TBD Meeting (3080-19)

SAN FRANCISCO – Here’s potential bad news for everyone who dines on skim milk and non-fat yogurt: High-fat dairy products may be better for you, at least if you want to stave off metabolic syndrome (MetS), according to a new study.

Jupiterimages/Getty Images

The findings aren’t conclusive. Still, researchers found that “among whites and African- Americans, the whole milk/high-fat dairy pattern had a protective effect on the risk of metabolic syndrome,” said epidemiologist and study lead author Dale Hardy, PhD, of Morehouse School of Medicine, in an interview. She presented the study findings at the scientific sessions of the American Diabetes Association.

Hardy launched her research as part of a project that’s examining relationships between diet, genes, type 2 diabetes, and cardiovascular diseases in whites and African-Americans.

According to a 2017 study, an estimated 34% of adults in the U.S. from 2007-2012 had MetS, defined as the presence of at least 3 of these factors – elevated waist circumference, elevated triglycerides, reduced high-density lipoprotein cholesterol, high blood pressure, and elevated fasting blood glucose (Prev Chronic Dis. 2017 Mar 16;14:E24).

MetS is linked to higher rates of a variety of ills, including cardiovascular disease, kidney disease, and early death.

For the new study, Dr. Hardy and colleagues examined data from the Atherosclerosis Risk in Communities study (1987-1998) and food questionnaires (1987 and 1993). There were 9,778 white participants and 2,922 African-American participants.

Subjects with diets higher in whole milk/high-fat dairy diets were significantly less likely to develop MetS per 5-unit increase at risk ratio (RR) =.96 (0.90-1.00), for whites and RR = .81 (0.72-0.90), for African-Americans.

But whites with skim milk/low-fat dairy diets had significantly higher risks of MetS per 5-unit increase at RR = 1.11 (1.06-1.17). There was also a higher risk for African-Americans but it was not statistically significant.

There was an even bigger bump in significant risk for those with diets higher in red and processed meat per 5-unit increase at RR = 1.17 (1.12-1.23), for whites and RR=1.16 (1.08-1.25), for African-Americans.

The researchers also found evidence that whole milk/high-fat dairy diets had an even greater protective effect in whites when genetic risk was present.

What’s going on? “Maybe the fat in the [dairy] foods is holding back glucose absorption and decreasing the risk for MetS over time,” Hardy said. “This fat is different from the animal fats from meats. Fat from dairy has a shorter molecular structure chain compared to the hard animal fats. Hard animal fats are more dangerous in terms of increasing the risk of type 2 diabetes and cardiovascular diseases.”

The dairy fat, Hardy said, could also be lowering insulin secretion.

So should everyone embrace whole milk and high-fat yogurt and cottage cheese? Hardy isn’t ready to offer this advice. “I don’t think that high-fat diary per se should be recommended as a miracle food to manage or prevent MetS,” she said. “I believe that the macronutrient composition of the meals and the day’s intake should be a more important feature of the diet. In addition, frequent exercise should be recommended to manage MetS.”

More analysis of the data is ongoing, Hardy said, and her team has found signs that diets higher in nuts and peanut butter are protective against MetS in whites.

The study was funded by the National Heart, Lung, and Blood Institute. The study authors had no relevant disclosures.

SOURCE: Hardy, D. et al. 2019 ADA annual meeting Abstract 1458-P.

SAN FRANCISCO – Here’s potential bad news for everyone who dines on skim milk and non-fat yogurt: High-fat dairy products may be better for you, at least if you want to stave off metabolic syndrome (MetS), according to a new study.

Jupiterimages/Getty Images

The findings aren’t conclusive. Still, researchers found that “among whites and African- Americans, the whole milk/high-fat dairy pattern had a protective effect on the risk of metabolic syndrome,” said epidemiologist and study lead author Dale Hardy, PhD, of Morehouse School of Medicine, in an interview. She presented the study findings at the scientific sessions of the American Diabetes Association.

Hardy launched her research as part of a project that’s examining relationships between diet, genes, type 2 diabetes, and cardiovascular diseases in whites and African-Americans.

According to a 2017 study, an estimated 34% of adults in the U.S. from 2007-2012 had MetS, defined as the presence of at least 3 of these factors – elevated waist circumference, elevated triglycerides, reduced high-density lipoprotein cholesterol, high blood pressure, and elevated fasting blood glucose (Prev Chronic Dis. 2017 Mar 16;14:E24).

MetS is linked to higher rates of a variety of ills, including cardiovascular disease, kidney disease, and early death.

For the new study, Dr. Hardy and colleagues examined data from the Atherosclerosis Risk in Communities study (1987-1998) and food questionnaires (1987 and 1993). There were 9,778 white participants and 2,922 African-American participants.

Subjects with diets higher in whole milk/high-fat dairy diets were significantly less likely to develop MetS per 5-unit increase at risk ratio (RR) =.96 (0.90-1.00), for whites and RR = .81 (0.72-0.90), for African-Americans.

But whites with skim milk/low-fat dairy diets had significantly higher risks of MetS per 5-unit increase at RR = 1.11 (1.06-1.17). There was also a higher risk for African-Americans but it was not statistically significant.

There was an even bigger bump in significant risk for those with diets higher in red and processed meat per 5-unit increase at RR = 1.17 (1.12-1.23), for whites and RR=1.16 (1.08-1.25), for African-Americans.

The researchers also found evidence that whole milk/high-fat dairy diets had an even greater protective effect in whites when genetic risk was present.

What’s going on? “Maybe the fat in the [dairy] foods is holding back glucose absorption and decreasing the risk for MetS over time,” Hardy said. “This fat is different from the animal fats from meats. Fat from dairy has a shorter molecular structure chain compared to the hard animal fats. Hard animal fats are more dangerous in terms of increasing the risk of type 2 diabetes and cardiovascular diseases.”

The dairy fat, Hardy said, could also be lowering insulin secretion.

So should everyone embrace whole milk and high-fat yogurt and cottage cheese? Hardy isn’t ready to offer this advice. “I don’t think that high-fat diary per se should be recommended as a miracle food to manage or prevent MetS,” she said. “I believe that the macronutrient composition of the meals and the day’s intake should be a more important feature of the diet. In addition, frequent exercise should be recommended to manage MetS.”

More analysis of the data is ongoing, Hardy said, and her team has found signs that diets higher in nuts and peanut butter are protective against MetS in whites.

The study was funded by the National Heart, Lung, and Blood Institute. The study authors had no relevant disclosures.

SOURCE: Hardy, D. et al. 2019 ADA annual meeting Abstract 1458-P.

SAN FRANCISCO – Here’s potential bad news for everyone who dines on skim milk and non-fat yogurt: High-fat dairy products may be better for you, at least if you want to stave off metabolic syndrome (MetS), according to a new study.

Jupiterimages/Getty Images

The findings aren’t conclusive. Still, researchers found that “among whites and African- Americans, the whole milk/high-fat dairy pattern had a protective effect on the risk of metabolic syndrome,” said epidemiologist and study lead author Dale Hardy, PhD, of Morehouse School of Medicine, in an interview. She presented the study findings at the scientific sessions of the American Diabetes Association.

Hardy launched her research as part of a project that’s examining relationships between diet, genes, type 2 diabetes, and cardiovascular diseases in whites and African-Americans.

According to a 2017 study, an estimated 34% of adults in the U.S. from 2007-2012 had MetS, defined as the presence of at least 3 of these factors – elevated waist circumference, elevated triglycerides, reduced high-density lipoprotein cholesterol, high blood pressure, and elevated fasting blood glucose (Prev Chronic Dis. 2017 Mar 16;14:E24).

MetS is linked to higher rates of a variety of ills, including cardiovascular disease, kidney disease, and early death.

For the new study, Dr. Hardy and colleagues examined data from the Atherosclerosis Risk in Communities study (1987-1998) and food questionnaires (1987 and 1993). There were 9,778 white participants and 2,922 African-American participants.

Subjects with diets higher in whole milk/high-fat dairy diets were significantly less likely to develop MetS per 5-unit increase at risk ratio (RR) =.96 (0.90-1.00), for whites and RR = .81 (0.72-0.90), for African-Americans.

But whites with skim milk/low-fat dairy diets had significantly higher risks of MetS per 5-unit increase at RR = 1.11 (1.06-1.17). There was also a higher risk for African-Americans but it was not statistically significant.

There was an even bigger bump in significant risk for those with diets higher in red and processed meat per 5-unit increase at RR = 1.17 (1.12-1.23), for whites and RR=1.16 (1.08-1.25), for African-Americans.

