TBD Meeting (4154-21)

A nationwide, retrospective, case-control study of older adults in Denmark suggests that the bisphosphonate alendronate that is widely used to treat osteoporosis may protect against new-onset type 2 diabetes. But these preliminary findings need to be confirmed in a randomized controlled trial, experts said.

The registry study showed that from 2008 to 2018, among individuals in Denmark age 50 and older (with a mean age of 67), those who were taking alendronate were 36% less likely to have new-onset type 2 diabetes than age- and sex-matched individuals who were not taking the drug, after controlling for multiple risk factors.

The results also suggest that longer alendronate use and higher compliance might be more protective.

Rikke Viggers, MD, a PhD student in the department of clinical medicine, Aalborg (Denmark) University, presented the findings during an oral session at the annual meeting of the European Association for the Study of Diabetes.

“Excitingly, our research suggests that alendronate, an inexpensive medicine widely used to treat osteoporosis, may also protect against type 2 diabetes,” Dr. Viggers summarized in a press release issued by the EASD.

“Type 2 diabetes is a serious lifelong condition that can lead to other serious health issues such as stroke, heart disease, blindness, and limb amputation,” she noted, “and anything that prevents or even delays it will also reduce a person’s risk of all these other conditions.”

“We believe that doctors should consider this when prescribing osteoporosis drugs to those with prediabetes or at high risk of type 2 diabetes,” she added.
 

Preliminary results, need for RCT

However, these are preliminary results, Dr. Viggers cautioned during the oral presentation and in an email. “This is a registry-based study,” she stressed, “and we cannot conclude causality.”

“We do not know if this effect [of decreased risk of developing diabetes among people taking alendronate] is ‘real’ and what the mechanisms are.”

“It could be a direct effect on peripheral tissues, for example, muscle and adipose tissue,” Dr. Viggers speculated, “or an indirect effect through bone metabolites that may impact glucose metabolism.”

The group is now conducting a randomized controlled trial in patients with diabetes and osteopenia or osteoporosis to examine the relationship between alendronate and insulin sensitivity, bone indices, and glycemic control.

They also aim to investigate whether alendronate is the optimal antiosteoporotic therapy for patients with type 2 diabetes. Preliminary results suggest that other bisphosphonates have similar effects.

“Alendronate decreases bone turnover and may not be beneficial in healthy bones,” Dr. Viggers noted. “However, as far as I know, potential other side effects have not been tested in healthy bones,” so further research is needed.

Current registry study findings

Glucose homeostasis has been linked to bone metabolism, Dr. Viggers said, and bisphosphonates were associated with increased insulin sensitivity and decreased risk of diabetes risk in two registry studies from Denmark and Taiwan.

The researchers aimed to investigate if the risk of developing type 2 diabetes was altered by previous use of alendronate.

Using data from the national Danish Patient Registry, they identified 163,588 individuals age 50 and older newly diagnosed with type 2 diabetes in 2008-2018.

They matched each patient with three individuals of the same gender and age range who did not have diabetes, for a total of 490,764 controls.

Roughly two-thirds of participants were in their 50s or 60s, a quarter were in their 70s, and 10% were 80 or older. About half of participants were women (45%).

Compared to the patients with new-onset type 2 diabetes, the control participants were healthier: they were less likely to have obesity (6% vs. 17%) and had a lower mean Charlson Comorbidity Index (0.38 vs. 0.88).

Using data from the national Danish Health Service Prescription Registry, the researchers identified individuals who filled prescriptions for alendronate in 2008-2018.

After controlling for heavy smoking, alcohol abuse, obesity, pancreatitis, hyperthyroidism, hypothyroidism, glucocorticoid use, marital status, household income, and Charlson Comorbidity Index, people taking alendronate were less likely to have new-onset diabetes than those not taking this drug (odds ratio, 0.64; 95% confidence interval, 0.62-0.66).

The odds of developing type 2 diabetes were even lower among those who took alendronate for 8 years or more versus never-users (OR, 0.47; 95% CI, 0.40-0.56), after controlling for the same variables.

Session Chair Zhila Semnani-Azad, a PhD student in nutritional science, University of Toronto, wanted to know if the researchers accounted for physical activity and vitamin D use. Dr. Viggers replied that the registries did not have this information.

The study was funded by a Steno Collaborative Project grant from the Novo Nordisk Foundation, Denmark. Dr. Viggers has disclosed receiving a grant from the foundation. Dr. Vega has disclosed serving as a consultant for Johnson & Johnson.

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

A nationwide, retrospective, case-control study of older adults in Denmark suggests that the bisphosphonate alendronate that is widely used to treat osteoporosis may protect against new-onset type 2 diabetes. But these preliminary findings need to be confirmed in a randomized controlled trial, experts said.

The registry study showed that from 2008 to 2018, among individuals in Denmark age 50 and older (with a mean age of 67), those who were taking alendronate were 36% less likely to have new-onset type 2 diabetes than age- and sex-matched individuals who were not taking the drug, after controlling for multiple risk factors.

The results also suggest that longer alendronate use and higher compliance might be more protective.

Rikke Viggers, MD, a PhD student in the department of clinical medicine, Aalborg (Denmark) University, presented the findings during an oral session at the annual meeting of the European Association for the Study of Diabetes.

“Excitingly, our research suggests that alendronate, an inexpensive medicine widely used to treat osteoporosis, may also protect against type 2 diabetes,” Dr. Viggers summarized in a press release issued by the EASD.

“Type 2 diabetes is a serious lifelong condition that can lead to other serious health issues such as stroke, heart disease, blindness, and limb amputation,” she noted, “and anything that prevents or even delays it will also reduce a person’s risk of all these other conditions.”

“We believe that doctors should consider this when prescribing osteoporosis drugs to those with prediabetes or at high risk of type 2 diabetes,” she added.
 

Preliminary results, need for RCT

However, these are preliminary results, Dr. Viggers cautioned during the oral presentation and in an email. “This is a registry-based study,” she stressed, “and we cannot conclude causality.”

“We do not know if this effect [of decreased risk of developing diabetes among people taking alendronate] is ‘real’ and what the mechanisms are.”

“It could be a direct effect on peripheral tissues, for example, muscle and adipose tissue,” Dr. Viggers speculated, “or an indirect effect through bone metabolites that may impact glucose metabolism.”

The group is now conducting a randomized controlled trial in patients with diabetes and osteopenia or osteoporosis to examine the relationship between alendronate and insulin sensitivity, bone indices, and glycemic control.

They also aim to investigate whether alendronate is the optimal antiosteoporotic therapy for patients with type 2 diabetes. Preliminary results suggest that other bisphosphonates have similar effects.

“Alendronate decreases bone turnover and may not be beneficial in healthy bones,” Dr. Viggers noted. “However, as far as I know, potential other side effects have not been tested in healthy bones,” so further research is needed.

Current registry study findings

Glucose homeostasis has been linked to bone metabolism, Dr. Viggers said, and bisphosphonates were associated with increased insulin sensitivity and decreased risk of diabetes risk in two registry studies from Denmark and Taiwan.

The researchers aimed to investigate if the risk of developing type 2 diabetes was altered by previous use of alendronate.

Using data from the national Danish Patient Registry, they identified 163,588 individuals age 50 and older newly diagnosed with type 2 diabetes in 2008-2018.

They matched each patient with three individuals of the same gender and age range who did not have diabetes, for a total of 490,764 controls.

Roughly two-thirds of participants were in their 50s or 60s, a quarter were in their 70s, and 10% were 80 or older. About half of participants were women (45%).

Compared to the patients with new-onset type 2 diabetes, the control participants were healthier: they were less likely to have obesity (6% vs. 17%) and had a lower mean Charlson Comorbidity Index (0.38 vs. 0.88).

Using data from the national Danish Health Service Prescription Registry, the researchers identified individuals who filled prescriptions for alendronate in 2008-2018.

After controlling for heavy smoking, alcohol abuse, obesity, pancreatitis, hyperthyroidism, hypothyroidism, glucocorticoid use, marital status, household income, and Charlson Comorbidity Index, people taking alendronate were less likely to have new-onset diabetes than those not taking this drug (odds ratio, 0.64; 95% confidence interval, 0.62-0.66).

The odds of developing type 2 diabetes were even lower among those who took alendronate for 8 years or more versus never-users (OR, 0.47; 95% CI, 0.40-0.56), after controlling for the same variables.

Session Chair Zhila Semnani-Azad, a PhD student in nutritional science, University of Toronto, wanted to know if the researchers accounted for physical activity and vitamin D use. Dr. Viggers replied that the registries did not have this information.

The study was funded by a Steno Collaborative Project grant from the Novo Nordisk Foundation, Denmark. Dr. Viggers has disclosed receiving a grant from the foundation. Dr. Vega has disclosed serving as a consultant for Johnson & Johnson.

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

A nationwide, retrospective, case-control study of older adults in Denmark suggests that the bisphosphonate alendronate that is widely used to treat osteoporosis may protect against new-onset type 2 diabetes. But these preliminary findings need to be confirmed in a randomized controlled trial, experts said.

The registry study showed that from 2008 to 2018, among individuals in Denmark age 50 and older (with a mean age of 67), those who were taking alendronate were 36% less likely to have new-onset type 2 diabetes than age- and sex-matched individuals who were not taking the drug, after controlling for multiple risk factors.

The results also suggest that longer alendronate use and higher compliance might be more protective.

Rikke Viggers, MD, a PhD student in the department of clinical medicine, Aalborg (Denmark) University, presented the findings during an oral session at the annual meeting of the European Association for the Study of Diabetes.

“Excitingly, our research suggests that alendronate, an inexpensive medicine widely used to treat osteoporosis, may also protect against type 2 diabetes,” Dr. Viggers summarized in a press release issued by the EASD.

“Type 2 diabetes is a serious lifelong condition that can lead to other serious health issues such as stroke, heart disease, blindness, and limb amputation,” she noted, “and anything that prevents or even delays it will also reduce a person’s risk of all these other conditions.”

