Diabetes

Long-term use of a proton-pump inhibitor (PPI) was associated with an increased risk of being diagnosed with type 2 diabetes in a large, population-based case-control study in Italy.

The risk of diabetes increased from 19% to 56% as treatment duration increased from 8 weeks to more than 2 years, and prolonged treatment was associated with an even higher risk of diabetes in the youngest patients (age 40-65) and those with the most comorbidities.

The results suggest that “physicians should therefore avoid unnecessary prescription of this class of drugs, particularly for long-term use,” say Stefano Ciardullo, MD, University of Milano-Bicocca, Italy, and colleagues, in their article recently published online in the Journal of Clinical Endocrinology & Metabolism.

“Nonetheless, epidemiologic evidence on the topic remains conflicting,” they acknowledge, adding that “future studies are still needed to validate our findings.”

If the results are confirmed, these “may have important implications for both public health and clinical practice, given the high number of patients being treated with PPIs and the influence of diabetes on morbidity and mortality related to its possible micro- and macrovascular complications,” Dr. Ciardullo and colleagues conclude.
 

Not enough data to support a change in practice

The current findings align with a recent analysis of three prospective cohort studies of U.S. health care workers that showed a progressively increased risk of diabetes with longer treatment with PPIs, David A. Leiman, MD, MSHP, who was not involved with the current study, told this news organization in an email. “But the effect size remains relatively small and may be explained by residual or unmeasured confounding,” he cautioned.

“Ultimately, there do not seem to be enough data to support a change in clinical practice from this study alone, and, as a result, clinicians should continue to inform patients of the best available evidence regarding the benefits and risks of PPIs,” said Dr. Leiman, assistant professor of medicine, Division of Gastroenterology, Duke University Medical Center, Durham, N.C.

“Recent best practice advice from the American Gastroenterological Association does not recommend screening for insulin resistance among PPI users [and recommends that the decision to discontinue PPIs] should be based solely on the lack of an indication for PPI use, and not because of concern for PPI-associated adverse events,” he noted.

“Clinicians should be prepared to discuss the described risks associated with PPIs,” said Dr. Leiman, but they should “also feel comfortable affirming their safety profile and substantial efficacy in managing symptoms and preventing complications when prescribed for the appropriate indication.”

First-choice therapy for acid-related disorders

PPIs have become first-choice therapy for patients with acid-related disorders such as gastroesophageal reflux disease, Barrett esophagus, and peptic ulcer, and to prevent gastrointestinal bleeding while on nonsteroidal anti-inflammatory drugs (NSAIDs), Dr. Ciardullo and colleagues explain.

However, several studies have identified potential fractures, hypomagnesemia, gastric carcinoids, chronic kidney disease, dementia, and Clostridium difficile diarrhea with prolonged use of PPIs, and these agents can cause changes in the gut microbiome that may play a role in diabetes and other metabolic diseases.

To investigate a potential association between PPIs and type 2 diabetes, the researchers analyzed data from 777,420 patients age 40 and older who were newly treated with PPIs between 2010 and 2015 in Lombardy, Italy.

Of these, 50,540 patients were diagnosed with type 2 diabetes during follow-up until 2020 (a mean follow-up of 6.2 years and a diabetes incidence of 10.6 cases per 1,000 person-years).

The researchers matched 50,535 patients diagnosed with diabetes during follow-up with 50,535 control patients who had the same age, sex, and clinical status.

Patients were a mean age of 66 years and half were men. The most prescribed PPIs were pantoprazole and omeprazole, and the patients diagnosed with diabetes were more likely to use antihypertensives and lipid-lowering drugs.

Compared with patients who received PPIs for less than 8 weeks, those who received PPIs for 8 weeks to 6 months had a 19% increased risk of being diagnosed with diabetes during follow-up (odds ratio, 1.19; 95% confidence interval, 1.15-1.24), after adjusting for age, clinical profile, comorbidities, medical therapy, and PPI type.

Patients who received PPIs for 6 months to 2 years had a 43% increased risk of the outcome (OR, 1.43; 95% CI, 1.38-1.49), and those who received PPIs for more than 2 years had a 56% increased risk of the outcome (OR, 1.56; 95% CI, 1.49-1.64).

The researchers acknowledge limitations including that the study was not a randomized controlled trial, and it lacked information about over-the-counter medications and unmeasured confounders such as body mass index or family history of diabetes that may have affected the outcomes.

Dr. Leiman added that patients may have had prediabetes or undiagnosed diabetes and symptoms such as heartburn or dyspepsia arising from complications of insulin resistance, for which PPIs might have been prescribed.

The study was funded by a grant from the Italian Ministry of Education, University and Research. Dr. Ciardullo and Dr. Leiman have reported no relevant financial relationships.

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

Long-term use of a proton-pump inhibitor (PPI) was associated with an increased risk of being diagnosed with type 2 diabetes in a large, population-based case-control study in Italy.

The risk of diabetes increased from 19% to 56% as treatment duration increased from 8 weeks to more than 2 years, and prolonged treatment was associated with an even higher risk of diabetes in the youngest patients (age 40-65) and those with the most comorbidities.

The results suggest that “physicians should therefore avoid unnecessary prescription of this class of drugs, particularly for long-term use,” say Stefano Ciardullo, MD, University of Milano-Bicocca, Italy, and colleagues, in their article recently published online in the Journal of Clinical Endocrinology & Metabolism.

“Nonetheless, epidemiologic evidence on the topic remains conflicting,” they acknowledge, adding that “future studies are still needed to validate our findings.”

If the results are confirmed, these “may have important implications for both public health and clinical practice, given the high number of patients being treated with PPIs and the influence of diabetes on morbidity and mortality related to its possible micro- and macrovascular complications,” Dr. Ciardullo and colleagues conclude.
 

Not enough data to support a change in practice

The current findings align with a recent analysis of three prospective cohort studies of U.S. health care workers that showed a progressively increased risk of diabetes with longer treatment with PPIs, David A. Leiman, MD, MSHP, who was not involved with the current study, told this news organization in an email. “But the effect size remains relatively small and may be explained by residual or unmeasured confounding,” he cautioned.

“Ultimately, there do not seem to be enough data to support a change in clinical practice from this study alone, and, as a result, clinicians should continue to inform patients of the best available evidence regarding the benefits and risks of PPIs,” said Dr. Leiman, assistant professor of medicine, Division of Gastroenterology, Duke University Medical Center, Durham, N.C.

“Recent best practice advice from the American Gastroenterological Association does not recommend screening for insulin resistance among PPI users [and recommends that the decision to discontinue PPIs] should be based solely on the lack of an indication for PPI use, and not because of concern for PPI-associated adverse events,” he noted.

“Clinicians should be prepared to discuss the described risks associated with PPIs,” said Dr. Leiman, but they should “also feel comfortable affirming their safety profile and substantial efficacy in managing symptoms and preventing complications when prescribed for the appropriate indication.”

First-choice therapy for acid-related disorders

PPIs have become first-choice therapy for patients with acid-related disorders such as gastroesophageal reflux disease, Barrett esophagus, and peptic ulcer, and to prevent gastrointestinal bleeding while on nonsteroidal anti-inflammatory drugs (NSAIDs), Dr. Ciardullo and colleagues explain.

However, several studies have identified potential fractures, hypomagnesemia, gastric carcinoids, chronic kidney disease, dementia, and Clostridium difficile diarrhea with prolonged use of PPIs, and these agents can cause changes in the gut microbiome that may play a role in diabetes and other metabolic diseases.

To investigate a potential association between PPIs and type 2 diabetes, the researchers analyzed data from 777,420 patients age 40 and older who were newly treated with PPIs between 2010 and 2015 in Lombardy, Italy.

Of these, 50,540 patients were diagnosed with type 2 diabetes during follow-up until 2020 (a mean follow-up of 6.2 years and a diabetes incidence of 10.6 cases per 1,000 person-years).

The researchers matched 50,535 patients diagnosed with diabetes during follow-up with 50,535 control patients who had the same age, sex, and clinical status.

Patients were a mean age of 66 years and half were men. The most prescribed PPIs were pantoprazole and omeprazole, and the patients diagnosed with diabetes were more likely to use antihypertensives and lipid-lowering drugs.

Compared with patients who received PPIs for less than 8 weeks, those who received PPIs for 8 weeks to 6 months had a 19% increased risk of being diagnosed with diabetes during follow-up (odds ratio, 1.19; 95% confidence interval, 1.15-1.24), after adjusting for age, clinical profile, comorbidities, medical therapy, and PPI type.

Patients who received PPIs for 6 months to 2 years had a 43% increased risk of the outcome (OR, 1.43; 95% CI, 1.38-1.49), and those who received PPIs for more than 2 years had a 56% increased risk of the outcome (OR, 1.56; 95% CI, 1.49-1.64).

The researchers acknowledge limitations including that the study was not a randomized controlled trial, and it lacked information about over-the-counter medications and unmeasured confounders such as body mass index or family history of diabetes that may have affected the outcomes.

Dr. Leiman added that patients may have had prediabetes or undiagnosed diabetes and symptoms such as heartburn or dyspepsia arising from complications of insulin resistance, for which PPIs might have been prescribed.

The study was funded by a grant from the Italian Ministry of Education, University and Research. Dr. Ciardullo and Dr. Leiman have reported no relevant financial relationships.

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

Long-term use of a proton-pump inhibitor (PPI) was associated with an increased risk of being diagnosed with type 2 diabetes in a large, population-based case-control study in Italy.

The risk of diabetes increased from 19% to 56% as treatment duration increased from 8 weeks to more than 2 years, and prolonged treatment was associated with an even higher risk of diabetes in the youngest patients (age 40-65) and those with the most comorbidities.

The results suggest that “physicians should therefore avoid unnecessary prescription of this class of drugs, particularly for long-term use,” say Stefano Ciardullo, MD, University of Milano-Bicocca, Italy, and colleagues, in their article recently published online in the Journal of Clinical Endocrinology & Metabolism.

“Nonetheless, epidemiologic evidence on the topic remains conflicting,” they acknowledge, adding that “future studies are still needed to validate our findings.”

If the results are confirmed, these “may have important implications for both public health and clinical practice, given the high number of patients being treated with PPIs and the influence of diabetes on morbidity and mortality related to its possible micro- and macrovascular complications,” Dr. Ciardullo and colleagues conclude.
 

Not enough data to support a change in practice

The current findings align with a recent analysis of three prospective cohort studies of U.S. health care workers that showed a progressively increased risk of diabetes with longer treatment with PPIs, David A. Leiman, MD, MSHP, who was not involved with the current study, told this news organization in an email. “But the effect size remains relatively small and may be explained by residual or unmeasured confounding,” he cautioned.

“Ultimately, there do not seem to be enough data to support a change in clinical practice from this study alone, and, as a result, clinicians should continue to inform patients of the best available evidence regarding the benefits and risks of PPIs,” said Dr. Leiman, assistant professor of medicine, Division of Gastroenterology, Duke University Medical Center, Durham, N.C.

“Recent best practice advice from the American Gastroenterological Association does not recommend screening for insulin resistance among PPI users [and recommends that the decision to discontinue PPIs] should be based solely on the lack of an indication for PPI use, and not because of concern for PPI-associated adverse events,” he noted.

“Clinicians should be prepared to discuss the described risks associated with PPIs,” said Dr. Leiman, but they should “also feel comfortable affirming their safety profile and substantial efficacy in managing symptoms and preventing complications when prescribed for the appropriate indication.”

First-choice therapy for acid-related disorders

PPIs have become first-choice therapy for patients with acid-related disorders such as gastroesophageal reflux disease, Barrett esophagus, and peptic ulcer, and to prevent gastrointestinal bleeding while on nonsteroidal anti-inflammatory drugs (NSAIDs), Dr. Ciardullo and colleagues explain.

However, several studies have identified potential fractures, hypomagnesemia, gastric carcinoids, chronic kidney disease, dementia, and Clostridium difficile diarrhea with prolonged use of PPIs, and these agents can cause changes in the gut microbiome that may play a role in diabetes and other metabolic diseases.

To investigate a potential association between PPIs and type 2 diabetes, the researchers analyzed data from 777,420 patients age 40 and older who were newly treated with PPIs between 2010 and 2015 in Lombardy, Italy.

Of these, 50,540 patients were diagnosed with type 2 diabetes during follow-up until 2020 (a mean follow-up of 6.2 years and a diabetes incidence of 10.6 cases per 1,000 person-years).

The researchers matched 50,535 patients diagnosed with diabetes during follow-up with 50,535 control patients who had the same age, sex, and clinical status.

Patients were a mean age of 66 years and half were men. The most prescribed PPIs were pantoprazole and omeprazole, and the patients diagnosed with diabetes were more likely to use antihypertensives and lipid-lowering drugs.

Compared with patients who received PPIs for less than 8 weeks, those who received PPIs for 8 weeks to 6 months had a 19% increased risk of being diagnosed with diabetes during follow-up (odds ratio, 1.19; 95% confidence interval, 1.15-1.24), after adjusting for age, clinical profile, comorbidities, medical therapy, and PPI type.

Patients who received PPIs for 6 months to 2 years had a 43% increased risk of the outcome (OR, 1.43; 95% CI, 1.38-1.49), and those who received PPIs for more than 2 years had a 56% increased risk of the outcome (OR, 1.56; 95% CI, 1.49-1.64).

