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| |  Aripiprazole Generally Safe, Tolerable for Children With Autism-Related Irritability: Presented at AACAP By Deborah Brauser HONOLULU -- November 12, 2009 -- Although more incidences of mild or moderate adverse events (AEs), extrapyramidal symptoms, and increased body weight can occur in children and adolescents with autistic disorder treated with aripiprazole for irritability compared with placebo, most of these effects only last for 3 weeks or less. “Autistic disorder is a neurodevelopmental disorder characterised by abnormalities in social interaction and communication and by restricted, repetitive, and stereotyped patterns of behaviours, activities, or interests,” said lead author Adelaide Robb, MD, Children’s National Medical Center, Washington, DC, during a poster session on October 29 here at the American Academy of Child and Adolescent Psychiatry (AACAP) 56th Annual Meeting. “Moderate or severe behavioural problems such as irritability, aggressiveness, and self-injurious behaviour are also often present.” The findings in the original placebo-controlled trials showed that aripiprazole was superior to placebo in reducing irritable and aggressive symptoms in children aged 6 to 17 years with autism during 8-week treatment periods. For this secondary analysis, the investigators examined AEs that led to discontinuation, common AEs, and extrapyramidal symptoms (EPS) in a safety sample of 212 of the children treated with aripiprazole (88.7% male; mean age, 9.6 years) and 101 treated with placebo (90.1% male; mean age, 9.5 years). EPS was defined as including generalised rigidity, hyperkinesias, bradykinesia, akinesia, dystonia, hypertonia, akathisia, and involuntary muscle contractions. At the end of the analysis, results showed discontinuation rates of 10.4% due to AEs for the children treated with aripiprazole versus 6.9% for the placebo-treated group. While most treatment-emergent AEs were classified as mild or moderate, the peak incidence of common AEs occurred at week 1 or 2. The exceptions were for tremor at week 3, extrapyramidal disorder at week 4, and drooling at week 5. There was also a statistically significant difference between the age groups for salivary hypersecretion at 6.6% for aripiprazole and 0% for placebo in ages 6-12, and 2.2% for aripiprazole and 2.2% for placebo in ages 13-17 (P = .016). In addition, EPS was found in 20.8% of the aripiprazole-treated patients versus 9.9% for placebo, and mean weight gain was 1.6 versus 0.5 kg, respectively (P < .001). Finally, metabolic and glucose measurements remained relatively stable for aripiprazole-treated patients, with no clinically meaningful differences found between the 2 groups in the median percent changes from baseline. “In summary, aripiprazole was found to be generally safe and well-tolerated in the treatment of irritability associated with autistic disorder,” said Dr. Robb. “We found that most AEs were mild or moderate and peak incidence occurred early on in treatment. These symptoms, which are common antipsychotic side effects, were gone in about 3 weeks on average.” “When you’re sitting with a parent in your office, you can tell them what types of side effects their children will have and how common they are compared to a sugar pill,” said Dr. Robb. “But you can also tell them how long it’s going to take until the side effect goes away after it starts. And I think that’s really important. It helps set somebody’s expectations and knowledge when they’re starting a medicine in a child where they already have issues with behaviour and irritability.” “My number 1 takeaway is that most of the side effects that are bothersome and lead to discontinuation for some people are no longer there by 3 weeks. So if you can sit through the 3 weeks of titrating the medicine up to an effective dose, you will get benefit and the troublesome side effects will be gone,” concluded Dr. Robb. Funding for this study was provided by Bristol-Myers Squibb and Otsuka America Pharmaceutical, Inc. [Presentation title: Safety and Tolerability of Aripiprazole in the Treatment of Irritability Associated With Autistic Disorder. Abstract P-3.50]
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