATE-Diabetes results were originally presented in March at the joint scientific sessions of the American College of Cardiology and the World Heart Federation. The study was simultaneously published in JAMA.
 

‘They’ve shown we can do better’

Asked to comment, Robert H. Eckel, MD, said in an interview, “I look at COORDINATE as a wake-up call to the need for multispecialty approaches to people with type 2 diabetes and cardiovascular disease. ... I think it’s a step in the door.”

Dr. Eckel, who has long advocated for a new “cardiometabolic” physician subspecialty, noted that COORDINATE-Diabetes “stopped short of training health care providers in the science and medicine of cardio-renal-metabolic disease.”

Nonetheless, regarding the efforts toward a more coordinated system of care, Dr. Eckel said, “I support the concept, unequivocally.” He is associated with the division of endocrinology, metabolism, and diabetes, University of Colorado at Denver, Aurora.

But the cost-effectiveness of the intervention “requires time to assess,” he added. “We don’t know anything yet other than [that] managing drug administration to meet goals that relate to outcomes in people with diabetes can be accomplished. They’ve shown that we can do better.”
 

Why should you care about a cardiology study?

In COORDINATE-Diabetes, 20 of the centers were randomly assigned to provide five interventions: assess local barriers, develop care pathways, coordinate care, educate clinicians, report data back to the clinics, and provide tools for the 459 participants. The other 23 clinics, with 590 participants, were randomly assigned to provide usual care per practice guidelines.

The primary outcome was the proportion of participants that prescribed all three groups of the recommended therapies at 6-12 months after enrollment; 37.9% prescribed the intervention, and 14.5% provided usual care, a significant 23% difference (P < .001). The rate of prescriptions of each of the three individual drug groups was also significantly higher with the intervention. No differences were seen in cardiovascular risk factors or outcomes.

Dr. Lingvay pointed out that the interventions tested in COORDINATE – such as fact sheets and medication passports for patients, system audits and feedback, and provider grand rounds – can be extrapolated to any specialist setting.

She added that the long-held model of team-based care means that “everyone involved in the care of these patients is responsible for ensuring best practices are followed.” Part of that, she said, is helping other specialists prescribe the same medications and communicate across the team.

For all specialists, she recommends using the resources available on the COORDINATE website.
 

‘It’s not a silver bullet; additional solutions are needed’

In his commentary, Dr. Kosiborod, executive director of the Cardiometabolic Center Alliance, noted, “The treatments studied in COORDINATE represent the biggest advances in a generation when it comes to improving outcomes in this population. ... We’re living in a renaissance age with the number of tools we have available. ... It’s getting better every day.”

Moreover, all the relevant professional society guidelines now recommend GLP-1 agonists and SGLT2 inhibitors. “And yet, when we look, less than 1 in 10 patients with type 2 diabetes and atherosclerotic cardiovascular disease are getting appropriate recommended care. One of the lessons of COORDINATE is that this needs to change if we’re really going to improve our patients’ lives.”

The barriers aren’t simply financial, Dr. Kosiborod said. He pointed to two studies that show that even reducing out-of-pocket costs resulted in only modest increases in adherence.

Educational gaps on the part of both clinicians and patients also factor in, as do misaligned incentives.

“Clinicians get paid for how many things they do, not necessarily how well they do them. Everyone wants to do the right thing, but ultimately, incentives do matter,” he emphasized.

While the COORDINATE-Diabetes interventions addressed several of the barriers, two-thirds of the participants still did not receive optimal therapy.

“It’s not a silver bullet. ... Additional solutions are needed,” Dr. Kosiborod observed.
 

Transformation occurs ‘when the status quo is no longer acceptable’

Enter his institution, the Cardiometabolic Center Alliance, part of Saint Luke’s Mid-America Heart Institute. The nonprofit system, which currently has 16 subscribing clinics around the country, offers patient-centered “team-based, coordinated, comprehensive care” for people with both type 2 diabetes and cardiovascular disease.