The researchers acknowledge limitations including that the study was not a randomized controlled trial, and it lacked information about over-the-counter medications and unmeasured confounders such as body mass index or family history of diabetes that may have affected the outcomes.

Dr. Leiman added that patients may have had prediabetes or undiagnosed diabetes and symptoms such as heartburn or dyspepsia arising from complications of insulin resistance, for which PPIs might have been prescribed.

The study was funded by a grant from the Italian Ministry of Education, University and Research. Dr. Ciardullo and Dr. Leiman have reported no relevant financial relationships.

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

Following a vegan diet for at least 3 months helped people with overweight or type 2 diabetes shed the pounds, but had only a marginal effect on hemoglobin A1c levels, on average, new research indicates.

No effect was seen on blood pressure, triglycerides, or high-density lipoprotein cholesterol. HbA1c was reduced by a mean of –0.18 percentage points (P = .002), and there was a small reduction in total cholesterol and low-density lipoprotein cholesterol, on average, across all the studies examined in this meta-analysis.

The work, which compared a number of trials looking at vegan diets versus “normal” eating or other kinds of weight loss diets, “indicates with reasonable certainty that adhering to a vegan diet for at least 12 weeks may result in clinically meaningful weight loss [and] can be used in the management of overweight and type 2 diabetes,” said Anne-Ditte Termannsen, PhD, who reported the findings during a press conference at the European Congress on Obesity 2022, where the work was also presented as a poster.

A vegan diet most likely led to weight loss because it is “associated with a reduced calorie intake due to a lower content of fat and higher content of dietary fiber,” added Dr. Termannsen of the Steno Diabetes Center Copenhagen.

Asked to comment, Janet Cade, PhD, who leads the Nutritional Epidemiology Group at the University of Leeds (England) said the results are likely attributable to fewer calories in the vegan diet, compared with the “control” diets. “Of course, a vegan diet can be healthier in a range of ways, such as higher fruit and vegetables, more fiber and antioxidants; however, the same would be true of a vegetarian diet,” she noted.

And she warned that longer-term data are needed on health outcomes associated with vegan diets, noting, “there have been links to poorer bone health and osteoporosis in people consuming a vegan diet.”

Gunter Kuhnle, PhD, professor of nutrition and food science, University of Reading (England) told the UK Science Media Centre: “The authors conducted a systematic review of intervention studies and found that, compared with no dietary interventions, vegan diets showed the strongest association with body-weight reduction.”

However, “When comparing vegan diets with other dietary interventions – such as the Mediterranean diet – the association was much weaker,” he noted.
 

Vegan, habitual, or a range of weight-loss diets

Dr. Termannsen and colleagues set out to look at the effect of a plant-based diet on cardiometabolic risk factors in people with overweight or type 2 diabetes. They searched the literature for randomized controlled trials with adult participants with overweight (body mass index ≥ 25 kg/m²), prediabetes, or type 2 diabetes.

Participants followed a vegan diet that lasted at least 12 weeks; habitual diets without any changes or energy restriction; a Mediterranean diet; a host of different “diabetes” diets; a low-fat diet; or portion-controlled diets.

“The vegan diets were nearly all low-fat vegan diets but vary substantially regarding the protein, fat, carbohydrate content. All but one study was ad libitum fat, and there were no energy restrictions,” Dr. Termannsen said.

Control diets were more varied. “Some continued their habitual diet, and about half were energy restricted and the others were not,” she acknowledged.

Outcomes comprised body weight, BMI, HbA1c, systolic and diastolic blood pressure, total cholesterol, LDL cholesterol, HDL cholesterol, and triglycerides, which were assessed across studies.

A total of 11 trials were included in the meta-analysis, and studies were a mean duration of 19 weeks. A total of 796 participants were included.

Compared with control diets, those on vegan diets lost on average –4.1 kg (–9 lb) (P < .001), with a range of –5.9 kg to –2.4 kg.

BMI dropped by –1.38 kg/m² (P < .001). Total cholesterol dropped by –0.30 mmol/L (–11.6 mg/dL; P = .007) and LDL cholesterol by –0.24 mmol/L (–9.28 mg/dL; P = .005).

Further analyses found even greater reductions in body weight and BMI when vegan diets were compared with continuing a normal diet without dietary changes, on average, at –7.4 kg (–16.3 lb) (P < .001) and –2.78 kg/m² (P < .001) respectively.

When compared with other intervention diets, however, body weight dropped by –2.7 kg (–6 lb; P < .001) and BMI by –0.87 kg/m² (P < .001).

Commenting on limitations of studies compared to the real world, Dr. Termannsen said: “Some studies reported high adherence to their diet, usually due to a high level of support, suggesting that providing continued face-to-face contact with participants may partly explain the adherence differences.”

“This also questions the long-term feasibility of the diet and the applicability of this as long-term care,” she added.

Following a vegan diet requires good planning to ensure adequate nutrition and avoid any deficiencies, she urged. “We need to remember that the menu plans in the studies were created by dietitians.”

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

Following a vegan diet for at least 3 months helped people with overweight or type 2 diabetes shed the pounds, but had only a marginal effect on hemoglobin A1c levels, on average, new research indicates.

No effect was seen on blood pressure, triglycerides, or high-density lipoprotein cholesterol. HbA1c was reduced by a mean of –0.18 percentage points (P = .002), and there was a small reduction in total cholesterol and low-density lipoprotein cholesterol, on average, across all the studies examined in this meta-analysis.

The work, which compared a number of trials looking at vegan diets versus “normal” eating or other kinds of weight loss diets, “indicates with reasonable certainty that adhering to a vegan diet for at least 12 weeks may result in clinically meaningful weight loss [and] can be used in the management of overweight and type 2 diabetes,” said Anne-Ditte Termannsen, PhD, who reported the findings during a press conference at the European Congress on Obesity 2022, where the work was also presented as a poster.

A vegan diet most likely led to weight loss because it is “associated with a reduced calorie intake due to a lower content of fat and higher content of dietary fiber,” added Dr. Termannsen of the Steno Diabetes Center Copenhagen.

Asked to comment, Janet Cade, PhD, who leads the Nutritional Epidemiology Group at the University of Leeds (England) said the results are likely attributable to fewer calories in the vegan diet, compared with the “control” diets. “Of course, a vegan diet can be healthier in a range of ways, such as higher fruit and vegetables, more fiber and antioxidants; however, the same would be true of a vegetarian diet,” she noted.

And she warned that longer-term data are needed on health outcomes associated with vegan diets, noting, “there have been links to poorer bone health and osteoporosis in people consuming a vegan diet.”

Gunter Kuhnle, PhD, professor of nutrition and food science, University of Reading (England) told the UK Science Media Centre: “The authors conducted a systematic review of intervention studies and found that, compared with no dietary interventions, vegan diets showed the strongest association with body-weight reduction.”

However, “When comparing vegan diets with other dietary interventions – such as the Mediterranean diet – the association was much weaker,” he noted.
 

Vegan, habitual, or a range of weight-loss diets

Dr. Termannsen and colleagues set out to look at the effect of a plant-based diet on cardiometabolic risk factors in people with overweight or type 2 diabetes. They searched the literature for randomized controlled trials with adult participants with overweight (body mass index ≥ 25 kg/m²), prediabetes, or type 2 diabetes.

Participants followed a vegan diet that lasted at least 12 weeks; habitual diets without any changes or energy restriction; a Mediterranean diet; a host of different “diabetes” diets; a low-fat diet; or portion-controlled diets.

“The vegan diets were nearly all low-fat vegan diets but vary substantially regarding the protein, fat, carbohydrate content. All but one study was ad libitum fat, and there were no energy restrictions,” Dr. Termannsen said.

Control diets were more varied. “Some continued their habitual diet, and about half were energy restricted and the others were not,” she acknowledged.

Outcomes comprised body weight, BMI, HbA1c, systolic and diastolic blood pressure, total cholesterol, LDL cholesterol, HDL cholesterol, and triglycerides, which were assessed across studies.

A total of 11 trials were included in the meta-analysis, and studies were a mean duration of 19 weeks. A total of 796 participants were included.

Compared with control diets, those on vegan diets lost on average –4.1 kg (–9 lb) (P < .001), with a range of –5.9 kg to –2.4 kg.

BMI dropped by –1.38 kg/m² (P < .001). Total cholesterol dropped by –0.30 mmol/L (–11.6 mg/dL; P = .007) and LDL cholesterol by –0.24 mmol/L (–9.28 mg/dL; P = .005).

Further analyses found even greater reductions in body weight and BMI when vegan diets were compared with continuing a normal diet without dietary changes, on average, at –7.4 kg (–16.3 lb) (P < .001) and –2.78 kg/m² (P < .001) respectively.

When compared with other intervention diets, however, body weight dropped by –2.7 kg (–6 lb; P < .001) and BMI by –0.87 kg/m² (P < .001).

Commenting on limitations of studies compared to the real world, Dr. Termannsen said: “Some studies reported high adherence to their diet, usually due to a high level of support, suggesting that providing continued face-to-face contact with participants may partly explain the adherence differences.”

“This also questions the long-term feasibility of the diet and the applicability of this as long-term care,” she added.

Following a vegan diet requires good planning to ensure adequate nutrition and avoid any deficiencies, she urged. “We need to remember that the menu plans in the studies were created by dietitians.”

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

Following a vegan diet for at least 3 months helped people with overweight or type 2 diabetes shed the pounds, but had only a marginal effect on hemoglobin A1c levels, on average, new research indicates.

No effect was seen on blood pressure, triglycerides, or high-density lipoprotein cholesterol. HbA1c was reduced by a mean of –0.18 percentage points (P = .002), and there was a small reduction in total cholesterol and low-density lipoprotein cholesterol, on average, across all the studies examined in this meta-analysis.

The work, which compared a number of trials looking at vegan diets versus “normal” eating or other kinds of weight loss diets, “indicates with reasonable certainty that adhering to a vegan diet for at least 12 weeks may result in clinically meaningful weight loss [and] can be used in the management of overweight and type 2 diabetes,” said Anne-Ditte Termannsen, PhD, who reported the findings during a press conference at the European Congress on Obesity 2022, where the work was also presented as a poster.

A vegan diet most likely led to weight loss because it is “associated with a reduced calorie intake due to a lower content of fat and higher content of dietary fiber,” added Dr. Termannsen of the Steno Diabetes Center Copenhagen.

Asked to comment, Janet Cade, PhD, who leads the Nutritional Epidemiology Group at the University of Leeds (England) said the results are likely attributable to fewer calories in the vegan diet, compared with the “control” diets. “Of course, a vegan diet can be healthier in a range of ways, such as higher fruit and vegetables, more fiber and antioxidants; however, the same would be true of a vegetarian diet,” she noted.

And she warned that longer-term data are needed on health outcomes associated with vegan diets, noting, “there have been links to poorer bone health and osteoporosis in people consuming a vegan diet.”

Gunter Kuhnle, PhD, professor of nutrition and food science, University of Reading (England) told the UK Science Media Centre: “The authors conducted a systematic review of intervention studies and found that, compared with no dietary interventions, vegan diets showed the strongest association with body-weight reduction.”

However, “When comparing vegan diets with other dietary interventions – such as the Mediterranean diet – the association was much weaker,” he noted.
 

Vegan, habitual, or a range of weight-loss diets

Dr. Termannsen and colleagues set out to look at the effect of a plant-based diet on cardiometabolic risk factors in people with overweight or type 2 diabetes. They searched the literature for randomized controlled trials with adult participants with overweight (body mass index ≥ 25 kg/m²), prediabetes, or type 2 diabetes.

Participants followed a vegan diet that lasted at least 12 weeks; habitual diets without any changes or energy restriction; a Mediterranean diet; a host of different “diabetes” diets; a low-fat diet; or portion-controlled diets.

“The vegan diets were nearly all low-fat vegan diets but vary substantially regarding the protein, fat, carbohydrate content. All but one study was ad libitum fat, and there were no energy restrictions,” Dr. Termannsen said.

Control diets were more varied. “Some continued their habitual diet, and about half were energy restricted and the others were not,” she acknowledged.

Outcomes comprised body weight, BMI, HbA1c, systolic and diastolic blood pressure, total cholesterol, LDL cholesterol, HDL cholesterol, and triglycerides, which were assessed across studies.

A total of 11 trials were included in the meta-analysis, and studies were a mean duration of 19 weeks. A total of 796 participants were included.

Compared with control diets, those on vegan diets lost on average –4.1 kg (–9 lb) (P < .001), with a range of –5.9 kg to –2.4 kg.

BMI dropped by –1.38 kg/m² (P < .001). Total cholesterol dropped by –0.30 mmol/L (–11.6 mg/dL; P = .007) and LDL cholesterol by –0.24 mmol/L (–9.28 mg/dL; P = .005).

Further analyses found even greater reductions in body weight and BMI when vegan diets were compared with continuing a normal diet without dietary changes, on average, at –7.4 kg (–16.3 lb) (P < .001) and –2.78 kg/m² (P < .001) respectively.

When compared with other intervention diets, however, body weight dropped by –2.7 kg (–6 lb; P < .001) and BMI by –0.87 kg/m² (P < .001).

