Type 2 Diabetes ICYMI

SAN FRANCISCO – Significant and rapid weight loss, fueled by a low-calorie diet, seemed to boost long-term diabetes prevention in patients who were prediabetic, a new study finds. And to the surprise of researchers, the results were the same regardless of dietary and exercise interventions more than 3 years after the initial weight loss.

There’s a big limitation, though: About half of the participants who initially lost weight dropped out during the 3-year study, and data about them are not yet available. Still, only 4% of those who completed the study converted to diabetes, compared with expected rates of as much as 16%.

This is a “fantastic success,” co-lead investigator and physiologist, Ian Macdonald, PhD, of the University of Nottingham (England), said in a presentation of the PREVIEW study at the annual scientific sessions of the American Diabetes Association.

The randomized, controlled, multicenter trial recruited 2,223 participants with prediabetes in several European countries and Australia and New Zealand. The participants, of whom about two-thirds were women, were aged 25-70 years (average, 52 years) and had an average body mass index of 35 kg/m².

They were assigned to a 2-month, rapid weight-loss program in which they were limited to no more than 800 calories per day. “The participants were fully briefed on the risks to health associated with prediabetes and on the problems of diabetes itself, and they were highly motivated to take part in the study,” Dr. Macdonald said in an interview after the presentation.

A total of 1,857 participants achieved the required weight loss of at least 8% and were then assigned to one of four interventions: a high-protein, low-glycemic diet (either with moderate- or high-intensity physical activity) or a moderate-protein, moderate-glycemic diet (either with moderate- or high-intensity physical activity).

A total of 962 participants remained in the study for another 34 months until completion, with roughly the same number (235-244) in each of the four intervention groups.

The researchers expected that 16% of those in the moderate-diet group would convert to type 2 diabetes, as would 11% of those in the high-protein, low-glycemic group, Dr. Macdonald said in the presentation.

The researchers, who offered limited statistical detail about the study, did not disclose how many participants in each group actually developed diabetes by 36 months (January 2019). Dr. Macdonald said in the interview that those numbers would not be available until the study has been accepted for publication. He noted, however, that the numbers in the two groups were nearly identical, and the researchers disclosed that the overall number was just 4% (n = 62).

That number is “substantially less than would be predicted,” Dr. Macdonald noted in the presentation, adding that “there is no difference” between the interventions.

He said protein consumption in the high-protein diet was not sustained, probably because of lack of adherence. In contrast, the physical activity in the groups increased significantly at the beginning of the study, he said, and “it did not fall off too badly.”

According to Dr. Macdonald, the prevention of progression to diabetes “was almost certainly because of this large, initial weight loss, which was at least partially and impressively sustained. A high-protein, low-glycemic diet was not superior to a moderate-protein, moderate-glycemic diet in relation to prevention of type 2 diabetes.”

The study was funded by the European Union and various other sources, including national funds, in the participating countries. Dr. Macdonald reported advisory board service with Nestlé Research, European Juice Manufacturers, and Mars.

SAN FRANCISCO – Significant and rapid weight loss, fueled by a low-calorie diet, seemed to boost long-term diabetes prevention in patients who were prediabetic, a new study finds. And to the surprise of researchers, the results were the same regardless of dietary and exercise interventions more than 3 years after the initial weight loss.

There’s a big limitation, though: About half of the participants who initially lost weight dropped out during the 3-year study, and data about them are not yet available. Still, only 4% of those who completed the study converted to diabetes, compared with expected rates of as much as 16%.

This is a “fantastic success,” co-lead investigator and physiologist, Ian Macdonald, PhD, of the University of Nottingham (England), said in a presentation of the PREVIEW study at the annual scientific sessions of the American Diabetes Association.

The randomized, controlled, multicenter trial recruited 2,223 participants with prediabetes in several European countries and Australia and New Zealand. The participants, of whom about two-thirds were women, were aged 25-70 years (average, 52 years) and had an average body mass index of 35 kg/m².

They were assigned to a 2-month, rapid weight-loss program in which they were limited to no more than 800 calories per day. “The participants were fully briefed on the risks to health associated with prediabetes and on the problems of diabetes itself, and they were highly motivated to take part in the study,” Dr. Macdonald said in an interview after the presentation.

A total of 1,857 participants achieved the required weight loss of at least 8% and were then assigned to one of four interventions: a high-protein, low-glycemic diet (either with moderate- or high-intensity physical activity) or a moderate-protein, moderate-glycemic diet (either with moderate- or high-intensity physical activity).

A total of 962 participants remained in the study for another 34 months until completion, with roughly the same number (235-244) in each of the four intervention groups.

The researchers expected that 16% of those in the moderate-diet group would convert to type 2 diabetes, as would 11% of those in the high-protein, low-glycemic group, Dr. Macdonald said in the presentation.

The researchers, who offered limited statistical detail about the study, did not disclose how many participants in each group actually developed diabetes by 36 months (January 2019). Dr. Macdonald said in the interview that those numbers would not be available until the study has been accepted for publication. He noted, however, that the numbers in the two groups were nearly identical, and the researchers disclosed that the overall number was just 4% (n = 62).

That number is “substantially less than would be predicted,” Dr. Macdonald noted in the presentation, adding that “there is no difference” between the interventions.

He said protein consumption in the high-protein diet was not sustained, probably because of lack of adherence. In contrast, the physical activity in the groups increased significantly at the beginning of the study, he said, and “it did not fall off too badly.”

According to Dr. Macdonald, the prevention of progression to diabetes “was almost certainly because of this large, initial weight loss, which was at least partially and impressively sustained. A high-protein, low-glycemic diet was not superior to a moderate-protein, moderate-glycemic diet in relation to prevention of type 2 diabetes.”

The study was funded by the European Union and various other sources, including national funds, in the participating countries. Dr. Macdonald reported advisory board service with Nestlé Research, European Juice Manufacturers, and Mars.

SAN FRANCISCO – Significant and rapid weight loss, fueled by a low-calorie diet, seemed to boost long-term diabetes prevention in patients who were prediabetic, a new study finds. And to the surprise of researchers, the results were the same regardless of dietary and exercise interventions more than 3 years after the initial weight loss.

There’s a big limitation, though: About half of the participants who initially lost weight dropped out during the 3-year study, and data about them are not yet available. Still, only 4% of those who completed the study converted to diabetes, compared with expected rates of as much as 16%.

This is a “fantastic success,” co-lead investigator and physiologist, Ian Macdonald, PhD, of the University of Nottingham (England), said in a presentation of the PREVIEW study at the annual scientific sessions of the American Diabetes Association.

The randomized, controlled, multicenter trial recruited 2,223 participants with prediabetes in several European countries and Australia and New Zealand. The participants, of whom about two-thirds were women, were aged 25-70 years (average, 52 years) and had an average body mass index of 35 kg/m².

They were assigned to a 2-month, rapid weight-loss program in which they were limited to no more than 800 calories per day. “The participants were fully briefed on the risks to health associated with prediabetes and on the problems of diabetes itself, and they were highly motivated to take part in the study,” Dr. Macdonald said in an interview after the presentation.

A total of 1,857 participants achieved the required weight loss of at least 8% and were then assigned to one of four interventions: a high-protein, low-glycemic diet (either with moderate- or high-intensity physical activity) or a moderate-protein, moderate-glycemic diet (either with moderate- or high-intensity physical activity).

A total of 962 participants remained in the study for another 34 months until completion, with roughly the same number (235-244) in each of the four intervention groups.

The researchers expected that 16% of those in the moderate-diet group would convert to type 2 diabetes, as would 11% of those in the high-protein, low-glycemic group, Dr. Macdonald said in the presentation.

The researchers, who offered limited statistical detail about the study, did not disclose how many participants in each group actually developed diabetes by 36 months (January 2019). Dr. Macdonald said in the interview that those numbers would not be available until the study has been accepted for publication. He noted, however, that the numbers in the two groups were nearly identical, and the researchers disclosed that the overall number was just 4% (n = 62).

That number is “substantially less than would be predicted,” Dr. Macdonald noted in the presentation, adding that “there is no difference” between the interventions.

He said protein consumption in the high-protein diet was not sustained, probably because of lack of adherence. In contrast, the physical activity in the groups increased significantly at the beginning of the study, he said, and “it did not fall off too badly.”

According to Dr. Macdonald, the prevention of progression to diabetes “was almost certainly because of this large, initial weight loss, which was at least partially and impressively sustained. A high-protein, low-glycemic diet was not superior to a moderate-protein, moderate-glycemic diet in relation to prevention of type 2 diabetes.”

The study was funded by the European Union and various other sources, including national funds, in the participating countries. Dr. Macdonald reported advisory board service with Nestlé Research, European Juice Manufacturers, and Mars.

SAN FRANCISCO – A large, long-term study is linking yet another glucagon-like peptide–1 receptor agonist diabetes drug to positive cardiovascular outcomes: Patients with type 2 diabetes and heart disease risk factors who took dulaglutide for about 5 years during the REWIND study had a 12% lower risk of major adverse cardiovascular events, compared with those who took placebo.

These new findings on cardiac risk are unusual compared with other newer-generation diabetes drugs, because a high percentage of the participants did not have existing cardiovascular disease. In addition, the study population had a higher percentage of women, compared with previous studies.

“We feel very strongly that the participants were similar to the ... ambulatory patients with type 2 diabetes with cardiovascular risk who are routinely seen in clinical practice,” study coauthor Jeffrey L. Probstfield, MD, of the University of Washington, Seattle, saidin a presentation at the annual scientific sessions of the American Diabetes Association. The findings were published simultaneously in The Lancet (2019 Jun 10. doi: 10.1016/S0140-6736(19)31149-3.

Dulaglutide’s serious adverse-effect profile was similar to that of placebo, the study authors noted, and the drug also showed benefits in renal outcomes, as reported in a separate study (Gerstein HC et al. Lancet. 2019 Jun 10. doi: 10.1016/S0140-6736(19)31150-3.

