Lorcaserin yields body weight reductions over 2 years
MedWire News: The selective serotonin 2C receptor agonist lorcaserin, in combination with counseling to encourage behavioral modification, effectively helps patients to lose weight and maintain their weight loss, shows a randomized, placebo-controlled trial.
"Lorcaserin was also associated with improved values for biomarkers that may be predictors of future cardiovascular events, including lipid levels, insulin resistance, levels of inflammatory markers, and blood pressure," say the researchers in the New England Journal of Medicine.
The Behavioral Modification and Lorcaserin for Overweight and Obesity Management (BLOOM) trial included 3182 patients, with an average body mass index of 36.2 kg/m2, who were randomly assigned to receive twice-daily lorcaserin 10 mg or placebo for 52 weeks.
All patients received individual nutritional and exercise counseling at 2 and 4 weeks and then monthly.
In all, 55.4% of the lorcaserin group and 45.1% of the placebo group remained in the trial for 1 year. In the intention-to-treat analysis, which includes all patients who started the study, 47.5% of patients in the lorcaserin group had lost at least 5% of their body weight after 1 year, compared with 20.3% of patients given placebo.
In the per protocol analysis (patients who completed all study visits), 66.4% versus 32.1% of patients taking lorcaserin and placebo, respectively, had lost at least 5% of their body weight, while 36.2% versus 13.6% lost at least 10%.
"The loss of 5% to 10% of body weight can have beneficial effects on hypertension, dyslipidemia, diabetes mellitus, arthritis, and sleep apnea and can also help prevent the development of Type 2 diabetes and heart disease," note Steven Smith (Florida Hospital and the Sanford-Burnham Institute, Winter Park, USA) and colleagues.
Levels of total, low- and high-density lipoprotein cholesterol, and triglycerides improved significantly more in the lorcaserin than placebo groups, as did levels of glucose, insulin, C-reactive protein, and blood pressure.
After 1 year of treatment, patients taking lorcaserin were randomly reassigned, in a 2:1 ratio, to either continue receiving the study drug or to take placebo, while patients in the placebo group continued on placebo.
During the second year, maintenance of at least 5% weight loss was observed among 67.9% of patients who took lorcaserin during both years, compared with 50.3% of those who switched to placebo during the second year, a significant difference.
Cardiac valvulopathy, which is a possible complication with some serotonergic agents, was no more common in the lorcaserin than placebo groups. Headache and nausea were more often reported by patients taking lorcaserin than placebo, but the researchers say that these events were mostly mild and generally resolved, even if patients continued to take the study drug.
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By Eleanor McDermid