Lorcaserin is safe, but only modestly effective (6 pounds greater weight loss than placebo)

Reference

Bohula EA, Wiviott SD, McGuire DK, et al, for the CAMELLIA–TIMI 61 Steering Committee and Investigators. Cardiovascular safety of lorcaserin in overweight or obese patients. N Engl J Med 2018;379:1107-1117.

Synopsis

Although lorcaserin has been approved for treatment of obesity by the FDA, they required a postmarketing randomized trial to assure cardiovascular safety. In this study, patients (N = 12,000) with a body mass index (BMI) of 27 kg/m2 or higher who had heart disease or multiple cardiovascular risk factors were randomized to receive lorcaserin 10 mg twice daily or matching placebo. All patients had access to a study nurse by phone. The groups were balanced at the start of the study, with a mean age of 64 years and a mean BMI of 35 kg/m2; 90% were hypertensive and 57% had diabetes mellitus. Approximately one-third of patients in each group stopped taking the study drug or placebo during the median 3.3-year follow-up period. Lorcaserin had a modest effect on weight: patients who took the drug lost a mean of 2.8 kg (~ 6 pounds) more than those who took the placebo. More patients in the lorcaserin group lost at least 10% of their body weight (14.6% vs 4.8%; P < .001; NNT = 10). There was no difference in the likelihood of cardiovascular events between the 2 groups (6.1% for lorcaserin vs 6.2% for placebo). There was also no difference in serious adverse events between groups. Patients randomized to receive lorcaserin were more likely to experience an adverse event that led to the discontinuation of the drug (7.2% vs 3.7%; P < .05; number needed to treat to harm = 29), mostly dizziness, fatigue, and headache. The overall rates of these events were low, with absolute risk increases of only 0.4% to 1.1%.