Pitolisant effectively reduces daytime sleepiness among patients of sleep apnea

A recent study published in the CHEST Journal unveiled promising long-term effects of Pitolisant in curbing excessive daytime sleepiness. Even in patients adhering to the standard continuous positive airway pressure (CPAP) therapy, daytime drowsiness can persist, posing a significant challenge to effective obstructive sleep apnea (OSA) management.

Initial outcomes of two 12-week randomized controlled trials (HAROSA 1 and HAROSA 2) demonstrated the efficacy of Pitolisant in reducing daytime sleepiness, with one trial focusing on CPAP-compliant patients and the other on those resistant or intolerant to CPAP. 

The subsequent open-label cohort study provided a resounding affirmative. Adults who participated in the initial trials underwent both Pitolisant and placebo arms and were offered Pitolisant for an additional 40 weeks (from week 13 onwards). The primary measure of success was the change in the Epworth Sleepiness Score (ESS) over the course of 52 weeks.

The results found the pooled mean difference in ESS from baseline to one year was -8.0 [-8.3, -7.5], indicating a significant reduction in daytime sleepiness. Importantly, this effect was consistent across patients using CPAP and those who were not.

In addition to its efficacy, the safety profile of Pitolisant over the year-long study was encouraging. The overall occurrence of treatment-emergent adverse events (TEAE) was 35.1%, with only 2.0% deemed serious. Special interest TEAE, including cardiovascular parameters, did not raise significant concerns.

This study suggests that Pitolisant not only tackles daytime sleepiness but does so sustainably over an extended period. Further exploration and validation are anticipated to solidify the role of Pitolisant in enhancing the quality of life for those navigating the challenges of OSA.

Source:

Pépin, J.-L., Attali, V., Caussé, C., Verbraecken, J., Hedner, J., Lecomte, I., Tamisier, R., Lévy, P., Lehert, P., & Dauvilliers, Y. (2023). Long-term efficacy and safety of pitolisant for residual sleepiness due to Obstructive Sleep Apnea. In CHEST. Elsevier BV. https://doi.org/10.1016/j.chest.2023.11.017