PDF(Pubmed)
Abstract：
Aim: To compare long-term safety and efficacy outcomes of centanafadine versus lisdexamfetamine dimesylate (lisdexamfetamine), methylphenidate hydrochloride (methylphenidate) and atomoxetine hydrochloride (atomoxetine), respectively, in adults with attention-deficit/hyperactivity disorder (ADHD) using matching-adjusted indirect comparisons (MAICs). Patients & methods: Patient-level data from a centanafadine trial (NCT03605849) and published aggregate data from a lisdexamfetamine trial (NCT00337285), a methylphenidate trial (NCT00326300) and an atomoxetine trial (NCT00190736) were used. Patient characteristics were matched in each comparison using propensity score weighting. Study outcomes were assessed up to 52 weeks and included safety (rates of adverse events [AEs]) and efficacy (mean change from baseline in the Adult ADHD Investigator Symptom Rating Scale [AISRS] or ADHD Rating Scale [ADHD-RS] score). Results: In all comparisons of matched populations, risks of AEs were statistically significantly lower with centanafadine or non-different between centanafadine and comparator; the largest differences in AE rates included upper respiratory tract infection (risk difference in percentage points: 18.75), insomnia (12.47) and dry mouth (12.33) versus lisdexamfetamine; decreased appetite (20.25), headache (18.53) and insomnia (12.65) versus methylphenidate; and nausea (26.18), dry mouth (25.07) and fatigue (13.95) versus atomoxetine (all p < 0.05). Centanafadine had a smaller reduction in the AISRS/ADHD-RS score versus lisdexamfetamine (6.15-point difference; p < 0.05) and no statistically significant difference in the change in AISRS score versus methylphenidate (1.75-point difference; p = 0.13) and versus atomoxetine (1.60-point difference; p = 0.21). Conclusion: At up to 52 weeks, centanafadine showed significantly lower incidence of several AEs than lisdexamfetamine, methylphenidate and atomoxetine; efficacy was lower than lisdexamfetamine and non-different from methylphenidate and atomoxetine.
摘要：
目的：比较centanafadine与lisdexamfetaminedimesylate（lisdexamfetamine）的长期安全性和有效性结果，盐酸哌醋甲酯（哌醋甲酯）和盐酸托莫西汀（托莫西汀），分别,在患有注意力缺陷/多动障碍（ADHD）的成年人中，使用匹配校正间接比较（MAIC）。患者和方法：来自centanafadine试验（NCT03605849）的患者水平数据和来自lisdexamfetamine试验（NCT00337285）的公开汇总数据，使用哌醋甲酯试验(NCT00326300)和托莫西汀试验(NCT00190736).在每个比较中使用倾向评分加权匹配患者特征。研究结果评估长达52周，包括安全性（不良事件发生率[AE]）和有效性（成人ADHD研究者症状评定量表[AISRS]或ADHD评定量表[ADHD-RS]评分相对于基线的平均变化）。结果：在所有匹配人群的比较中，使用centanafadine或centanafadine和comparator之间的不良事件的风险在统计学上显着降低;不良事件发生率的最大差异包括上呼吸道感染（风险差异百分比：18.75），失眠（12.47）和口干（12.33）与lisdexamfetamine；食欲下降（20.25），头痛（18.53）和失眠（12.65）与哌醋甲酯；和恶心（26.18），口干（25.07）和疲劳（13.95）与托莫西汀（均p<0.05）。Centanafadine在AISRS/ADHD-RS评分中的降低幅度小于右氨非他明（6.15分差异；p<0.05），而AISRS评分与哌醋甲酯（1.75分差异；p=0.13）和与阿托西汀（1.60分差异；p=0.21）的变化无统计学意义。结论：在长达52周，centanafadine显示几种AE的发生率明显低于lisdexamfetamine，哌醋甲酯和托莫西汀；疗效低于右旋氨氟胺，与哌醋甲酯和托莫西汀无差异。
