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Follow the LEADER-Liraglutide Effect and Action in Diabetes: Evaluation of Cardiovascular Outcome Results Trial.

ABSTRACT: This commentary analyzes the Liraglutide Effect and Action in Diabetes: Evaluation of Cardiovascular Outcome Results (LEADER) trial, which has reported the cardiovascular benefits of liraglutide. It places the results of this seminal trial in the context of the evolution of diabetes care, compares them with other recently published cardiovascular outcome trials, and suggests novel mechanisms to explain the benefits and properties of liraglutide. The editorial discusses the potential impact that LEADER will have on the prevention and management of diabetes and its vascular complications.

SUBMITTER: Kalra S

PROVIDER: S-EPMC5118235 | biostudies-literature | 2016 Dec

REPOSITORIES: biostudies-literature

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Follow the LEADER-Liraglutide Effect and Action in Diabetes: Evaluation of Cardiovascular Outcome Results Trial.

Kalra Sanjay S

Diabetes therapy : research, treatment and education of diabetes and related disorders 20160909 4

This commentary analyzes the Liraglutide Effect and Action in Diabetes: Evaluation of Cardiovascular Outcome Results (LEADER) trial, which has reported the cardiovascular benefits of liraglutide. It places the results of this seminal trial in the context of the evolution of diabetes care, compares them with other recently published cardiovascular outcome trials, and suggests novel mechanisms to explain the benefits and properties of liraglutide. The editorial discusses the potential impact that ...[more]

PMID: 27613064

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Project description:BackgroundThe cardiovascular effect of liraglutide, a glucagon-like peptide 1 analogue, when added to standard care in patients with type 2 diabetes, remains unknown.MethodsIn this double-blind trial, we randomly assigned patients with type 2 diabetes and high cardiovascular risk to receive liraglutide or placebo. 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 primary hypothesis was that liraglutide would be noninferior to placebo with regard to the primary outcome, with a margin of 1.30 for the upper boundary of the 95% confidence interval of the hazard ratio. No adjustments for multiplicity were performed for the prespecified exploratory outcomes.ResultsA total of 9340 patients underwent randomization. The median follow-up was 3.8 years. The primary outcome occurred in significantly fewer patients in the liraglutide group (608 of 4668 patients [13.0%]) than in the placebo group (694 of 4672 [14.9%]) (hazard ratio, 0.87; 95% confidence interval [CI], 0.78 to 0.97; P<0.001 for noninferiority; P=0.01 for superiority). Fewer patients died from cardiovascular causes in the liraglutide group (219 patients [4.7%]) than in the placebo group (278 [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 (381 patients [8.2%]) than in the placebo group (447 [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 most common adverse events leading to the discontinuation of liraglutide were gastrointestinal events. The incidence of pancreatitis was nonsignificantly lower in the liraglutide group than in the placebo group.ConclusionsIn the time-to-event analysis, the rate of the first occurrence of death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke among patients with type 2 diabetes mellitus was lower with liraglutide than with placebo. (Funded by Novo Nordisk and the National Institutes of Health; LEADER ClinicalTrials.gov number, NCT01179048.).

Dataset Information

Follow the LEADER-Liraglutide Effect and Action in Diabetes: Evaluation of Cardiovascular Outcome Results Trial.

Publications

Follow the LEADER-Liraglutide Effect and Action in Diabetes: Evaluation of Cardiovascular Outcome Results Trial.

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