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

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304 Appendix 12 Core symptoms Educational performance Quality of life Adverse events ATX Placebo (n = 85) (n = 85) Headache 17 (20%) 15 (18%) Rhinitis 14 (17%) 18 (21%) Decreased appetite 17 (20%) 5 (6%) Abdominal pain 14 (17%) 7 (8%) Pharyngitis 6 (7%) 13 (15%) Increased coughing 6 (7%) 11 (13%) Somnolence 9 (11%) 6 (7%) Vomiting 13 (15%) 1 (1%) Nausea 10 (12%) 2 (2%) Asthenia 9 (11%) 1 (1%) Emotional lability 6 (7%) 4 (5%) Rash 6 (7%) 4 (5%) Accidental injury 5 (6%) 4 (5%) Fever 6 (7%) 3 (4%) Dyspepsia 8 (9%) 0 (%) Dizziness 5 (6%) 0 (%) Not reported CGI severity score (baseline/change from baseline) ATX: 4.7 (0.6)/–1.2 (1.3) Placebo: 4.6 (0.6)/–0.5 (1.0) (ATX > placebo, p < 0.001) ADHD Rating Scale IV: total score (baseline/change from baseline) ATX: 37.6 (9.4)/–12.8 (12.4) Placebo 36.7 (8.8)/–5.0 (10.4) (ATX > placebo, p < 0.001) ADHD Rating Scale IV: inattention symptoms ATX: 21.9 (3.5)/–7.1 (6.9) Placebo: 21.4 (4.0)/–2.9 (5.7) (ATX > placebo, p < 0.001) ADHD Rating Scale IV: hyperactivity/impulsive symptoms ATX: 15.7 (8.0)/–5.7 (6.8) Placebo: 15.3 (7.1)/–2.1 (5.7) (ATX > placebo, p < 0.001) CPRS (ATX: n = 80, placebo: n = 77) ATX: 27.0 (5.5)/–7.6 (8.2) Placebo: 26.5 (5.8)/–2.4 (7.0) (ATX > placebo, p < 0.001) Change in height from baseline to end-point was similar for the two groups [mean change = 0.9 cm (SD 1.3) and 0.8 cm (SD 1.0), p < 0.65)] CTRS ATX: 21.5 (8.7)/–5.1 (8.0) Placebo: 21.6 (9.0)/–1.6 (8.3) (ATX > placebo, p = 0.02) Conclusions Authors’ conclusions: The authors state that once-daily administration of atomoxetine is an effective treatment for children with ADHD Reviewer’s comments: No comments noted
Study Intervention Participants Outcomes Core symptoms ADHD Rating Scale IV: total score; inattentive symptoms; hyperactive/impulsive symptoms CPRS: hyperactivity CTRS: hyperactivity Inclusion criteria 1. 6–15 years of age 2. Symptom severity above 1.5 SD for age and gender 3. No bipolar disorder or psychotic illness 4. No unstable medical illness or condition that requires ongoing psychoactive medication (other than ATX) Arm 1 ATX Mean dose: 1.56 mg/kg day; administered twice daily (Individuals administering medication not reported) References Michelson et al., 2004; 75 Michelson et al., 2003 315 Co-existent problems CPRS: oppositional; cognitive problems CTRS: oppositional; cognitive problems Source Updated search Diagnostic criteria DSM-IV Number Total randomised = 416 (male = 373) Arm 1 = 292 Arm 2 = 124 Arm 2 Placebo (Individuals administering medication not reported) Setting International Educational performance Not reported Design Parallel trial Psychological function Not reported Depression or anxiety Not reported Quality of life CGI Severity of Illness scale Child Health Questionnaire psychosocial summary score Total withdrawals = 10 Arm 1 = 9 Arm 2 = 1 Reasons for withdrawals: All discontinuations were due to adverse events (9 in ATX group and 1 in placebo group) Duration 9 months Purpose To assess the efficacy of ATX in preventing relapse in paediatric patients with ADHD during 9 months after an initial 12-week treatment period © Queen’s Printer and Controller of HMSO 2006. All rights reserved. Adverse events Some adverse events reported Age 10 years (mean); 2.3 years (SD) Health Technology Assessment 2006; Vol. 10: No. 23 Additional outcomes Relapse prevention (symptom return to ≥ 90% baseline ADHD Rating Scale IV total score and increase in CGI Severity of Illness scale of at least 2 points) IQ Not reported Co-morbid disorders ODD: 43%, depression: 2%, generalised anxiety disorder: 3% Diagnostic subtypes Combined: 73%; hyperactive/impulsive: 5%; inattentive: 22% Additional information Previous medication: The participants in this trial were children who responded to an initial 12-week open-label period of treatment with ATX. Patients who relapsed during the 9-month period were removed from the study and offered the option of entering an open-label extension of the study Concurrent medication: No participants were to be in receipt of ongoing psychoactive medication (other than ATX) for an unstable medical illness or condition 305
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366 Appendix 13 Study characteristi
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