The Food and Drug Administration has mandated that six glucagon-like peptide–1 receptor agonists (GLP-1 RAs) – albiglutide (Tanzeum), exenatide (Byetta), liraglutide (Victoza), lixisenatide (Adlyxin), semaglutide (Ozempic) and dulaglutide (Trulicity) – undergo testing of cardiovascular outcomes. Dulaglutide is the fourth, following albiglutide, liraglutide, and semaglutide, to show consistent, statistically significant reduction in major adverse cardiovascular events (MACE).

For the double-blind, randomized, placebo-controlled REWIND study, researchers recruited 9,901 participants who were at least 50 years old with type 2 diabetes, a hemoglobin A_1c (HbA_1c) level of 9.5% or less, and a body mass index of more than 23 kg/m². The participants came from 371 sites in 24 countries, including the United States and Canada. More than 80% were taking an angiotensin-converting enzyme inhibitor or angiotensin II receptor blocker, and other blood pressure drugs were also common.

The average mean age was 66 years; 46% of the participants were women, three-quarters were white, and 31% had previous cardiovascular disease. Previous GLP-1 RA studies of this type had markedly lower percentages of women – the other studies comprised 30%-39% women – and included higher percentages of participants with previous cardiovascular disease (73%-100%).

Of the participants in the current study, 4,949 were assigned to receive dulaglutide and 4,952 to receive placebo. They were followed for a median 5.4 years. About 57% never stopped using the drug, and 11% of those in the drug group and 7.5% in the placebo group stopped use because of adverse effects.

In regard to diabetes outcomes, HbA_1c levels fell in the drug group by a mean –0.61% (95% confidence interval, –0.65 to –0.58; P less than .0001), compared with placebo. Their weight decreased by a mean –1.5 kg (95% CI, -1.7 to -1.3; P less than .0001) Systolic blood pressure and LDL cholesterol levels were slightly lower in the drug group, but heart rate was higher.

On the heart front, MACE fell by 12% in the drug group, compared with placebo (hazard ratio, 0.88; 95% CI, 0.79-0.99; P = .026). “The effect of the intervention begins [within] the first year and continued in a progressive, proportional fashion throughout the follow-up period,” said study lead author Hertzel C. Gerstein, MD, of McMaster University and Hamilton Health Sciences, Hamilton, Ont.

However, she called attention to the results that pinpointed higher levels of microvascular-related eye outcomes (HR, 1.24; 95% CI, 0.92-1.68) and fatal myocardial infarction (HR, 1.29; 95% CI, 0.72-2.30) in the dulaglutide group. Both of those outcomes were rare – 171 eye outcomes and 46 fatal myocardial infarctions overall. She also questioned whether the adherence rates would be as high in a real-world setting.

Eli Lilly funded the study. Three of the authors were employees of Eli Lilly, eight reported financial relationships with the company, five reported financial relationships with other firms, and the remaining authors reported no competing interests.

SOURCE: Gerstein HC et al. Lancet. 2019 Jun 10. doi: 10.1016/S0140-6736(19)31149-3.

SAN FRANCISCO – A large, long-term study is linking yet another glucagon-like peptide–1 receptor agonist diabetes drug to positive cardiovascular outcomes: Patients with type 2 diabetes and heart disease risk factors who took dulaglutide for about 5 years during the REWIND study had a 12% lower risk of major adverse cardiovascular events, compared with those who took placebo.

These new findings on cardiac risk are unusual compared with other newer-generation diabetes drugs, because a high percentage of the participants did not have existing cardiovascular disease. In addition, the study population had a higher percentage of women, compared with previous studies.

“We feel very strongly that the participants were similar to the ... ambulatory patients with type 2 diabetes with cardiovascular risk who are routinely seen in clinical practice,” study coauthor Jeffrey L. Probstfield, MD, of the University of Washington, Seattle, saidin a presentation at the annual scientific sessions of the American Diabetes Association. The findings were published simultaneously in The Lancet (2019 Jun 10. doi: 10.1016/S0140-6736(19)31149-3.

Dulaglutide’s serious adverse-effect profile was similar to that of placebo, the study authors noted, and the drug also showed benefits in renal outcomes, as reported in a separate study (Gerstein HC et al. Lancet. 2019 Jun 10. doi: 10.1016/S0140-6736(19)31150-3.

The Food and Drug Administration has mandated that six glucagon-like peptide–1 receptor agonists (GLP-1 RAs) – albiglutide (Tanzeum), exenatide (Byetta), liraglutide (Victoza), lixisenatide (Adlyxin), semaglutide (Ozempic) and dulaglutide (Trulicity) – undergo testing of cardiovascular outcomes. Dulaglutide is the fourth, following albiglutide, liraglutide, and semaglutide, to show consistent, statistically significant reduction in major adverse cardiovascular events (MACE).

For the double-blind, randomized, placebo-controlled REWIND study, researchers recruited 9,901 participants who were at least 50 years old with type 2 diabetes, a hemoglobin A_1c (HbA_1c) level of 9.5% or less, and a body mass index of more than 23 kg/m². The participants came from 371 sites in 24 countries, including the United States and Canada. More than 80% were taking an angiotensin-converting enzyme inhibitor or angiotensin II receptor blocker, and other blood pressure drugs were also common.

The average mean age was 66 years; 46% of the participants were women, three-quarters were white, and 31% had previous cardiovascular disease. Previous GLP-1 RA studies of this type had markedly lower percentages of women – the other studies comprised 30%-39% women – and included higher percentages of participants with previous cardiovascular disease (73%-100%).

Of the participants in the current study, 4,949 were assigned to receive dulaglutide and 4,952 to receive placebo. They were followed for a median 5.4 years. About 57% never stopped using the drug, and 11% of those in the drug group and 7.5% in the placebo group stopped use because of adverse effects.

In regard to diabetes outcomes, HbA_1c levels fell in the drug group by a mean –0.61% (95% confidence interval, –0.65 to –0.58; P less than .0001), compared with placebo. Their weight decreased by a mean –1.5 kg (95% CI, -1.7 to -1.3; P less than .0001) Systolic blood pressure and LDL cholesterol levels were slightly lower in the drug group, but heart rate was higher.

On the heart front, MACE fell by 12% in the drug group, compared with placebo (hazard ratio, 0.88; 95% CI, 0.79-0.99; P = .026). “The effect of the intervention begins [within] the first year and continued in a progressive, proportional fashion throughout the follow-up period,” said study lead author Hertzel C. Gerstein, MD, of McMaster University and Hamilton Health Sciences, Hamilton, Ont.

However, she called attention to the results that pinpointed higher levels of microvascular-related eye outcomes (HR, 1.24; 95% CI, 0.92-1.68) and fatal myocardial infarction (HR, 1.29; 95% CI, 0.72-2.30) in the dulaglutide group. Both of those outcomes were rare – 171 eye outcomes and 46 fatal myocardial infarctions overall. She also questioned whether the adherence rates would be as high in a real-world setting.

Eli Lilly funded the study. Three of the authors were employees of Eli Lilly, eight reported financial relationships with the company, five reported financial relationships with other firms, and the remaining authors reported no competing interests.

SOURCE: Gerstein HC et al. Lancet. 2019 Jun 10. doi: 10.1016/S0140-6736(19)31149-3.

SAN FRANCISCO – A large, long-term study is linking yet another glucagon-like peptide–1 receptor agonist diabetes drug to positive cardiovascular outcomes: Patients with type 2 diabetes and heart disease risk factors who took dulaglutide for about 5 years during the REWIND study had a 12% lower risk of major adverse cardiovascular events, compared with those who took placebo.

These new findings on cardiac risk are unusual compared with other newer-generation diabetes drugs, because a high percentage of the participants did not have existing cardiovascular disease. In addition, the study population had a higher percentage of women, compared with previous studies.

“We feel very strongly that the participants were similar to the ... ambulatory patients with type 2 diabetes with cardiovascular risk who are routinely seen in clinical practice,” study coauthor Jeffrey L. Probstfield, MD, of the University of Washington, Seattle, saidin a presentation at the annual scientific sessions of the American Diabetes Association. The findings were published simultaneously in The Lancet (2019 Jun 10. doi: 10.1016/S0140-6736(19)31149-3.

Dulaglutide’s serious adverse-effect profile was similar to that of placebo, the study authors noted, and the drug also showed benefits in renal outcomes, as reported in a separate study (Gerstein HC et al. Lancet. 2019 Jun 10. doi: 10.1016/S0140-6736(19)31150-3.

The Food and Drug Administration has mandated that six glucagon-like peptide–1 receptor agonists (GLP-1 RAs) – albiglutide (Tanzeum), exenatide (Byetta), liraglutide (Victoza), lixisenatide (Adlyxin), semaglutide (Ozempic) and dulaglutide (Trulicity) – undergo testing of cardiovascular outcomes. Dulaglutide is the fourth, following albiglutide, liraglutide, and semaglutide, to show consistent, statistically significant reduction in major adverse cardiovascular events (MACE).

For the double-blind, randomized, placebo-controlled REWIND study, researchers recruited 9,901 participants who were at least 50 years old with type 2 diabetes, a hemoglobin A_1c (HbA_1c) level of 9.5% or less, and a body mass index of more than 23 kg/m². The participants came from 371 sites in 24 countries, including the United States and Canada. More than 80% were taking an angiotensin-converting enzyme inhibitor or angiotensin II receptor blocker, and other blood pressure drugs were also common.

The average mean age was 66 years; 46% of the participants were women, three-quarters were white, and 31% had previous cardiovascular disease. Previous GLP-1 RA studies of this type had markedly lower percentages of women – the other studies comprised 30%-39% women – and included higher percentages of participants with previous cardiovascular disease (73%-100%).

Of the participants in the current study, 4,949 were assigned to receive dulaglutide and 4,952 to receive placebo. They were followed for a median 5.4 years. About 57% never stopped using the drug, and 11% of those in the drug group and 7.5% in the placebo group stopped use because of adverse effects.

In regard to diabetes outcomes, HbA_1c levels fell in the drug group by a mean –0.61% (95% confidence interval, –0.65 to –0.58; P less than .0001), compared with placebo. Their weight decreased by a mean –1.5 kg (95% CI, -1.7 to -1.3; P less than .0001) Systolic blood pressure and LDL cholesterol levels were slightly lower in the drug group, but heart rate was higher.

