期刊
JOURNAL OF THE AMERICAN ACADEMY OF CHILD AND ADOLESCENT PSYCHIATRY
卷 45, 期 11, 页码 1294-1302出版社
ELSEVIER SCIENCE INC
DOI: 10.1097/01.chi.0000235082.63156.27
关键词
preschoolers; attention-deficit/hyperactivity disorder; methylphenidate; adverse events; safety; tolerability
资金
- NIMH NIH HHS [U01 MH60900, U01 MH60943, U01 MH60848, U01 MH60903, U01 MH60642, U01 MH60833, K23 MH001883-05] Funding Source: Medline
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 (chi(2) = 5.4, p < .03), trouble sleeping (chi(2) = 5.4, p < .03), and weight loss (chi(2) = 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.
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