The researchers also found evidence that whole milk/high-fat dairy diets had an even greater protective effect in whites when genetic risk was present.

What’s going on? “Maybe the fat in the [dairy] foods is holding back glucose absorption and decreasing the risk for MetS over time,” Hardy said. “This fat is different from the animal fats from meats. Fat from dairy has a shorter molecular structure chain compared to the hard animal fats. Hard animal fats are more dangerous in terms of increasing the risk of type 2 diabetes and cardiovascular diseases.”

The dairy fat, Hardy said, could also be lowering insulin secretion.

So should everyone embrace whole milk and high-fat yogurt and cottage cheese? Hardy isn’t ready to offer this advice. “I don’t think that high-fat diary per se should be recommended as a miracle food to manage or prevent MetS,” she said. “I believe that the macronutrient composition of the meals and the day’s intake should be a more important feature of the diet. In addition, frequent exercise should be recommended to manage MetS.”

More analysis of the data is ongoing, Hardy said, and her team has found signs that diets higher in nuts and peanut butter are protective against MetS in whites.

The study was funded by the National Heart, Lung, and Blood Institute. The study authors had no relevant disclosures.

SOURCE: Hardy, D. et al. 2019 ADA annual meeting Abstract 1458-P.

SAN FRANCISCO – A new meta-analysis suggests – but does not prove – that black patients with type 2 diabetes may not benefit from the widely heralded cardioprotective effects of the diabetes drugs classified as sodium-glucose transporter 2 inhibitors and glucagonlike peptide–1 receptor agonists.

“Both are excellent classes of medications that improve hemoglobin A_1c, reduce weight, and may have a renal-protective effect. But because there is no clear evidence of [their] cardiovascular benefit in [black] patients, it may remain appropriate to use other [drugs] when metformin fails,” said internist and lead study author Basem Mishriky, MD, of East Carolina University, Greenville, N.C. He spoke after the report was presented at the annual scientific sessions of the American Diabetes Association.

Dr. Mishriky cautioned that the findings of the analysis were not conclusive because the trials included in their analysis had a low number of black patients and were not powered to uncover racial differences.

Recent study results have suggested that sodium-glucose cotransporter 2 (SGLT2) inhibitors and glucagonlike peptide–1 receptor (GLP-1R) agonists have significant positive effects on cardiovascular risk. In a 2019 meta-analysis, researchers examined the results of eight trials with 60,082 participants and found that the risk of a composite measure of nonfatal stroke, nonfatal myocardial infarction, and cardiovascular mortality fell by about 12% (SGLT2 inhibitors: hazard ratio, 0.86; 95% confidence interval, 0.74-1.01 and GLP-1R agonists: HR, 0.88, 95% CI, 0.78-0.98). The study was published in Diabetic Medicine (2019;36[4]:444-52).

Dr. Mishriky and his colleagues decided to conduct their analysis after noticing the high number of white patients included in the cardiac safety trials of these medications. “We cannot assume that a drug causes benefit in [black] patients just because it improved outcomes in a population that was predominantly white,” he said. “The onset of the traditional risk factors for cardiovascular disease, such as diabetes, obesity, and hypertension, occur at an earlier age in [black] patients, and there is a high prevalence of sickle cell trait in [black] patients, which is associated with increased risk for diabetes-related complications.”

In addition, some medications, such as angiotensin-converting enzyme inhibitors, may result in lower reductions in blood pressure in black patients, compared with their white counterparts, he noted.

For the new study, Dr. Mishriky and his colleagues included six cardiovascular safety trials of medications in the two classes of drugs (two for SGLT2 inhibitors and four for GLP-1R agonists) that reported statistically significant decreases in cardiovascular risk. The trials included a total of 53,978 patients, of whom 2,794 (5%) were black.

The researchers found no significant evidence of a difference in the incidence of major adverse cardiovascular events (death from cardiovascular causes, nonfatal myocardial infarction, and nonfatal stroke) between the diabetes medications (SGLT2 inhibitors or GLP-1R agonists) and placebo among black patients with type 2 diabetes and cardiovascular disease, Dr. Mishriky said.

When the two classes of drugs were pooled, the cardiovascular risk in patients who took the drugs, compared with those who received placebo, was statistically insignificant (risk ratio, 0.97; 95% CI, 0.68-1.39, P = .88). The risk was also statistically insignificant when the SGLT2 inhibitors and GLP-1R agonists were compared separately with placebo (RR, 1.00; 95% CI, 0.47-2.14; P = .99 and RR, 0.96; 95% CI, 0.61-1.53; P = .87; respectively). A comparison of the results for the SGLT2 inhibitors and the GLP-1R agonists showed no difference either.

Dr Mishriky said the results suggest that alternative medications to SGLT2 inhibitors and GLP-1R agonists, such as pioglitazone (Actos) and dipeptidyl peptidase–4 (DPP-4) inhibitors, might be considered for black patients who fail metformin.

He noted that, given the limitations of the trials included in the analysis, additional trials with SGLT2 inhibitors and GLP-1R agonists were needed to evaluate cardiovascular benefit in black patients.

An expanded version of the meta-analysis will be published soon, he added.

Dr Mishriky and his colleagues reported no relevant disclosures.

SOURCE: Mishriky B et al. ADA 2019, Abstract 242-OR.

SAN FRANCISCO – A new meta-analysis suggests – but does not prove – that black patients with type 2 diabetes may not benefit from the widely heralded cardioprotective effects of the diabetes drugs classified as sodium-glucose transporter 2 inhibitors and glucagonlike peptide–1 receptor agonists.

“Both are excellent classes of medications that improve hemoglobin A_1c, reduce weight, and may have a renal-protective effect. But because there is no clear evidence of [their] cardiovascular benefit in [black] patients, it may remain appropriate to use other [drugs] when metformin fails,” said internist and lead study author Basem Mishriky, MD, of East Carolina University, Greenville, N.C. He spoke after the report was presented at the annual scientific sessions of the American Diabetes Association.

Dr. Mishriky cautioned that the findings of the analysis were not conclusive because the trials included in their analysis had a low number of black patients and were not powered to uncover racial differences.

Recent study results have suggested that sodium-glucose cotransporter 2 (SGLT2) inhibitors and glucagonlike peptide–1 receptor (GLP-1R) agonists have significant positive effects on cardiovascular risk. In a 2019 meta-analysis, researchers examined the results of eight trials with 60,082 participants and found that the risk of a composite measure of nonfatal stroke, nonfatal myocardial infarction, and cardiovascular mortality fell by about 12% (SGLT2 inhibitors: hazard ratio, 0.86; 95% confidence interval, 0.74-1.01 and GLP-1R agonists: HR, 0.88, 95% CI, 0.78-0.98). The study was published in Diabetic Medicine (2019;36[4]:444-52).

Dr. Mishriky and his colleagues decided to conduct their analysis after noticing the high number of white patients included in the cardiac safety trials of these medications. “We cannot assume that a drug causes benefit in [black] patients just because it improved outcomes in a population that was predominantly white,” he said. “The onset of the traditional risk factors for cardiovascular disease, such as diabetes, obesity, and hypertension, occur at an earlier age in [black] patients, and there is a high prevalence of sickle cell trait in [black] patients, which is associated with increased risk for diabetes-related complications.”

In addition, some medications, such as angiotensin-converting enzyme inhibitors, may result in lower reductions in blood pressure in black patients, compared with their white counterparts, he noted.

For the new study, Dr. Mishriky and his colleagues included six cardiovascular safety trials of medications in the two classes of drugs (two for SGLT2 inhibitors and four for GLP-1R agonists) that reported statistically significant decreases in cardiovascular risk. The trials included a total of 53,978 patients, of whom 2,794 (5%) were black.

The researchers found no significant evidence of a difference in the incidence of major adverse cardiovascular events (death from cardiovascular causes, nonfatal myocardial infarction, and nonfatal stroke) between the diabetes medications (SGLT2 inhibitors or GLP-1R agonists) and placebo among black patients with type 2 diabetes and cardiovascular disease, Dr. Mishriky said.

When the two classes of drugs were pooled, the cardiovascular risk in patients who took the drugs, compared with those who received placebo, was statistically insignificant (risk ratio, 0.97; 95% CI, 0.68-1.39, P = .88). The risk was also statistically insignificant when the SGLT2 inhibitors and GLP-1R agonists were compared separately with placebo (RR, 1.00; 95% CI, 0.47-2.14; P = .99 and RR, 0.96; 95% CI, 0.61-1.53; P = .87; respectively). A comparison of the results for the SGLT2 inhibitors and the GLP-1R agonists showed no difference either.

