A one-year randomized trial of lorcaserin for weight loss in obese and overweight adults: the BLOSSOM trial.

Abstract

CONTEXT:

Lorcaserin is a novel selective agonist of the serotonin 2C receptor.

OBJECTIVE:

Our objective was to evaluate the effects of lorcaserin on body weight, cardiovascular risk factors, and safety in obese and overweight patients.

DESIGN AND SETTING:

This randomized, placebo-controlled, double-blind, parallel arm trial took place at 97 U.S. research centers.

PATIENTS:

Patients included 4008 patients, aged 18-65 yr, with a body mass index between 30 and 45 kg/m(2) or between 27 and 29.9 kg/m(2) with an obesity-related comorbid condition.

INTERVENTIONS:

Patients were randomly assigned in a 2:1:2 ratio to receive lorcaserin 10 mg twice daily (BID), lorcaserin 10 mg once daily (QD), or placebo. All patients received diet and exercise counseling.

MAIN OUTCOME MEASURES:

The ordered primary endpoints were proportion of patients achieving at least 5% reduction in body weight, mean change in body weight, and proportion of patients achieving at least 10% reduction in body weight at 1 yr. Serial echocardiograms monitored heart valve function.

RESULTS:

Significantly more patients treated with lorcaserin 10 mg BID and QD lost at least 5% of baseline body weight (47.2 and 40.2%, respectively) as compared with placebo (25.0%, P < 0.001 vs. lorcaserin BID). Least squares mean (95% confidence interval) weight loss with lorcaserin BID and QD was 5.8% (5.5-6.2%) and 4.7% (4.3-5.2%), respectively, compared with 2.8% (2.5-3.2%) with placebo (P < 0.001 vs. lorcaserin BID; least squares mean difference, 3.0%). Weight loss of at least 10% was achieved by 22.6 and 17.4% of patients receiving lorcaserin 10 mg BID and QD, respectively, and 9.7% of patients in the placebo group (P < 0.001 vs. lorcaserin BID). Headache, nausea, and dizziness were the most common lorcaserin-related adverse events. U.S. Food and Drug Administration-defined echocardiographic valvulopathy occurred in 2.0% of patients on placebo and 2.0% on lorcaserin 10 mg BID.

CONCLUSIONS:

Lorcaserin administered in conjunction with a lifestyle modification program was associated with dose-dependent weight loss that was significantly greater than with placebo.

• Authors: Meredith C Fidler, Matilde Sanchez, Brian Raether, Neil J Weissman, Steven R Smith, William R Shanahan, Christen M Anderson, BLOSSOM Clinical Trial Group
• Journal: The Journal of clinical endocrinology and metabolism (J Clin Endocrinol Metab) Vol. 96 Issue 10 Pg. 3067-77 (Oct 2011) ISSN: 1945-7197 [Electronic] United States
• PMID: 21795446 (Publication Type: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Anti-Obesity Agents
• Benzazepines
• Lipids
• Receptor, Serotonin, 5-HT2C
• Serotonin 5-HT2 Receptor Agonists
• lorcaserin

Topics

• Absorptiometry, Photon
• Adolescent
• Adult
• Aged
• Anti-Obesity Agents (adverse effects, therapeutic use)
• Benzazepines (adverse effects, therapeutic use)
• Body Mass Index
• Cardiovascular Diseases (epidemiology)
• Double-Blind Method
• Echocardiography
• Female
• Humans
• Lipids (blood)
• Male
• Middle Aged
• Obesity (complications, drug therapy)
• Overweight (complications, drug therapy)
• Receptor, Serotonin, 5-HT2C (drug effects)
• Risk Factors
• Sample Size
• Serotonin 5-HT2 Receptor Agonists (adverse effects, therapeutic use)
• Weight Loss (drug effects)
• Young Adult