Results From Long-Term Cardiovascular Safety Study of Lorcaserin Announced

Findings from a large post-marketing study of lorcaserin HCI (Belviq; Eisai) indicate that the treatment does not appear to increase the incidence of major adverse cardiovascular events (MACE) in overweight or obese individuals.

Lorcaserin, a serotonin 2C receptor agonist, is currently approved as an adjunct to diet and exercise for chronic weight management in adults with a BMI of ≥30kg/m² or ≥27kg/m² in the presence of at least 1 weight-related comorbidity (eg, hypertension, dyslipidemia, type 2 diabetes mellitus [T2DM]).

Approximately 12,000 patients took part in the CAMELLIA-TIMI 61 trial in which participants were randomized to either lorcaserin HCl 10mg twice daily or placebo. Long-term cardiovascular (CV) safety and the incidence of MACE were selected as primary outcome measures.

Results showed that long-term treatment with lorcaserin did not increase the incidence of MACE (cardiovascular death or non-fatal myocardial infarction [MI] or non-fatal stroke) in overweight and obese patients at high risk for CV events. With regard to a broader composite endpoint (cardiovascular death, non-fatal MI, non-fatal stroke, hospitalization due to unstable angina, heart failure or coronary revascularization), lorcaserin was found to be non-inferior to placebo, with similar event rates in both arms.

As for secondary outcomes, treatment with lorcaserin was associated with significant improvements in blood pressure, lipids, glucose levels, and renal function, as well as a reduction in conversion to T2DM in those without diabetes at baseline.

“CAMELLIA-TIMI 61 was a rigorous evaluation of the safety and efficacy of Belviq as a metabolic intervention on cardiovascular health in a high cardiovascular risk patient population,” said Marc Sabatine, MD, MPH, Chairman, TIMI Study Group, Brigham and Women’s Hospital.  “We look forward to sharing the full results with the scientific community.”

The Company plans to release the full results in late August.

For more information visit ClinicalTrials.gov.