Randy Dotinga

SAN FRANCISCO – At first, the diabetes professionals in the audience at the annual scientific sessions of the American Diabetes Association overwhelmingly raised their hands to say they would support using SGLT2 inhibitors as adjunctive therapy in patients with type 1 diabetes. Then two physicians debated whether the drugs were too risky – predictably, one said yes, the other said no. In the end, most of the audience was unconvinced by one of the doctors. Which one? Well, we’ll get to that.

First, let’s look at the issue that divided the two physicians: Should the sodium-glucose cotransporter 2 (SGLT2) inhibitors canagliflozin (Invokana), dapagliflozin (Farxiga), and empagliflozin (Jardiance) – now commonly used to treat patients with type 2 diabetes – also be prescribed for patients with type 1 diabetes?

The drugs are not cleared in the United States for use in patients with type 1 diabetes, although drug makers are seeking approval. Earlier in 2019, the Food and Drug Administration turned down a request for the approval of sotagliflozin (Zynquista), a dual SGLT1 and SGLT2 inhibitor, for adults with type 1 diabetes. However, the drug has been approved in the European Union for certain overweight patients with type 1 diabetes.

In addition, the drugs are very costly, compared with some of the other diabetes medications, and physicians say that puts them out of reach for some patients.
 

The case for ...

In arguing that SGLT2 inhibitors would be appropriate as a therapy for patients with type 1 diabetes, Bruce A. Perkins, MD, MPH, professor and clinician-scientist at Leadership Sinai Center for Diabetes at the University of Toronto, emphasized the need for new treatments in type 1 diabetes.

“Even today, people with type 1 tell us they feel isolated, they fear hypoglycemia, they fear complications. And they have this undue burden of self-management,” he said. “We can do much better. Insulin therapy still needs us desperately needing more.”

Dr. Perkins highlighted the drugs’ widely lauded effects on cardiac and renal health and noted that a 2019 meta-analysis of 10 trials found that, compared with placebo, the drugs were associated with mean reductions in hemoglobin A_1c (–0.39%; 95% confidence interval, –0.43 to –0.36) and body weight (–3.47%; 95% CI, –3.78 to –3.16).

That analysis also showed a higher risk of genital infection (3.57; 95% CI, 2.97-4.29) and diabetic ketoacidosis (DKA; 3.11; 95% CI, 2.11-4.58) with SGLT inhibitors, but the authors concluded that, despite the adverse events, the available data suggested that adding the inhibitors to basal insulin could be beneficial in patients with type 1 diabetes (Diabetes Metab Res Rev. 2019 Apr 11. doi: 10.1002/dmrr.3169).

In reference to the findings on DKA, Dr. Perkins said recent research has suggested that the DKA risk could be lowered by decreasing the dose of the SGLT2 inhibitors. “[DKA] is a problem, there’s no question, but there’s a background population risk. Whether we introduce an SGLT2 or not, we have to deal with this issue. We can deal with and overcome the excess DKA risk.”

In the big picture, he said, “it would be a crime not to make this treatment available to some patients. Meaningful benefits far outweigh the risks.”
 

The case against ...

On the other side of the debate was David M. Nathan, MD, of Harvard Medical School and the Clinical Research Center and Diabetes Center at Massachusetts General Hospital, Boston, who acknowledged the benefits of the SGLT2 inhibitors in type 2 diabetes.

However, he pointed to findings from a 2015 trial of canagliflozin as an add-on in type 1 diabetes (Diabetes Care. 2015;38[12]:2258-65). In that 18-week, randomized phase 2 trial, the investigators found that patients who took the drug had significantly higher rates of serious adverse events (7.7% or 6.8%, depending on dose, vs. 0% for placebo), urinary tract infections (4.3% and 5.1% vs. 1.7%), and DKA (4.3% and 6.0% vs. 0%).

“It would have cost $400 a month for the ‘pleasure’ of those side effects,” Dr. Nathan said.

He also noted a 2015 report on a 29-day, randomized, placebo-controlled study of sotagliflozin, the dual SGLT1 and SGLT2 inhibitor drug, as an add-on treatment for type 1 diabetes, in which investigators reported two episodes of DKA (13%) in the SGLT2 group, compared with none in placebo (Diabetes Care. 2015;38[7]:1181-8).

Dr. Nathan also pointed to a recent FDA warning about cases of Fournier gangrene, a rare type of serious genital infection, in patients taking SGLT2 inhibitors.

“To me, the risk [of using SGLT2 inhibitors in type 1 diabetes] outweighs the benefit by a lot,” he said, echoing comments he made in an editorial he wrote in 2017, that “any added benefits of adjunctive therapies for type 1 diabetes must be carefully balanced against their added risk and cost. Physicians and patients should beware” (N Engl J Med. 2017; 377:2390-1).
 

The outcome...

The audience was not sufficiently convinced by Dr. Nathan to swing the final vote fully in his favor, but he did manage to dent the initial support for using SGLT2 inhibitors in patients with type 1 disease. Before the debate, the show of hands suggested that roughly 80% of the audience thought SGLT2 inhibitors would be an appropriate therapy option for patients with type 1 diabetes. When the moderator asked the same question again after the arguments had been presented, that initial support had been eroded to about 70%. Dr. Nathan had clearly raised some doubts among the attendees, but Dr. Perkins’ perspective prevailed.

Dr. Perkins reported speaker fees from Medtronic, Abbott, Sanofi and Lilly; advisory panel service for Abbott, Boehringer Ingelheim, and Insulet; and research support to his institution from Boehringer Ingelheim and Bank of Montreal. Dr. Nathan reports no disclosures.

SAN FRANCISCO – At first, the diabetes professionals in the audience at the annual scientific sessions of the American Diabetes Association overwhelmingly raised their hands to say they would support using SGLT2 inhibitors as adjunctive therapy in patients with type 1 diabetes. Then two physicians debated whether the drugs were too risky – predictably, one said yes, the other said no. In the end, most of the audience was unconvinced by one of the doctors. Which one? Well, we’ll get to that.

First, let’s look at the issue that divided the two physicians: Should the sodium-glucose cotransporter 2 (SGLT2) inhibitors canagliflozin (Invokana), dapagliflozin (Farxiga), and empagliflozin (Jardiance) – now commonly used to treat patients with type 2 diabetes – also be prescribed for patients with type 1 diabetes?

The drugs are not cleared in the United States for use in patients with type 1 diabetes, although drug makers are seeking approval. Earlier in 2019, the Food and Drug Administration turned down a request for the approval of sotagliflozin (Zynquista), a dual SGLT1 and SGLT2 inhibitor, for adults with type 1 diabetes. However, the drug has been approved in the European Union for certain overweight patients with type 1 diabetes.

In addition, the drugs are very costly, compared with some of the other diabetes medications, and physicians say that puts them out of reach for some patients.
 

The case for ...

In arguing that SGLT2 inhibitors would be appropriate as a therapy for patients with type 1 diabetes, Bruce A. Perkins, MD, MPH, professor and clinician-scientist at Leadership Sinai Center for Diabetes at the University of Toronto, emphasized the need for new treatments in type 1 diabetes.

“Even today, people with type 1 tell us they feel isolated, they fear hypoglycemia, they fear complications. And they have this undue burden of self-management,” he said. “We can do much better. Insulin therapy still needs us desperately needing more.”

Dr. Perkins highlighted the drugs’ widely lauded effects on cardiac and renal health and noted that a 2019 meta-analysis of 10 trials found that, compared with placebo, the drugs were associated with mean reductions in hemoglobin A_1c (–0.39%; 95% confidence interval, –0.43 to –0.36) and body weight (–3.47%; 95% CI, –3.78 to –3.16).