On the heart front, MACE fell by 12% in the drug group, compared with placebo (hazard ratio, 0.88; 95% CI, 0.79-0.99; P = .026). “The effect of the intervention begins [within] the first year and continued in a progressive, proportional fashion throughout the follow-up period,” said study lead author Hertzel C. Gerstein, MD, of McMaster University and Hamilton Health Sciences, Hamilton, Ont.

However, she called attention to the results that pinpointed higher levels of microvascular-related eye outcomes (HR, 1.24; 95% CI, 0.92-1.68) and fatal myocardial infarction (HR, 1.29; 95% CI, 0.72-2.30) in the dulaglutide group. Both of those outcomes were rare – 171 eye outcomes and 46 fatal myocardial infarctions overall. She also questioned whether the adherence rates would be as high in a real-world setting.

Eli Lilly funded the study. Three of the authors were employees of Eli Lilly, eight reported financial relationships with the company, five reported financial relationships with other firms, and the remaining authors reported no competing interests.

SOURCE: Gerstein HC et al. Lancet. 2019 Jun 10. doi: 10.1016/S0140-6736(19)31149-3.

The monoclonal antibody teplizumab may delay the onset of type 1 diabetes in individuals at high risk, according to research presented at the annual scientific sessions of the American Diabetes Association.

In this study, 76 first-degree relatives of individuals with type 1 diabetes – who did not themselves have the disease but were considered at high risk because of antibodies and abnormal glucose tolerance tests – were randomized to a single two-week outpatient course of intravenous teplizumab or saline placebo. The patients, of whom 72% were 18 years of age or younger, were followed for a median of 745 days and had twice-yearly oral glucose tolerance testing.

Overall, 43% of the 44 patients who received teplizumab were diagnosed with type 1 diabetes during the course of the study, compared with 72% of the 32 who received the placebo. The treatment was associated with a 59% reduction in the hazard ratio for type 1 diabetes, even after adjusting for age, the results of a second oral glucose-tolerance testing before randomization, or the presence of anti-GAD65 antibodies.

The median time to diagnosis was 48.4 months in the teplizumab group and 24.4 months in the placebo group. The greatest effect was seen in the first year after randomization, during which only 7% of the teplizumab group were diagnosed with type 1 diabetes, compared with 44% of the placebo group. The findings were published simultaneously in the New England Journal of Medicine.

“The delay of progression to type 1 diabetes is of clinical importance, particularly for children, in whom the diagnosis is associated with adverse outcomes, and given the challenges of daily management of the condition,” said Dr. Kevan C. Herold, professor of immunobiology and medicine at Yale University, New Haven, Conn., and coauthors.

There were significantly more adverse events in the teplizumab group, compared with placebo, with three-quarters of the 20 grade 3 adverse events being lymphopenia during the first 30 days. In all but one participant, however, the lymphopenia resolved by day 45. Participants receiving teplizumab also reported a higher incidence of dermatologic adverse events, such as a spontaneously-resolving rash that was experienced by just over one-third of the group.

The researchers also looked for evidence of T-cell unresponsiveness, which has been previously seen in patients with new-onset type 1 diabetes who received treatment with teplizumab. They noted an increase in a particular type of CD8+ T cell associated with T-cell unresponsiveness at months 3 and 6 in participants treated with teplizumab.

Teplizumab is an Fc receptor-nonbinding monoclonal antibody that has been shown to reduce the loss of beta-cell function in patients with type 1 diabetes (Diabetes. 2013 Nov;62(11):3766-74).

The study was supported by the National Institutes of Health, the Juvenile Diabetes Research Foundation, and the American Diabetes Association, with the study drug and additional site monitoring provided by MacroGenics. Eight authors declared grants, personal fees, and other support from private industry, with one also declaring income and stock options from MacroGenics.

SOURCE: Herold K et al. NEJM. 2019 Jun 9. doi: 10.1056/NEJMoa1902226*

*Correction, 6/9/2019: An earlier version of this story misstated the doi number for the journal article. The number is 10.1056/NEJMoa1902226.

The monoclonal antibody teplizumab may delay the onset of type 1 diabetes in individuals at high risk, according to research presented at the annual scientific sessions of the American Diabetes Association.

In this study, 76 first-degree relatives of individuals with type 1 diabetes – who did not themselves have the disease but were considered at high risk because of antibodies and abnormal glucose tolerance tests – were randomized to a single two-week outpatient course of intravenous teplizumab or saline placebo. The patients, of whom 72% were 18 years of age or younger, were followed for a median of 745 days and had twice-yearly oral glucose tolerance testing.

Overall, 43% of the 44 patients who received teplizumab were diagnosed with type 1 diabetes during the course of the study, compared with 72% of the 32 who received the placebo. The treatment was associated with a 59% reduction in the hazard ratio for type 1 diabetes, even after adjusting for age, the results of a second oral glucose-tolerance testing before randomization, or the presence of anti-GAD65 antibodies.

The median time to diagnosis was 48.4 months in the teplizumab group and 24.4 months in the placebo group. The greatest effect was seen in the first year after randomization, during which only 7% of the teplizumab group were diagnosed with type 1 diabetes, compared with 44% of the placebo group. The findings were published simultaneously in the New England Journal of Medicine.

“The delay of progression to type 1 diabetes is of clinical importance, particularly for children, in whom the diagnosis is associated with adverse outcomes, and given the challenges of daily management of the condition,” said Dr. Kevan C. Herold, professor of immunobiology and medicine at Yale University, New Haven, Conn., and coauthors.

There were significantly more adverse events in the teplizumab group, compared with placebo, with three-quarters of the 20 grade 3 adverse events being lymphopenia during the first 30 days. In all but one participant, however, the lymphopenia resolved by day 45. Participants receiving teplizumab also reported a higher incidence of dermatologic adverse events, such as a spontaneously-resolving rash that was experienced by just over one-third of the group.

The researchers also looked for evidence of T-cell unresponsiveness, which has been previously seen in patients with new-onset type 1 diabetes who received treatment with teplizumab. They noted an increase in a particular type of CD8+ T cell associated with T-cell unresponsiveness at months 3 and 6 in participants treated with teplizumab.

Teplizumab is an Fc receptor-nonbinding monoclonal antibody that has been shown to reduce the loss of beta-cell function in patients with type 1 diabetes (Diabetes. 2013 Nov;62(11):3766-74).

The study was supported by the National Institutes of Health, the Juvenile Diabetes Research Foundation, and the American Diabetes Association, with the study drug and additional site monitoring provided by MacroGenics. Eight authors declared grants, personal fees, and other support from private industry, with one also declaring income and stock options from MacroGenics.

SOURCE: Herold K et al. NEJM. 2019 Jun 9. doi: 10.1056/NEJMoa1902226*

*Correction, 6/9/2019: An earlier version of this story misstated the doi number for the journal article. The number is 10.1056/NEJMoa1902226.

The monoclonal antibody teplizumab may delay the onset of type 1 diabetes in individuals at high risk, according to research presented at the annual scientific sessions of the American Diabetes Association.

In this study, 76 first-degree relatives of individuals with type 1 diabetes – who did not themselves have the disease but were considered at high risk because of antibodies and abnormal glucose tolerance tests – were randomized to a single two-week outpatient course of intravenous teplizumab or saline placebo. The patients, of whom 72% were 18 years of age or younger, were followed for a median of 745 days and had twice-yearly oral glucose tolerance testing.

Overall, 43% of the 44 patients who received teplizumab were diagnosed with type 1 diabetes during the course of the study, compared with 72% of the 32 who received the placebo. The treatment was associated with a 59% reduction in the hazard ratio for type 1 diabetes, even after adjusting for age, the results of a second oral glucose-tolerance testing before randomization, or the presence of anti-GAD65 antibodies.

The median time to diagnosis was 48.4 months in the teplizumab group and 24.4 months in the placebo group. The greatest effect was seen in the first year after randomization, during which only 7% of the teplizumab group were diagnosed with type 1 diabetes, compared with 44% of the placebo group. The findings were published simultaneously in the New England Journal of Medicine.

“The delay of progression to type 1 diabetes is of clinical importance, particularly for children, in whom the diagnosis is associated with adverse outcomes, and given the challenges of daily management of the condition,” said Dr. Kevan C. Herold, professor of immunobiology and medicine at Yale University, New Haven, Conn., and coauthors.

There were significantly more adverse events in the teplizumab group, compared with placebo, with three-quarters of the 20 grade 3 adverse events being lymphopenia during the first 30 days. In all but one participant, however, the lymphopenia resolved by day 45. Participants receiving teplizumab also reported a higher incidence of dermatologic adverse events, such as a spontaneously-resolving rash that was experienced by just over one-third of the group.

The researchers also looked for evidence of T-cell unresponsiveness, which has been previously seen in patients with new-onset type 1 diabetes who received treatment with teplizumab. They noted an increase in a particular type of CD8+ T cell associated with T-cell unresponsiveness at months 3 and 6 in participants treated with teplizumab.

Teplizumab is an Fc receptor-nonbinding monoclonal antibody that has been shown to reduce the loss of beta-cell function in patients with type 1 diabetes (Diabetes. 2013 Nov;62(11):3766-74).

The study was supported by the National Institutes of Health, the Juvenile Diabetes Research Foundation, and the American Diabetes Association, with the study drug and additional site monitoring provided by MacroGenics. Eight authors declared grants, personal fees, and other support from private industry, with one also declaring income and stock options from MacroGenics.

SOURCE: Herold K et al. NEJM. 2019 Jun 9. doi: 10.1056/NEJMoa1902226*

*Correction, 6/9/2019: An earlier version of this story misstated the doi number for the journal article. The number is 10.1056/NEJMoa1902226.

SAN FRANCISCO – Seventy-percent of type 2 diabetes patients who lost more than 33 pounds on a liquid diet over a few months, and kept it off, were free of the disease at 2 years, according to United Kingdom investigators.

