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迟发性运动障碍中美金刚与苯海索治疗的间接比较。

Indirect treatment comparison of valbenazine and deutetrabenazine efficacy and safety in tardive dyskinesia.

机构信息

Novel Health Strategies, Columbia, MD 21044, USA.

Neurocrine Biosciences, Inc., San Diego, CA 92130, USA.

出版信息

J Comp Eff Res. 2019 Oct;8(13):1077-1088. doi: 10.2217/cer-2019-0059. Epub 2019 Aug 29.

Abstract

Utilize the Bucher indirect treatment comparison (ITC) method to compare valbenazine and deutetrabenazine efficacy using clinical trial data. Outcomes included mean change from baseline in Abnormal Involuntary Movement Scale (AIMS) total score, AIMS response (≥50% improvement), clinical global impression of change response (score ≤2) and safety outcomes. Data were pooled by trial and dose; outcomes were analyzed at multiple time points. ITC of AIMS score improvement significantly favored valbenazine 80 mg/day at 6 weeks versus deutetrabenazine 36 mg/day at 8 weeks, while valbenazine 40 mg/day was statistically similar to all doses of deutetrabenazine at all time points. No significant differences between drugs were found in AIMS and clinical global impression of change responses and safety outcomes. In this ITC of pooled trial data, valbenazine was generally favorable over deutetrabenazine, although dose titration and equivalency should be considered when interpreting results.

摘要

利用 Bucher 间接治疗比较(ITC)方法,利用临床试验数据比较 valbenazine 和 deutetrabenazine 的疗效。结果包括基线时异常不自主运动量表(AIMS)总分的平均变化、AIMS 反应(≥50%改善)、临床整体印象变化反应(评分≤2)和安全性结果。按试验和剂量进行数据合并;在多个时间点分析结果。6 周时 valbenazine 80mg/天与 8 周时 deutetrabenazine 36mg/天相比,AIMS 评分改善的 ITC 明显有利,而 valbenazine 40mg/天在所有时间点与 deutetrabenazine 的所有剂量均具有统计学相似性。在 AIMS 和临床整体印象变化反应以及安全性结果方面,两种药物之间未发现显著差异。在这项汇总试验数据的 ITC 中,valbenazine 总体上优于 deutetrabenazine,但在解释结果时应考虑剂量滴定和等效性。

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