That analysis also showed a higher risk of genital infection (3.57; 95% CI, 2.97-4.29) and diabetic ketoacidosis (DKA; 3.11; 95% CI, 2.11-4.58) with SGLT inhibitors, but the authors concluded that, despite the adverse events, the available data suggested that adding the inhibitors to basal insulin could be beneficial in patients with type 1 diabetes (Diabetes Metab Res Rev. 2019 Apr 11. doi: 10.1002/dmrr.3169).

In reference to the findings on DKA, Dr. Perkins said recent research has suggested that the DKA risk could be lowered by decreasing the dose of the SGLT2 inhibitors. “[DKA] is a problem, there’s no question, but there’s a background population risk. Whether we introduce an SGLT2 or not, we have to deal with this issue. We can deal with and overcome the excess DKA risk.”

In the big picture, he said, “it would be a crime not to make this treatment available to some patients. Meaningful benefits far outweigh the risks.”
 

The case against ...

On the other side of the debate was David M. Nathan, MD, of Harvard Medical School and the Clinical Research Center and Diabetes Center at Massachusetts General Hospital, Boston, who acknowledged the benefits of the SGLT2 inhibitors in type 2 diabetes.

However, he pointed to findings from a 2015 trial of canagliflozin as an add-on in type 1 diabetes (Diabetes Care. 2015;38[12]:2258-65). In that 18-week, randomized phase 2 trial, the investigators found that patients who took the drug had significantly higher rates of serious adverse events (7.7% or 6.8%, depending on dose, vs. 0% for placebo), urinary tract infections (4.3% and 5.1% vs. 1.7%), and DKA (4.3% and 6.0% vs. 0%).

“It would have cost $400 a month for the ‘pleasure’ of those side effects,” Dr. Nathan said.

He also noted a 2015 report on a 29-day, randomized, placebo-controlled study of sotagliflozin, the dual SGLT1 and SGLT2 inhibitor drug, as an add-on treatment for type 1 diabetes, in which investigators reported two episodes of DKA (13%) in the SGLT2 group, compared with none in placebo (Diabetes Care. 2015;38[7]:1181-8).

Dr. Nathan also pointed to a recent FDA warning about cases of Fournier gangrene, a rare type of serious genital infection, in patients taking SGLT2 inhibitors.

“To me, the risk [of using SGLT2 inhibitors in type 1 diabetes] outweighs the benefit by a lot,” he said, echoing comments he made in an editorial he wrote in 2017, that “any added benefits of adjunctive therapies for type 1 diabetes must be carefully balanced against their added risk and cost. Physicians and patients should beware” (N Engl J Med. 2017; 377:2390-1).
 

The outcome...

The audience was not sufficiently convinced by Dr. Nathan to swing the final vote fully in his favor, but he did manage to dent the initial support for using SGLT2 inhibitors in patients with type 1 disease. Before the debate, the show of hands suggested that roughly 80% of the audience thought SGLT2 inhibitors would be an appropriate therapy option for patients with type 1 diabetes. When the moderator asked the same question again after the arguments had been presented, that initial support had been eroded to about 70%. Dr. Nathan had clearly raised some doubts among the attendees, but Dr. Perkins’ perspective prevailed.

Dr. Perkins reported speaker fees from Medtronic, Abbott, Sanofi and Lilly; advisory panel service for Abbott, Boehringer Ingelheim, and Insulet; and research support to his institution from Boehringer Ingelheim and Bank of Montreal. Dr. Nathan reports no disclosures.

SAN FRANCISCO – At first, the diabetes professionals in the audience at the annual scientific sessions of the American Diabetes Association overwhelmingly raised their hands to say they would support using SGLT2 inhibitors as adjunctive therapy in patients with type 1 diabetes. Then two physicians debated whether the drugs were too risky – predictably, one said yes, the other said no. In the end, most of the audience was unconvinced by one of the doctors. Which one? Well, we’ll get to that.

First, let’s look at the issue that divided the two physicians: Should the sodium-glucose cotransporter 2 (SGLT2) inhibitors canagliflozin (Invokana), dapagliflozin (Farxiga), and empagliflozin (Jardiance) – now commonly used to treat patients with type 2 diabetes – also be prescribed for patients with type 1 diabetes?

The drugs are not cleared in the United States for use in patients with type 1 diabetes, although drug makers are seeking approval. Earlier in 2019, the Food and Drug Administration turned down a request for the approval of sotagliflozin (Zynquista), a dual SGLT1 and SGLT2 inhibitor, for adults with type 1 diabetes. However, the drug has been approved in the European Union for certain overweight patients with type 1 diabetes.

In addition, the drugs are very costly, compared with some of the other diabetes medications, and physicians say that puts them out of reach for some patients.
 

The case for ...

In arguing that SGLT2 inhibitors would be appropriate as a therapy for patients with type 1 diabetes, Bruce A. Perkins, MD, MPH, professor and clinician-scientist at Leadership Sinai Center for Diabetes at the University of Toronto, emphasized the need for new treatments in type 1 diabetes.

“Even today, people with type 1 tell us they feel isolated, they fear hypoglycemia, they fear complications. And they have this undue burden of self-management,” he said. “We can do much better. Insulin therapy still needs us desperately needing more.”

Dr. Perkins highlighted the drugs’ widely lauded effects on cardiac and renal health and noted that a 2019 meta-analysis of 10 trials found that, compared with placebo, the drugs were associated with mean reductions in hemoglobin A_1c (–0.39%; 95% confidence interval, –0.43 to –0.36) and body weight (–3.47%; 95% CI, –3.78 to –3.16).

That analysis also showed a higher risk of genital infection (3.57; 95% CI, 2.97-4.29) and diabetic ketoacidosis (DKA; 3.11; 95% CI, 2.11-4.58) with SGLT inhibitors, but the authors concluded that, despite the adverse events, the available data suggested that adding the inhibitors to basal insulin could be beneficial in patients with type 1 diabetes (Diabetes Metab Res Rev. 2019 Apr 11. doi: 10.1002/dmrr.3169).

In reference to the findings on DKA, Dr. Perkins said recent research has suggested that the DKA risk could be lowered by decreasing the dose of the SGLT2 inhibitors. “[DKA] is a problem, there’s no question, but there’s a background population risk. Whether we introduce an SGLT2 or not, we have to deal with this issue. We can deal with and overcome the excess DKA risk.”

In the big picture, he said, “it would be a crime not to make this treatment available to some patients. Meaningful benefits far outweigh the risks.”
 

The case against ...

On the other side of the debate was David M. Nathan, MD, of Harvard Medical School and the Clinical Research Center and Diabetes Center at Massachusetts General Hospital, Boston, who acknowledged the benefits of the SGLT2 inhibitors in type 2 diabetes.

However, he pointed to findings from a 2015 trial of canagliflozin as an add-on in type 1 diabetes (Diabetes Care. 2015;38[12]:2258-65). In that 18-week, randomized phase 2 trial, the investigators found that patients who took the drug had significantly higher rates of serious adverse events (7.7% or 6.8%, depending on dose, vs. 0% for placebo), urinary tract infections (4.3% and 5.1% vs. 1.7%), and DKA (4.3% and 6.0% vs. 0%).

“It would have cost $400 a month for the ‘pleasure’ of those side effects,” Dr. Nathan said.