Commenting on limitations of studies compared to the real world, Dr. Termannsen said: “Some studies reported high adherence to their diet, usually due to a high level of support, suggesting that providing continued face-to-face contact with participants may partly explain the adherence differences.”

“This also questions the long-term feasibility of the diet and the applicability of this as long-term care,” she added.

Following a vegan diet requires good planning to ensure adequate nutrition and avoid any deficiencies, she urged. “We need to remember that the menu plans in the studies were created by dietitians.”

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

Counting calories, joining a gym, and taking part in exercise programs are popular methods used by people in the United Kingdom who want to shed some pounds, but they seem to be fairly ineffective strategies, according to an investigation.

A survey of adults with obesity from six countries in western Europe found that most who set out to reduce a meaningful amount of weight failed in their attempt.

The preliminary results, presented in two posters at the European Congress on Obesity, underlined the need for better support and solutions for weight management, the authors suggested.

Marc Evans, MB, BCh, a consultant physician in diabetes and endocrinology, from University Hospital, Cardiff, Wales, who led the analysis, said that, “while obesity’s impact on health is well known, our finding that a sizable proportion of adults with obesity appear at elevated risk of hospitalization or surgery due to multiple underlying illnesses, undoubtedly adds a sense of urgency to tackling Europe’s growing obesity epidemic.”

The study, which also involved analytics consultancy firm Lane Clark & Peacock, conducted a cross-sectional survey of 1,850 adults. Of those 500 were from the UK, and the remainder from France, Germany, Italy, Spain, and Sweden.

All participants had a body mass index of 30 kg/m², or higher. More specifically, 56.3%; were classified as obesity class I, 26.8% obesity class II, and 16.9% obesity class III.
 

Obesity-related conditions

In total, 25.7% of participants reported no obesity-related health conditions, 28.4% had one condition, 19.6% had two, and 26.3% had three or more. The most common comorbidities were hypertension, dyslipidemia, and type 2 diabetes.

Overall, 78.6% of respondents reported having tried to lose weight in the previous year. Asked in a questionnaire about how they had tried to achieve this, the responses indicated that the most common strategies were:

• Calorie-controlled/restricted diet (71.9%)
• Exercise program course (21.9%)
• Pharmaceutical treatment/medication (12.3%)
• Joined a gym (12%)
• Digital health app (9.7%)

Among other participants, 8.1% said they had used alternative treatments, 7.6% a weight loss service, and 2.1% cognitive-behavioral therapy.

Analysis of the survey results showed that 78% of the individuals who attempted to lose weight did not achieve a clinically meaningful loss of 5% or more of their body weight, while some actually weighed more afterward.

Exercise and restricted diet

Notably, while exercise and calorie-controlled or restricted diets were among the most popular weight-loss methods in U.K. participants, they were amongst the least successful strategies. For instance, while 26.5% of adults who controlled their diet said they had lost weight, 17.1% reported their weight had increased. For those who took part in an exercise program, 33.3% said they lost weight, but 15.5% said they gained weight.

Signing up for gym membership also scored poorly, with 27% shedding weight, compared with 32.4% who put weight on.

“Our survey results indicate that, while the majority of adults with obesity are actively trying to reduce their weight, using a variety of strategies, most are unsuccessful,” said Dr. Evans.

Further studies were needed to assess whether people who lose weight succeed in maintaining their weight loss, the authors said.

The conference posters have yet to be published in a journal but were peer reviewed by the ECO selection committee.

The studies were sponsored by Novo Nordisk, a researcher into and manufacturer of diabetes and obesity medications, and employer of several of the coauthors.

A version of this article first appeared on Medscape UK/Univadis.

Counting calories, joining a gym, and taking part in exercise programs are popular methods used by people in the United Kingdom who want to shed some pounds, but they seem to be fairly ineffective strategies, according to an investigation.

A survey of adults with obesity from six countries in western Europe found that most who set out to reduce a meaningful amount of weight failed in their attempt.

The preliminary results, presented in two posters at the European Congress on Obesity, underlined the need for better support and solutions for weight management, the authors suggested.

Marc Evans, MB, BCh, a consultant physician in diabetes and endocrinology, from University Hospital, Cardiff, Wales, who led the analysis, said that, “while obesity’s impact on health is well known, our finding that a sizable proportion of adults with obesity appear at elevated risk of hospitalization or surgery due to multiple underlying illnesses, undoubtedly adds a sense of urgency to tackling Europe’s growing obesity epidemic.”

The study, which also involved analytics consultancy firm Lane Clark & Peacock, conducted a cross-sectional survey of 1,850 adults. Of those 500 were from the UK, and the remainder from France, Germany, Italy, Spain, and Sweden.

All participants had a body mass index of 30 kg/m², or higher. More specifically, 56.3%; were classified as obesity class I, 26.8% obesity class II, and 16.9% obesity class III.
 

Obesity-related conditions

In total, 25.7% of participants reported no obesity-related health conditions, 28.4% had one condition, 19.6% had two, and 26.3% had three or more. The most common comorbidities were hypertension, dyslipidemia, and type 2 diabetes.

Overall, 78.6% of respondents reported having tried to lose weight in the previous year. Asked in a questionnaire about how they had tried to achieve this, the responses indicated that the most common strategies were:

• Calorie-controlled/restricted diet (71.9%)
• Exercise program course (21.9%)
• Pharmaceutical treatment/medication (12.3%)
• Joined a gym (12%)
• Digital health app (9.7%)

Among other participants, 8.1% said they had used alternative treatments, 7.6% a weight loss service, and 2.1% cognitive-behavioral therapy.

Analysis of the survey results showed that 78% of the individuals who attempted to lose weight did not achieve a clinically meaningful loss of 5% or more of their body weight, while some actually weighed more afterward.

Exercise and restricted diet

Notably, while exercise and calorie-controlled or restricted diets were among the most popular weight-loss methods in U.K. participants, they were amongst the least successful strategies. For instance, while 26.5% of adults who controlled their diet said they had lost weight, 17.1% reported their weight had increased. For those who took part in an exercise program, 33.3% said they lost weight, but 15.5% said they gained weight.

Signing up for gym membership also scored poorly, with 27% shedding weight, compared with 32.4% who put weight on.

“Our survey results indicate that, while the majority of adults with obesity are actively trying to reduce their weight, using a variety of strategies, most are unsuccessful,” said Dr. Evans.

Further studies were needed to assess whether people who lose weight succeed in maintaining their weight loss, the authors said.

The conference posters have yet to be published in a journal but were peer reviewed by the ECO selection committee.

The studies were sponsored by Novo Nordisk, a researcher into and manufacturer of diabetes and obesity medications, and employer of several of the coauthors.

A version of this article first appeared on Medscape UK/Univadis.

Counting calories, joining a gym, and taking part in exercise programs are popular methods used by people in the United Kingdom who want to shed some pounds, but they seem to be fairly ineffective strategies, according to an investigation.

A survey of adults with obesity from six countries in western Europe found that most who set out to reduce a meaningful amount of weight failed in their attempt.

The preliminary results, presented in two posters at the European Congress on Obesity, underlined the need for better support and solutions for weight management, the authors suggested.

Marc Evans, MB, BCh, a consultant physician in diabetes and endocrinology, from University Hospital, Cardiff, Wales, who led the analysis, said that, “while obesity’s impact on health is well known, our finding that a sizable proportion of adults with obesity appear at elevated risk of hospitalization or surgery due to multiple underlying illnesses, undoubtedly adds a sense of urgency to tackling Europe’s growing obesity epidemic.”

The study, which also involved analytics consultancy firm Lane Clark & Peacock, conducted a cross-sectional survey of 1,850 adults. Of those 500 were from the UK, and the remainder from France, Germany, Italy, Spain, and Sweden.

All participants had a body mass index of 30 kg/m², or higher. More specifically, 56.3%; were classified as obesity class I, 26.8% obesity class II, and 16.9% obesity class III.
 

Obesity-related conditions

In total, 25.7% of participants reported no obesity-related health conditions, 28.4% had one condition, 19.6% had two, and 26.3% had three or more. The most common comorbidities were hypertension, dyslipidemia, and type 2 diabetes.

Overall, 78.6% of respondents reported having tried to lose weight in the previous year. Asked in a questionnaire about how they had tried to achieve this, the responses indicated that the most common strategies were:

• Calorie-controlled/restricted diet (71.9%)
• Exercise program course (21.9%)
• Pharmaceutical treatment/medication (12.3%)
• Joined a gym (12%)
• Digital health app (9.7%)

Among other participants, 8.1% said they had used alternative treatments, 7.6% a weight loss service, and 2.1% cognitive-behavioral therapy.

Analysis of the survey results showed that 78% of the individuals who attempted to lose weight did not achieve a clinically meaningful loss of 5% or more of their body weight, while some actually weighed more afterward.

Exercise and restricted diet

Notably, while exercise and calorie-controlled or restricted diets were among the most popular weight-loss methods in U.K. participants, they were amongst the least successful strategies. For instance, while 26.5% of adults who controlled their diet said they had lost weight, 17.1% reported their weight had increased. For those who took part in an exercise program, 33.3% said they lost weight, but 15.5% said they gained weight.

Signing up for gym membership also scored poorly, with 27% shedding weight, compared with 32.4% who put weight on.

“Our survey results indicate that, while the majority of adults with obesity are actively trying to reduce their weight, using a variety of strategies, most are unsuccessful,” said Dr. Evans.

Further studies were needed to assess whether people who lose weight succeed in maintaining their weight loss, the authors said.

The conference posters have yet to be published in a journal but were peer reviewed by the ECO selection committee.

The studies were sponsored by Novo Nordisk, a researcher into and manufacturer of diabetes and obesity medications, and employer of several of the coauthors.

A version of this article first appeared on Medscape UK/Univadis.

Topline results from the phase 3 DELIVER trial show dapagliflozin (Farxiga) significantly reduced the primary endpoint of cardiovascular death or worsening heart failure in patients with mildly reduced or preserved ejection fraction, AstraZeneca announced today.

The sodium-glucose cotransporter 2 (SGLT2) inhibitor is not approved in this setting but is already approved for treatment of type 2 diabetes, chronic kidney disease, and heart failure with reduced ejection fraction.

“The results of DELIVER extend the benefit of dapagliflozin to the full spectrum of patients with heart failure,” principal investigator of the trial, Scott Solomon, MD, Harvard Medical School and Brigham and Women’s Hospital, Boston, said in the news release.

The safety and tolerability of dapagliflozin in the trial were consistent with its established safety profile, the company says.

The full trial results will be submitted for presentation at a forthcoming medical meeting, and regulatory submissions will be made in the coming months, it notes.

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

Topline results from the phase 3 DELIVER trial show dapagliflozin (Farxiga) significantly reduced the primary endpoint of cardiovascular death or worsening heart failure in patients with mildly reduced or preserved ejection fraction, AstraZeneca announced today.

The sodium-glucose cotransporter 2 (SGLT2) inhibitor is not approved in this setting but is already approved for treatment of type 2 diabetes, chronic kidney disease, and heart failure with reduced ejection fraction.

“The results of DELIVER extend the benefit of dapagliflozin to the full spectrum of patients with heart failure,” principal investigator of the trial, Scott Solomon, MD, Harvard Medical School and Brigham and Women’s Hospital, Boston, said in the news release.

The safety and tolerability of dapagliflozin in the trial were consistent with its established safety profile, the company says.

The full trial results will be submitted for presentation at a forthcoming medical meeting, and regulatory submissions will be made in the coming months, it notes.

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

Topline results from the phase 3 DELIVER trial show dapagliflozin (Farxiga) significantly reduced the primary endpoint of cardiovascular death or worsening heart failure in patients with mildly reduced or preserved ejection fraction, AstraZeneca announced today.

The sodium-glucose cotransporter 2 (SGLT2) inhibitor is not approved in this setting but is already approved for treatment of type 2 diabetes, chronic kidney disease, and heart failure with reduced ejection fraction.

“The results of DELIVER extend the benefit of dapagliflozin to the full spectrum of patients with heart failure,” principal investigator of the trial, Scott Solomon, MD, Harvard Medical School and Brigham and Women’s Hospital, Boston, said in the news release.

The safety and tolerability of dapagliflozin in the trial were consistent with its established safety profile, the company says.

The full trial results will be submitted for presentation at a forthcoming medical meeting, and regulatory submissions will be made in the coming months, it notes.

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

CHICAGO – Recent research has changed at least one physician’s understanding of obesity and boosted her hope for fighting it.

Caroline Apovian, MD, codirector of the Center for Weight Management and Wellness at Brigham and Women’s Hospital, described some of the new insights about obesity she has gained during her talk at the annual meeting of the American College of Physicians.

“When I was a medical student a while back, I learned that fat tissue just sat there and stored fat,” she said. “Now we know it’s an endocrine organ.”

This tissue secretes hormones, such as leptin, and other factors that have an array of effects on the brain, pancreas, heart, liver, and muscles. Moreover, it has plasticity, with the ability to change, constantly adjusting our metabolism as nutrient supply and demand changes, she continued.

Obesity leads to a decline in this plasticity, leading to fibrosis and inflammation and other problems. These changes can further impair the function of adipose tissue, leading to metabolic disease. But the central role of adipose tissue, and its dynamic nature, presents an opportunity for treatment, Dr. Apovian said, during her talk.
 

