Two-thirds of patients who continued taking BELVIQ® (10 mg twice daily) beyond Year 1 maintained CLINICALLY MEANINGFUL WEIGHT LOSS THROUGH YEAR 2



At Year 2,
67.9% (258/380) of patients who continued taking BELVIQ® after Year 1 maintained 5% weight loss vs 50.3% (88/175) of patients who were switched to placebo∥2,3



  • Of the 3182 patients who were randomized in Year 1, 1553 were randomized in Year 2; patients in all groups (BELVIQ Year 1 and 2, BELVIQ Year 1/placebo Year 2, placebo Year 1 and 2) regained weight in Year 2 but remained below their mean baseline weight3
  • Response to therapy should be evaluated by Week 12. If a patient has not lost at least 5% of baseline body weight, discontinue BELVIQ, as it is unlikely that the patient will achieve and sustain clinically meaningful weight loss with continued treatment. If the patient achieves 5% weight loss at 12 weeks, continuation of treatment may be considered among other factors3
  • At Year 1, more patients taking BELVIQ achieved and maintained 5% weight loss vs placebo

MITT Year 2 population: LOCF method was employed for body weight.


Results from a 2-year trial with overweight adults with 1 weight-related comorbidity or obese adults. At Week 52, BELVIQ patients were randomly reassigned either to BELVIQ 10 mg BID with lifestyle modification or to placebo with lifestyle modification. The primary endpoint for Year 2 was the proportion of patients who had a reduction in baseline body weight of 5% at the end of Year 1 and maintained this reduction at Year 2.1,3

  1. BELVIQ®/BELVIQ XR® [package insert]. Woodcliff Lake, NJ: Eisai Inc.
  2. Data on file.
  3. Smith SR, Weissman NJ, Anderson CM, et al; and the Behavioral Modification and Lorcaserin for Overweight and Obesity Management (BLOOM) Study Group. Multicenter, placebo-controlled trial of lorcaserin for weight management. N Engl J Med. 2010;363(3):245-256.

Behavioral Modification and Lorcaserin for Overweight and Obesity Management (BLOOM)

  • Inclusion criteria:
    • Participants (N=3182) were adults aged 18 to 65 years
    • BMI of 30 to 45 kg/m2, or of 27 to 45 kg/m2 with 1 weight-related comorbid condition (hypertension, dyslipidemia, cardiovascular disease, impaired glucose tolerance, sleep apnea)
  • 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 requirements
  • Primary endpoints:
    • 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:
    • Change from baseline in lipids, glycemic variables, blood pressure, BMI, waist circumference
    • Proportion of patients who developed FDA-defined valvulopathy (mild or greater aortic regurgitation and/or moderate or greater mitral regurgitation) at Week 52
  • At Week 52, placebo patients continued receiving placebo, and BELVIQ patients were rerandomized either to BELVIQ or placebo for an additional 52 weeks. The primary endpoint for Year 2 was the proportion of patients who had a reduction in baseline body weight of 5% at the end of Year 1 and who maintained this reduction during Year 2
References Study Description

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