用于治疗注意力缺陷多动障碍的维洛沙嗪：随机临床试验的系统评价和荟萃分析

Viloxazine for Attention-Deficit Hyperactivity Disorder: A Systematic Review and Meta-analysis of Randomized Clinical Trials.

作者信息

Singh Alok, Balasundaram Mahesh Kumar, Singh Abhishek

机构信息

Department of Pharmacology, All India Institute of Medical Sciences, Raipur, Chhattisgarh, India.

Little One's Pediatric Clinic Satna, Madhya Pradesh, India.

出版信息

J Cent Nerv Syst Dis. 2022 May 20;14:11795735221092522. doi: 10.1177/11795735221092522. eCollection 2022.

BACKGROUND

Recently, the United States Food and Drug Administration (USFDA) approved viloxazine extended-release (ER) to manage attention-deficit hyperactivity disorder (ADHD) in pediatric patients of 6-17 years of age.

OBJECTIVE

To perform a meta-analysis to determine the safety and efficacy of viloxazine ER in the management of ADHD.

DATA SOURCE AND METHODS

A literature search was performed through the databases Cochrane Library, PubMed, and clinicaltrials.gov, for a period from inception to August 2021, with the keywords: viloxazine, SPN-812, ADHD, and randomized clinical trials. The randomized controlled trials published in English language that analyzed the efficacy and safety were included. The risk of bias (RoB) was assessed by RoB tool. The outcomes included in this study were the proportion of patients with a 50% reduction in ADHD-Rating Scale-5 (ADHD-RS-5 responders) and improvement in CGI-I scale and the proportion of patients with at least one adverse event, the incidence of somnolence and Serious Adverse Events (SAEs).

RESULTS

This meta-analysis includes 1605 patients from five randomized clinical trials; all of the trials were at low risk of bias. Viloxazine group had more ADHD-RS-5 responders as compared to placebo; RR = 1.62; 95% CI = 1.36-1.93; = <.00001. Significantly higher number of patients showed improved CGI-I score; RR = 1.53; 95% CI = 1.32-1.78; = <.00001. A higher proportion of patients was observed with at least one adverse event (RR = 1.52; 95% CI = 1.24-1.85; = <.0001), and somnolence (RR = 3.93; 95% CI = 2.11-7.31; = <.0001) in viloxazine group. The incidence of SAEs was more in viloxazine group (RR = 2.98; 95% CI = .67-13.3; = .15).

CONCLUSIONS

Viloxazine was found to be significantly superior to placebo in both efficacy outcomes. Adverse events and somnolence were significantly more than the placebo. The incidence was SAEs was more in the viloxazine group but was not statistically significant.

背景

最近，美国食品药品监督管理局（USFDA）批准了缓释维洛沙嗪用于治疗6至17岁儿科患者的注意力缺陷多动障碍（ADHD）。

目的

进行一项荟萃分析，以确定缓释维洛沙嗪治疗ADHD的安全性和有效性。

数据来源与方法

通过Cochrane图书馆、PubMed和clinicaltrials.gov数据库进行文献检索，检索时间从数据库建立至2021年8月，关键词为：维洛沙嗪、SPN-812、ADHD和随机临床试验。纳入以英文发表的分析疗效和安全性的随机对照试验。采用偏倚风险（RoB）工具评估偏倚风险。本研究纳入的结局指标包括ADHD评定量表-5（ADHD-RS-5）得分降低50%的患者比例（ADHD-RS-5反应者）、临床总体印象改善量表（CGI-I）得分的改善情况、至少发生1次不良事件的患者比例、嗜睡发生率和严重不良事件（SAE）发生率。

结果

该荟萃分析纳入了来自5项随机临床试验的1605例患者；所有试验的偏倚风险均较低。与安慰剂组相比，维洛沙嗪组ADHD-RS-5反应者更多；RR = 1.62；95%CI = 1.36 - 1.93；P = <.00001。显示CGI-I评分改善的患者数量显著更多；RR = 1.53；95%CI = 1.32 - 1.78；P = <.00001。维洛沙嗪组观察到至少发生1次不良事件的患者比例更高（RR = 1.52；95%CI = 1.24 - 1.85；P = <.0001），嗜睡发生率更高（RR = 3.93；95%CI = 2.11 - 7.31；P = <.0001）。维洛沙嗪组SAE的发生率更高（RR = 2.98；95%CI = .67 - 13.3；P = .15）。