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