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Semaglutide and Cardiovascular Outcomes in Patients with Type 2 Diabetes

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dc.contributor.author Marso, Steven P.
dc.contributor.author Bain, Stephen C.
dc.contributor.author Consoli, Agostino
dc.contributor.author Eliaschewitz, Freddy G.
dc.contributor.author Jódar Gimeno, Esteban
dc.contributor.author Leiter, Lawrence A.
dc.contributor.author Lingvay, Ildiko
dc.contributor.author Rosenstock, Julio
dc.contributor.author Seufert, Jochen
dc.contributor.author Vilsbøll, Tina
dc.date.accessioned 2018-04-05T07:10:18Z
dc.date.available 2018-04-05T07:10:18Z
dc.date.issued 2016
dc.identifier.citation Marso, S. P., Bain, S. C., Consoli, A., Eliaschewitz, F. G., Jódar, E., Leiter, L. A., ... & Woo, V. (2016). Semaglutide and cardiovascular outcomes in patients with type 2 diabetes. New England Journal of Medicine, 375(19), 1834-1844. DOI: 10.1056/NEJMoa1607141 spa
dc.identifier.issn 0028-4793
dc.identifier.issn 1533-4406
dc.identifier.uri http://hdl.handle.net/11268/7179
dc.description.abstract Background: Regulatory guidance specifies the need to establish cardiovascular safety of new diabetes therapies in patients with type 2 diabetes in order to rule out excess cardiovascular risk. The cardiovascular effects of semaglutide, a glucagon-like peptide 1 analogue with an extended half-life of approximately 1 week, in type 2 diabetes are unknown. Methods: We randomly assigned 3297 patients with type 2 diabetes who were on a standard-care regimen to receive once-weekly semaglutide (0.5 mg or 1.0 mg) or placebo for 104 weeks. The primary composite outcome was the first occurrence of cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke. We hypothesized that semaglutide would be noninferior to placebo for the primary outcome. The noninferiority margin was 1.8 for the upper boundary of the 95% confidence interval of the hazard ratio. Results: At baseline, 2735 of the patients (83.0%) had established cardiovascular disease, chronic kidney disease, or both. The primary outcome occurred in 108 of 1648 patients (6.6%) in the semaglutide group and in 146 of 1649 patients (8.9%) in the placebo group (hazard ratio, 0.74; 95% confidence interval [CI], 0.58 to 0.95; P<0.001 for noninferiority). Nonfatal myocardial infarction occurred in 2.9% of the patients receiving semaglutide and in 3.9% of those receiving placebo (hazard ratio, 0.74; 95% CI, 0.51 to 1.08; P=0.12); nonfatal stroke occurred in 1.6% and 2.7%, respectively (hazard ratio, 0.61; 95% CI, 0.38 to 0.99; P=0.04). Rates of death from cardiovascular causes were similar in the two groups. Rates of new or worsening nephropathy were lower in the semaglutide group, but rates of retinopathy complications (vitreous hemorrhage, blindness, or conditions requiring treatment with an intravitreal agent or photocoagulation) were significantly higher (hazard ratio, 1.76; 95% CI, 1.11 to 2.78; P=0.02). Fewer serious adverse events occurred in the semaglutide group, although more patients discontinued treatment because of adverse events, mainly gastrointestinal. Conclusions: In patients with type 2 diabetes who were at high cardiovascular risk, the rate of cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke was significantly lower among patients receiving semaglutide than among those receiving placebo, an outcome that confirmed the noninferiority of semaglutide. (Funded by Novo Nordisk; SUSTAIN-6 ClinicalTrials.gov number, NCT01720446.) spa
dc.description.sponsorship SIN FINANCIACIÓN spa
dc.language.iso eng spa
dc.title Semaglutide and Cardiovascular Outcomes in Patients with Type 2 Diabetes spa
dc.type article spa
dc.description.impact 72.406 JCR (2016) Q1, 1/155 Medicine, General & Internal spa
dc.identifier.doi 10.1056/NEJMoa1607141
dc.rights.accessRights openAccess spa
dc.subject.uem Cardiopatía coronaria spa
dc.subject.uem Diabetes tipo 2 spa
dc.subject.unesco Medicina preventiva spa
dc.subject.unesco Enfermedad cardiovascular spa
dc.description.filiation UEM spa
dc.relation.publisherversion http://www.nejm.org/doi/10.1056/NEJMoa1607141?url_ver =Z39.88-2003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_p ub%3dwww.ncbi.nlm.nih.gov spa
dc.peerreviewed Si spa


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