Hints to why obesity has become more common

More than 42% of the U.S. population – “unbelievably,” Dr. Apovian said – is obese, meaning they have a BMI over 30, according to the Centers for Disease Control and Prevention. That’s up by about 25% since 1960, although calories eaten hasn’t increased, and physical activity has increased somewhat, she said.

The root cause is still a bit of a mystery, but according to “good hints and clues” from animal models that are starting to be translated to the study of human obesity, “it has to do with epigenetics and how our brains and our bodies are perceiving the environment,” she noted, during her presentation.

“Our genes haven’t changed. Our environment has changed,” she said.

The industrialization of the food supply, the use of pesticides and preservatives, the dawn of fast food have all combined, most likely, to do “a number on our bodies,” Dr. Apovian said.

But not all hope is lost thanks to new research, Dr. Apovian suggested.
 

New treatments show promise for helping patients’ obesity

New research that has increased Dr. Apovian’s understanding of the sophisticated role of adipose tissue may be helpful for treating patients with obesity, offering more targets for intervention, she told the audience.

Some treatment avenues already identified have started producing results, Dr. Apovian noted.

Gastric bypass surgery typically leads to a loss of 25% of body weight, but is often shunned by patients, she said. “With such a great surgical procedure, we still only do 256,000 procedures and we have millions of Americans with a BMI over 30.”

Weight control with obsessive dieting, meal-planning and calorie-counting, “can be done, but it’s really hard,” Dr. Apovian noted.

More appealing therapies targeting hormones and appetite suppression have produced impressive results. Recently approved semaglutide produced 14% weight loss, compared with about 2% for placebo, she said.

Results just released for tirzepatide, a dual agonist of gut hormones GLP-1 and GIP, show a 22% total weight loss, compared with about 2% for placebo, with about 56% of patients losing more than 20% of their body weight, Dr. Apovian said.

Referencing studies finding that several hormones are altered during weight loss, she predicted that targeting multiple hormones with drug treatment will also be necessary for best results.

But, she noted, “we’re treating obesity now with one- or two-drug combos.”
 

Medication costs are too high for many patients

Isis Smith, MD, an internist at University Medical Center in New Orleans, said in an interview that the cost of the most effective medications – which are not covered by Medicaid – means that many of her patients don’t have access to these treatments.

“We’re talking about $1,000 a month. And so there is no way they can afford [them]. I can prescribe phentermine [but] unless a patient has another indication, Medicaid will not pay for it,” she explained.

“I love hearing about all of the new developments. ... It’s interesting to hear, but we need to get insurance to pay so that I can actually prescribe,” Dr. Smith noted.

Dr. Apovian reports financial relationships with Xeno Biosciences, Cowen, Allergan, Novo Nordisk, Abbott Nutrition, and other companies.

CHICAGO – Recent research has changed at least one physician’s understanding of obesity and boosted her hope for fighting it.

Caroline Apovian, MD, codirector of the Center for Weight Management and Wellness at Brigham and Women’s Hospital, described some of the new insights about obesity she has gained during her talk at the annual meeting of the American College of Physicians.

“When I was a medical student a while back, I learned that fat tissue just sat there and stored fat,” she said. “Now we know it’s an endocrine organ.”

This tissue secretes hormones, such as leptin, and other factors that have an array of effects on the brain, pancreas, heart, liver, and muscles. Moreover, it has plasticity, with the ability to change, constantly adjusting our metabolism as nutrient supply and demand changes, she continued.

Obesity leads to a decline in this plasticity, leading to fibrosis and inflammation and other problems. These changes can further impair the function of adipose tissue, leading to metabolic disease. But the central role of adipose tissue, and its dynamic nature, presents an opportunity for treatment, Dr. Apovian said, during her talk.
 

Hints to why obesity has become more common

More than 42% of the U.S. population – “unbelievably,” Dr. Apovian said – is obese, meaning they have a BMI over 30, according to the Centers for Disease Control and Prevention. That’s up by about 25% since 1960, although calories eaten hasn’t increased, and physical activity has increased somewhat, she said.

The root cause is still a bit of a mystery, but according to “good hints and clues” from animal models that are starting to be translated to the study of human obesity, “it has to do with epigenetics and how our brains and our bodies are perceiving the environment,” she noted, during her presentation.

“Our genes haven’t changed. Our environment has changed,” she said.

The industrialization of the food supply, the use of pesticides and preservatives, the dawn of fast food have all combined, most likely, to do “a number on our bodies,” Dr. Apovian said.

But not all hope is lost thanks to new research, Dr. Apovian suggested.
 

New treatments show promise for helping patients’ obesity

New research that has increased Dr. Apovian’s understanding of the sophisticated role of adipose tissue may be helpful for treating patients with obesity, offering more targets for intervention, she told the audience.

Some treatment avenues already identified have started producing results, Dr. Apovian noted.

Gastric bypass surgery typically leads to a loss of 25% of body weight, but is often shunned by patients, she said. “With such a great surgical procedure, we still only do 256,000 procedures and we have millions of Americans with a BMI over 30.”

Weight control with obsessive dieting, meal-planning and calorie-counting, “can be done, but it’s really hard,” Dr. Apovian noted.

More appealing therapies targeting hormones and appetite suppression have produced impressive results. Recently approved semaglutide produced 14% weight loss, compared with about 2% for placebo, she said.

Results just released for tirzepatide, a dual agonist of gut hormones GLP-1 and GIP, show a 22% total weight loss, compared with about 2% for placebo, with about 56% of patients losing more than 20% of their body weight, Dr. Apovian said.

Referencing studies finding that several hormones are altered during weight loss, she predicted that targeting multiple hormones with drug treatment will also be necessary for best results.

But, she noted, “we’re treating obesity now with one- or two-drug combos.”
 

Medication costs are too high for many patients

Isis Smith, MD, an internist at University Medical Center in New Orleans, said in an interview that the cost of the most effective medications – which are not covered by Medicaid – means that many of her patients don’t have access to these treatments.

“We’re talking about $1,000 a month. And so there is no way they can afford [them]. I can prescribe phentermine [but] unless a patient has another indication, Medicaid will not pay for it,” she explained.

“I love hearing about all of the new developments. ... It’s interesting to hear, but we need to get insurance to pay so that I can actually prescribe,” Dr. Smith noted.

Dr. Apovian reports financial relationships with Xeno Biosciences, Cowen, Allergan, Novo Nordisk, Abbott Nutrition, and other companies.

CHICAGO – Recent research has changed at least one physician’s understanding of obesity and boosted her hope for fighting it.

Caroline Apovian, MD, codirector of the Center for Weight Management and Wellness at Brigham and Women’s Hospital, described some of the new insights about obesity she has gained during her talk at the annual meeting of the American College of Physicians.

“When I was a medical student a while back, I learned that fat tissue just sat there and stored fat,” she said. “Now we know it’s an endocrine organ.”

This tissue secretes hormones, such as leptin, and other factors that have an array of effects on the brain, pancreas, heart, liver, and muscles. Moreover, it has plasticity, with the ability to change, constantly adjusting our metabolism as nutrient supply and demand changes, she continued.

Obesity leads to a decline in this plasticity, leading to fibrosis and inflammation and other problems. These changes can further impair the function of adipose tissue, leading to metabolic disease. But the central role of adipose tissue, and its dynamic nature, presents an opportunity for treatment, Dr. Apovian said, during her talk.
 

Hints to why obesity has become more common

More than 42% of the U.S. population – “unbelievably,” Dr. Apovian said – is obese, meaning they have a BMI over 30, according to the Centers for Disease Control and Prevention. That’s up by about 25% since 1960, although calories eaten hasn’t increased, and physical activity has increased somewhat, she said.

The root cause is still a bit of a mystery, but according to “good hints and clues” from animal models that are starting to be translated to the study of human obesity, “it has to do with epigenetics and how our brains and our bodies are perceiving the environment,” she noted, during her presentation.

“Our genes haven’t changed. Our environment has changed,” she said.

The industrialization of the food supply, the use of pesticides and preservatives, the dawn of fast food have all combined, most likely, to do “a number on our bodies,” Dr. Apovian said.

But not all hope is lost thanks to new research, Dr. Apovian suggested.
 

New treatments show promise for helping patients’ obesity

New research that has increased Dr. Apovian’s understanding of the sophisticated role of adipose tissue may be helpful for treating patients with obesity, offering more targets for intervention, she told the audience.

Some treatment avenues already identified have started producing results, Dr. Apovian noted.

Gastric bypass surgery typically leads to a loss of 25% of body weight, but is often shunned by patients, she said. “With such a great surgical procedure, we still only do 256,000 procedures and we have millions of Americans with a BMI over 30.”

Weight control with obsessive dieting, meal-planning and calorie-counting, “can be done, but it’s really hard,” Dr. Apovian noted.

More appealing therapies targeting hormones and appetite suppression have produced impressive results. Recently approved semaglutide produced 14% weight loss, compared with about 2% for placebo, she said.

Results just released for tirzepatide, a dual agonist of gut hormones GLP-1 and GIP, show a 22% total weight loss, compared with about 2% for placebo, with about 56% of patients losing more than 20% of their body weight, Dr. Apovian said.

Referencing studies finding that several hormones are altered during weight loss, she predicted that targeting multiple hormones with drug treatment will also be necessary for best results.

But, she noted, “we’re treating obesity now with one- or two-drug combos.”
 

Medication costs are too high for many patients

Isis Smith, MD, an internist at University Medical Center in New Orleans, said in an interview that the cost of the most effective medications – which are not covered by Medicaid – means that many of her patients don’t have access to these treatments.

“We’re talking about $1,000 a month. And so there is no way they can afford [them]. I can prescribe phentermine [but] unless a patient has another indication, Medicaid will not pay for it,” she explained.

“I love hearing about all of the new developments. ... It’s interesting to hear, but we need to get insurance to pay so that I can actually prescribe,” Dr. Smith noted.

Dr. Apovian reports financial relationships with Xeno Biosciences, Cowen, Allergan, Novo Nordisk, Abbott Nutrition, and other companies.

Mild traumatic brain injury (TBI) is linked to a significantly increased risk for a host of subsequent cardiovascular, endocrine, neurologic, and psychiatric disorders, new research shows.

Incidence of hypertension, coronary heart disease, diabetes, stroke, depression, and dementia all began to increase soon after the brain injury and persisted over a decade in both mild and moderate to severe TBI.

Researchers found the multisystem comorbidities in all age groups, including in patients as young as 18. They also found that patients who developed multiple postinjury problems had higher mortality during the decade-long follow-up.

The findings suggest patients with TBI may require longer follow-up and proactive screening for multisystem disease, regardless of age or injury severity.

“The fact that both patients with mild and moderate to severe injuries both had long-term ongoing associations with comorbidities that continued over time and that they are cardiovascular, endocrine, neurologic, and behavioral health oriented was pretty striking,” study author Ross Zafonte, DO, PhD, president of Spaulding Rehab Hospital and professor and chair of physical medicine and rehab at Harvard Medical School, both in Boston, told this news organization.

The study was published online in JAMA Network Open.
 

Injury severity not a factor

An estimated 2.8 million individuals in the United States experience TBI every year. Worldwide, the figure may be as high as 74 million.

Studies have long suggested a link between brain injury and subsequent neurologic disorders, but research suggesting a possible link to cardiovascular and endocrine problems has recently gained attention.

Building on a 2021 study that showed increased incidence of cardiovascular issues following a concussion, the researchers examined medical records of previously healthy patients treated for TBI between 2000 and 2015 who also had at least 1 follow-up visit between 6 months and 10 years after the initial injury.

Researchers analyzed data from 13,053 individuals – 4,351 with mild injury (mTBI), 4351 with moderate to severe injury (msTBI), and 4351 with no TBI. The most common cause of injury was a fall. Patients with sports-related injuries were excluded.

Incidence of hypertension was significantly higher among patients with mTBI (hazard ratio, 2.5; 95% confidence interval, 2.1-2.9) and msTBI (HR, 2.4; 95% CI, 2.0-2.9), compared with the unaffected group. Risk for other cardiovascular problems, including hyperlipidemia, obesity, and coronary artery disease, were also higher in the affected groups.

TBI patients also reported higher incidence of endocrine diseases, including diabetes (mTBI: HR, 1.9; 95% CI, 1.4-2.7; msTBI: HR, 1.9; 95% CI, 1.4-2.6). Elevated risk for ischemic stroke or transient ischemic attack was also increased (mTBI: HR, 2.2; 95% CI, 1.4-3.3; msTBI: HR, 3.6; 95% CI, 2.4-5.3).

Regardless of injury severity, patients with TBI had a higher risk for neurologic and psychiatric diseases, particularly depression, dementia, and psychotic disorders. “This tells us that mild TBI is not clean of events,” Dr. Zafonte said.

Surprising rate of comorbidity in youth

Investigators found increased risk for posttrauma comorbidities in all age groups, but researchers were struck by the high rates in younger patients, aged 18-40. Compared with age-matched individuals with no TBI history, hypertension risk was nearly six times higher in those with mTBI (HR, 5.9; 95% CI, 3.9-9.1) and nearly four times higher in patients with msTBI (HR, 3.9; 95% CI, 2.5-6.1).

Rates of hyperlipidemia and diabetes were also higher in younger patients in the mTBI group and posttraumatic seizures and psychiatric disorders were elevated regardless of TBI severity.