He also noted a 2015 report on a 29-day, randomized, placebo-controlled study of sotagliflozin, the dual SGLT1 and SGLT2 inhibitor drug, as an add-on treatment for type 1 diabetes, in which investigators reported two episodes of DKA (13%) in the SGLT2 group, compared with none in placebo (Diabetes Care. 2015;38[7]:1181-8).

Dr. Nathan also pointed to a recent FDA warning about cases of Fournier gangrene, a rare type of serious genital infection, in patients taking SGLT2 inhibitors.

“To me, the risk [of using SGLT2 inhibitors in type 1 diabetes] outweighs the benefit by a lot,” he said, echoing comments he made in an editorial he wrote in 2017, that “any added benefits of adjunctive therapies for type 1 diabetes must be carefully balanced against their added risk and cost. Physicians and patients should beware” (N Engl J Med. 2017; 377:2390-1).
 

The outcome...

The audience was not sufficiently convinced by Dr. Nathan to swing the final vote fully in his favor, but he did manage to dent the initial support for using SGLT2 inhibitors in patients with type 1 disease. Before the debate, the show of hands suggested that roughly 80% of the audience thought SGLT2 inhibitors would be an appropriate therapy option for patients with type 1 diabetes. When the moderator asked the same question again after the arguments had been presented, that initial support had been eroded to about 70%. Dr. Nathan had clearly raised some doubts among the attendees, but Dr. Perkins’ perspective prevailed.

Dr. Perkins reported speaker fees from Medtronic, Abbott, Sanofi and Lilly; advisory panel service for Abbott, Boehringer Ingelheim, and Insulet; and research support to his institution from Boehringer Ingelheim and Bank of Montreal. Dr. Nathan reports no disclosures.

SAN FRANCISCO – Can you be “fat but fit” if you’re obese but don’t suffer from metabolic syndrome? Some advocates have claimed you can, but new findings presented at the annual scientific sessions of the American Diabetes Association provide more evidence that those extra pounds translate to extra cardiac risk.

Fat-but-fit is a misnomer, Yvonne Commodore-Mensah, PhD, RN, assistant professor at Johns Hopkins School of Nursing, Baltimore, said in an interview. “The metabolically healthy obese are not so healthy. [We found] they had a higher risk of heart disease than people who were metabolically healthy and nonobese.”

Studies began supporting the fat-but-fit “paradox” in the late 1990s. They showed “that all-cause and CVD [cardiovascular] mortality risk in obese individuals, as defined by body mass index (BMI), body fat percentage, or waist circumference, who are fit (i.e., cardiorespiratory fitness level above the age-specific and sex-specific 20th percentile) is not significantly different from their normal-weight and fit counterparts” (Br J Sports Med. 2018;52[3]:151-3).

However, a 2017 study had found that “metabolically healthy obese individuals had a higher risk of coronary heart disease, cerebrovascular disease, and heart failure [compared with] normal weight, metabolically healthy individuals” (J Am Coll Cardiol. 2017;70[12]:1429-37). And a 2016 meta-analysis of 22 studies had produced similar results but also found that metabolically healthy obese individuals were better off, cardiac-health–wise, than those of normal weight who were metabolically unhealthy (Eur J Prev Cardiol. 2016;23[9]:956-66).

Dr. Commodore-Mensah and colleagues sought to establish through their study whether there was evidence of subclinical heart disease in people who are considered obese but metabolically healthy (Abstract 272-OR).

They tracked 11,884 participants in the Atherosclerosis Risk in Communities Study (ARIC) from 1990-1992 to 2016-2018. The study, which continues today, includes participants in suburban Minneapolis; Jackson, Miss.; Forsyth County, N.C.; and Washington County, Md.

None of the participants had previous cardiovascular disease at baseline (1990-1992). The researchers divided the participants into four groups at baseline: Nonobese (with metabolic syndrome, 20% of the total number of participants; or without metabolic syndrome, 51%) and obese (with metabolic syndrome, 20%; or without metabolic syndrome, 9%).

The average age range in the groups was 56-57 years. The percentage of women in the groups ranged from 53% to 58%, except for the obese and metabolically healthy group (73%). The percentage of black participants in the groups ranged from 17% (nonobese, metabolically unhealthy) to 45% (obese, metabolically healthy).

“People who were younger, women, and black were more likely to be classified as metabolically healthy obese,” Dr. Commodore-Mensah said.

According to one adjusted model with a median follow-up of 16 years and a total of 3,560 events, obese participants had a higher risk of incident cardiovascular disease, compared with their nonobese counterparts, regardless of whether they had metabolic syndrome.

When compared with the nonobese, metabolically healthy group, the risk grew in the nonobese, metabolically unhealthy group (hazard ratio, .24; 95% confidence interval, 1.12-1.36), as well as in the obese, metabolically healthy (HR, 1.33; 95% CI, 1.15-1.53) and the obese, metabolically unhealthy (HR, 2.11; 95% CI, 1.90-2.35) groups.

The researchers also focused on the cardiac biomarker known as high-sensitive cardiac troponin T (hs-cTnT), which indicates chronic myocardial damage. “This biomarker provides us with a window to the heart,” Dr. Commodore-Mensah said.

According to previous findings reported in 2014, ARIC participants who had hs-cTnT levels of 14 ng/L or higher were much more likely than were those with undetectable levels to suffer from heart failure, death from any cause, and coronary heart disease (JACC Heart Fail. 2014;2[6]:600-7).

Based on an analysis of the hs-cTnT levels in the present study, the researchers believe obese, metabolically healthy participants fell in the intermediate range of excess subclinical myocardial damage, between the nonobese and the obese participants who are also metabolically unhealthy.

“This group is not protected from heart disease,” Dr. Commodore-Mensah said. “They should be targeted, and they would benefit from behavioral changes, such as modifying their diet and increasing physical activity levels.”

The study is funded by the National Institutes of Health. Dr. Commodore-Mensah and six coauthors reported no relevant disclosures. Two coauthors reported various disclosures.

SAN FRANCISCO – Can you be “fat but fit” if you’re obese but don’t suffer from metabolic syndrome? Some advocates have claimed you can, but new findings presented at the annual scientific sessions of the American Diabetes Association provide more evidence that those extra pounds translate to extra cardiac risk.

Fat-but-fit is a misnomer, Yvonne Commodore-Mensah, PhD, RN, assistant professor at Johns Hopkins School of Nursing, Baltimore, said in an interview. “The metabolically healthy obese are not so healthy. [We found] they had a higher risk of heart disease than people who were metabolically healthy and nonobese.”

Studies began supporting the fat-but-fit “paradox” in the late 1990s. They showed “that all-cause and CVD [cardiovascular] mortality risk in obese individuals, as defined by body mass index (BMI), body fat percentage, or waist circumference, who are fit (i.e., cardiorespiratory fitness level above the age-specific and sex-specific 20th percentile) is not significantly different from their normal-weight and fit counterparts” (Br J Sports Med. 2018;52[3]:151-3).

However, a 2017 study had found that “metabolically healthy obese individuals had a higher risk of coronary heart disease, cerebrovascular disease, and heart failure [compared with] normal weight, metabolically healthy individuals” (J Am Coll Cardiol. 2017;70[12]:1429-37). And a 2016 meta-analysis of 22 studies had produced similar results but also found that metabolically healthy obese individuals were better off, cardiac-health–wise, than those of normal weight who were metabolically unhealthy (Eur J Prev Cardiol. 2016;23[9]:956-66).

Dr. Commodore-Mensah and colleagues sought to establish through their study whether there was evidence of subclinical heart disease in people who are considered obese but metabolically healthy (Abstract 272-OR).

