TY - JOUR
T1 - Long-term atomoxetine treatment in adolescents with attention-deficit/hyperactivity disorder
AU - Wilens, Timothy E.
AU - Newcorn, Jeffrey H.
AU - Kratochvil, Christopher J.
AU - Gao, Haitao
AU - Thomason, Christine K.
AU - Rogers, Ann K.
AU - Feldman, Peter D.
AU - Levine, Louise R.
N1 - Funding Information:
Supported by Eli Lilly and Company, Indianapolis, Indiana. Dr. Wilens has received research grants from Cephalon, Eli Lilly and Company, GlaxoSmithKline, Janssen Pharmaceutica Products, NeuroSearch, New River Pharmaceuticals, Novartis Pharmaceuticals, Ortho-McNeil Pharmaceutical, and Shire. He has been a consultant for Abbott Laboratories, Cephalon Incorporated, Eli Lilly and Company, NeuroSearch, Novartis Pharmaceuticals, Ortho-McNeil Pharmaceutical, Sanofi-Sythelabo, and Shire and has been a speaker for Eli Lilly and Company, Janssen Pharmaceutica Products, Novartis Pharmaceuticals, Ortho-McNeil Pharmaceutical, and Shire. Dr. Newcorn has received research support from Eli Lilly and Company, Ortho-McNeil Pharmaceutical, and Shire and has served on the speakers’ bureau of Eli Lilly and Company, Janssen Pharmaceutica Products, Novartis Pharmaceuticals, and Ortho-McNeil Pharmaceutical. He has served as a consultant or advisor for Celltech Group, Eli Lilly and Company, Novartis Pharmaceuticals, and Ortho-McNeil Pharmaceutical. Dr. Kratochvil has received research support from Cephalon Incorporated, Eli Lilly and Company, Forest Pharmaceuticals Incorporated, GlaxoSmithKline, and Ortho-McNeil Pharmaceutical and has served on the speakers’ bureau of Eli Lilly and Company and Novartis Pharmaceuticals. He has served as a consultant or advisor for AstraZeneca International, the Bristol-Meyers Squibb Company, Cephalon Incorporated, Eli Lilly and Company, Organon, and Pfizer Incorporated. Drs. Feldman, Gao, Levine, Rogers, and Thomason are or have been employees and shareholders of Eli Lilly and Company. All authors contributed equally to the preparation and review of this manuscript.
PY - 2006/7
Y1 - 2006/7
N2 - Objective: To determine the efficacy and safety of atomoxetine in adolescent subjects treated for attention-deficit/hyperactivity disorder (ADHD) for up to 2 years. Study design: Data from 13 atomoxetine studies (6 double-blind, 7 open-label) were pooled for subjects age 12 to 18 with ADHD as defined by the American Psychiatric Association's Diagnostic and Statistical Manual of Mental Disorders IV. Results: Of the 601 atomoxetine-treated subjects in this meta-analysis, 537 (89.4%) completed 3 months of acute treatment. A total of 259 subjects (48.4%) are continuing atomoxetine treatment; 219 of these subjects have completed at least 2 years of treatment. The mean dose of atomoxetine at endpoint was 1.41 mg/kg/day. Mean ADHD Rating Scale IV, parent version, investigator-administered and -scored total scores showed significant improvement (P < .001) over the first 3 months. Symptoms remained improved up to 24 months without dosage escalation. During the 2-year treatment period, 99 (16.5%) subjects discontinued treatment due to lack of effectiveness, and 31 (5.2%) subjects discontinued treatment due to adverse events. No clinically significant abnormalities in height, weight, blood pressure, pulse, mean laboratory values, or electrocardiography parameters were found. Conclusions: Two-year data from this ongoing study indicate that atomoxetine maintains efficacy among adolescents with ADHD, with no evidence of drug tolerance and no new or unexpected safety concerns.
AB - Objective: To determine the efficacy and safety of atomoxetine in adolescent subjects treated for attention-deficit/hyperactivity disorder (ADHD) for up to 2 years. Study design: Data from 13 atomoxetine studies (6 double-blind, 7 open-label) were pooled for subjects age 12 to 18 with ADHD as defined by the American Psychiatric Association's Diagnostic and Statistical Manual of Mental Disorders IV. Results: Of the 601 atomoxetine-treated subjects in this meta-analysis, 537 (89.4%) completed 3 months of acute treatment. A total of 259 subjects (48.4%) are continuing atomoxetine treatment; 219 of these subjects have completed at least 2 years of treatment. The mean dose of atomoxetine at endpoint was 1.41 mg/kg/day. Mean ADHD Rating Scale IV, parent version, investigator-administered and -scored total scores showed significant improvement (P < .001) over the first 3 months. Symptoms remained improved up to 24 months without dosage escalation. During the 2-year treatment period, 99 (16.5%) subjects discontinued treatment due to lack of effectiveness, and 31 (5.2%) subjects discontinued treatment due to adverse events. No clinically significant abnormalities in height, weight, blood pressure, pulse, mean laboratory values, or electrocardiography parameters were found. Conclusions: Two-year data from this ongoing study indicate that atomoxetine maintains efficacy among adolescents with ADHD, with no evidence of drug tolerance and no new or unexpected safety concerns.
UR - https://www.scopus.com/pages/publications/33746154521
U2 - 10.1016/j.jpeds.2006.01.052
DO - 10.1016/j.jpeds.2006.01.052
M3 - Article
C2 - 16860138
AN - SCOPUS:33746154521
SN - 0022-3476
VL - 149
SP - 112
EP - 119
JO - Journal of Pediatrics
JF - Journal of Pediatrics
IS - 1
ER -