In the pooled BLOOM and BLOSSOM (MITT population)*

Patients taking BELVIQ® experienced a decrease in BLOOD PRESSURE and HEART RATE

All patients received lifestyle modification counseling1


  • The effect of BELVIQ® on cardiovascular morbidity and mortality has not been established
  • Because BELVIQ may cause a slow heartbeat, it should be used with caution in patients with a history of bradycardia or heart block greater than first degree
  • BELVIQ is not indicated for the treatment of blood pressure and heart rate.

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.

Least squares mean (LSM) adjusted for baseline value, treatment, study, and treatment study by interaction.

References Study Description Mean Changes in Cardiometabolic Parameters Changes in Lipid 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 years
    • 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
  • 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 requirements2,3
  • 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 endpoints2,3:
    • 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.

BLOOM, Behavioral Modification and Lorcaserin for Overweight and Obesity Management; BLOSSOM, Behavioral Modification and Lorcaserin Second Study for Obesity Management; LOCF, last observation carried forward; MITT, modified intent-to-treat population.

*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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