They tracked 11,884 participants in the Atherosclerosis Risk in Communities Study (ARIC) from 1990-1992 to 2016-2018. The study, which continues today, includes participants in suburban Minneapolis; Jackson, Miss.; Forsyth County, N.C.; and Washington County, Md.

None of the participants had previous cardiovascular disease at baseline (1990-1992). The researchers divided the participants into four groups at baseline: Nonobese (with metabolic syndrome, 20% of the total number of participants; or without metabolic syndrome, 51%) and obese (with metabolic syndrome, 20%; or without metabolic syndrome, 9%).

The average age range in the groups was 56-57 years. The percentage of women in the groups ranged from 53% to 58%, except for the obese and metabolically healthy group (73%). The percentage of black participants in the groups ranged from 17% (nonobese, metabolically unhealthy) to 45% (obese, metabolically healthy).

“People who were younger, women, and black were more likely to be classified as metabolically healthy obese,” Dr. Commodore-Mensah said.

According to one adjusted model with a median follow-up of 16 years and a total of 3,560 events, obese participants had a higher risk of incident cardiovascular disease, compared with their nonobese counterparts, regardless of whether they had metabolic syndrome.

When compared with the nonobese, metabolically healthy group, the risk grew in the nonobese, metabolically unhealthy group (hazard ratio, .24; 95% confidence interval, 1.12-1.36), as well as in the obese, metabolically healthy (HR, 1.33; 95% CI, 1.15-1.53) and the obese, metabolically unhealthy (HR, 2.11; 95% CI, 1.90-2.35) groups.

The researchers also focused on the cardiac biomarker known as high-sensitive cardiac troponin T (hs-cTnT), which indicates chronic myocardial damage. “This biomarker provides us with a window to the heart,” Dr. Commodore-Mensah said.

According to previous findings reported in 2014, ARIC participants who had hs-cTnT levels of 14 ng/L or higher were much more likely than were those with undetectable levels to suffer from heart failure, death from any cause, and coronary heart disease (JACC Heart Fail. 2014;2[6]:600-7).

Based on an analysis of the hs-cTnT levels in the present study, the researchers believe obese, metabolically healthy participants fell in the intermediate range of excess subclinical myocardial damage, between the nonobese and the obese participants who are also metabolically unhealthy.

“This group is not protected from heart disease,” Dr. Commodore-Mensah said. “They should be targeted, and they would benefit from behavioral changes, such as modifying their diet and increasing physical activity levels.”

The study is funded by the National Institutes of Health. Dr. Commodore-Mensah and six coauthors reported no relevant disclosures. Two coauthors reported various disclosures.

SAN FRANCISCO – Can you be “fat but fit” if you’re obese but don’t suffer from metabolic syndrome? Some advocates have claimed you can, but new findings presented at the annual scientific sessions of the American Diabetes Association provide more evidence that those extra pounds translate to extra cardiac risk.

Fat-but-fit is a misnomer, Yvonne Commodore-Mensah, PhD, RN, assistant professor at Johns Hopkins School of Nursing, Baltimore, said in an interview. “The metabolically healthy obese are not so healthy. [We found] they had a higher risk of heart disease than people who were metabolically healthy and nonobese.”

Studies began supporting the fat-but-fit “paradox” in the late 1990s. They showed “that all-cause and CVD [cardiovascular] mortality risk in obese individuals, as defined by body mass index (BMI), body fat percentage, or waist circumference, who are fit (i.e., cardiorespiratory fitness level above the age-specific and sex-specific 20th percentile) is not significantly different from their normal-weight and fit counterparts” (Br J Sports Med. 2018;52[3]:151-3).

However, a 2017 study had found that “metabolically healthy obese individuals had a higher risk of coronary heart disease, cerebrovascular disease, and heart failure [compared with] normal weight, metabolically healthy individuals” (J Am Coll Cardiol. 2017;70[12]:1429-37). And a 2016 meta-analysis of 22 studies had produced similar results but also found that metabolically healthy obese individuals were better off, cardiac-health–wise, than those of normal weight who were metabolically unhealthy (Eur J Prev Cardiol. 2016;23[9]:956-66).

Dr. Commodore-Mensah and colleagues sought to establish through their study whether there was evidence of subclinical heart disease in people who are considered obese but metabolically healthy (Abstract 272-OR).

They tracked 11,884 participants in the Atherosclerosis Risk in Communities Study (ARIC) from 1990-1992 to 2016-2018. The study, which continues today, includes participants in suburban Minneapolis; Jackson, Miss.; Forsyth County, N.C.; and Washington County, Md.

None of the participants had previous cardiovascular disease at baseline (1990-1992). The researchers divided the participants into four groups at baseline: Nonobese (with metabolic syndrome, 20% of the total number of participants; or without metabolic syndrome, 51%) and obese (with metabolic syndrome, 20%; or without metabolic syndrome, 9%).

The average age range in the groups was 56-57 years. The percentage of women in the groups ranged from 53% to 58%, except for the obese and metabolically healthy group (73%). The percentage of black participants in the groups ranged from 17% (nonobese, metabolically unhealthy) to 45% (obese, metabolically healthy).

“People who were younger, women, and black were more likely to be classified as metabolically healthy obese,” Dr. Commodore-Mensah said.

According to one adjusted model with a median follow-up of 16 years and a total of 3,560 events, obese participants had a higher risk of incident cardiovascular disease, compared with their nonobese counterparts, regardless of whether they had metabolic syndrome.

When compared with the nonobese, metabolically healthy group, the risk grew in the nonobese, metabolically unhealthy group (hazard ratio, .24; 95% confidence interval, 1.12-1.36), as well as in the obese, metabolically healthy (HR, 1.33; 95% CI, 1.15-1.53) and the obese, metabolically unhealthy (HR, 2.11; 95% CI, 1.90-2.35) groups.

The researchers also focused on the cardiac biomarker known as high-sensitive cardiac troponin T (hs-cTnT), which indicates chronic myocardial damage. “This biomarker provides us with a window to the heart,” Dr. Commodore-Mensah said.

According to previous findings reported in 2014, ARIC participants who had hs-cTnT levels of 14 ng/L or higher were much more likely than were those with undetectable levels to suffer from heart failure, death from any cause, and coronary heart disease (JACC Heart Fail. 2014;2[6]:600-7).

Based on an analysis of the hs-cTnT levels in the present study, the researchers believe obese, metabolically healthy participants fell in the intermediate range of excess subclinical myocardial damage, between the nonobese and the obese participants who are also metabolically unhealthy.

“This group is not protected from heart disease,” Dr. Commodore-Mensah said. “They should be targeted, and they would benefit from behavioral changes, such as modifying their diet and increasing physical activity levels.”

The study is funded by the National Institutes of Health. Dr. Commodore-Mensah and six coauthors reported no relevant disclosures. Two coauthors reported various disclosures.

SAN FRANCISCO – Are you having trouble helping patients take their diabetes medications as directed? Try installing 32-inch screens in the examination rooms for a lab result show-and-tell. Keep pharmaceutical marketers out of your hair (and office). Talk about smartphone alarms, promote auto-fill services, and understand why patients don’t adhere to their regimens.

Those are among the suggestions offered by two physicians during a symposium on drug adherence at the annual scientific sessions of the American Diabetes Association.

“Nonadherence is not a case of patients being bad,” said internist and researcher Niteesh K. Choudhry, MD, PhD, of Harvard Medical School and Brigham and Women’s Hospital, Boston. “When half of your patients are nonadherent, I can guarantee you [they] aren’t trying to hurt themselves.”

