Oral Semaglutide wins FDA approval
Results of a randomized, double-blind, placebo-controlled trial, the PIONEER 6
was published in the ‘The New England Journal of Medicine. 3183 patients who
are at high cardiovascular risk were randomly selected for the study to establish
the cardiovascular safety of a once-daily oral semaglutide drug named Rybelsus.
Results for components of the primary outcome revealed that death from
cardiovascular causes is 0.9% in the oral semaglutide group and 1.9% in the placebo
group. The percentage of nonfatal myocardial infarction was found to be 2.3% in the
oral semaglutide group and 1.9% in the placebo group; the nonfatal stroke was
reported as 0.8% in the oral semaglutide group and 1.0% in the other. Death from any
cause occurred in 1.4% in the oral semaglutide group and 2.8% in the placebo group.
Gastrointestinal adverse events leading to discontinuation of oral semaglutide or
placebo were more common with oral semaglutide.
The trial concluded that in patients with type 2 diabetes, the cardiovascular risk
profile of oral semaglutide was not inferior to that of placebo.