Semaglutide Found Noninferior to Placebo for Diabetes Patients at High Cardiovascular Risk

The unapproved glucagon-like peptide-1 (GLP-1) analogue semaglutide is noninferior to placebo in its association with rates of cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke among patients with type 2 diabetes at high cardiovascular risk, according to the results of a recent study.

Recent research evaluating the effects of the sodium-glucose cotransporter 2 inhibitor empagliflozin and the GLP-1 analogue liraglutide have demonstrated improved cardiovascular outcomes in patients with type 2 diabetes.
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In order to establish the cardiovascular safety of semaglutide, researchers designed the Trial to Evaluate Cardiovascular and Other Long-term Outcomes with Semaglutide in Subjects with Type 2 Diabetes (SUSTAIN-6).

For their randomized, double-blind, placebo-controlled, parallel-group trial, the researchers randomly assigned 2735 participants to receive 0.5 mg or 1.0 mg of once-weekly subcutaneous semaglutide or volume-matched placebo. The trial included 104 weeks of treatment and a 5-week follow-up period. Patients were eligible if they had type 2 diabetes and a glycated hemoglobin level of 7% or more, and had not been treated with an antihyperglycemia drug or with no more than 2 oral antihyperglycemia agents, with or without basal or premixed insulin.

Overall, cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke occurred in 108 of 1648 patients in the semaglutide group and 146 of the 1649 patients in the placebo group. While rates of new or worsening nephropathy were lower in the semaglutide group, rates of retinopathy complications were significantly higher.

“In patients with type 2 diabetes who were at high cardiovascular risk, the rate of cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke was significantly lower among patients receiving semaglutide than among those receiving placebo, an outcome that confirmed the noninferiority of semaglutide.”

—Michael Potts

Reference:

Marso SP, Bain SC, Consoli A, et al; SUSTAIN-6 Investigators. Semaglutide and cardiovascular outcomes in patients with type 2 diabetes [published online September 16, 2016]. N Engl J Med. doi:10.1056/NEJMoa1607141.