Department of Pharmacy, Louis Stokes Cleveland Veterans Affairs Medical Center, OH, USA.
Ann Pharmacother. 2012 Jul-Aug;46(7-8):1010-5. doi: 10.1345/aph.1Q714. Epub 2012 Jul 3.
To review the pharmacology, pharmacokinetics, efficacy, and safety of dalfampridine.
A search of PubMed (1966-March 2012) was conducted using the words dalfampridine and Ampyra. Bibliographies of retrieved articles were reviewed to identify additional references.
All identified studies published in English involving the efficacy and safety of dalfampridine were reviewed.
Dalfampridine (Ampyra) is a broad-spectrum potassium channel blocker that is indicated as a treatment to improve walking in patients with multiple sclerosis (MS). Dalfampridine is the only medication approved for this indication. Efficacy has been demonstrated in 2 Phase 3 trials involving patients with MS. Dalfampridine 10 mg twice daily improved walking, as shown by a higher proportion of timed walk responders in the dalfampridine-treated group (42.9% and 35%) versus the placebo-treated group (9.3% and 8%) during the 2 studies (p < 0.001). The maximum recommended dose of dalfampridine is 10 mg twice daily; higher doses are associated with an increased risk of seizures. At doses greater than 10 mg twice daily, the frequency of other adverse reactions and discontinuations was greater and showed no additional benefit. The average wholesale price of a 10-mg dalfampridine tablet is $21.12, which would make a 1-month supply of therapy cost $1267.20.
In clinical trials, dalfampridine improved walking speed in approximately one third of patients with MS. The risk of seizures appears to be dose-related and the incidence is low at doses of 10 mg twice daily. Because of the cost, dalfampridine should be reserved for patients who meet criteria for the drug and continued only if they have an adequate response.
综述地夫可特的药理学、药代动力学、疗效和安全性。
使用地夫可特和安必能这两个词对 PubMed(1966 年-2012 年 3 月)进行了检索。检索文章的参考文献进行了回顾,以确定其他参考文献。
对所有已发表的英文研究进行了综述,这些研究涉及地夫可特的疗效和安全性。
地夫可特(安必能)是一种广谱钾通道阻滞剂,被批准用于改善多发性硬化症(MS)患者的步行能力。地夫可特是唯一批准用于该适应症的药物。在两项涉及 MS 患者的 3 期临床试验中证明了其疗效。地夫可特 10mg,每日两次治疗组的定时行走应答者比例(42.9%和 35%)明显高于安慰剂治疗组(9.3%和 8%)(p < 0.001),表明地夫可特改善了行走能力。地夫可特的最大推荐剂量为每日两次 10mg;更高的剂量与癫痫发作风险增加相关。每日两次超过 10mg 的剂量,其他不良反应和停药的频率更高,并且没有额外的益处。一片 10mg 地夫可特的平均批发价格为 21.12 美元,这意味着一个月的治疗费用为 1267.20 美元。
在临床试验中,地夫可特使大约三分之一的 MS 患者的步行速度提高。癫痫发作的风险似乎与剂量有关,每日两次 10mg 的剂量发生率较低。由于成本原因,地夫可特应保留给符合药物标准的患者,并且只有在他们有足够的反应时才继续使用。