M. Alexander Otto/MDedge News

The odds of remission – meaning a hemoglobin A1c below 6.5% on repeat testing, off all medications – were directly related to the amount of weight patients lost; 60% of subjects who lost 22-33 pounds were free of type 2 disease at 2 years, versus 29% who lost 11-21 pounds, and 5% who lost less than 11 pounds.

“If people lose” around 30 pounds “and keep it off for 2 years, there’s a two-thirds chance of them escaping type 2 [diabetes]. People want to understand their options, and this is an option. This is very good news for people with diabetes,” said senior investigator Roy Taylor, MD, a professor of medicine and metabolism at the University of Newcastle, Newcastle upon Tyne, England, who presented the findings of the Diabetes Remission Clinical Trial (DiRECT) at the annual scientific sessions of the American Diabetes Association (Lancet Diabetes Endocrinol. 2019 May;7(5):344-355).

A subgroup analysis he also presented found that beta cell function rebounds rapidly after weight loss and is pretty much normal at 2 years, so long as people keep the weight off.


The study is rooted in previous work by Dr. Taylor and his colleagues that found that very low-calorie diets normalized fasting plasma glucose in just 7 days in patients with type 2 diabetes due to a rapid fall in liver fat content and subsequent restoration of insulin sensitivity. That and other findings suggested that fast weight loss – instead of the traditional gradual approach – might help.

He and his team randomized 149 volunteers from primary care practices in the United Kingdom to standard care, and 149 others to rapid weight loss; more than a quarter of the patients who were asked agreed to participate.

[email protected]
 

SOURCE: Zhyzhneuskaya SV et al., ADA 2019 abstract 66-OR

SAN FRANCISCO – Seventy-percent of type 2 diabetes patients who lost more than 33 pounds on a liquid diet over a few months, and kept it off, were free of the disease at 2 years, according to United Kingdom investigators.

M. Alexander Otto/MDedge News

The odds of remission – meaning a hemoglobin A1c below 6.5% on repeat testing, off all medications – were directly related to the amount of weight patients lost; 60% of subjects who lost 22-33 pounds were free of type 2 disease at 2 years, versus 29% who lost 11-21 pounds, and 5% who lost less than 11 pounds.

“If people lose” around 30 pounds “and keep it off for 2 years, there’s a two-thirds chance of them escaping type 2 [diabetes]. People want to understand their options, and this is an option. This is very good news for people with diabetes,” said senior investigator Roy Taylor, MD, a professor of medicine and metabolism at the University of Newcastle, Newcastle upon Tyne, England, who presented the findings of the Diabetes Remission Clinical Trial (DiRECT) at the annual scientific sessions of the American Diabetes Association (Lancet Diabetes Endocrinol. 2019 May;7(5):344-355).

A subgroup analysis he also presented found that beta cell function rebounds rapidly after weight loss and is pretty much normal at 2 years, so long as people keep the weight off.


The study is rooted in previous work by Dr. Taylor and his colleagues that found that very low-calorie diets normalized fasting plasma glucose in just 7 days in patients with type 2 diabetes due to a rapid fall in liver fat content and subsequent restoration of insulin sensitivity. That and other findings suggested that fast weight loss – instead of the traditional gradual approach – might help.

He and his team randomized 149 volunteers from primary care practices in the United Kingdom to standard care, and 149 others to rapid weight loss; more than a quarter of the patients who were asked agreed to participate.

[email protected]
 

SOURCE: Zhyzhneuskaya SV et al., ADA 2019 abstract 66-OR

SAN FRANCISCO – Seventy-percent of type 2 diabetes patients who lost more than 33 pounds on a liquid diet over a few months, and kept it off, were free of the disease at 2 years, according to United Kingdom investigators.

M. Alexander Otto/MDedge News

The odds of remission – meaning a hemoglobin A1c below 6.5% on repeat testing, off all medications – were directly related to the amount of weight patients lost; 60% of subjects who lost 22-33 pounds were free of type 2 disease at 2 years, versus 29% who lost 11-21 pounds, and 5% who lost less than 11 pounds.

“If people lose” around 30 pounds “and keep it off for 2 years, there’s a two-thirds chance of them escaping type 2 [diabetes]. People want to understand their options, and this is an option. This is very good news for people with diabetes,” said senior investigator Roy Taylor, MD, a professor of medicine and metabolism at the University of Newcastle, Newcastle upon Tyne, England, who presented the findings of the Diabetes Remission Clinical Trial (DiRECT) at the annual scientific sessions of the American Diabetes Association (Lancet Diabetes Endocrinol. 2019 May;7(5):344-355).

A subgroup analysis he also presented found that beta cell function rebounds rapidly after weight loss and is pretty much normal at 2 years, so long as people keep the weight off.


The study is rooted in previous work by Dr. Taylor and his colleagues that found that very low-calorie diets normalized fasting plasma glucose in just 7 days in patients with type 2 diabetes due to a rapid fall in liver fat content and subsequent restoration of insulin sensitivity. That and other findings suggested that fast weight loss – instead of the traditional gradual approach – might help.

He and his team randomized 149 volunteers from primary care practices in the United Kingdom to standard care, and 149 others to rapid weight loss; more than a quarter of the patients who were asked agreed to participate.

[email protected]
 

SOURCE: Zhyzhneuskaya SV et al., ADA 2019 abstract 66-OR

SAN FRANCISCO – Vitamin D supplementation did not significantly reduce the risk of progression from prediabetes to type 2 diabetes, according to the landmark D2d study.

A possible reason why the observed reduction was not statistically significant was that most participants already had acceptable levels of vitamin D. Still, the intervention “did not significantly reduce the risk [of diabetes],” Anastassios G. Pittas, MD, professor of medicine at Tufts Medical Center, Boston, said at the annual scientific sessions of the American Diabetes Association.

Vitamin D supplementation has been a hot topic on a range of medical fronts. As a 2016 report noted, “low vitamin D levels are also associated with hypertension, cancer, and cardiovascular disease. In addition, [diabetes] and chronic kidney disease (CKD) are also related to vitamin D levels. Vitamin D deficiency has been linked to onset and progression of [diabetes],” (World J Diabetes. 2016;7[5]:89-100).

However, as the report noted, “evidence regarding vitamin D levels and [diabetes] is contradictory, and well-controlled studies are needed.”

For the D2d study, which was coordinated out of the division of endocrinology at Tufts Medical Center, Dr. Pittas and associates recruited 2,423 patients who were considered to have prediabetes, with at least 2 of 3 ADA criteria: fasting plasma glucose level of 100-125 mg/dL; plasma glucose level 2 hours after a 75-g oral glucose load of 140-199 mg/dL; and hemoglobin A_1c (HbA_1c) level of 5.7%-6.4%.

All of the patients were at least 30 years old with the exception of American Indians, Alaska Natives, Native Hawaiians and other Pacific Islanders who were allowed to be aged 25-30 years. About 22% had low vitamin D levels.

The mean age of the patients was 60 years, mean body mass index was 32, 45% were women, and 33% were non-white. The trial was powered to show a reduction of 25% or more in diabetes risk with vitamin D.

The researchers randomly assigned 1,211 patients to take a once-daily capsule of vitamin D3 (cholecalciferol; 4,000 IU per day); 1,212 received a placebo.

Patients in the vitamin D group greatly boosted their mean serum 25-hydroxyvitamin D levels, from 27.7 ng/mL at baseline to 54.3 ng/mL at 24 months. In contrast, those in the placebo group saw little change, going from 28.2 ng/mL at baseline to 28.8 ng/mL at 24 months.

At a median follow-up of 2.5 years, with 99% of the study participants remaining in the trial, 616 patients developed diabetes (293 in the vitamin D group, 323 in the placebo group).

The risk was lower in the vitamin D group although the difference was not statistically significant. An analysis revealed no clear differences in any of the subgroups (race, age, body mass index, latitude-based geographic location, calcium supplement intake, and others).

However, a post hoc analysis of patients with vitamin D deficiency, which is defined by the National Academy of Medicine as having a 25-hydroxyvitamin D level of less than 12 ng/mL, showed that the vitamin D group had a 62% reduction in risk of diabetes, compared with placebo.

“Response to a nutritional intervention depends on nutritional status at baseline. Thus, if vitamin D has an effect on diabetes prevention, then people with lower levels of serum 25-hydroxyvitamin D would be expected to have a larger effect from supplementation than would those with higher baseline levels,” Dr. Pittas said.

SOURCE: Pittas AG et al. ADA 2019

This article was updated on 6/18/2019.

SAN FRANCISCO – Vitamin D supplementation did not significantly reduce the risk of progression from prediabetes to type 2 diabetes, according to the landmark D2d study.

A possible reason why the observed reduction was not statistically significant was that most participants already had acceptable levels of vitamin D. Still, the intervention “did not significantly reduce the risk [of diabetes],” Anastassios G. Pittas, MD, professor of medicine at Tufts Medical Center, Boston, said at the annual scientific sessions of the American Diabetes Association.

Vitamin D supplementation has been a hot topic on a range of medical fronts. As a 2016 report noted, “low vitamin D levels are also associated with hypertension, cancer, and cardiovascular disease. In addition, [diabetes] and chronic kidney disease (CKD) are also related to vitamin D levels. Vitamin D deficiency has been linked to onset and progression of [diabetes],” (World J Diabetes. 2016;7[5]:89-100).

However, as the report noted, “evidence regarding vitamin D levels and [diabetes] is contradictory, and well-controlled studies are needed.”

For the D2d study, which was coordinated out of the division of endocrinology at Tufts Medical Center, Dr. Pittas and associates recruited 2,423 patients who were considered to have prediabetes, with at least 2 of 3 ADA criteria: fasting plasma glucose level of 100-125 mg/dL; plasma glucose level 2 hours after a 75-g oral glucose load of 140-199 mg/dL; and hemoglobin A_1c (HbA_1c) level of 5.7%-6.4%.

All of the patients were at least 30 years old with the exception of American Indians, Alaska Natives, Native Hawaiians and other Pacific Islanders who were allowed to be aged 25-30 years. About 22% had low vitamin D levels.