“We believe that doctors should consider this when prescribing osteoporosis drugs to those with prediabetes or at high risk of type 2 diabetes,” she added.
 

Preliminary results, need for RCT

However, these are preliminary results, Dr. Viggers cautioned during the oral presentation and in an email. “This is a registry-based study,” she stressed, “and we cannot conclude causality.”

“We do not know if this effect [of decreased risk of developing diabetes among people taking alendronate] is ‘real’ and what the mechanisms are.”

“It could be a direct effect on peripheral tissues, for example, muscle and adipose tissue,” Dr. Viggers speculated, “or an indirect effect through bone metabolites that may impact glucose metabolism.”

The group is now conducting a randomized controlled trial in patients with diabetes and osteopenia or osteoporosis to examine the relationship between alendronate and insulin sensitivity, bone indices, and glycemic control.

They also aim to investigate whether alendronate is the optimal antiosteoporotic therapy for patients with type 2 diabetes. Preliminary results suggest that other bisphosphonates have similar effects.

“Alendronate decreases bone turnover and may not be beneficial in healthy bones,” Dr. Viggers noted. “However, as far as I know, potential other side effects have not been tested in healthy bones,” so further research is needed.

Current registry study findings

Glucose homeostasis has been linked to bone metabolism, Dr. Viggers said, and bisphosphonates were associated with increased insulin sensitivity and decreased risk of diabetes risk in two registry studies from Denmark and Taiwan.

The researchers aimed to investigate if the risk of developing type 2 diabetes was altered by previous use of alendronate.

Using data from the national Danish Patient Registry, they identified 163,588 individuals age 50 and older newly diagnosed with type 2 diabetes in 2008-2018.

They matched each patient with three individuals of the same gender and age range who did not have diabetes, for a total of 490,764 controls.

Roughly two-thirds of participants were in their 50s or 60s, a quarter were in their 70s, and 10% were 80 or older. About half of participants were women (45%).

Compared to the patients with new-onset type 2 diabetes, the control participants were healthier: they were less likely to have obesity (6% vs. 17%) and had a lower mean Charlson Comorbidity Index (0.38 vs. 0.88).

Using data from the national Danish Health Service Prescription Registry, the researchers identified individuals who filled prescriptions for alendronate in 2008-2018.

After controlling for heavy smoking, alcohol abuse, obesity, pancreatitis, hyperthyroidism, hypothyroidism, glucocorticoid use, marital status, household income, and Charlson Comorbidity Index, people taking alendronate were less likely to have new-onset diabetes than those not taking this drug (odds ratio, 0.64; 95% confidence interval, 0.62-0.66).

The odds of developing type 2 diabetes were even lower among those who took alendronate for 8 years or more versus never-users (OR, 0.47; 95% CI, 0.40-0.56), after controlling for the same variables.

Session Chair Zhila Semnani-Azad, a PhD student in nutritional science, University of Toronto, wanted to know if the researchers accounted for physical activity and vitamin D use. Dr. Viggers replied that the registries did not have this information.

The study was funded by a Steno Collaborative Project grant from the Novo Nordisk Foundation, Denmark. Dr. Viggers has disclosed receiving a grant from the foundation. Dr. Vega has disclosed serving as a consultant for Johnson & Johnson.

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

Carrying excess weight is associated with an increased risk for certain heart problems even when there are no metabolic disturbances, data from a large French longitudinal study have shown.

In an analysis of almost 3 million people with no prior heart issues, there was a 34% increased risk for developing heart failure and a 33% increased risk for developing atrial fibrillation, it was reported at the annual meeting of the European Association for the Study of Diabetes.

There appeared to be no increase in the risk for heart attacks, ischemic stroke, or cardiovascular death, but the study’s 5-year follow-up period may have been too short to see such differences.

“Our findings highlight the importance of preventing poor metabolic health,” study investigator Laurent Fauchier, MD, PhD, of Centre Hospitalier Universitaire Trousseau (France), observed in a press release that highlighted his EASD presentation.

“Encouraging weight loss in people with obesity, regardless of whether or not they are ‘metabolically healthy,’ will help prevent atrial fibrillation and heart failure,” he suggested.
 

‘Metabolically healthy obesity’ – a misnomer?

‘Metabolically healthy obesity’, or MHO, has been suggested as a term to describe those who have a body mass index greater than 30 mg/m² but no obvious metabolic abnormalities, such as hypertension, dyslipidemia, or diabetes. It’s a term that could cover around a third of people with obesity, but it’s one that not everyone agrees with.

“I don’t feel the label ‘MHO’ is useful,” Frederick Ho, PhD, who is part of team at the University of Glasgow (Scotland) that has done similar research in a U.K. population, said in an interview.

Courtesy Dr. Ho

“Even if – and this is a big if– [people with obesity] are at no higher risk of heart attack or stroke, they are still at higher risk of many other diseases, including heart failure and respiratory diseases. The term ‘healthy’ is sometimes interpreted as no additional health risk at all, which is not true,” Dr. Ho, a research fellow in public health, qualified.
 

Hospital discharge records checked

For their analysis Dr. Fauchier and coinvestigators obtained the medical records of all patients who had been discharged from French hospitals in 2013 and who had at least 5 years’ worth of follow-up data. For inclusion, there had to be no prior history of major cardiovascular events (MACE), which included myocardial infarction (MI), heart failure, and ischemic stroke. Patients who were underweight or malnourished were excluded.

In all, around 2.8 million patients were included for the analysis, of whom 9.5% (n = 272,838) were classified as being obese and the remainder as ‘nonobese’ (n = 2,600,201). Patients were then subdivided according to whether they had diabetes, hypertension, and hyperlipidemia, with those who did not have any of these conditions being classified as ‘metabolically healthy’ and those who had all three as ‘metabolically unhealthy.’

The results, published in Diabetes, Obesity and Metabolism, showed that just under a third (32.8%) of the obese patients were ‘metabolically healthy,’ compared with 72.7% of those who were not obese.

The adjusted hazard ratio (aHR) for experiencing MACE with heart failure was 1.22 comparing those who were obese and ‘metabolically healthy’ with those who were not obese and had no metabolic abnormalities (95% confidence interval, 1.19-1.24). Corresponding aHRs for new-onset heart failure and new-onset atrial fibrillation were 1.34 (CI, 1.31-1.37) and 1.33 (CI, 1.30-1.37). For MI, ischemic stroke, and cardiovascular death aHRs were a respective 0.92 (CI, 0.87-0.98), 0.93 (CI, 0.88-0.98), and 0.99 (CI, 0.93-1.0).
 

Findings consistent with UK Biobank data

While these are observational associations that do not show cause and effect, they do agree with other recently published data from the UK Biobank as Dr. Ho pointed out. These data are “quite interesting and partly consistent with what we found previously, e.g., a higher heart failure risk,” he said.

“We’d expect people with ‘metabolically healthy’ obesity to develop heart attack and stroke a little later than those who were initially metabolically unhealthy,” Dr. Ho noted, observing that the study was very large, but it does has a relatively short period of follow up.

“This is partly because quite a few of those with ‘MHO’ would become metabolically unhealthy after a few years,” Dr. Ho added.

Importantly, he noted, “this study has omitted several important confounders, such as physical activity and diet, which are both strong predictors of MHO and cardiovascular outcomes.”

Naveed Sattar, FMedSci, FRCPath, FRCPGlas, FRSE, professor and honorary consultant in cardiovascular and medical sciences at the University of Glasgow, with whom Dr. Ho has collaborated, gave his thoughts on the topic in an interview.

“Carrying excess weight can give considerable risks for conditions such as heart failure or respiratory disease in ways (not yet fully understood) that are not captured by metabolic health factors,” he said.

“This means that even if someone were to be labeled as living with metabolically healthy obesity, losing weight may still benefit that individual in many ways and reduce their risk of several other important health outcomes. They may also feel better.” 

Furthermore, he added: “Our Glasgow team has therefore strongly cautioned on the use of the term metabolically healthy obesity, and these new data do not change our view.”

Dr. Fauchier has acted as a speaker or consultant for AstraZeneca, Bayer, Bristol Myers Squibb Pfizer, Boehringer Ingelheim, Medtronic, Novartis, and XO. Dr. Ho had no relevant conflicts of interest. Dr. Sattar has received grants and personal fees from Boehringer Ingelheim, and personal fees from Amgen, AstraZeneca, Eli Lilly, Merck Sharp & Dohme, Novartis, Novo Nordisk, Pfizer, and Sanofi.

Carrying excess weight is associated with an increased risk for certain heart problems even when there are no metabolic disturbances, data from a large French longitudinal study have shown.

In an analysis of almost 3 million people with no prior heart issues, there was a 34% increased risk for developing heart failure and a 33% increased risk for developing atrial fibrillation, it was reported at the annual meeting of the European Association for the Study of Diabetes.

There appeared to be no increase in the risk for heart attacks, ischemic stroke, or cardiovascular death, but the study’s 5-year follow-up period may have been too short to see such differences.

“Our findings highlight the importance of preventing poor metabolic health,” study investigator Laurent Fauchier, MD, PhD, of Centre Hospitalier Universitaire Trousseau (France), observed in a press release that highlighted his EASD presentation.

“Encouraging weight loss in people with obesity, regardless of whether or not they are ‘metabolically healthy,’ will help prevent atrial fibrillation and heart failure,” he suggested.
 

‘Metabolically healthy obesity’ – a misnomer?

‘Metabolically healthy obesity’, or MHO, has been suggested as a term to describe those who have a body mass index greater than 30 mg/m² but no obvious metabolic abnormalities, such as hypertension, dyslipidemia, or diabetes. It’s a term that could cover around a third of people with obesity, but it’s one that not everyone agrees with.

“I don’t feel the label ‘MHO’ is useful,” Frederick Ho, PhD, who is part of team at the University of Glasgow (Scotland) that has done similar research in a U.K. population, said in an interview.

