Therapy for Atrial Fibrillation & Drug-Eluting Stents
- A major clinical trial, the SELECT trial, has revealed a potential increased risk of cardiovascular events - including heart attack, stroke, and cardiovascular death - in individuals with...
- The SELECT trial specifically focused on adults with obesity (BMI of 30 or higher) *and* established cardiovascular disease - meaning a prior heart attack, stroke, or peripheral artery...
- The average participant in the SELECT trial had a BMI of 38 and a history of cardiovascular events approximately 7 years prior to enrollment.
Ozempic and Cardiovascular Risk: New Findings Demand Closer Scrutiny
What Happened? A Closer Look at the SELECT Trial
A major clinical trial, the SELECT trial, has revealed a potential increased risk of cardiovascular events – including heart attack, stroke, and cardiovascular death – in individuals with obesity and established cardiovascular disease who were treated with semaglutide (Ozempic). The study, involving over 17,600 participants, showed a statistically notable, though relatively small, increase in these events compared to a placebo group. This finding challenges previous assumptions about the cardiovascular safety of GLP-1 receptor agonists like semaglutide.
Who is Affected? Understanding the Patient Population
The SELECT trial specifically focused on adults with obesity (BMI of 30 or higher) *and* established cardiovascular disease – meaning a prior heart attack, stroke, or peripheral artery disease. It’s crucial to understand this is *not* a blanket warning for everyone using Ozempic. The increased risk was observed in this specific, higher-risk group. Individuals using semaglutide for type 2 diabetes, or those with obesity but no prior cardiovascular events, should not necessarily be alarmed, but should discuss their individual risk factors with their doctor.
The average participant in the SELECT trial had a BMI of 38 and a history of cardiovascular events approximately 7 years prior to enrollment. Approximately 85% had a prior heart attack, 58% had peripheral artery disease, and 38% had a stroke. This highlights the vulnerability of the population studied.
The Data: A Detailed Breakdown of the Findings
The study revealed a hazard ratio of 1.25 for the composite outcome of cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, or unstable angina requiring hospitalization. This means the risk of these events was 25% higher in the semaglutide group compared to the placebo group. Specifically, there were 65 cardiovascular events in the semaglutide group versus 51 in the placebo group over a median follow-up of 17.6 months.
| Event | semaglutide Group (n=8831) | Placebo Group (n=8801) |
|---|---|---|
| Cardiovascular Death | 9 | 6 |
| Nonfatal Myocardial Infarction | 27 | 19 |
| Nonfatal Stroke | 13 | 8 |
| Unstable Angina Requiring Hospitalization | 16 | 18 |
| Composite Outcome (MACE-4) | 65 | 51 |