Dr Mishriky said the results suggest that alternative medications to SGLT2 inhibitors and GLP-1R agonists, such as pioglitazone (Actos) and dipeptidyl peptidase–4 (DPP-4) inhibitors, might be considered for black patients who fail metformin.

He noted that, given the limitations of the trials included in the analysis, additional trials with SGLT2 inhibitors and GLP-1R agonists were needed to evaluate cardiovascular benefit in black patients.

An expanded version of the meta-analysis will be published soon, he added.

Dr Mishriky and his colleagues reported no relevant disclosures.

SOURCE: Mishriky B et al. ADA 2019, Abstract 242-OR.

SAN FRANCISCO – A new meta-analysis suggests – but does not prove – that black patients with type 2 diabetes may not benefit from the widely heralded cardioprotective effects of the diabetes drugs classified as sodium-glucose transporter 2 inhibitors and glucagonlike peptide–1 receptor agonists.

“Both are excellent classes of medications that improve hemoglobin A_1c, reduce weight, and may have a renal-protective effect. But because there is no clear evidence of [their] cardiovascular benefit in [black] patients, it may remain appropriate to use other [drugs] when metformin fails,” said internist and lead study author Basem Mishriky, MD, of East Carolina University, Greenville, N.C. He spoke after the report was presented at the annual scientific sessions of the American Diabetes Association.

Dr. Mishriky cautioned that the findings of the analysis were not conclusive because the trials included in their analysis had a low number of black patients and were not powered to uncover racial differences.

Recent study results have suggested that sodium-glucose cotransporter 2 (SGLT2) inhibitors and glucagonlike peptide–1 receptor (GLP-1R) agonists have significant positive effects on cardiovascular risk. In a 2019 meta-analysis, researchers examined the results of eight trials with 60,082 participants and found that the risk of a composite measure of nonfatal stroke, nonfatal myocardial infarction, and cardiovascular mortality fell by about 12% (SGLT2 inhibitors: hazard ratio, 0.86; 95% confidence interval, 0.74-1.01 and GLP-1R agonists: HR, 0.88, 95% CI, 0.78-0.98). The study was published in Diabetic Medicine (2019;36[4]:444-52).

Dr. Mishriky and his colleagues decided to conduct their analysis after noticing the high number of white patients included in the cardiac safety trials of these medications. “We cannot assume that a drug causes benefit in [black] patients just because it improved outcomes in a population that was predominantly white,” he said. “The onset of the traditional risk factors for cardiovascular disease, such as diabetes, obesity, and hypertension, occur at an earlier age in [black] patients, and there is a high prevalence of sickle cell trait in [black] patients, which is associated with increased risk for diabetes-related complications.”

In addition, some medications, such as angiotensin-converting enzyme inhibitors, may result in lower reductions in blood pressure in black patients, compared with their white counterparts, he noted.

For the new study, Dr. Mishriky and his colleagues included six cardiovascular safety trials of medications in the two classes of drugs (two for SGLT2 inhibitors and four for GLP-1R agonists) that reported statistically significant decreases in cardiovascular risk. The trials included a total of 53,978 patients, of whom 2,794 (5%) were black.

The researchers found no significant evidence of a difference in the incidence of major adverse cardiovascular events (death from cardiovascular causes, nonfatal myocardial infarction, and nonfatal stroke) between the diabetes medications (SGLT2 inhibitors or GLP-1R agonists) and placebo among black patients with type 2 diabetes and cardiovascular disease, Dr. Mishriky said.

When the two classes of drugs were pooled, the cardiovascular risk in patients who took the drugs, compared with those who received placebo, was statistically insignificant (risk ratio, 0.97; 95% CI, 0.68-1.39, P = .88). The risk was also statistically insignificant when the SGLT2 inhibitors and GLP-1R agonists were compared separately with placebo (RR, 1.00; 95% CI, 0.47-2.14; P = .99 and RR, 0.96; 95% CI, 0.61-1.53; P = .87; respectively). A comparison of the results for the SGLT2 inhibitors and the GLP-1R agonists showed no difference either.

Dr Mishriky said the results suggest that alternative medications to SGLT2 inhibitors and GLP-1R agonists, such as pioglitazone (Actos) and dipeptidyl peptidase–4 (DPP-4) inhibitors, might be considered for black patients who fail metformin.

He noted that, given the limitations of the trials included in the analysis, additional trials with SGLT2 inhibitors and GLP-1R agonists were needed to evaluate cardiovascular benefit in black patients.

An expanded version of the meta-analysis will be published soon, he added.

Dr Mishriky and his colleagues reported no relevant disclosures.

SOURCE: Mishriky B et al. ADA 2019, Abstract 242-OR.

SAN FRANCISCO – Powerful drugs now make it possible to lower LDL cholesterol levels to dramatically low levels. But is this a good idea? There are risks, and a cardiologist urged diabetes professionals to not overdo cholesterol reduction. But a colleague argued in favor of aggressively targeting “bad” cholesterol.

Catherine Hackett

“We used to say you can’t be too rich or too thin. We now say you can’t be too rich or too thin or have a too-low LDL cholesterol,” said cardiologist Steven E. Nissen, MD, chairman of cardiovascular medicine at the Cleveland Clinic Foundation, who spoke at the annual scientific sessions of the American Diabetes Association about the wisdom of extreme LDL cholesterol lowering.

Dr. Nissen faced off in a debate with cardiologist Sanket Dhruva, MD, of the University of California, San Francisco, who doesn’t support aggressive LDL cholesterol lowering.

It is fine, Dr. Dhruva said, to treat patients so their LDL cholesterol levels drop below 100 mg/dL. “I don’t think there’s any argument there.”

But Dr. Dhruva questioned whether it’s a good idea to generally decrease LDL cholesterol well below 70 mg/dL, as is now possible with the use of proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors.

SAN FRANCISCO – Powerful drugs now make it possible to lower LDL cholesterol levels to dramatically low levels. But is this a good idea? There are risks, and a cardiologist urged diabetes professionals to not overdo cholesterol reduction. But a colleague argued in favor of aggressively targeting “bad” cholesterol.

Catherine Hackett

“We used to say you can’t be too rich or too thin. We now say you can’t be too rich or too thin or have a too-low LDL cholesterol,” said cardiologist Steven E. Nissen, MD, chairman of cardiovascular medicine at the Cleveland Clinic Foundation, who spoke at the annual scientific sessions of the American Diabetes Association about the wisdom of extreme LDL cholesterol lowering.

Dr. Nissen faced off in a debate with cardiologist Sanket Dhruva, MD, of the University of California, San Francisco, who doesn’t support aggressive LDL cholesterol lowering.

It is fine, Dr. Dhruva said, to treat patients so their LDL cholesterol levels drop below 100 mg/dL. “I don’t think there’s any argument there.”

But Dr. Dhruva questioned whether it’s a good idea to generally decrease LDL cholesterol well below 70 mg/dL, as is now possible with the use of proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors.

SAN FRANCISCO – Powerful drugs now make it possible to lower LDL cholesterol levels to dramatically low levels. But is this a good idea? There are risks, and a cardiologist urged diabetes professionals to not overdo cholesterol reduction. But a colleague argued in favor of aggressively targeting “bad” cholesterol.

Catherine Hackett

“We used to say you can’t be too rich or too thin. We now say you can’t be too rich or too thin or have a too-low LDL cholesterol,” said cardiologist Steven E. Nissen, MD, chairman of cardiovascular medicine at the Cleveland Clinic Foundation, who spoke at the annual scientific sessions of the American Diabetes Association about the wisdom of extreme LDL cholesterol lowering.

Dr. Nissen faced off in a debate with cardiologist Sanket Dhruva, MD, of the University of California, San Francisco, who doesn’t support aggressive LDL cholesterol lowering.

It is fine, Dr. Dhruva said, to treat patients so their LDL cholesterol levels drop below 100 mg/dL. “I don’t think there’s any argument there.”

But Dr. Dhruva questioned whether it’s a good idea to generally decrease LDL cholesterol well below 70 mg/dL, as is now possible with the use of proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors.

SAN FRANCISCO – New research suggests that the health of Americans with diabetes changed markedly in the past 2 decades, improving on three out of five fronts.