Overall, patients with msTBI, but not those with mTBI, were at higher risk for mortality, compared with the unexposed group (432 deaths [9.9%] vs. 250 deaths [5.7%]; P < .001).

“It’s clear that what we may be dealing with is that it holds up even for the younger people,” Dr. Zafonte said. “We used to think brain injury risk is worse in the severe cases, which it is, and it’s worse later on among those who are older, which it is. But our younger folks don’t get away either.”

While the study offers associations between TBI and multisystem health problems, Dr. Zafonte said it’s impossible to say at this point whether the brain injury caused the increased risk for cardiovascular or endocrine problems. Other organ injuries sustained in the trauma may be a contributing factor.

“Further data is needed to elucidate the mechanism and the causative relationships, which we do not have here,” he said.

Many of the postinjury comorbidities emerged a median of 3.5 years after TBI, regardless of severity. But some of the cardiovascular and psychiatric conditions emerged far sooner than that.

That’s important because research suggests less than half of patients with TBI receive follow-up care.

“It does make sense for folks who are interacting with people who’ve had a TBI to be suspicious of medical comorbidities relatively early on, within the first couple of years,” Dr. Zafonte said.

In an invited commentary, Vijay Krishnamoorthy, MD, MPH, PhD, Duke University, Durham, N.C., and Monica S. Vavilala, MD, University of Washington, Seattle, highlight some of the study’s limitations, including a lack of information on comorbidity severity and the lack of a matched group of patients who experienced non-head trauma.

Despite those limitations, the study offers important information on how TBI may affect organs beyond the brain, they noted.

“These observations, if replicated in future studies, raise intriguing implications in the future care of patients with TBI, including heightened chronic disease-screening measures and possibly enhanced guidelines for chronic extracranial organ system care for patients who experience TBI,” Dr. Krishnamoorthy and Dr. Vavilala wrote.

The study received no specific funding. Dr. Zafonte reported having received personal fees from Springer/Demos, serving on scientific advisory boards for Myomo and OnCare and has received funding from the Football Players Health Study at Harvard, funded in part by the National Football League Players Association. Dr. Krishnamoorthy and Dr. Vavilala disclosed no relevant financial relationships.

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

Mild traumatic brain injury (TBI) is linked to a significantly increased risk for a host of subsequent cardiovascular, endocrine, neurologic, and psychiatric disorders, new research shows.

Incidence of hypertension, coronary heart disease, diabetes, stroke, depression, and dementia all began to increase soon after the brain injury and persisted over a decade in both mild and moderate to severe TBI.

Researchers found the multisystem comorbidities in all age groups, including in patients as young as 18. They also found that patients who developed multiple postinjury problems had higher mortality during the decade-long follow-up.

The findings suggest patients with TBI may require longer follow-up and proactive screening for multisystem disease, regardless of age or injury severity.

“The fact that both patients with mild and moderate to severe injuries both had long-term ongoing associations with comorbidities that continued over time and that they are cardiovascular, endocrine, neurologic, and behavioral health oriented was pretty striking,” study author Ross Zafonte, DO, PhD, president of Spaulding Rehab Hospital and professor and chair of physical medicine and rehab at Harvard Medical School, both in Boston, told this news organization.

The study was published online in JAMA Network Open.
 

Injury severity not a factor

An estimated 2.8 million individuals in the United States experience TBI every year. Worldwide, the figure may be as high as 74 million.

Studies have long suggested a link between brain injury and subsequent neurologic disorders, but research suggesting a possible link to cardiovascular and endocrine problems has recently gained attention.

Building on a 2021 study that showed increased incidence of cardiovascular issues following a concussion, the researchers examined medical records of previously healthy patients treated for TBI between 2000 and 2015 who also had at least 1 follow-up visit between 6 months and 10 years after the initial injury.

Researchers analyzed data from 13,053 individuals – 4,351 with mild injury (mTBI), 4351 with moderate to severe injury (msTBI), and 4351 with no TBI. The most common cause of injury was a fall. Patients with sports-related injuries were excluded.

Incidence of hypertension was significantly higher among patients with mTBI (hazard ratio, 2.5; 95% confidence interval, 2.1-2.9) and msTBI (HR, 2.4; 95% CI, 2.0-2.9), compared with the unaffected group. Risk for other cardiovascular problems, including hyperlipidemia, obesity, and coronary artery disease, were also higher in the affected groups.

TBI patients also reported higher incidence of endocrine diseases, including diabetes (mTBI: HR, 1.9; 95% CI, 1.4-2.7; msTBI: HR, 1.9; 95% CI, 1.4-2.6). Elevated risk for ischemic stroke or transient ischemic attack was also increased (mTBI: HR, 2.2; 95% CI, 1.4-3.3; msTBI: HR, 3.6; 95% CI, 2.4-5.3).

Regardless of injury severity, patients with TBI had a higher risk for neurologic and psychiatric diseases, particularly depression, dementia, and psychotic disorders. “This tells us that mild TBI is not clean of events,” Dr. Zafonte said.

Surprising rate of comorbidity in youth

Investigators found increased risk for posttrauma comorbidities in all age groups, but researchers were struck by the high rates in younger patients, aged 18-40. Compared with age-matched individuals with no TBI history, hypertension risk was nearly six times higher in those with mTBI (HR, 5.9; 95% CI, 3.9-9.1) and nearly four times higher in patients with msTBI (HR, 3.9; 95% CI, 2.5-6.1).

Rates of hyperlipidemia and diabetes were also higher in younger patients in the mTBI group and posttraumatic seizures and psychiatric disorders were elevated regardless of TBI severity.

Overall, patients with msTBI, but not those with mTBI, were at higher risk for mortality, compared with the unexposed group (432 deaths [9.9%] vs. 250 deaths [5.7%]; P < .001).

“It’s clear that what we may be dealing with is that it holds up even for the younger people,” Dr. Zafonte said. “We used to think brain injury risk is worse in the severe cases, which it is, and it’s worse later on among those who are older, which it is. But our younger folks don’t get away either.”

While the study offers associations between TBI and multisystem health problems, Dr. Zafonte said it’s impossible to say at this point whether the brain injury caused the increased risk for cardiovascular or endocrine problems. Other organ injuries sustained in the trauma may be a contributing factor.

“Further data is needed to elucidate the mechanism and the causative relationships, which we do not have here,” he said.

Many of the postinjury comorbidities emerged a median of 3.5 years after TBI, regardless of severity. But some of the cardiovascular and psychiatric conditions emerged far sooner than that.

That’s important because research suggests less than half of patients with TBI receive follow-up care.

“It does make sense for folks who are interacting with people who’ve had a TBI to be suspicious of medical comorbidities relatively early on, within the first couple of years,” Dr. Zafonte said.

In an invited commentary, Vijay Krishnamoorthy, MD, MPH, PhD, Duke University, Durham, N.C., and Monica S. Vavilala, MD, University of Washington, Seattle, highlight some of the study’s limitations, including a lack of information on comorbidity severity and the lack of a matched group of patients who experienced non-head trauma.

Despite those limitations, the study offers important information on how TBI may affect organs beyond the brain, they noted.

“These observations, if replicated in future studies, raise intriguing implications in the future care of patients with TBI, including heightened chronic disease-screening measures and possibly enhanced guidelines for chronic extracranial organ system care for patients who experience TBI,” Dr. Krishnamoorthy and Dr. Vavilala wrote.

The study received no specific funding. Dr. Zafonte reported having received personal fees from Springer/Demos, serving on scientific advisory boards for Myomo and OnCare and has received funding from the Football Players Health Study at Harvard, funded in part by the National Football League Players Association. Dr. Krishnamoorthy and Dr. Vavilala disclosed no relevant financial relationships.

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

Mild traumatic brain injury (TBI) is linked to a significantly increased risk for a host of subsequent cardiovascular, endocrine, neurologic, and psychiatric disorders, new research shows.

Incidence of hypertension, coronary heart disease, diabetes, stroke, depression, and dementia all began to increase soon after the brain injury and persisted over a decade in both mild and moderate to severe TBI.

Researchers found the multisystem comorbidities in all age groups, including in patients as young as 18. They also found that patients who developed multiple postinjury problems had higher mortality during the decade-long follow-up.

The findings suggest patients with TBI may require longer follow-up and proactive screening for multisystem disease, regardless of age or injury severity.

“The fact that both patients with mild and moderate to severe injuries both had long-term ongoing associations with comorbidities that continued over time and that they are cardiovascular, endocrine, neurologic, and behavioral health oriented was pretty striking,” study author Ross Zafonte, DO, PhD, president of Spaulding Rehab Hospital and professor and chair of physical medicine and rehab at Harvard Medical School, both in Boston, told this news organization.

The study was published online in JAMA Network Open.
 

Injury severity not a factor

An estimated 2.8 million individuals in the United States experience TBI every year. Worldwide, the figure may be as high as 74 million.

Studies have long suggested a link between brain injury and subsequent neurologic disorders, but research suggesting a possible link to cardiovascular and endocrine problems has recently gained attention.

Building on a 2021 study that showed increased incidence of cardiovascular issues following a concussion, the researchers examined medical records of previously healthy patients treated for TBI between 2000 and 2015 who also had at least 1 follow-up visit between 6 months and 10 years after the initial injury.

Researchers analyzed data from 13,053 individuals – 4,351 with mild injury (mTBI), 4351 with moderate to severe injury (msTBI), and 4351 with no TBI. The most common cause of injury was a fall. Patients with sports-related injuries were excluded.

Incidence of hypertension was significantly higher among patients with mTBI (hazard ratio, 2.5; 95% confidence interval, 2.1-2.9) and msTBI (HR, 2.4; 95% CI, 2.0-2.9), compared with the unaffected group. Risk for other cardiovascular problems, including hyperlipidemia, obesity, and coronary artery disease, were also higher in the affected groups.

TBI patients also reported higher incidence of endocrine diseases, including diabetes (mTBI: HR, 1.9; 95% CI, 1.4-2.7; msTBI: HR, 1.9; 95% CI, 1.4-2.6). Elevated risk for ischemic stroke or transient ischemic attack was also increased (mTBI: HR, 2.2; 95% CI, 1.4-3.3; msTBI: HR, 3.6; 95% CI, 2.4-5.3).

Regardless of injury severity, patients with TBI had a higher risk for neurologic and psychiatric diseases, particularly depression, dementia, and psychotic disorders. “This tells us that mild TBI is not clean of events,” Dr. Zafonte said.

Surprising rate of comorbidity in youth

Investigators found increased risk for posttrauma comorbidities in all age groups, but researchers were struck by the high rates in younger patients, aged 18-40. Compared with age-matched individuals with no TBI history, hypertension risk was nearly six times higher in those with mTBI (HR, 5.9; 95% CI, 3.9-9.1) and nearly four times higher in patients with msTBI (HR, 3.9; 95% CI, 2.5-6.1).

Rates of hyperlipidemia and diabetes were also higher in younger patients in the mTBI group and posttraumatic seizures and psychiatric disorders were elevated regardless of TBI severity.

Overall, patients with msTBI, but not those with mTBI, were at higher risk for mortality, compared with the unexposed group (432 deaths [9.9%] vs. 250 deaths [5.7%]; P < .001).

“It’s clear that what we may be dealing with is that it holds up even for the younger people,” Dr. Zafonte said. “We used to think brain injury risk is worse in the severe cases, which it is, and it’s worse later on among those who are older, which it is. But our younger folks don’t get away either.”

While the study offers associations between TBI and multisystem health problems, Dr. Zafonte said it’s impossible to say at this point whether the brain injury caused the increased risk for cardiovascular or endocrine problems. Other organ injuries sustained in the trauma may be a contributing factor.

“Further data is needed to elucidate the mechanism and the causative relationships, which we do not have here,” he said.

Many of the postinjury comorbidities emerged a median of 3.5 years after TBI, regardless of severity. But some of the cardiovascular and psychiatric conditions emerged far sooner than that.

That’s important because research suggests less than half of patients with TBI receive follow-up care.

“It does make sense for folks who are interacting with people who’ve had a TBI to be suspicious of medical comorbidities relatively early on, within the first couple of years,” Dr. Zafonte said.

In an invited commentary, Vijay Krishnamoorthy, MD, MPH, PhD, Duke University, Durham, N.C., and Monica S. Vavilala, MD, University of Washington, Seattle, highlight some of the study’s limitations, including a lack of information on comorbidity severity and the lack of a matched group of patients who experienced non-head trauma.

Despite those limitations, the study offers important information on how TBI may affect organs beyond the brain, they noted.

“These observations, if replicated in future studies, raise intriguing implications in the future care of patients with TBI, including heightened chronic disease-screening measures and possibly enhanced guidelines for chronic extracranial organ system care for patients who experience TBI,” Dr. Krishnamoorthy and Dr. Vavilala wrote.

The study received no specific funding. Dr. Zafonte reported having received personal fees from Springer/Demos, serving on scientific advisory boards for Myomo and OnCare and has received funding from the Football Players Health Study at Harvard, funded in part by the National Football League Players Association. Dr. Krishnamoorthy and Dr. Vavilala disclosed no relevant financial relationships.

