Efficacy and Safety of PRC-063 for Attention-Deficit/Hyperactivity Disorder: A Systematic Review and Meta-analysis From Randomized Controlled Trials

Efficacy and Safety of PRC-063 for Attention-Deficit/Hyperactivity Disorder: A Systematic Review and Meta-analysis From Randomized Controlled Trials

Authors
Zhu, S. Wang, T. Wang, J. Yang, S. Yu, Z. Gao, H. Chen, G.
Year
2023
Journal
Journal of Attention Disorders
Volume
Pages
10870547231153941
Objective: A new formulation of extended-release methylphenidate (PRC-063) was approved to treat ADHD. This metaanalysis was conducted to study the efficacy and safety of PRC-063 for ADHD. Method: We searched for published trials to October 2022 in several databases. Results: A total of 1,215 patients from 5 RCTs were included. We observed significant improvement for PRC-063 in ADHD Rating Scale (ADHD-RS; MD = −6.73, 95% CI [−10.34, −3.12]) compared with placebo. The effect of PRC-063 on the sleep problems due to ADHD was not statistically different from placebo. Six subscales of Pittsburg Sleep Quality Index (PSQI) showed no statistical significance between PRC-063 and placebo. The result showed no significant difference comparing PRC-063 with placebo in serious treatment-emergent adverse events (TEAEs) (RR = 0.80, 95% CI [0.03, 19.34]). In subgroup analysis according to age, PRC-063 was more efficacious in minors compare to adults. Conclusion: PRC-063 is an efficacious and safe treatment for ADHD, especially in children and adolescents.

Oversett med Google Translate
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Type of intervention

Treatment and Child Welfare Interventions

Topic

Mental Health Problems and Disorders

ADHD

Intervention

Pharmacological Treatment

Stimulants

Age group

School Aged Children (6-12 years)

Adolescents (13-18 years)

Age not specified

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