In studies with BELVIQ® 10 mg twice daily

Patients taking BELVIQ® showed improvement
in MULTIPLE CARDIOMETABOLIC PARAMETERS


‡Statistically significant vs placebo.

Pooled BLOOM/BLOSSOM: BELVIQ®, N=3096; placebo, N=3039. BLOOM-DM: BELVIQ®, N=256; placebo, N=252.

  • In the BLOOM-DM trial, statistical testing was not performed as specified by the multiplicity testing rule for TC, LDL, HDL, TG, SBP, DBP. In the BLOSSOM trial, fasting plasma glucose was not controlled for type I error.
  • All patients received lifestyle modification counseling
  • Weight loss may increase the risk of hypoglycemia in patients with type 2 diabetes mellitus who are being treated with antidiabetic medications, so measurement of blood sugar levels before and during treatment with BELVIQ is recommended. Decreases in doses of antidiabetic medications or changes in medication regimen should be considered
  • The effect of BELVIQ® on cardiovascular morbidity and mortality has not been established
  • BELVIQ® is not indicated for the treatment of blood pressure, heart rate, cholesterol, or type 2 diabetes

DBP=diastolic blood pressure; HDL=high-density lipoprotein; LDL=low-density lipoprotein; SBP=systolic blood pressure; TC=total cholesterol; TG=triglycerides.
* MITT using LOCF method; all patients who received study medication and had a postbaseline body weight measurement. Pooled   BLOOM/BLOSSOM trials: 44% of patients receiving BELVIQ® and 51% of patients receiving placebo withdrew prior to Week 52.   BLOOM-DM: 34% of patients receiving BELVIQ® and 38% receiving placebo withdrew prior to Week 52.
In BLOOM-DM trial at baseline, 91.5% of patients took metformin, 50.4% took a sulfonylurea (SFU), and 41.9% took both.4
§Measured in BLOOM only (BELVIQ®, n=1538; placebo, n=1499).2

  1. BELVIQ®/BELVIQ XR® [package insert]. Woodcliff Lake, NJ: Eisai Inc.
  2. Data on file.
  3. O’Neil PM. Smith SR, Weissman NJ, et al. Randomized placebo-controlled clinical trial of locaserin for weight loss in type 2 diabetes mellitus: the BLOOM-DM study. Obesity. 2012;20(7):1426-1436.

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).

References Study Description

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