©Tashatuvango/Thinkstockphotos.com

As the age of statins dawned, cholesterol levels dipped dramatically, while blood pressure levels and smoking prevalence also fell. But hemoglobin A_1c levels stubbornly stayed steady, and obesity rates ballooned.

In light of the not entirely impressive numbers, “maybe we need to follow the model of team collaboration we see in the heart care setting,” said study lead author Carla I. Mercado, PhD, an epidemiologist with the Centers for Disease Control & Prevention. She spoke in an interview at the annual scientific sessions of the American Diabetes Association, where she presented the study findings.

For the new study, Dr. Mercado and colleagues used data from the National Health and Nutrition Examination Survey (NHANES) to track the health of adults with diabetes in the United States during 1999-2016. “With all the efforts on diabetes care management, we wanted to see if our efforts are making a difference in the population,” Dr. Mercado said.

The 5,534 participants had self-reported diabetes, were not pregnant, and underwent a physical examination. Throughout the periods examined (1999-2004, 2005-2010, and 2011-2016), the proportion of women remained steady at about one-half. So did the racial makeup, which ranged from 59% to 63% non-Hispanic white, 15% to 18% black, 7% to 10% Mexican-American, and 12% to 15% “other.”

Nearly half were aged 45-64, and 89%-90% had health insurance. There was a significant change in the education levels among those aged 25 and older: The percentage with at least a college degree grew from 14% in 1999-2004 to 21% in 2011-2016, while those with less than a high-school diploma fell from 34% to 23% over that period.

From 1999-2004 to 2011-2016

• Cholesterol: Most notably, the percentage of participants with non-HDL cholesterol levels below 130 mg/dL soared, from 30% to 54%. The CDC considers levels less than 100 mg/dL to be ideal. “I’m sure this is driven by medication use,” Dr. Mercado said.
• Smoking: The percentage of never smokers rose, from 44% to 47% of the subjects, while that of current smokers dropped, from 26% to 21%, a significant difference.
• Hypertension: The percentages with blood pressure levels less than 120/80 mm Hg – considered normal levels by the CDC – rose significantly, from 26% to 30%. “People are a lot more aware of blood pressure,” Dr. Mercado said.
• Glycemic control: HbA_1c levels stayed roughly steady. About 10% had levels at or above 10% in both 1999-2004 and 2011-2016, and the number with A_1c levels below 6% dipped slightly from 19% to 17%.
• Obesity: The proportion of participants with body mass index levels at or above 30 kg/m², the line between overweight and obese, rose from 54% to 61%. The percentage of those with BMIs below 25 kg/m² – considered to have normal weights – fell significantly, from 17% to 12%.

The researchers also looked at the percentage who reached ABCS goals (A_1c at or below 9%, blood pressure below 140/90 mm Hg, non-HDL cholesterol under 160 mg/dL, and current nonsmoking status). The percentage who met all of these criteria grew from 26% to 40%, while those who met three of them stayed steady (40%-39%).

The study was funded by the CDC. The study authors report no relevant disclosures.

SAN FRANCISCO – New research suggests that the health of Americans with diabetes changed markedly in the past 2 decades, improving on three out of five fronts.

©Tashatuvango/Thinkstockphotos.com

As the age of statins dawned, cholesterol levels dipped dramatically, while blood pressure levels and smoking prevalence also fell. But hemoglobin A_1c levels stubbornly stayed steady, and obesity rates ballooned.

In light of the not entirely impressive numbers, “maybe we need to follow the model of team collaboration we see in the heart care setting,” said study lead author Carla I. Mercado, PhD, an epidemiologist with the Centers for Disease Control & Prevention. She spoke in an interview at the annual scientific sessions of the American Diabetes Association, where she presented the study findings.

For the new study, Dr. Mercado and colleagues used data from the National Health and Nutrition Examination Survey (NHANES) to track the health of adults with diabetes in the United States during 1999-2016. “With all the efforts on diabetes care management, we wanted to see if our efforts are making a difference in the population,” Dr. Mercado said.

The 5,534 participants had self-reported diabetes, were not pregnant, and underwent a physical examination. Throughout the periods examined (1999-2004, 2005-2010, and 2011-2016), the proportion of women remained steady at about one-half. So did the racial makeup, which ranged from 59% to 63% non-Hispanic white, 15% to 18% black, 7% to 10% Mexican-American, and 12% to 15% “other.”

Nearly half were aged 45-64, and 89%-90% had health insurance. There was a significant change in the education levels among those aged 25 and older: The percentage with at least a college degree grew from 14% in 1999-2004 to 21% in 2011-2016, while those with less than a high-school diploma fell from 34% to 23% over that period.

From 1999-2004 to 2011-2016

• Cholesterol: Most notably, the percentage of participants with non-HDL cholesterol levels below 130 mg/dL soared, from 30% to 54%. The CDC considers levels less than 100 mg/dL to be ideal. “I’m sure this is driven by medication use,” Dr. Mercado said.
• Smoking: The percentage of never smokers rose, from 44% to 47% of the subjects, while that of current smokers dropped, from 26% to 21%, a significant difference.
• Hypertension: The percentages with blood pressure levels less than 120/80 mm Hg – considered normal levels by the CDC – rose significantly, from 26% to 30%. “People are a lot more aware of blood pressure,” Dr. Mercado said.
• Glycemic control: HbA_1c levels stayed roughly steady. About 10% had levels at or above 10% in both 1999-2004 and 2011-2016, and the number with A_1c levels below 6% dipped slightly from 19% to 17%.
• Obesity: The proportion of participants with body mass index levels at or above 30 kg/m², the line between overweight and obese, rose from 54% to 61%. The percentage of those with BMIs below 25 kg/m² – considered to have normal weights – fell significantly, from 17% to 12%.

The researchers also looked at the percentage who reached ABCS goals (A_1c at or below 9%, blood pressure below 140/90 mm Hg, non-HDL cholesterol under 160 mg/dL, and current nonsmoking status). The percentage who met all of these criteria grew from 26% to 40%, while those who met three of them stayed steady (40%-39%).

The study was funded by the CDC. The study authors report no relevant disclosures.

SAN FRANCISCO – New research suggests that the health of Americans with diabetes changed markedly in the past 2 decades, improving on three out of five fronts.

©Tashatuvango/Thinkstockphotos.com

As the age of statins dawned, cholesterol levels dipped dramatically, while blood pressure levels and smoking prevalence also fell. But hemoglobin A_1c levels stubbornly stayed steady, and obesity rates ballooned.

In light of the not entirely impressive numbers, “maybe we need to follow the model of team collaboration we see in the heart care setting,” said study lead author Carla I. Mercado, PhD, an epidemiologist with the Centers for Disease Control & Prevention. She spoke in an interview at the annual scientific sessions of the American Diabetes Association, where she presented the study findings.

For the new study, Dr. Mercado and colleagues used data from the National Health and Nutrition Examination Survey (NHANES) to track the health of adults with diabetes in the United States during 1999-2016. “With all the efforts on diabetes care management, we wanted to see if our efforts are making a difference in the population,” Dr. Mercado said.

The 5,534 participants had self-reported diabetes, were not pregnant, and underwent a physical examination. Throughout the periods examined (1999-2004, 2005-2010, and 2011-2016), the proportion of women remained steady at about one-half. So did the racial makeup, which ranged from 59% to 63% non-Hispanic white, 15% to 18% black, 7% to 10% Mexican-American, and 12% to 15% “other.”

Nearly half were aged 45-64, and 89%-90% had health insurance. There was a significant change in the education levels among those aged 25 and older: The percentage with at least a college degree grew from 14% in 1999-2004 to 21% in 2011-2016, while those with less than a high-school diploma fell from 34% to 23% over that period.

From 1999-2004 to 2011-2016

• Cholesterol: Most notably, the percentage of participants with non-HDL cholesterol levels below 130 mg/dL soared, from 30% to 54%. The CDC considers levels less than 100 mg/dL to be ideal. “I’m sure this is driven by medication use,” Dr. Mercado said.
• Smoking: The percentage of never smokers rose, from 44% to 47% of the subjects, while that of current smokers dropped, from 26% to 21%, a significant difference.
• Hypertension: The percentages with blood pressure levels less than 120/80 mm Hg – considered normal levels by the CDC – rose significantly, from 26% to 30%. “People are a lot more aware of blood pressure,” Dr. Mercado said.
• Glycemic control: HbA_1c levels stayed roughly steady. About 10% had levels at or above 10% in both 1999-2004 and 2011-2016, and the number with A_1c levels below 6% dipped slightly from 19% to 17%.
• Obesity: The proportion of participants with body mass index levels at or above 30 kg/m², the line between overweight and obese, rose from 54% to 61%. The percentage of those with BMIs below 25 kg/m² – considered to have normal weights – fell significantly, from 17% to 12%.

