In a nutshell
The authors aimed to determine the association between semaglutide (NN9535) and cardiovascular (CVD) outcomes in patients with type 2 diabetes. The authors concluded that in patients at high CVD risk, the rate of CVD death, heart attack and stroke was significantly lower in patients who received semaglutide compared to patients who received a placebo.
Some background
Diabetes is a major risk factor for the development of cardiovascular (CVD; heart and blood vessel) disease. Some treatments, such as empagliflozin and liraglutide, have been found to help to reduce the risk of CVD events, such as heart attack or stroke.
Semaglutide, like liraglutide, is a new treatment that increases insulin secretion that results in improves blood glucose control and reduces body weight. The CVD safety of semaglutide is still unknown.
Methods & findings
The aim of this study was to determine the CVD effects of semaglutide in type 2 diabetes.
3,297 patients were randomly assigned to one of two groups. In group 1, 1,648 patients received semaglutide once-weekly. In group 2, 1,649 patients received a placebo (substance with no effect on the body). Patients were followed for 2.1 years.
The primary outcome (defined as the first occurrence of CVD death, non-fatal heart attack or non-fatal stroke) occurred in 6.6% of group 1 and 8.9% of group 2. Non-fatal heart attacks occurred in 2.9% of group 1 and 3.9% of group 2. Non-fatal strokes occurred in 1.6% of group 1 and 2.7% of group 2. CVD death was similar in both groups (2.7% in group 1 and 2.8% in group 2).
Diabetic retinopathy (eye disease related to diabetes) occurred in 3% of group 1 and 1.8% of group 2. Patients in group 1 experienced more gastrointestinal problems than group 2. Treatment discontinuation in group 1 (mainly due to gastrointestinal problems) was more common than in group 2.
The bottom line
The authors concluded that in patients with type II diabetes who were at high CVD risk, the rate of CVD death, heart attack and stroke was significantly lower in patients who received semaglutide compared to patients who received a placebo.
The fine print
This study was funded by Novo Nordisk, the manufacturer of semaglutide.
Published By :
The New England Journal of Medicine
Date :
Sep 15, 2016