Lorcaserin helped sustain weight loss without increasing the rate of major cardiovascular events in overweight or obese patients at high risk for a cardiovascular event, according to data presented at the European Society of Cardiology (ESC) Congress 2018 and published in The New England Journal of Medicine

Lorcaserin (Belviq; Eisai) is a selective serotonin 2C receptor agonist currently approved as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults with an initial BMI of ≥30kg/m2 or ≥27kg/m2 in the presence of at least one weight-related comorbidity (eg, hypertension, dyslipidemia, type 2 diabetes).  

In the CAMELLIA–TIMI 61 study, 12,000 overweight or obese patients with atherosclerotic cardiovascular disease or multiple cardiovascular risk factors were randomized to receive either lorcaserin 10mg twice daily or placebo. The primary safety outcome of the study was the incidence of major cardiovascular events (composite of cardiovascular death, myocardial infarction, or stroke), while the primary cardiovascular efficacy outcome was major cardiovascular events + hospitalization for unstable angina, heart failure, or coronary revascularization (extended major cardiovascular events).

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At a median follow-up of 3.3 years, the rate of major cardiovascular events was 2.0% per year in the lorcaserin group vs 2.1% per year in the placebo group (hazard ratio [HR] 0.99, 95% CI, 0.85–1.14; P <.001 for non-inferiority), while the rate of extended major cardiovascular events was 4.1% per year and 4.2% per year, respectively (HR 0.97, 95% CI, 0.87-1.07; P=.55).

At 1 year, compared with placebo, significantly more patients treated with lorcaserin lost greater ≥5% of body weight (39% vs 17%; odds ratio [OR] 3.01; 95%CI 2.74-3.30; P<0.001) or ≥10% of body weight (15% vs 5%; OR 3.40; CI: 2.92-3.95; P<0.001); the difference remained significant through 40 months.

“The study showed for the first time in a rigorous, randomized way that this weight loss drug helps people lose weight without causing an increase in adverse cardiovascular events in a population at higher risk for heart attacks and strokes,” said lead author Erin Bohula, MD, DPhil, staff investigator for the Thrombolysis in Myocardial Infarction (TIMI) Study Group at Brigham and Women’s Hospital.

For more information visit NEJM.org.