Safety and efficacy of istradefylline in Parkinson's disease patients with and without pre-existing dyskinesia: Pooled analysis of 8 randomized controlled trials.

IF 2.5 4区医学 Q2 CLINICAL NEUROLOGY

Journal of Movement Disorders Pub Date : 2025-04-25 DOI:10.14802/jmd.25047

Nobutaka Hattori, Lawrence Elmer, Stuart H Isaacson, Rajesh Pahwa, Olivier Rascol, Kapil Sethi, Fabrizio Stocchi, Yu Nakajima, Hannah Cummings, Lia Kostiuk

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Abstract

Objectives: Evaluate the efficacy of istradefylline in people with Parkinson's disease with motor fluctuations, with and without dyskinesia, and characterize potential predictors for treatment-emergent dyskinesia with istradefylline.

Methods: Pooled analysis of 8 phase 2b/3 trials of istradefylline (20 or 40mg/day) versus placebo.

Results: Data from 2719 patients, including 56% with baseline dyskinesia, were analyzed post-hoc. The presence of baseline dyskinesia did not affect mean reductions in OFF-time, increases in ON-time without troublesome dyskinesia, or improvements in Unified Parkinson's Disease Rating Scale motor scores associated with istradefylline treatment. Dyskinesia was reported by 17% of istradefylline-treated patients, with higher rates for women (21%), patients with BMI <18.5 kg/m2 (22%), and patients treated with COMT inhibitors plus dopamine agonists (22%) and MAO-B inhibitors (25%).

Conclusion: Istradefylline treatment resulted in greater reductions in total OFF hours/day and increases in ON-time without troublesome dyskinesia versus placebo regardless of the presence or absence of pre-existing dyskinesia.

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司地替林治疗帕金森病患者的安全性和有效性：8项随机对照试验的汇总分析

目的：评估iststradefylline对伴有运动波动、伴有和不伴有运动障碍的帕金森病患者的疗效，并描述iststradefylline治疗后出现的运动障碍的潜在预测因素。方法：对8项2b/3期试验进行汇总分析，将isstradefylline（20或40mg/天）与安慰剂进行比较。结果：对2719例患者的数据进行事后分析，其中56%为基线运动障碍患者。基线运动障碍的存在不影响OFF-time的平均减少，无麻烦的运动障碍的ON-time的增加，或统一帕金森病评定量表运动评分的改善，与司他替林治疗相关。在接受司特defylline治疗的患者中，有17%的患者报告出现运动障碍，其中女性患者的比例更高（21%）。结论：与安慰剂相比，司特defylline治疗导致无运动障碍的总OFF小时/天的减少和on时间的增加，无论是否存在先前存在的运动障碍。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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