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Comparative efficacy, acceptability, and tolerability of lisdexamfetamine in child and adolescent ADHD: a meta-analysis of randomized, controlled trials.

ABSTRACT: Several studies have shown that lisdexamfetamine (LDX) is efficacious in children and adolescents with attention-deficit/hyperactivity disorder (ADHD).Aims of this study were to systematically review the efficacy, acceptability, and tolerability of LDX in child and adolescent ADHD. Any randomized controlled trials (RCTs) of LDX versus placebo carried out in children and adolescents with ADHD were included.The searches of the SCOPUS, MEDLINE, CINAHL and Cochrane Controlled Trials Register were performed in September 2014. Additional searches in the ClinicalTrials. gov and EU Clinical Trials Register database were conducted.This review included all RCTs of LDX versus placebo which were carried out in children and adolescents up to 18 years old. Additionally, the included studies must have reported the final outcomes of: i) severity of ADHD symptoms with standardized scales, ii) rates of improvement, iii) rates of discontinuation. To be more thorough, the languages of such RCTs were not limited.The abstracts from databases were inspected and the full text versions of relevant trials were examined and extracted for important outcomes. The efficacious measurements included either the pooled mean end-point or changed scores of ADHD rating scales, and the rate of improvement. Acceptability and tolerability were measured by the pooled overall discontinuation rate and the pooled discontinuation rate due to adverse events, respectively. A random effect model technique was utilized to synthesize the mean differences (either standardized mean differences or weighted mean differences) and relative risks (RRs) with 95% confidence intervals (CIs).A total of 1,016 children and adolescents with ADHD were included. The dosage of LDX was 30 to 70 mg/day. The pooled mean change scores of LDX-treated group was significantly greater than that of the placebo (weighted mean difference [95% CI] of -15.20 [-19.95, -10.46], I (2)=94%). The pooled improvement rate of the LDX-treated group was also significantly higher than that of the placebo (RR [95% CI] of 0.34 [0.24, 0.47], I (2)=80%). The pooled overall discontinuation rate between the two groups was not significantly different (RR [95% CI] of 0.78 [0.46, 1.31], I (2)=63%). Similarly, the pooled discontinuation rate due to adverse events between the two groups showed no significant difference (RR [95% CI] of 1.99 [0.70, 5.64], I (2)=0%).The number of included studies was limited (five RCTs).According to the present review, LDX was effective and well-tolerated in the treatment of child and adolescent ADHD. Unfortunately, the acceptability of LDX was not better than the placebo. Since the number of included studies was limited, the outcome from this review should be carefully interpreted and considered as preliminary. Further studies, therefore, should be conducted to confirm these findings.Lisdexamfetamine is an efficacious stimulant for treating child and adolescent ADHD.

SUBMITTER: Maneeton B

PROVIDER: S-EPMC4389815 | biostudies-other | 2015

REPOSITORIES: biostudies-other

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Comparative efficacy, acceptability, and tolerability of lisdexamfetamine in child and adolescent ADHD: a meta-analysis of randomized, controlled trials.

Maneeton Benchalak B Maneeton Narong N Likhitsathian Surinporn S Suttajit Sirijit S Narkpongphun Assawin A Srisurapanont Manit M Woottiluk Pakapan P

Drug design, development and therapy 20150401

<h4>Background</h4>Several studies have shown that lisdexamfetamine (LDX) is efficacious in children and adolescents with attention-deficit/hyperactivity disorder (ADHD).<h4>Objectives</h4>Aims of this study were to systematically review the efficacy, acceptability, and tolerability of LDX in child and adolescent ADHD. Any randomized controlled trials (RCTs) of LDX versus placebo carried out in children and adolescents with ADHD were included.<h4>Data sources</h4>The searches of the SCOPUS, MEDL ...[more]

PMID: 25897203

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Project description:BackgroundTo assess the blood pressure and lipid-lowering efficacy and tolerability of 'polypills' used in cardiovascular disease prevention trials.Methodology/principal findingsSystematic review and meta-analysis.Search strategyThe Cochrane Central Register of Controlled Trials, Medline, and PubMed databases were searched for eligible trials. Study inclusion criteria: Randomised controlled trials of at least six weeks duration, which compared a 'polypill' (that included at least one anti-hypertensive and one lipid-lowering medication) with a placebo (or one active component).Outcome measuresChange from baseline in systolic and diastolic blood pressures, and total and LDL-cholesterol; discontinuation of study medication and reported adverse effects. Of 44 potentially eligible studies, six trials (including 2,218 patients without previous cardiovascular disease) fulfilled the inclusion criteria. Compared with placebo, 'polypills' reduced systolic blood pressure by -9.2 mmHg (95% confidence interval (CI): -13.4, -5.0) diastolic blood pressure by -5.0 mmHg (95%CI: -7.4, -2.6), total cholesterol by -1.22 mmol/L (95%CI: -1.60, -0.84) and LDL-cholesterol by -1.02 mmol/L (95%CI: -1.37, -0.67). However, those taking a 'polypill' (vs. placebo or component) were more likely to discontinue medication (20% vs 14%) (Odds ratio: 1.5 (95% CI: 1.2, 1.9)). There was no significant difference in reported adverse effects amongst those on a 'polypill' (36% vs. 28%) (OR: 1.3 (95%CI: 0.7, 2.5)). There was high statistical heterogeneity in comparisons for blood pressure and lipid-lowering but use of random-effects and quality-effects models produced very similar results.Conclusions/significanceCompared with placebo, the 'polypills' reduced blood pressure and lipids. Tolerability was lower amongst those on 'polypills' than those on placebo or one component, but differences were moderate. Effectiveness trials are needed to help clarify the status of 'polypills' in primary care and prevention strategies.

Project description:Background:Depression and anxiety are the most common mental disorders in children and adolescents. Bibliotherapy is a treatment using written materials for mental health problems. Its main advantages are ease of use, low cost, low staffing demands, and greater privacy. Yet few meta-analyses have focused on the effect of bibliotherapy on depression and anxiety disorders in children and adolescents. Methods:We included randomized controlled trials comparing bibliotherapy with control conditions for depression and anxiety in children and adolescents (aged ?18 years). Five electronic databases (PubMed, Embase, Cochrane, Web of Science, and PsycINFO) were searched from inception to January 2017. Efficacy was defined as mean change scores in depression and anxiety symptoms. Acceptability was defined as the proportion of participants who discontinued the treatment. Random effects model was used. An intention-to-treat analysis was conducted. Results:Eight studies with 979 participants were selected. At posttreatment, bibliotherapy was significantly more effective than the control conditions in reducing the symptoms of depression or anxiety (standardized mean difference, -0.52; 95% confidence interval [CI], -0.89 to -0.15). Bibliotherapy did not have statistically significantly more all-cause discontinuations than controls (risk ratios, 1.66; 95% CI, 0.93 to 2.95). We also performed subgroup analyses for efficacy outcomes in different categories (types of disorder, mean age, control conditions, and parental involvement) of studies and found that bibliotherapy has been more effective in depressive adolescents. Limitations:Limited studies were eligible in this review and hence there was potential publication bias. Conclusion:According to the findings in this review, bibliotherapy may be more beneficial in treating depression in adolescents, but shows less robust effects for anxiety in children. Further well-defined clinical studies should be performed to confirm these outcomes.

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Comparative efficacy, acceptability, and tolerability of lisdexamfetamine in child and adolescent ADHD: a meta-analysis of randomized, controlled trials.

Publications

Comparative efficacy, acceptability, and tolerability of lisdexamfetamine in child and adolescent ADHD: a meta-analysis of randomized, controlled trials.

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