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Semaglutide and Cardiovascular Outcomes in Patients with Type 2 Diabetes.

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Affiliations

  • 1. From the Research Medical Center, Kansas City, MO (S.P.M.); School of Medicine, Swansea University, Swansea, United Kingdom (S.C.B.); Department of Medicine and Aging Science and Center of Excellence on Aging and Translational Medicine, G. d'Annunzio University, Chieti-Pescara, Italy (A.C.); CPClin Research Center/Hospital Israelita Albert Einstein, São Paulo (F.G.E.); Hospital Universitario Quirón Salud Madrid, Facultad de Ciencias de la Salud, Universidad Europea de Madrid, Madrid (E.J.); Li Ka Shing Knowledge Institute and Keenan Research Centre for Biomedical Science, St. Michael's Hospital, University of Toronto, Toronto (L.A.L.), and the University of Manitoba, Winnipeg (V.W.) - both in Canada; University of Texas Southwestern Medical Center (I.L.) and Dallas Diabetes Research Center at Medical City (J.R.) - both in Dallas; University of Freiburg Medical Center, Faculty of Medicine, University of Freiburg, Freiburg, Germany (J.S.); Physicians East, Greenville, NC (M.L.W.); and Novo Nordisk, Søborg (O.H., A.G.H., J.P.), and the Center for Diabetes Research, Gentofte Hospital, University of Copenhagen, Hellerup (T.V.) - both in Denmark.
      Authors
    • Marso SP 1
    • Bain SC 1
    • Consoli A 1
    • Eliaschewitz FG 1
    • Jódar E 1
    • Leiter LA 1
    • Lingvay I 1
    • Rosenstock J 1
    • Seufert J 1
    • Warren ML 1
    • Woo V 1
    • Hansen O 1
    • Holst AG 1
    • Pettersson J 1
    • Vilsbøll T 1
    (15 authors)

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The New England Journal of Medicine, 15 Sep 2016, 375(19):1834-1844
https://doi.org/10.1056/nejmoa1607141 PMID: 27633186 

A comment on this article appears in "Semaglutide and Cardiovascular Outcomes in Patients with Type 2 Diabetes." N Engl J Med. 2017 Mar 2;376(9):891. This is a comment on "" N Engl J Med. 2017 Mar 2;376(9):891. A comment on this article appears in "Semaglutide reduced a composite of CV events at 2 years in patients with type 2 diabetes and high CV risk." Ann Intern Med. 2017 Jan 17;166(2):JC8. Show all (9)

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 .).

Full text links 

Read article at publisher's site: https://doi.org/10.1056/nejmoa1607141

Read article for free, from open access legal sources, via Unpaywall: https://cronfa.swan.ac.uk/Record/cronfa30129/Download/0030129-12112016114729.pdfUnpaywall

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Novo Nordisk Fonden (3)