TY - JOUR
T1 - European, randomized, phase 3 study of lisdexamfetamine dimesylate in children and adolescents with attention-deficit/hyperactivity disorder
AU - Coghill, David
AU - Banaschewski, Tobias
AU - Lecendreux, Michel
AU - Soutullo, Cesar
AU - Johnson, Mats
AU - Zuddas, Alessandro
AU - Anderson, Colleen
AU - Civil, Richard
AU - Higgins, Nicholas
AU - Lyne, Andrew
AU - Squires, Liza
N1 - Copyright © 2012 Elsevier B.V. and ECNP. All rights reserved.
PY - 2013/10
Y1 - 2013/10
N2 - This study evaluated the efficacy and safety of lisdexamfetamine dimesylate (LDX) compared with placebo in children and adolescents with attention-deficit/hyperactivity disorder (ADHD) in Europe. Osmotic-release oral system methylphenidate (OROS-MPH) was included as a reference arm. Patients (6-17 years old) with a baseline ADHD Rating Scale version IV (ADHD-RS-IV) total score =28 were randomized (1:1:1) to dose-optimized LDX (30, 50, or 70mg/day), OROS-MPH (18, 36, or 54mg/day) or placebo for 7 weeks. Primary and key secondary efficacy measures were the investigator-rated ADHD-RS-IV and the Clinical Global Impressions-Improvement (CGI-I) rating, respectively. Safety assessments included treatment-emergent adverse events (TEAEs), electrocardiograms, and vital signs. Of 336 patients randomized, 196 completed the study. The difference between LDX and placebo in least squares mean change in ADHD-RS-IV total score from baseline to endpoint was -18.6 (95% confidence interval [CI]: -21.5 to -15.7) (p<0.001; effect size, 1.80). The difference between OROS-MPH and placebo
in least squares mean change in ADHD-RS-IV total score from baseline to endpoint was13.0(95% CI: 5.9 to 10.2) (p<0.001; effect size, 1.26). The proportions (95% CI) of patients showing improvement (CGI-I of 1 or 2) at endpoint were 78% (70–86), 14% (8–21), and 61% (51–70) for LDX, placebo, and OROS-MPH. The most common TEAEs for LDX were decreased
appetite, headache, and insomnia. Mean changes in vital signs were modest and consistent with the known profile of LDX. LDX was effective and generally well tolerated in children and adolescents with ADHD.
AB - This study evaluated the efficacy and safety of lisdexamfetamine dimesylate (LDX) compared with placebo in children and adolescents with attention-deficit/hyperactivity disorder (ADHD) in Europe. Osmotic-release oral system methylphenidate (OROS-MPH) was included as a reference arm. Patients (6-17 years old) with a baseline ADHD Rating Scale version IV (ADHD-RS-IV) total score =28 were randomized (1:1:1) to dose-optimized LDX (30, 50, or 70mg/day), OROS-MPH (18, 36, or 54mg/day) or placebo for 7 weeks. Primary and key secondary efficacy measures were the investigator-rated ADHD-RS-IV and the Clinical Global Impressions-Improvement (CGI-I) rating, respectively. Safety assessments included treatment-emergent adverse events (TEAEs), electrocardiograms, and vital signs. Of 336 patients randomized, 196 completed the study. The difference between LDX and placebo in least squares mean change in ADHD-RS-IV total score from baseline to endpoint was -18.6 (95% confidence interval [CI]: -21.5 to -15.7) (p<0.001; effect size, 1.80). The difference between OROS-MPH and placebo
in least squares mean change in ADHD-RS-IV total score from baseline to endpoint was13.0(95% CI: 5.9 to 10.2) (p<0.001; effect size, 1.26). The proportions (95% CI) of patients showing improvement (CGI-I of 1 or 2) at endpoint were 78% (70–86), 14% (8–21), and 61% (51–70) for LDX, placebo, and OROS-MPH. The most common TEAEs for LDX were decreased
appetite, headache, and insomnia. Mean changes in vital signs were modest and consistent with the known profile of LDX. LDX was effective and generally well tolerated in children and adolescents with ADHD.
UR - http://www.scopus.com/inward/record.url?scp=84884288612&partnerID=8YFLogxK
U2 - 10.1016/j.euroneuro.2012.11.012
DO - 10.1016/j.euroneuro.2012.11.012
M3 - Article
C2 - 23332456
SN - 1873-7862
VL - 23
SP - 1208
EP - 1218
JO - European Neuropsychopharmacology
JF - European Neuropsychopharmacology
IS - 10
ER -