The mean age of the patients was 60 years, mean body mass index was 32, 45% were women, and 33% were non-white. The trial was powered to show a reduction of 25% or more in diabetes risk with vitamin D.

The researchers randomly assigned 1,211 patients to take a once-daily capsule of vitamin D3 (cholecalciferol; 4,000 IU per day); 1,212 received a placebo.

Patients in the vitamin D group greatly boosted their mean serum 25-hydroxyvitamin D levels, from 27.7 ng/mL at baseline to 54.3 ng/mL at 24 months. In contrast, those in the placebo group saw little change, going from 28.2 ng/mL at baseline to 28.8 ng/mL at 24 months.

At a median follow-up of 2.5 years, with 99% of the study participants remaining in the trial, 616 patients developed diabetes (293 in the vitamin D group, 323 in the placebo group).

The risk was lower in the vitamin D group although the difference was not statistically significant. An analysis revealed no clear differences in any of the subgroups (race, age, body mass index, latitude-based geographic location, calcium supplement intake, and others).

However, a post hoc analysis of patients with vitamin D deficiency, which is defined by the National Academy of Medicine as having a 25-hydroxyvitamin D level of less than 12 ng/mL, showed that the vitamin D group had a 62% reduction in risk of diabetes, compared with placebo.

“Response to a nutritional intervention depends on nutritional status at baseline. Thus, if vitamin D has an effect on diabetes prevention, then people with lower levels of serum 25-hydroxyvitamin D would be expected to have a larger effect from supplementation than would those with higher baseline levels,” Dr. Pittas said.

SOURCE: Pittas AG et al. ADA 2019

This article was updated on 6/18/2019.

SAN FRANCISCO – Vitamin D supplementation did not significantly reduce the risk of progression from prediabetes to type 2 diabetes, according to the landmark D2d study.

A possible reason why the observed reduction was not statistically significant was that most participants already had acceptable levels of vitamin D. Still, the intervention “did not significantly reduce the risk [of diabetes],” Anastassios G. Pittas, MD, professor of medicine at Tufts Medical Center, Boston, said at the annual scientific sessions of the American Diabetes Association.

Vitamin D supplementation has been a hot topic on a range of medical fronts. As a 2016 report noted, “low vitamin D levels are also associated with hypertension, cancer, and cardiovascular disease. In addition, [diabetes] and chronic kidney disease (CKD) are also related to vitamin D levels. Vitamin D deficiency has been linked to onset and progression of [diabetes],” (World J Diabetes. 2016;7[5]:89-100).

However, as the report noted, “evidence regarding vitamin D levels and [diabetes] is contradictory, and well-controlled studies are needed.”

For the D2d study, which was coordinated out of the division of endocrinology at Tufts Medical Center, Dr. Pittas and associates recruited 2,423 patients who were considered to have prediabetes, with at least 2 of 3 ADA criteria: fasting plasma glucose level of 100-125 mg/dL; plasma glucose level 2 hours after a 75-g oral glucose load of 140-199 mg/dL; and hemoglobin A_1c (HbA_1c) level of 5.7%-6.4%.

All of the patients were at least 30 years old with the exception of American Indians, Alaska Natives, Native Hawaiians and other Pacific Islanders who were allowed to be aged 25-30 years. About 22% had low vitamin D levels.

The mean age of the patients was 60 years, mean body mass index was 32, 45% were women, and 33% were non-white. The trial was powered to show a reduction of 25% or more in diabetes risk with vitamin D.

The researchers randomly assigned 1,211 patients to take a once-daily capsule of vitamin D3 (cholecalciferol; 4,000 IU per day); 1,212 received a placebo.

Patients in the vitamin D group greatly boosted their mean serum 25-hydroxyvitamin D levels, from 27.7 ng/mL at baseline to 54.3 ng/mL at 24 months. In contrast, those in the placebo group saw little change, going from 28.2 ng/mL at baseline to 28.8 ng/mL at 24 months.

At a median follow-up of 2.5 years, with 99% of the study participants remaining in the trial, 616 patients developed diabetes (293 in the vitamin D group, 323 in the placebo group).

The risk was lower in the vitamin D group although the difference was not statistically significant. An analysis revealed no clear differences in any of the subgroups (race, age, body mass index, latitude-based geographic location, calcium supplement intake, and others).

However, a post hoc analysis of patients with vitamin D deficiency, which is defined by the National Academy of Medicine as having a 25-hydroxyvitamin D level of less than 12 ng/mL, showed that the vitamin D group had a 62% reduction in risk of diabetes, compared with placebo.

“Response to a nutritional intervention depends on nutritional status at baseline. Thus, if vitamin D has an effect on diabetes prevention, then people with lower levels of serum 25-hydroxyvitamin D would be expected to have a larger effect from supplementation than would those with higher baseline levels,” Dr. Pittas said.

SOURCE: Pittas AG et al. ADA 2019

This article was updated on 6/18/2019.

After increasing for almost 2 decades, the incidence of adult diabetes in the United States has dropped 35%, and the prevalence has held steady since about 2008, according to a review of Centers for Disease Control and Prevention data.

It’s the longest plateau in prevalence since the 1980s, and the longest period of declining incidence ever recorded. The findings suggest that efforts “to stem the tide of type 2 diabetes may be working ... [but] we still have a very long way to go,” investigator Ann Albright, PhD, director of the CDC Division of Diabetes Translation, said in a press statement.

However, the authors noted that “obesity and severe obesity trends have generally increased over the past 10 years, and prediabetes remains unchanged and high, affecting 84 million U.S. adults, or 34% of the US adult population,” and they emphasized the need for continued focus on prevention for type 2 diabetes and diabetes complications, as well as better screening and detection of the disease.

Dr Albright and her colleagues reviewed the CDC’s annual National Health Interview Survey data from 1980-2017. Diabetes diagnoses were by self-report, and the data did not distinguish between type 1 and type 2 disease, although it is known that about 95% of diabetes cases are type 2 (BMJ Open Diab Res Care. 2019 May 28;7:e000657. doi:10.1136/bmjdrc-2019-000657).

New cases declined from a high of 1.73 million in 2008 to 1.34 million in 2017, a drop of 3.1% a year, from 7.8 to 6 new cases/1,000 adults. The findings were driven largely by decreasing incidence in non-Hispanic whites.

Prevalence peaked at 8.2/100 adults in 2009, and has remained there since, possibly because people with diabetes are living longer with the disease, the investigators said.

Similar prevalence trends were seen across age, racial, education, and ethnic groups, and in both men and women. The findings were all statistically significant.

The drop in incidence corresponds with flat or downward trends in several type 2 risk factors, including sugar, soda, and total calorie intake, and physical inactivity. In 2010, the American Diabetes Association recommended hemoglobin A_1c for diabetes diagnosis, which might have also decreased the incidence because it is less sensitive than traditional fasting blood glucose. Increased screening in recent years might have depleted the pool of new cases as well, the authors said.

The CDC has been emphasizing type 2 education and prevention through its National Diabetes Prevention Program, which might also have helped.

There was no external funding for the survey, and the investigators reported no disclosures or conflicts of interest.

SOURCE: Benoit SR et al. BMJ Open Diab Res Care. 2019 May 28. doi:10.1136/bmjdrc-2019-000657

After increasing for almost 2 decades, the incidence of adult diabetes in the United States has dropped 35%, and the prevalence has held steady since about 2008, according to a review of Centers for Disease Control and Prevention data.

It’s the longest plateau in prevalence since the 1980s, and the longest period of declining incidence ever recorded. The findings suggest that efforts “to stem the tide of type 2 diabetes may be working ... [but] we still have a very long way to go,” investigator Ann Albright, PhD, director of the CDC Division of Diabetes Translation, said in a press statement.

However, the authors noted that “obesity and severe obesity trends have generally increased over the past 10 years, and prediabetes remains unchanged and high, affecting 84 million U.S. adults, or 34% of the US adult population,” and they emphasized the need for continued focus on prevention for type 2 diabetes and diabetes complications, as well as better screening and detection of the disease.

Dr Albright and her colleagues reviewed the CDC’s annual National Health Interview Survey data from 1980-2017. Diabetes diagnoses were by self-report, and the data did not distinguish between type 1 and type 2 disease, although it is known that about 95% of diabetes cases are type 2 (BMJ Open Diab Res Care. 2019 May 28;7:e000657. doi:10.1136/bmjdrc-2019-000657).

New cases declined from a high of 1.73 million in 2008 to 1.34 million in 2017, a drop of 3.1% a year, from 7.8 to 6 new cases/1,000 adults. The findings were driven largely by decreasing incidence in non-Hispanic whites.

Prevalence peaked at 8.2/100 adults in 2009, and has remained there since, possibly because people with diabetes are living longer with the disease, the investigators said.

Similar prevalence trends were seen across age, racial, education, and ethnic groups, and in both men and women. The findings were all statistically significant.

The drop in incidence corresponds with flat or downward trends in several type 2 risk factors, including sugar, soda, and total calorie intake, and physical inactivity. In 2010, the American Diabetes Association recommended hemoglobin A_1c for diabetes diagnosis, which might have also decreased the incidence because it is less sensitive than traditional fasting blood glucose. Increased screening in recent years might have depleted the pool of new cases as well, the authors said.

The CDC has been emphasizing type 2 education and prevention through its National Diabetes Prevention Program, which might also have helped.

There was no external funding for the survey, and the investigators reported no disclosures or conflicts of interest.

SOURCE: Benoit SR et al. BMJ Open Diab Res Care. 2019 May 28. doi:10.1136/bmjdrc-2019-000657

After increasing for almost 2 decades, the incidence of adult diabetes in the United States has dropped 35%, and the prevalence has held steady since about 2008, according to a review of Centers for Disease Control and Prevention data.

It’s the longest plateau in prevalence since the 1980s, and the longest period of declining incidence ever recorded. The findings suggest that efforts “to stem the tide of type 2 diabetes may be working ... [but] we still have a very long way to go,” investigator Ann Albright, PhD, director of the CDC Division of Diabetes Translation, said in a press statement.

