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Oral Semaglutide Cuts Serious Heart-Failure Events 22% in Type 2 Diabetes With Heart Failure

Findings point to a strong signal in HFpEF, a hard-to-treat subtype, spurring calls for confirmatory trials.

Overview

  • A JAMA Internal Medicine secondary analysis of the SOUL trial found a 22% reduction in hospitalizations and deaths from heart failure among participants with type 2 diabetes who had heart failure at baseline.
  • The benefit was greatest in HFpEF, with a 41% lower risk of heart failure–related events, while no statistically significant benefit was seen in HFrEF.
  • No heart-failure benefit was detected in participants without heart failure at the start of the study.
  • The randomized, double-blind trial enrolled about 9,650 people across 33 countries and followed them for nearly four years on daily oral semaglutide versus placebo.
  • Serious adverse events occurred at similar rates in both groups, though investigators noted the analysis was exploratory, the trial was funded by Novo Nordisk, and longer-term safety warrants continued monitoring.