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首页> 外文期刊>European journal of neurology: the official journal of the European Federation of Neurological Societies >Success rate, efficacy, and safety/tolerability of overnight switching from immediate- to extended-release pramipexole in advanced Parkinson's disease
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Success rate, efficacy, and safety/tolerability of overnight switching from immediate- to extended-release pramipexole in advanced Parkinson's disease

机译：在晚期帕金森氏病中从夜间释放普拉克索转为从缓释普拉克索过夜的成功率，疗效和安全性/耐受性

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Background and purpose: For Parkinson's disease (PD), an extended-release (ER) pramipexole formulation taken once daily, has shown efficacy, safety, and tolerability resembling those of immediate-release (IR) pramipexole taken three times daily. The present study assessed, in advanced PD, the success of an overnight switch from adjunctive IR to ER. Methods: Levodopa users experiencing motor fluctuations were randomized to adjunctive double-blind (DB) placebo, IR, or ER. Amongst completers of ≥18 weeks, ER recipients were kept on DB ER, whilst IR recipients were switched overnight to DB ER at unchanged daily dosage. After a DB week, switch success was assessed. During the next 5 weeks, all patients underwent ER titration to optimal open-label maintenance dosage. Results: One week post-switch, 86.2% of 123 IR-to-ER and 83.8% of 105 ER-to-ER patients had ≤15% (or ≤3-point, for pre-switch scores ≤20) increase on UPDRS Parts II + III, and 77.9% (of 122) and 70.2% (of 104) had ≤1-h increase in daily OFF-time. At 32 weeks, the groups showed comparable improvements from DB baseline (pramipexole inception), including, on UPDRS II + III, adjusted mean (SE) changes of -14.8 (1.5) for IR-to-ER and -13.3 (1.6) for ER-to-ER. Rates of premature discontinuation owing to adverse events were 6.5% for IR-to-ER and 4.9% for ER-to-ER. Conclusions: By OFF-time and UPDRS criteria, majorities of patients with advanced PD were successfully switched overnight from pramipexole IR to ER at unchanged daily dosage. During subsequent maintenance, pramipexole showed sustained efficacy, safety, and tolerability, regardless of formulation (IR or ER) in the preceding DB trial.
机译：背景与目的：对于帕金森氏病（PD），每天服用一次的缓释（ER）普拉克索制剂已显示出类似于每日服用三次的速释（IR）普拉克索的功效，安全性和耐受性。本研究在晚期PD中评估了从辅助IR到ER的通宵转换的成功。方法：将左旋多巴使用者出现运动波动的情况随机分配至辅助双盲（DB）安慰剂，IR或ER。在≥18周的完成者中，ER接受者被保留在DB ER上，而IR接受者则以每日剂量不变的方式隔夜转入DB ER。在DB周之后，评估了切换成功。在接下来的5周内，所有患者均接受ER滴定至最佳开放标签维持剂量。结果：转换后一周，123​​名IR-to-ER患者中的86.2％和105名ER-er-ER患者中83.8％的UPDRS升高了≤15％（或≤3分，转换前分数≤20）第二部分和第三部分以及122个零件中的77.9％和104个零件中的70.2％的每日停机时间增加了≤1-h。在第32周时，这些组显示出相对于DB基线（普拉克索开始）的可比改善，包括在UPDRS II + III上，IR-to-ER的调整后平均（SE）更改为-14.8（1.5），而-13.3（1.6）调整后。 ER对ER。因不良事件而导致的过早停药率，IR-to-ER为6.5％，ER-to-ER为4.9％。结论：根据非工作时间和UPDRS标准，大多数晚期PD患者在不改变日剂量的情况下成功地从普拉克索IR改为ER过夜。在随后的维护期间，无论先前的DB试验中采用何种制剂（IR或ER），普拉克索均显示出持续的功效，安全性和耐受性。

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