In the pooled BLOOM and BLOSSOM (MITT population)*
Patients taking BELVIQ® experienced a decrease in BLOOD PRESSURE and HEART RATE
All patients received lifestyle modification counseling1
- The effect of BELVIQ® on cardiovascular morbidity and mortality has not been established
- Because BELVIQ may cause a slow heartbeat, it should be used with caution in patients with a history of bradycardia or heart block greater than first degree
- BELVIQ is not indicated for the treatment of blood pressure and heart rate.
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.
†Least squares mean (LSM) adjusted for baseline value, treatment, study, and treatment study by interaction.