The researchers also looked at the percentage who reached ABCS goals (A_1c at or below 9%, blood pressure below 140/90 mm Hg, non-HDL cholesterol under 160 mg/dL, and current nonsmoking status). The percentage who met all of these criteria grew from 26% to 40%, while those who met three of them stayed steady (40%-39%).

The study was funded by the CDC. The study authors report no relevant disclosures.

SAN FRANCISCO – SGLT2 inhibitors did a better job than GLP-1 receptor agonists at preventing heart failure hospitalizations in elderly patients with type 2 diabetes, but at the cost of more strokes, myocardial infarctions, and deaths among those without preexisting cardiovascular disease, according to Harvard University investigators.

Using Medicare claims data and propensity scoring, they matched 43,609 elderly patients who started a sodium-glucose cotransporter 2 (SGLT2) inhibitor for type 2 diabetes, 77% of whom were taking canagliflozin (Invokana), to 43,609 who started a glucagonlike peptide–1 (GLP-1)–receptor agonist, 60% of whom were taking liraglutide (Victoza).

Patients were paired by age, comorbidities, diabetes severity, and dozens of other variables, more than 120 in all. The data window ran from April 2013 through December 2016.

The idea was to compare the drugs directly in order to help clinicians decide which class to choose for older patients as second-line therapy, an important consideration at a time when there’s not much guidance specifically for the elderly, and manufacturers are issuing dueling placebo-controlled trials.

Both classes have shown cardiovascular benefits, but studies were mostly in younger people with preexisting cardiovascular disease (CVD). “The comparative impact of these agents in the older population has not yet been established,” lead investigator Elisabetta Patorno, MD, DrPH, of Harvard University, Boston, said at the annual scientific sessions of the American Diabetes Association.

General themes are emerging from Dr. Patorno’s work; it seems that deciding between the two classes has a lot to do with whether the main concern is heart failure or cardiovascular events. Even so, she said, it’s too early to incorporate the observations into guidelines. The analysis is ongoing, and there are plans to compare impacts on renal disease and other problems.

In the meantime, she and her colleagues found that initiating an SGLT2 inhibitor versus a GLP-1 receptor agonist in the elderly was associated with a 34% decreased risk of heart failure hospitalization (2.5 fewer hospitalizations per 1,000 patient years), with an even larger drop among people who had preexisting CVD.

There was, however, a 41% increased risk of lower limb amputations (0.8 more events per 1,000 patient years) and a 62% increase in diabetic ketoacidosis (DKA, 1 more event), problems previously associated with the class.

Results were comparable – fewer heart failure hospitalizations but more amputations and DKA – when SGLT2 initiation was compared to initiation with dipeptidyl peptidase-4 (DPP-4) inhibitors, another second-line option for type 2 diabetes that includes sitagliptin (Januvia), among others.

There was a 25% increased relative risk of the composite primary outcome of myocardial infarction, stroke, and all-cause mortality when patients without baseline CVD were started on an SGLT2 inhibitor instead of a GLP-1 receptor agonist (3.7 more events per 1,000 patient years). There was no increased risk among patients who already had CVD.

SGLT2 initiation actually had a protective effect, compared with dipeptidyl peptidase-4 inhibitors, with a 23% decreased risk of the composite outcome (6.5 fewer events) among patients both with and without baseline CVD. The findings were all statistically significant.

The average age in the study was 71.5 years; 45% of the subjects were men; 40% had a history of cardiovascular disease; and 60% were on metformin and 24% on insulin at study entry.

The work was funded by the National Institutes of Health. Dr. Patorno disclosed research grants form Boehringer Ingelheim and GlaxoSmithKline. Other investigators reported relationships with numerous pharmaceutical companies.

aotto@mdedge.com

SAN FRANCISCO – SGLT2 inhibitors did a better job than GLP-1 receptor agonists at preventing heart failure hospitalizations in elderly patients with type 2 diabetes, but at the cost of more strokes, myocardial infarctions, and deaths among those without preexisting cardiovascular disease, according to Harvard University investigators.

Using Medicare claims data and propensity scoring, they matched 43,609 elderly patients who started a sodium-glucose cotransporter 2 (SGLT2) inhibitor for type 2 diabetes, 77% of whom were taking canagliflozin (Invokana), to 43,609 who started a glucagonlike peptide–1 (GLP-1)–receptor agonist, 60% of whom were taking liraglutide (Victoza).

Patients were paired by age, comorbidities, diabetes severity, and dozens of other variables, more than 120 in all. The data window ran from April 2013 through December 2016.

The idea was to compare the drugs directly in order to help clinicians decide which class to choose for older patients as second-line therapy, an important consideration at a time when there’s not much guidance specifically for the elderly, and manufacturers are issuing dueling placebo-controlled trials.

Both classes have shown cardiovascular benefits, but studies were mostly in younger people with preexisting cardiovascular disease (CVD). “The comparative impact of these agents in the older population has not yet been established,” lead investigator Elisabetta Patorno, MD, DrPH, of Harvard University, Boston, said at the annual scientific sessions of the American Diabetes Association.

General themes are emerging from Dr. Patorno’s work; it seems that deciding between the two classes has a lot to do with whether the main concern is heart failure or cardiovascular events. Even so, she said, it’s too early to incorporate the observations into guidelines. The analysis is ongoing, and there are plans to compare impacts on renal disease and other problems.

In the meantime, she and her colleagues found that initiating an SGLT2 inhibitor versus a GLP-1 receptor agonist in the elderly was associated with a 34% decreased risk of heart failure hospitalization (2.5 fewer hospitalizations per 1,000 patient years), with an even larger drop among people who had preexisting CVD.

There was, however, a 41% increased risk of lower limb amputations (0.8 more events per 1,000 patient years) and a 62% increase in diabetic ketoacidosis (DKA, 1 more event), problems previously associated with the class.

Results were comparable – fewer heart failure hospitalizations but more amputations and DKA – when SGLT2 initiation was compared to initiation with dipeptidyl peptidase-4 (DPP-4) inhibitors, another second-line option for type 2 diabetes that includes sitagliptin (Januvia), among others.

There was a 25% increased relative risk of the composite primary outcome of myocardial infarction, stroke, and all-cause mortality when patients without baseline CVD were started on an SGLT2 inhibitor instead of a GLP-1 receptor agonist (3.7 more events per 1,000 patient years). There was no increased risk among patients who already had CVD.

SGLT2 initiation actually had a protective effect, compared with dipeptidyl peptidase-4 inhibitors, with a 23% decreased risk of the composite outcome (6.5 fewer events) among patients both with and without baseline CVD. The findings were all statistically significant.

The average age in the study was 71.5 years; 45% of the subjects were men; 40% had a history of cardiovascular disease; and 60% were on metformin and 24% on insulin at study entry.

The work was funded by the National Institutes of Health. Dr. Patorno disclosed research grants form Boehringer Ingelheim and GlaxoSmithKline. Other investigators reported relationships with numerous pharmaceutical companies.

aotto@mdedge.com

SAN FRANCISCO – SGLT2 inhibitors did a better job than GLP-1 receptor agonists at preventing heart failure hospitalizations in elderly patients with type 2 diabetes, but at the cost of more strokes, myocardial infarctions, and deaths among those without preexisting cardiovascular disease, according to Harvard University investigators.

Using Medicare claims data and propensity scoring, they matched 43,609 elderly patients who started a sodium-glucose cotransporter 2 (SGLT2) inhibitor for type 2 diabetes, 77% of whom were taking canagliflozin (Invokana), to 43,609 who started a glucagonlike peptide–1 (GLP-1)–receptor agonist, 60% of whom were taking liraglutide (Victoza).

Patients were paired by age, comorbidities, diabetes severity, and dozens of other variables, more than 120 in all. The data window ran from April 2013 through December 2016.

The idea was to compare the drugs directly in order to help clinicians decide which class to choose for older patients as second-line therapy, an important consideration at a time when there’s not much guidance specifically for the elderly, and manufacturers are issuing dueling placebo-controlled trials.

Both classes have shown cardiovascular benefits, but studies were mostly in younger people with preexisting cardiovascular disease (CVD). “The comparative impact of these agents in the older population has not yet been established,” lead investigator Elisabetta Patorno, MD, DrPH, of Harvard University, Boston, said at the annual scientific sessions of the American Diabetes Association.

