Real-world data reveal preventive potential of semaglutide for CV events
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Key takeaways:
- Danish registry data show 31% of people with obesity and a first MI met SELECT trial criteria and are eligible for semaglutide.
- Clinicians can prevent one major adverse CV event for every 49 patients treated.
Data show one in three patients in Denmark with obesity, no diabetes and a first-time MI met eligibility criteria for the SELECT CV outcomes trial, and that one major CV event can be prevented for every 49 people who receive semaglutide.
The analysis of real-world registry data could be useful for clinicians and regulatory authorities regarding the eligibility and preventive potential of the GLP-1 receptor agonist semaglutide 2.4 mg (Wegovy, Novo Nordisk) for people with overweight or obesity who had an MI but do not have diabetes, Michael Maeng, MD, PhD, clinical professor in the department of cardiological medicine at Aarhus University Hospital, Denmark, and colleagues wrote in a research letter in the Journal of the American College of Cardiology.
As Healio previously reported, the SELECT trial, presented at the American Heart Association Scientific Sessions in November, found semaglutide was superior to placebo in reducing the incidence of major adverse CV event, defined as CV death, nonfatal MI or nonfatal stroke, with an HR of 0.8 (95% CI, 0.72-0.9).
“These results raise important questions for clinicians and regulatory authorities,” Maeng and colleagues wrote. “Using the semi-nationwide Western Denmark Heart Registry, we aimed to provide estimates of the prevalence of patients meeting SELECT eligibility criteria, the 5-year MACE incidence, and the corresponding number needed to treat to reduce one MACE in real-world consecutive patients with first-time MI from a low-risk European country.”
In an observational study, Maeng and colleagues analyzed data from 34,405 patients with a first-time MI and CAD from 2010 to 2021, using Danish health registries. Researchers then applied SELECT trial inclusion and exclusion criteria to the real-world cohort: adults aged 45 years and older without diabetes and with a BMI of 27 kg/m2 or higher; they determined 31% would have been eligible for inclusion in SELECT. The SELECT-eligible patients had a mean BMI of 29 kg/m2; median age was 64 years; 32% were smokers and 53% had hypertension. The researchers estimated 5-year cumulative incidence proportions accounting for the competing risk for non-CV death, as well as the preventive potential of semaglutide to prevent MACE during a 5-year period — the number needed to treat — based on observed cumulative incidence while assuming a similar efficacy as seen in SELECT.
During follow-up, researchers observed 972 MACE events among the SELECT-eligible patients and 544 recurrent MIs, 174 ischemic strokes and 338 CV deaths. The 5-year MACE incidence was 10.7% (95% CI, 10-11.3) among the SELECT-eligible patients. The estimated number needed to treat to prevent one MACE event was 49 patients (95% CI, 35-98).
“These results are of paramount importance to regulatory authorities and clinicians when implementing semaglutide in clinical practice,” the researchers wrote.
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