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