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Vienna, Austria – September 10, 2024 – A new study presented at the European Respiratory Society (ERS) Congress reveals that sulthiame, a drug traditionally used for epilepsy, may offer a promising treatment for obstructive sleep apnea (OSA). The findings suggest significant improvements in symptoms and blood oxygen levels among patients with OSA who were treated with sulthiame.

Obstructive sleep apnea, characterized by loud snoring, interrupted breathing during sleep, and frequent awakenings, poses risks beyond mere tiredness. The condition is linked to increased risks of high blood pressure, stroke, heart disease, and type 2 diabetes. Despite its prevalence, many affected individuals remain undiagnosed.

Professor Jan Hedner of Sahlgrenska University Hospital and the University of Gothenburg in Sweden presented the trial results, highlighting the potential of sulthiame as an alternative to the conventional treatment, continuous positive airway pressure (CPAP) machines. CPAP, though effective, is often poorly tolerated by patients, underscoring the need for alternative therapies.

The study, a double-blind, randomized, placebo-controlled trial—the gold standard in clinical research—enrolled 298 patients with OSA from 28 centers across Spain, France, Belgium, Germany, and the Czech Republic. Participants were either unable to tolerate or refused CPAP or oral appliances.

Patients were divided into four groups: those receiving 100 mg, 200 mg, and 300 mg doses of sulthiame daily, and a placebo group. Polysomnography, a comprehensive sleep study, was used to assess patients’ sleep patterns, breathing, and blood oxygen levels at the start, four weeks, and twelve weeks into the trial.

Results demonstrated that sulthiame reduced the frequency of breathing pauses and improved blood oxygen levels. Specifically, the number of respiratory pauses, measured by the Apnea-Hypopnea Index (AHI), decreased by 17.8% in the lowest dose group, 34.8% in the medium dose group, and 39.9% in the highest dose group. Another measure, AHI4, showed a near 50% reduction in respiratory pauses with more significant improvements in oxygen levels.

Patients reported less daytime sleepiness while on sulthiame. Side effects were generally mild to moderate, including pins and needles, headache, fatigue, and nausea.

Professor Hedner remarked, “The promising results suggest that sulthiame could serve as an effective treatment for OSA, particularly for patients who struggle with current mechanical treatments. However, further research, including a phase III trial, is needed to confirm these findings and evaluate long-term effects.”

Professor Sophia Schiza, Head of the ERS assembly on sleep disordered breathing and Professor of Respiratory and Sleep Medicine at the University of Crete, Greece, noted, “This study is one of the first to explore drug treatment for OSA and presents promising results. Further research is crucial to determine the long-term benefits and potential side effects, including the impact on blood pressure and cardiovascular health.”

For more details, refer to the abstract no: OA5433, presented during the session “Emerging Insights in Prognostic Aspects and Positive Airway Pressure Treatment for Obstructive Sleep Apnoea” at the ERS Congress.

[More information available here](k4.ersnet.org/prod/v2/Front/Pr … ?e=549&session=17922).

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