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

Results of a meta-analysis carried out by a French team indicate that there is a link between a father’s or mother’s autoimmune disease and their children’s risk of developing certain neurodevelopmental disorders (autism spectrum disorder [ASD] and attention-deficit/hyperactivity disorder). This meta-analysis is the first to separately explore the link between a father’s or mother’s autoimmune disease and the onset of neurodevelopmental disorders in their children.

According to its authors, these associations may result from exposure to environmental factors that contribute to autoimmune disorders, such as exposure to pollutants or cigarette smoke, and/or genetic predisposition, including genes relating to cytokines or to the HLA system.

Research is needed to determine the pathophysiologic links between these associations. This study suggests that there could be a shared mechanism between both parents, even though the maternal route seems to constitute an additional excess risk.
 

Why is this important?

Neurodevelopmental disorders are said to occur because of a close interrelationship between a person’s genes and environment. Immune-mediated adverse reactions may play an important role in triggering such disorders, as has been shown in associated epidemiologic studies and in animal studies. Autoimmune and autoinflammatory disorders are effectively characterized by the activation of the immune system, the circulation of autoantibodies, and the secretion of cytokines that are harmful to certain tissues.

Some relevant studies suggest a link between autoimmune disorders in the family or in the mother and the onset of neurodevelopmental disorders in their children. However, none of the studies have distinguished the influence of each of the parents so as to provide data that can be used to assess whether this association is more likely to be direct, and thus established during pregnancy, or rather genetic or environmental.
 

Main findings

Overall, the meta-analysis involved 14 studies that included 845,411 mothers and 601,148 fathers with an autoimmune disease, 4,984,965 control mothers and 4,992,854 control fathers. There were 182,927 children with neurodevelopmental disorders and 14,168,474 with no such diagnosis.

Globally, autoimmune diseases in mothers (adjusted odds ratio, 1.27 [1.03-1.57]; P = .02; I2 = 65%) and in fathers (AOR, 1.18 [1.07-1.30]; P = .01; I2 = 15.5%) are associated with a diagnosis of ASD in children. Similarly, they are associated with an increased risk of ADHD in children (AOR, 1.31 [1.11-1.55]; P = .001; I2 = 93% and AOR, 1.14 [1.10-1.17]; P < .0001; I2 = 0%, respectively, for mothers and fathers).

In mothers, type 1 diabetes (AOR, 1.60 [1.18-2.18]; P = .002; I2 = 0%), psoriasis (AOR, 1.45 [1.14-1.85]; P = .002; I2 = 0%), and rheumatoid arthritis (AOR, 1.38 [1.14-1.68]; P = .001; I2 = 0.8%) were associated with a risk of ASD in children. These three conditions also predisposed children to the risk of ADHD (AOR, 1.36 [1.24-1.52]; 1.41 [1.29-1.54]; and 1.32 [1.25-1.40], respectively, all P < .0001).

In fathers, type 1 diabetes considered in isolation was associated with a risk of ASD and ADHD in children (AOR, 1.42 [1.10-1.83] and 1.19 [1.08-1.31], respectively), while psoriasis (AOR, 1.18 [1.12-1.24]; P < .0001) is associated with a risk of ADHD in children.

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

Results of a meta-analysis carried out by a French team indicate that there is a link between a father’s or mother’s autoimmune disease and their children’s risk of developing certain neurodevelopmental disorders (autism spectrum disorder [ASD] and attention-deficit/hyperactivity disorder). This meta-analysis is the first to separately explore the link between a father’s or mother’s autoimmune disease and the onset of neurodevelopmental disorders in their children.

According to its authors, these associations may result from exposure to environmental factors that contribute to autoimmune disorders, such as exposure to pollutants or cigarette smoke, and/or genetic predisposition, including genes relating to cytokines or to the HLA system.

Research is needed to determine the pathophysiologic links between these associations. This study suggests that there could be a shared mechanism between both parents, even though the maternal route seems to constitute an additional excess risk.
 

Why is this important?

Neurodevelopmental disorders are said to occur because of a close interrelationship between a person’s genes and environment. Immune-mediated adverse reactions may play an important role in triggering such disorders, as has been shown in associated epidemiologic studies and in animal studies. Autoimmune and autoinflammatory disorders are effectively characterized by the activation of the immune system, the circulation of autoantibodies, and the secretion of cytokines that are harmful to certain tissues.

Some relevant studies suggest a link between autoimmune disorders in the family or in the mother and the onset of neurodevelopmental disorders in their children. However, none of the studies have distinguished the influence of each of the parents so as to provide data that can be used to assess whether this association is more likely to be direct, and thus established during pregnancy, or rather genetic or environmental.
 

Main findings

Overall, the meta-analysis involved 14 studies that included 845,411 mothers and 601,148 fathers with an autoimmune disease, 4,984,965 control mothers and 4,992,854 control fathers. There were 182,927 children with neurodevelopmental disorders and 14,168,474 with no such diagnosis.

Globally, autoimmune diseases in mothers (adjusted odds ratio, 1.27 [1.03-1.57]; P = .02; I2 = 65%) and in fathers (AOR, 1.18 [1.07-1.30]; P = .01; I2 = 15.5%) are associated with a diagnosis of ASD in children. Similarly, they are associated with an increased risk of ADHD in children (AOR, 1.31 [1.11-1.55]; P = .001; I2 = 93% and AOR, 1.14 [1.10-1.17]; P < .0001; I2 = 0%, respectively, for mothers and fathers).

In mothers, type 1 diabetes (AOR, 1.60 [1.18-2.18]; P = .002; I2 = 0%), psoriasis (AOR, 1.45 [1.14-1.85]; P = .002; I2 = 0%), and rheumatoid arthritis (AOR, 1.38 [1.14-1.68]; P = .001; I2 = 0.8%) were associated with a risk of ASD in children. These three conditions also predisposed children to the risk of ADHD (AOR, 1.36 [1.24-1.52]; 1.41 [1.29-1.54]; and 1.32 [1.25-1.40], respectively, all P < .0001).

In fathers, type 1 diabetes considered in isolation was associated with a risk of ASD and ADHD in children (AOR, 1.42 [1.10-1.83] and 1.19 [1.08-1.31], respectively), while psoriasis (AOR, 1.18 [1.12-1.24]; P < .0001) is associated with a risk of ADHD in children.

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

Results of a meta-analysis carried out by a French team indicate that there is a link between a father’s or mother’s autoimmune disease and their children’s risk of developing certain neurodevelopmental disorders (autism spectrum disorder [ASD] and attention-deficit/hyperactivity disorder). This meta-analysis is the first to separately explore the link between a father’s or mother’s autoimmune disease and the onset of neurodevelopmental disorders in their children.

According to its authors, these associations may result from exposure to environmental factors that contribute to autoimmune disorders, such as exposure to pollutants or cigarette smoke, and/or genetic predisposition, including genes relating to cytokines or to the HLA system.

Research is needed to determine the pathophysiologic links between these associations. This study suggests that there could be a shared mechanism between both parents, even though the maternal route seems to constitute an additional excess risk.
 

Why is this important?

Neurodevelopmental disorders are said to occur because of a close interrelationship between a person’s genes and environment. Immune-mediated adverse reactions may play an important role in triggering such disorders, as has been shown in associated epidemiologic studies and in animal studies. Autoimmune and autoinflammatory disorders are effectively characterized by the activation of the immune system, the circulation of autoantibodies, and the secretion of cytokines that are harmful to certain tissues.

Some relevant studies suggest a link between autoimmune disorders in the family or in the mother and the onset of neurodevelopmental disorders in their children. However, none of the studies have distinguished the influence of each of the parents so as to provide data that can be used to assess whether this association is more likely to be direct, and thus established during pregnancy, or rather genetic or environmental.
 

Main findings

Overall, the meta-analysis involved 14 studies that included 845,411 mothers and 601,148 fathers with an autoimmune disease, 4,984,965 control mothers and 4,992,854 control fathers. There were 182,927 children with neurodevelopmental disorders and 14,168,474 with no such diagnosis.

Globally, autoimmune diseases in mothers (adjusted odds ratio, 1.27 [1.03-1.57]; P = .02; I2 = 65%) and in fathers (AOR, 1.18 [1.07-1.30]; P = .01; I2 = 15.5%) are associated with a diagnosis of ASD in children. Similarly, they are associated with an increased risk of ADHD in children (AOR, 1.31 [1.11-1.55]; P = .001; I2 = 93% and AOR, 1.14 [1.10-1.17]; P < .0001; I2 = 0%, respectively, for mothers and fathers).

In mothers, type 1 diabetes (AOR, 1.60 [1.18-2.18]; P = .002; I2 = 0%), psoriasis (AOR, 1.45 [1.14-1.85]; P = .002; I2 = 0%), and rheumatoid arthritis (AOR, 1.38 [1.14-1.68]; P = .001; I2 = 0.8%) were associated with a risk of ASD in children. These three conditions also predisposed children to the risk of ADHD (AOR, 1.36 [1.24-1.52]; 1.41 [1.29-1.54]; and 1.32 [1.25-1.40], respectively, all P < .0001).

In fathers, type 1 diabetes considered in isolation was associated with a risk of ASD and ADHD in children (AOR, 1.42 [1.10-1.83] and 1.19 [1.08-1.31], respectively), while psoriasis (AOR, 1.18 [1.12-1.24]; P < .0001) is associated with a risk of ADHD in children.

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

More than half of patients taking the two highest doses of tirzepatide as a once-weekly injection lost at least 20% of their body weight in the first phase 3 trial to examine this agent in patients with obesity, but without diabetes, according to preliminary top-line results from the SURMOUNT-1 trial announced by Lilly.  

The full results will be reported at an upcoming medical conference and published at a later date, Lilly added.

There was much excitement in response to the news, but others have urged caution and noted that, even if tirzepatide is eventually approved for obesity, one of the major barriers to use in the United States will be insurance coverage.

“Wow (and a double Wow!) 52lb weight loss (22.5%) at highest dose of tirzepatide,” tweeted Sek Kathiresan, MD, a cardiologist who is cofounder of Verve Therapeutics and on leave from Harvard (@skathire).

“Thus far the challenge with GLP-1s [agonists] for management of obesity is that insurance usually isn’t covering them. This makes them unaffordable for most people,” replied James Marroquin, MD, of the University of Texas at Austin. (@Jamesmarroquin).

Yoni Freedhoff, MD, of the University of Ottawa (Ont.) who writes a column for this news organization on obesity, said if tirzepatide pans out, along with other similar agents already on the market for this indication, “the next few decades should see the pharmaceutical management of obesity rival its surgical management.”

Would compete with ‘game-changer’ semaglutide?

Tirzepatide has been dubbed a “twincretin” because it works not only as an agonist of the glucagonlike peptide-1 (GLP-1) receptor, but also of the glucose-dependent insulinotropic polypeptide (GIP) receptor. It has been much hyped based on the results of the series of SURPASS clinical trials, which have formed the basis of the application for type 2 diabetes approval, about which the U.S. Food and Drug Administration is expected to make a decision soon.

Several GLP-1 agonists are on the market for both type 2 diabetes and for obesity indications separately, including semaglutide (marketed as Wegovy for obesity, also a once-weekly injection) and liraglutide (Saxenda for obesity, a daily injection), both Novo Nordisk agents.

Wegovy was approved for weight loss in the United States last year, with doctors telling this news organization then that a third of patients who take the drug are likely to lose 20% or more of their starting weight, an outcome that approaches reductions seen with bariatric surgery.

Dr. Freedhoff said he’d like to see “reimbursement by insurers who will see these drugs serving as important ancillary treatments for the myriad of weight-responsive conditions they’re already covering.”

SURMOUNT-1 data: ‘Impressive body weight’ reductions

The new tirzepatide data come from the multicenter, randomized, double-blind, placebo-controlled SURMOUNT-1 trial, which included 2539 participants from the United States, Argentina, Brazil, China, India, Japan Mexico, Russia, and Taiwan. They had obesity or overweight plus at least one comorbidity but not diabetes. They were randomized to 5-mg, 10-mg, or 15-mg once-weekly tirzepatide or placebo injections for 18 months (72 weeks).

Efficacy was analyzed in two ways. Prior to factoring in drug discontinuation, participants taking tirzepatide experienced weight loss of 16.0% (35 lb/16 kg) with 5 mg, 21.4% (49 lb/22 kg) with 10 mg, and 22.5% (52 lb/24 kg) on 15 mg. In contrast, the placebo group lost just 2.4% of body weight (5 lb/2 kg).  

But treatment discontinuation rates because of adverse events were 4.3%, 7.1%, 6.2%, and 2.6%, for tirzepatide 5 mg, 10 mg, 15 mg, and placebo, respectively. Overall treatment discontinuation rates were 14.3%, 16.4%, 15.1%, and 26.4%, respectively.  

When efficacy was assessed regardless of treatment discontinuation, average body weight reductions were 15.0%, 19.5%, 20.9%, and 3.1% for tirzepatide 5 mg, 10 mg, 15 mg, and placebo, respectively.  

More than half of patients taking tirzepatide 10 mg and 15 mg (55% and 63%, respectively) lost at least 20% of their body weight, compared with just 1.3% taking placebo.

Overall safety and tolerability were similar to those of other GLP-1 agonists, with adverse events being gastrointestinal in nature and increasing with higher doses. Nausea affected 24.6%, 33.3%, and 31.0% of the tirzepatide 5-mg, 10-mg, and 15-mg dose groups, respectively, and vomiting was experienced by 8.3%, 10.7%, and 12.2% of patients, respectively. Diarrhea and constipation were also reported more often with the drug than placebo.

