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Tulosta

Atomoksetiinin haittavaikutukset lapsilla ja nuorilla

Näytönastekatsaukset
21.6.2016
Arja Voutilainen

Näytön aste: A

Atomoksetiinin haittavaikutukset lyhytkestoisessa hoidossa lapsilla ja nuorilla ovat tavallisia mutta yleensä lieviä.

In a recent meta-analysis «Schwartz S, Correll CU. Efficacy and safety of atomoxetine in children and adolescents with attention-deficit/hyperactivity disorder: results from a comprehensive meta-analysis and metaregression. J A»1, efficacy and safety of atomoxetine (ATX) compared with placebo in the treatment of children and adolescents. Study inclusion criteria were as follows: ATX monotherapy versus placebo; double blinded randomized controlled design; primary ADHD of any type, with oppositional defiant disorder (ODD), anxiety, and depression comorbidities allowed; patient age < 18 years; patient IQ of > 75. The primary outcome measure was baseline to end-point change in parent-rated, 18-item ADHD efficacy scale (ADHD-RS IV P/I), Swanson, Nolan, and Pelham rating scale-revised-IV ADHD (SNAP-RS IV ADHD), ADHD-RS Japanese version, investigator-administered (ADHD-RS J/I Total) or Parent/Investigator ADHD checklist score. Data from the safety outcomes were also extracted.

Altogether 25 RCTs, with 3 928 participants were included in the analysis. The mean follow-up time was 8.6 weeks (range: 4 – 18 weeks). The average ATX dose was 1,17 mg/kg/day. Mean age was 10,3 years, with 68,2% being <13 years old. Altogether, 51,3% were anti-ADHD medication naïve, and 44,6% had comorbid ODD/CD.

All-cause discontinuation with ATX was similar to that of placebo. However, ATX had higher discontinuation rate due to adverse effects (AEs) (RR = 1,89; CI 95% = 1,08 – 3,31; p=0,03). At least 1 AE (70,4% versus 56,1%; p<0,01) and at least 1 psychiatric AE (21,5% versus 7,4; p<0,01) were more frequent with ATX. The most common AEs associated with ATX were gastrointestinal symptoms, including vomiting, abdominal pain, nausea and diarrhea (22,1% versus 12,4%; p<0,0001), nervous system symptoms, including dizziness, headache, somnolence, sedation and drowsiness (21,8% versus 15,2%; p<0,0001), anorexia (19,2% versus 5,2%; p<0,0001) and fatigue (11,7% versus 4,6%; p<0,0001). Serious AEs (1,5% versus 1,0%, NS), aggression (7,5% versus 6,0%; NS), depression (2,9% versus 6,0%, NS), insomnia (7,1% versus 6,8%; NS) and suicidal ideation (1,3% versus 0,9%; NS) were not different from placebo.

Compared to placebo, patients with ATX treatment had an increase in diastolic BP (2,5 mmHg; CI 95% 1,8 to 3,1; p<0,0001), systolic BP (1,5 mmHg; CI 95% 0,6 to ,3; p<0,001), and heart rate (6 beats per minute; CI 95% 5 to 7; p<0,0001). They also had decreased body weight (-1,4 kg; CI 95% -1,1 to -1,8; p<0,0001) and shorter QTc on ECG (-12,8 ms; CI 95% -9,0 to -16,2; p<0,0001).

  • Study quality: Moderate
  • Applicability: Good for short term treatment of children and adolescents in Finland
  • Comment: The quality of evidence from this meta-analysis is downgraded, because no assessment of included studies were reported. However, it is not suggested to cause bias to the results regarding side-effects.

Kirjallisuutta

  1. Schwartz S, Correll CU. Efficacy and safety of atomoxetine in children and adolescents with attention-deficit/hyperactivity disorder: results from a comprehensive meta-analysis and metaregression. J Am Acad Child Adolesc Psychiatry 2014;53:174-87 «PMID: 24472252»PubMed
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