两项 3 期临床试验中 6 至 12 岁儿童使用缓释/控释哌甲酯后情绪不稳定的事后分析。

A Post-Hoc Analysis of Emotional Lability With Delayed-Release/Extended-Release Methylphenidate in Children Aged 6 to 12 Years of Age Participating in Two Phase 3 Clinical Trials.

机构信息

UTHSC Center on Developmental Disabilities, Memphis, TN, USA.

Pediatrix Neurology and Epilepsy Research Center, Winter Park, FL, USA.

出版信息

J Atten Disord. 2024 Jun;28(8):1186-1197. doi: 10.1177/10870547241243155. Epub 2024 Apr 10.

OBJECTIVE

DR/ER-MPH (formerly HLD200) is an evening-dosed delayed-release and extended-release methylphenidate approved for the treatment of ADHD in patients ≥6 years. analyses of two pivotal Phase 3 trials: HLD200-107 (NCT02493777) and HLD200-108 (NCT02520388) evaluated emotional lability (EL) with DR/ER-MPH treatment.

METHODS

Differences in Conners Global Index-Parent (CGI-P) EL subscale scores and age- and gender-adjusted -scores over an open-label titration phase (HLD200-107) and between treatment and placebo groups at endpoint (HLD200-108) were evaluated.

RESULTS

In HLD200-107 ( = 117) mean CGI-P EL subscale scores improved from 5.3 to 1.3 ( < .0001) after 6 weeks; in HLD200-108 significant improvements were observed in the treatment group ( = 81) versus placebo ( = 80; 3.11 vs. 4.08; = .0053). -scores showed an improvement with DR/ER-MPH treatment in both trials. Few emotional adverse events (AEs) were reported.

CONCLUSION

DR/ER-MPH treatment resulted in statistically significant improvements in EL to the level of non-ADHD peers as contextualized by -scores.

目的

DR/ER-MPH（原名为 HLD200）是一种晚间给药的延迟释放和延长释放哌甲酯，适用于治疗 6 岁及以上的注意力缺陷多动障碍（ADHD）患者。两项关键的 3 期临床试验（HLD200-107[NCT02493777]和 HLD200-108[NCT02520388]）分析了 DR/ER-MPH 治疗的情绪不稳（EL）情况。

方法

通过 Conners 全球指数-家长版（CGI-P）EL 子量表评分和年龄及性别调整的评分，评估开放标签滴定阶段（HLD200-107）和终点时（HLD200-108）DR/ER-MPH 治疗与安慰剂组之间的差异。

结果

在 HLD200-107 试验（n=117）中，CGI-P EL 子量表评分从 6 周时的 5.3 分改善至 1.3 分（ < .0001）；在 HLD200-108 试验中，治疗组（n=81）与安慰剂组（n=80）相比，CGI-P 评分显著改善（3.11 分比 4.08 分； = .0053）。年龄及性别调整评分显示，DR/ER-MPH 治疗在两项试验中均有改善。报告的情绪不良事件（AE）较少。