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GXR may be effective cotreatment for ADHD
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When used in conjunction with psychostimulants, the selective alpha-2A-agonist guanfacine extended release (GXR) may offer a safe and effective alternative for children with attention-deficit/hyperactivity disorder who do not respond well to psychostimulant therapy alone, according to data presented at the 2010 American Psychiatric Association Annual Meeting in New Orleans.
Researchers from several institutions conducted an open-label extension study to determine the long-term effects of adding GXR (Intuniv, Shire) to psychostimulants for treatment of ADHD. They included 53 children aged 6 to 17 years who experienced negative results with psychostimulant therapy alone and had participated in an antecedent open-label safety study involving cotreatment with GXR.
Combination therapy was continued. Children received 4 mg or less daily of GXR, although the researchers adjusted both GXR and psychostimulant doses if necessary. Efficacy outcomes were measured by changes in ADHD Rating Scale IV (ADHD-RS-IV) total score from baseline to endpoint.
Results revealed that 86.6% of children had treatment-related adverse events, according to the researchers. The majority appeared mild to moderate in intensity, but 3.8% experienced severe negative effects. The most commonly reported adverse events were: upper respiratory tract infection, headache, abdominal pain, nasopharyngitis and decreased appetite.
The mean ADHD-RS-IV baseline scores were 30.2 for children aged 6 to 12 years and 26.7 for those aged 13 to 17. The researchers noted marked decreases in these scores, with the first age group having a mean reduction of 16.9 and the second demonstrating a 13.7 decrease by endpoint.
The study results show promising long-term safety and efficacy data for treating ADHD with GXR and psychostimulants, but the researchers acknowledged the need for controlled trials to confirm their conclusions. The study was supported by funding from Shire.
For more information:
- Youcha S. #NR5-33. Presented at: 2010 American Psychiatric Association Annual Meeting; May 22-26, 2010; New Orleans.