General themes are emerging from Dr. Patorno’s work; it seems that deciding between the two classes has a lot to do with whether the main concern is heart failure or cardiovascular events. Even so, she said, it’s too early to incorporate the observations into guidelines. The analysis is ongoing, and there are plans to compare impacts on renal disease and other problems.

In the meantime, she and her colleagues found that initiating an SGLT2 inhibitor versus a GLP-1 receptor agonist in the elderly was associated with a 34% decreased risk of heart failure hospitalization (2.5 fewer hospitalizations per 1,000 patient years), with an even larger drop among people who had preexisting CVD.

There was, however, a 41% increased risk of lower limb amputations (0.8 more events per 1,000 patient years) and a 62% increase in diabetic ketoacidosis (DKA, 1 more event), problems previously associated with the class.

Results were comparable – fewer heart failure hospitalizations but more amputations and DKA – when SGLT2 initiation was compared to initiation with dipeptidyl peptidase-4 (DPP-4) inhibitors, another second-line option for type 2 diabetes that includes sitagliptin (Januvia), among others.

There was a 25% increased relative risk of the composite primary outcome of myocardial infarction, stroke, and all-cause mortality when patients without baseline CVD were started on an SGLT2 inhibitor instead of a GLP-1 receptor agonist (3.7 more events per 1,000 patient years). There was no increased risk among patients who already had CVD.

SGLT2 initiation actually had a protective effect, compared with dipeptidyl peptidase-4 inhibitors, with a 23% decreased risk of the composite outcome (6.5 fewer events) among patients both with and without baseline CVD. The findings were all statistically significant.

The average age in the study was 71.5 years; 45% of the subjects were men; 40% had a history of cardiovascular disease; and 60% were on metformin and 24% on insulin at study entry.

The work was funded by the National Institutes of Health. Dr. Patorno disclosed research grants form Boehringer Ingelheim and GlaxoSmithKline. Other investigators reported relationships with numerous pharmaceutical companies.

aotto@mdedge.com

The Centers for Disease Control and Prevention will activate its Emergency Operations Center in Atlanta on June 13 to consolidate efforts against an ongoing Ebola outbreak in the Democratic Republic of the Congo (DRC). With over 2,000 confirmed cases, the outbreak is the second largest ever recorded.

It recently spread to neighboring Uganda, by a family who crossed the border from the DRC.

As of June 11, 187 CDC staff have completed 278 deployments to the DRC, Uganda, and other neighboring countries, as well as to the World Health Organization in Geneva.

“We are activating the Emergency Operations Center at CDC headquarters to provide enhanced operational support to our” Ebola response team in the Congo. The level 3 activation – the lowest level – “allows the agency to provide increased operational support” and “logistics planning for a longer term, sustained effort,” CDC said in a press release.

Activation “does not mean that the threat of Ebola to the United States has increased.” The risk of global spread remains low, CDC said.

The outbreak is occurring in an area of armed conflict and other problems that complicate public health efforts and increase the risk of disease spread.

aotto@mdedge.com

The Centers for Disease Control and Prevention will activate its Emergency Operations Center in Atlanta on June 13 to consolidate efforts against an ongoing Ebola outbreak in the Democratic Republic of the Congo (DRC). With over 2,000 confirmed cases, the outbreak is the second largest ever recorded.

It recently spread to neighboring Uganda, by a family who crossed the border from the DRC.

As of June 11, 187 CDC staff have completed 278 deployments to the DRC, Uganda, and other neighboring countries, as well as to the World Health Organization in Geneva.

“We are activating the Emergency Operations Center at CDC headquarters to provide enhanced operational support to our” Ebola response team in the Congo. The level 3 activation – the lowest level – “allows the agency to provide increased operational support” and “logistics planning for a longer term, sustained effort,” CDC said in a press release.

Activation “does not mean that the threat of Ebola to the United States has increased.” The risk of global spread remains low, CDC said.

The outbreak is occurring in an area of armed conflict and other problems that complicate public health efforts and increase the risk of disease spread.

aotto@mdedge.com

The Centers for Disease Control and Prevention will activate its Emergency Operations Center in Atlanta on June 13 to consolidate efforts against an ongoing Ebola outbreak in the Democratic Republic of the Congo (DRC). With over 2,000 confirmed cases, the outbreak is the second largest ever recorded.

It recently spread to neighboring Uganda, by a family who crossed the border from the DRC.

As of June 11, 187 CDC staff have completed 278 deployments to the DRC, Uganda, and other neighboring countries, as well as to the World Health Organization in Geneva.

“We are activating the Emergency Operations Center at CDC headquarters to provide enhanced operational support to our” Ebola response team in the Congo. The level 3 activation – the lowest level – “allows the agency to provide increased operational support” and “logistics planning for a longer term, sustained effort,” CDC said in a press release.

Activation “does not mean that the threat of Ebola to the United States has increased.” The risk of global spread remains low, CDC said.

The outbreak is occurring in an area of armed conflict and other problems that complicate public health efforts and increase the risk of disease spread.

aotto@mdedge.com

SAN FRANCISCO – Most patients with diabetes should aim to spend at least 17 hours a day – more than 70% of their time – in a blood glucose range of 70-180 mg/dL, according to new guidelines for continuous glucose monitoring presented at the annual scientific sessions of the American Diabetes Association.

M. Alexander Otto/MDedge News

Time spent below 70 mg/dL should be less than 1 hour a day, under 4% of the time in other words, and time spent below 54 mg/dL – the cut point for potentially serious hypoglycemia – less than 15 minutes (1%). Time spent at or above 180 mg/dL should be less than 6 hours (25%) a day, and above 250 mg/dL – the cut point for potentially serious hyperglycemia – less than 1 hour and 15 minutes (5%).

The advice comes from an international panel of diabetologists, researchers, and patients convened at the Advanced Technologies and Treatments for Diabetes Congress in Berlin earlier this year.

The goal was to give clinicians and patients handy treatment targets for continuous glucose monitors (CGMs), something that has been missing until now. The targets “should be considered an integral component of CGM data analysis and day-to-day treatment decision making,” said lead author Tadej Battelino, MD, PhD, head of the department of pediatric and adolescent endocrinology at Ljubljana (Slovenia) University, who presented the guidelines at the meeting.

The ADA, the European Association for the Study of Diabetes, and other leading diabetes groups have endorsed them.

CGMs have always offered the promise of tighter glycemic control, and their use is expanding, but they still have not led to a robust improvement in diabetes management, and in at least one study, they actually deteriorated control. There has been doubt about how to use them.

Dr. Battelino and associates thought that the main problem was a lack of clear, easy-to-understand treatment goals. The ADA and others previously recommended a CGM target of 70-180 mg/dL, but stopped short of saying how long people should be in that and other ranges. The new guidelines close the gap by adding the key element of duration.

“We ... pretty much defined what we believe is a safe way to live with diabetes,” Dr. Battelino said at the meeting. The work was based on literature review and expert opinion.

He and his colleagues noted in their journal write-up that for many the goals will be aspirational, but patients and doctors should not give up. The important thing is incremental change, with the hope of eventually meeting the targets. Even a small time-in-range increase reduces the risk of retinopathy and nephropathy, and improves hemoglobin A_1c levels.

“You don’t have to get there all at once. Everyone needs to know that, whether they’re 14 or 44,” said coauthor Irl B. Hirsch, MD, chair of diabetes treatment and teaching at the University of Washington, Seattle, who moderated Dr. Battelino’s presentation.

To make the guidelines operational, the team created a simple, intuitive version of the ambulatory glucose profile they hope will be accepted as the new standard by CGM makers and included in device software. It reports the percentage of time in the 70-180 mg/dL range in green, the percentage below range in red, and the percentage above range in yellow. With a glance, both patients and doctors will know what is going on day by day, and what, if anything, needs to change.

The time-in-range bar was set at 50% for older and sicker patients, but their time-below-range goal was reduced from 4% to 1%, to emphasize the need to prevent hypoglycemia.

The target range was lowered for pregnant women to 63-140 mg/dL at least 70% of the time, because blood glucose levels are lower in pregnancy. However, “greater emphasis should be placed on getting to goal as soon as possible” with pregnant women and those planning to get pregnant, the panel said.

The work was funded by a number of companies, including Abbott, AstraZeneca, Dexcom, Eli Lilly, Medtronic, and Novo Nordisk. Dr. Battelino, Dr. Hirsch, and their coauthors reported various ties to those and other companies.

