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- Title
957 – Post hoc comparison of the efficacy of lisdexamfetamine dimesylate and osmotic-release oral system methlyphenidate in children and adolescents with adhd.
- Authors
Coghill, D.; Banaschewski, T.; Lecendreux, M.; Soutullo, C.; Johnson, M.; Zuddas, A.; Anderson, C.; Civil, R.; Higgins, N.; Bloomfield, R.; Squires, L.
- Abstract
Introduction: In a European, phase 3 study (SPD489-325), lisdexamfetamine dimesylate (LDX) and osmotic-release oral system methylphenidate (OROS-MPH) were more effective than placebo in improving core symptoms in children and adolescents with attention-deficit/hyperactivity disorder (ADHD). Objectives and aims: To compare post hoc the efficacy of LDX and OROS-MPH in study SPD489-325. Methods: This 7-week, randomized, double-blind, parallel-group, dose-optimized, placebo-controlled trial enrolled patients aged 6-17 years with ADHD of at least moderate severity. Patients were randomized (1:1:1) to receive a once-daily dose of LDX (30, 50, 70mg/day), OROS-MPH (18, 36, 54mg/day) or placebo. Efficacy was assessed using the ADHD Rating Scale version IV (ADHD-RS-IV) and the Clinical Global Impression-Improvement (CGI-I) scale. Endpoint was defined as the last ontherapy treatment visit with a valid assessment. Results: The full analysis set comprised 317 patients (LDX, n=104; placebo, n=106; OROS-MPH, n=107). The difference between LDX and OROS-MPH in least squares mean change (95% confidence interval [CI]) in ADHD-RS-IV total score from baseline to endpoint was statistically significant in favour of LDX (-5.6 [-8.4, -2.7]; p <0.001; effect size, 0.541). The difference (LDX minus OROS-MPH) in the percentage of patients (95% CI) with an improved CGI-I score at endpoint was also statistically significant in favour of LDX (17.4 [5.0, 29.8]; p <0.05). Conclusions: This post hoc analysis indicated that LDX is significantly more effective than OROS-MPH in improving core symptoms and global functioning in children and adolescents with ADHD. Supported by: Funding from Shire Development LLC.
- Subjects
TEENAGERS; LEAST squares; GOAL (Psychology); STATISTICAL correlation; CONFIDENCE intervals
- Publication
European Psychiatry, 2013, Vol 28, p1
- ISSN
0924-9338
- Publication type
Abstract
- DOI
10.1016/S0924-9338(13)76103-0