A recent study found a new drug therapy as a promising treatment for obstructive sleep apnea (OSA) by offering an effective alternative for patients who do not tolerate conventional therapies such as continuous positive airway pressure (CPAP) or mandibular advancement devices (MAD). This study was presented in the American Thoracic Society 2024 International Conference found sulthiame (STM), a carbonic anhydrase inhibitor to demonstrate significant efficacy in reducing apneas during sleep.

This recent double-blind, randomized, placebo-controlled, multi-center dose-ranging study included a total of 298 patients with moderate-to-severe OSA to evaluate the impact of three different doses of STM when compared to a placebo. The participants comprised 26.2% females with a mean age of 56.1 years, a mean BMI of 29.1 and an average apnea-hypopnea index (AHI) of 29.0 were administered a daily evening dose of either 100mg, 200mg or 300mg of STM or a placebo. The study utilized polysomnography with recordings taken at baseline, after four weeks and after 15 weeks of treatment to assess the efficacy of the drug.

A relative change in AHI from baseline to week 15 was the primary endpoint, this revealed a dose-dependent reduction in AHI. At the 100mg dose, a 17.8% reduction was observed, while the 200mg and 300mg doses achieved reductions of 34.8% and 39.9%, respectively. Post-hoc analysis further confirmed a substantial placebo-adjusted dose-dependent reduction in AHI by highlighting the significant impact of STM on sleep-disordered breathing.

Also, STM treatment led to an improvement in overnight oxygen saturation, with a mean increase of 0.95% and 0.87% for the 200mg and 300mg doses, respectively. This improvement was statistically significant by indicating that STM effectively reduces hypoxia associated with OSA. The drug also improved sleep quality with a significant reduction in the Total Arousal Index and without adversely affecting sleep macrostructure.

For the patients undergoing excessive daytime sleepiness which was measured by the Epworth Sleepiness Scale (ESS), STM treatment provided marked benefits. Those with an ESS score of 11 or higher showed significant improvement when compared to the placebo group.

The frequency of adverse events (AEs) increased with dosage, but they were predominantly mild or moderate which included symptoms like intermittent paresthesia, headache, fatigue and nausea. Importantly, no cardiovascular safety issues were reported during the 15-week treatment period, underscoring the favorable tolerability profile of STM. Overall, the findings of this study illuminate the role STM drug therapy to treat moderate-to-severe OSA. With its ability to consistently reduce sleep-disordered breathing, improve sleep quality and oxygenation, and reduce daytime sleepiness, STM offers new options for efficient and well-tolerated treatment of OSA. 

Reference:

Hedner, J., Grote, L., Stenlof, K., Kuhn, K., Hansen, C., Voelp, A., & Randerath, W. J. (2024). Efficacy, Safety, and Tolerability of Three Doses of Sulthiame in Patients With Obstructive Sleep Apnea. A Randomized, Double-blind, Placebo Controlled, Dose-ranging Study (STM-042/K). In B14. LATE BREAKING ABSTRACTS: SCIENCE THAT WILL IMPACT CLINICAL CARE. American Thoracic Society 2024 International Conference, May 17-22, 2024 - San Diego, CA. American Thoracic Society. https://doi.org/10.1164/ajrccm-conference.2024.209.1_meetingabstracts.a2992



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