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Postgrad Med.
<> 2014
Oct;126(6):7-18. doi: 10.3810/pgm.2014.10.2817.
Safety and efficacy of lorcaserin: a combined analysis of the BLOOM and
BLOSSOM trials.
Aronne L
1, Shanahan W
Fain R
Glicklich A
Soliman W
Li Y
Smith S
Author information

Lorcaserin, a novel selective 5-HT2C receptor agonist, is approved by the
US Food and Drug Administration (FDA) for weight management in combination
with lifestyle modification for adults with obesity and adults with
overweight and ≥ 1 weight-related comorbid condition. The safety and
effectiveness of lorcaserin in adult patients without type 2 diabetes
mellitus was established based on 2 phase III clinical trials of similar
design: Behavioral Modification and Lorcaserin for Overweight and Obesity
Management (BLOOM) and Behavioral Modification and Lorcaserin Second Study
for Obesity Management (BLOSSOM). This report presents a prespecified
analysis of pooled data from these trials.

Co-primary end points in this analysis include the proportion of patients
with a reduction in baseline body weight of ≥ 5% and ≥ 10%, and a change in
weight from baseline. Key secondary end points include changes from
baseline values in lipid parameters, quality-of-life measures, glycemic
indicators, and vital signs.

At week 52, more than twice as many lorcaserin-treated patients achieved a
weight loss of ≥ 5% compared with placebo (lorcaserin, 47.1%; placebo,
22.6%), and lorcaserin-treated patients lost significantly more body weight
(lorcaserin, -5.8%; placebo, -2.5%). A significantly greater proportion of
lorcaserin-treated patients achieved a weight loss of ≥ 10% (lorcaserin,
22.4%; placebo, 8.7%). There were statistically significant improvements in
lipid parameters, glycemic indicators, quality-of-life measures, and vital
signs in the lorcaserin group compared with placebo. The most common
adverse events associated with lorcaserin treatment were headache, upper
respiratory tract infection, and nasopharyngitis. Lorcaserin-treated
patients had a rate of FDA-defined valvulopathy similar to placebo.

This pooled analysis of the phase III BLOOM and BLOSSOM trials shows that
lorcaserin 10 mg twice daily, in combination with diet and exercise, is
safe and tolerable, and is associated with statistically significant weight
loss and clinically relevant improvements in cardiometabolic parameters.
PMID:25414931 [PubMed - indexed for MEDLINE]