Recent findings from the phase 3 SOUL trial indicate that once-daily oral semaglutide (Rybelsus, Novo Nordisk) significantly reduces the risk of major adverse cardiovascular (CV) events in individuals with diabetes who also suffer from heart disease and/or chronic kidney disease (CKD). This pivotal trial, which was initiated in 2019, involved 9,650 participants and demonstrated an approximate 14% reduction in major adverse CV events compared to standard care alone.
Trial Overview and Results
The SOUL trial was a randomized, controlled, multicenter, double-blind, parallel-group study designed to assess the efficacy of oral semaglutide in conjunction with standard care. Major adverse CV events in this context were defined as a composite endpoint that includes cardiovascular death, nonfatal myocardial infarction (MI), and nonfatal stroke. Notably, 49% of participants received SGLT2 inhibitors at some point during the trial, complementing their standard care regimen.
The trial successfully achieved its primary endpoint, showing a significant reduction in the occurrence of major adverse CV events among those treated with oral semaglutide compared to those receiving placebo, in addition to standard care. The safety profile of oral semaglutide was consistent with previous studies, indicating that it was well-tolerated among participants.
Future Implications and Regulatory Plans
Novo Nordisk has announced plans to seek regulatory approval for a label expansion of oral semaglutide in both the United States and the European Union, with filings expected to occur around the turn of the year. The complete results of the SOUL trial will be presented at a scientific conference in 2025, providing further insights into the drug’s potential benefits.
Martin Holst Lange, executive vice president and head of development at Novo Nordisk, expressed satisfaction with the trial’s outcomes. “We are pleased to see that the results from SOUL demonstrate that oral semaglutide reduces the risk of cardiovascular events and that the benefits of oral semaglutide come on top of standard care,” he stated. He highlighted the importance of addressing both diabetes and cardiovascular disease, noting that approximately one in three adults with type 2 diabetes also have cardiovascular disease.
As these results emerge, oral semaglutide may represent a significant advancement in the treatment landscape for patients with diabetes and concomitant cardiovascular conditions, potentially improving outcomes and quality of life for millions.
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