Novo Nordisk announced that the U.S. Food and Drug Administration (FDA) has approved a new indication for Ozempic (semaglutide) injection 0.5 mg or 1 mg to reduce the risk of major adverse cardiovascular events (MACE) such as heart attack, stroke, or death in adults with type 2 diabetes and known heart disease.1 Additional details were added to the Rybelsus (semaglutide) tablets 7 mg or 14 mg Prescribing Information about the primary analysis for PIONEER 6. Cardiovascular disease (CVD) is the main cause of death and disability among people with type 2 diabetes. Adults with type 2 diabetes are two to four times more likely to develop CVD than adults without diabetes. The FDA's decision on Ozempic is based on results from the SUSTAIN 6 cardiovascular outcomes trial (CVOT) which examined the cardiovascular safety of adding Ozempic or placebo to standard of care in adults with type 2 diabetes and established cardiovascular disease. In the 2-year SUSTAIN 6 trial, Ozempic significantly reduced the risk of the occurrence of a three-component MACE endpoint consisting of cardiovascular death, non-fatal heart attack or non-fatal stroke. The estimated relative risk reduction of MACE was 26% vs placebo (HR 0.74 [95% CI: 0.58, 0.95], p<0.001 for noninferiority, median observation time 2.1 years) with the primary composite outcome occurring in 6.6% of patients treated with Ozempic® vs 8.9% with placebo.1,4 During the trial, gastrointestinal adverse events were more frequent in the Ozempic® group than in the placebo group. The majority of gastrointestinal adverse events occurred during the first 30 weeks.