In the BLOOM and BLOSSOM 1-year trial results in patients without diabetes (MITT population)*†

Changes in Lipid Profile1

All patients received lifestyle modification counseling




  • The effect of BELVIQ® on cardiovascular morbidity and mortality has not been established

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.

†In the BLOOM trial, 33.5% of BELVIQ patients had dyslipidemia and 3.8% were concomitantly taking lipid-modifying agents, while 33.1% of placebo patients had dyslipidemia and 5.1% were taking lipid-modifying agents. In BLOSSOM, 28.4% of BELVIQ patients had dyslipidemia and 20.1% were concomitantly taking lipid-modifying agents, while 27.4% of placebo patients had dyslipidemia and 20.3% were taking lipid-modifying agents.2

‡Statistically significant vs placebo.1

 

 

 

References Study Description Mean Changes in Cardiometabolic Parameters BELVIQ Safety Profile
  1. BELVIQ®/BELVIQ XR® [package insert]. Woodcliff Lake, NJ: Eisai Inc.
  2. Data on file.

Behavioral Modification and Lorcaserin for Overweight and Obesity Management (BLOOM)
Behavioral Modification and Lorcaserin Second Study for Obesity Management (BLOSSOM)

  • Inclusion criteria:
    • Adults aged 18 to 65 years1
    • BMI of 30 to 45 kg/m2, or of 27 to 29.9 kg/m2 with 1 weight-related comorbid condition (hypertension, dyslipidemia, cardiovascular disease, impaired glucose tolerance, sleep apnea)1,3,4
  • As part of a lifestyle modification program, all patients were instructed to exercise moderately for 30 minutes each day, and to reduce daily calorie intake to 600 kcal below estimated energy requirements3,4
  • Primary endpoints1:
    • Proportion of patients with 5% weight loss from baseline
    • Proportion with 10% weight loss from baseline
    • Change in body weight from baseline to Week 52
  • Selected secondary endpoints3,4:
    • Change from baseline in lipids, glycemic variables, blood pressure, waist circumference, BMI, and body composition (BLOSSOM)
    • Proportion of patients who developed FDA-defined valvulopathy (mild or greater aortic regurgitation and/or moderate or greater mitral regurgitation) at Week 52

Mean Changes in Cardiometabolic Parameters and Waist Circumference at 1 Year1

  • The effect of BELVIQ® on cardiovascular morbidity and mortality has not been established.

*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.

†Statistically significant versus placebo.

‡Measured in BLOOM only (n=1538).

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