However, the authors noted that “obesity and severe obesity trends have generally increased over the past 10 years, and prediabetes remains unchanged and high, affecting 84 million U.S. adults, or 34% of the US adult population,” and they emphasized the need for continued focus on prevention for type 2 diabetes and diabetes complications, as well as better screening and detection of the disease.

Dr Albright and her colleagues reviewed the CDC’s annual National Health Interview Survey data from 1980-2017. Diabetes diagnoses were by self-report, and the data did not distinguish between type 1 and type 2 disease, although it is known that about 95% of diabetes cases are type 2 (BMJ Open Diab Res Care. 2019 May 28;7:e000657. doi:10.1136/bmjdrc-2019-000657).

New cases declined from a high of 1.73 million in 2008 to 1.34 million in 2017, a drop of 3.1% a year, from 7.8 to 6 new cases/1,000 adults. The findings were driven largely by decreasing incidence in non-Hispanic whites.

Prevalence peaked at 8.2/100 adults in 2009, and has remained there since, possibly because people with diabetes are living longer with the disease, the investigators said.

Similar prevalence trends were seen across age, racial, education, and ethnic groups, and in both men and women. The findings were all statistically significant.

The drop in incidence corresponds with flat or downward trends in several type 2 risk factors, including sugar, soda, and total calorie intake, and physical inactivity. In 2010, the American Diabetes Association recommended hemoglobin A_1c for diabetes diagnosis, which might have also decreased the incidence because it is less sensitive than traditional fasting blood glucose. Increased screening in recent years might have depleted the pool of new cases as well, the authors said.

The CDC has been emphasizing type 2 education and prevention through its National Diabetes Prevention Program, which might also have helped.

There was no external funding for the survey, and the investigators reported no disclosures or conflicts of interest.

SOURCE: Benoit SR et al. BMJ Open Diab Res Care. 2019 May 28. doi:10.1136/bmjdrc-2019-000657

Danish researchers have linked multiple factors to higher risk of first-time diabetic foot ulcers (DFUs) in patients with type 1 and type 2 diabetes, although some of the factors – older age, smoking, history of cardiovascular disease, and longer duration of diabetes – seem to indicate increased risk only in type 1 disease, according to the new study findings.

The authors suggest that since clinical information gathered from patients during routine follow-up visits often includes mention of the risk factors for first-time DFU, it could form the basis of a risk stratification process for first-time DFU that can be integrated into the electronic record system and easily incorporated into routine care.

DFU is a significant complication for both type 1 and type 2 diabetes, but no previous research has stratified the risk factors for first-time DFUs by type of diabetes, emphasized the study authors, led by Sine Hangaard, MSc, of Steno Diabetes Center Copenhagen.

For the new study, the researchers tracked 5,588 patients with type 1 diabetes and 7,113 with type 2, all of whom were treated at a hospital clinic in Denmark between 2001 and 2015. The authors noted that the patients with type 2 disease who were treated at the center were clinically more complicated and had a longer disease duration than average type 2 patients, whereas the patients with type 1 diabetes did not differ from average type 1 patients.

Several factors boosted the risk of first-time DFU in both types of disease, including high or low levels of albumin excretion, advanced diabetic retinopathy, limited or nonexistent vibration sense, symptoms of neuropathy, and absence of foot pulses per univariable regression (all P less than .01). The researchers linked the neuropathy and absences of foot pulses to especially high spikes in risk.

Female gender was protective for type 1 and type 2 disease (hazard ratios, 0.7 and 0.5, respectively; P = .0000). Various body mass index levels seemed to have no impact on risk.

Three factors that posed a higher risk for first-time DFU in type 1 disease, but not type 2, were: smoking (HR, 1.4 vs. no smoking, P = .0220), age of 60-79 years (HR, 1.7 vs. age 40-59; P = .0000), cardiovascular disease (HR, 2.2 vs. no cardiovascular disease; P = .0000), and diabetes duration of between 5 and 20 years (HR, 2.2 vs. less than 5 years; P = .0027) or 20 years or more (HR, 5.2 vs. less than 5 years; P = .0000).

The authors noted that “25% of all patients with diabetes develop DFU during their lifetime, and DFUs precede 80% of all lower leg amputations in patients with diabetes.” In addition, DFU often occurs in feet already compromised by neuropathy or peripheral vascular disease, and is therefore associated with greater risk for infection, poorer outcomes, recurrent ulceration, amputation, and increased mortality. These risks underscore the need for the earliest-possible identification of first-time DFU and timely adoption of effective, preventative strategies, they wrote.

The study was not funded. Several of the authors reported that they own shares in Novo Nordisk.

SOURCE: Hangaard S et al. Diabetes Res Clin Pract. 2019 Apr 18;151:177-86.

Danish researchers have linked multiple factors to higher risk of first-time diabetic foot ulcers (DFUs) in patients with type 1 and type 2 diabetes, although some of the factors – older age, smoking, history of cardiovascular disease, and longer duration of diabetes – seem to indicate increased risk only in type 1 disease, according to the new study findings.

The authors suggest that since clinical information gathered from patients during routine follow-up visits often includes mention of the risk factors for first-time DFU, it could form the basis of a risk stratification process for first-time DFU that can be integrated into the electronic record system and easily incorporated into routine care.

DFU is a significant complication for both type 1 and type 2 diabetes, but no previous research has stratified the risk factors for first-time DFUs by type of diabetes, emphasized the study authors, led by Sine Hangaard, MSc, of Steno Diabetes Center Copenhagen.

For the new study, the researchers tracked 5,588 patients with type 1 diabetes and 7,113 with type 2, all of whom were treated at a hospital clinic in Denmark between 2001 and 2015. The authors noted that the patients with type 2 disease who were treated at the center were clinically more complicated and had a longer disease duration than average type 2 patients, whereas the patients with type 1 diabetes did not differ from average type 1 patients.

Several factors boosted the risk of first-time DFU in both types of disease, including high or low levels of albumin excretion, advanced diabetic retinopathy, limited or nonexistent vibration sense, symptoms of neuropathy, and absence of foot pulses per univariable regression (all P less than .01). The researchers linked the neuropathy and absences of foot pulses to especially high spikes in risk.

Female gender was protective for type 1 and type 2 disease (hazard ratios, 0.7 and 0.5, respectively; P = .0000). Various body mass index levels seemed to have no impact on risk.

Three factors that posed a higher risk for first-time DFU in type 1 disease, but not type 2, were: smoking (HR, 1.4 vs. no smoking, P = .0220), age of 60-79 years (HR, 1.7 vs. age 40-59; P = .0000), cardiovascular disease (HR, 2.2 vs. no cardiovascular disease; P = .0000), and diabetes duration of between 5 and 20 years (HR, 2.2 vs. less than 5 years; P = .0027) or 20 years or more (HR, 5.2 vs. less than 5 years; P = .0000).

The authors noted that “25% of all patients with diabetes develop DFU during their lifetime, and DFUs precede 80% of all lower leg amputations in patients with diabetes.” In addition, DFU often occurs in feet already compromised by neuropathy or peripheral vascular disease, and is therefore associated with greater risk for infection, poorer outcomes, recurrent ulceration, amputation, and increased mortality. These risks underscore the need for the earliest-possible identification of first-time DFU and timely adoption of effective, preventative strategies, they wrote.

The study was not funded. Several of the authors reported that they own shares in Novo Nordisk.

SOURCE: Hangaard S et al. Diabetes Res Clin Pract. 2019 Apr 18;151:177-86.

Danish researchers have linked multiple factors to higher risk of first-time diabetic foot ulcers (DFUs) in patients with type 1 and type 2 diabetes, although some of the factors – older age, smoking, history of cardiovascular disease, and longer duration of diabetes – seem to indicate increased risk only in type 1 disease, according to the new study findings.

The authors suggest that since clinical information gathered from patients during routine follow-up visits often includes mention of the risk factors for first-time DFU, it could form the basis of a risk stratification process for first-time DFU that can be integrated into the electronic record system and easily incorporated into routine care.

DFU is a significant complication for both type 1 and type 2 diabetes, but no previous research has stratified the risk factors for first-time DFUs by type of diabetes, emphasized the study authors, led by Sine Hangaard, MSc, of Steno Diabetes Center Copenhagen.

For the new study, the researchers tracked 5,588 patients with type 1 diabetes and 7,113 with type 2, all of whom were treated at a hospital clinic in Denmark between 2001 and 2015. The authors noted that the patients with type 2 disease who were treated at the center were clinically more complicated and had a longer disease duration than average type 2 patients, whereas the patients with type 1 diabetes did not differ from average type 1 patients.

Several factors boosted the risk of first-time DFU in both types of disease, including high or low levels of albumin excretion, advanced diabetic retinopathy, limited or nonexistent vibration sense, symptoms of neuropathy, and absence of foot pulses per univariable regression (all P less than .01). The researchers linked the neuropathy and absences of foot pulses to especially high spikes in risk.

Female gender was protective for type 1 and type 2 disease (hazard ratios, 0.7 and 0.5, respectively; P = .0000). Various body mass index levels seemed to have no impact on risk.

Three factors that posed a higher risk for first-time DFU in type 1 disease, but not type 2, were: smoking (HR, 1.4 vs. no smoking, P = .0220), age of 60-79 years (HR, 1.7 vs. age 40-59; P = .0000), cardiovascular disease (HR, 2.2 vs. no cardiovascular disease; P = .0000), and diabetes duration of between 5 and 20 years (HR, 2.2 vs. less than 5 years; P = .0027) or 20 years or more (HR, 5.2 vs. less than 5 years; P = .0000).

The authors noted that “25% of all patients with diabetes develop DFU during their lifetime, and DFUs precede 80% of all lower leg amputations in patients with diabetes.” In addition, DFU often occurs in feet already compromised by neuropathy or peripheral vascular disease, and is therefore associated with greater risk for infection, poorer outcomes, recurrent ulceration, amputation, and increased mortality. These risks underscore the need for the earliest-possible identification of first-time DFU and timely adoption of effective, preventative strategies, they wrote.