The model is led by preventive cardiology in collaboration with endocrinology and primary care. Support staff includes advance practice providers, nurse navigators, certified diabetes educators, dietitians, and pharmacists. Individualized treatment plans aim for “aggressive secondary risk reduction,” Dr. Kosiborod noted.

Six-month data from the Cardiometabolic Center Alliance show an increase from 28.2% at baseline to 67.1% (P < .0001) in prescribing of a four-agent guideline-directed medical therapy “bundle,” including the three from COORDINATE-Diabetes plus an antiplatelet or anticoagulant agent. Dr. Kosiborod presented these data during the ADA meeting in a poster.

Remaining questions involve sustainability, scalability, and system transformation, which require buy-in from multiple stakeholders, he noted.

He contends that it can be done. A prior example of “rapid and lasting care transformation” occurred in November 2006 with the launch of the “Door to Balloon (D2B) Alliance for Quality,” which dramatically increased the proportion of patients who received primary angioplasty within 90 minutes at hospitals around the United States. From January 2005 to September 2010, those proportions rose from 27.3% to 70.4%.

“Patients were coming into the emergency department with myocardial infarctions and waiting for hours before the interventional cardiologist came. The community said we needed a nationwide quality improvement initiative. ... Almost every hospital in the country changed their systems of care. It was a huge national effort. ... When we no longer consider the status quo acceptable, we can actually make something very special happen very quickly.”

After the session, Dr. Kosiborod said in an interview that the Cardiometabolic Center Alliance is now gathering data to make the financial case for the approach.

“We’re trying to develop a model that tells the admins which patients will save money, because, of course, if you can create a financial incentive, it only makes it go faster. ... We want to synchronize it in the best way possible.”

Dr. Lingvay has receiving nonfinancial support and grants from Novo Nordisk, personal fees or nonfinancial support from Sanofi, Lilly, Boehringer Ingelheim, Merck/Pfizer, Mylan, AstraZeneca, Johnson & Johnson, Intercept, Target Pharma, Zealand, Shionogi, Carmot, Structure, Bayer, Mediflix, WebMD, GI Dynamics, Intarcia Therapeutics, Mannkind, Novartis, Structure Therapeutics, and Valeritas. Dr. Kosiborod is a consultant for Alnylam Pharmaceuticals, Amgen, Applied Therapeutics, AstraZeneca, Bayer, Boehringer Ingelheim, Cytokinetics, Dexcom, Eli Lilly, ESPERION Therapeutics, Janssen Pharmaceuticals, Lexicon Pharmaceuticals, Merck, Novo Nordisk, Pharmacosmos, Pfizer, Sanofi, Vifor Pharma Management, and Youngene Therapeutics. He also receives research support from AstraZeneca and Boehringer Ingelheim. Dr. Eckel serves on consulting/advisory boards for Amgen, Arrowhead, Better, Ionis, Kowa, Lexicon, Novo Nordisk, Precision BioSciences, The Healthy Aging Company, Tolmar, and Weight Watchers.

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

SAN DIEGO – Prescribing optimal medical therapy for people with both type 2 diabetes and cardiovascular disease can and should improve, speakers urged at the annual scientific sessions of the American Diabetes Association.

A symposium there focused on the recent randomized, controlled COORDINATE-Diabetes trial, which investigated a multipronged educational intervention in 43 U.S. cardiology clinics aimed at improving prescribing of guideline-recommended treatments for people with both type 2 diabetes and cardiovascular disease. Compared with clinics that were randomly assigned to offer usual care, the intervention significantly increased recommended prescribing of high-intensity statins, angiotensin-converting enzyme inhibitors or angiotensin receptor blockers (ARBs), and sodium-glucose cotransporter 2 (SGLT2) inhibitors and/or glucagonlike peptide 1 receptor agonists (GLP-1 agonists).

