Abstract

To review the evidence from randomized controlled trials (RCTs) on the safety and efficacy of guanfacine in pediatric attention deficit hyperactivity disorder (ADHD), a bibliographic search up to May 2014 was performed using the Cochrane Library׳s Central Register of Controlled Trials, the Embase, PsycINFO, and Medline databases, and clinical trials registers. The search terms used were: [“guanfacine”] and [“child” or “adolescent” or “pediatrics”] and [“randomized controlled trial”] and [“Attention Deficit Disorder with Hyperactivity” or “Attention Deficit Disorder” or “Attention Hyperactivity Disorder” or “Hyperactivity” or “ADHD”]. A meta-analysis was performed using response, defined as a score≤2 on the Clinical Global Impression Improvement score, as the outcome measure. In all, 7 out of 48 studies were included, for a total of 1752 participants. All studies compared guanfacine versus placebo, with a duration ranging from 6 to 16 weeks. In all, the Clinical Global Impression Improvement score was reported as a secondary measure. Overall, 694/1177 (59.0%) participants in the guanfacine group benefited from the treatment compared to 192/575 (33.3%) in the placebo group (pooled OR 3.2; 95%CI 2.4–4.1). The participants with at least one adverse event were 948 (82.4%) in the guanfacine and 376 (67.9%) in the placebo group (OR 2.6; 95%CI 1.6–4.4). Somnolence (OR 4.9), sedation (OR 2.8), and fatigue (OR 2.2), were the adverse events with the greatest risk of occurrence in the guanfacine versus the placebo group. On the basis of seven randomized, placebo controlled trials guanfacine resulted safe and effective in treating children and adolescents with ADHD

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