Universal Base-Edited CAR7 T Cells for T-Cell Acute Lymphoblastic Leukemia
- 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.This translates to a hazard ratio...
- These findings primarily impact individuals with obesity *and* pre-existing cardiovascular disease.
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 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 consistent across various subgroups, although some signals were more pronounced in those with prior heart failure.
| Event | Semaglutide Group (%) | Placebo Group (%) |
|---|---|---|
| Cardiovascular Death | 1.5% | 1.2% |
| Non-fatal Stroke | 1.7% | 1.3% |
| Non-Fatal Heart attack | 3.4% | 2.4% |
| MACE (Combined) | 6.5% | 4.9% |
Who is Affected? Understanding Patient Risk
These findings primarily impact individuals with obesity *and* pre-existing cardiovascular disease. This includes those with a history of heart attack, stroke, peripheral artery disease, or established heart failure. The trial did *not* include patients with type 2 diabetes, so the results cannot be directly extrapolated to that population. Though, given that semaglutide is frequently used off-label for weight loss in individuals without diabetes, this is a critical consideration for a broad range of patients and their physicians.
It’s crucial to differentiate between this population and those using semaglutide for diabetes management, where previous trials (like LEVOSTAR) have shown cardiovascular *benefit*. The SELECT trial focused specifically on a cohort with established cardiovascular issues,a key distinction.
why Does This Matter? The Potential Mechanisms at Play
The reasons behind the increased cardiovascular risk are currently unclear and require further investigation. Several hypotheses are being explored. One possibility is that rapid weight loss itself can induce metabolic stress and potentially trigger cardiac events. Another is that semaglutide may have direct effects on the cardiovascular system that haven’t been fully elucidated. It’s also possible that the study population,already at high cardiovascular risk,was more susceptible to adverse events.