Courtesy Dr. Ho

“Even if – and this is a big if– [people with obesity] are at no higher risk of heart attack or stroke, they are still at higher risk of many other diseases, including heart failure and respiratory diseases. The term ‘healthy’ is sometimes interpreted as no additional health risk at all, which is not true,” Dr. Ho, a research fellow in public health, qualified.
 

Hospital discharge records checked

For their analysis Dr. Fauchier and coinvestigators obtained the medical records of all patients who had been discharged from French hospitals in 2013 and who had at least 5 years’ worth of follow-up data. For inclusion, there had to be no prior history of major cardiovascular events (MACE), which included myocardial infarction (MI), heart failure, and ischemic stroke. Patients who were underweight or malnourished were excluded.

In all, around 2.8 million patients were included for the analysis, of whom 9.5% (n = 272,838) were classified as being obese and the remainder as ‘nonobese’ (n = 2,600,201). Patients were then subdivided according to whether they had diabetes, hypertension, and hyperlipidemia, with those who did not have any of these conditions being classified as ‘metabolically healthy’ and those who had all three as ‘metabolically unhealthy.’

The results, published in Diabetes, Obesity and Metabolism, showed that just under a third (32.8%) of the obese patients were ‘metabolically healthy,’ compared with 72.7% of those who were not obese.

The adjusted hazard ratio (aHR) for experiencing MACE with heart failure was 1.22 comparing those who were obese and ‘metabolically healthy’ with those who were not obese and had no metabolic abnormalities (95% confidence interval, 1.19-1.24). Corresponding aHRs for new-onset heart failure and new-onset atrial fibrillation were 1.34 (CI, 1.31-1.37) and 1.33 (CI, 1.30-1.37). For MI, ischemic stroke, and cardiovascular death aHRs were a respective 0.92 (CI, 0.87-0.98), 0.93 (CI, 0.88-0.98), and 0.99 (CI, 0.93-1.0).
 

Findings consistent with UK Biobank data

While these are observational associations that do not show cause and effect, they do agree with other recently published data from the UK Biobank as Dr. Ho pointed out. These data are “quite interesting and partly consistent with what we found previously, e.g., a higher heart failure risk,” he said.

“We’d expect people with ‘metabolically healthy’ obesity to develop heart attack and stroke a little later than those who were initially metabolically unhealthy,” Dr. Ho noted, observing that the study was very large, but it does has a relatively short period of follow up.

“This is partly because quite a few of those with ‘MHO’ would become metabolically unhealthy after a few years,” Dr. Ho added.

Importantly, he noted, “this study has omitted several important confounders, such as physical activity and diet, which are both strong predictors of MHO and cardiovascular outcomes.”

Naveed Sattar, FMedSci, FRCPath, FRCPGlas, FRSE, professor and honorary consultant in cardiovascular and medical sciences at the University of Glasgow, with whom Dr. Ho has collaborated, gave his thoughts on the topic in an interview.

“Carrying excess weight can give considerable risks for conditions such as heart failure or respiratory disease in ways (not yet fully understood) that are not captured by metabolic health factors,” he said.

“This means that even if someone were to be labeled as living with metabolically healthy obesity, losing weight may still benefit that individual in many ways and reduce their risk of several other important health outcomes. They may also feel better.” 

Furthermore, he added: “Our Glasgow team has therefore strongly cautioned on the use of the term metabolically healthy obesity, and these new data do not change our view.”

Dr. Fauchier has acted as a speaker or consultant for AstraZeneca, Bayer, Bristol Myers Squibb Pfizer, Boehringer Ingelheim, Medtronic, Novartis, and XO. Dr. Ho had no relevant conflicts of interest. Dr. Sattar has received grants and personal fees from Boehringer Ingelheim, and personal fees from Amgen, AstraZeneca, Eli Lilly, Merck Sharp & Dohme, Novartis, Novo Nordisk, Pfizer, and Sanofi.

Carrying excess weight is associated with an increased risk for certain heart problems even when there are no metabolic disturbances, data from a large French longitudinal study have shown.

In an analysis of almost 3 million people with no prior heart issues, there was a 34% increased risk for developing heart failure and a 33% increased risk for developing atrial fibrillation, it was reported at the annual meeting of the European Association for the Study of Diabetes.

There appeared to be no increase in the risk for heart attacks, ischemic stroke, or cardiovascular death, but the study’s 5-year follow-up period may have been too short to see such differences.

“Our findings highlight the importance of preventing poor metabolic health,” study investigator Laurent Fauchier, MD, PhD, of Centre Hospitalier Universitaire Trousseau (France), observed in a press release that highlighted his EASD presentation.

“Encouraging weight loss in people with obesity, regardless of whether or not they are ‘metabolically healthy,’ will help prevent atrial fibrillation and heart failure,” he suggested.
 

‘Metabolically healthy obesity’ – a misnomer?

‘Metabolically healthy obesity’, or MHO, has been suggested as a term to describe those who have a body mass index greater than 30 mg/m² but no obvious metabolic abnormalities, such as hypertension, dyslipidemia, or diabetes. It’s a term that could cover around a third of people with obesity, but it’s one that not everyone agrees with.

“I don’t feel the label ‘MHO’ is useful,” Frederick Ho, PhD, who is part of team at the University of Glasgow (Scotland) that has done similar research in a U.K. population, said in an interview.

Courtesy Dr. Ho

“Even if – and this is a big if– [people with obesity] are at no higher risk of heart attack or stroke, they are still at higher risk of many other diseases, including heart failure and respiratory diseases. The term ‘healthy’ is sometimes interpreted as no additional health risk at all, which is not true,” Dr. Ho, a research fellow in public health, qualified.
 

Hospital discharge records checked

For their analysis Dr. Fauchier and coinvestigators obtained the medical records of all patients who had been discharged from French hospitals in 2013 and who had at least 5 years’ worth of follow-up data. For inclusion, there had to be no prior history of major cardiovascular events (MACE), which included myocardial infarction (MI), heart failure, and ischemic stroke. Patients who were underweight or malnourished were excluded.

In all, around 2.8 million patients were included for the analysis, of whom 9.5% (n = 272,838) were classified as being obese and the remainder as ‘nonobese’ (n = 2,600,201). Patients were then subdivided according to whether they had diabetes, hypertension, and hyperlipidemia, with those who did not have any of these conditions being classified as ‘metabolically healthy’ and those who had all three as ‘metabolically unhealthy.’

The results, published in Diabetes, Obesity and Metabolism, showed that just under a third (32.8%) of the obese patients were ‘metabolically healthy,’ compared with 72.7% of those who were not obese.

The adjusted hazard ratio (aHR) for experiencing MACE with heart failure was 1.22 comparing those who were obese and ‘metabolically healthy’ with those who were not obese and had no metabolic abnormalities (95% confidence interval, 1.19-1.24). Corresponding aHRs for new-onset heart failure and new-onset atrial fibrillation were 1.34 (CI, 1.31-1.37) and 1.33 (CI, 1.30-1.37). For MI, ischemic stroke, and cardiovascular death aHRs were a respective 0.92 (CI, 0.87-0.98), 0.93 (CI, 0.88-0.98), and 0.99 (CI, 0.93-1.0).
 

Findings consistent with UK Biobank data

While these are observational associations that do not show cause and effect, they do agree with other recently published data from the UK Biobank as Dr. Ho pointed out. These data are “quite interesting and partly consistent with what we found previously, e.g., a higher heart failure risk,” he said.

“We’d expect people with ‘metabolically healthy’ obesity to develop heart attack and stroke a little later than those who were initially metabolically unhealthy,” Dr. Ho noted, observing that the study was very large, but it does has a relatively short period of follow up.

“This is partly because quite a few of those with ‘MHO’ would become metabolically unhealthy after a few years,” Dr. Ho added.

Importantly, he noted, “this study has omitted several important confounders, such as physical activity and diet, which are both strong predictors of MHO and cardiovascular outcomes.”

Naveed Sattar, FMedSci, FRCPath, FRCPGlas, FRSE, professor and honorary consultant in cardiovascular and medical sciences at the University of Glasgow, with whom Dr. Ho has collaborated, gave his thoughts on the topic in an interview.

“Carrying excess weight can give considerable risks for conditions such as heart failure or respiratory disease in ways (not yet fully understood) that are not captured by metabolic health factors,” he said.

“This means that even if someone were to be labeled as living with metabolically healthy obesity, losing weight may still benefit that individual in many ways and reduce their risk of several other important health outcomes. They may also feel better.” 

Furthermore, he added: “Our Glasgow team has therefore strongly cautioned on the use of the term metabolically healthy obesity, and these new data do not change our view.”

Dr. Fauchier has acted as a speaker or consultant for AstraZeneca, Bayer, Bristol Myers Squibb Pfizer, Boehringer Ingelheim, Medtronic, Novartis, and XO. Dr. Ho had no relevant conflicts of interest. Dr. Sattar has received grants and personal fees from Boehringer Ingelheim, and personal fees from Amgen, AstraZeneca, Eli Lilly, Merck Sharp & Dohme, Novartis, Novo Nordisk, Pfizer, and Sanofi.

Both high C-reactive protein (CRP) and older age predict mortality from COVID-19 in patients with diabetes, new research suggests.

The data, from the retrospective ACCREDIT cohort study, were presented at the virtual annual meeting of the European Association for the Study of Diabetes (EASD 2021) by Daniel Kevin Llanera, MD.

The combination of older age and high levels of the inflammatory marker CRP were linked to a tripled risk for death by day 7 after hospitalization for COVID-19 among people with diabetes. But, in contrast to other studies, recent A1c and body mass index did not predict COVID-19 outcomes.

“Both of these variables are easily available upon admission to hospital,” Dr. Llanera, who now works at Imperial College, London, said in an EASD press release.

“This means we can easily identify patients early on in their hospital stay who will likely require more aggressive interventions to try and improve survival.”

