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Title
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Long-term efficacy and safety of pitolisant for residual sleepiness due to OSA
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Author
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Abstract
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| Background In 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 Question Does the efficacy and safety of pitolisant persist when these patients take it long-term? Study Design and Methods All 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. Results Out 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. Interpretation Pitolisant 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). |
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Language
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English
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Source (journal)
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Chest / American College of Chest Physicians. - Chicago, Ill., 1970, currens
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Publication
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Chicago, Ill.
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2024
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ISSN
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0012-3692
[print]
1931-3543
[online]
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DOI
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10.1016/J.CHEST.2023.11.017
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Volume/pages
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165
:3
(2024)
, p. 692-703
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ISI
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001206585400001
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Pubmed ID
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37979718
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Full text (Publisher's DOI)
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Full text (open access)
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