According to Dr. Choudhry’s own research published in 2011 and based on 2008 data, about 25% of patients do not fill prescriptions after leaving their doctors’ offices. That level for diabetes medications – 42% of patients – is especially high (Am J Med. 2011;124[11]:1081.e9-22).

Other findings, he said, have suggested that half of patients fail to adhere to evidence-based prescribed regimens over the long term. And three groups have especially low levels of adherence: people of color, women, and patients who are caregivers (possibly because they are too busy caring for others to care for themselves).

Various factors affect adherence, including forgetfulness, drug interactions or side effects, and the different colors and shapes of pills. The latter can confuse patients because colors and shapes may be different from prescription to prescription even for the same medication, he said.

Dr. Choudhry added that there’s another factor: multiple prescriptions from multiple physicians that require multiple pharmacy visits. His findings suggest that adherence improves when prescriptions are consolidated to limit the need to visit the drugstore. “The chaos of our health care system leads to nonadherence,” he said (Arch Intern Med. 2011;171[9]:814-22).

Internist Lawrence Garber, MD, of Reliant Medical Group in Worcester, Mass., offered these tips about boosting drug adherence:

• Develop trust with patients. “They need to trust that I’m their advocate, and that they’re my No. 1 reason for prescribing the medication, and not making myself more money,” he said.
• Provide educational resources. “We give them resources online. If their EHR [electronic health record] identifies that they’re diabetic, then they get information about diabetes printed out.”
• Use technology to promote messages about diabetes. Dr. Garber said his clinic has installed screens in the examination rooms so that he can show patients their data. “It [makes it] very clear for them to see why what they’re doing now is not working,’’ and why there is a need to change to a different regimen. In addition, screens in the waiting room can display educational slides about diabetes.
• Set up clinic-wide medication protocols. “We’ve set up protocols and pathways for diabetes, hypertension, and high cholesterol to make it easy to prescribe medications that are lower cost and to make sure we’re following the same path,” Dr. Garber said.
• Stay independent. “I haven’t seen a drug rep in decades. It’s an organizational policy that we don’t see them, so we’re less likely to be biased.”
• Make it easier for patients to take medications. Dr. Garber urged colleagues to talk to their patients about using strategies such as printed pill schedules, weekly pill organizers, auto refills, and smartphone alarm reminders to facilitate adherence.

And, he said, you may wish to make it clear that you will check on whether prescriptions are filled. That way, “the patients know that you’re looking,” and it can actually lead to improved adherence.

Dr. Choudhry reported that his research has been funded by unrestricted grants to his institution from insurers, government funders, nonprofit foundations, pharmaceutical companies (including Merck, Sanofi, and Astra Zeneca), and device makers (including Medisafe). Dr. Garber reported no relevant disclosures.

SAN FRANCISCO – Are you having trouble helping patients take their diabetes medications as directed? Try installing 32-inch screens in the examination rooms for a lab result show-and-tell. Keep pharmaceutical marketers out of your hair (and office). Talk about smartphone alarms, promote auto-fill services, and understand why patients don’t adhere to their regimens.

Those are among the suggestions offered by two physicians during a symposium on drug adherence at the annual scientific sessions of the American Diabetes Association.

“Nonadherence is not a case of patients being bad,” said internist and researcher Niteesh K. Choudhry, MD, PhD, of Harvard Medical School and Brigham and Women’s Hospital, Boston. “When half of your patients are nonadherent, I can guarantee you [they] aren’t trying to hurt themselves.”

According to Dr. Choudhry’s own research published in 2011 and based on 2008 data, about 25% of patients do not fill prescriptions after leaving their doctors’ offices. That level for diabetes medications – 42% of patients – is especially high (Am J Med. 2011;124[11]:1081.e9-22).

Other findings, he said, have suggested that half of patients fail to adhere to evidence-based prescribed regimens over the long term. And three groups have especially low levels of adherence: people of color, women, and patients who are caregivers (possibly because they are too busy caring for others to care for themselves).

Various factors affect adherence, including forgetfulness, drug interactions or side effects, and the different colors and shapes of pills. The latter can confuse patients because colors and shapes may be different from prescription to prescription even for the same medication, he said.

Dr. Choudhry added that there’s another factor: multiple prescriptions from multiple physicians that require multiple pharmacy visits. His findings suggest that adherence improves when prescriptions are consolidated to limit the need to visit the drugstore. “The chaos of our health care system leads to nonadherence,” he said (Arch Intern Med. 2011;171[9]:814-22).

Internist Lawrence Garber, MD, of Reliant Medical Group in Worcester, Mass., offered these tips about boosting drug adherence:

• Develop trust with patients. “They need to trust that I’m their advocate, and that they’re my No. 1 reason for prescribing the medication, and not making myself more money,” he said.
• Provide educational resources. “We give them resources online. If their EHR [electronic health record] identifies that they’re diabetic, then they get information about diabetes printed out.”
• Use technology to promote messages about diabetes. Dr. Garber said his clinic has installed screens in the examination rooms so that he can show patients their data. “It [makes it] very clear for them to see why what they’re doing now is not working,’’ and why there is a need to change to a different regimen. In addition, screens in the waiting room can display educational slides about diabetes.
• Set up clinic-wide medication protocols. “We’ve set up protocols and pathways for diabetes, hypertension, and high cholesterol to make it easy to prescribe medications that are lower cost and to make sure we’re following the same path,” Dr. Garber said.
• Stay independent. “I haven’t seen a drug rep in decades. It’s an organizational policy that we don’t see them, so we’re less likely to be biased.”
• Make it easier for patients to take medications. Dr. Garber urged colleagues to talk to their patients about using strategies such as printed pill schedules, weekly pill organizers, auto refills, and smartphone alarm reminders to facilitate adherence.

And, he said, you may wish to make it clear that you will check on whether prescriptions are filled. That way, “the patients know that you’re looking,” and it can actually lead to improved adherence.

Dr. Choudhry reported that his research has been funded by unrestricted grants to his institution from insurers, government funders, nonprofit foundations, pharmaceutical companies (including Merck, Sanofi, and Astra Zeneca), and device makers (including Medisafe). Dr. Garber reported no relevant disclosures.

SAN FRANCISCO – Are you having trouble helping patients take their diabetes medications as directed? Try installing 32-inch screens in the examination rooms for a lab result show-and-tell. Keep pharmaceutical marketers out of your hair (and office). Talk about smartphone alarms, promote auto-fill services, and understand why patients don’t adhere to their regimens.

Those are among the suggestions offered by two physicians during a symposium on drug adherence at the annual scientific sessions of the American Diabetes Association.

“Nonadherence is not a case of patients being bad,” said internist and researcher Niteesh K. Choudhry, MD, PhD, of Harvard Medical School and Brigham and Women’s Hospital, Boston. “When half of your patients are nonadherent, I can guarantee you [they] aren’t trying to hurt themselves.”

According to Dr. Choudhry’s own research published in 2011 and based on 2008 data, about 25% of patients do not fill prescriptions after leaving their doctors’ offices. That level for diabetes medications – 42% of patients – is especially high (Am J Med. 2011;124[11]:1081.e9-22).

Other findings, he said, have suggested that half of patients fail to adhere to evidence-based prescribed regimens over the long term. And three groups have especially low levels of adherence: people of color, women, and patients who are caregivers (possibly because they are too busy caring for others to care for themselves).

Various factors affect adherence, including forgetfulness, drug interactions or side effects, and the different colors and shapes of pills. The latter can confuse patients because colors and shapes may be different from prescription to prescription even for the same medication, he said.

