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Lorcaserin - A New, but Not Yet Approved, Weight Loss Drug
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.)
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