BLOOM
BLOOM top line results were released on 30 March 2009. Measurements of efficacy using an intention to treat – last observation carried forward (ITT-LOCF), analysis showed that 47.5% of lorcaserin patients lost at least 5% of their body weight, compared to 20.3% for placebo. This result satisfies one of two alternate efficacy benchmarks in the most recent FDA draft guidance, which provides that a weight-management product can be considered effective if after one year of treatment the proportion of subjects who lose greater than or equal to 5% of baseline body weight in the active-product group is at least 35%, is approximately double the proportion in the placebo-treated group, and the difference between groups is statistically significant.
Additionally, 22.6% of lorcaserin patients lost at least 10% of their body weight, compared to 7.7% for placebo. Lorcaserin patients achieved an average weight loss of 5.8% of their body weight, or 12.7 pounds, compared to 2.2%, or 4.7 pounds, for placebo. Among the most frequent adverse events reported with lorcaserin were headache, dizziness, and nausea.
Read more about this topic: Lorcaserin, Clinical Trials, Phase III Clinical Trials
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