A One-Year Randomized Trial of Lorcaserin for Weight Loss in Obese and Overweight Adults: The BLOSSOM Trial Article

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cited authors

  • Fidler, Meredith C., Sanchez, Matilde, Raether, Brian, Weissman, Neil J., Smith, Steven R., Shanahan, William R., Anderson, Christen M., BLOSSOM Clinical Trial Grp

funding text

  • This study was funded by Arena Pharmaceuticals, San Diego, CA. The study was designed by Arena Pharmaceuticals in collaboration with members of an advisory board and study investigators. Data were collected electronically and maintained by an external contract research organization. The data were interpreted and the manuscript written by the authors. All authors had full access to the data and shared the responsibility for the decision to submit for publication. Disclosure Summary: The study was funded by Arena Pharmaceuticals. M. C. F., M. S., B. R., W. R. S., and C. M. A. were employees of Arena Pharmaceuticals; S. R. S. and N.J.M. were advisors for Arena Pharmaceuticals.

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. (J Clin Endocrinol Metab 96: 3067-3077, 2011)

authors

Publication Date

  • October 1, 2011

webpage

published in

category

start page

  • 3067

end page

  • 3077

volume

  • 96

issue

  • 10

WoS Citations

  • 302

WoS References

  • 40