- Oral semaglutide (Rybelsus) is approved as an antihyperglycemic agent in India to address metabolic control (reduction of blood sugar and body weight).
- However, unlike its injectable counterpart (not available in India), cardio-renal benefits are not yet tested in an adequately powered cardiovascular outcomes trial (CVOT). The SOUL trial, initiated in 2019 would address this specific issue.
- While we wait for the results, Sinha & Ghosal (Diabetes Ther (2024). https://doi.org/10.1007/s13300-024-01635-1) speculate the probable results based on annualized cardiovascular event rates extracted from the placebo arms of the injectable semaglutide RCTs and pooled hazard ratio from the previous PIONNER 6, SUSTAIN 6, and FLOW trials.
- The outcomes are expected to be positive for MACE driven predominantly by reduction in CV death events.
- In addition, the authors predict an early termination of the trial at 3.78 years against the expected 5 years and 5 weeks.