Dr. Choudhry added that there’s another factor: multiple prescriptions from multiple physicians that require multiple pharmacy visits. His findings suggest that adherence improves when prescriptions are consolidated to limit the need to visit the drugstore. “The chaos of our health care system leads to nonadherence,” he said (Arch Intern Med. 2011;171[9]:814-22).

Internist Lawrence Garber, MD, of Reliant Medical Group in Worcester, Mass., offered these tips about boosting drug adherence:

• Develop trust with patients. “They need to trust that I’m their advocate, and that they’re my No. 1 reason for prescribing the medication, and not making myself more money,” he said.
• Provide educational resources. “We give them resources online. If their EHR [electronic health record] identifies that they’re diabetic, then they get information about diabetes printed out.”
• Use technology to promote messages about diabetes. Dr. Garber said his clinic has installed screens in the examination rooms so that he can show patients their data. “It [makes it] very clear for them to see why what they’re doing now is not working,’’ and why there is a need to change to a different regimen. In addition, screens in the waiting room can display educational slides about diabetes.
• Set up clinic-wide medication protocols. “We’ve set up protocols and pathways for diabetes, hypertension, and high cholesterol to make it easy to prescribe medications that are lower cost and to make sure we’re following the same path,” Dr. Garber said.
• Stay independent. “I haven’t seen a drug rep in decades. It’s an organizational policy that we don’t see them, so we’re less likely to be biased.”
• Make it easier for patients to take medications. Dr. Garber urged colleagues to talk to their patients about using strategies such as printed pill schedules, weekly pill organizers, auto refills, and smartphone alarm reminders to facilitate adherence.

And, he said, you may wish to make it clear that you will check on whether prescriptions are filled. That way, “the patients know that you’re looking,” and it can actually lead to improved adherence.

Dr. Choudhry reported that his research has been funded by unrestricted grants to his institution from insurers, government funders, nonprofit foundations, pharmaceutical companies (including Merck, Sanofi, and Astra Zeneca), and device makers (including Medisafe). Dr. Garber reported no relevant disclosures.

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.

Children with Down syndrome often have sleep‐disordered breathing (SDB), and a new study suggests that long-term monitoring via sleep studies is warranted because the condition frequently persists and recurs.

©DenKuvaiev/Thinkstock

“Current screening recommendations to assess for SDB at a particular age may not be adequate in this population,” the authors of the study stated, adding that “persistence/recurrence of SDB is not easily predicted.”

The study, led by Joy Nehme, BSc, of Children’s Hospital of Eastern Ontario and the University of Ottawa, was published in Pediatric Pulmonology.

According to the study, research suggests that 43%-66% of children with Down syndrome have SDB, a category that encompasses sleep apnea (both obstructive and central) and hypoventilation. Those numbers are several times higher than the prevalence of SDB in children in the general population (1%-5%).

“Because SDB is associated with cardiometabolic and neurocognitive morbidity, its prompt and accurate diagnosis is important,” the researchers wrote. However, diagnosis requires a sleep study, which is not always performed although the American Academy of Pediatrics recommends children with Down syndrome undergo one by age 4.

Treatments include adenotonsillectomy (considered first-line), positive airway pressure, and lingual tonsillectomy.

The study aims to fill in gaps in knowledge about the condition over the long term since “there is little available literature on the trajectory of SDB in children and youth with Down syndrome over time.”

The researchers launched a retrospective study of 560 children with Down syndrome who were treated from 2004 to 2015 at Children’s Hospital of Eastern Ontario. Of those, 120 showed signs of SDB and underwent sleep studies (48% male, median age 6.6 years [range 4.5-10.5], median total apnea‐hypopnea index events per hour = 3.4 [1.6-10.8]).

Of the 120 children, 67 (56%) had obstructive-mixed SDB, 9 (8%) had central sleep apnea, and 5 (4%) had hypoventilation. The others (39, 32%) had no SDB.

Fifty-four children underwent at least two sleep studies during the period of the study, with at least one undergoing seven.

Researchers found weak, nonsignificant evidence that SDB persistence/occurrence varied by age (odds ratio per year = 1.15; 95% confidence interval, 0.96-1.41; P = .13).

As for treatment, adenotonsillectomy was most common, although “previous studies have ... shown that moderate to severe OSA in children with Down syndrome is likely to persist after a tonsillectomy.”

In regard to obstructive sleep apnea (OSA) specifically, the authors wrote, “our study ... showed that OSA‐SDB persisted or recurred in the vast majority of children. Further, persistence/recurrence could not be predicted by clinical features or SDB severity in our study. This, therefore, highlights the need for serial longitudinal screening for SDB in this population and for follow‐up PSG to ensure the success of treatment interventions.”

No study funding was reported. The study authors reported no disclosures.

SOURCE: Nehme J et al. Pediatr Pulmonol. 2019 Jun 6. doi: 10.1002/ppul.24380.

Children with Down syndrome often have sleep‐disordered breathing (SDB), and a new study suggests that long-term monitoring via sleep studies is warranted because the condition frequently persists and recurs.

©DenKuvaiev/Thinkstock

“Current screening recommendations to assess for SDB at a particular age may not be adequate in this population,” the authors of the study stated, adding that “persistence/recurrence of SDB is not easily predicted.”

The study, led by Joy Nehme, BSc, of Children’s Hospital of Eastern Ontario and the University of Ottawa, was published in Pediatric Pulmonology.

According to the study, research suggests that 43%-66% of children with Down syndrome have SDB, a category that encompasses sleep apnea (both obstructive and central) and hypoventilation. Those numbers are several times higher than the prevalence of SDB in children in the general population (1%-5%).

“Because SDB is associated with cardiometabolic and neurocognitive morbidity, its prompt and accurate diagnosis is important,” the researchers wrote. However, diagnosis requires a sleep study, which is not always performed although the American Academy of Pediatrics recommends children with Down syndrome undergo one by age 4.

Treatments include adenotonsillectomy (considered first-line), positive airway pressure, and lingual tonsillectomy.

The study aims to fill in gaps in knowledge about the condition over the long term since “there is little available literature on the trajectory of SDB in children and youth with Down syndrome over time.”

The researchers launched a retrospective study of 560 children with Down syndrome who were treated from 2004 to 2015 at Children’s Hospital of Eastern Ontario. Of those, 120 showed signs of SDB and underwent sleep studies (48% male, median age 6.6 years [range 4.5-10.5], median total apnea‐hypopnea index events per hour = 3.4 [1.6-10.8]).

Of the 120 children, 67 (56%) had obstructive-mixed SDB, 9 (8%) had central sleep apnea, and 5 (4%) had hypoventilation. The others (39, 32%) had no SDB.

Fifty-four children underwent at least two sleep studies during the period of the study, with at least one undergoing seven.

Researchers found weak, nonsignificant evidence that SDB persistence/occurrence varied by age (odds ratio per year = 1.15; 95% confidence interval, 0.96-1.41; P = .13).

As for treatment, adenotonsillectomy was most common, although “previous studies have ... shown that moderate to severe OSA in children with Down syndrome is likely to persist after a tonsillectomy.”

In regard to obstructive sleep apnea (OSA) specifically, the authors wrote, “our study ... showed that OSA‐SDB persisted or recurred in the vast majority of children. Further, persistence/recurrence could not be predicted by clinical features or SDB severity in our study. This, therefore, highlights the need for serial longitudinal screening for SDB in this population and for follow‐up PSG to ensure the success of treatment interventions.”

No study funding was reported. The study authors reported no disclosures.

SOURCE: Nehme J et al. Pediatr Pulmonol. 2019 Jun 6. doi: 10.1002/ppul.24380.

