The DOI matches its Crossref record; 32 of the 32 references it cites were found in a registry or an index.
Pitolisant for Daytime Sleepiness in Patients with Obstructive Sleep Apnea Who Refuse Continuous Positive Airway Pressure Treatment. A Randomized Trial
Open accessAbstract
Abstract Rationale Excessive daytime sleepiness is a common disabling symptom in obstructive sleep apnea syndrome. Objectives To evaluate the efficacy and safety of pitolisant, a selective histamine H3 receptor antagonist with wake-promoting effects, for the treatment of daytime sleepiness in patients with moderate to severe obstructive sleep apnea refusing continuous positive airway pressure treatment. Methods In an international, multicenter, double-blind, randomized (3:1), placebo-controlled, parallel-design trial, pitolisant was individually titrated at up to 20 mg/d over 12 weeks. The primary endpoint was the change in the Epworth Sleepiness Scale score. Key secondary endpoints were maintenance of wakefulness assessed on the basis of the Oxford Sleep Resistance test, safety, Clinical Global Impression of severity, patient’s global opinion, EuroQol quality-of-life questionnaire, and Pichot fatigue questionnaire. Measurements and Main Results A total of 268 patients with obstructive sleep apnea (75% male; mean age, 52 yr; apnea–hypopnea index, 49/h; baseline sleepiness score, 15.7) were randomized (200 to pitolisant and 68 to placebo) and analyzed on an intention-to-treat basis. The Epworth Sleepiness Scale score was reduced more with pitolisant than with placebo (−2.8; 95% confidence interval, −4.0 to −1.5; P < 0.001). Wake maintenance tests were not improved. The Pichot fatigue score was reduced with pitolisant. The overall impact of pitolisant was confirmed by both physicians’ and patients’ questionnaires. Adverse event incidence, mainly headache, insomnia, nausea, and vertigo, was similar in the pitolisant and placebo groups (29.5% and 25.4%, respectively), with no cardiovascular or other significant safety concerns. Conclusions Pitolisant significantly reduced self-reported daytime sleepiness and fatigue and improved patient-reported outcomes and physician disease severity assessment in sleepy patients with obstructive sleep apnea refusing or nonadherent to continuous positive airway pressure. Clinical trial registered with www.clinicaltrials.gov (NCT01072968) and EU Clinical Trials Register (EudraCT 2009-017251-94).
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Obstructive sleep apnoea syndrome
Lévy, P., Kohler, M., McNicholas, W. T., Barbé, F., McEvoy, R. D., Somers, V. K., Lavie, L., & Pépin, J.-L. (2015) · Nature Reviews Disease Primers · doi:10.1038/nrdp.2015.15 · Cited by 1,235
Self-citationTrends in CPAP adherence over twenty years of data collection: A flattened curve
Rotenberg, B. W., Murariu, D., & Pang, K. P. (2016) · Journal of Otolaryngology - Head & Neck Surgery · doi:10.1186/s40463-016-0156-0 · Cited by 742
Pitolisant versus placebo or modafinil in patients with narcolepsy: a double-blind, randomised trial
Dauvilliers, Y., Bassetti, C., Lammers, G. J., Arnulf, I., Mayer, G., Rodenbeck, A., Lehert, P., Ding, C.-L., Lecomte, J.-M., & Schwartz, J.-C. (2013) · The Lancet Neurology · doi:10.1016/s1474-4422(13)70225-4 · Cited by 362
Self-citationSzakacs, Z., Dauvilliers, Y., Mikhaylov, V., Poverennova, I., Krylov, S., Jankovic, S., Sonka, K., Lehert, P., Lecomte, I., Lecomte, J.-M., et al. (2017) · The Lancet Neurology · doi:10.1016/s1474-4422(16)30333-7 · Cited by 338
Self-citationSchweitzer, P. K., Rosenberg, R., Zammit, G. K., Gotfried, M., Chen, D., Carter, L. P., Wang, H., Lu, Y., Black, J., Malhotra, A., et al. (2019) · American Journal of Respiratory and Critical Care Medicine · doi:10.1164/rccm.201806-1100oc · Cited by 320
