Liraglutide provided cardiovascular benefit to oldest patients, post hoc analysis finds
Researchers analyzed the industry-funded LEADER trial, focusing on the oldest patients who were randomized to liraglutide or placebo.
Liraglutide reduced cardiovascular events more among type 2 diabetes patients ages 75 years and older than among those ages 60 to 74 years, according to a recent study.
The study was a post hoc analysis of the Liraglutide Effect and Action in Diabetes: Evaluation of Cardiovascular Outcome Results (LEADER) trial, which randomized 9,340 patients ages 50 years and older to 1.8 mg of liraglutide per day or placebo. The research was funded by Novo Nordisk, and the results were summarized in the July 2016 ACP Diabetes Monthly. The post hoc analysis, published by Annals of Internal Medicine on Dec. 4, focused on older patients in the trial, particularly the 836 participants ages 75 years and older and the 6,138 participants ages 60 to 74 years, all of whom had risk factors for cardiovascular disease.
The study's primary outcome was major adverse cardiovascular events (MACEs), defined as cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke, and the post hoc analysis also looked at an expanded composite outcome, which included coronary revascularization and hospitalization for unstable angina pectoris or heart failure as well as MACEs. Patients ages 75 years and older had a 34% and 29% reduction in risk for these outcomes, respectively, with liraglutide, a greater reduction than that seen in patients ages 60 to 74 years. Patients ages 75 years and older had a 35% risk reduction in all-cause death with liraglutide, compared to a 6% risk reduction in patients ages 60 to 74 years.
Patients in the older age group had higher rates of adverse events, with the most common being neoplasms and gastrointestinal disorders. Both gastrointestinal disorders and gallstone disease were more common among patients taking liraglutide than those on placebo, regardless of age subgroup.
The analysis provides evidence that liraglutide significantly reduced the risk of MACEs and all-cause death among high-risk elderly patients, the study authors concluded. They noted that there are not much other clinical trial data available on such patients, “a vulnerable population in which treatment options that evidently benefit important clinical end points are limited.” The analysis was limited by the relatively small number of patients ages 75 years and older, short follow-up, and the exploratory nature of post hoc analyses.