“Tirzepatide delivered impressive body weight reductions in SURMOUNT-1, which could represent an important step forward for helping the patient and physician partnership treat this complex disease,” said study investigator Louis J. Aronne, MD, director of the Comprehensive Weight Control Center and the Sanford I. Weill Professor of Metabolic Research at Weill Cornell Medicine, New York, in a press release.

Further studies are ongoing for tirzepatide as a potential treatment for obesity or overweight, according to the Lilly statement. SURMOUNT is a phase 3 global clinical development program for tirzepatide that began in late 2019 with over 5,000 people with obesity or overweight across six clinical trials. Results from SURMOUNT-2, SURMOUNT-3, and SURMOUNT-4 are expected in 2023.

Tirzepatide is also being studied as a potential treatment for nonalcoholic fatty liver disease and heart failure with preserved ejection fraction. Studies of tirzepatide in obstructive sleep apnea and of morbidity/mortality in obesity are also planned.

Dr. Aronne is cofounder, chief scientific advisor, and a member of the board of directors for Intellihealth. He is also a paid scientific advisory board member for Eli Lilly. Dr. Freedhoff has served or is serving as a director, officer, partner, employee, adviser, consultant, or trustee for the Bariatric Medical Institute and Constant Health and has received a research grant from Novo Nordisk.

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

More than half of patients taking the two highest doses of tirzepatide as a once-weekly injection lost at least 20% of their body weight in the first phase 3 trial to examine this agent in patients with obesity, but without diabetes, according to preliminary top-line results from the SURMOUNT-1 trial announced by Lilly.  

The full results will be reported at an upcoming medical conference and published at a later date, Lilly added.

There was much excitement in response to the news, but others have urged caution and noted that, even if tirzepatide is eventually approved for obesity, one of the major barriers to use in the United States will be insurance coverage.

“Wow (and a double Wow!) 52lb weight loss (22.5%) at highest dose of tirzepatide,” tweeted Sek Kathiresan, MD, a cardiologist who is cofounder of Verve Therapeutics and on leave from Harvard (@skathire).

“Thus far the challenge with GLP-1s [agonists] for management of obesity is that insurance usually isn’t covering them. This makes them unaffordable for most people,” replied James Marroquin, MD, of the University of Texas at Austin. (@Jamesmarroquin).

Yoni Freedhoff, MD, of the University of Ottawa (Ont.) who writes a column for this news organization on obesity, said if tirzepatide pans out, along with other similar agents already on the market for this indication, “the next few decades should see the pharmaceutical management of obesity rival its surgical management.”

Would compete with ‘game-changer’ semaglutide?

Tirzepatide has been dubbed a “twincretin” because it works not only as an agonist of the glucagonlike peptide-1 (GLP-1) receptor, but also of the glucose-dependent insulinotropic polypeptide (GIP) receptor. It has been much hyped based on the results of the series of SURPASS clinical trials, which have formed the basis of the application for type 2 diabetes approval, about which the U.S. Food and Drug Administration is expected to make a decision soon.

Several GLP-1 agonists are on the market for both type 2 diabetes and for obesity indications separately, including semaglutide (marketed as Wegovy for obesity, also a once-weekly injection) and liraglutide (Saxenda for obesity, a daily injection), both Novo Nordisk agents.

Wegovy was approved for weight loss in the United States last year, with doctors telling this news organization then that a third of patients who take the drug are likely to lose 20% or more of their starting weight, an outcome that approaches reductions seen with bariatric surgery.

Dr. Freedhoff said he’d like to see “reimbursement by insurers who will see these drugs serving as important ancillary treatments for the myriad of weight-responsive conditions they’re already covering.”

SURMOUNT-1 data: ‘Impressive body weight’ reductions

The new tirzepatide data come from the multicenter, randomized, double-blind, placebo-controlled SURMOUNT-1 trial, which included 2539 participants from the United States, Argentina, Brazil, China, India, Japan Mexico, Russia, and Taiwan. They had obesity or overweight plus at least one comorbidity but not diabetes. They were randomized to 5-mg, 10-mg, or 15-mg once-weekly tirzepatide or placebo injections for 18 months (72 weeks).

Efficacy was analyzed in two ways. Prior to factoring in drug discontinuation, participants taking tirzepatide experienced weight loss of 16.0% (35 lb/16 kg) with 5 mg, 21.4% (49 lb/22 kg) with 10 mg, and 22.5% (52 lb/24 kg) on 15 mg. In contrast, the placebo group lost just 2.4% of body weight (5 lb/2 kg).  

But treatment discontinuation rates because of adverse events were 4.3%, 7.1%, 6.2%, and 2.6%, for tirzepatide 5 mg, 10 mg, 15 mg, and placebo, respectively. Overall treatment discontinuation rates were 14.3%, 16.4%, 15.1%, and 26.4%, respectively.  

When efficacy was assessed regardless of treatment discontinuation, average body weight reductions were 15.0%, 19.5%, 20.9%, and 3.1% for tirzepatide 5 mg, 10 mg, 15 mg, and placebo, respectively.  

More than half of patients taking tirzepatide 10 mg and 15 mg (55% and 63%, respectively) lost at least 20% of their body weight, compared with just 1.3% taking placebo.

Overall safety and tolerability were similar to those of other GLP-1 agonists, with adverse events being gastrointestinal in nature and increasing with higher doses. Nausea affected 24.6%, 33.3%, and 31.0% of the tirzepatide 5-mg, 10-mg, and 15-mg dose groups, respectively, and vomiting was experienced by 8.3%, 10.7%, and 12.2% of patients, respectively. Diarrhea and constipation were also reported more often with the drug than placebo.

“Tirzepatide delivered impressive body weight reductions in SURMOUNT-1, which could represent an important step forward for helping the patient and physician partnership treat this complex disease,” said study investigator Louis J. Aronne, MD, director of the Comprehensive Weight Control Center and the Sanford I. Weill Professor of Metabolic Research at Weill Cornell Medicine, New York, in a press release.

Further studies are ongoing for tirzepatide as a potential treatment for obesity or overweight, according to the Lilly statement. SURMOUNT is a phase 3 global clinical development program for tirzepatide that began in late 2019 with over 5,000 people with obesity or overweight across six clinical trials. Results from SURMOUNT-2, SURMOUNT-3, and SURMOUNT-4 are expected in 2023.

Tirzepatide is also being studied as a potential treatment for nonalcoholic fatty liver disease and heart failure with preserved ejection fraction. Studies of tirzepatide in obstructive sleep apnea and of morbidity/mortality in obesity are also planned.

Dr. Aronne is cofounder, chief scientific advisor, and a member of the board of directors for Intellihealth. He is also a paid scientific advisory board member for Eli Lilly. Dr. Freedhoff has served or is serving as a director, officer, partner, employee, adviser, consultant, or trustee for the Bariatric Medical Institute and Constant Health and has received a research grant from Novo Nordisk.

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

More than half of patients taking the two highest doses of tirzepatide as a once-weekly injection lost at least 20% of their body weight in the first phase 3 trial to examine this agent in patients with obesity, but without diabetes, according to preliminary top-line results from the SURMOUNT-1 trial announced by Lilly.  

The full results will be reported at an upcoming medical conference and published at a later date, Lilly added.

There was much excitement in response to the news, but others have urged caution and noted that, even if tirzepatide is eventually approved for obesity, one of the major barriers to use in the United States will be insurance coverage.

“Wow (and a double Wow!) 52lb weight loss (22.5%) at highest dose of tirzepatide,” tweeted Sek Kathiresan, MD, a cardiologist who is cofounder of Verve Therapeutics and on leave from Harvard (@skathire).

“Thus far the challenge with GLP-1s [agonists] for management of obesity is that insurance usually isn’t covering them. This makes them unaffordable for most people,” replied James Marroquin, MD, of the University of Texas at Austin. (@Jamesmarroquin).

Yoni Freedhoff, MD, of the University of Ottawa (Ont.) who writes a column for this news organization on obesity, said if tirzepatide pans out, along with other similar agents already on the market for this indication, “the next few decades should see the pharmaceutical management of obesity rival its surgical management.”

Would compete with ‘game-changer’ semaglutide?

Tirzepatide has been dubbed a “twincretin” because it works not only as an agonist of the glucagonlike peptide-1 (GLP-1) receptor, but also of the glucose-dependent insulinotropic polypeptide (GIP) receptor. It has been much hyped based on the results of the series of SURPASS clinical trials, which have formed the basis of the application for type 2 diabetes approval, about which the U.S. Food and Drug Administration is expected to make a decision soon.

Several GLP-1 agonists are on the market for both type 2 diabetes and for obesity indications separately, including semaglutide (marketed as Wegovy for obesity, also a once-weekly injection) and liraglutide (Saxenda for obesity, a daily injection), both Novo Nordisk agents.

Wegovy was approved for weight loss in the United States last year, with doctors telling this news organization then that a third of patients who take the drug are likely to lose 20% or more of their starting weight, an outcome that approaches reductions seen with bariatric surgery.

Dr. Freedhoff said he’d like to see “reimbursement by insurers who will see these drugs serving as important ancillary treatments for the myriad of weight-responsive conditions they’re already covering.”

SURMOUNT-1 data: ‘Impressive body weight’ reductions

The new tirzepatide data come from the multicenter, randomized, double-blind, placebo-controlled SURMOUNT-1 trial, which included 2539 participants from the United States, Argentina, Brazil, China, India, Japan Mexico, Russia, and Taiwan. They had obesity or overweight plus at least one comorbidity but not diabetes. They were randomized to 5-mg, 10-mg, or 15-mg once-weekly tirzepatide or placebo injections for 18 months (72 weeks).

Efficacy was analyzed in two ways. Prior to factoring in drug discontinuation, participants taking tirzepatide experienced weight loss of 16.0% (35 lb/16 kg) with 5 mg, 21.4% (49 lb/22 kg) with 10 mg, and 22.5% (52 lb/24 kg) on 15 mg. In contrast, the placebo group lost just 2.4% of body weight (5 lb/2 kg).  

But treatment discontinuation rates because of adverse events were 4.3%, 7.1%, 6.2%, and 2.6%, for tirzepatide 5 mg, 10 mg, 15 mg, and placebo, respectively. Overall treatment discontinuation rates were 14.3%, 16.4%, 15.1%, and 26.4%, respectively.  

When efficacy was assessed regardless of treatment discontinuation, average body weight reductions were 15.0%, 19.5%, 20.9%, and 3.1% for tirzepatide 5 mg, 10 mg, 15 mg, and placebo, respectively.  

More than half of patients taking tirzepatide 10 mg and 15 mg (55% and 63%, respectively) lost at least 20% of their body weight, compared with just 1.3% taking placebo.

Overall safety and tolerability were similar to those of other GLP-1 agonists, with adverse events being gastrointestinal in nature and increasing with higher doses. Nausea affected 24.6%, 33.3%, and 31.0% of the tirzepatide 5-mg, 10-mg, and 15-mg dose groups, respectively, and vomiting was experienced by 8.3%, 10.7%, and 12.2% of patients, respectively. Diarrhea and constipation were also reported more often with the drug than placebo.

“Tirzepatide delivered impressive body weight reductions in SURMOUNT-1, which could represent an important step forward for helping the patient and physician partnership treat this complex disease,” said study investigator Louis J. Aronne, MD, director of the Comprehensive Weight Control Center and the Sanford I. Weill Professor of Metabolic Research at Weill Cornell Medicine, New York, in a press release.

Further studies are ongoing for tirzepatide as a potential treatment for obesity or overweight, according to the Lilly statement. SURMOUNT is a phase 3 global clinical development program for tirzepatide that began in late 2019 with over 5,000 people with obesity or overweight across six clinical trials. Results from SURMOUNT-2, SURMOUNT-3, and SURMOUNT-4 are expected in 2023.

Tirzepatide is also being studied as a potential treatment for nonalcoholic fatty liver disease and heart failure with preserved ejection fraction. Studies of tirzepatide in obstructive sleep apnea and of morbidity/mortality in obesity are also planned.

Dr. Aronne is cofounder, chief scientific advisor, and a member of the board of directors for Intellihealth. He is also a paid scientific advisory board member for Eli Lilly. Dr. Freedhoff has served or is serving as a director, officer, partner, employee, adviser, consultant, or trustee for the Bariatric Medical Institute and Constant Health and has received a research grant from Novo Nordisk.

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

Heart failure with preserved ejection fraction (HFpEF) is common in elderly adults with type 2 diabetes (T2D), and these individuals are at high risk for frailty and cognitive impairment. Empagliflozin has been shown to reduce cardiovascular death or hospitalization for heart failure in individuals with HFpEF with or without diabetes, but little is known about the impact of empagliflozin on cognition in patients with diabetes and HFpEF. In a prospective observation study of 162 frail older adults with T2D and HFpEF, Mone and colleagues reported that after receiving empagliflozin for 1 month, there was a significant improvement in the Montreal Cognitive Assessment score, but no improvement was seen with metformin or insulin. Although the study was limited by its observational design, small sample size, and short follow-up, it indicates that improved cognition may be another unexpected benefit of empagliflozin in patients with HFpEF.

