Zesiewicz Theresa A, Chriscoe Stephen, Jimenez Theresa, Upward James, Davy Maria, VanMeter Susan
University of South Florida, Tampa, FL, USA.
GlaxoSmithKline, Research Triangle Park, Raleigh-Durham, NC, USA.
Neurodegener Dis Manag. 2017 Feb;7(1):61-72. doi: 10.2217/nmt-2016-0038. Epub 2017 Jan 25.
This Phase IV, double-blind, randomized, parallel-group study characterized the dose-response and tolerability of fixed doses of ropinirole prolonged release (PR) in subjects with advanced Parkinson's disease.
PATIENTS & METHODS: Subjects receiving concomitant l-dopa received once-daily ropinirole PR 4, 8, 12, 16 or 24 mg, or placebo, up-titrated for 13 weeks, maintained for 4 weeks.
At maintenance period week 4, ropinirole PR significantly reduced total awake 'Off-time' (16 mg; p = 0.027); increased absolute awake time spent 'On' without troublesome dyskinesia from baseline versus placebo (8 mg; p = 0.036); improved Unified Parkinson's Disease Rating Scale motor scores versus placebo (all doses; p = 0.005-0.016). Incidence of adverse events was similar between treatment groups; no dose-related trends were observed.
Ropinirole PR (16 mg) reduced 'Off-time' with 8 mg the likely lowest maximally effective dose, and the safety profile was consistent with previous studies.
本IV期双盲随机平行组研究旨在确定晚期帕金森病患者中罗匹尼罗缓释片（PR）固定剂量的剂量反应和耐受性。
正在接受左旋多巴治疗的受试者每日一次服用4、8、12、16或24毫克罗匹尼罗PR或安慰剂，剂量递增13周，维持4周。
在维持期第4周，罗匹尼罗PR显著减少总清醒“关”期时间（16毫克；p = 0.027）；与安慰剂相比，从基线起增加了无严重异动症的绝对清醒“开”期时间（8毫克；p = 0.036）；与安慰剂相比，改善了统一帕金森病评定量表运动评分（所有剂量；p = 0.005 - 0.016）。各治疗组不良事件发生率相似；未观察到剂量相关趋势。
罗匹尼罗PR（16毫克）减少了“关”期时间，8毫克可能是最低最大有效剂量，且安全性与既往研究一致。
