Semaglutide and Cardiovascular Outcomes in Patients With Type 2 Diabetes
November 10, 2016. This randomized controlled trial evaluated the cardiovascular (CV) impact of semaglutide, a long-acting glucagon-like peptide-1 (GLP-1) analogue. Investigators in the SUSTAIN-6 study assigned 3297 patients to receive once-weekly semaglutide 0.5 mg or 1.0 mg or placebo for 104 weeks. At baseline, 83% of patients had established CV disease and/or chronic kidney disease. The primary composite outcome was the first occurrence of CV death, nonfatal myocardial infarction, or nonfatal stroke. The primary outcome occurred in 6.6% of semaglutide and 8.9% of placebo patients (hazard ratio [HR], 0.74; 95% confidence interval [CI], 0.58 to 0.95; P<0.001 for noninferiority). New or worsening nephropathy rates were also reduced in the semaglutide group, although rates of retinopathy complications were significantly higher with semaglutide vs placebo (hazard ratio, 1.76; 95% CI, 1.11 to 2.78; P=0.02). Compared with placebo, fewer serious adverse events (AEs) occurred in the semaglutide group; however, more semaglutide patients discontinued treatment due to AEs (primarily gastrointestinal). Investigators concluded that, in a high CV risk group with type 2 diabetes, patients receiving semaglutide experienced reduced composite CV risk vs patients receiving placebo.