Recent findings from the SOUL trial have highlighted the cardiovascular benefits of oral semaglutide in patients with type 2 diabetes. The study demonstrated a 14% reduction in major adverse cardiovascular events (MACE), including heart attack, stroke, and cardiovascular death, over a median follow-up of 49.5 months.
Study Overview
The SOUL trial was a phase 3b, randomized, double-blind, placebo-controlled study involving 9,650 participants aged 50 years or older with type 2 diabetes and established atherosclerotic cardiovascular disease (ASCVD), chronic kidney disease (CKD), or both. Participants were assigned to receive either once-daily oral semaglutide (up to 14 mg) or placebo, in addition to standard care.
Key Findings
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14% Reduction in MACE: Patients receiving semaglutide experienced a 14% relative risk reduction in MACE compared to placebo.
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26% Decrease in Non-Fatal Heart Attacks: The primary driver of the MACE reduction was a significant 26% decrease in non-fatal myocardial infarctions. American College of Cardiology
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12% Reduction in Non-Fatal Strokes: There was also a 12% reduction in non-fatal strokes among the semaglutide group. American College of Cardiology
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7% Lower Cardiovascular Mortality: The rate of cardiovascular death was 7% lower in the semaglutide group compared to placebo.
Importantly, these benefits were observed without a significant increase in serious adverse events.
Clinical Implications
The SOUL trial's results suggest that oral semaglutide can be an effective option for reducing cardiovascular risk in patients with type 2 diabetes and coexisting ASCVD or CKD. The oral formulation may also improve patient adherence compared to injectable therapies.
Conclusion
The SOUL trial reinforces the role of semaglutide in cardiovascular risk reduction among high-risk type 2 diabetes patients. As research continues, semaglutide may become a cornerstone in the management of both glycemic control and cardiovascular health.