“It makes sense that CRP and age are important,” said Simon Heller, MB BChir, DM, of the University of Sheffield, England. “It may be that diabetes alone overwhelmed the additional effects of obesity and A1c.

“Certainly in other studies, age was the overwhelming bad prognostic sign among people with diabetes, and perhaps long-term diabetes has effects on the immune system which we haven’t yet identified.”
 

Kidney disease in younger patients also linked to poorer outcomes

The study, conducted when Dr. Llanera worked for the Countess of Chester NHS Foundation Trust, involved 1,004 patients with diabetes admitted with COVID-19 to seven hospitals in northwest England from Jan. 1 through June 30, 2020. The patients were a mean age of 74.1 years, 60.7% were male, and 45% were in the most deprived quintile based on the U.K. government deprivation index. Overall, 56.2% had macrovascular complications and 49.6% had microvascular complications.

They had a median BMI of 27.6 kg/m², which is lower than that reported in previous studies and might explain the difference, Dr. Llanera noted.

The primary outcome, death within 7 days of admission, occurred in 24%. By day 30, 33% had died. These rates are higher than the rate found in previous studies, possibly because of greater socioeconomic deprivation and older age of the population, Dr. Llanera speculated.

A total of 7.5% of patients received intensive care by day 7 and 9.8% required intravenous insulin infusions.

On univariate analysis, insulin infusion was found to be protective, with those receiving it half as likely to die as those who didn’t need IV insulin (odds ratio [OR], 0.5).

In contrast, chronic kidney disease in people younger than 70 years increased the risk of death more than twofold (OR, 2.74), as did type 2 diabetes compared with other diabetes types (OR, 2.52).

As in previous studies, use of angiotensin-converting enzyme inhibitors and angiotensin II receptor blockers were not associated with COVID-19 outcomes, nor was the presence of diabetes-related complications.

In multivariate analysis, CRP and age emerged as the most significant predictors of the primary outcome, with those deemed high risk by a logistic regression model having an OR of 3.44 for death by day 7 compared with those at lower risk based on the two factors.

Data for glycemic control during the time of hospitalization weren’t available for this study, Dr. Llanera said in response to a question.

“We didn’t look into glycemic control during admission, just at entry, so I can’t answer whether strict glucose control is of benefit. I think it’s worth exploring further whether the use of IV insulin may be of benefit.”

Dr. Llanera also pointed out that people with diabetic kidney disease are in a chronic proinflammatory state and have immune dysregulation, thus potentially hindering their ability to “fight off” the virus.

“In addition, ACE2 receptors are upregulated in the kidneys of patients with diabetic kidney disease. These are molecules that facilitate entry of SARS-CoV-2 into the cells. This may lead to direct attack of the kidneys by the virus, possibly leading to worse overall outcomes,” he said.

Dr. Llanera has reported no relevant financial relationships. Dr. Heller has reported serving as consultant or speaker for Novo Nordisk, Eli Lilly, Sanofi Aventis, Mannkind, Zealand, MSD, and Boehringer Ingelheim.

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

Both high C-reactive protein (CRP) and older age predict mortality from COVID-19 in patients with diabetes, new research suggests.

The data, from the retrospective ACCREDIT cohort study, were presented at the virtual annual meeting of the European Association for the Study of Diabetes (EASD 2021) by Daniel Kevin Llanera, MD.

The combination of older age and high levels of the inflammatory marker CRP were linked to a tripled risk for death by day 7 after hospitalization for COVID-19 among people with diabetes. But, in contrast to other studies, recent A1c and body mass index did not predict COVID-19 outcomes.

“Both of these variables are easily available upon admission to hospital,” Dr. Llanera, who now works at Imperial College, London, said in an EASD press release.

“This means we can easily identify patients early on in their hospital stay who will likely require more aggressive interventions to try and improve survival.”

“It makes sense that CRP and age are important,” said Simon Heller, MB BChir, DM, of the University of Sheffield, England. “It may be that diabetes alone overwhelmed the additional effects of obesity and A1c.

“Certainly in other studies, age was the overwhelming bad prognostic sign among people with diabetes, and perhaps long-term diabetes has effects on the immune system which we haven’t yet identified.”
 

Kidney disease in younger patients also linked to poorer outcomes

The study, conducted when Dr. Llanera worked for the Countess of Chester NHS Foundation Trust, involved 1,004 patients with diabetes admitted with COVID-19 to seven hospitals in northwest England from Jan. 1 through June 30, 2020. The patients were a mean age of 74.1 years, 60.7% were male, and 45% were in the most deprived quintile based on the U.K. government deprivation index. Overall, 56.2% had macrovascular complications and 49.6% had microvascular complications.

They had a median BMI of 27.6 kg/m², which is lower than that reported in previous studies and might explain the difference, Dr. Llanera noted.

The primary outcome, death within 7 days of admission, occurred in 24%. By day 30, 33% had died. These rates are higher than the rate found in previous studies, possibly because of greater socioeconomic deprivation and older age of the population, Dr. Llanera speculated.

A total of 7.5% of patients received intensive care by day 7 and 9.8% required intravenous insulin infusions.

On univariate analysis, insulin infusion was found to be protective, with those receiving it half as likely to die as those who didn’t need IV insulin (odds ratio [OR], 0.5).

In contrast, chronic kidney disease in people younger than 70 years increased the risk of death more than twofold (OR, 2.74), as did type 2 diabetes compared with other diabetes types (OR, 2.52).

As in previous studies, use of angiotensin-converting enzyme inhibitors and angiotensin II receptor blockers were not associated with COVID-19 outcomes, nor was the presence of diabetes-related complications.

In multivariate analysis, CRP and age emerged as the most significant predictors of the primary outcome, with those deemed high risk by a logistic regression model having an OR of 3.44 for death by day 7 compared with those at lower risk based on the two factors.

Data for glycemic control during the time of hospitalization weren’t available for this study, Dr. Llanera said in response to a question.

“We didn’t look into glycemic control during admission, just at entry, so I can’t answer whether strict glucose control is of benefit. I think it’s worth exploring further whether the use of IV insulin may be of benefit.”

Dr. Llanera also pointed out that people with diabetic kidney disease are in a chronic proinflammatory state and have immune dysregulation, thus potentially hindering their ability to “fight off” the virus.

“In addition, ACE2 receptors are upregulated in the kidneys of patients with diabetic kidney disease. These are molecules that facilitate entry of SARS-CoV-2 into the cells. This may lead to direct attack of the kidneys by the virus, possibly leading to worse overall outcomes,” he said.

Dr. Llanera has reported no relevant financial relationships. Dr. Heller has reported serving as consultant or speaker for Novo Nordisk, Eli Lilly, Sanofi Aventis, Mannkind, Zealand, MSD, and Boehringer Ingelheim.

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

Both high C-reactive protein (CRP) and older age predict mortality from COVID-19 in patients with diabetes, new research suggests.

The data, from the retrospective ACCREDIT cohort study, were presented at the virtual annual meeting of the European Association for the Study of Diabetes (EASD 2021) by Daniel Kevin Llanera, MD.

The combination of older age and high levels of the inflammatory marker CRP were linked to a tripled risk for death by day 7 after hospitalization for COVID-19 among people with diabetes. But, in contrast to other studies, recent A1c and body mass index did not predict COVID-19 outcomes.

“Both of these variables are easily available upon admission to hospital,” Dr. Llanera, who now works at Imperial College, London, said in an EASD press release.

“This means we can easily identify patients early on in their hospital stay who will likely require more aggressive interventions to try and improve survival.”

“It makes sense that CRP and age are important,” said Simon Heller, MB BChir, DM, of the University of Sheffield, England. “It may be that diabetes alone overwhelmed the additional effects of obesity and A1c.

“Certainly in other studies, age was the overwhelming bad prognostic sign among people with diabetes, and perhaps long-term diabetes has effects on the immune system which we haven’t yet identified.”
 

Kidney disease in younger patients also linked to poorer outcomes

The study, conducted when Dr. Llanera worked for the Countess of Chester NHS Foundation Trust, involved 1,004 patients with diabetes admitted with COVID-19 to seven hospitals in northwest England from Jan. 1 through June 30, 2020. The patients were a mean age of 74.1 years, 60.7% were male, and 45% were in the most deprived quintile based on the U.K. government deprivation index. Overall, 56.2% had macrovascular complications and 49.6% had microvascular complications.

They had a median BMI of 27.6 kg/m², which is lower than that reported in previous studies and might explain the difference, Dr. Llanera noted.

The primary outcome, death within 7 days of admission, occurred in 24%. By day 30, 33% had died. These rates are higher than the rate found in previous studies, possibly because of greater socioeconomic deprivation and older age of the population, Dr. Llanera speculated.

A total of 7.5% of patients received intensive care by day 7 and 9.8% required intravenous insulin infusions.

On univariate analysis, insulin infusion was found to be protective, with those receiving it half as likely to die as those who didn’t need IV insulin (odds ratio [OR], 0.5).

In contrast, chronic kidney disease in people younger than 70 years increased the risk of death more than twofold (OR, 2.74), as did type 2 diabetes compared with other diabetes types (OR, 2.52).

As in previous studies, use of angiotensin-converting enzyme inhibitors and angiotensin II receptor blockers were not associated with COVID-19 outcomes, nor was the presence of diabetes-related complications.

In multivariate analysis, CRP and age emerged as the most significant predictors of the primary outcome, with those deemed high risk by a logistic regression model having an OR of 3.44 for death by day 7 compared with those at lower risk based on the two factors.

Data for glycemic control during the time of hospitalization weren’t available for this study, Dr. Llanera said in response to a question.

“We didn’t look into glycemic control during admission, just at entry, so I can’t answer whether strict glucose control is of benefit. I think it’s worth exploring further whether the use of IV insulin may be of benefit.”

Dr. Llanera also pointed out that people with diabetic kidney disease are in a chronic proinflammatory state and have immune dysregulation, thus potentially hindering their ability to “fight off” the virus.

