Multicenter, placebo-controlled trial of lorcaserin for weight management
- PMID:20647200
- DOI: 10.1056/NEJMoa0909809
Multicenter, placebo-controlled trial of lorcaserin for weight management
Abstract
Background: Lorcaserin is a selective serotonin 2C receptor agonist that could be useful in reducing body weight.
Methods: 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.
Results: 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.
Conclusions: 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; ClinicalTrials.gov number,NCT00395135.)
2010 Massachusetts Medical Society
Comment in
- Drug management of obesity--efficacy versus safety.Astrup A.Astrup A.N Engl J Med. 2010 Jul 15;363(3):288-90. doi: 10.1056/NEJMe1004076.N Engl J Med. 2010.PMID:20647205No abstract available.
- [Lorcaserin for weight reduction for overweight and adipose adults].Spaar A.Spaar A.Praxis (Bern 1994). 2010 Nov 17;99(23):1437-8. doi: 10.1024/1661-8157/a000313.Praxis (Bern 1994). 2010.PMID:21082598German.No abstract available.
- Trial of lorcaserin for weight management.Floyd JS, Heckbert SR.Floyd JS, et al.N Engl J Med. 2010 Dec 16;363(25):2469; author reply 2469-70. doi: 10.1056/NEJMc1009975.N Engl J Med. 2010.PMID:21158669No abstract available.
- Trial of lorcaserin for weight management.Jia J, Xiong L, Chen S.Jia J, et al.N Engl J Med. 2010 Dec 16;363(25):2468-9; author reply 2469-70. doi: 10.1056/NEJMc1009975.N Engl J Med. 2010.PMID:21158670No abstract available.
- Trial of lorcaserin for weight management.von Haehling S.von Haehling S.N Engl J Med. 2010 Dec 16;363(25):2468; author reply 2469-70. doi: 10.1056/NEJMc1009975.N Engl J Med. 2010.PMID:21158671No abstract available.
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