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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Available from: Emil Chuang, Oct 03, 2015
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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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    • "Drug Reference N ( T2D ) BMI ( mean ) Age ( mean ) 1 - year ∆%WL ( mean ) % with >5% WL ( versus placebo ) Frequent side effects Uncommon side effects Lorcaserin [ Smith et al . 2010 ] ( BLOOM ) 3182 ( 0 ) 36 . 2 44 . 1 3 . 7% 45% versus 20% Dry mouth Fatigue Dizziness Headache Nausea Urinary tract infection Constipation / diarrhoea Hypoglycaemia ( in patients with T2D ) Lorcaserin [ Fidler et al . 2011 ]"
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    ABSTRACT: Public health initiatives focused on obesity prevention and lifestyle intervention programmes for patients with obesity have struggled to contain the obesity epidemic to date. In recent years, antiobesity drug therapies have had a limited role in clinical treatment algorithms for patients with obesity. Indeed, a number of high-profile antiobesity drug suspensions have markedly impacted upon the landscape of obesity pharmacotherapy. In this review, we discuss the advent of an increasing array of pharmacotherapeutic agents, which are effective both in inducing weight loss and in maintaining weight loss achieved by lifestyle measures. The development of these drugs as antiobesity agents has followed varying paths, ranging from lorcaserin, a selective serotonin agent, exploiting the beneficial central actions of fenfluramine but without the associated systemic side effects, to liraglutide, a gut hormone already used as a glucose-lowering drug but with appetite-suppressant properties, or the novel drug combination of phentermine/topiramate, two 'old' drugs used in lower doses than with previous therapeutic uses, resulting in an additive effect on weight loss and fewer side effects. We summarize the key findings from recent randomized controlled trials of these three drugs. Although these agents lead to clinically important weight loss when used as monotherapy, the use of antiobesity drugs as adjunctive therapy post intensive lifestyle intervention could prove to be the most successful strategy. Moreover, a progressive approach to obesity pharmacotherapy perhaps offers the best opportunity to finally address the obesity crisis on a mass scale.
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    • "The BLOOM-DM (Behavioral Modification and Lorcaserin for Obesity and Overweight Management in Diabetes Mellitus) trial showed a statistically significant improvement in FPG and A1c in subjects with T2DM when treated with lorcaserin versus placebo for 52 weeks.175 The BLOSSOM (Behavioral modification and Lorcaserin Second Study for Obesity Management) and BLOOM trials did show improvements in glucose after 52 and 104 weeks, respectively, of therapy but both specifically excluded people with known T2DM and did not report glucose-related data on prediabetes subgroups.176,177 Nonetheless, the lifestyle intervention trials have shown that loss of as little as 5%–10% of bodyweight can have beneficial effects on preventing the development of T2DM; thus, one would predict that the weight loss demonstrated with lorcaserin will have a similar beneficial effect. "
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