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Randomized controlled trial

SELECT: semaglutide (Wegovy) and heart attacks and strokes

With a mean follow-up of 39.8 months, a major cardiovascular event occurred in 6.5% of patients on semaglutide 2.4 mg once weekly and in 8.0% on placebo (hazard ratio 0.80; 95% CI, 0.72 to 0.90; p < 0.001).

Lincoff AM et al. Semaglutide and Cardiovascular Outcomes in Obesity without Diabetes. New England Journal of Medicine, 2023. DOI: 10.1056/NEJMoa2307563

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Key facts

Drug
semaglutide
Design
Randomized controlled trial
Participants
17,604
Duration
Event-driven (follow-up is given in the results)
Funding
Novo Nordisk
Registry
NCT03574597
Population
17,604 adults aged 45 or older with established cardiovascular disease and a BMI of 27 or more, without diabetes.
Primary outcome
First major cardiovascular event (cardiovascular death, nonfatal heart attack or nonfatal stroke), semaglutide 2.4 mg versus placebo.

What it found

With a mean follow-up of 39.8 months, a major cardiovascular event occurred in 6.5% of patients on semaglutide 2.4 mg once weekly and in 8.0% on placebo (hazard ratio 0.80; 95% CI, 0.72 to 0.90; p < 0.001). It is the first trial to show a reduction in cardiovascular events with an obesity drug in people without diabetes. Adverse effects led 16.6% of patients on semaglutide to stop treatment permanently, compared with 8.2% on placebo. Mean exposure to treatment was 34.2 months.

Limitations

Funded by Novo Nordisk. The population had prior cardiovascular disease, so the absolute benefit cannot be extrapolated to people with obesity who do not have that risk. The change in weight is not part of the paper’s abstract and is detailed in the full text.

What it means for you

In people with prior cardiovascular disease and overweight or obesity, without diabetes, semaglutide 2.4 mg (Wegovy) reduced the risk of heart attack, stroke or cardiovascular death compared with placebo. The result cannot simply be applied to people without cardiovascular disease. If you have a history of heart disease, it is a useful finding to discuss with your doctor.

Further reading

Related trials

  • semaglutideEvent-driven

    SOUL

    Over a mean follow-up of 47.5 months, a major cardiovascular event occurred in 12.0% of participants on oral semaglutide and 13.8% on placebo.

  • semaglutide104 weeks

    SUSTAIN-6

    With subcutaneous semaglutide (0.5 or 1 mg once weekly) over a median of 2.1 years, a major cardiovascular event occurred in 6.6% of patients, compared with 8.9% on placebo.

  • semaglutide104 weeks

    evoke and evoke+

    At 104 weeks, CDR-SB worsened by 2.3 and 2.2 points on semaglutide in evoke and evoke+ and by 2.3 and 2.1 on placebo, with no significant differences.

  • semaglutide72 weeks

    ESSENCE

    At 72 weeks, steatohepatitis resolved without worsening of fibrosis in 62.9% on semaglutide and 34.3% on placebo, and fibrosis was reduced without worsening of steatohepatitis in 36.8% versus 22.4%.

Sources

The original paper and the records consulted for this summary, with the date they were accessed.

  1. New England Journal of Medicine.Lincoff AM, et al. Semaglutide and Cardiovascular Outcomes in Obesity without Diabetes. N Engl J Med. 2023;389(24):2221-2232.accessed .
  2. National Library of Medicine (PubMed).PubMed record PMID 37952131 (abstract).accessed .