Summaries of Must-Read Clinical Literature, Guidelines, and FDA Actions
Semaglutide and CV Outcomes in Patients with T2D
N Engl J Med; ePub 2016 Sep 16; Marso, et al
The rate of cardiovascular (CV) death, nonfatal myocardial infarction (MI), or nonfatal stroke was significantly lower among patients with type 2 diabetes (T2D) who were at high CV risk and receiving semaglutide than among those receiving placebo, a recent study found. The trial randomly assigned 3,297 patients with T2D who were on a standard-care regimen to receive once-weekly semaglutide (0.5 mg or 1.0 mg) or placebo for 104 weeks. Primary outcome was the first occurrence of CV death, nonfatal MI, or nonfatal stroke. Researchers found:
- 2,735 (83.0%) patients had established CVD, chronic kidney disease (CKD), or both at baseline.
- Primary outcome occurred in 108 of 1,648 patients (6.6%) in the semaglutide group vs 146 of 1,649 patients (8.9%) in the placebo group (HR, 0.74).
- Nonfatal MI occurred in 2.9% of patients receiving semaglutide vs 3.9% of those receiving placebo (HR, 0.74).
- Nonfatal stroke occurred in 1.6% and 2.7%, respectively (HR, 0.61).
- Rates of death from CV causes were similar in the 2 groups.
Marso SP, Bain SC, Consoli A, et al. Semaglutide and cardiovascular outcomes in patients with type 2 diabetes. [Published online ahead of print September 16, 2016]. N Engl J Med. doi:10.1056/NEJMoa1607141.
This has been quite a year for cardiovascular outcome studies in diabetes. Approximately a year ago, empagliflozin, an SGLT-2 inhibitor, was shown in patients with diabetes and established cardiovascular disease to significantly decrease cardiovascular outcomes, defined as death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke.1 This past spring, liraglutide, a GLP-1 receptor agonist in patients with diabetes at high CV risk (72% has established coronary disease), was shown to significantly decrease cardiovascular outcomes.2 Semaglutide, a once weekly GLP-1 receptor agonist, now joins empagliflozin and liraglutide as having a significant beneficial effect in decreasing the incidence of cardiovascular outcomes in high-risk patients over 2 to 4 years. —Neil Skolnik, MD
1. Zinman B, Wanner C, Lachin JM, et al. Empagliflozin, cardiovascular outcomes, and mortality in type 2 diabetes. N Engl J Med. 2015;373:2117-28. doi:10.1056/NEJMoa1504720.
2. Marso SP, Daniels GH, Brown-Frandsen K, et al. Liraglutide and cardiovascular outcomes in type 2 diabetes. N Engl J Med. 2016;375:311-22. doi:10.1056/NEJMoa1603827.