1, 4 Narcolepsy is also associated with low levels of CSF histamine, a wake-promoting amine. 4 Narcolepsy without cataplexy, or type 2 narcolepsy, is associated with normal levels of orexin A in CSF, and this diagnosis is made only when type 1 narcolepsy is ruled out. 3 Pathophysiologically, narcolepsy with cataplexy is associated with loss of orexin-producing neurons with low or undetectable orexin A levels in cerebrospinal fluid (CSF) and is labeled as type 1 narcolepsy. 1 Due to these symptoms, the quality of life of narcoleptic individuals is lower than that of the general population. Other signs of narcolepsy are hypnagogic hallucinations and sleep paralysis. 1 Additionally, affecting 60–70% of narcoleptic individuals, 2 narcolepsy can occur with cataplexy or a sudden loss of muscle tone that is triggered by positive or negative emotions. Narcolepsy, which affects 0.03–0.05% of individuals in North America and Europe, is a neurological disease characterized by excessive daytime sleepiness (EDS). ![]() These four trials show that pitolisant is an effective drug to treat EDS and cataplexy in narcolepsy. This review focuses on the outcomes of four clinical trials of pitolisant to treat narcolepsy. Nonrandomized and randomized studies were included. A comprehensive search of online databases (eg, Medline, PubMed, EMBASE, the Cochrane Library Database, Ovid MEDLINE, Europe PubMed Central, EBSCOhost CINAHL, ProQuest Research Library, Google Scholar, and ) was performed. Pitolisant has been studied in animal models of narcolepsy and used in clinical trials as a treatment for narcolepsy. The small molecule drug, pitolisant, acts as an inverse agonist/antagonist at the H 3 receptor, thus increasing histaminergic tone in the wake promoting system of the brain. A greater diversity of drug options is needed to treat narcolepsy. These drugs have abuse, tolerability, and adherence issues. Currently used drugs treat EDS alone (modafinil/armodafinil, methylphenidate, and amphetamine), cataplexy alone (“off-label” use of antidepressants), or both EDS and cataplexy (sodium oxybate). Narcolepsy decreases the quality of life of the afflicted individuals. ![]() In 60–70% of individuals with narcolepsy, it is also characterized by cataplexy or a sudden loss of muscle tone that is triggered by positive or negative emotions. Narcolepsy is a neurological disease that affects 1 in 2,000 individuals and is characterized by excessive daytime sleepiness (EDS).
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