This page was translated automatically from Turkish. Read the original

Bu sayfa, 26. Dünya Psikiyatri Kongresi'nde sunulan çalışmanın yapay zekâ desteğiyle hazırlanmış Türkçe özetidir. Çalışmanın sahibi sunan yazarlardır; atıf için orijinal kaynağa başvurun.

EV1268

Repeated dosing of 50 mg daridorexant in patients with severe obstructive sleep apnea: effects on sleep-disordered breathing and sleep

REPEATED DOSING OF 50 MG DARIDOREXANT IN PATIENTS WITH SEVERE OBSTRUCTIVE SLEEP APNEA: EFFECT ON SLEEP-DISORDERED BREATHING AND SLEEP

Daridorexant 50 mg administered for five nights in participants with severe obstructive sleep apnea had no clinically meaningful adverse effect on sleep-disordered breathing.

The aim was to investigate the effects of repeated oral doses of daridorexant, a dual orexin receptor antagonist, on overnight breathing and sleep in severe obstructive sleep apnea (OSA). This randomized, double-blind, placebo-controlled, two-period, crossover, single-center phase 1 study enrolled 16 participants with an apnea–hypopnea index (AHI) of 30 events/hour or greater, and 50 mg daridorexant was administered for five consecutive nights; individuals with insomnia symptoms and those using continuous positive airway pressure were excluded. A washout period of 1 to 2 weeks separated the two treatment periods; polysomnography (PSG), including oximetry, was recorded at screening, on Night 1 (first dose), and on Night 5 (last dose), and all endpoints were assessed using linear mixed-effects modeling. The thresholds for clinical significance were defined as an increase in AHI of more than 10 events/hour and a decrease in oxygen saturation (SpO2) of more than 2% over total sleep time (TST). Treatment differences (daridorexant minus placebo) were -3.74 events/hour for AHI (upper bound of the 95% confidence interval [CI]: 4.23) and -0.12% for SpO2 (lower bound of the 95% CI: -0.62%); neither exceeded the threshold for clinical significance. No treatment difference in AHI or SpO2 was observed during non-REM sleep; during REM sleep, AHI decreased by 8.2 events/hour compared with placebo (90% CI: -13.7 to -2.7). No treatment differences were found in the total number of apneas and hypopneas, the longest and mean duration of respiratory events, or the minimum and mean SpO2 values. In conclusion, daridorexant 50 mg did not worsen sleep-disordered breathing to a clinically meaningful extent in severe OSA, increased objectively measured total sleep time in participants without insomnia symptoms, and was safe and well tolerated.

Tüm WCP 2026 özetleri