![]() ![]() 11 In addition, recent findings have established an increased number of histaminergic neurons in NT1, suggesting involvement of the histamine system as a compensatory mechanism to orexin deficit. ![]() 8– 10 The autoimmune hypothesis is supported by the large association of NT1 with human leukocyte antigen marker DQB1*0602. ![]() 6, 7 The pathophysiology of the selective and substantial loss of orexinergic neurons is still unclear, although inflammatory/autoimmune processes seem to be highly involved. NT1 is characterized by cataplexy and cerebro-spinal fluid (CSF) orexin deficiency due to loss of orexinergic neurons in the lateral hypothalamus. ![]() The International Classification of Sleep Disorders third edition 5 defines narcolepsy type 1 (NT1) and type 2 (NT2). 1 Disease onset may occur at any age, although adolescents and young adults are mainly affected. This condition affects 0.026%–0.05% of the general population in North America and Europe. Narcolepsy is a rare sleep disorder characterized by excessive daytime sleepiness (EDS) and abnormal rapid eye movement (REM) sleep manifestations (ie, cataplectic attacks, sleep paralysis, hypnagogic, and hypnopompic hallucinations). Further long-term randomized controlled trials comparing the efficacy of pitolisant with active comparators (ie, modafinil and sodium oxybate) may clarify its real place in therapy and its possible use as a first-line agent on the basis of its safety and tolerability. Headache, insomnia, and nausea were the prominent side effects. In addition, pitolisant revealed a safe profile when compared with placebo and active comparators. Our review confirmed the effectiveness of pitolisant in treating major clinically relevant narcolepsy symptoms, including cataplexy, as compared to placebo. One proof-of-concept study followed by two pivotal studies, three randomized controlled trials, and two open studies were evaluated. The development program of pitolisant was characterized by eight Phase II/III studies. We report on the efficacy and safety data of pitolisant in narcoleptic patients regarding cataplexy episodes and subjective and objective daytime sleepiness. We performed a systematic review of the literature using PubMed, Embase, and Google Scholar. This article reviews the pharmacokinetic and pharmacodynamic profile of pitolisant, highlighting its effectiveness and safety in patients with narcolepsy. Pitolisant is a first-in-class new drug currently authorized by the European Medicines Agency to treat narcolepsy with or without cataplexy in adults and with an expanded evaluation for the treatment of neurologic diseases such as Parkinson’s disease and epilepsy. Currently, the diagnosis delay ranges from 8 to 10 years and drug therapy may only attenuate symptoms. Disease onset may occur at any age, although adolescents and young adults are mainly affected. 2015 7:81-83.Narcolepsy is a rare sleep disorder characterized by excessive daytime sleepiness and rapid eye movement sleep dysregulation, manifesting as cataplexy and sleep paralysis, as well as hypnagogic and hypnopompic hallucinations. Baclofen for narcolepsy with cataplexy: two cases. The distinguishing motor features of cataplexy: a study from video-recorded attacks. Clinical features, diagnosis and treatment of narcolepsy. Life effects of narcolepsy in 180 patients from North America, Asia and Europe compared to matched controls. Broughton R, Ghanem Q, Hishikawa Y, et al.The clinical features of cataplexy: a questionnaire study in narcolepsy patients with and without hypocretin-1 deficiency. Overeem S, van Nues S, van der Zande WL, Donjacour CE, van Mierlo P, Lammers GJ.Cataplexy-clinical aspects, pathophysiology and management strategy. Dauvilliers Y, Siegel JM, Lopez R, Torontali ZA, Peever JH.Listening to the patient voice in narcolepsy: diagnostic delay, disease burden, and treatment efficacy. Maski K, Steinhart E, Williams D, et al.The clinical spectrum of narcolepsy with cataplexy: a reappraisal. Reducing the clinical and socioeconomic burden of narcolepsy by earlier diagnosis and effective treatment. Validation of a cataplexy questionnaire in 983 sleep-disorders patients. Anic-Labat S, Guilleminault C, Kraemer HC, Meehan J, Arrigoni J, Mignot E.Narcolepsy: Pathophysiology, Diagnosis, and Treatment. In: Baumann CR, Bassetti CL, Scammell TE, eds. Darien, IL: American Academy of Sleep Medicine 2014. International Classification of Sleep Disorders. ![]()
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