TY - JOUR
T1 - Safety and tolerability of methylphenidate in preschool children with ADHD
AU - Wigal, Tim
AU - Greenhill, Laurence
AU - Chuang, Shirley
AU - McGough, James
AU - Vitiello, Benedetto
AU - Skrobala, Anne
AU - Swanson, James
AU - Wigal, Sharon
AU - Abikoff, Howard
AU - Kollins, Scott
AU - McCracken, James
AU - Riddle, Mark
AU - Posner, Kelly
AU - Ghuman, Jaswinder
AU - Davies, Mark
AU - Thorp, Ben
AU - Stehli, Annamarie
PY - 2006/11
Y1 - 2006/11
N2 - OBJECTIVE: To report on the safety and tolerability of methylphenidate (MPH) 3- to 5-year-old children with attention-deficit/hyperactivity disorder (ADHD) during 1 year of treatment. METHOD: Exactly 183 children (3-5 years old) entered a treatment study of MPH, consisting of a 1-week open-label lead-in (n = 183); a 5-week placebo-controlled, double-blind phase (n = 165); a 5-week double-blind, parallel phase (n = 114); and 10 months of open-label maintenance (n = 140 entered, 95 completed). Mean total daily MPH doses rose from the titration trial best dose, 14.1 (±8.1) mg/day, to 20.5 (±9.7) mg/day mean total daily dose at the end of maintenance. Pulse, blood pressure, and the presence of treatment emergent adverse events (AEs), parent and teacher AE ratings, and vital signs were recorded in each phase. RESULTS: Thirty percent of parents spontaneously reported moderate to severe AEs in all study phases after baseline. These included emotional outbursts, difficulty falling asleep, repetitive behaviors/thoughts, appetite decrease, and irritability. During titration, decreased appetite (χ = 5.4, p < .03), trouble sleeping (χ = 5.4, p < .03), and weight loss (χ = 4.0, p < .05) occurred statistically more often on MPH than on placebo. During maintenance, trouble sleeping and appetite loss persisted and other MPH-related AEs decreased. There were transient, one-time pulse and blood pressure elevations in five children. Twenty-one children (11%) discontinued because of drug-attributed AEs. CONCLUSIONS: Eleven percent of preschoolers discontinued treatment because of intolerable MPH AEs. Of the serious AEs reported, one occurred in baseline, two in lead-in, three in titration, one in parallel, and one in maintenance. Only one was possibly related to MPH. Copyright 2006
AB - OBJECTIVE: To report on the safety and tolerability of methylphenidate (MPH) 3- to 5-year-old children with attention-deficit/hyperactivity disorder (ADHD) during 1 year of treatment. METHOD: Exactly 183 children (3-5 years old) entered a treatment study of MPH, consisting of a 1-week open-label lead-in (n = 183); a 5-week placebo-controlled, double-blind phase (n = 165); a 5-week double-blind, parallel phase (n = 114); and 10 months of open-label maintenance (n = 140 entered, 95 completed). Mean total daily MPH doses rose from the titration trial best dose, 14.1 (±8.1) mg/day, to 20.5 (±9.7) mg/day mean total daily dose at the end of maintenance. Pulse, blood pressure, and the presence of treatment emergent adverse events (AEs), parent and teacher AE ratings, and vital signs were recorded in each phase. RESULTS: Thirty percent of parents spontaneously reported moderate to severe AEs in all study phases after baseline. These included emotional outbursts, difficulty falling asleep, repetitive behaviors/thoughts, appetite decrease, and irritability. During titration, decreased appetite (χ = 5.4, p < .03), trouble sleeping (χ = 5.4, p < .03), and weight loss (χ = 4.0, p < .05) occurred statistically more often on MPH than on placebo. During maintenance, trouble sleeping and appetite loss persisted and other MPH-related AEs decreased. There were transient, one-time pulse and blood pressure elevations in five children. Twenty-one children (11%) discontinued because of drug-attributed AEs. CONCLUSIONS: Eleven percent of preschoolers discontinued treatment because of intolerable MPH AEs. Of the serious AEs reported, one occurred in baseline, two in lead-in, three in titration, one in parallel, and one in maintenance. Only one was possibly related to MPH. Copyright 2006
KW - Adverse events
KW - Attention-deficit/hyperactivity disorder
KW - Methylphenidate
KW - Preschoolers
KW - Safety
KW - Tolerability
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U2 - 10.1097/01.chi.0000235082.63156.27
DO - 10.1097/01.chi.0000235082.63156.27
M3 - Article
C2 - 17028508
AN - SCOPUS:33750498069
SN - 0890-8567
VL - 45
SP - 1294
EP - 1303
JO - Journal of the American Academy of Child and Adolescent Psychiatry
JF - Journal of the American Academy of Child and Adolescent Psychiatry
IS - 11
ER -