COORDINATE-Diabetes was aimed at cardiologists, who typically see these patients more often than do endocrinologists. However, the results are relevant to all health care providers involved in the care of those with type 2 diabetes, speakers argued at the ADA symposium.

“This is a cardiology study. I think it’s safe to say that not too many of you in the room are cardiologists. So why would you care about the results of the COORDINATE study?” said Ildiko Lingvay, MD, of the University of Texas Southwestern Medical Center, Dallas.

Dr. Lingvay went on to outline reasons that the COORDINATE findings apply to endocrinologists and primary care clinicians, as well as cardiologists. For one, a study from her institution that was presented at a recent internal medicine meeting showed that, among more than 10,000 patients with type 2 diabetes and cardiovascular disease, heart failure, and/or chronic kidney disease, the proportion of patients who were prescribed the appropriate guideline-indicated medications was 20.1% for those seen in primary care, 24.8% in endocrinology, 20.3% in cardiology, and 18.3% in nephrology.

“So, we [endocrinologists are] not that much better [than other specialties]” at prescribing, she noted.

Mikhail N. Kosiborod, MD, in independent commentary called the COORDINATE trial and other similar initiatives “the beginning of care transformation.”

The COORDINATE-Diabetes results were originally presented in March at the joint scientific sessions of the American College of Cardiology and the World Heart Federation. The study was simultaneously published in JAMA.
 

‘They’ve shown we can do better’

Asked to comment, Robert H. Eckel, MD, said in an interview, “I look at COORDINATE as a wake-up call to the need for multispecialty approaches to people with type 2 diabetes and cardiovascular disease. ... I think it’s a step in the door.”

Dr. Eckel, who has long advocated for a new “cardiometabolic” physician subspecialty, noted that COORDINATE-Diabetes “stopped short of training health care providers in the science and medicine of cardio-renal-metabolic disease.”

Nonetheless, regarding the efforts toward a more coordinated system of care, Dr. Eckel said, “I support the concept, unequivocally.” He is associated with the division of endocrinology, metabolism, and diabetes, University of Colorado at Denver, Aurora.

But the cost-effectiveness of the intervention “requires time to assess,” he added. “We don’t know anything yet other than [that] managing drug administration to meet goals that relate to outcomes in people with diabetes can be accomplished. They’ve shown that we can do better.”
 

Why should you care about a cardiology study?

In COORDINATE-Diabetes, 20 of the centers were randomly assigned to provide five interventions: assess local barriers, develop care pathways, coordinate care, educate clinicians, report data back to the clinics, and provide tools for the 459 participants. The other 23 clinics, with 590 participants, were randomly assigned to provide usual care per practice guidelines.

The primary outcome was the proportion of participants that prescribed all three groups of the recommended therapies at 6-12 months after enrollment; 37.9% prescribed the intervention, and 14.5% provided usual care, a significant 23% difference (P < .001). The rate of prescriptions of each of the three individual drug groups was also significantly higher with the intervention. No differences were seen in cardiovascular risk factors or outcomes.

Dr. Lingvay pointed out that the interventions tested in COORDINATE – such as fact sheets and medication passports for patients, system audits and feedback, and provider grand rounds – can be extrapolated to any specialist setting.

She added that the long-held model of team-based care means that “everyone involved in the care of these patients is responsible for ensuring best practices are followed.” Part of that, she said, is helping other specialists prescribe the same medications and communicate across the team.

For all specialists, she recommends using the resources available on the COORDINATE website.
 

‘It’s not a silver bullet; additional solutions are needed’

In his commentary, Dr. Kosiborod, executive director of the Cardiometabolic Center Alliance, noted, “The treatments studied in COORDINATE represent the biggest advances in a generation when it comes to improving outcomes in this population. ... We’re living in a renaissance age with the number of tools we have available. ... It’s getting better every day.”

