In the BLOOM and BLOSSOM 1-year trial results in patients without diabetes (MITT population)*†
Changes in Lipid Profile1
All patients received lifestyle modification counseling
- The effect of BELVIQ® on cardiovascular morbidity and mortality has not been established
Pooled data results from two pivotal trials with overweight adults with ≥1 weight-related comorbidity or obese adults randomized to BELVIQ 10 mg BID with lifestyle modification or to placebo with lifestyle modification. The primary endpoints were the proportion of patients with ≥5% weight loss from baseline, the proportion with ≥10% weight loss from baseline, and change in body weight from baseline to Week 52. Mean baseline body weight: BELVIQ 100.4 kg and placebo 100.2 kg.
*Modified Intent-to-Treat population using Last Observation Carried Forward method; all patients who received study medication and had a post-baseline measurement. 44% of BELVIQ patients and 51% of placebo patients withdrew prior to Week 52.
†In the BLOOM trial, 33.5% of BELVIQ patients had dyslipidemia and 3.8% were concomitantly taking lipid-modifying agents, while 33.1% of placebo patients had dyslipidemia and 5.1% were taking lipid-modifying agents. In BLOSSOM, 28.4% of BELVIQ patients had dyslipidemia and 20.1% were concomitantly taking lipid-modifying agents, while 27.4% of placebo patients had dyslipidemia and 20.3% were taking lipid-modifying agents.2
‡Statistically significant vs placebo.1