APPENDICES. A systematic review and economic model of the ...

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302 Appendix 12 Core symptoms Educational performance Quality of life Adverse events Dizziness 1(1.2)/4(9.1) a /2(2.4)/4(4.8) Diarrhoea 5(6.0)/0/4(4.8)/0 Depression 5(6.0)/1(2.3)/0/2(2.4) Pruritus 0/0/1(1.2)/5(6.0) No adverse event was statistically significantly more frequent among the 1.2 or 1.8 mg/kg/day ATX dose groups compared with placebo; however, in the 0.5mg/kg/day group dizziness a occurred significantly more frequently compared with placebo Withdrawals: adverse events Arm 1: n = 1 Arm 2: n = 2 Arm 3: n = 4 Arm 4: n = 0 Conclusions Authors’ conclusions: Among children and adolescents aged 8–18 years, atomoxetine was superior to placebo in reducing ADHD symptoms. ATX was associated with a graded dose–response, and 1.2 mg/kg/day seems to be as effective as 1.8 mg/kg/day and is likely to be the most appropriate initial target dose for most patients. Treatment with ATX was safe and well tolerated Reviewer’s comments: No comments noted
Study Intervention Participants Outcomes Core symptoms ADHD Rating Scale IV: total score; inattention symptoms; hyperactivity/impulsive symptoms CPRS CTRS Reference Michelson et al., 2002; 74 Dunn et al., 2002; 312 Bukstein, 2003313 and Michelson, 2002 314 Co-existent problems Not reported Inclusion criteria 1. 6–16 years of age 2. Had to meet symptom severity threshold 3. No serious medical illness 4. No history of psychosis or bipolar disorder, alcohol or drug abuse within the past 3 months 5. No ongoing use of psychoactive medications other than the study drug Source Updated search Educational performance Not reported Arm 1 ATX 0.5 mg/kg/day for 3 days, followed by 0.75 mg/kg/day for the remainder of the first week. The dose was then increased to 1.0 or 1.5 mg/kg/day; administered once daily (a.m.) (Individual administering medication not reported) Setting USA Psychological function Not reported Diagnostic criteria DSM-IV Number Total randomised = 171 (male = 120) Arm 1 = 85 Arm 2 = 86 Arm 2 Placebo No details reported (Individual administering medication not reported) Design Parallel trial Depression or anxiety Not reported Quality of life CGI severity score Total withdrawals = 23 Arm 1 = 12 Arm 2 = 11 Adverse events 16 types of adverse effects reported assessed by open-ended questioning; blood pressure; pulse; weight; height One assigned patient did not receive any medication, and analyses excluded this patient Duration 6 weeks Purpose To assess the efficacy of one-daily ATX in the treatment of children and adolescents with ADHD This trial is also reported in several abstracts 312–314 © Queen’s Printer and Controller of HMSO 2006. All rights reserved. Age 10 years (mean); 2 years (SD) Health Technology Assessment 2006; Vol. 10: No. 23 Additional outcomes Parent rating of behaviour in evening: problems with homework/tasks; sitting through dinner; difficulty playing quietly; inattentive and distractible; arguing or struggling; irritability; difficulty with transitions; difficulty settling at bedtime; difficulty falling asleep. Parent rating of behaviour in morning: difficulty getting out of bed; difficulty getting ready; arguing or struggling; irritability IQ Not reported Co-morbid disorders ODD: n = 34; depression: n = 3; generalised anxiety disorder: n = 1; specific phobia: n = 5 Diagnostic subtypes ADHD subtype: 58% mixed; 2% hyperactive/impulsive; 41% inattentive Additional information Previous medication: All patients followed a minimum 5-day medication-free evaluation period before randomisation. 94 of the children reported having been previously treated with a stimulant Concurrent medication: Participants in the trial were not to receive ongoing psychoactive medications other than the study drug 303
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