Moreover, all the relevant professional society guidelines now recommend GLP-1 agonists and SGLT2 inhibitors. “And yet, when we look, less than 1 in 10 patients with type 2 diabetes and atherosclerotic cardiovascular disease are getting appropriate recommended care. One of the lessons of COORDINATE is that this needs to change if we’re really going to improve our patients’ lives.”

The barriers aren’t simply financial, Dr. Kosiborod said. He pointed to two studies that show that even reducing out-of-pocket costs resulted in only modest increases in adherence.

Educational gaps on the part of both clinicians and patients also factor in, as do misaligned incentives.

“Clinicians get paid for how many things they do, not necessarily how well they do them. Everyone wants to do the right thing, but ultimately, incentives do matter,” he emphasized.

While the COORDINATE-Diabetes interventions addressed several of the barriers, two-thirds of the participants still did not receive optimal therapy.

“It’s not a silver bullet. ... Additional solutions are needed,” Dr. Kosiborod observed.
 

Transformation occurs ‘when the status quo is no longer acceptable’

Enter his institution, the Cardiometabolic Center Alliance, part of Saint Luke’s Mid-America Heart Institute. The nonprofit system, which currently has 16 subscribing clinics around the country, offers patient-centered “team-based, coordinated, comprehensive care” for people with both type 2 diabetes and cardiovascular disease.

The model is led by preventive cardiology in collaboration with endocrinology and primary care. Support staff includes advance practice providers, nurse navigators, certified diabetes educators, dietitians, and pharmacists. Individualized treatment plans aim for “aggressive secondary risk reduction,” Dr. Kosiborod noted.

Six-month data from the Cardiometabolic Center Alliance show an increase from 28.2% at baseline to 67.1% (P < .0001) in prescribing of a four-agent guideline-directed medical therapy “bundle,” including the three from COORDINATE-Diabetes plus an antiplatelet or anticoagulant agent. Dr. Kosiborod presented these data during the ADA meeting in a poster.

Remaining questions involve sustainability, scalability, and system transformation, which require buy-in from multiple stakeholders, he noted.

He contends that it can be done. A prior example of “rapid and lasting care transformation” occurred in November 2006 with the launch of the “Door to Balloon (D2B) Alliance for Quality,” which dramatically increased the proportion of patients who received primary angioplasty within 90 minutes at hospitals around the United States. From January 2005 to September 2010, those proportions rose from 27.3% to 70.4%.

“Patients were coming into the emergency department with myocardial infarctions and waiting for hours before the interventional cardiologist came. The community said we needed a nationwide quality improvement initiative. ... Almost every hospital in the country changed their systems of care. It was a huge national effort. ... When we no longer consider the status quo acceptable, we can actually make something very special happen very quickly.”

After the session, Dr. Kosiborod said in an interview that the Cardiometabolic Center Alliance is now gathering data to make the financial case for the approach.

“We’re trying to develop a model that tells the admins which patients will save money, because, of course, if you can create a financial incentive, it only makes it go faster. ... We want to synchronize it in the best way possible.”

Dr. Lingvay has receiving nonfinancial support and grants from Novo Nordisk, personal fees or nonfinancial support from Sanofi, Lilly, Boehringer Ingelheim, Merck/Pfizer, Mylan, AstraZeneca, Johnson & Johnson, Intercept, Target Pharma, Zealand, Shionogi, Carmot, Structure, Bayer, Mediflix, WebMD, GI Dynamics, Intarcia Therapeutics, Mannkind, Novartis, Structure Therapeutics, and Valeritas. Dr. Kosiborod is a consultant for Alnylam Pharmaceuticals, Amgen, Applied Therapeutics, AstraZeneca, Bayer, Boehringer Ingelheim, Cytokinetics, Dexcom, Eli Lilly, ESPERION Therapeutics, Janssen Pharmaceuticals, Lexicon Pharmaceuticals, Merck, Novo Nordisk, Pharmacosmos, Pfizer, Sanofi, Vifor Pharma Management, and Youngene Therapeutics. He also receives research support from AstraZeneca and Boehringer Ingelheim. Dr. Eckel serves on consulting/advisory boards for Amgen, Arrowhead, Better, Ionis, Kowa, Lexicon, Novo Nordisk, Precision BioSciences, The Healthy Aging Company, Tolmar, and Weight Watchers.

