Weekly subcutaneous injections of efpeglenatide, a novel exendin-based GLP1-RA, was shown to reduce the risk of cardiovascular events in patients with type 2 diabetes (T2D) and a history of cardiovascular disease or current kidney disease plus one cardiovascular risk factor, according to a study published June 28 in the New England Journal of Medicine in conjunction with the American Diabetes Association's Annual Scientific Sessions.

The study randomized 4,076 patients (mean age, 64.5 years; 33% female) with T2D from 344 sites in 28 countries to efpeglenatide 4 mg, efpeglenatide 6 mg or placebo to evaluate the effect on cardiovascular and renal outcomes. Kidney disease was defined as an estimated glomerular filtration rate of 25.0 to 59.9 ml/min/1.73 m² of body-surface area. Results were stratified by SGLT2 use at baseline.

The primary outcome of first major adverse cardiovascular event (MACE), defined as nonfatal stroke, nonfatal myocardial infarction, cardiovascular death or death from undetermined causes, occurred in 7% of patients who received efpeglenatide and 9.2% of patients who received placebo over the median follow-up of 1.81 years (3.9 vs. 5.3 events/100 person-years; hazard ratio, 0.73; 95% confidence interval 0.58-0.92; p<0.001). Additionally, the composite renal outcome event, defined as a decline in kidney function or macroalbuminuria occurred in 13% of patients treated with efpeglenatide and 18.4% of patients treated with placebo.

Gastrointestinal adverse events occurring more frequently with efpeglenatide than placebo were constipation, nausea, diarrhea, bloating and vomiting.

Hertzel C. Gerstein, MD, et al., write, "The results suggest that these cardiovascular and renal benefits occurred independently of the baseline use of SGLT2 inhibitors, the baseline use of metformin, and the baseline eGFR."

Keywords: Cardiovascular Diseases, Metformin, Diabetes Mellitus, Type 2, Glomerular Filtration Rate, Body Surface Area, Risk Factors, Cardiovascular System, Kidney, Myocardial Infarction, Injections, Subcutaneous, Kidney Diseases, Nausea, Vomiting, Stroke, Constipation, Diarrhea

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