SOURCE: Battelino T et al. Diabetes Care. 2019 Jun 8. doi: 10.2337/dci19-0028.

SAN FRANCISCO – Most patients with diabetes should aim to spend at least 17 hours a day – more than 70% of their time – in a blood glucose range of 70-180 mg/dL, according to new guidelines for continuous glucose monitoring presented at the annual scientific sessions of the American Diabetes Association.

M. Alexander Otto/MDedge News

Time spent below 70 mg/dL should be less than 1 hour a day, under 4% of the time in other words, and time spent below 54 mg/dL – the cut point for potentially serious hypoglycemia – less than 15 minutes (1%). Time spent at or above 180 mg/dL should be less than 6 hours (25%) a day, and above 250 mg/dL – the cut point for potentially serious hyperglycemia – less than 1 hour and 15 minutes (5%).

The advice comes from an international panel of diabetologists, researchers, and patients convened at the Advanced Technologies and Treatments for Diabetes Congress in Berlin earlier this year.

The goal was to give clinicians and patients handy treatment targets for continuous glucose monitors (CGMs), something that has been missing until now. The targets “should be considered an integral component of CGM data analysis and day-to-day treatment decision making,” said lead author Tadej Battelino, MD, PhD, head of the department of pediatric and adolescent endocrinology at Ljubljana (Slovenia) University, who presented the guidelines at the meeting.

The ADA, the European Association for the Study of Diabetes, and other leading diabetes groups have endorsed them.

CGMs have always offered the promise of tighter glycemic control, and their use is expanding, but they still have not led to a robust improvement in diabetes management, and in at least one study, they actually deteriorated control. There has been doubt about how to use them.

Dr. Battelino and associates thought that the main problem was a lack of clear, easy-to-understand treatment goals. The ADA and others previously recommended a CGM target of 70-180 mg/dL, but stopped short of saying how long people should be in that and other ranges. The new guidelines close the gap by adding the key element of duration.

“We ... pretty much defined what we believe is a safe way to live with diabetes,” Dr. Battelino said at the meeting. The work was based on literature review and expert opinion.

He and his colleagues noted in their journal write-up that for many the goals will be aspirational, but patients and doctors should not give up. The important thing is incremental change, with the hope of eventually meeting the targets. Even a small time-in-range increase reduces the risk of retinopathy and nephropathy, and improves hemoglobin A_1c levels.

“You don’t have to get there all at once. Everyone needs to know that, whether they’re 14 or 44,” said coauthor Irl B. Hirsch, MD, chair of diabetes treatment and teaching at the University of Washington, Seattle, who moderated Dr. Battelino’s presentation.

To make the guidelines operational, the team created a simple, intuitive version of the ambulatory glucose profile they hope will be accepted as the new standard by CGM makers and included in device software. It reports the percentage of time in the 70-180 mg/dL range in green, the percentage below range in red, and the percentage above range in yellow. With a glance, both patients and doctors will know what is going on day by day, and what, if anything, needs to change.

The time-in-range bar was set at 50% for older and sicker patients, but their time-below-range goal was reduced from 4% to 1%, to emphasize the need to prevent hypoglycemia.

The target range was lowered for pregnant women to 63-140 mg/dL at least 70% of the time, because blood glucose levels are lower in pregnancy. However, “greater emphasis should be placed on getting to goal as soon as possible” with pregnant women and those planning to get pregnant, the panel said.

The work was funded by a number of companies, including Abbott, AstraZeneca, Dexcom, Eli Lilly, Medtronic, and Novo Nordisk. Dr. Battelino, Dr. Hirsch, and their coauthors reported various ties to those and other companies.

SOURCE: Battelino T et al. Diabetes Care. 2019 Jun 8. doi: 10.2337/dci19-0028.

SAN FRANCISCO – Most patients with diabetes should aim to spend at least 17 hours a day – more than 70% of their time – in a blood glucose range of 70-180 mg/dL, according to new guidelines for continuous glucose monitoring presented at the annual scientific sessions of the American Diabetes Association.

M. Alexander Otto/MDedge News

Time spent below 70 mg/dL should be less than 1 hour a day, under 4% of the time in other words, and time spent below 54 mg/dL – the cut point for potentially serious hypoglycemia – less than 15 minutes (1%). Time spent at or above 180 mg/dL should be less than 6 hours (25%) a day, and above 250 mg/dL – the cut point for potentially serious hyperglycemia – less than 1 hour and 15 minutes (5%).

The advice comes from an international panel of diabetologists, researchers, and patients convened at the Advanced Technologies and Treatments for Diabetes Congress in Berlin earlier this year.

The goal was to give clinicians and patients handy treatment targets for continuous glucose monitors (CGMs), something that has been missing until now. The targets “should be considered an integral component of CGM data analysis and day-to-day treatment decision making,” said lead author Tadej Battelino, MD, PhD, head of the department of pediatric and adolescent endocrinology at Ljubljana (Slovenia) University, who presented the guidelines at the meeting.

The ADA, the European Association for the Study of Diabetes, and other leading diabetes groups have endorsed them.

CGMs have always offered the promise of tighter glycemic control, and their use is expanding, but they still have not led to a robust improvement in diabetes management, and in at least one study, they actually deteriorated control. There has been doubt about how to use them.

Dr. Battelino and associates thought that the main problem was a lack of clear, easy-to-understand treatment goals. The ADA and others previously recommended a CGM target of 70-180 mg/dL, but stopped short of saying how long people should be in that and other ranges. The new guidelines close the gap by adding the key element of duration.

“We ... pretty much defined what we believe is a safe way to live with diabetes,” Dr. Battelino said at the meeting. The work was based on literature review and expert opinion.

He and his colleagues noted in their journal write-up that for many the goals will be aspirational, but patients and doctors should not give up. The important thing is incremental change, with the hope of eventually meeting the targets. Even a small time-in-range increase reduces the risk of retinopathy and nephropathy, and improves hemoglobin A_1c levels.

“You don’t have to get there all at once. Everyone needs to know that, whether they’re 14 or 44,” said coauthor Irl B. Hirsch, MD, chair of diabetes treatment and teaching at the University of Washington, Seattle, who moderated Dr. Battelino’s presentation.

To make the guidelines operational, the team created a simple, intuitive version of the ambulatory glucose profile they hope will be accepted as the new standard by CGM makers and included in device software. It reports the percentage of time in the 70-180 mg/dL range in green, the percentage below range in red, and the percentage above range in yellow. With a glance, both patients and doctors will know what is going on day by day, and what, if anything, needs to change.

The time-in-range bar was set at 50% for older and sicker patients, but their time-below-range goal was reduced from 4% to 1%, to emphasize the need to prevent hypoglycemia.

The target range was lowered for pregnant women to 63-140 mg/dL at least 70% of the time, because blood glucose levels are lower in pregnancy. However, “greater emphasis should be placed on getting to goal as soon as possible” with pregnant women and those planning to get pregnant, the panel said.

The work was funded by a number of companies, including Abbott, AstraZeneca, Dexcom, Eli Lilly, Medtronic, and Novo Nordisk. Dr. Battelino, Dr. Hirsch, and their coauthors reported various ties to those and other companies.

SOURCE: Battelino T et al. Diabetes Care. 2019 Jun 8. doi: 10.2337/dci19-0028.

SAN FRANCISCO – Women with breast cancer faced an adjusted 23% higher risk of developing diabetes during the 5 years after their diagnosis, a new Danish study finds.

Randy Dotinga/MDedge News

The findings are “quite a clear signal of increased diabetes following breast cancer,” said epidemiologist and study coauthor Reimar W. Thomsen, MD, PhD, of Aarhus (Denmark) University Hospital, in an interview. “It’s very important to tell [patients with breast cancer] what they may expect in the long term.”

He spoke at the annual scientific sessions of the American Diabetes Association, where he presented the study findings.

Much of the research into links between breast cancer and diabetes has focused on whether diabetes is a risk factor for breast cancer, and not the other way around. A 2018 meta-analysis of 18 studies found a slightly higher risk of breast cancer in women with diabetes (summary relative risk, 1.13; 95% confidence interval, 1.04-1.24). However, the researchers found evidence that the risk factor might be adiposity, and not diabetes itself (Diabetes. 2018 Jul;67[Supplement 1]. doi: 10.2337/db18-180-OR).

