کد مقاله کد نشریه سال انتشار مقاله انگلیسی ترجمه فارسی نسخه تمام متن
5643758 1586476 2017 5 صفحه PDF سفارش دهید دانلود کنید
عنوان انگلیسی مقاله ISI
The European Medicines Agency review of pitolisant for treatment of narcolepsy: summary of the scientific assessment by the Committee for Medicinal Products for Human Use
ترجمه فارسی عنوان
ارزیابی آژانس های دارویی اروپا در مورد پیتولیزنت برای درمان نارکولپسی: خلاصه ای از ارزیابی علمی کمیته دارویی برای استفاده انسانی
موضوعات مرتبط
علوم زیستی و بیوفناوری علم عصب شناسی عصب شناسی
چکیده انگلیسی


- A marketing authorization was issued in the European Union (EU) for pitolisant for the treatment of narcolepsy.
- Pitolisant is a first-in-class drug acting on histamine H3 receptors.
- This article summarizes the scientific review leading to approval of pitolisant in the EU.

On 31 March 2016, the European Commission issued a decision for a marketing authorisation valid throughout the European Union (EU) for pitolisant (Wakix) for the treatment of narcolepsy with or without cataplexy in adults. Pitolisant is an antagonist/inverse agonist of the human histamine H3 receptor. The dose should be selected using an up-titration scheme depending on individual patient response and tolerance and should not exceed 36 mg/day.The main evidence of efficacy of pitolisant was based on two Phase III clinical trials. The improvement on excessive daytime sleepiness was shown against placebo in the Harmony I study (−3.33 points; 95% confidence interval (CI) [−5.83; −0.83]; p = 0.024) and in Harmony CTP (−3.41 points; 95% CI [−4.95; −1.87]; p < 0.0001). The daily cataplexy rate in Harmony I improved against placebo with a rate ratio (rR) of 0.38 whilst in the Harmony CTP the ratio of improvement on weekly cataplexy rate against placebo was 0.512. The most commonly reported adverse reactions were headache, insomnia and nausea. This article summarizes the scientific review leading to approval of pitolisant in the EU. The assessment report and product information are available on the European Medicines Agency website (http://www.ema.europa.eu).

ناشر
Database: Elsevier - ScienceDirect (ساینس دایرکت)
Journal: Sleep Medicine - Volume 33, May 2017, Pages 125-129
نویسندگان
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