“In addition, ACE2 receptors are upregulated in the kidneys of patients with diabetic kidney disease. These are molecules that facilitate entry of SARS-CoV-2 into the cells. This may lead to direct attack of the kidneys by the virus, possibly leading to worse overall outcomes,” he said.

Dr. Llanera has reported no relevant financial relationships. Dr. Heller has reported serving as consultant or speaker for Novo Nordisk, Eli Lilly, Sanofi Aventis, Mannkind, Zealand, MSD, and Boehringer Ingelheim.

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

Among those with type 2 diabetes, women receive some cardioprotective treatments less often than men, according to a post hoc analysis of data from the REWIND trial, conducted in nearly 10,000 adults from 24 countries.

At study entry, significantly fewer women received a statin, at 73%, or daily aspirin, at 44%, compared with men, who had treatment rates of 81% and 58%, respectively, Giulia Ferrannini, MD, reported at the annual meeting of the European Association for the Study of Diabetes.

The data also show that significantly fewer women received treatment with an ACE inhibitor or angiotensin-receptor blocker (ARB), at 80%, than men, at 83%, although the absolute between-group difference was modest. Rates of a fourth metric of appropriate treatment, receipt of antihypertensive medications if systolic blood pressure was at least 130 mm Hg, were nearly identical among women and men.
 

Cardiovascular risk in women “less well managed”

“This is confirmation that women are less well managed than men when it comes to cardiovascular risk, especially if they have [type 2] diabetes,” Dr. Ferrannini said in an interview.

Similar observations have been documented before, including in a report in 2019.

The treatment disparity by sex among the 9901 women and men with type 2 diabetes enrolled in REWIND is particularly striking because in clinical trials “patients are generally better managed than in the real world,” Dr. Ferrannini noted. “Despite this, the pattern of disadvantage to women was still evident,” she added.

“In cardiovascular protection the gender issue is preponderant. Women are less well treated,” she said.

REWIND is the cardiovascular outcomes trial for the once-weekly injectable glucagonlike peptide–1 receptor agonist dulaglutide (Trulicity, Lilly) in patients with type 2 diabetes.

The primary results, reported at the 2019 scientific sessions of the American Diabetes Association and simultaneously published in The Lancet, showed dulaglutide significantly reduced major adverse cardiovascular events (MACE) by 12%, compared with placebo. The study ran at about 300 centers worldwide, including many U.S. and Canadian sites, and 46% of enrolled patients were women.

But despite undertreatment, women had significantly better outcomes in terms of MACE, the primary endpoint, during a median 5.4 years of follow-up compared with men. After adjustment for sex, other baseline characteristics, and study-treatment assignment, women had a significant 27% lower composite rate of nonfatal MI, nonfatal stroke, or death from either cardiovascular or unknown causes, compared with men, said Dr. Ferrannini, a researcher at the Karolinska Institute in Stockholm.

The analysis by sex also showed that women had a significant outcome advantage, compared with men, for three of the four components of the combined MACE outcome: nonfatal MI, cardiovascular death, and all-cause death, as well as for the outcome of hospitalization for heart failure, which was not part of the composite MACE outcome. The only MACE outcome component that showed no significant between-group difference was nonfatal stroke, which had roughly equal incidence rates among women and men.
 

Women had half the prevalence of CVD at baseline

The results also showed that the women with type 2 diabetes enrolled in REWIND had a prevalence of existing cardiovascular disease of 20%, which was half the rate of men at study entry, at 41%. However, the between-sex differences in the primary outcome, as well as each of the individual cardiovascular disease outcomes, didn’t change based on whether or not patients had a history of cardiovascular disease at baseline.

Only one outcome showed a between-sex difference linked to prevalent cardiovascular disease at study entry, the rate of all-cause mortality, which was not significantly different between men and women with a history of cardiovascular disease, but was 39% lower in women compared with men without such a history.

“The good news is that, at baseline and after 2 years, the majority of participants were meeting the relevant treatment targets regardless of sex,” commented Peter Novodvorsky, MUDr, a diabetes researcher at the University of Sheffield (England), who chaired the session during which Dr. Ferrannini presented her findings.
 

A role for geography, or selection bias?

The new analyses did not examine whether the overall pattern of undertreatment of women differed among each of the 24 participating countries, or by region of the world.

“We have to assume that these results reflect current [routine] practice” in the 24 countries that contributed patients to the trial, noted Dr. Novodvorsky.

There is also “the well-known issue of selection bias” in randomized trials. The current findings raise the question of whether the women willing to take part in the trial somehow differed from the men, he suggested.

Dr. Ferrannini added: “Even if we do observe a gender difference in management, if the majority of women with type 2 diabetes are appropriately treated, this ‘restores’ their cardiovascular risk advantage, compared with men, with the exception of stroke.”

The main hypothesis generated by the post hoc analysis of REWIND is that “women with diabetes have better outcomes than men if they are treated properly,” she stressed, noting that this “would have to be tested in a trial designed to ascertain gender differences.”

REWIND was sponsored by Eli Lilly. Dr. Ferrannini has reported no relevant financial relationships.

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

Among those with type 2 diabetes, women receive some cardioprotective treatments less often than men, according to a post hoc analysis of data from the REWIND trial, conducted in nearly 10,000 adults from 24 countries.

At study entry, significantly fewer women received a statin, at 73%, or daily aspirin, at 44%, compared with men, who had treatment rates of 81% and 58%, respectively, Giulia Ferrannini, MD, reported at the annual meeting of the European Association for the Study of Diabetes.

The data also show that significantly fewer women received treatment with an ACE inhibitor or angiotensin-receptor blocker (ARB), at 80%, than men, at 83%, although the absolute between-group difference was modest. Rates of a fourth metric of appropriate treatment, receipt of antihypertensive medications if systolic blood pressure was at least 130 mm Hg, were nearly identical among women and men.
 

Cardiovascular risk in women “less well managed”

“This is confirmation that women are less well managed than men when it comes to cardiovascular risk, especially if they have [type 2] diabetes,” Dr. Ferrannini said in an interview.

Similar observations have been documented before, including in a report in 2019.

The treatment disparity by sex among the 9901 women and men with type 2 diabetes enrolled in REWIND is particularly striking because in clinical trials “patients are generally better managed than in the real world,” Dr. Ferrannini noted. “Despite this, the pattern of disadvantage to women was still evident,” she added.

“In cardiovascular protection the gender issue is preponderant. Women are less well treated,” she said.

REWIND is the cardiovascular outcomes trial for the once-weekly injectable glucagonlike peptide–1 receptor agonist dulaglutide (Trulicity, Lilly) in patients with type 2 diabetes.

The primary results, reported at the 2019 scientific sessions of the American Diabetes Association and simultaneously published in The Lancet, showed dulaglutide significantly reduced major adverse cardiovascular events (MACE) by 12%, compared with placebo. The study ran at about 300 centers worldwide, including many U.S. and Canadian sites, and 46% of enrolled patients were women.

But despite undertreatment, women had significantly better outcomes in terms of MACE, the primary endpoint, during a median 5.4 years of follow-up compared with men. After adjustment for sex, other baseline characteristics, and study-treatment assignment, women had a significant 27% lower composite rate of nonfatal MI, nonfatal stroke, or death from either cardiovascular or unknown causes, compared with men, said Dr. Ferrannini, a researcher at the Karolinska Institute in Stockholm.

The analysis by sex also showed that women had a significant outcome advantage, compared with men, for three of the four components of the combined MACE outcome: nonfatal MI, cardiovascular death, and all-cause death, as well as for the outcome of hospitalization for heart failure, which was not part of the composite MACE outcome. The only MACE outcome component that showed no significant between-group difference was nonfatal stroke, which had roughly equal incidence rates among women and men.
 

Women had half the prevalence of CVD at baseline

The results also showed that the women with type 2 diabetes enrolled in REWIND had a prevalence of existing cardiovascular disease of 20%, which was half the rate of men at study entry, at 41%. However, the between-sex differences in the primary outcome, as well as each of the individual cardiovascular disease outcomes, didn’t change based on whether or not patients had a history of cardiovascular disease at baseline.

Only one outcome showed a between-sex difference linked to prevalent cardiovascular disease at study entry, the rate of all-cause mortality, which was not significantly different between men and women with a history of cardiovascular disease, but was 39% lower in women compared with men without such a history.

“The good news is that, at baseline and after 2 years, the majority of participants were meeting the relevant treatment targets regardless of sex,” commented Peter Novodvorsky, MUDr, a diabetes researcher at the University of Sheffield (England), who chaired the session during which Dr. Ferrannini presented her findings.
 

A role for geography, or selection bias?

The new analyses did not examine whether the overall pattern of undertreatment of women differed among each of the 24 participating countries, or by region of the world.

“We have to assume that these results reflect current [routine] practice” in the 24 countries that contributed patients to the trial, noted Dr. Novodvorsky.

There is also “the well-known issue of selection bias” in randomized trials. The current findings raise the question of whether the women willing to take part in the trial somehow differed from the men, he suggested.

Dr. Ferrannini added: “Even if we do observe a gender difference in management, if the majority of women with type 2 diabetes are appropriately treated, this ‘restores’ their cardiovascular risk advantage, compared with men, with the exception of stroke.”

The main hypothesis generated by the post hoc analysis of REWIND is that “women with diabetes have better outcomes than men if they are treated properly,” she stressed, noting that this “would have to be tested in a trial designed to ascertain gender differences.”

REWIND was sponsored by Eli Lilly. Dr. Ferrannini has reported no relevant financial relationships.

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

Among those with type 2 diabetes, women receive some cardioprotective treatments less often than men, according to a post hoc analysis of data from the REWIND trial, conducted in nearly 10,000 adults from 24 countries.

At study entry, significantly fewer women received a statin, at 73%, or daily aspirin, at 44%, compared with men, who had treatment rates of 81% and 58%, respectively, Giulia Ferrannini, MD, reported at the annual meeting of the European Association for the Study of Diabetes.