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

Mothers with obsessive-compulsive disorder (OCD) are more likely to have adverse pregnancy, delivery, and neonatal outcomes than are those without the disorder, according to new research.

In an observational study that followed almost 3 million pregnancies in two countries over 20 years, children of women with OCD were at increased risk for low Apgar score at 5 minutes in Sweden (adjusted risk ratio [aRR], 1.62) and British Columbia, Canada (aRR, 2.30). The risks for adverse outcomes were greater among women with OCD who were taking serotonin reuptake inhibitors (SRIs), compared with those who were not.

“To me, the most relevant things to consider are the clinical implications of these findings,” lead author Lorena Fernández de la Cruz, PhD, principal researcher at Karolinska Institute in Stockholm, told this news organization. She noted that some of the outcomes, such as preeclampsia, can be prevented or improved with collaboration among clinicians and increased monitoring.

The study was published online in JAMA Network Open.
 

Increased risk

OCD affects roughly 1%-3% of the population. Although it is sometimes seen as a mild psychiatric disorder, OCD entails a range of adverse outcomes, and this research suggests that the adverse outcomes extend to maternal health, Dr. Fernández de la Cruz stressed.

The researchers drew data from population registers in Sweden and British Columbia for all singleton births over a roughly 20-year period ending in 2019, with subcohorts identified by formal OCD diagnosis and exposure to SRIs within 30 days before conception. Statistical analyses were performed on a range of pregnancy, delivery, and neonatal outcomes.

In an analysis adjusted for common risk factors such as age, BMI, and smoking, Swedish women with OCD had elevated risk for several adverse outcomes, including a 40% increased risk for gestational diabetes. In British Columbia, fewer adverse pregnancy outcomes for women were associated with an OCD diagnosis.

The study, which also tracked neonatal outcomes, found that infants of mothers with OCD in both Sweden and British Columbia had higher rates of preterm birth (Sweden: aRR, 1.33; BC: aRR, 1.58), low birth weight (Sweden: aRR, 1.28; BC: aRR, 1.40), and neonatal respiratory distress (Sweden: aRR, 1.63; BC: aRR, 1.47).

These results, the authors say, show a need for more monitoring of maternal OCD and collaboration among obstetricians and psychologists. “All this evidence shows that OCD should be detected and treated so that adverse outcomes can be prevented or properly handled,” said Dr. Fernández de la Cruz.
 

SRI medication

SRIs are frequently used to treat OCD. The subclass of selective SRIs, which includes common antidepressants, has been associated with worsened pregnancy outcomes, but it remains unclear whether all SRIs increase pregnancy risks.

To understand the role of SRIs better in this study, the authors compared the outcomes for women taking SRIs and those who were not prescribed the medication, which is a novel aspect of the study, according to Dr. Fernández de la Cruz. Women who took the medication were at greater risk for several adverse outcomes, although all women with an OCD diagnosis were at higher risk than were those without the condition. The investigators hope to continue studying the role of OCD medication during pregnancy in more detail.

The rates of SRI use varied between the two cohorts: 81% of Canadian patients took the medication, compared with 37% of Swedish patients. The disparate rates, along with other clinical practices, may have contributed to differences in outcomes for the two cohorts.

It is also important to bear in mind, however, that patients taking the medication tend to have more severe cases of OCD, said Dr. Fernández de la Cruz. Thus, the increased risk may or may not result from the medication itself. “It is important to understand that there may be other variables besides medication explaining why one group had higher risks than the other,” she said.
 

