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 notable weight loss, this benefit was accompanied by a concerning signal regarding cardiovascular safety.
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.
| Event | Semaglutide Group (%) | Placebo Group (%) |
|---|---|---|
| Cardiovascular death | 1.5% | 0.8% |
| non-Fatal Stroke | 2.6% | 1.7% |
| Non-fatal Heart Attack | 3.7% | 2.4% |
| MACE (Combined) | 6.5% | 4.9% |
Who is Affected? Understanding the Patient Population
This study specifically focused on adults with obesity (BMI of 30 or higher) *and* established cardiovascular disease – meaning they had a prior heart attack, stroke, or peripheral artery disease.It’s crucial to understand that these findings do *not* necessarily apply to individuals using semaglutide for weight loss who do not have pre-existing heart conditions. However, it raises questions about the long-term cardiovascular effects of these medications even in those without prior disease.
The average age of participants was 61.3 years, and approximately half were women. This demographic is particularly vulnerable to cardiovascular events, making the findings even more concerning.
Why does This Matter? The Implications for Patients and Physicians
The SELECT trial challenges the widely held belief that weight loss, in and of itself, always translates to improved cardiovascular health. While semaglutide is highly effective for weight reduction, this benefit appears to be counterbalanced by a potential increase in cardiovascular risk in a specific patient population. This necessitates a more nuanced approach to prescribing these medications.
Physicians should carefully assess patients’ cardiovascular risk factors before initiating semaglutide therapy. Those with established heart disease should be closely monitored for any signs of cardiovascular events. Furthermore, patients should be educated about the potential risks and benefits of the medication.
Timeline of Events and Ongoing Research
August 17, 2023: Results of the SELECT trial are publicly released and published ahead of print in the New England Journal of Medicine.
Ongoing: Novo Nordisk,the manufacturer of semaglutide,is conducting