The data also show that significantly fewer women received treatment with an ACE inhibitor or angiotensin-receptor blocker (ARB), at 80%, than men, at 83%, although the absolute between-group difference was modest. Rates of a fourth metric of appropriate treatment, receipt of antihypertensive medications if systolic blood pressure was at least 130 mm Hg, were nearly identical among women and men.
 

Cardiovascular risk in women “less well managed”

“This is confirmation that women are less well managed than men when it comes to cardiovascular risk, especially if they have [type 2] diabetes,” Dr. Ferrannini said in an interview.

Similar observations have been documented before, including in a report in 2019.

The treatment disparity by sex among the 9901 women and men with type 2 diabetes enrolled in REWIND is particularly striking because in clinical trials “patients are generally better managed than in the real world,” Dr. Ferrannini noted. “Despite this, the pattern of disadvantage to women was still evident,” she added.

“In cardiovascular protection the gender issue is preponderant. Women are less well treated,” she said.

REWIND is the cardiovascular outcomes trial for the once-weekly injectable glucagonlike peptide–1 receptor agonist dulaglutide (Trulicity, Lilly) in patients with type 2 diabetes.

The primary results, reported at the 2019 scientific sessions of the American Diabetes Association and simultaneously published in The Lancet, showed dulaglutide significantly reduced major adverse cardiovascular events (MACE) by 12%, compared with placebo. The study ran at about 300 centers worldwide, including many U.S. and Canadian sites, and 46% of enrolled patients were women.

But despite undertreatment, women had significantly better outcomes in terms of MACE, the primary endpoint, during a median 5.4 years of follow-up compared with men. After adjustment for sex, other baseline characteristics, and study-treatment assignment, women had a significant 27% lower composite rate of nonfatal MI, nonfatal stroke, or death from either cardiovascular or unknown causes, compared with men, said Dr. Ferrannini, a researcher at the Karolinska Institute in Stockholm.

The analysis by sex also showed that women had a significant outcome advantage, compared with men, for three of the four components of the combined MACE outcome: nonfatal MI, cardiovascular death, and all-cause death, as well as for the outcome of hospitalization for heart failure, which was not part of the composite MACE outcome. The only MACE outcome component that showed no significant between-group difference was nonfatal stroke, which had roughly equal incidence rates among women and men.
 

Women had half the prevalence of CVD at baseline

The results also showed that the women with type 2 diabetes enrolled in REWIND had a prevalence of existing cardiovascular disease of 20%, which was half the rate of men at study entry, at 41%. However, the between-sex differences in the primary outcome, as well as each of the individual cardiovascular disease outcomes, didn’t change based on whether or not patients had a history of cardiovascular disease at baseline.

Only one outcome showed a between-sex difference linked to prevalent cardiovascular disease at study entry, the rate of all-cause mortality, which was not significantly different between men and women with a history of cardiovascular disease, but was 39% lower in women compared with men without such a history.

“The good news is that, at baseline and after 2 years, the majority of participants were meeting the relevant treatment targets regardless of sex,” commented Peter Novodvorsky, MUDr, a diabetes researcher at the University of Sheffield (England), who chaired the session during which Dr. Ferrannini presented her findings.
 

A role for geography, or selection bias?

The new analyses did not examine whether the overall pattern of undertreatment of women differed among each of the 24 participating countries, or by region of the world.

“We have to assume that these results reflect current [routine] practice” in the 24 countries that contributed patients to the trial, noted Dr. Novodvorsky.

There is also “the well-known issue of selection bias” in randomized trials. The current findings raise the question of whether the women willing to take part in the trial somehow differed from the men, he suggested.

Dr. Ferrannini added: “Even if we do observe a gender difference in management, if the majority of women with type 2 diabetes are appropriately treated, this ‘restores’ their cardiovascular risk advantage, compared with men, with the exception of stroke.”

The main hypothesis generated by the post hoc analysis of REWIND is that “women with diabetes have better outcomes than men if they are treated properly,” she stressed, noting that this “would have to be tested in a trial designed to ascertain gender differences.”

REWIND was sponsored by Eli Lilly. Dr. Ferrannini has reported no relevant financial relationships.

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

The annual meeting of the European Association for the Study of Diabetes 2021 will delve into individualized approaches in diabetes management, particularly with regard to tailoring drug therapy for type 2 diabetes and management of type 1 diabetes.  

Sara Freeman/MDedge News

The virtual meeting, taking place Sept. 28 to Oct. 1 in Central European Summer Time, will feature results from TriMASTER (a three-way cross-over trial of precision medicine strategy of second-/third-line therapy in type 2 diabetes), new subgroup analyses from the GRADE (Glycemia Reduction Approaches in Diabetes: A Comparative Effectiveness) study, the final version of a consensus statement on type 1 diabetes management, and new data on the dual incretin agonist tirzepatide, as well as much more.

“I’m a strong believer in personalization. I don’t think the big blockbuster [drugs] will serve the entire community with diabetes. Even in type 1 diabetes, there’s evidence of heterogeneity. ... We need a better way to identify individual needs. I think that’s where we’re going. ... It’s one of the themes of the conference,” EASD President Stefano Del Prato, MD, professor of endocrinology at the University of Pisa (Italy), told this news organization.

He noted that EASD and the American Diabetes Association have recently teamed up with other organizations to form the Precision Medicine in Diabetes Initiative

As would be expected, the meeting will also feature numerous presentations on the COVID-19 pandemic, including studies looking at how people with COVID-19 and diabetes have fared; how the pandemic has affected diabetes care; and the still unclear impact of SARS-CoV-2 on pancreatic beta cells and whether, in some instances, it triggers new-onset diabetes.  
 

New data from previously reported trials

There will be new data from several previously reported trials focusing on specific groups of patients with type 2 diabetes. One is the EMPEROR-Preserved study of empagliflozin (Jardiance) in individuals with heart failure and preserved ejection fraction. Initially presented in August 2021 at the annual congress of the European Society of Cardiology, the new data will focus on patient subpopulations, efficacy endpoints, and safety in patients with and without diabetes. A companion study, EMPEROR-Reduced, in those with heart failure and reduced ejection fraction, was presented at the ESC Congress in August 2020.

New findings will also be presented from the DAPA-CKD study of dapagliflozin (Farxiga) in patients with chronic kidney disease. The study was stopped early in March 2020 because of overwhelming efficacy of the drug in preventing CKD. Now, the data will be analyzed in terms of metabolic, nephrology, and cardiology parameters.

And from FIDELIO-DKD and FIGARO-DKD, trials of the nonsteroidal mineralocorticoid receptor antagonist finerenone (Kerendia), new data will also focus on a variety of subgroups of individuals with type 2 diabetes and chronic kidney disease.

“Our goal is to cover most aspects of what’s happening in the type 2 diabetes field,” EASD Honorary Secretary Mikael Rydén, MD, PhD, professor and senior consultant in endocrinology at the Karolinska Institute and Karolinska University Hospital, Stockholm, said in an interview.

Dr. Rydén, who chairs the meeting’s scientific program committee, added: “We can only focus on so much every year but we try to be active and changing from year to year. I’m convinced that a clinician or translational researcher will definitely have a number of very interesting symposia to follow and learn new things. If you follow all of these things, you will know a lot about what’s cooking in the diabetes world.”
 

Consensus on type 1 diabetes management: Special considerations

Both Dr. Del Prato and Dr. Rydén cited presentation of the new type 1 diabetes ADA/EASD consensus report as among the most clinically important of the conference. Initially presented in draft form at the ADA Scientific Sessions in June 2021, the document aims to move away from routinely applying principles derived from studies of patients with type 2 diabetes to those with type 1 diabetes, an autoimmune disease with unique characteristics.

The final version of the document is expected to include information on goals of therapy, glycemic targets, prevention and management of hypoglycemia and diabetic ketoacidosis, psychosocial care, and special populations, among other issues. It is also expected to include a section dedicated to adjunctive treatments beyond insulin, including metformin, pramlintide, glucagonlike peptide–1 agonists, and sodium-glucose cotransporter 2 inhibitors for certain patients.  

Dr. Del Prato noted, “From a clinical point of view, this is quite an important step that two major organizations came together recommending some strategies for treating type 2 diabetes ... It really deals with a big problem and tries to provide the tools for improving homogenization of the treatment of type 1 diabetes across the different health systems.”

And Dr. Rydén commented: “I think it’s really important to have, since there’s been so much focus on type 2 diabetes for the last few years, and to have the ADA and EASD getting together and actually write this.”

But Dr. Rydén also pointed out that outcomes data are much more conclusive for drugs in type 2 diabetes to inform international guidelines, whereas “this is much more difficult to demonstrate with type 1 diabetes. With a new pump or [continuous glucose monitor (CGM)] you might show a reduction in [hemoglobin] A1c of X percent or X mmol/mol or hypoglycemia events, but it’s much harder to show improvements in hard outcomes like deaths and cardiovascular events. I’m really looking forward to having this presented.”
 

Diabetes in 2021: It’s personal

Several meeting sessions will specifically address precision medicine approaches, including the TriMASTER study, which aims to identify subgroups of patients with type 2 diabetes who respond well or poorly to particular drugs based on clinical characteristics so that treatments can be better targeted to individuals. In total, 600 patients with type 2 diabetes and suboptimal glycemic control with metformin were randomized to a dipeptidyl peptidase–4 inhibitor, an SGLT2 inhibitor, or thiazolidinedione (TZD).

According to Dr. Rydén, “The TriMASTER final results will be interesting. TZDs still have a place. ... You can’t give them to people with heart failure, but I think like a carpenter you have to have many tools in your toolbox. And I still think that there are some individuals who respond well to pioglitazone. [The study findings] could be influential, depending on the results.”

