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首页> 外文期刊>European journal of neurology: the official journal of the European Federation of Neurological Societies >Long-term efficacy and safety of safinamide as add-on therapy in early Parkinson's disease
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Long-term efficacy and safety of safinamide as add-on therapy in early Parkinson's disease

机译：沙芬酰胺作为早期帕金森氏病附加疗法的长期疗效和安全性

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Background and purpose: Safinamide is an α-aminoamide with both dopaminergic and non-dopaminergic mechanisms of action in Phase III clinical development as a once-daily add-on to dopamine agonist (DA) therapy for early Parkinson's disease (PD). Methods: Study 017 was a 12-month, randomized, double-blind, placebo-controlled pre-planned extension study to the previously reported Study 015. Patients received safinamide 100 or 200 mg/day or placebo added to a single DA in early PD. The primary efficacy endpoint was the time from baseline (Study 015 randomization) to 'intervention', defined as increase in DA dose; addition of another DA, levodopa or other PD treatment; or discontinuation due to lack of efficacy. Safinamide groups were pooled for the primary efficacy endpoint analysis; post hoc analyses were performed on each separate dose group. Results: Of the 269 patients randomized in Study 015, 227 (84%) enrolled in Study 017 and 187/227 (82%) patients completed the extension study. Median time to intervention was 559 and 466 days in the pooled safinamide and placebo groups, respectively (log-rank test; P = 0.3342). In post hoc analyses, patients receiving safinamide 100 mg/day experienced a significantly lower rate of intervention compared with placebo (25% vs. 51%, respectively) and a delay in median time to intervention of 9 days (P < 0.05; 240- to 540-day analysis). Conclusions: The pooled data from the safinamide groups failed to reach statistical significance for the primary endpoint of median time from baseline to additional drug intervention. Post hoc analyses indicate that safinamide 100 mg/day may be effective as add-on treatment to DA in PD.
机译：背景和目的：沙芬酰胺是一种α-氨基酰胺，在III期临床开发中具有多巴胺能和非多巴胺能作用机制，作为帕金森氏病（PD）的每日一次多巴胺激动剂（DA）的每日补充。方法：研究017是一项为期12个月，随机，双盲，安慰剂对照的预先计划的扩展研究，该研究是对先前报道的研究015的研究。患者在早期PD中接受了100或200 mg /天的沙非胺或安慰剂加到单个DA中。主要疗效终点是从基线（研究015年随机化）到“干预”的时间，即定义为DA剂量的增加;增加另一种DA，左旋多巴或其他PD治疗;或由于缺乏疗效而停药。合并沙芬酰胺组以进行主要功效终点分析;对每个单独的剂量组进行事后分析。结果：在研究015中随机分配的269位患者中，有227位（84％）参与了研究017，187 / 227（82％）位患者完成了扩展研究。合并沙芬酰胺和安慰剂组的中位干预时间分别为559天和466天（对数秩检验; P = 0.3342）。在事后分析中，接受沙非酰胺100毫克/天的患者与安慰剂相比，干预率显着降低（分别为25％和51％），中位干预时间延迟了9天（P <0.05; 240-至540天分析）。结论：沙芬酰胺组的汇总数据对于从基线到其他药物干预的中位时间的主要终点未能达到统计学显着性。事后分析表明，沙丁胺100毫克/天可作为PD中DA的附加治疗有效。

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