Safety and efficacy of lorcaserin: a combined analysis of the BLOOM and BLOSSOM trials.

Abstract

BACKGROUND:

Lorcaserin, a novel selective 5-HT2C receptor agonist, is approved by the US Food and Drug Administration (FDA) for weight management in combination with lifestyle modification for adults with obesity and adults with overweight and ≥ 1 weight-related comorbid condition. The safety and effectiveness of lorcaserin in adult patients without type 2 diabetes mellitus was established based on 2 phase III clinical trials of similar design: Behavioral Modification and Lorcaserin for Overweight and Obesity Management (BLOOM) and Behavioral Modification and Lorcaserin Second Study for Obesity Management (BLOSSOM). This report presents a prespecified analysis of pooled data from these trials.

METHODS:

Co-primary end points in this analysis include the proportion of patients with a reduction in baseline body weight of ≥ 5% and ≥ 10%, and a change in weight from baseline. Key secondary end points include changes from baseline values in lipid parameters, quality-of-life measures, glycemic indicators, and vital signs.

RESULTS:

At week 52, more than twice as many lorcaserin-treated patients achieved a weight loss of ≥ 5% compared with placebo (lorcaserin, 47.1%; placebo, 22.6%), and lorcaserin-treated patients lost significantly more body weight (lorcaserin, -5.8%; placebo, -2.5%). A significantly greater proportion of lorcaserin-treated patients achieved a weight loss of ≥ 10% (lorcaserin, 22.4%; placebo, 8.7%). There were statistically significant improvements in lipid parameters, glycemic indicators, quality-of-life measures, and vital signs in the lorcaserin group compared with placebo. The most common adverse events associated with lorcaserin treatment were headache, upper respiratory tract infection, and nasopharyngitis. Lorcaserin-treated patients had a rate of FDA-defined valvulopathy similar to placebo.

CONCLUSIONS:

This pooled analysis of the phase III BLOOM and BLOSSOM trials shows that lorcaserin 10 mg twice daily, in combination with diet and exercise, is safe and tolerable, and is associated with statistically significant weight loss and clinically relevant improvements in cardiometabolic parameters.

• Authors: Louis Aronne, William Shanahan, Randi Fain, Alan Glicklich, William Soliman, Yuhan Li, Steven Smith
• Journal: Postgraduate medicine (Postgrad Med) Vol. 126 Issue 6 Pg. 7-18 (Oct 2014) ISSN: 1941-9260 [Electronic] England
• PMID: 25414931 (Publication Type: Clinical Trial, Phase III, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Anti-Obesity Agents
• Benzazepines
• Blood Glucose
• Cholesterol, HDL
• Cholesterol, LDL
• Glycated Hemoglobin A
• Serotonin 5-HT2 Receptor Agonists
• Triglycerides
• lorcaserin

Topics

• Adolescent
• Adult
• Aged
• Anti-Obesity Agents (therapeutic use)
• Benzazepines (adverse effects, therapeutic use)
• Blood Glucose (metabolism)
• Blood Pressure (drug effects)
• Cholesterol, HDL (blood)
• Cholesterol, LDL (blood)
• Double-Blind Method
• Female
• Glycated Hemoglobin (metabolism)
• Headache (chemically induced)
• Heart Rate (drug effects)
• Humans
• Life Style
• Male
• Middle Aged
• Nasopharyngitis (chemically induced)
• Obesity (blood, drug therapy)
• Quality of Life
• Respiratory Tract Infections (chemically induced)
• Serotonin 5-HT2 Receptor Agonists (therapeutic use)
• Triglycerides (blood)
• Waist Circumference (drug effects)
• Weight Loss (drug effects)
• Young Adult