{"id":"2f3c090734a8","type":"article","url":"https://hartvaat.nl/2016/07/28/liraglutide-en-cardiovasculaire-uitkomsten-bij-diabetes-type-2-nejm-leader-trial/","title":"Liraglutide en cardiovasculaire uitkomsten bij diabetes type 2: NEJM LEADER-trial","title_en":"Liraglutide and Cardiovascular Outcomes in Type 2 Diabetes.","category":"preventie","category_label":"Preventie","professions":["apotheker","cardioloog","huisarts","internist"],"tags":["diabetes-en-hart","diabetes-type-1","diabetes-type-2","figaro-dkd","obesitas","pathfinder-trial","select-trial","soul-trial","summit-trial"],"journal":"The New England journal of medicine","doi":"10.1056/NEJMoa1603827","source_url":"https://doi.org/10.1056/NEJMoa1603827","authors":["Steven P Marso","Gilbert H Daniels","Kirstine Brown-Frandsen","Peter Kristensen","Johannes F E Mann","Michael A Nauck","Steven E Nissen","Stuart Pocock","Neil R Poulter","Lasse S Ravn","William M Steinberg","Mette Stockner","Bernard Zinman","Richard M Bergenstal","John B Buse"],"significance":10,"published":"2016-07-28","source_date":"2016-07-28","image":"","kennis":["https://hartvaat.nl/kennis/cardiometabool/diabetes-en-cardiovasculair-risico/","https://hartvaat.nl/kennis/cardiometabool/diabetes-type-1-en-hart/"],"congress":"","summary_en":"The LEADER trial demonstrated that liraglutide, a GLP-1 receptor agonist, significantly reduced cardiovascular death, nonfatal myocardial infarction, and nonfatal stroke compared with placebo in patients with type 2 diabetes at high cardiovascular risk. This landmark study established GLP-1 receptor agonists as a cornerstone of cardiovascular risk reduction in diabetes.","created":"2026-07-03T10:26:14Z","updated":"2026-07-03T13:25:35Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Landmark NEJM LEADER-trial die aantoonde dat liraglutide cardiovasculaire events en mortaliteit significant vermindert bij patiënten met diabetes type 2 en hoog cardiovasculair risico. Baanbrekend voor de rol van GLP-1-agonisten in cardiovasculaire preventie.","abstract_original":"BACKGROUND: The cardiovascular effect of liraglutide, a glucagon-like peptide 1 analogue, when added to standard care in patients with type 2 diabetes, remains unknown. METHODS: In 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. RESULTS: A 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. CONCLUSIONS: In 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.)."}