• Weight Loss Efficacy  at Year 1

    Patients taking BELVIQ® ACHIEVED AND SUSTAINED CLINICALLY SIGNIFICANT WEIGHT LOSS at Year 1 (MITT population)*

    • Response to therapy should be evaluated by Week 12. If a patient has not lost at least 5% of baseline body weight, discontinue BELVIQ® or BELVIQ XR®, as it is unlikely that the patient will achieve and sustain clinically meaningful weight loss with continued treatment. If a patient has lost 5% of baseline body weight by Week 12, continuation of treatment may be considered among other factors

    Patients taking BELVIQ® showed WEIGHT LOSS AT WEEK 2 (MITT population)2

    • At the 2-week visit, patients taking BELVIQ® (N=2918) lost an average of 3.3 lbs vs 2.0 lbs for those taking placebo (N=2865) (part of the preplanned analysis)

    * Modified intent-to-treat population (MITT) using last observation carried forward (LOCF) method; all patients who received study medication and had a postbaseline body weight measurement. Pooled BLOOM/BLOSSOM trials: 44% of patients taking BELVIQ® and 51% of patients taking placebo withdrew prior to Week 52. Mean baseline body weight: BELVIQ® (100.4 kg/221.3 lb) and placebo (100.2 kg/220.9 lb).

    View Impact on Blood Pressure, Heart Rate, and Other Cardiometabolic Parameters
    References Study Description Access Savings and Support Resources
    1. BELVIQ®/BELVIQ XR® [package insert]. Woodcliff Lake, NJ: Eisai Inc.
    2. Data on file.

    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).
  • Weight Loss Efficacy at Year 1 - Odds Ratio

    Patients treated with BELVIQ® were 3 TO 4 TIMES MORE LIKELY TO ACHIEVE 10% WEIGHT LOSS vs placebo in studies of more than 6600 patients

    In the pooled BLOOM/BLOSSOM trials of BELVIQ® (N=3098) vs placebo (N=3038)1,2:

    • 47.1% of patients achieved 5% weight loss with BELVIQ® vs 22.6% with placebo (P<.001)
    • 22.4% of patients achieved 10% weight loss with BELVIQ® vs 8.7% with placebo (P<.001)
    • The mean weight loss was 5.8% with BELVIQ® vs 2.5% with placebo (P<.001)
    • All patients received lifestyle modification counseling

    In the BLOOM-DM study of BELVIQ® (N=251) vs placebo (N=248)1,2:

    • 37.5% of patients achieved 5% weight loss with BELVIQ® vs 16.1% with placebo (P<.001)
    • 16.3% of patients achieved 10% weight loss with BELVIQ® vs 4.4% with placebo (P<.001)
    • The mean weight loss was 4.5% with BELVIQ® vs 1.5% with placebo (P<.001)
    • All patients received lifestyle modification counseling

    * Modified intent-to-treat population (MITT) using last observation carried forward (LOCF) method; all patients who received study medication and had a postbaseline body weight measurement. Pooled BLOOM/BLOSSOM trials: 44% of patients taking BELVIQ® and 51% of patients taking placebo withdrew prior to Week 52. Mean baseline body weight: BELVIQ® (100.4 kg/221.3 lb) and placebo (100.2 kg/220.9 lb).

    ‡ BLOOM-DM: MITT using LOCF method. 34% of patients taking BELVIQ® and 38% of patients taking placebo withdrew prior to Week 52. Mean baseline body weight: BELVIQ® (103.5 kg/228.2 lb) and placebo (102.3 kg/225.5 lb).

    View Impact on Blood Pressure, Heart Rate, and Other Cardiometabolic Parameters
    References Study Description
    1. BELVIQ®/BELVIQ XR® [package insert]. Woodcliff Lake, NJ: Eisai Inc.
    2. Data on file.

    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).

  • Post-hoc Analyses - Avg Pounds Lost in Patients Achieving 10% Weight Loss

    Patients taking BELVIQ® who achieved 10% weight loss LOST AN AVERAGE OF 33 LBS (ranging from 15 lbs to 82 lbs)*

    * BELVIQ® (n=741); patients who achieved 10% weight loss with placebo (n=276) lost an average of 34 lbs (ranging from 18 lbs to 124 lbs).

    †For those who achieved 5% and 10% weight loss, 1 patient lost 80-90 lbs with BELVIQ®.
    ‡For those who achieved 5% and 10% weight loss, 1 patient lost 120-130 lbs, 1 lost 90-100 lbs, and 1 lost 80-90 lbs with placebo.

    View Impact on Blood Pressure, Heart Rate, and Other Cardiometabolic Parameters
    References Study Description Why >5%?

    5% weight loss is the FDA efficacy benchmark 3

    The FDA has outlined recommendations for products intended for chronic weight management.

    The FDA considers a product effective for weight management if, after 1 year of treatment:

    • The difference in mean weight loss between the active-product and placebo-treated groups is 5% and the difference is statistically significant, or
    • The proportion of subjects who lose 5% of baseline body weight in the active-product group is at least 35% and approximately double the proportion in the placebo-treated group, and the difference between groups is statistically significant
    1. Data on file.

    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).

  • Post-hoc Analyses - Avg Pounds Lost in Patients Achieving 5% Weight Loss

    Post hoc subgroup analyses at Year 1 (MITT population)2

    Material limitations: Not adjusted for multiplicity or adequately powered to show statistical significance.

    Patients taking BELVIQ® who achieved 5% weight loss LOST AN AVERAGE OF 24 LBS (ranging from 8 lbs to 82 lbs)§

    §BELVIQ® (n=1562); patients who achieved 5% weight loss with placebo (n=729) lost an average of 23 lbs (ranging from 8 lbs to 124 lbs).

    †For those who achieved 5% and 10% weight loss, 1 patient lost 80-90 lbs with BELVIQ®.
    ‡For those who achieved 5% and 10% weight loss, 1 patient lost 120-130 lbs, 1 lost 90-100 lbs, and 1 lost 80-90 lbs with placebo.

    View Impact on Blood Pressure, Heart Rate, and Other Cardiometabolic Parameters
    References Study Description
    1. Data on file.

    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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