Novo Nordisk announced today the headline results:
The trial achieved its primary endpoint by demonstrating non-inferiority of major adverse cardiovascular events (MACE) with oral semaglutide compared with placebo, both in addition to standard care. The results are based on the accumulated occurrence of 137 major adverse cardiovascular events, with a median follow-up time of 16 months. The primary endpoint of the PIONEER 6 trial was defined as the MACE composite outcome of the first occurrence of cardiovascular death, non-fatal myocardial infarction or non-fatal stroke and showed a hazard ratio of 0.79 in favour of oral semaglutide compared with placebo. The 21 percent reduction in MACE in favor of oral semaglutide did not reach statistical significance.
The MACE results demonstrated by oral semaglutide were driven by a statistically significant reduction in cardiovascular death of 51 percent (HR 0.49, p=0.03), while non-fatal myocardial infarction (HR 1.18, non-significant) or non-fatal stroke (HR 0.74, non-significant) were broadly similarly distributed between the two treatment arms. In addition, a statistically significant reduction in all-cause mortality of 49 percent (HR 0.51, p=0.008) in favor of oral semaglutide was observed. The improvements in secondary endpoints including HbA1c, body weight and blood pressure were similar to results reported throughout the PIONEER program for oral semaglutide. Furthermore, the safety profile of oral semaglutide in PIONEER 6 was consistent with the established safety profile observed in previous PIONEER clinical trials.
TrialSite News will provide a separate overview of Semaglutide pricing for its existing treatments.