Pitolisant与安慰剂或莫达非尼嗜睡症患者:一项双盲,随机试验。

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Dauvilliers Y, Bassetti C,拉默斯GJ,阿努尔夫我,梅耶尔G, Rodenbeck, Lehert P,丁CL, Lecomte JM,施瓦茨JC

Pitolisant与安慰剂或莫达非尼嗜睡症患者:一项双盲,随机试验。

柳叶刀神经。2013年11月,12 (11):1068 - 75。doi: 10.1016 / s1474 - 4422 (13) 70225 - 4。Epub 2013 10月7。

PubMed ID

24107292 (在PubMed

]

文摘

背景:嗜睡症的特点是日间极度嗜睡(EDS)和猝倒。组胺神经元保持清醒至关重要。我们评估的安全性和有效性pitolisant(以前称为BF2.649),选择性逆组胺H3受体受体激动剂激活这些神经元,嗜睡症患者。与这些相应平行的组织方法:双盲,随机,对照试验,我们从32招募了嗜睡症患者睡眠障碍中心5个欧洲国家。病人有资格如果他们18岁或以上,没有了精神兴奋药至少14天,并EDS(定义为埃普沃思嗜睡量表(ESS)得分至少14)。使用一个计算机生成的随机序列,我们随机分配病人接受pitolisant,莫达非尼,或安慰剂(比)。治疗持续8周:3周的灵活剂量根据研究者的判断(10 mg, 20 mg,或者pitolisant每天40毫克;100毫克,每天200毫克到400毫克的莫达非尼)其次是5周的稳定的剂量。病人花了四片一天double-dummy设计确保屏蔽。主要分析,评估在意向处理人口,我们评估pitolisant与安慰剂的优越性,pitolisant与莫达非尼的non-inferiority。 This trial is registered with ClinicalTrials.gov, number NCT01067222. FINDINGS: Between May 26, 2009, and June 30, 2010, we screened 110 patients, 95 of whom were eligible and randomly assigned to treatment: 30 to placebo, 32 to pitolisant, and 33 to modafinil. Over the 8-week treatment period, mean ESS score reductions were -3.4 (SD 4.2) in the placebo group, -5.8 (6.2) in the pitolisant group, and -6.9 (6.2) in the modafinil group. Our primary analysis of between-group differences in mean ESS score at endpoint (adjusted for baseline) showed pitolisant to be superior to placebo (difference -3.0, 95% CI -5.6 to -0.4; p=0.024), but not non-inferior to modafinil (difference 0.12, 95% CI -2.5 to 2.7; p=0.250). We recorded 22 adverse events with pitolisant, 26 with modafinil, and ten with placebo. Six severe adverse events were treatment-related: one with pitolisant (abdominal discomfort) and five with modafinil (abdominal pain, abnormal behaviour, amphetamine-like withdrawal symptoms, lymphoadenopathy, and inner ear disorders). INTERPRETATION: Pitolisant at doses up to 40 mg was efficacious on EDS compared with placebo and well tolerated compared with modafinil. If these findings are substantiated in further studies, pitolisant could offer a new treatment option for patients with narcolepsy. FUNDING: Bioprojet, France.

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药物

Pitolisant