The study was not funded. Several of the authors reported that they own shares in Novo Nordisk.

SOURCE: Hangaard S et al. Diabetes Res Clin Pract. 2019 Apr 18;151:177-86.

Adolescents and adults had similar weight loss after bariatric surgery, but diabetes and hypertension reoccurred more often in the older cohort, according to two related studies of 5-year outcomes after Roux-en-Y gastric bypass.

However, despite adolescents’ better outcomes for diabetes and hypertension, their rate of abdominal reoperations was significantly higher during the 5-year follow-up period, and at 2 years post surgery, they were found to have low ferritin levels. The rates of death were similar in the two groups at 5 years.

“We have documented similar and durable weight loss after gastric bypass in adolescents and adults, but important differences between these cohorts were observed in specific health outcomes,” wrote Thomas H. Inge, MD, PhD, of the University of Colorado at Denver, Aurora, and his coauthors. The study was published in the New England Journal of Medicine.

To evaluate and compare outcomes after bariatric surgery, the researchers undertook the Teen–Longitudinal Assessment of Bariatric Surgery (Teen-LABS) study and the LABS study. The two were related but independent observational studies of postsurgery patient cohorts. The Teen-LABS study included 161 adolescents with severe obesity, and the LABS study included 396 adults who reported becoming obese during adolescence.

At 5-year follow-up, there was no significant difference in mean percentage weight change between adolescents (−26%; 95% confidence interval, −29 to −23) and adults (−29%; 95% CI, −31 to −27; P = .08). Adolescents were more likely than were adults to have remission of type 2 diabetes (86% vs. 53%, respectively; risk ratio, 1.27; 95% CI, 1.03 to 1.57; P = .03) as well as hypertension (68% vs. 41%; risk ratio, 1.51; 95% CI, 1.21 to 1.88; P less than .001).

In addition, 20% of adolescents and 16% of adults underwent intra-abdominal procedures within 5 years of surgery, with cholecystectomy being the most common, followed by surgery for bowel obstruction or hernia repair, and gastrostomy. At 2 years, ferritin levels were lower in adolescents than in adults (48% of patients vs. 29%, respectively). Five-year ferritin levels were not assessed.

In all, three adolescents (1.9%) and seven adults (1.8%) died over the 5-year period. Among the adolescents, one patient with type 1 diabetes died 3 years after surgery from complications after a hypoglycemic episode, and the other two deaths, both 4 years after surgery, were consistent with overdose. Among the adults, three of the deaths occurred within 3 weeks of surgery and were related to gastric bypass, two were of indeterminate cause (at 11 months and 5 years after surgery), one was by suicide at 3 years, and one was from colon cancer at 4 years.

The authors acknowledged the limitations of their study, including its observational design, low counts for some of the outcomes, and a lack of nonsurgical controls. They also noted potential unmeasured biases in the adult cohort, including the effects of weight cycling and inaccuracies in recalling adolescent weight issues.

The study and several of its authors were supported by grants from the National Institute of Diabetes and Digestive and Kidney Diseases. Several authors reported receiving grants, honoraria, and consulting fees from medical technology and pharmaceutical companies.

SOURCE: Inge TH et al. N Engl J Med. 2019 May 16. doi: 10.1056/NEJMoa1813909.

Adolescents and adults had similar weight loss after bariatric surgery, but diabetes and hypertension reoccurred more often in the older cohort, according to two related studies of 5-year outcomes after Roux-en-Y gastric bypass.

However, despite adolescents’ better outcomes for diabetes and hypertension, their rate of abdominal reoperations was significantly higher during the 5-year follow-up period, and at 2 years post surgery, they were found to have low ferritin levels. The rates of death were similar in the two groups at 5 years.

“We have documented similar and durable weight loss after gastric bypass in adolescents and adults, but important differences between these cohorts were observed in specific health outcomes,” wrote Thomas H. Inge, MD, PhD, of the University of Colorado at Denver, Aurora, and his coauthors. The study was published in the New England Journal of Medicine.

To evaluate and compare outcomes after bariatric surgery, the researchers undertook the Teen–Longitudinal Assessment of Bariatric Surgery (Teen-LABS) study and the LABS study. The two were related but independent observational studies of postsurgery patient cohorts. The Teen-LABS study included 161 adolescents with severe obesity, and the LABS study included 396 adults who reported becoming obese during adolescence.

At 5-year follow-up, there was no significant difference in mean percentage weight change between adolescents (−26%; 95% confidence interval, −29 to −23) and adults (−29%; 95% CI, −31 to −27; P = .08). Adolescents were more likely than were adults to have remission of type 2 diabetes (86% vs. 53%, respectively; risk ratio, 1.27; 95% CI, 1.03 to 1.57; P = .03) as well as hypertension (68% vs. 41%; risk ratio, 1.51; 95% CI, 1.21 to 1.88; P less than .001).

In addition, 20% of adolescents and 16% of adults underwent intra-abdominal procedures within 5 years of surgery, with cholecystectomy being the most common, followed by surgery for bowel obstruction or hernia repair, and gastrostomy. At 2 years, ferritin levels were lower in adolescents than in adults (48% of patients vs. 29%, respectively). Five-year ferritin levels were not assessed.

In all, three adolescents (1.9%) and seven adults (1.8%) died over the 5-year period. Among the adolescents, one patient with type 1 diabetes died 3 years after surgery from complications after a hypoglycemic episode, and the other two deaths, both 4 years after surgery, were consistent with overdose. Among the adults, three of the deaths occurred within 3 weeks of surgery and were related to gastric bypass, two were of indeterminate cause (at 11 months and 5 years after surgery), one was by suicide at 3 years, and one was from colon cancer at 4 years.

The authors acknowledged the limitations of their study, including its observational design, low counts for some of the outcomes, and a lack of nonsurgical controls. They also noted potential unmeasured biases in the adult cohort, including the effects of weight cycling and inaccuracies in recalling adolescent weight issues.

The study and several of its authors were supported by grants from the National Institute of Diabetes and Digestive and Kidney Diseases. Several authors reported receiving grants, honoraria, and consulting fees from medical technology and pharmaceutical companies.

SOURCE: Inge TH et al. N Engl J Med. 2019 May 16. doi: 10.1056/NEJMoa1813909.

Adolescents and adults had similar weight loss after bariatric surgery, but diabetes and hypertension reoccurred more often in the older cohort, according to two related studies of 5-year outcomes after Roux-en-Y gastric bypass.

However, despite adolescents’ better outcomes for diabetes and hypertension, their rate of abdominal reoperations was significantly higher during the 5-year follow-up period, and at 2 years post surgery, they were found to have low ferritin levels. The rates of death were similar in the two groups at 5 years.

“We have documented similar and durable weight loss after gastric bypass in adolescents and adults, but important differences between these cohorts were observed in specific health outcomes,” wrote Thomas H. Inge, MD, PhD, of the University of Colorado at Denver, Aurora, and his coauthors. The study was published in the New England Journal of Medicine.

To evaluate and compare outcomes after bariatric surgery, the researchers undertook the Teen–Longitudinal Assessment of Bariatric Surgery (Teen-LABS) study and the LABS study. The two were related but independent observational studies of postsurgery patient cohorts. The Teen-LABS study included 161 adolescents with severe obesity, and the LABS study included 396 adults who reported becoming obese during adolescence.

At 5-year follow-up, there was no significant difference in mean percentage weight change between adolescents (−26%; 95% confidence interval, −29 to −23) and adults (−29%; 95% CI, −31 to −27; P = .08). Adolescents were more likely than were adults to have remission of type 2 diabetes (86% vs. 53%, respectively; risk ratio, 1.27; 95% CI, 1.03 to 1.57; P = .03) as well as hypertension (68% vs. 41%; risk ratio, 1.51; 95% CI, 1.21 to 1.88; P less than .001).

In addition, 20% of adolescents and 16% of adults underwent intra-abdominal procedures within 5 years of surgery, with cholecystectomy being the most common, followed by surgery for bowel obstruction or hernia repair, and gastrostomy. At 2 years, ferritin levels were lower in adolescents than in adults (48% of patients vs. 29%, respectively). Five-year ferritin levels were not assessed.

In all, three adolescents (1.9%) and seven adults (1.8%) died over the 5-year period. Among the adolescents, one patient with type 1 diabetes died 3 years after surgery from complications after a hypoglycemic episode, and the other two deaths, both 4 years after surgery, were consistent with overdose. Among the adults, three of the deaths occurred within 3 weeks of surgery and were related to gastric bypass, two were of indeterminate cause (at 11 months and 5 years after surgery), one was by suicide at 3 years, and one was from colon cancer at 4 years.

The authors acknowledged the limitations of their study, including its observational design, low counts for some of the outcomes, and a lack of nonsurgical controls. They also noted potential unmeasured biases in the adult cohort, including the effects of weight cycling and inaccuracies in recalling adolescent weight issues.

The study and several of its authors were supported by grants from the National Institute of Diabetes and Digestive and Kidney Diseases. Several authors reported receiving grants, honoraria, and consulting fees from medical technology and pharmaceutical companies.

SOURCE: Inge TH et al. N Engl J Med. 2019 May 16. doi: 10.1056/NEJMoa1813909.

The Food and Drug Administration has issued a safety communication about the risks associated with the use of unauthorized diabetes management devices.

This safety communication applies to continuous glucose monitors, insulin pumps, and automated insulin-dosing systems and is intended for both patients who manage their diabetes with any of various devices and the health care providers who treat and manage those patients.

The agency’s concerns were underscored by a recent report it received about a patient who used a combination of unauthorized devices and who needed medical intervention as a result.

“Because of the complexity of these devices and the life-saving care they provide, it’s important that patients are aware of the risks that arise when they’re not used as intended, or when [patients] use devices not authorized for sale in the [United States],” Jeff Shuren, MD, director of the agency’s Center for Devices and Radiological Health, said in a news release. “[This] warning is part of our ongoing public health commitment to protect patients and communicate with the public when we become aware of issues stemming from the use, or misuse, of medical devices.”

