M.DyerS.Zegers-HochschildF.de MouzonJ.IshiharaO.BankerM.et al (2021)
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In this pooled analysis of patients with heart failure and preserved ejection fraction across the SELECT, FLOW, STEP-HFpEF and STEP-HFpEF diabetes trials, semaglutide significantly reduced the risk of cardiovascular death or worsening heart failure as compared with placebo, as well as worsening heart failure events alone, but the effects on cardiovascular death were not significant, Mikhail Kosiborod, MD, FACC, FAHA, cardiologist at Saint Lukes Mid America Heart Institute and professor of medicine at the University of Missouri-Kansas City School of Medicine, said during a presentation
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A favorable ruling could extend compounding rights, but as of April 7, 2025, preparation for the deadlines is prudent (FDAs Semaglutide Shortage Resolution)
Pivotal for inclusion of cardiovascular benefit language in the eventual label, mirroring the path semaglutide took with SELECT