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Time course of the effects of lisdexamfetamine dimesylate in two phase 3, randomized, double‐blind, placebo‐controlled trials in adults with binge‐eating disorder
Author(s) -
McElroy Susan L.,
Hudson James I.,
Gasior Maria,
Herman Barry K.,
Radewonuk Jana,
Wilfley Denise,
Busner Joan
Publication year - 2017
Publication title -
international journal of eating disorders
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.785
H-Index - 138
eISSN - 1098-108X
pISSN - 0276-3478
DOI - 10.1002/eat.22722
Subject(s) - placebo , binge eating , psychology , binge eating disorder , psychiatry , medicine , eating disorders , bulimia nervosa , alternative medicine , pathology
Objective This study examined the time course of efficacy‐related endpoints for lisdexamfetamine dimesylate (LDX) versus placebo in adults with protocol‐defined moderate to severe binge‐eating disorder (BED). Methods In two 12‐week, double‐blind, placebo‐controlled studies, adults meeting DSM‐IV‐TR BED criteria were randomized 1:1 to receive placebo or dose‐optimized LDX (50 or 70 mg). Analyses across visits used mixed‐effects models for repeated measures (binge eating days/week, binge eating episodes/week, Yale‐Brown Obsessive Compulsive Scale modified for Binge Eating [Y‐BOCS‐BE] scores, percentage body weight change) and chi‐square tests (Clinical Global Impressions—Improvement [CGI‐I; from the perspective of BED symptoms] scale dichotomized as improved or not improved). These analyses were not part of the prespecified testing strategy, so reported p values are nominal (unadjusted and descriptive only). Results Least squares mean treatment differences for change from baseline in both studies favored LDX over placebo (all nominal p values < .001) starting at Week 1 for binge eating days/week, binge‐eating episodes/week, and percentage weight change and at the first posttreatment assessment (Week 4) for Y‐BOCS‐BE total and domain scores. On the CGI‐I, more participants on LDX than placebo were categorized as improved starting at Week 1 in both studies (both nominal p values < .001). Across these efficacy‐related endpoints, the superiority of LDX over placebo was maintained at each posttreatment assessment in both studies (all nominal p values < .001). Discussion In adults with BED, LDX treatment appeared to be associated with improvement on efficacy measures as early as 1 week, which was maintained throughout the 12‐week studies.