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- A major clinical trial, the SELECT trial, has revealed a potential increased risk of serious cardiovascular events - including heart attack, stroke, and cardiovascular death - in adults...
- The study found that 6.5% of participants taking semaglutide experienced a major adverse cardiovascular event (MACE) compared to 4.9% in the placebo group.
- Thes findings primarily affect individuals with obesity *and* pre-existing cardiovascular disease, such as a history of heart attack, stroke, or peripheral artery disease.
Ozempic and Cardiovascular Risk: new Findings Demand Closer Scrutiny
Table of Contents
What happened? A Closer Look at the SELECT Trial
A major clinical trial, the SELECT trial, has revealed a potential increased risk of serious cardiovascular events - including heart attack, stroke, and cardiovascular death – in adults with obesity and established cardiovascular disease who were treated with semaglutide (Ozempic) compared to those receiving a placebo. The trial involved over 17,600 participants across 30 countries and followed them for an average of 3.4 years. While semaglutide demonstrated significant weight loss, the cardiovascular safety signal is prompting a reassessment of its use in this specific patient population.
The Data: Key Findings from the SELECT Trial
The study found that 6.5% of participants taking semaglutide experienced a major adverse cardiovascular event (MACE) compared to 4.9% in the placebo group. This translates to a hazard ratio of 1.33, indicating a 33% increased risk.Importantly, the weight loss achieved with semaglutide – an average of approximately 15% of initial body weight - did *not* appear to offset this cardiovascular risk. The findings were presented at the European Congress on Obesity and concurrently published online.
| outcome | Semaglutide Group (%) | Placebo Group (%) | Hazard Ratio |
|---|---|---|---|
| MACE (Heart Attack, Stroke, Cardiovascular Death) | 6.5 | 4.9 | 1.33 |
| Cardiovascular Death | 3.0 | 2.2 | 1.35 |
| Non-Fatal Stroke | 1.7 | 1.3 | 1.31 |
Who is Affected? Understanding Patient Risk
Thes findings primarily affect individuals with obesity *and* pre-existing cardiovascular disease, such as a history of heart attack, stroke, or peripheral artery disease. The trial specifically enrolled participants with established cardiovascular disease, meaning they already had a higher baseline risk. It’s crucial to differentiate this population from individuals with obesity *without* existing heart conditions, where the cardiovascular effects of semaglutide may differ. Currently, the FDA is reviewing the data and assessing potential label changes.
The SELECT trial did *not* include patients with type 2 diabetes. The cardiovascular benefits of semaglutide have been previously demonstrated in individuals with type 2 diabetes in trials like LEVOLEV and SOULMATES, and these findings should not be extrapolated to that population.
Why Does This Matter? The Complex Relationship Between Weight Loss and Heart Health
This study highlights the complex interplay between weight loss and cardiovascular health.While obesity is a major risk factor for heart disease, simply losing weight doesn’t automatically guarantee cardiovascular protection. The mechanism behind the increased risk observed in the SELECT trial is currently unknown, but several hypotheses are being explored. These include potential effects of semaglutide on blood pressure, inflammation, or other cardiovascular pathways.