Therapy Proves Effective Against Placebo for Excessive Daytime Sleepiness, Narcolepsy

Data published in Pharmacological Research outlines the success of pitolisant, a novel histamine H3 receptor agonist, at improving excessive daytime sleepiness in patients with narcolepsy and/or obstructive sleep apnea (OSA).

A meta-analysis of randomized controlled trials in PubMed, Embase, and Cochrane library databases from earliest date through November 2020 were assessed. Primary outcomes were measured using changes in Epworth Sleepiness Scare, mean sleep latency, a European quality-of-life questionnaire, and a risk ratio of treatment-emergent adverse events.

The final cohort included 678 patients from the randomized controlled trials. The analysis concluded that pitolisant significantly decreased excessive daytime sleepiness with a “mean difference of -2.86 percentage points (95% CI: -3.75 to -1.96), increased mean sleep latency by MD of 3.14 min (95% CI: 2.18-4.11), and increased EQ-5D by MD of 3.32 points (95% CI: 0.26-6.39) compared with placebo.

The risk ratio was found to be 1.37 (95% CI: 1.08-1.74) and insomnia was the only treatment-emergent adverse event found to be associated with treatment.

“In conclusion, pitolisant showed great efficacy and controllable security versus placebo for excessive daytime sleepiness in narcolepsy and OSA,” explained researchers of the analysis. “Compared with narcolepsy, patients with OSA were deemed to benefit more from pitolisant especially in terms of improving mobility and quality of life of patients without continuous positive airway pressure therapy.”

Reference:
Wang J, Li X, Yang S, et al. Pitolisant versus placebo for excessive daytime sleepiness in narcolepsy and obstructive sleep apnea: A meta-analysis from randomized controlled trials. Pharmacol Res. 2021;167:105522. doi:10.1016/j.phrs.2021.105522