EASD 2018—Lorcaserin safe, effective for weight loss in large trial

  • Robert Davies and Harry O'Connor
  • Conference Reports
Access to the full content of this site is available only to registered healthcare professionals. Access to the full content of this site is available only to registered healthcare professionals.


  • 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.

Study design

  • 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.

Key results

  • 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.

Please confirm your acceptance

To gain full access to GPnotebook please confirm:

By submitting here you confirm that you have accepted Terms of Use and Privacy Policy of GPnotebook.