In studies with BELVIQ® 10 mg twice daily

Discontinuation rates due to adverse reactions were SIMILAR BETWEEN BELVIQ® AND PLACEBO1

Discontinuation rates due to adverse reactions

Clinical Trials Experience1 with BELVIQ® 10 mg Twice Daily

All patients received lifestyle modification counseling

  • In clinical trials of at least 1-year duration, 6888 (3451 BELVIQ vs 3437 placebo) patients were evaluated, including 508 overweight patients with type 2 diabetes
  • The most common adverse reactions leading to discontinuation more often among BELVIQ-treated patients than placebo-treated patients were headache (1.3% vs 0.8%), depression (0.9% vs 0.5%), and dizziness (0.7% vs 0.2%)
  1. BELVIQ®/BELVIQ XR® [package insert]. Woodcliff Lake, NJ: Eisai Inc.

Study Description -
BLOOM AND BLOSSOM (POOLED)1

BLOOM (N=3182) and BLOSSOM (N=4008) were 2 randomized, double-blind, placebo-controlled pivotal trials with durations ranging from 52 weeks to 104 weeks of overweight adults with 1 weight-related comorbidity (without type 2 diabetes mellitus) or obese adults randomized to BELVIQ® 10 mg BID with lifestyle modification or to placebo with lifestyle modification.

Primary endpoints at Year 1:

  • Proportion of patients with 5% weight loss from baseline
  • Proportion of patients with 10% weight loss from baseline
  • Change in body weight from baseline

Mean baseline body weight: BELVIQ® (100.4 kg/221.3 lb) and placebo (100.2 kg/220.9 lb).


BLOOM-DM1

BLOOM-DM (N=604) was a randomized, double-blind, placebo-controlled clinical trial with obese or overweight adults with poorly controlled type 2 diabetes being treated with metformin and/or an SFU. Patients were randomized to BELVIQ® 10 mg BID with lifestyle modification or to placebo with lifestyle modification.

Primary endpoints at Year 1:

  • Proportion of patients with 5% weight loss from baseline
  • Proportion of patients with 10% weight loss from baseline
  • Change in body weight from baseline

Mean baseline body weight: BELVIQ® (103.5 kg/228.2 lb) and placebo (102.3 kg/225.5 lb).

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