ADA 2019—Oral semaglutide is tied to 50% decline in CV, all-cause death


  • Emily Willingham, PhD
  • Conference Reports
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Takeaway

  • Oral semaglutide does not increase risk for cardiovascular (CV) disease (CVD) over placebo in patients with type 2 diabetes (T2D). 
  • The drug was tied to 50% reduced CVD death and all-cause mortality in the PIONEER 6 trial.

Why this matters

  • Oral semaglutide offers a noninjection option for patients with T2D, high CVD risk, and chronic kidney disease.
  • The oral drug is under review by the FDA and in Europe and Canada.

Key results

  • Major adverse cardiovascular events in 3.8% with oral semaglutide vs 4.8% with placebo: HR, 0.79 (95% CI, 0.57-1.11; P<.001 noninferiority>
  • For each component of the composite, HRs (95% CIs) with semaglutide vs placebo were:
    • Cardiovascular death: 0.49 (0.27-0.92);
    • Nonfatal myocardial infarction: 1.18 (0.73-1.90);
    • Nonfatal stroke: 0.74 (0.35-1.57); and
    • All-cause death: 0.51 (0.31-0.84).
  • More gastrointestinal events seen with semaglutide.

Study design

  • Trial conducted in 21 countries, included 3183 participants taking either 14 mg semaglutide once a day (n=1591) or placebo (n=1592).
  • Primary endpoint: time to first major cardiac event.
  • Funding: Novo Nordisk.

Limitations

  • Authors urge caution interpreting data showing no treatment interactions in subgroups because of small numbers and wide CIs.

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