Otsuka Pharmaceutical Development & Commercialization, Inc, Princeton, NJ, USA.
Analysis Group, Inc, Montréal, QC, Canada.
Curr Med Res Opin. 2024 Aug;40(8):1397-1406. doi: 10.1080/03007995.2024.2373883. Epub 2024 Jul 10.
To compare safety and efficacy of centanafadine versus methylphenidate hydrochloride extended release (ER; Concerta) in adults with ADHD.
Without head-to-head trials, anchored matching-adjusted indirect comparisons (MAIC) of adverse event rates reported across trials and mean change from baseline in Adult ADHD Investigator Symptom Rating Scale (AISRS) score between centanafadine and methylphenidate hydrochloride ER were conducted. Pooled patient-level data from two centanafadine trials (NCT03605680/NCT03605836) and aggregate data from one published methylphenidate hydrochloride ER trial (NCT00937040) were used. Characteristics of individual patients from the centanafadine trials were matched to aggregate baseline characteristics from the methylphenidate hydrochloride ER trial using propensity score weighting. A sensitivity analysis assessed the robustness of the results to the capping of extreme weights (i.e. >99 percentile).
Compared with methylphenidate hydrochloride ER, centanafadine was associated with significantly lower risk of dry mouth (risk difference [RD] in percentage points: -11.95), initial insomnia (-11.10), decreased appetite (-8.05), anxiety (-5.39), palpitations (-5.25), and feeling jittery (-4.73) though a significantly smaller reduction in AISRS score (4.16-point). In the sensitivity analysis, the safety results were consistent with the primary analysis but there was no significant difference in efficacy between centanafadine and methylphenidate hydrochloride ER.
In this MAIC, centanafadine had better safety and possibly lower efficacy than methylphenidate hydrochloride ER. While safety results were robust across analyses, there was no efficacy difference between centanafadine and methylphenidate hydrochloride ER in the sensitivity analysis. Considering its favorable safety profile, centanafadine may be preferred among patients for whom treatment-related adverse events are a concern.
比较塞坦那非与盐酸哌甲酯控释剂（Concerta）治疗成人注意力缺陷多动障碍（ADHD）的安全性和疗效。
由于没有头对头试验，因此进行了基于不良事件发生率的锚定匹配调整间接比较（MAIC），以及塞坦那非与盐酸哌甲酯控释剂之间成人 ADHD 研究者症状评定量表（AISRS）评分从基线的平均变化。使用来自两项塞坦那非试验（NCT03605680/NCT03605836）的汇总患者水平数据和一项已发表的盐酸哌甲酯控释剂试验（NCT00937040）的汇总数据。使用倾向评分加权法，将来自塞坦那非试验的个别患者特征与来自盐酸哌甲酯控释剂 ER 试验的汇总基线特征相匹配。敏感性分析评估了结果对极端权重上限（即 >99 百分位）的稳健性。
与盐酸哌甲酯控释剂相比，塞坦那非与口干（风险差异[RD]百分比：-11.95）、初始失眠（-11.10）、食欲下降（-8.05）、焦虑（-5.39）、心悸（-5.25）和感觉紧张不安（-4.73）的风险显著降低，而 AISRS 评分的降幅较小（4.16 分）。在敏感性分析中，安全性结果与主要分析一致，但塞坦那非与盐酸哌甲酯控释剂之间的疗效无显著差异。
在这项 MAIC 中，塞坦那非的安全性优于盐酸哌甲酯控释剂，且可能疗效较低。虽然在各种分析中安全性结果都很稳健，但在敏感性分析中，塞坦那非与盐酸哌甲酯控释剂之间的疗效没有差异。考虑到其良好的安全性，对于关注治疗相关不良事件的患者，塞坦那非可能是首选药物。
