- FDA approved oral semaglutide for reducing cardiovascular risk in high-risk type 2 diabetes patients.
- The SOUL trial showed a 14% relative risk reduction in major adverse cardiovascular events over 4 years.
- MACE events occurred in 12.0% of the semaglutide group versus 13.8% in the placebo group.
- Oral semaglutide's safety profile was consistent with previous trials, with fewer serious adverse events than placebo.
FDA Approval
The FDA has approved oral semaglutide, marketed as Rybelsus®, for reducing cardiovascular risk in adults with type 2 diabetes who are at high risk for major adverse cardiovascular events (MACE). This approval includes both primary and secondary prevention, making it the only oral GLP-1 medication with this indication.
SOUL Trial Results
The phase 3b SOUL trial evaluated the effects of oral semaglutide 14 mg, alongside standard care, on reducing MACE risk. The trial's primary endpoint was the time to first occurrence of MACE, which includes cardiovascular death, non-fatal myocardial infarction, or nonfatal stroke. Results showed a 14% relative risk reduction in MACE over four years, with MACE events occurring in 12.0% of the semaglutide group compared to 13.8% in the placebo group.
Safety Profile
The safety profile of oral semaglutide 14 mg was consistent with previous trials. Serious adverse events were less common in the semaglutide group (47.9%) compared to the placebo group (50.3%). However, there was a higher incidence of gastrointestinal disorders in the semaglutide group (5.0% versus 4.4%). Adverse events leading to discontinuation were mainly gastrointestinal disorders and infections.
Background
Initially approved in 2019, Rybelsus® was the first GLP-1 medicine in pill form for improving glycemic control in adults with type 2 diabetes. The new cardiovascular indication further expands its therapeutic use, supported by extensive clinical trial and real-world evidence.
