講師資料
Talks：
Pitolisant efficacy in the treatment of EDS in different diseases in adults and in children
Name：
Dr. Christian Caussé, MD
Position：
Medical Affairs Director
Affiliation：
Bioprojet Pharma
Email：
Photo：
Research Interests：
Sleep disorders, narcolepsy, Obstructive Sleep Anea
Selected Publications：
1. Dauvilliers, Yves et al. “Safety and efficacy of pitolisant in children aged 6 years or older with narcolepsy with or without cataplexy: a double-blind, randomised, placebo-controlled trial.” The Lancet. Neurology vol. 22,4 (2023): 303-311. doi:10.1016/S1474-4422(23)00036-4
2. Pépin, Jean-Louis et al. “Long-Term Efficacy and Safety of Pitolisant for Residual Sleepiness Due to OSA.” Chest vol. 165,3 (2024): 692-703. doi:10.1016/j.chest.2023.11.017
3. Craig, Sonya et al. “Investigation and management of residual sleepiness in CPAP-treated patients with obstructive sleep apnoea: the European view.” European respiratory review : an official journal of the European Respiratory Society vol. 31,164 210230. 25 May. 2022, doi:10.1183/16000617.0230-2021
Abstract：
Pitolisant data of efficacy and safety were evaluated to treat sleepiness, cataplexy and fatigue in patients suffering from different diseases. The potent and significant results allowed the first marketing approvals for Wakix which were obtained in Europe (EMA), in the USA (FDA), in Canada, in Taiwan and many other countries for the narcolepsy in Adults and in Children with 3 pivotal clinical studies and 1 long term study. Pitolisant and sodium oxybate are the only two drugs approved in children with narcolepsy by different health authorities such as the EMA and the FDA. Then 3 pivotal studies with pitolisant allowed the EMA authorization for the treatment of adult sleepy OSA patients treated or not with CPAP. Other developments of pitolisant showing encouraging results are on going to treat sleepiness in children with suffer from Prader-Willi syndrome or Steinert disease (DM1), and Idiopathic Hypersomnia in adults. The choice of a drug and in particular a Wake Promoting Agent depends on the health authorities marketing approval based on the Benefit-Risk evaluation of that drug and depends on the profile of the patient and could depend on Experts guidelines. That is why the Benefit-Risk is evaluated by the health Authorities and is useful for the physicians in order to propose a first prescription as shown in 2 NetworkMetaAnalysis. 
2025年會：