Sleep apnoea and the brain: a complex relationship
Rosenzweig, I., Glasser, M., Polsek, D., Leschziner, G. D., Williams, S. C. R., & Morrell, M. J. (2015) · The Lancet Respiratory Medicine · doi:10.1016/s2213-2600(15)00090-9 · Cited by 277
Hudgel, D. W., Patel, S. R., Ahasic, A. M., Bartlett, S. J., Bessesen, D. H., Coaker, M. A., Fiander, P. M., Grunstein, R. R., Gurubhagavatula, I., Kapur, V. K., et al. (2018) · American Journal of Respiratory and Critical Care Medicine · doi:10.1164/rccm.201807-1326st · Cited by 266
Hypertension and sleep: Overview of a tight relationship
Pepin, J.-L., Borel, A.-L., Tamisier, R., Baguet, J.-P., Levy, P., & Dauvilliers, Y. (2014) · Sleep Medicine Reviews · doi:10.1016/j.smrv.2014.03.003 · Cited by 245
Self-citationRanderath, W., Bassetti, C. L., Bonsignore, M. R., Farre, R., Ferini-Strambi, L., Grote, L., Hedner, J., Kohler, M., Martinez-Garcia, M.-A., Mihaicuta, S., et al. (2018) · European Respiratory Journal · doi:10.1183/13993003.02616-2017 · Cited by 245
Self-citationLong-term use of pitolisant to treat patients with narcolepsy: Harmony III Study
Dauvilliers, Y. A., Arnulf, I., Szakács, Z., Leu‐Semenescu, S., Lecomte, I., Scart‐Grès, C., Lecomte, J., Schwartz, J.-C., HARMONY III study group, Arnulf, I., et al. (2019) · SLEEP · doi:10.1093/sleep/zsz174 · Cited by 245
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Update on Persistent Excessive Daytime Sleepiness in OSA
Javaheri, S., & Javaheri, S. (2020) · Chest · doi:10.1016/j.chest.2020.02.036 · Cited by 122
European Respiratory Society statement on sleep apnoea, sleepiness and driving risk
Bonsignore, M. R., Randerath, W., Schiza, S., Verbraecken, J., Elliott, M. W., Riha, R., Barbe, F., Bouloukaki, I., Castrogiovanni, A., Deleanu, O., et al. (2021) · European Respiratory Journal · doi:10.1183/13993003.01272-2020 · Cited by 84
Self-citationFietze, I., Blum, H.-C., Grüger, H., Käßner, F., Maurer, J. T., Nilius, G., Penzel, T., Triché, D., & Arzt, M. (2021) · Somnologie · doi:10.1007/s11818-021-00305-9 · Cited by 7
Metadata
- Authors
- Dauvilliers, Y., Verbraecken, J., Partinen, M., Hedner, J., Saaresranta, T., Georgiev, O., Tiholov, R., Lecomte, I., Tamisier, R., Lévy, P., Scart-Gres, C., Lecomte, J.-M., Schwartz, J.-C., Pépin, J.-L., Attali, V., Bourgin, P., Gagnadoux, F., Baharloo, F., Berg, S., Polo, O., Hedner, J. A., Peker, Y., Blau, A., Borreguero, D. G., Puertas Cuesta, F. J., Belev, G., Ivanov, Y., Metev, H., Petkova, D., Dokic, D., Marku, M. I., Kaeva, B. J., Jankovic, S., Kopitovic, I., & Vukcevic, M.
- Venue
- American Journal of Respiratory and Critical Care Medicine
- Publisher
- Oxford University Press (OUP)
- Published
- 2020-05-01
- Volume
- 201
- Issue
- 9
- Pages
- 1135-1145
- ISSN
- 1073-449X (ISSN-L)
- 1535-4970
- OpenAlex
- W3000649099
- Cited by
- 268
- References
- 32
- FWCI
- 29.42
- Type
- journal article
- Language
- en
- Open access
- hybrid
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- Dauvilliers, Y., Verbraecken, J., Partinen, M., Hedner, J., Saaresranta, T., Georgiev, O., Tiholov, R., Lecomte, I., Tamisier, R., Lévy, P., Scart-Gres, C., Lecomte, J.-M., Schwartz, J.-C., Pépin, J.-L., Attali, V., Bourgin, P., Gagnadoux, F., Baharloo, F., Berg, S., . . . Vukcevic, M. (2020). Pitolisant for Daytime Sleepiness in Patients with Obstructive Sleep Apnea Who Refuse Continuous Positive Airway Pressure Treatment. A Randomized Trial. American Journal of Respiratory and Critical Care Medicine. https://doi.org/10.1164/rccm.201907-1284oc
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Contains information from the Semantic Scholar Academic Graph Datasets, made available under the ODC Attribution License (ODC-BY 1.0).
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