May 18, 2012

Autism Research: Safety and Tolerability of Aripiprazole in the Treatment of Irritability Associated with Autistic Disorder in Pediatric Subjects (6-17 Years Old): Results from a Pooled Analysis of 2 Studies

Abilify (Aripiprazole) Autism Treatment Research:

Safety and Tolerability of Abilify (Aripiprazole) for Irritability in Autism Studied in Recent Research

Research Studies Safety and Tolerability of Abilify (Aripiprazole) as an Autism Treatment for Irritabiity

Many children utilize Abilify (aripiprazole) to manage symptoms associated with autism.  Unfortunately, there has been a lack of larger studies focusing on the safety and tolerability of Abilify as an autism treatment in the pediatric population.  A recent study was designed to provide more data on that topic.  The findings were published in an article titled Safety and Tolerability of Aripiprazole in the Treatment of Irritability Associated with Autistic Disorder in Pediatric Subjects (6-17 Years Old): Results from a Pooled Analysis of 2 Studies.

The study combined data from two 8-week trials utilizing Abilify (aripiprazole) for the treatment of irritability.  Both trials were double-blind, randomized, multi-center, parallel group studies.  One trial utilized a flexible dosing schedule while the other trial utilized a fixed dosing schedule.  The focus of each study was the occurrence of side effects from Abilify (aripiprazole).

The following side effects were reported during the 2 trials:

  • Sedation (20.8%)
  • Fatigue (16.5%)
  • Vomiting (13.7%)
  • Increased Appetite (12.7%)
  • Somnolence (10.4%)
  • Tremor (9.9%)

The authors claim that most of the side effects from Abilify (aripiprazole) occurred shortly after beginning therapy and were generally considered mild to moderate in nature.  They also found that fatigue was related to the dose of Abilify.  The researchers also identified a relationship between Abilify and mean weight change compared to placebo.

The authors reported that 20.8% of children taking Abilify in this study experienced extrapyramidal side effects compared to 9.9% in the placebo group.  They also reported that 3.3% experienced akathisia side effects while taking Abilify (aripiprazole) compared to 8.9% in the placebo group.

The authors state that these studies show Abilify to be generally safe and well-tolerated for the treatment of irritability in children with autism spectrum disorders.  They also stress that providers need to be aware of possible side effects from aripiprazole and how to best manage them should they occur.

The article was published in 2011 in The Primary Care Companion to CNS Disorders.

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