Oral Semaglutide Linked to Lower Risk of MACE: Daily Dose

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Patient Care brings primary care clinicians a lot of medical news every day—it’s easy to miss an important study. The Daily Dose provides a concise summary of one of the website's leading stories you may not have seen.

On October 21, 2024, we reported on topline findings from the phase 3 SOUL clinical trial that examined the effect of oral semaglutide (Rybelsus; Novo Nordisk) vs placebo on cardiovascular outcomes in people with type 2 diabetes (T2D) and established cardiovascular disease (CVD) and/or chronic kidney disease (CKD).

The study

The study enrolled 9650 adults aged 50 years or older with T2D, CVD, and/or CKD who were randomly assigned to receive oral semaglutide 14 mg once daily or placebo, both in addition to standard of care. The primary outcome was time from random assignment to first occurrence of major adverse cardiovascular events (MACE) in the event-driven trial, with a target of 1225 first adjudication-confirmed MACEs.

The findings

Results showed that oral semaglutide was associated with a reduction in MACE of 14% in patients with T2D, CVD, and/or CKD.

All 3 components of the primary endpoint (CV death, nonfatal myocardial infarction or nonfatal stroke), contributed to the statistically significant and superior reduction in MACE for oral semaglutide compared to placebo. Oral semaglutide was also found to be safe and well-tolerated, which is in line with previous studies of the drug.

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