Dalfampridine Extended Release In Multiple Sclerosis
Dalfampridine Extended Release In Multiple Sclerosis
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DOI：
10.2165/11205910-000000000-00000
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发表时间：
2010-01-01
期刊：
影响因子：
6
通讯作者：
Keating, Gillian M.
中科院分区：
文献类型：
--
作者：
Chwieduk, Claudine M.;Keating, Gillian M.
达法普定缓释剂是一种口服达福普定(法普利丁，4-氨基吡啶)，一种钾通道拮抗剂，可改善多发性硬化症(MS)患者的步行能力。在三项为期15周的随机双盲试验中，口服达法普林ER改善多发性硬化症患者的步行能力。在一项II期试验中，每日两次服用达法普利定10、15或20毫克的定时25英尺步行(T25FW)试验(主要终点)的步行速度改善百分比与基线或安慰剂相比没有显著改善。然而，根据一项事后分析，服用达福普利定ER的有效率显著高于安慰剂，在双盲治疗期间，达福普利丁ER应答者的合并结果显示步行速度持续平均改善25%-29%。在两个III期试验中，每日两次服用10毫克达福普林ER的计时行走应答者(主要终点)的比例显著高于安慰剂组，两个III期试验的非对比扩展的中间结果表明，在接受达福普林ER治疗的长达2.5年的时间里，行走速度的持续改善保持在基线以上。根据三项随机、双盲、安慰剂对照试验的结果，多发性硬化症患者通常对每天两次口服达福普林ER 10毫克的耐受性良好。
Dalfampridine extended release (ER) is an orally administered formulation of dalfampridine (fampridine, 4-aminopyridine), a potassium channel antagonist indicated for the improvement in walking ability in patients with multiple sclerosis (MS).Oral dalfampridine ER improved walking ability in patients with MS in three randomized, double-blind trials of up to 15 weeks' duration.In a phase II trial, percentage improvements in walking speed on the Timed 25-Foot Walk (T25FW) test (primary endpoint) were not significant versus baseline or placebo during treatment with dalfampridine ER 10, 15 or 20 mg twice daily. However, according to a post hoc analysis, response rates were significantly higher with dalfampridine ER than placebo, with a consistent mean improvement in walking speed of 25-29% seen in the pooled results from dalfampridine ER responders during the double-blind treatment period.In two phase III trials, the proportion of timed walk responders (primary endpoint) was significantly greater with dalfampridine ER 10 mg twice daily than with placebo, with improvements in walking speed of approximately 25% seen during dalfampridine ER treatment amongst timed walk responders.Interim results of noncomparative extensions of the two phase III trials showed that consistent improvements in walking speed were sustained above baseline for up to 2.5 years of dalfampridine ER treatment.Oral dalfampridine ER 10 mg twice daily was generally well tolerated in patients with MS, according to the results of the three randomized, double-blind, placebo-controlled trials.