‘Multifactorial’ reasons

In addition to medication, other factors may play a role in the association between OCD and adverse pregnancy and neonatal outcomes, including genetics, lifestyle, and psychiatric comorbidities. The authors addressed some of these potential confounders in additional analyses, including sister and cousin comparisons in the Swedish arm of the study, which found weakened associations, compared with population wide statistics.

Commenting on the research, Benicio Frey, PhD, professor of psychiatry and behavioral neurosciences at McMaster University in Hamilton, Ont., said that acknowledging these confounding factors is a strength of the study. Psychiatric conditions such as depression and anxiety are common among patients with OCD. Of the patients with OCD in this study, 72% and 51% had other psychiatric diagnoses in Sweden and British Columbia, respectively. About 7% of the women without OCD had one of these conditions.

However, Dr. Frey said that the effect of adjusting for psychiatric comorbidities on some outcomes should be stated more clearly. “I see a clear difference,” he said. The relative risk for gestational diabetes among the Swedish cohort, for example, drops from a 40% increased risk to 19% increased when adjusted for mood and anxiety disorders. 

Regardless of the cause, the results are important and demonstrate a need to provide additional care for pregnant women with psychiatric conditions, said Dr. Frey. “The important take-home message for policymakers and health care providers is to make sure that they assess for OCD and then monitor those individuals very closely. What I would suggest as a caution is that the reasons behind it are multifactorial.”

The study was supported by the Swedish Research Council for Health, Working Life, and Welfare and by the Canadian Institute of Health Research. Dr. Fernández de la Cruz and Dr. Frey reported no relevant financial relationships.

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

Mothers with obsessive-compulsive disorder (OCD) are more likely to have adverse pregnancy, delivery, and neonatal outcomes than are those without the disorder, according to new research.

In an observational study that followed almost 3 million pregnancies in two countries over 20 years, children of women with OCD were at increased risk for low Apgar score at 5 minutes in Sweden (adjusted risk ratio [aRR], 1.62) and British Columbia, Canada (aRR, 2.30). The risks for adverse outcomes were greater among women with OCD who were taking serotonin reuptake inhibitors (SRIs), compared with those who were not.

“To me, the most relevant things to consider are the clinical implications of these findings,” lead author Lorena Fernández de la Cruz, PhD, principal researcher at Karolinska Institute in Stockholm, told this news organization. She noted that some of the outcomes, such as preeclampsia, can be prevented or improved with collaboration among clinicians and increased monitoring.

The study was published online in JAMA Network Open.
 

Increased risk

OCD affects roughly 1%-3% of the population. Although it is sometimes seen as a mild psychiatric disorder, OCD entails a range of adverse outcomes, and this research suggests that the adverse outcomes extend to maternal health, Dr. Fernández de la Cruz stressed.

The researchers drew data from population registers in Sweden and British Columbia for all singleton births over a roughly 20-year period ending in 2019, with subcohorts identified by formal OCD diagnosis and exposure to SRIs within 30 days before conception. Statistical analyses were performed on a range of pregnancy, delivery, and neonatal outcomes.

In an analysis adjusted for common risk factors such as age, BMI, and smoking, Swedish women with OCD had elevated risk for several adverse outcomes, including a 40% increased risk for gestational diabetes. In British Columbia, fewer adverse pregnancy outcomes for women were associated with an OCD diagnosis.

The study, which also tracked neonatal outcomes, found that infants of mothers with OCD in both Sweden and British Columbia had higher rates of preterm birth (Sweden: aRR, 1.33; BC: aRR, 1.58), low birth weight (Sweden: aRR, 1.28; BC: aRR, 1.40), and neonatal respiratory distress (Sweden: aRR, 1.63; BC: aRR, 1.47).

These results, the authors say, show a need for more monitoring of maternal OCD and collaboration among obstetricians and psychologists. “All this evidence shows that OCD should be detected and treated so that adverse outcomes can be prevented or properly handled,” said Dr. Fernández de la Cruz.
 

