Group BMaLfOaOMBS. Multicenter, placebo-controlled trial of lorcaserin for weight management

Translational Research Institute for Metabolism and Diabetes, Florida Hospital and the Sanford-Burnham Institute, Winter Park, FL 32789, USA.
New England Journal of Medicine (Impact Factor: 55.87). 07/2010; 363(3):245-56. DOI: 10.1056/NEJMoa0909809
Source: PubMed


Lorcaserin is a selective serotonin 2C receptor agonist that could be useful in reducing body weight.
In this double-blind clinical trial, we randomly assigned 3182 obese or overweight adults (mean body-mass index [the weight in kilograms divided by the square of the height in meters] of 36.2) to receive lorcaserin at a dose of 10 mg, or placebo, twice daily for 52 weeks. All patients also underwent diet and exercise counseling. At week 52, patients in the placebo group continued to receive placebo but patients in the lorcaserin group were randomly reassigned to receive either placebo or lorcaserin. Primary outcomes were weight loss at 1 year and maintenance of weight loss at 2 years. Serial echocardiography was used to identify patients in whom valvulopathy (as defined by the Food and Drug Administration) developed.
At 1 year, 55.4% of patients (883 of 1595) receiving lorcaserin and 45.1% of patients (716 of 1587) receiving placebo remained in the trial; 1553 patients continued into year 2. At 1 year, 47.5% of patients in the lorcaserin group and 20.3% in the placebo group had lost 5% or more of their body weight (P<0.001), corresponding to an average loss of 5.8+/-0.2 kg with lorcaserin and 2.2+/-0.1 kg with placebo during year 1 (P<0.001). Among the patients who received lorcaserin during year 1 and who had lost 5% or more of their baseline weight at 1 year, the loss was maintained in more patients who continued to receive lorcaserin during year 2 (67.9%) than in patients who received placebo during year 2 (50.3%, P<0.001). Among 2472 patients evaluated at 1 year and 1127 evaluated at 2 years, the rate of cardiac valvulopathy was not increased with the use of lorcaserin. Among the most frequent adverse events reported with lorcaserin were headache, dizziness, and nausea. The rates of serious adverse events in the two groups were similar.
In conjunction with behavioral modification, lorcaserin was associated with significant weight loss and improved maintenance of weight loss, as compared with placebo. (Funded by Arena Pharmaceuticals; number, NCT00395135.)

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    • "Lorcaserin is a selective serotonin 2C receptor agonist, which promotes satiety via stimulation of proopiomelanocortin (POMC) neurons. Clinical studies involving overweight and obese individuals with one obesity-related comorbidity have shown modest weight reduction of ~ 5% [95]. On the up side, the drug has shown a relatively good tolerability profile and the increased incidence of valvulopathy observed in rodents has not been borne out in humans thus far [94]. "
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    • "It was approved for the treatment of obesity in the United States in 2012. There are three registration trials for lorcaserin: Behavioral Modification and Lorcaserin for Overweight and Obesity Management (BLOOM) trial [123], Behavioral Modification and Lorcaserin Second Study for Obesity Management (BLOSSOM) trial [124], and the Behavioral Modification and Lorcaserin for Overweight and Obesity Management in Diabetes Mellitus (BLOOM-DM) trial [125]. In comparison to placebo, lorcaserin decreased waist circumference, blood pressure, total cholesterol, low-density lipoprotein-cholesterol and triglycerides. "
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