Among patients with Type 2 Diabetes and elevated cardiovascular risk, liraglutide decreased the risk of major adverse cardiovascular events, including death from cardiovascular causes.
In a multicentre RCT study «Marso SP, Daniels GH, Brown-Frandsen K ym. Liraglu...»1, 9340 patients with type 2 diabetes and on a standard care regimen, were randomized to receive liraglutide or placebo. The median follow-up was 3.8 years. Patients had HbA1c level of 7.0% or more. They were at least 50 years of age, and had at least one cardiovascular coexisting condition (those under 60 years of age) or cardiovascular risk factor (those aged 60 years or more). The primary composite outcome in the time-to-event analysis was the first occurrence of death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke. The study was designed as a noninferiority study.
The primary outcome occurred in significantly fewer patients in the liraglutide group than in the placebo group (13.0% vs. 14.9%; hazard ratio, 0.87; 95% CI, 0.78 to 0.97; P<0.001 for non-inferiority; P = 0.01 for superiority). Fewer patients died from cardiovascular causes in the liraglutide group than in the placebo group (4.7% vs. 6.0%; hazard ratio, 0.78; 95% CI, 0.66 to 0.93; P = 0.007). The rate of death from any cause was lower in the liraglutide group than in the placebo group (8.2% vs. 9.6%; hazard ratio, 0.85; 95% CI, 0.74 to 0.97; P = 0.02). The rates of nonfatal myocardial infarction, nonfatal stroke, and hospitalization for heart failure were nonsignificantly lower in the liraglutide group than in the placebo group.
The mean HbA1c at the beginning of the study was 8.7% in both groups. The decrease in HbA1c value was faster and greater in liraglutide group than in placebo group. The prespecified analysis at 36 months showed a mean difference between the liraglutide group and the placebo group of −0.40 percentage points (95% CI, −0.45 to −0.34).
Adverse events leading to the permanent discontinuation of the trial regimen were more common with liraglutide than with placebo (9.5% vs. 7.3%; P<0.001). This appeared to have been driven by gastrointestinal disorders in the liraglutide group. There were no statistically significant differences in the total number of any, serious or severe adverse events.