AT THE ADA ANNUAL SCIENTIFIC SESSIONS

SAN DIEGO (FRONTLINE MEDICAL NEWS) – In a follow-up to the blockbuster trial results linking the type 2 diabetes drug empagliflozin (Jardiance) to a dramatically lower risk of cardiac death, researchers report that the drug improved weight-related measures in multiple groups.

Two daily doses of empagliflozin, 10 mg and 25 mg, “had consistent and robust effects on lowering weight, waist circumference, and other markers of body fat across most patients regardless of their age, sex, or degree of abdominal obesity,” study lead author Ian J. Neeland, MD, of the department of medicine at UT Southwestern Medical Center, Dallas, said in an interview. “Our next step is to determine if these effects may contribute to the improvement in cardiovascular risk seen with the drug.”

Dr. Neeland presented the findings, a secondary analysis of the landmark EMPA-REG OUTCOME study , at the annual scientific sessions of the American Diabetes Association.

“In the EMPA-REG OUTCOME study, empagliflozin treatment significantly reduced the risk of cardiovascular death by 38%,” Dr. Neeland said. “We also observed that patients treated with empagliflozin had improvements in markers of body fatness such as weight, waist circumference, and estimated total body fat. Since we know that obesity is a major risk factor for cardiovascular disease, we were interested in finding out if the improvements in weight and other markers of body fatness may have contributed to the observed cardiovascular benefits of empagliflozin in the study. One part of this was to examine whether the drug had consistent effects on body fat according to other important cardiovascular risk factors.”

The researchers analyzed changes in body weight, waist circumference, index of central obesity, and estimated total body fat from baseline to week 164 in a study that randomly assigned participants with type 2 diabetes and cardiovascular disease to placebo or 10 mg or 25 mg of empagliflozin. The number of patients in the groups were 2,333, 2,345 and 2,342, respectively, and their mean baseline weight was around 86.0 kg.

In general, researchers found that across groups, weight measures improved more in drug-treated patients than those treated with placebo. The higher dose (25 mg) often had a greater effect; the two available doses of the drug are 10 mg and 20 mg.

For example, the placebo-adjusted mean reduction in weight was –1.70 kg in men (95% confidence interval, –2.14 to –1.27) in the 10-mg group and 2.18 kg (95% CI, –2.61 to –1.75) in the 25-mg group. For women, the reduction was –1.32 kg (95% CI, –2.02 to –0.62) in the 10-mg group and –1.44 kg (95% CI, –2.15 to –0.73) in the 25-mg group.

“Patients lost on average 1.5-2 kg of weight – about 4 pounds – with empagliflozin, compared with placebo,” Dr. Neeland said. “Although quality of life and other metrics of better health were not systematically collected, we do know that people who lose weight and waist circumference tend to feel better, have fewer health problems, and live longer, compared with people who remain obese.”

Dr. Neeland said researchers still need to understand whether the improvements in obesity markers contribute to the drug’s positive cardiac effects.

Study funding was not reported. The original EMPA-REG OUTCOME trial was funded by Boehringer Ingelheim and Eli Lilly. Dr. Neeland disclosed consultant/speakers bureau support from Boehringer Ingelheim. He is a scientific advisory board member for Advanced MR Analytics AB.

cenews@frontlinemedcom.com

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