An EASD/ADA symposium entitled “Optimizing diabetes diagnosis, prevention, and care: Is precision medicine the answer?” will offer three distinct perspectives, with one speaker arguing it’s the future of diabetes medicine, another that it isn’t, and a third explaining that “the devil is in the details.”

The Diabetologia symposium will focus on a related concept: The use of artificial intelligence in diabetes research and care, with particular application to glucose control, neuropathy, and wound healing.

And during the 36th Camillo Golgi Lecture, kidney disease expert H.J. Lambers Heerspink, PhD, of the University of Groningen (the Netherlands), will speak about personalizing treatment for patients with type 2 diabetes, arguing that “the mean is meaningless.”
 

Next-generation incretin therapy: Is weight loss the treatment?

New data will continue the buzz from the ADA meeting surrounding tirzepatide, the dual GLP-1 receptor agonist and glucose-dependent insulinotropic polypeptide agent.

A session will add new data from SURPASS-3 CGM, looking at the effect of the drug captured by continuous glucose monitoring in patients with type 2 diabetes; SURPASS-3 MRI, examining the effect of the drug on liver fat content and abdominal adipose tissue; and SURPASS-4, investigating efficacy and safety of tirzepatide once-weekly versus insulin glargine in patients with type 2 diabetes and increased cardiovascular risk.

The drug is notable for its dramatic reductions in both A1c and weight, although questions remain about the incidence of gastrointestinal side effects and effects on long-term cardiovascular and renal outcomes.

Dr. Rydén commented: “Given its effects on A1c and body weight, we would expect a positive result, but one never knows. It’s at least safe, that’s for sure. I think this mode of action is extremely interesting.”

Dr. Del Prato noted that tirzepatide could also “open up a new area of intervention for type 1 diabetes. The initial data were promising. ... It’s worth keeping an eye on.”

A related symposium will address the future of incretin-based treatments overall, while the EASD-Lancet symposium will examine whether the treatment of obesity is the «future» of diabetes treatment.
 

COVID-19, hypoglycemia, bone, and much more

As always, there’s much more on the agenda. Other noteworthy sessions include those addressing hypoglycemia management; a joint EASD/European Society of Endocrinology session on diabetes and bone; a debate about whether women with diabetes are at higher cardiovascular risk than men; and in-hospital management of hyperglycemia. 

A new feature of the meeting will be a daily roundup/wrap-up, where members of the program committee and speakers will summarize the day’s highlights. And another feature, “EASD e-Learning,” has been expanded to include more clinical topics around insulin use, nonalcoholic fatty liver disease, obesity, and neuropathy. 

Overall, Dr. Del Prato said, “it’s a very populated program, with more than 700 presenters, 162 invited symposia speakers, and 53 chairs. It’s covering widely different areas from basic to clinical research. ... It’s a lot of stuff going on.”

Both Dr. Rydén and Dr. Del Prato have disclosures with multiple manufacturers of diabetes-related products.

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

The annual meeting of the European Association for the Study of Diabetes 2021 will delve into individualized approaches in diabetes management, particularly with regard to tailoring drug therapy for type 2 diabetes and management of type 1 diabetes.  

Sara Freeman/MDedge News

The virtual meeting, taking place Sept. 28 to Oct. 1 in Central European Summer Time, will feature results from TriMASTER (a three-way cross-over trial of precision medicine strategy of second-/third-line therapy in type 2 diabetes), new subgroup analyses from the GRADE (Glycemia Reduction Approaches in Diabetes: A Comparative Effectiveness) study, the final version of a consensus statement on type 1 diabetes management, and new data on the dual incretin agonist tirzepatide, as well as much more.

“I’m a strong believer in personalization. I don’t think the big blockbuster [drugs] will serve the entire community with diabetes. Even in type 1 diabetes, there’s evidence of heterogeneity. ... We need a better way to identify individual needs. I think that’s where we’re going. ... It’s one of the themes of the conference,” EASD President Stefano Del Prato, MD, professor of endocrinology at the University of Pisa (Italy), told this news organization.

He noted that EASD and the American Diabetes Association have recently teamed up with other organizations to form the Precision Medicine in Diabetes Initiative

As would be expected, the meeting will also feature numerous presentations on the COVID-19 pandemic, including studies looking at how people with COVID-19 and diabetes have fared; how the pandemic has affected diabetes care; and the still unclear impact of SARS-CoV-2 on pancreatic beta cells and whether, in some instances, it triggers new-onset diabetes.  
 

New data from previously reported trials

There will be new data from several previously reported trials focusing on specific groups of patients with type 2 diabetes. One is the EMPEROR-Preserved study of empagliflozin (Jardiance) in individuals with heart failure and preserved ejection fraction. Initially presented in August 2021 at the annual congress of the European Society of Cardiology, the new data will focus on patient subpopulations, efficacy endpoints, and safety in patients with and without diabetes. A companion study, EMPEROR-Reduced, in those with heart failure and reduced ejection fraction, was presented at the ESC Congress in August 2020.

New findings will also be presented from the DAPA-CKD study of dapagliflozin (Farxiga) in patients with chronic kidney disease. The study was stopped early in March 2020 because of overwhelming efficacy of the drug in preventing CKD. Now, the data will be analyzed in terms of metabolic, nephrology, and cardiology parameters.

And from FIDELIO-DKD and FIGARO-DKD, trials of the nonsteroidal mineralocorticoid receptor antagonist finerenone (Kerendia), new data will also focus on a variety of subgroups of individuals with type 2 diabetes and chronic kidney disease.

“Our goal is to cover most aspects of what’s happening in the type 2 diabetes field,” EASD Honorary Secretary Mikael Rydén, MD, PhD, professor and senior consultant in endocrinology at the Karolinska Institute and Karolinska University Hospital, Stockholm, said in an interview.

Dr. Rydén, who chairs the meeting’s scientific program committee, added: “We can only focus on so much every year but we try to be active and changing from year to year. I’m convinced that a clinician or translational researcher will definitely have a number of very interesting symposia to follow and learn new things. If you follow all of these things, you will know a lot about what’s cooking in the diabetes world.”
 

Consensus on type 1 diabetes management: Special considerations

Both Dr. Del Prato and Dr. Rydén cited presentation of the new type 1 diabetes ADA/EASD consensus report as among the most clinically important of the conference. Initially presented in draft form at the ADA Scientific Sessions in June 2021, the document aims to move away from routinely applying principles derived from studies of patients with type 2 diabetes to those with type 1 diabetes, an autoimmune disease with unique characteristics.

The final version of the document is expected to include information on goals of therapy, glycemic targets, prevention and management of hypoglycemia and diabetic ketoacidosis, psychosocial care, and special populations, among other issues. It is also expected to include a section dedicated to adjunctive treatments beyond insulin, including metformin, pramlintide, glucagonlike peptide–1 agonists, and sodium-glucose cotransporter 2 inhibitors for certain patients.  

Dr. Del Prato noted, “From a clinical point of view, this is quite an important step that two major organizations came together recommending some strategies for treating type 2 diabetes ... It really deals with a big problem and tries to provide the tools for improving homogenization of the treatment of type 1 diabetes across the different health systems.”

And Dr. Rydén commented: “I think it’s really important to have, since there’s been so much focus on type 2 diabetes for the last few years, and to have the ADA and EASD getting together and actually write this.”

But Dr. Rydén also pointed out that outcomes data are much more conclusive for drugs in type 2 diabetes to inform international guidelines, whereas “this is much more difficult to demonstrate with type 1 diabetes. With a new pump or [continuous glucose monitor (CGM)] you might show a reduction in [hemoglobin] A1c of X percent or X mmol/mol or hypoglycemia events, but it’s much harder to show improvements in hard outcomes like deaths and cardiovascular events. I’m really looking forward to having this presented.”
 

Diabetes in 2021: It’s personal

Several meeting sessions will specifically address precision medicine approaches, including the TriMASTER study, which aims to identify subgroups of patients with type 2 diabetes who respond well or poorly to particular drugs based on clinical characteristics so that treatments can be better targeted to individuals. In total, 600 patients with type 2 diabetes and suboptimal glycemic control with metformin were randomized to a dipeptidyl peptidase–4 inhibitor, an SGLT2 inhibitor, or thiazolidinedione (TZD).

According to Dr. Rydén, “The TriMASTER final results will be interesting. TZDs still have a place. ... You can’t give them to people with heart failure, but I think like a carpenter you have to have many tools in your toolbox. And I still think that there are some individuals who respond well to pioglitazone. [The study findings] could be influential, depending on the results.”

An EASD/ADA symposium entitled “Optimizing diabetes diagnosis, prevention, and care: Is precision medicine the answer?” will offer three distinct perspectives, with one speaker arguing it’s the future of diabetes medicine, another that it isn’t, and a third explaining that “the devil is in the details.”

The Diabetologia symposium will focus on a related concept: The use of artificial intelligence in diabetes research and care, with particular application to glucose control, neuropathy, and wound healing.

And during the 36th Camillo Golgi Lecture, kidney disease expert H.J. Lambers Heerspink, PhD, of the University of Groningen (the Netherlands), will speak about personalizing treatment for patients with type 2 diabetes, arguing that “the mean is meaningless.”
 

Next-generation incretin therapy: Is weight loss the treatment?

New data will continue the buzz from the ADA meeting surrounding tirzepatide, the dual GLP-1 receptor agonist and glucose-dependent insulinotropic polypeptide agent.

A session will add new data from SURPASS-3 CGM, looking at the effect of the drug captured by continuous glucose monitoring in patients with type 2 diabetes; SURPASS-3 MRI, examining the effect of the drug on liver fat content and abdominal adipose tissue; and SURPASS-4, investigating efficacy and safety of tirzepatide once-weekly versus insulin glargine in patients with type 2 diabetes and increased cardiovascular risk.

The drug is notable for its dramatic reductions in both A1c and weight, although questions remain about the incidence of gastrointestinal side effects and effects on long-term cardiovascular and renal outcomes.

