Guanfacine for attention deficit and hyperactivity disorder in pediatrics: a systematic review and meta-analysis
Simona Ruggiero1, Antonio Clavenna2, Laura Reale2
1Center of Pharmacosurveillance and Pharmacoepidemiology, Department of Experimental Medicine, Section of Pharmacology "L. Donatelli", Faculty of Medicine and Surgery, Second University of Naples, Italy.
Insights
Guanfacine is a safe and effective treatment for pediatric Attention Deficit Hyperactivity Disorder (ADHD). This review of randomized controlled trials found it significantly improved symptoms compared to placebo, though with increased risks of somnolence and fatigue.
Area of Science:
- Pharmacology
- Pediatric Medicine
- Clinical Trials
Background:
- Attention Deficit Hyperactivity Disorder (ADHD) is a prevalent neurodevelopmental disorder in children and adolescents.
- Non-stimulant medications are crucial for managing ADHD symptoms, especially when stimulant treatments are ineffective or contraindicated.
Purpose of the Study:
- To systematically review and meta-analyze randomized controlled trials (RCTs) evaluating the safety and efficacy of guanfacine for pediatric ADHD.
- To determine the overall treatment response and identify common adverse events associated with guanfacine use in this population.
Main Methods:
- A comprehensive literature search was conducted across major databases (Cochrane, Embase, PsycINFO, Medline) and clinical trial registers up to May 2014.
- Seven RCTs involving 1752 participants were included, comparing guanfacine against placebo over 6-16 weeks.
- Meta-analysis focused on the Clinical Global Impression Improvement score as the primary outcome measure for treatment response.
Main Results:
- Guanfacine demonstrated significantly higher treatment response rates (59.0%) compared to placebo (33.3%), with a pooled odds ratio of 3.2.
- Adverse events were more frequent in the guanfacine group (82.4%) versus placebo (67.9%).
- The most common adverse events associated with guanfacine were somnolence, sedation, and fatigue.
Conclusions:
- Guanfacine is a safe and effective therapeutic option for children and adolescents diagnosed with ADHD.
- Clinicians should consider the increased risk of specific adverse events, such as somnolence, when prescribing guanfacine.
- Further research may explore long-term efficacy and safety profiles in pediatric ADHD populations.
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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