The Action to Control Cardiovascular Risk in Diabetes (ACCORD) study continues to provide valuable information for the management of T2D. ACCORD Lipid had previously shown that fenofibrate vs. placebo added to simvastatin did not reduce major atherosclerotic cardiovascular events in about 5500 patients with T2D who were at high risk for cardiovascular disease. Ferreira and colleagues have now reported that fenofibrate in ACCORD Lipid reduced hospitalization for heart failure or cardiovascular death by 18%, with the benefit predominantly in those treated with standard glucose-lowering therapy. This analysis was done post hoc and is hypothesis-generating for fenofibrate reducing HF-related events. The soon to be completed PROMINENT study of pemafibrate includes a secondary composite cardiovascular outcome with hospitalization for heart failure as a component, so more information regarding the impact of fibrates on heart failure will be available soon.

Diabetes is associated with a threefold greater risk for stroke and microvascular disease. In another analysis of ACCORD, Kaze and colleagues reported that a higher urine albumin‐to‐creatinine ratio and a lower estimated glomerular filtration rate were each independently associated with an increased risk for stroke. Although further adequately powered studies are required, this analysis suggests that prevention of kidney disease and its progression may help mitigate the risk for stroke in people with T2D.

People with severe mental illness (SMI), such as schizophrenia, bipolar disorder, or depression, are at increased risk for T2D, but it is unknown whether they are more likely to develop the complications of diabetes. Scheuer and colleagues published data from a large nationwide registry in Denmark. They found that, compared with people without SMI, people with SMI were more likely to develop nephropathy or cardiovascular disease, have an amputation, and that the nephropathy and cardiovascular disease occurred at younger ages in those with SMI. Although there are limitations with registry data, this study supports diabetes guidelines that recommend cardiorenal protection with sodium-glucose cotransporter 2 (SGLT2) inhibitors and glucagon-like peptide 1 (GLP-1) receptor agonists in patients with T2D who are at high risk for nephropathy progression and cardiovascular disease. Because this study suggests that SMI along with T2D confers greater risk for nephropathy and cardiovascular disease at younger ages, perhaps we should consider these cardiorenal protective agents early on in persons with T2D and SMI.

Heart failure with preserved ejection fraction (HFpEF) is common in elderly adults with type 2 diabetes (T2D), and these individuals are at high risk for frailty and cognitive impairment. Empagliflozin has been shown to reduce cardiovascular death or hospitalization for heart failure in individuals with HFpEF with or without diabetes, but little is known about the impact of empagliflozin on cognition in patients with diabetes and HFpEF. In a prospective observation study of 162 frail older adults with T2D and HFpEF, Mone and colleagues reported that after receiving empagliflozin for 1 month, there was a significant improvement in the Montreal Cognitive Assessment score, but no improvement was seen with metformin or insulin. Although the study was limited by its observational design, small sample size, and short follow-up, it indicates that improved cognition may be another unexpected benefit of empagliflozin in patients with HFpEF.

The Action to Control Cardiovascular Risk in Diabetes (ACCORD) study continues to provide valuable information for the management of T2D. ACCORD Lipid had previously shown that fenofibrate vs. placebo added to simvastatin did not reduce major atherosclerotic cardiovascular events in about 5500 patients with T2D who were at high risk for cardiovascular disease. Ferreira and colleagues have now reported that fenofibrate in ACCORD Lipid reduced hospitalization for heart failure or cardiovascular death by 18%, with the benefit predominantly in those treated with standard glucose-lowering therapy. This analysis was done post hoc and is hypothesis-generating for fenofibrate reducing HF-related events. The soon to be completed PROMINENT study of pemafibrate includes a secondary composite cardiovascular outcome with hospitalization for heart failure as a component, so more information regarding the impact of fibrates on heart failure will be available soon.

Diabetes is associated with a threefold greater risk for stroke and microvascular disease. In another analysis of ACCORD, Kaze and colleagues reported that a higher urine albumin‐to‐creatinine ratio and a lower estimated glomerular filtration rate were each independently associated with an increased risk for stroke. Although further adequately powered studies are required, this analysis suggests that prevention of kidney disease and its progression may help mitigate the risk for stroke in people with T2D.

People with severe mental illness (SMI), such as schizophrenia, bipolar disorder, or depression, are at increased risk for T2D, but it is unknown whether they are more likely to develop the complications of diabetes. Scheuer and colleagues published data from a large nationwide registry in Denmark. They found that, compared with people without SMI, people with SMI were more likely to develop nephropathy or cardiovascular disease, have an amputation, and that the nephropathy and cardiovascular disease occurred at younger ages in those with SMI. Although there are limitations with registry data, this study supports diabetes guidelines that recommend cardiorenal protection with sodium-glucose cotransporter 2 (SGLT2) inhibitors and glucagon-like peptide 1 (GLP-1) receptor agonists in patients with T2D who are at high risk for nephropathy progression and cardiovascular disease. Because this study suggests that SMI along with T2D confers greater risk for nephropathy and cardiovascular disease at younger ages, perhaps we should consider these cardiorenal protective agents early on in persons with T2D and SMI.

Heart failure with preserved ejection fraction (HFpEF) is common in elderly adults with type 2 diabetes (T2D), and these individuals are at high risk for frailty and cognitive impairment. Empagliflozin has been shown to reduce cardiovascular death or hospitalization for heart failure in individuals with HFpEF with or without diabetes, but little is known about the impact of empagliflozin on cognition in patients with diabetes and HFpEF. In a prospective observation study of 162 frail older adults with T2D and HFpEF, Mone and colleagues reported that after receiving empagliflozin for 1 month, there was a significant improvement in the Montreal Cognitive Assessment score, but no improvement was seen with metformin or insulin. Although the study was limited by its observational design, small sample size, and short follow-up, it indicates that improved cognition may be another unexpected benefit of empagliflozin in patients with HFpEF.

The Action to Control Cardiovascular Risk in Diabetes (ACCORD) study continues to provide valuable information for the management of T2D. ACCORD Lipid had previously shown that fenofibrate vs. placebo added to simvastatin did not reduce major atherosclerotic cardiovascular events in about 5500 patients with T2D who were at high risk for cardiovascular disease. Ferreira and colleagues have now reported that fenofibrate in ACCORD Lipid reduced hospitalization for heart failure or cardiovascular death by 18%, with the benefit predominantly in those treated with standard glucose-lowering therapy. This analysis was done post hoc and is hypothesis-generating for fenofibrate reducing HF-related events. The soon to be completed PROMINENT study of pemafibrate includes a secondary composite cardiovascular outcome with hospitalization for heart failure as a component, so more information regarding the impact of fibrates on heart failure will be available soon.

Diabetes is associated with a threefold greater risk for stroke and microvascular disease. In another analysis of ACCORD, Kaze and colleagues reported that a higher urine albumin‐to‐creatinine ratio and a lower estimated glomerular filtration rate were each independently associated with an increased risk for stroke. Although further adequately powered studies are required, this analysis suggests that prevention of kidney disease and its progression may help mitigate the risk for stroke in people with T2D.

People with severe mental illness (SMI), such as schizophrenia, bipolar disorder, or depression, are at increased risk for T2D, but it is unknown whether they are more likely to develop the complications of diabetes. Scheuer and colleagues published data from a large nationwide registry in Denmark. They found that, compared with people without SMI, people with SMI were more likely to develop nephropathy or cardiovascular disease, have an amputation, and that the nephropathy and cardiovascular disease occurred at younger ages in those with SMI. Although there are limitations with registry data, this study supports diabetes guidelines that recommend cardiorenal protection with sodium-glucose cotransporter 2 (SGLT2) inhibitors and glucagon-like peptide 1 (GLP-1) receptor agonists in patients with T2D who are at high risk for nephropathy progression and cardiovascular disease. Because this study suggests that SMI along with T2D confers greater risk for nephropathy and cardiovascular disease at younger ages, perhaps we should consider these cardiorenal protective agents early on in persons with T2D and SMI.

Key takeaways

Metformin may be associated with a lower risk of neurodegenerative disease, in particular when the drug has been prescribed for at least 4 years, according to a systematic review and meta-analysis of longitudinal data.

However, the heterogeneity between the available studies and the potential heterogeneity of diagnostic criteria may mean that validation studies are needed.
 

Why is this important?

Data suggest that metformin, the most commonly prescribed antidiabetic drug, may be neuroprotective, while diabetes is associated with an excess risk of neurodegenerative disease. Results of studies conducted specifically to investigate the benefit of the antidiabetic drug on cognitive prognosis have been unclear. A meta-analysis was published in 2020, but it included cross-sectional and case-control studies. Given the long observation period needed to measure such an outcome, only cohort studies conducted over several years can provide reliable results. This new meta-analysis attempts to circumvent this limitation.

Methods

The meta-analysis was conducted using studies published up to March 2021 that met the inclusion criteria (population-based cohort studies published in English in which the administration of metformin and associated risk of exposure were reported).

Main results

Twelve studies were included in this analysis, of which eight were retrospective and 11 were considered to be of good methodologic quality. In total, 194,792 patients were included.

Pooled data showed that the relative risk associated with onset of neurodegenerative disease was 0.77 (95% CI, 0.67-0.88) for patients with diabetes taking metformin versus those not taking metformin. However, heterogeneity between studies was high (I2; 78.8%; P < .001).

The effect was greater with longer metformin use, with an RR of 0.29 (95% CI, 0.13-0.44) for those who took metformin for 4 years or more. Similarly, the studies conducted in Asian countries versus other locations suggested an added benefit for this population (RR, 0.69; 95% CI, 0.64-0.74).

Sensitivity analyses confirmed these results, and subtype analyses showed no difference according to the nature of the neurodegenerative disease.

A version of this article first appeared on Univadis.

Key takeaways

Metformin may be associated with a lower risk of neurodegenerative disease, in particular when the drug has been prescribed for at least 4 years, according to a systematic review and meta-analysis of longitudinal data.

However, the heterogeneity between the available studies and the potential heterogeneity of diagnostic criteria may mean that validation studies are needed.
 

Why is this important?

Data suggest that metformin, the most commonly prescribed antidiabetic drug, may be neuroprotective, while diabetes is associated with an excess risk of neurodegenerative disease. Results of studies conducted specifically to investigate the benefit of the antidiabetic drug on cognitive prognosis have been unclear. A meta-analysis was published in 2020, but it included cross-sectional and case-control studies. Given the long observation period needed to measure such an outcome, only cohort studies conducted over several years can provide reliable results. This new meta-analysis attempts to circumvent this limitation.

Methods

The meta-analysis was conducted using studies published up to March 2021 that met the inclusion criteria (population-based cohort studies published in English in which the administration of metformin and associated risk of exposure were reported).

Main results

Twelve studies were included in this analysis, of which eight were retrospective and 11 were considered to be of good methodologic quality. In total, 194,792 patients were included.

Pooled data showed that the relative risk associated with onset of neurodegenerative disease was 0.77 (95% CI, 0.67-0.88) for patients with diabetes taking metformin versus those not taking metformin. However, heterogeneity between studies was high (I2; 78.8%; P < .001).

The effect was greater with longer metformin use, with an RR of 0.29 (95% CI, 0.13-0.44) for those who took metformin for 4 years or more. Similarly, the studies conducted in Asian countries versus other locations suggested an added benefit for this population (RR, 0.69; 95% CI, 0.64-0.74).

Sensitivity analyses confirmed these results, and subtype analyses showed no difference according to the nature of the neurodegenerative disease.

A version of this article first appeared on Univadis.

Key takeaways

Metformin may be associated with a lower risk of neurodegenerative disease, in particular when the drug has been prescribed for at least 4 years, according to a systematic review and meta-analysis of longitudinal data.

However, the heterogeneity between the available studies and the potential heterogeneity of diagnostic criteria may mean that validation studies are needed.
 

Why is this important?

Data suggest that metformin, the most commonly prescribed antidiabetic drug, may be neuroprotective, while diabetes is associated with an excess risk of neurodegenerative disease. Results of studies conducted specifically to investigate the benefit of the antidiabetic drug on cognitive prognosis have been unclear. A meta-analysis was published in 2020, but it included cross-sectional and case-control studies. Given the long observation period needed to measure such an outcome, only cohort studies conducted over several years can provide reliable results. This new meta-analysis attempts to circumvent this limitation.

Methods

The meta-analysis was conducted using studies published up to March 2021 that met the inclusion criteria (population-based cohort studies published in English in which the administration of metformin and associated risk of exposure were reported).

Main results

Twelve studies were included in this analysis, of which eight were retrospective and 11 were considered to be of good methodologic quality. In total, 194,792 patients were included.

Pooled data showed that the relative risk associated with onset of neurodegenerative disease was 0.77 (95% CI, 0.67-0.88) for patients with diabetes taking metformin versus those not taking metformin. However, heterogeneity between studies was high (I2; 78.8%; P < .001).

The effect was greater with longer metformin use, with an RR of 0.29 (95% CI, 0.13-0.44) for those who took metformin for 4 years or more. Similarly, the studies conducted in Asian countries versus other locations suggested an added benefit for this population (RR, 0.69; 95% CI, 0.64-0.74).

Sensitivity analyses confirmed these results, and subtype analyses showed no difference according to the nature of the neurodegenerative disease.

A version of this article first appeared on Univadis.