SRI medication

SRIs are frequently used to treat OCD. The subclass of selective SRIs, which includes common antidepressants, has been associated with worsened pregnancy outcomes, but it remains unclear whether all SRIs increase pregnancy risks.

To understand the role of SRIs better in this study, the authors compared the outcomes for women taking SRIs and those who were not prescribed the medication, which is a novel aspect of the study, according to Dr. Fernández de la Cruz. Women who took the medication were at greater risk for several adverse outcomes, although all women with an OCD diagnosis were at higher risk than were those without the condition. The investigators hope to continue studying the role of OCD medication during pregnancy in more detail.

The rates of SRI use varied between the two cohorts: 81% of Canadian patients took the medication, compared with 37% of Swedish patients. The disparate rates, along with other clinical practices, may have contributed to differences in outcomes for the two cohorts.

It is also important to bear in mind, however, that patients taking the medication tend to have more severe cases of OCD, said Dr. Fernández de la Cruz. Thus, the increased risk may or may not result from the medication itself. “It is important to understand that there may be other variables besides medication explaining why one group had higher risks than the other,” she said.
 

‘Multifactorial’ reasons

In addition to medication, other factors may play a role in the association between OCD and adverse pregnancy and neonatal outcomes, including genetics, lifestyle, and psychiatric comorbidities. The authors addressed some of these potential confounders in additional analyses, including sister and cousin comparisons in the Swedish arm of the study, which found weakened associations, compared with population wide statistics.

Commenting on the research, Benicio Frey, PhD, professor of psychiatry and behavioral neurosciences at McMaster University in Hamilton, Ont., said that acknowledging these confounding factors is a strength of the study. Psychiatric conditions such as depression and anxiety are common among patients with OCD. Of the patients with OCD in this study, 72% and 51% had other psychiatric diagnoses in Sweden and British Columbia, respectively. About 7% of the women without OCD had one of these conditions.

However, Dr. Frey said that the effect of adjusting for psychiatric comorbidities on some outcomes should be stated more clearly. “I see a clear difference,” he said. The relative risk for gestational diabetes among the Swedish cohort, for example, drops from a 40% increased risk to 19% increased when adjusted for mood and anxiety disorders. 

Regardless of the cause, the results are important and demonstrate a need to provide additional care for pregnant women with psychiatric conditions, said Dr. Frey. “The important take-home message for policymakers and health care providers is to make sure that they assess for OCD and then monitor those individuals very closely. What I would suggest as a caution is that the reasons behind it are multifactorial.”

The study was supported by the Swedish Research Council for Health, Working Life, and Welfare and by the Canadian Institute of Health Research. Dr. Fernández de la Cruz and Dr. Frey reported no relevant financial relationships.

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

Mothers with obsessive-compulsive disorder (OCD) are more likely to have adverse pregnancy, delivery, and neonatal outcomes than are those without the disorder, according to new research.

In an observational study that followed almost 3 million pregnancies in two countries over 20 years, children of women with OCD were at increased risk for low Apgar score at 5 minutes in Sweden (adjusted risk ratio [aRR], 1.62) and British Columbia, Canada (aRR, 2.30). The risks for adverse outcomes were greater among women with OCD who were taking serotonin reuptake inhibitors (SRIs), compared with those who were not.

“To me, the most relevant things to consider are the clinical implications of these findings,” lead author Lorena Fernández de la Cruz, PhD, principal researcher at Karolinska Institute in Stockholm, told this news organization. She noted that some of the outcomes, such as preeclampsia, can be prevented or improved with collaboration among clinicians and increased monitoring.

The study was published online in JAMA Network Open.
 

Increased risk

OCD affects roughly 1%-3% of the population. Although it is sometimes seen as a mild psychiatric disorder, OCD entails a range of adverse outcomes, and this research suggests that the adverse outcomes extend to maternal health, Dr. Fernández de la Cruz stressed.