Dr. Rydén commented: “Given its effects on A1c and body weight, we would expect a positive result, but one never knows. It’s at least safe, that’s for sure. I think this mode of action is extremely interesting.”

Dr. Del Prato noted that tirzepatide could also “open up a new area of intervention for type 1 diabetes. The initial data were promising. ... It’s worth keeping an eye on.”

A related symposium will address the future of incretin-based treatments overall, while the EASD-Lancet symposium will examine whether the treatment of obesity is the «future» of diabetes treatment.
 

COVID-19, hypoglycemia, bone, and much more

As always, there’s much more on the agenda. Other noteworthy sessions include those addressing hypoglycemia management; a joint EASD/European Society of Endocrinology session on diabetes and bone; a debate about whether women with diabetes are at higher cardiovascular risk than men; and in-hospital management of hyperglycemia. 

A new feature of the meeting will be a daily roundup/wrap-up, where members of the program committee and speakers will summarize the day’s highlights. And another feature, “EASD e-Learning,” has been expanded to include more clinical topics around insulin use, nonalcoholic fatty liver disease, obesity, and neuropathy. 

Overall, Dr. Del Prato said, “it’s a very populated program, with more than 700 presenters, 162 invited symposia speakers, and 53 chairs. It’s covering widely different areas from basic to clinical research. ... It’s a lot of stuff going on.”

Both Dr. Rydén and Dr. Del Prato have disclosures with multiple manufacturers of diabetes-related products.

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

The annual meeting of the European Association for the Study of Diabetes 2021 will delve into individualized approaches in diabetes management, particularly with regard to tailoring drug therapy for type 2 diabetes and management of type 1 diabetes.  

Sara Freeman/MDedge News

The virtual meeting, taking place Sept. 28 to Oct. 1 in Central European Summer Time, will feature results from TriMASTER (a three-way cross-over trial of precision medicine strategy of second-/third-line therapy in type 2 diabetes), new subgroup analyses from the GRADE (Glycemia Reduction Approaches in Diabetes: A Comparative Effectiveness) study, the final version of a consensus statement on type 1 diabetes management, and new data on the dual incretin agonist tirzepatide, as well as much more.

“I’m a strong believer in personalization. I don’t think the big blockbuster [drugs] will serve the entire community with diabetes. Even in type 1 diabetes, there’s evidence of heterogeneity. ... We need a better way to identify individual needs. I think that’s where we’re going. ... It’s one of the themes of the conference,” EASD President Stefano Del Prato, MD, professor of endocrinology at the University of Pisa (Italy), told this news organization.

He noted that EASD and the American Diabetes Association have recently teamed up with other organizations to form the Precision Medicine in Diabetes Initiative

As would be expected, the meeting will also feature numerous presentations on the COVID-19 pandemic, including studies looking at how people with COVID-19 and diabetes have fared; how the pandemic has affected diabetes care; and the still unclear impact of SARS-CoV-2 on pancreatic beta cells and whether, in some instances, it triggers new-onset diabetes.  
 

New data from previously reported trials

There will be new data from several previously reported trials focusing on specific groups of patients with type 2 diabetes. One is the EMPEROR-Preserved study of empagliflozin (Jardiance) in individuals with heart failure and preserved ejection fraction. Initially presented in August 2021 at the annual congress of the European Society of Cardiology, the new data will focus on patient subpopulations, efficacy endpoints, and safety in patients with and without diabetes. A companion study, EMPEROR-Reduced, in those with heart failure and reduced ejection fraction, was presented at the ESC Congress in August 2020.

New findings will also be presented from the DAPA-CKD study of dapagliflozin (Farxiga) in patients with chronic kidney disease. The study was stopped early in March 2020 because of overwhelming efficacy of the drug in preventing CKD. Now, the data will be analyzed in terms of metabolic, nephrology, and cardiology parameters.

And from FIDELIO-DKD and FIGARO-DKD, trials of the nonsteroidal mineralocorticoid receptor antagonist finerenone (Kerendia), new data will also focus on a variety of subgroups of individuals with type 2 diabetes and chronic kidney disease.

“Our goal is to cover most aspects of what’s happening in the type 2 diabetes field,” EASD Honorary Secretary Mikael Rydén, MD, PhD, professor and senior consultant in endocrinology at the Karolinska Institute and Karolinska University Hospital, Stockholm, said in an interview.

Dr. Rydén, who chairs the meeting’s scientific program committee, added: “We can only focus on so much every year but we try to be active and changing from year to year. I’m convinced that a clinician or translational researcher will definitely have a number of very interesting symposia to follow and learn new things. If you follow all of these things, you will know a lot about what’s cooking in the diabetes world.”
 

Consensus on type 1 diabetes management: Special considerations

Both Dr. Del Prato and Dr. Rydén cited presentation of the new type 1 diabetes ADA/EASD consensus report as among the most clinically important of the conference. Initially presented in draft form at the ADA Scientific Sessions in June 2021, the document aims to move away from routinely applying principles derived from studies of patients with type 2 diabetes to those with type 1 diabetes, an autoimmune disease with unique characteristics.

The final version of the document is expected to include information on goals of therapy, glycemic targets, prevention and management of hypoglycemia and diabetic ketoacidosis, psychosocial care, and special populations, among other issues. It is also expected to include a section dedicated to adjunctive treatments beyond insulin, including metformin, pramlintide, glucagonlike peptide–1 agonists, and sodium-glucose cotransporter 2 inhibitors for certain patients.  

Dr. Del Prato noted, “From a clinical point of view, this is quite an important step that two major organizations came together recommending some strategies for treating type 2 diabetes ... It really deals with a big problem and tries to provide the tools for improving homogenization of the treatment of type 1 diabetes across the different health systems.”

And Dr. Rydén commented: “I think it’s really important to have, since there’s been so much focus on type 2 diabetes for the last few years, and to have the ADA and EASD getting together and actually write this.”

But Dr. Rydén also pointed out that outcomes data are much more conclusive for drugs in type 2 diabetes to inform international guidelines, whereas “this is much more difficult to demonstrate with type 1 diabetes. With a new pump or [continuous glucose monitor (CGM)] you might show a reduction in [hemoglobin] A1c of X percent or X mmol/mol or hypoglycemia events, but it’s much harder to show improvements in hard outcomes like deaths and cardiovascular events. I’m really looking forward to having this presented.”
 

Diabetes in 2021: It’s personal

Several meeting sessions will specifically address precision medicine approaches, including the TriMASTER study, which aims to identify subgroups of patients with type 2 diabetes who respond well or poorly to particular drugs based on clinical characteristics so that treatments can be better targeted to individuals. In total, 600 patients with type 2 diabetes and suboptimal glycemic control with metformin were randomized to a dipeptidyl peptidase–4 inhibitor, an SGLT2 inhibitor, or thiazolidinedione (TZD).

According to Dr. Rydén, “The TriMASTER final results will be interesting. TZDs still have a place. ... You can’t give them to people with heart failure, but I think like a carpenter you have to have many tools in your toolbox. And I still think that there are some individuals who respond well to pioglitazone. [The study findings] could be influential, depending on the results.”

An EASD/ADA symposium entitled “Optimizing diabetes diagnosis, prevention, and care: Is precision medicine the answer?” will offer three distinct perspectives, with one speaker arguing it’s the future of diabetes medicine, another that it isn’t, and a third explaining that “the devil is in the details.”

The Diabetologia symposium will focus on a related concept: The use of artificial intelligence in diabetes research and care, with particular application to glucose control, neuropathy, and wound healing.

And during the 36th Camillo Golgi Lecture, kidney disease expert H.J. Lambers Heerspink, PhD, of the University of Groningen (the Netherlands), will speak about personalizing treatment for patients with type 2 diabetes, arguing that “the mean is meaningless.”
 

Next-generation incretin therapy: Is weight loss the treatment?

New data will continue the buzz from the ADA meeting surrounding tirzepatide, the dual GLP-1 receptor agonist and glucose-dependent insulinotropic polypeptide agent.

A session will add new data from SURPASS-3 CGM, looking at the effect of the drug captured by continuous glucose monitoring in patients with type 2 diabetes; SURPASS-3 MRI, examining the effect of the drug on liver fat content and abdominal adipose tissue; and SURPASS-4, investigating efficacy and safety of tirzepatide once-weekly versus insulin glargine in patients with type 2 diabetes and increased cardiovascular risk.

The drug is notable for its dramatic reductions in both A1c and weight, although questions remain about the incidence of gastrointestinal side effects and effects on long-term cardiovascular and renal outcomes.

Dr. Rydén commented: “Given its effects on A1c and body weight, we would expect a positive result, but one never knows. It’s at least safe, that’s for sure. I think this mode of action is extremely interesting.”

Dr. Del Prato noted that tirzepatide could also “open up a new area of intervention for type 1 diabetes. The initial data were promising. ... It’s worth keeping an eye on.”

A related symposium will address the future of incretin-based treatments overall, while the EASD-Lancet symposium will examine whether the treatment of obesity is the «future» of diabetes treatment.
 

COVID-19, hypoglycemia, bone, and much more

As always, there’s much more on the agenda. Other noteworthy sessions include those addressing hypoglycemia management; a joint EASD/European Society of Endocrinology session on diabetes and bone; a debate about whether women with diabetes are at higher cardiovascular risk than men; and in-hospital management of hyperglycemia. 

A new feature of the meeting will be a daily roundup/wrap-up, where members of the program committee and speakers will summarize the day’s highlights. And another feature, “EASD e-Learning,” has been expanded to include more clinical topics around insulin use, nonalcoholic fatty liver disease, obesity, and neuropathy. 

Overall, Dr. Del Prato said, “it’s a very populated program, with more than 700 presenters, 162 invited symposia speakers, and 53 chairs. It’s covering widely different areas from basic to clinical research. ... It’s a lot of stuff going on.”

Both Dr. Rydén and Dr. Del Prato have disclosures with multiple manufacturers of diabetes-related products.

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