[en] Summary : The cardiovascular safety of sitagliptin has been evaluated in TECOS («Trial Evaluating Cardiovascular Outcomes with Sitagliptin»). TECOS recruited patients with type 2 diabetes and a history of cardiovascular disease who received, as add-on to their usual therapy, either sitagliptin (n = 7.257) or placebo (n = 7.266), with a median follow-up of 3 years. The primary cardiovascular outcome was a composite of cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, or hospitalization for unstable angina. Sitagliptin was noninferior to placebo for the primary composite cardiovascular outcome (hazard ratio, 0.98; 95 % confidence interval, 0.88 to 1.09; P<0.001). Rates of hospitalization for heart failure did not differ between the two groups (hazard ratio, 1.00; 95 % CI, 0.83 to 1.20; P=0.98). The cardiovascular safety of sitagliptin, which was already shown in meta-analyses of phase II-III randomised controlled trials and in observational cohort studies in real life, is now confirmed in the landmark prospective cardiovascular outcome study TECOS. [fr] Résumé : La sécurité cardiovasculaire de la sitagliptine a été évaluée dans l’étude TECOS («Trial Evaluating Cardiovascular Outcomes with Sitagliptin»). TECOS a recruté des patients diabétiques de type 2 avec une histoire de maladie cardiovasculaire qui ont reçu, en plus de leur traitement habituel, soit la sitagliptine (n = 7.257), soit un placebo (n = 7.266), avec un suivi médian de 3 ans. Le critère d’évaluation primaire incluant les décès de cause cardiovasculaire, les infarctus du myocarde non mortels, les accidents vasculaires cérébraux non mortels et les hospitalisations pour angor instable est survenu de façon comparable dans les deux groupes (hasard ratio : 0,98; intervalle de confiance à 95 % : 0,88 - 1,09; P < 0,001 pour la non-infériorité). Le traitement par sitagliptine n’a pas été associé à un risque accru d’hospitalisations pour insuffisance cardiaque (hasard ratio : 1,00; intervalle de confiance à 95 % : 0,83 – 1,20; P = 0,98). La sécurité de la sitagliptine, déjà apparente dans les méta-analyses des essais cliniques contrôlés de phases II-III et également objectivée dans des études observationnelles de cohorte en vie réelle, est donc confirmée dans la grande étude prospective TECOS.
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