Safety and tolerability of aripiprazole in the treatment of irritability associated with autistic disorder in pediatric patients: Results from a 52-week open-label study

Abstract

ObjectiveEvaluate the time-course, severity and resolution patterns of adverse events (AEs) occurring with long-term aripiprazole treatment for irritability associated with autistic disorder.MethodsParticipants were treated with aripiprazole in a 52-week, open-label, flexibly dosed (2–15 mg/day) study. Subjects had either completed one of two 8-week randomised trials or were de novo. AEs with an incidence of ≥10% were evaluated by incidence, peak first onset, severity, percent resolved and time to resolution.ResultsA total of 330 subjects entered open-label treatment; 199 completed 52 weeks. Mean dose for the population stabilised at around 10 mg/day after approximately 4 months. Thirteen AEs had an incidence of ≥10%; most were mild or moderate in severity. Vomiting, diarrhoea and headache had an early first onset and tended to resolve fairly quickly.Sedation, fatigue and insomnia also appeared early and resolved in a majority of cases, but not as quickly. Increased appetite appeared early (followed by increased weight) and fewer weight-related AEs resolved. More than half of the subjects increased their weight by at least one percentile category rank; nevertheless, only a small proportion of subjects with normal baseline metabolic or glucose measures had a treatment-emergent, clinically relevant laboratory abnormality. Nasopharyngitis, upper respiratory infection, cough, nasal congestion and pyrexia all had peak onset at variable times during the study, resolving in nearly all cases, with short time to resolution.ConclusionAEs were mostly mild or moderate and of variable duration. Increased weight was observed.

Aripiprazole for treating irritability in children & adolescents with autism: A systematic review

“…These studies had not examined the effect of aripiprazole on irritability in autism. The other reasons for exclusion were as follows: not a clinical trial 10 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 , not double blind trials 37 39 40 41 42 , post-hoc analyses 43 44 45 , no control group 46 , case reports 47 48 49 50 51 52 53 54 55 , switching risperidone to aripiprazole 56 57 , data re-analysis 58 , assessed body mass index changes 59 , prevention of irritability 60 , and retrospective studies 61 62 63 64 65 . One study reported anti-manic effect of aripiprazole in patients with autism spectrum disorder and bipolar disorder 66 .…”