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Guanfacine extended-release efficacious, well-tolerated for adolescent ADHD

Results from a 13-week, multicenter, randomized, double blind, placebo-controlled trial indicate guanfacine extended-release was associated with significant improvement in attention deficit/hyperactivity disorder symptoms in adolescents.

To evaluate the safety and efficacy of guanfacine extended-release in adolescents with ADHD, Timothy E. Wilens, MD, of Massachusetts General Hospital in Boston, and colleagues randomly assigned 157 adolescents with ADHD to receive guanfacine and 157 to receive placebo for 13 weeks. Study participants, aged 13 to 17 years, received 1 mg to 7 mg of guanfacine extended-release per day. Changes in ADHD Rating Scale-IV total score, Clinical Global Impression-Severity of Illness, and Weiss Functional Impairment Rating Scale-Parent Report scores were assessed.

Timothy E. Wilens

The majority of adolescents received optimal doses of 3 mg, 4 mg, 5 mg or 6 mg, according to the researchers, with 46.5% receiving an optimal dose greater than the currently approved maximum dose limit of 4 mg.

ADHD Rating Scale-IV total scores improved among adolescents receiving guanfacine extended-release compared with placebo (P < .001).

More adolescents in the guanfacine extended-release group showed significant improvement in Clinical Global Impression-Severity of Illness scores (P = .01).

There were no statistically significant differences in Weiss Functional Impairment Rating Scale-Parent Report scores between treatment groups at week 13.

Most adverse events occurring during treatment were mild to moderate. Sedation-related events were the most commonly reported.

“Guanfacine extended-release was associated with statistically significant improvements in ADHD symptoms in adolescents. Guanfacine extended-release was well tolerated, with no new safety signals reported,” the researchers concluded. – by Amanda Oldt

Disclosure: Please see the full study for a list of all authors’ relevant financial disclosures.