The Food and Drug Administration (FDA) has approved a new indication for Ozempic (semaglutide; Novo Nordisk) injection to reduce the risk of major adverse cardiovascular events (MACE) in adults with type 2 diabetes and established cardiovascular (CV) disease.
The approval was based on data from the 2-year, multicenter, double-blind, placebo-controlled SUSTAIN 6 trial that assessed the risk of MACE when adding Ozempic or placebo to standard of care in adults with diabetes and established CV disease (N=3297). Patients were randomized 1:1 to receive Ozempic (0.5mg or 1mg) once weekly or placebo. The primary end point was the time to first occurrence of MACE, defined as CV death, nonfatal myocardial infarction, or nonfatal stroke.
Results demonstrated that Ozempic significantly reduced the risk of MACE occurrence by 26% compared with placebo (estimated hazard ratio [HR] for time to first MACE 0.74 (95% CI, 0.58-0.95; P <.001); the primary composite end point occurred in 6.6% of the Ozempic group vs 8.9% of the placebo arm. Regarding safety, the Ozempic treatment arm was observed to have a higher frequency of gastrointestinal adverse reactions, including nausea, vomiting, and/or diarrhea, vs placebo.
In addition, the prescribing information for Rybelsus (semaglutide tablets) has been updated to include primary analysis data from the PIONEER 6 trial establishing noninferiority to placebo for time to first MACE (HR 0.79 (95% CI, 0.57-1.11) over a median observation time of 16 months. The proportion of patients who experienced at least 1 MACE was 3.8% with Rybelsus (14mg) and 4.8% for placebo. Rybelsus is currently being evaluated in the phase 3 SOUL trial for its CV effects in adults with type 2 diabetes and established CV disease.
For more information visit novonordisk-us.com.