* 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 ParametersIn the pooled BLOOM/BLOSSOM trials of BELVIQ® (N=3098) vs placebo (N=3038)1,2:
In the BLOOM-DM study of BELVIQ® (N=251) vs placebo (N=248)1,2:
* 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* 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.
Post hoc subgroup analyses at Year 1 (MITT population)2
Material limitations: Not adjusted for multiplicity or adequately powered to show statistical significance.
§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.
BELVIQ/BELVIQ XR is indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults with an initial body mass index (BMI) of 30 kg/m2 or greater (obese), or 27 kg/m2 or greater (overweight) in the presence of at least one weight-related comorbid condition (e.g., hypertension, dyslipidemia, type 2 diabetes).
Limitations of Use:
BELVIQ®/BELVIQ XR® is a federally controlled substance (CIV) because it may be abused or lead to dependence.
For more information about BELVIQ®/BELVIQ XR®, see full Prescribing Information.