Publication details
Studie LEADER (Liraglutide Effect and Action in Diabetes: Evaluation of cardiovascular outcome Results)
| Title in English | The LEADER Trial (Liraglutide Effect and Action in Diabetes: Evaluation of Cardiovascular Outcome Results) |
|---|---|
| Authors | |
| Year of publication | 2018 |
| Type | Article in Periodical |
| Magazine / Source | Intervenční a akutní kardiologie |
| MU Faculty or unit | |
| Citation | |
| Keywords | liraglutide; diabetes mellitus; cardiovascular safety |
| Description | The LEADER trial investigated the cardiovascular safety of liraglutide compared with placebo in patients with diabetes mellitus andcardiovascular disease. The minimum planned follow-up was 42 months, with a maximum of 60 months. The primary compositeoutcome was death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke. The secondary outcome wasa composite of the primary outcome plus coronary revascularization, or hospitalization for unstable angina pectoris or heart failure.A total of 4 668 patients were assigned to the treatment arm and 4 672 patients to the placebo arm. The primary compositeoutcome was in the favour of patients treated with liraglutide: there was a reduction in the risk of cardiovascular death, nonfatalmyocardial infarction, or nonfatal stroke by 13% (p<0.001 for noninferiority; p<0.01 for superiority). With regard to the individualcomponents of the primary outcome, there was a substantial decline in the risk of cardiovascular death by 22 % (p<0.007). Withregard to the secondary outcomes, the reduction in the risk of overall mortality by 15 % (p<0.02) was a very positive finding. Anotherimportant finding was the fact that there was no difference in the rates of hospitalization for heart failure (p<0.14). Furthermore,the trial investigated microvascular complications that were divided into renal and ocular events. The overall rate of microvascularcomplications was 7.6% in patients treated with liraglutide versus 8.9% in the placebo group (p<0.02). This reduced rate was dueto renal complications (p < 0.003), with ocular complications not having been statistically significant (p<0.33). When evaluating the safety of liraglutide, the overall rates of adverse events were similar to those in the placebo group. There wasno increase in the occurrence of tumours (both benign and malignant) or pancreatitis. In addition to being effective in treatingdiabetes mellitus, liraglutide has been demonstrated to favourably affect cardiovascular parameters, including overall mortality;therefore, it appears to be a promising modern drug in treating diabetic patients with cardiovascular or renal risks. |