Sultiame shows therapeutic potential in obstructive sleep apnoea

In patients with obstructive sleep apnoea (OSA), treatment with sultiame yields improvements in nocturnal hypoxia, sleep quality, and excessive daytime sleepiness, according to a phase II trial.

A total of 298 adults (74 percent female) with untreated, moderate-to-severe OSA and an Apnoea–Hypopnea Index (AHI) of ≥15 to ≤50 events/h participated in the trial. These patients were randomly assigned to receive treatment with sultiame at 100 (n=74), 200 (n=74), or 300 mg (n=75) or identical placebo (n=75). Treatment was administered once daily, at bedtime, for 15 weeks.

The primary outcome was the relative change in AHI3a (AHI with a ≥3-percent fall in oxyhaemoglobin saturation or an event-related arousal) from baseline to week 15.

A total of 240 patients completed 15 weeks of treatment. Compared with placebo, sultiame was associated with significant improvements in AHI3a at week 15, with the efficacy increasing with the dose (100 mg: adjusted means change, –16.4 percent, 95 percent confidence interval [CI], –31.3 to –1.4; p=0.032; 200 mg: –30.2 percent, 95 percent CI, –45.4 to –15.1; p<0.0001; 300 mg: 34.6 percent, 95 percent CI, –49.1 to –20.0; p<0.0001).

In terms of safety, the incidence of adverse events (AE) increased dose-dependently: 73 percent of patients in the 100-mg group, 84 percent in the 200 mg group, and 91 percent in the 300 mg group vs 61 percent in the placebo group. The most common AEs were paraesthesia, headache, COVID-19, and nasopharyngitis.