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

Description

This clinical trial was designed to evaluate the efficacy and safety of lorcaserin which is a selective serotonin 2C receptor agonist used for weight management. A total of 3,182 obese or overweight adults [mean body mass index (BMI) of 36.2 kg/m2] were randomly assigned to receive 10 mg lorcaserin, or placebo, twice daily for 52 weeks. After 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. During year 1, the proportion of patients with a loss of 5% or more of the initial body weight in the lorcaserin group was more than twice than in the placebo group. In year 2, patients who continued to take lorcaserin were significantly better able to maintain their year 1 weight loss than those who were switched to placebo. The weight loss in the lorcaserin group at 1 year was associated with improvements in serum lipid levels, insulin resistance and blood pressure. Lorcaserin use also resulted in reduced waist circumference and decreased levels of inflammatory markers. Moreover, lorcaserin caused no significant increase, relative to placebo, in the incidence of FDA-defined valvulopathy. Thus, these results suggest that lorcaserin in conjunction with behavioural modification (diet and exercise) is an effective molecule to significantly reduce body weight and maintain weight loss. In his editorial comment, Astrup A highlighted the fact that the use of lorcaserin was justified not because of its better efficiency to manage obesity compared to currently available drugs but because it appears to be associated with a better safety and adverse-event profile as well as to provide significant beneficial effects on cardiometabolic risk factors.