centanafadine 与 lisdexamfetamine、哌甲酯和阿托西汀治疗成人注意缺陷多动障碍的匹配调整间接比较：长期安全性和疗效。
A matching-adjusted indirect comparison of centanafadine versus lisdexamfetamine, methylphenidate and atomoxetine in adults with attention-deficit/hyperactivity disorder: long-term safety and efficacy.
机构信息
Otsuka Pharmaceutical Development & Commercialization, Inc., 508 Carnegie Center, Princeton, NJ 08540, USA.
Analysis Group, Inc., 1190 avenue des Canadiens-de-Montréal, Tour Deloitte, Suite 1500, Montréal, QC, H3B 0G7, Canada.
出版信息
J Comp Eff Res. 2024 Sep;13(9):e240089. doi: 10.57264/cer-2024-0089. Epub 2024 Aug 12.
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). 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). 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). 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.
使用匹配调整间接比较（MAIC）比较 centanafadine 与 lisdexamfetamine 二甲磺酸盐（lisdexamfetamine）、盐酸哌甲酯（methylphenidate）和盐酸托莫西汀（atomoxetine）分别在成人注意力缺陷/多动障碍（ADHD）中的长期安全性和疗效结果。使用 centanafadine 试验（NCT03605849）的患者水平数据和已发表的 lisdexamfetamine 试验（NCT00337285）、methylphenidate 试验（NCT00326300）和 atomoxetine 试验（NCT00190736）的汇总数据。在每项比较中，使用倾向评分加权对患者特征进行匹配。研究结果评估长达 52 周，包括安全性（不良事件[AE]发生率）和疗效（成人 ADHD 研究者症状评定量表[AISRS]或 ADHD 评定量表[ADHD-RS]评分的基线变化均值）。在所有匹配人群的比较中，centanafadine 的 AE 风险均显著低于 lisdexamfetamine 或与对照药物无差异；AE 发生率差异最大的包括上呼吸道感染（风险差异百分比：18.75）、失眠（12.47）和口干（12.33）与 lisdexamfetamine 相比；食欲下降（20.25）、头痛（18.53）和失眠（12.65）与 methylphenidate 相比；恶心（26.18）、口干（25.07）和疲劳（13.95）与 atomoxetine 相比（均 p<0.05）。与 lisdexamfetamine 相比，centanafadine 对 AISRS/ADHD-RS 评分的降低幅度较小（差异为 6.15 分；p<0.05），与 methylphenidate 相比，AISRS 评分的变化无统计学意义（差异为 1.75 分；p=0.13），与 atomoxetine 相比（差异为 1.60 分；p=0.21）。在长达 52 周的时间内，centanafadine 与 lisdexamfetamine、methylphenidate 和 atomoxetine 相比，AE 发生率明显较低；疗效低于 lisdexamfetamine，与 methylphenidate 和 atomoxetine 无差异。
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