For the new study, researchers used health registries to track women in Denmark for up to 12 years, during 2005-2016. They compared 33,909 women who were older than 50 years and who had new-onset breast cancer with 313,998 women without breast cancer in a matched comparison cohort. The average age in both groups was 66 years; obesity was rare (4% vs. 3%, respectively), but statin therapy (21% in both groups) and hormone replacement therapy (36% vs. 32%) were more prevalent.

In the first year after a breast cancer diagnosis, the women in the breast cancer group were 15% more likely to develop diabetes (per use of diabetes medication or hospital-diagnosed diabetes) than those in the comparison group (adjusted hazard ratio, 1.15; 95% CI, 1.01-1.30) with adjustments for factors such as age, marital status, residence, medical history, medications, and comorbidity.

Over a median follow-up period of 5.2 years, the risk of diabetes was 23% higher in the breast cancer group, at 8.4 new cases per 1,000 women, compared with 6.8 new cases per 1,000 women in the comparison group (aHR, 1.23; 95% CI, 1.16-1.30). Unadjusted hazard ratios were similar.

Women in the breast cancer group who developed diabetes were more likely to use insulin-based therapy, suggesting they had more severe diabetes, compared with those in the control group (5% vs. 2%, respectively; P less than .00001). They were also more likely to be treated with insulin only (4% vs. 1%, P less than .00001).

It is not clear why patients with breast cancer face a higher risk of diabetes. Dr. Thomsen speculated that cancer drugs might play a role and he noted that cancer itself can cause inflammation and “lead to consequences.”

A 2018 study linked usage of hormone therapies, including tamoxifen (HR, 2.25; 95% CI, 1.19-4.26; P = .013) and aromatase inhibitors (HR, 4.27;95% CI, 1.42-12.84), in patients with breast cancer to higher levels of diabetes, compared with patients who did not use hormone therapy (J Clin Oncol. 2018;36[20]:2061-9).

Dr. Thomsen emphasized that physicians should monitor patients with breast cancer for diabetes. “It develops over time, and the risk is increasing, so you need to be aware of that.”

No study funding was reported. One of the researchers reported numerous ties to a range of drug companies. Dr. Thomsen and the other researchers reported no relevant disclosures.

SAN FRANCISCO – Women with breast cancer faced an adjusted 23% higher risk of developing diabetes during the 5 years after their diagnosis, a new Danish study finds.

Randy Dotinga/MDedge News

The findings are “quite a clear signal of increased diabetes following breast cancer,” said epidemiologist and study coauthor Reimar W. Thomsen, MD, PhD, of Aarhus (Denmark) University Hospital, in an interview. “It’s very important to tell [patients with breast cancer] what they may expect in the long term.”

He spoke at the annual scientific sessions of the American Diabetes Association, where he presented the study findings.

Much of the research into links between breast cancer and diabetes has focused on whether diabetes is a risk factor for breast cancer, and not the other way around. A 2018 meta-analysis of 18 studies found a slightly higher risk of breast cancer in women with diabetes (summary relative risk, 1.13; 95% confidence interval, 1.04-1.24). However, the researchers found evidence that the risk factor might be adiposity, and not diabetes itself (Diabetes. 2018 Jul;67[Supplement 1]. doi: 10.2337/db18-180-OR).

For the new study, researchers used health registries to track women in Denmark for up to 12 years, during 2005-2016. They compared 33,909 women who were older than 50 years and who had new-onset breast cancer with 313,998 women without breast cancer in a matched comparison cohort. The average age in both groups was 66 years; obesity was rare (4% vs. 3%, respectively), but statin therapy (21% in both groups) and hormone replacement therapy (36% vs. 32%) were more prevalent.

In the first year after a breast cancer diagnosis, the women in the breast cancer group were 15% more likely to develop diabetes (per use of diabetes medication or hospital-diagnosed diabetes) than those in the comparison group (adjusted hazard ratio, 1.15; 95% CI, 1.01-1.30) with adjustments for factors such as age, marital status, residence, medical history, medications, and comorbidity.

Over a median follow-up period of 5.2 years, the risk of diabetes was 23% higher in the breast cancer group, at 8.4 new cases per 1,000 women, compared with 6.8 new cases per 1,000 women in the comparison group (aHR, 1.23; 95% CI, 1.16-1.30). Unadjusted hazard ratios were similar.

Women in the breast cancer group who developed diabetes were more likely to use insulin-based therapy, suggesting they had more severe diabetes, compared with those in the control group (5% vs. 2%, respectively; P less than .00001). They were also more likely to be treated with insulin only (4% vs. 1%, P less than .00001).

It is not clear why patients with breast cancer face a higher risk of diabetes. Dr. Thomsen speculated that cancer drugs might play a role and he noted that cancer itself can cause inflammation and “lead to consequences.”

A 2018 study linked usage of hormone therapies, including tamoxifen (HR, 2.25; 95% CI, 1.19-4.26; P = .013) and aromatase inhibitors (HR, 4.27;95% CI, 1.42-12.84), in patients with breast cancer to higher levels of diabetes, compared with patients who did not use hormone therapy (J Clin Oncol. 2018;36[20]:2061-9).

Dr. Thomsen emphasized that physicians should monitor patients with breast cancer for diabetes. “It develops over time, and the risk is increasing, so you need to be aware of that.”

No study funding was reported. One of the researchers reported numerous ties to a range of drug companies. Dr. Thomsen and the other researchers reported no relevant disclosures.

SAN FRANCISCO – Women with breast cancer faced an adjusted 23% higher risk of developing diabetes during the 5 years after their diagnosis, a new Danish study finds.

Randy Dotinga/MDedge News

The findings are “quite a clear signal of increased diabetes following breast cancer,” said epidemiologist and study coauthor Reimar W. Thomsen, MD, PhD, of Aarhus (Denmark) University Hospital, in an interview. “It’s very important to tell [patients with breast cancer] what they may expect in the long term.”

He spoke at the annual scientific sessions of the American Diabetes Association, where he presented the study findings.

Much of the research into links between breast cancer and diabetes has focused on whether diabetes is a risk factor for breast cancer, and not the other way around. A 2018 meta-analysis of 18 studies found a slightly higher risk of breast cancer in women with diabetes (summary relative risk, 1.13; 95% confidence interval, 1.04-1.24). However, the researchers found evidence that the risk factor might be adiposity, and not diabetes itself (Diabetes. 2018 Jul;67[Supplement 1]. doi: 10.2337/db18-180-OR).

For the new study, researchers used health registries to track women in Denmark for up to 12 years, during 2005-2016. They compared 33,909 women who were older than 50 years and who had new-onset breast cancer with 313,998 women without breast cancer in a matched comparison cohort. The average age in both groups was 66 years; obesity was rare (4% vs. 3%, respectively), but statin therapy (21% in both groups) and hormone replacement therapy (36% vs. 32%) were more prevalent.

In the first year after a breast cancer diagnosis, the women in the breast cancer group were 15% more likely to develop diabetes (per use of diabetes medication or hospital-diagnosed diabetes) than those in the comparison group (adjusted hazard ratio, 1.15; 95% CI, 1.01-1.30) with adjustments for factors such as age, marital status, residence, medical history, medications, and comorbidity.

Over a median follow-up period of 5.2 years, the risk of diabetes was 23% higher in the breast cancer group, at 8.4 new cases per 1,000 women, compared with 6.8 new cases per 1,000 women in the comparison group (aHR, 1.23; 95% CI, 1.16-1.30). Unadjusted hazard ratios were similar.

Women in the breast cancer group who developed diabetes were more likely to use insulin-based therapy, suggesting they had more severe diabetes, compared with those in the control group (5% vs. 2%, respectively; P less than .00001). They were also more likely to be treated with insulin only (4% vs. 1%, P less than .00001).

It is not clear why patients with breast cancer face a higher risk of diabetes. Dr. Thomsen speculated that cancer drugs might play a role and he noted that cancer itself can cause inflammation and “lead to consequences.”

A 2018 study linked usage of hormone therapies, including tamoxifen (HR, 2.25; 95% CI, 1.19-4.26; P = .013) and aromatase inhibitors (HR, 4.27;95% CI, 1.42-12.84), in patients with breast cancer to higher levels of diabetes, compared with patients who did not use hormone therapy (J Clin Oncol. 2018;36[20]:2061-9).

Dr. Thomsen emphasized that physicians should monitor patients with breast cancer for diabetes. “It develops over time, and the risk is increasing, so you need to be aware of that.”

No study funding was reported. One of the researchers reported numerous ties to a range of drug companies. Dr. Thomsen and the other researchers reported no relevant disclosures.

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.