The release noted that the agency reviews some of the diabetes management devices as an entity, or system, or as being compatible with other approved components, such as integrated continuous glucose-monitoring systems. “This is known as interoperability, which allows patients to safely tailor their diabetes management to their individual preferences by choosing devices that are authorized by the FDA to work together,” it said.

However, the agency said it is aware that some manufacturers are illegally marketing devices that it hasn’t reviewed for safety and effectiveness and that some patients combine devices or components that are not intended for use with each other in an effort to cut costs or because of personal preferences. When patients do that, it introduces new risks that “could result in inaccurate glucose level readings or unsafe insulin dosing, which can lead to risks requiring medical intervention, such as severe low blood sugar, coma, diabetic ketoacidosis, and death,” it warned.

The agency said it realized that patients with chronic conditions such as diabetes preferred having a range of options so that they could tailor their treatment and management to their specific needs, but that it was important that they were fully aware of the risks of doing so.

It recommended that patients speak to their doctor about their device and component needs and use only those that the FDA has reviewed for safety and effectiveness. In addition, any concerns about the cost or availability of approved systems should be taken up with the treating doctor and insurance provider, who can advise on coverage and acceptable, alternative options.

Any adverse events should be reported to the agency through its MedWatch reporting system.

More information about safety in diabetes management devices and components is available at safety communication and the agency’s news release.

[email protected]

The Food and Drug Administration has issued a safety communication about the risks associated with the use of unauthorized diabetes management devices.

This safety communication applies to continuous glucose monitors, insulin pumps, and automated insulin-dosing systems and is intended for both patients who manage their diabetes with any of various devices and the health care providers who treat and manage those patients.

The agency’s concerns were underscored by a recent report it received about a patient who used a combination of unauthorized devices and who needed medical intervention as a result.

“Because of the complexity of these devices and the life-saving care they provide, it’s important that patients are aware of the risks that arise when they’re not used as intended, or when [patients] use devices not authorized for sale in the [United States],” Jeff Shuren, MD, director of the agency’s Center for Devices and Radiological Health, said in a news release. “[This] warning is part of our ongoing public health commitment to protect patients and communicate with the public when we become aware of issues stemming from the use, or misuse, of medical devices.”

The release noted that the agency reviews some of the diabetes management devices as an entity, or system, or as being compatible with other approved components, such as integrated continuous glucose-monitoring systems. “This is known as interoperability, which allows patients to safely tailor their diabetes management to their individual preferences by choosing devices that are authorized by the FDA to work together,” it said.

However, the agency said it is aware that some manufacturers are illegally marketing devices that it hasn’t reviewed for safety and effectiveness and that some patients combine devices or components that are not intended for use with each other in an effort to cut costs or because of personal preferences. When patients do that, it introduces new risks that “could result in inaccurate glucose level readings or unsafe insulin dosing, which can lead to risks requiring medical intervention, such as severe low blood sugar, coma, diabetic ketoacidosis, and death,” it warned.

The agency said it realized that patients with chronic conditions such as diabetes preferred having a range of options so that they could tailor their treatment and management to their specific needs, but that it was important that they were fully aware of the risks of doing so.

It recommended that patients speak to their doctor about their device and component needs and use only those that the FDA has reviewed for safety and effectiveness. In addition, any concerns about the cost or availability of approved systems should be taken up with the treating doctor and insurance provider, who can advise on coverage and acceptable, alternative options.

Any adverse events should be reported to the agency through its MedWatch reporting system.

More information about safety in diabetes management devices and components is available at safety communication and the agency’s news release.

[email protected]

The Food and Drug Administration has issued a safety communication about the risks associated with the use of unauthorized diabetes management devices.

This safety communication applies to continuous glucose monitors, insulin pumps, and automated insulin-dosing systems and is intended for both patients who manage their diabetes with any of various devices and the health care providers who treat and manage those patients.

The agency’s concerns were underscored by a recent report it received about a patient who used a combination of unauthorized devices and who needed medical intervention as a result.

“Because of the complexity of these devices and the life-saving care they provide, it’s important that patients are aware of the risks that arise when they’re not used as intended, or when [patients] use devices not authorized for sale in the [United States],” Jeff Shuren, MD, director of the agency’s Center for Devices and Radiological Health, said in a news release. “[This] warning is part of our ongoing public health commitment to protect patients and communicate with the public when we become aware of issues stemming from the use, or misuse, of medical devices.”

The release noted that the agency reviews some of the diabetes management devices as an entity, or system, or as being compatible with other approved components, such as integrated continuous glucose-monitoring systems. “This is known as interoperability, which allows patients to safely tailor their diabetes management to their individual preferences by choosing devices that are authorized by the FDA to work together,” it said.

However, the agency said it is aware that some manufacturers are illegally marketing devices that it hasn’t reviewed for safety and effectiveness and that some patients combine devices or components that are not intended for use with each other in an effort to cut costs or because of personal preferences. When patients do that, it introduces new risks that “could result in inaccurate glucose level readings or unsafe insulin dosing, which can lead to risks requiring medical intervention, such as severe low blood sugar, coma, diabetic ketoacidosis, and death,” it warned.

The agency said it realized that patients with chronic conditions such as diabetes preferred having a range of options so that they could tailor their treatment and management to their specific needs, but that it was important that they were fully aware of the risks of doing so.

It recommended that patients speak to their doctor about their device and component needs and use only those that the FDA has reviewed for safety and effectiveness. In addition, any concerns about the cost or availability of approved systems should be taken up with the treating doctor and insurance provider, who can advise on coverage and acceptable, alternative options.

Any adverse events should be reported to the agency through its MedWatch reporting system.

More information about safety in diabetes management devices and components is available at safety communication and the agency’s news release.

[email protected]

Background: Multiple large, randomized, controlled trials and meta-analyses that used aspirin as primary prevention for vascular events showed decreased vascular events, but a significant counterbalanced risk of bleeding. Since diabetes carries a higher risk of vascular events, this study examines aspirin for primary prevention of vascular events in diabetic patients.

Overall, aspirin provided no difference in mortality but showed an absolute 1.3% decrease in first vascular events or revascularization procedures with an absolute 1.1% increase in first occurrence of major bleeding event. Approximately 60% of the bleeding events were gastrointestinal or “other” urinary/nose bleeding, and there was no statistically significant increase in intracranial hemorrhage, hemorrhagic stroke, or vision-threatening eye bleeding. Vascular events were defined as transient ischemic attack (TIA), nonfatal MI, nonfatal ischemic stroke, or vascular death excluding intracranial hemorrhage. The major limitation of this study is that it had a composite of endpoints of different clinical significance. Furthermore, TIA as a major vascular event was added after the study began to increase statistical power, and when it is excluded, the difference for vascular events is not statistically significant.

Bottom line: Aspirin when used in primary prevention of vascular events in diabetes provides no improvement in mortality, and the benefit of prevention of vascular events must be weighed against the risks of bleeding.

Citation: The ASCEND Study Collaborative Group. Effects of aspirin for primary prevention in diabetes. N Eng J Med. 2018 Oct 18;379(16):1529-39.

Dr. Scott is an assistant professor in the division of hospital medicine, University of New Mexico.

Background: Multiple large, randomized, controlled trials and meta-analyses that used aspirin as primary prevention for vascular events showed decreased vascular events, but a significant counterbalanced risk of bleeding. Since diabetes carries a higher risk of vascular events, this study examines aspirin for primary prevention of vascular events in diabetic patients.

Overall, aspirin provided no difference in mortality but showed an absolute 1.3% decrease in first vascular events or revascularization procedures with an absolute 1.1% increase in first occurrence of major bleeding event. Approximately 60% of the bleeding events were gastrointestinal or “other” urinary/nose bleeding, and there was no statistically significant increase in intracranial hemorrhage, hemorrhagic stroke, or vision-threatening eye bleeding. Vascular events were defined as transient ischemic attack (TIA), nonfatal MI, nonfatal ischemic stroke, or vascular death excluding intracranial hemorrhage. The major limitation of this study is that it had a composite of endpoints of different clinical significance. Furthermore, TIA as a major vascular event was added after the study began to increase statistical power, and when it is excluded, the difference for vascular events is not statistically significant.

Bottom line: Aspirin when used in primary prevention of vascular events in diabetes provides no improvement in mortality, and the benefit of prevention of vascular events must be weighed against the risks of bleeding.

Citation: The ASCEND Study Collaborative Group. Effects of aspirin for primary prevention in diabetes. N Eng J Med. 2018 Oct 18;379(16):1529-39.

Dr. Scott is an assistant professor in the division of hospital medicine, University of New Mexico.

Background: Multiple large, randomized, controlled trials and meta-analyses that used aspirin as primary prevention for vascular events showed decreased vascular events, but a significant counterbalanced risk of bleeding. Since diabetes carries a higher risk of vascular events, this study examines aspirin for primary prevention of vascular events in diabetic patients.

Overall, aspirin provided no difference in mortality but showed an absolute 1.3% decrease in first vascular events or revascularization procedures with an absolute 1.1% increase in first occurrence of major bleeding event. Approximately 60% of the bleeding events were gastrointestinal or “other” urinary/nose bleeding, and there was no statistically significant increase in intracranial hemorrhage, hemorrhagic stroke, or vision-threatening eye bleeding. Vascular events were defined as transient ischemic attack (TIA), nonfatal MI, nonfatal ischemic stroke, or vascular death excluding intracranial hemorrhage. The major limitation of this study is that it had a composite of endpoints of different clinical significance. Furthermore, TIA as a major vascular event was added after the study began to increase statistical power, and when it is excluded, the difference for vascular events is not statistically significant.

Bottom line: Aspirin when used in primary prevention of vascular events in diabetes provides no improvement in mortality, and the benefit of prevention of vascular events must be weighed against the risks of bleeding.

Citation: The ASCEND Study Collaborative Group. Effects of aspirin for primary prevention in diabetes. N Eng J Med. 2018 Oct 18;379(16):1529-39.

Dr. Scott is an assistant professor in the division of hospital medicine, University of New Mexico.