• Chest · Mar 2024

    Long-term efficacy and safety of pitolisant for residual sleepiness due to Obstructive Sleep Apnea.

    • Jean-Louis Pépin, Valérie Attali, Christian Caussé, Johan Verbraecken, Jan Hedner, Isabelle Lecomte, Renaud Tamisier, Patrick Lévy, Philippe Lehert, and Yves Dauvilliers.
    • HP2 Laboratory, INSERM U1300, University Grenoble Alpes, Grenoble, France; EFCR (Cardiovascular and Respiratory Function) Laboratory, Grenoble Alpes University Hospital, Grenoble, France. Electronic address: JPepin@chu-grenoble.fr.
    • Chest. 2024 Mar 1; 165 (3): 692703692-703.

    BackgroundIn people with OSA, excessive daytime sleepiness is a prominent symptom and can persist despite adherence to CPAP, the first-line therapy for OSA. Pitolisant was effective in reducing daytime sleepiness in two 12-week randomized controlled trials (RCTs), one in patients adherent to CPAP (BF2.649 in Patients With OSA and Treated by CPAP But Still Complaining of EDS [HAROSA 1]) and the other in patients refusing or not tolerating CPAP (BF2.649 in Patients With OSA, Still Complaining of EDS and Refusing to be Treated by CPAP [HAROSA 2]).Research QuestionDoes the efficacy and safety of pitolisant persist when these patients take it long-term?Study Design And MethodsAll adults included in the HAROSA 1 and HAROSA 2 RCTs (both pitolisant and placebo arms) were offered pitolisant (up to 20 mg/d) after completion of the short-term double-anonymized phase (ie, from week 13) in an open-label cohort study. The primary efficacy outcome was the change in Epworth Sleepiness Scale score between baseline and week 52. Safety outcomes were treatment-emergent adverse event(s) (TEAE[s]), serious TEAEs, and special interest TEAEs.ResultsOut of 512 adults included in the two RCTs, 376 completed the 1-year follow-up. The pooled mean difference in Epworth Sleepiness Scale score from baseline to 1 year for the intention-to-treat sample was -8.0 (95% CI, -8.3 to -7.5). The overall proportions of TEAEs, serious TEAEs, and TEAEs of special interest were 35.1%, 2.0%, and 11.1%, respectively, without any significant difference between patients in the initial pitolisant and placebo arms. No cardiovascular safety issues were reported.InterpretationPitolisant is effective in reducing daytime sleepiness over 1 year in adults with OSA, with or without CPAP treatment. Taken for 1 year, it has a good safety profile (including cardiovascular).Trial RegistrationClinicalTrials.gov; Nos.: NCT01071876 and NCT01072968; URL: www.Clinicaltrialsgov.Copyright © 2023 The Author(s). Published by Elsevier Inc. All rights reserved.

      Pubmed     Copy Citation     Plaintext  

      Add institutional full text...

    Notes

     
    Knowledge, pearl, summary or comment to share?
    300 characters remaining
    help        
    You can also include formatting, links, images and footnotes in your notes
    • Simple formatting can be added to notes, such as *italics*, _underline_ or **bold**.
    • Superscript can be denoted by <sup>text</sup> and subscript <sub>text</sub>.
    • Numbered or bulleted lists can be created using either numbered lines 1. 2. 3., hyphens - or asterisks *.
    • Links can be included with: [my link to pubmed](http://pubmed.com)
    • Images can be included with: ![alt text](https://bestmedicaljournal.com/study_graph.jpg "Image Title Text")
    • For footnotes use [^1](This is a footnote.) inline.
    • Or use an inline reference [^1] to refer to a longer footnote elseweher in the document [^1]: This is a long footnote..

    hide…