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

作者：Zhu S, Wang T, Wang J, Yang S, Yu Z, Gao H, Chen G · 发表于：Journal of attention disorders · 年份：2023 · DOI：10.1177/10870547231153941 · 研究领域：Attention Deficit Disorder with Hyperactivity、Central Nervous System Stimulants、Methylphenidate、Child、Adult、Adolescent、Humans、Randomized Controlled Trials as Topic、Data Management、Treatment Outcome、Double-Blind Method、Dose-Response Relationship, Drug

OBJECTIVE: A new formulation of extended-release methylphenidate (PRC-063) was approved to treat ADHD. This meta-analysis 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.