Children with Down syndrome often have sleep‐disordered breathing (SDB), and a new study suggests that long-term monitoring via sleep studies is warranted because the condition frequently persists and recurs.

©DenKuvaiev/Thinkstock

“Current screening recommendations to assess for SDB at a particular age may not be adequate in this population,” the authors of the study stated, adding that “persistence/recurrence of SDB is not easily predicted.”

The study, led by Joy Nehme, BSc, of Children’s Hospital of Eastern Ontario and the University of Ottawa, was published in Pediatric Pulmonology.

According to the study, research suggests that 43%-66% of children with Down syndrome have SDB, a category that encompasses sleep apnea (both obstructive and central) and hypoventilation. Those numbers are several times higher than the prevalence of SDB in children in the general population (1%-5%).

“Because SDB is associated with cardiometabolic and neurocognitive morbidity, its prompt and accurate diagnosis is important,” the researchers wrote. However, diagnosis requires a sleep study, which is not always performed although the American Academy of Pediatrics recommends children with Down syndrome undergo one by age 4.

Treatments include adenotonsillectomy (considered first-line), positive airway pressure, and lingual tonsillectomy.

The study aims to fill in gaps in knowledge about the condition over the long term since “there is little available literature on the trajectory of SDB in children and youth with Down syndrome over time.”

The researchers launched a retrospective study of 560 children with Down syndrome who were treated from 2004 to 2015 at Children’s Hospital of Eastern Ontario. Of those, 120 showed signs of SDB and underwent sleep studies (48% male, median age 6.6 years [range 4.5-10.5], median total apnea‐hypopnea index events per hour = 3.4 [1.6-10.8]).

Of the 120 children, 67 (56%) had obstructive-mixed SDB, 9 (8%) had central sleep apnea, and 5 (4%) had hypoventilation. The others (39, 32%) had no SDB.

Fifty-four children underwent at least two sleep studies during the period of the study, with at least one undergoing seven.

Researchers found weak, nonsignificant evidence that SDB persistence/occurrence varied by age (odds ratio per year = 1.15; 95% confidence interval, 0.96-1.41; P = .13).

As for treatment, adenotonsillectomy was most common, although “previous studies have ... shown that moderate to severe OSA in children with Down syndrome is likely to persist after a tonsillectomy.”

In regard to obstructive sleep apnea (OSA) specifically, the authors wrote, “our study ... showed that OSA‐SDB persisted or recurred in the vast majority of children. Further, persistence/recurrence could not be predicted by clinical features or SDB severity in our study. This, therefore, highlights the need for serial longitudinal screening for SDB in this population and for follow‐up PSG to ensure the success of treatment interventions.”

No study funding was reported. The study authors reported no disclosures.

SOURCE: Nehme J et al. Pediatr Pulmonol. 2019 Jun 6. doi: 10.1002/ppul.24380.

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.

SEATTLE – The one constant in multiple sclerosis (MS) is its lack of constancy. “As our lives are dynamic and change over time, MS is also dynamic and changes over time.” This is especially the case in women, noted Mitzi Joi Williams, MD.

bowdenimages/iStock/Getty Images

About three in four people with MS are female – about 750,000 in the United States. And the risk and incidence may be highest in African American women.

In a presentation about the unique needs of women with MS, Dr. Williams, an assistant professor of internal medicine at the Morehouse School of Medicine in Atlanta, offered these tips at the annual meeting of the Consortium of Multiple Sclerosis Centers.

Pay attention to sexual dysfunction

Patients with MS often are ashamed to talk about sexual dysfunction, Dr. Williams said, but it is on many minds. “If I have a program on intimacy in MS, people are out the door.”

She urged colleagues to understand that MS can affect sexuality through three routes: primary, secondary, and tertiary dysfunction.

In primary sexual dysfunction, brain and spinal lesions directly related to MS can cause problems such as lack of sensation or abnormal sensations, decreased libido, vaginal dryness, and difficult orgasm.

Secondary sexual dysfunction refers to problems caused by symptoms of MS such as fatigue, which can worsen as the day progresses and affect nighttime intimacy, she said. Bladder dysfunction is another sensitive area in sexuality, with patients – especially women – “concerned that they will lose control of their bladder or they have already lost control.”

Cognitive dysfunction also can disrupt sexual function. “It is important to focus, and certain things cannot happen if you do not. If you are not able to focus and concentrate, it can affect interest,” Dr. Williams said.

Additionally, medications can improve some symptoms while making others worse. For example, a drug may relieve spasticity but boost fatigue. “We have to walk this tightrope,” she said. “But if we are not asking our patients, they may not volunteer this information.”

Finally, she said, MS can spark tertiary sexual dysfunction – poor body image, depression, anxiety, and disruptive changes in familial roles. For example, one partner may become a caregiver, and “it is hard to go from caregiving to sexy time.”

“It is something we have to acknowledge and find ways to deal with,” Dr. Williams said.

To address these issues, she pointed to strategies for symptomatic relief and disease-modifying therapy (DMT) and pinpointed several treatment options.

• Fatigue – stimulants, diet, exercise.
• Spasticity – muscle relaxants, exercise.
• Bladder dysfunction – fluid restriction, medication.
• Paresthesia – antidepressants, anticonvulsants.
• Numbness – vibrators, devices to increase stimulation.

Sexual therapy, couples therapy, and pelvic floor physical therapy also can be helpful.

Be aware of special needs during prepregnancy and pregnancy

“MS itself does not have a lot of effects on fertility, pregnancy, or pregnancy outcomes,” Dr. Williams said. However, “medications cause concern about how we manage pregnancy and fertility.”

In vitro fertilization may increase the risk of relapse, she added, and patients on dimethyl fumarate who experience vomiting or diarrhea may not be able to properly absorb oral contraceptives.

Women with MS may not need to go off DMT when they are trying to conceive, she said. “If patients have very aggressive disease, they may need to be on DMT through conception, through the first trimester, and even the entire pregnancy to prevent long-term disability.”

What about pregnancy itself? “An MS diagnosis alone does not mean that a pregnancy is high risk,” she said. “There are not necessarily additional tests and ultrasounds that are recommended for our patients based on MS diagnosis alone.”

Treatment discontinuation may be warranted during pregnancy, when MS generally improves. However, some MS symptoms – fatigue, bladder dysfunction, and balance – may increase. Corticosteroids can be appropriate if relapses occur during pregnancy.

Menopause and MS symptoms may overlap

Symptoms such as hot flashes, mood changes, sleep disturbance, bladder dysfunction, and decreased energy may be signs of MS, or they could indicate menopause, Dr. Williams said. “Sometimes patients come in and they are getting worse, and we look into it and discover they are premenopausal.”

A decline in estrogen during menopause may worsen MS symptoms, she added, and hormone therapy may be appropriate. A phase 2 study found a benefit in menopausal patients with MS for estriol in conjunction with a DMT, but more studies are needed.

Dr. Williams reported no relevant financial disclosures.

SEATTLE – The one constant in multiple sclerosis (MS) is its lack of constancy. “As our lives are dynamic and change over time, MS is also dynamic and changes over time.” This is especially the case in women, noted Mitzi Joi Williams, MD.

bowdenimages/iStock/Getty Images

About three in four people with MS are female – about 750,000 in the United States. And the risk and incidence may be highest in African American women.

In a presentation about the unique needs of women with MS, Dr. Williams, an assistant professor of internal medicine at the Morehouse School of Medicine in Atlanta, offered these tips at the annual meeting of the Consortium of Multiple Sclerosis Centers.

