- Lorcaserin is the first weight-loss drug with a proven cardiovascular (CV) safety profile.
- As an adjunct to lifestyle management, lorcaserin aids modest, durable weight loss and improved glycemic control in patients with type 2 diabetes (T2D).
Why this matters
- There is a clinical need for safe and effective weight-loss drugs as, currently, none meet the FDA’s CV safety requirements.
- Randomized, double-blind, placebo-controlled trial across 8 countries recruiting 12,000 overweight and obese patients with established CV disease or T2D and other CV risk factors.
- Participants randomly assigned 1:1 to receive 10 mg lorcaserin or placebo twice daily for a median follow-up of 3.3 years.
- Primary CV endpoint was a composite of major adverse cardiac events (MACE, consisting of CV death, myocardial infarction, and stroke).
- The primary metabolic endpoint was prevention of incident diabetes in prediabetes patients.
- Secondary metabolic endpoints included prevention of incident diabetes in nondiabetes patients and remission of diabetes in patients with T2D.
- Funding: Eisai Inc.
- Annualized rate of MACE was 2.0% per year in the lorcaserin group and 2.1% per year in the placebo group (HR, 0.99; 95% CI, 0.85-1.14; P<.001 for noninferiority>
- Lorcaserin reduced the risk of incident diabetes by 19% in prediabetics (HR, 0.81; 95% CI, 0.66-0.99; P=.038) and 23% in nondiabetics (HR, 0.77; 0.63-0.94; P=.012).
- Patients with type 2 diabetes mellitus in the lorcaserin group achieved a reduction of 0.33% in HbA1c from baseline compared with placebo at 1 year (95% CI, 0.29-0.38; P<.0001>
- No specific QoL metrics.