Results from Phase III trials of Belviq for Obesity published-Eisai/Arena Pharma

Eisai and Arena Pharmaceuticals have announced that a pooled analysis of the BLOOM and BLOSSOM pivotal, Phase III clinical trials of Belviq (lorcaserin HCl) was published in the October issue of Postgraduate Medicine. In the pooled analysis, Belviq 10 mg twice daily, as compared to placebo and both in conjunction with diet and exercise, was associated with statistically significant weight loss and clinically relevant improvements in cardiometabolic parameters. Results show that a statistically significantly greater number of patients taking Belviq lost greater than or equal to 5% and greater than or equal to 10% of body weight compared to placebo (47.1% vs. 22.6% and 22.4% vs. 8.7%, respectively) after one year of treatment. The mean percent weight loss for patients taking Belviq was also statistically significantly greater than placebo (-5.8% vs. -2.5%). Mean percent weight loss for those completing one year of treatment was -8.0% for Belviq and -3.7% for placebo, respectively. Echocardiograms were conducted on all patients as part of the primary safety endpoint of the trials.

There was no apparent increased risk of cardiac valvulopathy associated with use in the combined dataset. The rates of FDA-defined valvulopathy were 2.3% and 2.2% for patients taking Belviq or placebo, respectively. Additionally, the data showed that after one year, there were statistically significant improvements in lipid parameters, including total cholesterol, triglyceride levels and HDL cholesterol. The most common adverse events in the pooled analysis included headache, upper respiratory tract infection and nasopharynigtis. See: "Safety and Efficacy of Lorcaserin: A Combined Analysis of the BLOOM and BLOSSOM Trials." Louis Aronne et al. Postgraduate Medicine: Volume 126 No. 6 2014 DOI: 10.3810/pgm.2014.10.2817