The researchers drew data from population registers in Sweden and British Columbia for all singleton births over a roughly 20-year period ending in 2019, with subcohorts identified by formal OCD diagnosis and exposure to SRIs within 30 days before conception. Statistical analyses were performed on a range of pregnancy, delivery, and neonatal outcomes.

In an analysis adjusted for common risk factors such as age, BMI, and smoking, Swedish women with OCD had elevated risk for several adverse outcomes, including a 40% increased risk for gestational diabetes. In British Columbia, fewer adverse pregnancy outcomes for women were associated with an OCD diagnosis.

The study, which also tracked neonatal outcomes, found that infants of mothers with OCD in both Sweden and British Columbia had higher rates of preterm birth (Sweden: aRR, 1.33; BC: aRR, 1.58), low birth weight (Sweden: aRR, 1.28; BC: aRR, 1.40), and neonatal respiratory distress (Sweden: aRR, 1.63; BC: aRR, 1.47).

These results, the authors say, show a need for more monitoring of maternal OCD and collaboration among obstetricians and psychologists. “All this evidence shows that OCD should be detected and treated so that adverse outcomes can be prevented or properly handled,” said Dr. Fernández de la Cruz.
 

SRI medication

SRIs are frequently used to treat OCD. The subclass of selective SRIs, which includes common antidepressants, has been associated with worsened pregnancy outcomes, but it remains unclear whether all SRIs increase pregnancy risks.

To understand the role of SRIs better in this study, the authors compared the outcomes for women taking SRIs and those who were not prescribed the medication, which is a novel aspect of the study, according to Dr. Fernández de la Cruz. Women who took the medication were at greater risk for several adverse outcomes, although all women with an OCD diagnosis were at higher risk than were those without the condition. The investigators hope to continue studying the role of OCD medication during pregnancy in more detail.

The rates of SRI use varied between the two cohorts: 81% of Canadian patients took the medication, compared with 37% of Swedish patients. The disparate rates, along with other clinical practices, may have contributed to differences in outcomes for the two cohorts.

It is also important to bear in mind, however, that patients taking the medication tend to have more severe cases of OCD, said Dr. Fernández de la Cruz. Thus, the increased risk may or may not result from the medication itself. “It is important to understand that there may be other variables besides medication explaining why one group had higher risks than the other,” she said.
 

‘Multifactorial’ reasons

In addition to medication, other factors may play a role in the association between OCD and adverse pregnancy and neonatal outcomes, including genetics, lifestyle, and psychiatric comorbidities. The authors addressed some of these potential confounders in additional analyses, including sister and cousin comparisons in the Swedish arm of the study, which found weakened associations, compared with population wide statistics.

Commenting on the research, Benicio Frey, PhD, professor of psychiatry and behavioral neurosciences at McMaster University in Hamilton, Ont., said that acknowledging these confounding factors is a strength of the study. Psychiatric conditions such as depression and anxiety are common among patients with OCD. Of the patients with OCD in this study, 72% and 51% had other psychiatric diagnoses in Sweden and British Columbia, respectively. About 7% of the women without OCD had one of these conditions.

However, Dr. Frey said that the effect of adjusting for psychiatric comorbidities on some outcomes should be stated more clearly. “I see a clear difference,” he said. The relative risk for gestational diabetes among the Swedish cohort, for example, drops from a 40% increased risk to 19% increased when adjusted for mood and anxiety disorders. 

Regardless of the cause, the results are important and demonstrate a need to provide additional care for pregnant women with psychiatric conditions, said Dr. Frey. “The important take-home message for policymakers and health care providers is to make sure that they assess for OCD and then monitor those individuals very closely. What I would suggest as a caution is that the reasons behind it are multifactorial.”

The study was supported by the Swedish Research Council for Health, Working Life, and Welfare and by the Canadian Institute of Health Research. Dr. Fernández de la Cruz and Dr. Frey reported no relevant financial relationships.

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