Pay attention to sexual dysfunction

Patients with MS often are ashamed to talk about sexual dysfunction, Dr. Williams said, but it is on many minds. “If I have a program on intimacy in MS, people are out the door.”

She urged colleagues to understand that MS can affect sexuality through three routes: primary, secondary, and tertiary dysfunction.

In primary sexual dysfunction, brain and spinal lesions directly related to MS can cause problems such as lack of sensation or abnormal sensations, decreased libido, vaginal dryness, and difficult orgasm.

Secondary sexual dysfunction refers to problems caused by symptoms of MS such as fatigue, which can worsen as the day progresses and affect nighttime intimacy, she said. Bladder dysfunction is another sensitive area in sexuality, with patients – especially women – “concerned that they will lose control of their bladder or they have already lost control.”

Cognitive dysfunction also can disrupt sexual function. “It is important to focus, and certain things cannot happen if you do not. If you are not able to focus and concentrate, it can affect interest,” Dr. Williams said.

Additionally, medications can improve some symptoms while making others worse. For example, a drug may relieve spasticity but boost fatigue. “We have to walk this tightrope,” she said. “But if we are not asking our patients, they may not volunteer this information.”

Finally, she said, MS can spark tertiary sexual dysfunction – poor body image, depression, anxiety, and disruptive changes in familial roles. For example, one partner may become a caregiver, and “it is hard to go from caregiving to sexy time.”

“It is something we have to acknowledge and find ways to deal with,” Dr. Williams said.

To address these issues, she pointed to strategies for symptomatic relief and disease-modifying therapy (DMT) and pinpointed several treatment options.

• Fatigue – stimulants, diet, exercise.
• Spasticity – muscle relaxants, exercise.
• Bladder dysfunction – fluid restriction, medication.
• Paresthesia – antidepressants, anticonvulsants.
• Numbness – vibrators, devices to increase stimulation.

Sexual therapy, couples therapy, and pelvic floor physical therapy also can be helpful.

Be aware of special needs during prepregnancy and pregnancy

“MS itself does not have a lot of effects on fertility, pregnancy, or pregnancy outcomes,” Dr. Williams said. However, “medications cause concern about how we manage pregnancy and fertility.”

In vitro fertilization may increase the risk of relapse, she added, and patients on dimethyl fumarate who experience vomiting or diarrhea may not be able to properly absorb oral contraceptives.

Women with MS may not need to go off DMT when they are trying to conceive, she said. “If patients have very aggressive disease, they may need to be on DMT through conception, through the first trimester, and even the entire pregnancy to prevent long-term disability.”

What about pregnancy itself? “An MS diagnosis alone does not mean that a pregnancy is high risk,” she said. “There are not necessarily additional tests and ultrasounds that are recommended for our patients based on MS diagnosis alone.”

Treatment discontinuation may be warranted during pregnancy, when MS generally improves. However, some MS symptoms – fatigue, bladder dysfunction, and balance – may increase. Corticosteroids can be appropriate if relapses occur during pregnancy.

Menopause and MS symptoms may overlap

Symptoms such as hot flashes, mood changes, sleep disturbance, bladder dysfunction, and decreased energy may be signs of MS, or they could indicate menopause, Dr. Williams said. “Sometimes patients come in and they are getting worse, and we look into it and discover they are premenopausal.”

A decline in estrogen during menopause may worsen MS symptoms, she added, and hormone therapy may be appropriate. A phase 2 study found a benefit in menopausal patients with MS for estriol in conjunction with a DMT, but more studies are needed.

Dr. Williams reported no relevant financial disclosures.

SEATTLE – The one constant in multiple sclerosis (MS) is its lack of constancy. “As our lives are dynamic and change over time, MS is also dynamic and changes over time.” This is especially the case in women, noted Mitzi Joi Williams, MD.

bowdenimages/iStock/Getty Images

About three in four people with MS are female – about 750,000 in the United States. And the risk and incidence may be highest in African American women.

In a presentation about the unique needs of women with MS, Dr. Williams, an assistant professor of internal medicine at the Morehouse School of Medicine in Atlanta, offered these tips at the annual meeting of the Consortium of Multiple Sclerosis Centers.

Pay attention to sexual dysfunction

Patients with MS often are ashamed to talk about sexual dysfunction, Dr. Williams said, but it is on many minds. “If I have a program on intimacy in MS, people are out the door.”

She urged colleagues to understand that MS can affect sexuality through three routes: primary, secondary, and tertiary dysfunction.

In primary sexual dysfunction, brain and spinal lesions directly related to MS can cause problems such as lack of sensation or abnormal sensations, decreased libido, vaginal dryness, and difficult orgasm.

Secondary sexual dysfunction refers to problems caused by symptoms of MS such as fatigue, which can worsen as the day progresses and affect nighttime intimacy, she said. Bladder dysfunction is another sensitive area in sexuality, with patients – especially women – “concerned that they will lose control of their bladder or they have already lost control.”

Cognitive dysfunction also can disrupt sexual function. “It is important to focus, and certain things cannot happen if you do not. If you are not able to focus and concentrate, it can affect interest,” Dr. Williams said.

Additionally, medications can improve some symptoms while making others worse. For example, a drug may relieve spasticity but boost fatigue. “We have to walk this tightrope,” she said. “But if we are not asking our patients, they may not volunteer this information.”

Finally, she said, MS can spark tertiary sexual dysfunction – poor body image, depression, anxiety, and disruptive changes in familial roles. For example, one partner may become a caregiver, and “it is hard to go from caregiving to sexy time.”

“It is something we have to acknowledge and find ways to deal with,” Dr. Williams said.

To address these issues, she pointed to strategies for symptomatic relief and disease-modifying therapy (DMT) and pinpointed several treatment options.

• Fatigue – stimulants, diet, exercise.
• Spasticity – muscle relaxants, exercise.
• Bladder dysfunction – fluid restriction, medication.
• Paresthesia – antidepressants, anticonvulsants.
• Numbness – vibrators, devices to increase stimulation.

Sexual therapy, couples therapy, and pelvic floor physical therapy also can be helpful.

Be aware of special needs during prepregnancy and pregnancy

“MS itself does not have a lot of effects on fertility, pregnancy, or pregnancy outcomes,” Dr. Williams said. However, “medications cause concern about how we manage pregnancy and fertility.”

In vitro fertilization may increase the risk of relapse, she added, and patients on dimethyl fumarate who experience vomiting or diarrhea may not be able to properly absorb oral contraceptives.

Women with MS may not need to go off DMT when they are trying to conceive, she said. “If patients have very aggressive disease, they may need to be on DMT through conception, through the first trimester, and even the entire pregnancy to prevent long-term disability.”

What about pregnancy itself? “An MS diagnosis alone does not mean that a pregnancy is high risk,” she said. “There are not necessarily additional tests and ultrasounds that are recommended for our patients based on MS diagnosis alone.”

Treatment discontinuation may be warranted during pregnancy, when MS generally improves. However, some MS symptoms – fatigue, bladder dysfunction, and balance – may increase. Corticosteroids can be appropriate if relapses occur during pregnancy.

Menopause and MS symptoms may overlap

Symptoms such as hot flashes, mood changes, sleep disturbance, bladder dysfunction, and decreased energy may be signs of MS, or they could indicate menopause, Dr. Williams said. “Sometimes patients come in and they are getting worse, and we look into it and discover they are premenopausal.”

A decline in estrogen during menopause may worsen MS symptoms, she added, and hormone therapy may be appropriate. A phase 2 study found a benefit in menopausal patients with MS for estriol in conjunction with a DMT, but more studies are needed.

Dr. Williams reported no relevant financial 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 – 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.