JDC Gems

5. Drug Update

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.

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