Hypothetical patient portrayal. Individual results may vary.
Both studies were 12-week, randomized, double-blind, parallel-group, placebo-controlled, dose-optimization studies of adults aged 18 to 55 years (N=374 and N=350) with protocol-defined moderate to severe B.E.D.1
Moderate to severe B.E.D. was defined in the studies as a subject having at least 3 binge days per week for 2 weeks prior to the baseline visit and a Clinical Global Impression–Severity (CGI-S) score ≥4 (at least moderately ill).*1
*Diagnosis was confirmed based on criteria from the Diagnostic and Statistical Manual of Mental Disorders, 4th edition, text revision, as these studies were conducted before the release of the DSM-5®.
Primary Endpoint: Change from baseline at week 12 in the mean number of binge days per week compared with placebo.1,2
Key Secondary Endpoints1,2:
Study clinicians used the Yale-Brown Obsessive Compulsive Scale Modified for Binge Eating (Y-BOCS-BE) to assess the change over time in obsession with binge eating thoughts and compulsiveness of binge eating behaviors.2
Y-BOCS-BE is a composite score composed of 10 criteria, each rated from 0 (“no symptoms”) to 4 (“extreme symptoms”), and summed to a total score ranging from 0 to 40.2,3
At each study visit, clinicians used the CGI-I scale to assess overall improvement in the clinical state of the patient relative to the patient’s baseline. CGI-I responses were dichotomized into 2 categories: Improved (included very much improved and much improved) and Not Improved (included minimally improved, no change, minimally worse, much worse, and very much worse).
4-week cessation of binge eating was defined as no binge episodes during the 28 days leading up to the final study visit. If a subject discontinued prior to having 28 days’ diary information or had missing diary information in the last 28 days, they were counted as not having experienced a 4-week cessation.
All Vyvanse subjects started at 30 mg/day and were titrated to an optimal dose of 50 or 70 mg/day. Patients were not treated with 30 mg/day beyond week 1.†1,2
†Subjects were titrated from 30 mg/day to 50 mg/day. Additional increases to 70 mg/day were made as tolerated and clinically indicated. The maximum dose was 70 mg/day.
Study 343 results—at week 12, 82.1% of adult patients taking Vyvanse were considered improved and 17.9% not improved vs 47.3% and 52.7%, respectively, for placebo‡
Study 344 results—at week 12, 86.2% of adult patients taking Vyvanse were considered improved and 13.8% not improved vs 42.9% and 57.1%, respectively, for placebo‡
‡P<.001 vs placebo.
Study 343 results—40% of adult patients treated with Vyvanse experienced a 4-week cessation of binge eating, vs 14.1% of adult patients treated with placebo§
Study 344 results—36.2% of adult patients treated with Vyvanse experienced a 4-week cessation of binge eating, vs 13.1% of adult patients treated with placebo§
§P<.001 vs placebo.
This 38-week study (N=418) was preceded by a 4-week screening phase; followed by a 12-week open-label treatment phase (4 weeks of dose-optimization with 8 weeks of dose-maintenance); a 26-week double-blind, placebo-controlled, randomized-withdrawal phase (n=267); and a follow-up visit one week after treatment completion.1,2
Primary Endpoint: Maintenance of efficacy as measured by time to relapse in the double-blind, placebo-controlled, randomized-withdrawal phase1,2
Adults aged 18-55 years were eligible to participate in the study if they met DSM-IV-TR® criteria for B.E.D. and were considered moderate to severe (≥3 binge eating days per week during the 14 days before open-label baseline) and had a CGI-S score ≥4 (at least moderately ill) at screening and open-label baseline.1,2
At the end of the open-label treatment phase, subjects were considered Vyvanse responders if they presented with ≤1 binge eating days per week for 4 consecutive weeks prior to the last visit at the end of the open-label treatment phase and a CGI-S score ≤2 at the same visit. Vyvanse responders were randomized to continuation of Vyvanse or placebo for up to 26 weeks for observation for relapse.1,2
CGI-S=Clinical Global Impressions-Severity
All subjects were started on Vyvanse 30 mg/day and dose-optimized to either 50 mg/day or 70 mg/day as tolerated and clinically indicated.2
*Based on dose-optimization during open-label treatment phase
After 6 months, Vyvanse patients were ~10 times less likely to relapse vs placebo (hazard ratio 0.090, 95% CI [0.04,0.23]; P<0.001).2
†Relapse was defined as ≥2 binge days per week for 2 consecutive weeks prior to any visit and an increase in CGI-S score of ≥2 points from randomized-withdrawal baseline.1,2
Periodically reevaluate patients for the continued need for Vyvanse.
Hypothetical patient portrayal
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