Anti-epileptic drug shows promise in reducing symptoms of obstructive sleep apnea

The epilepsy drug sulthiame, sold in Europe under the brand name Ospolot, appears to be effective in reducing the symptoms of obstructive sleep apnoea (OSA). Current Clinical Trials Announced European Respiratory Society (ERS) Congress 2024.¹

Patients taking carbonic anhydrase inhibitors experienced fewer breathing interruptions during sleep and improved oxygen levels. The apnea-hypopnea index (AHI3a), which tracks the frequency of breathing stops, decreased by 17.8% in patients taking the lowest dose (100 mg), 34.8% in those taking the medium dose (200 mg), and 39.9% in those taking the highest dose (300 mg). When using the AHI4 index, when oxygen levels are more severely affected, breathing stops decreased by almost 50%. Patients also reported less daytime sleepiness while taking the drug.

These findings are based on a double-blind, randomized, placebo-controlled trial, presented at the ERS meeting by Jan Hedner, MD, professor of respiratory medicine at Sahlgrenska University Hospital and University of Gothenburg in Sweden and lead author of the study.²

The study included 298 OSA patients who were being treated at 28 different centers in Spain, France, Belgium, Germany and the Czech Republic. All patients reported being unable to tolerate or refusing to use continuous positive airway pressure (CPAP) machines or mouthpieces to keep their airways open. Instead, sulthiame is taken as an oral tablet and works by stimulating the muscles in the upper airway.

“The standard treatment for obstructive sleep apnea is to sleep with a machine that delivers air through a face mask to open the airways,” Hedner explains. “Unfortunately, many people find it difficult to use these machines long-term, so alternative treatments need to be found. We also need a better understanding of the underlying mechanisms of OSA to help clinicians provide more individualized treatment.”

New study gives hope to OSA patients who can't tolerate CPAP machines | Image credit: sbw19 – stock.adobe.com

Participants were split into four groups: 74 patients took the lowest dose of 100mg sulthiame per day, 74 took 200mg per day, 75 took 300mg per day, and 75 took placebo tablets. Patients underwent polysomnography (which records breathing patterns, blood oxygen levels, heart rhythm, eye movements, and brain and muscle activity while sleeping) at the start of the study and after four and 12 weeks of treatment.

Side effects from epilepsy medications included paresthesia or tingling, headache, fatigue, and nausea, but these symptoms were generally mild or moderate.

For Americans, it's important to note that sulthiame is not approved in the U.S., but it has shown promise as an alternative treatment for sleep disorders. As Hedner said, sulthiame may also reduce the need for CPAP machines. American Journal of Managed Care^® After presenting the findings to date at the American Thoracic Society 2024 International Conference in May 2024.³

During the interviewHedner highlighted that sulthiame improves sleep quality, reduces hypoxia, and addresses excessive daytime sleepiness, suggesting that it may be part of a more personalized pharmacological approach to treating sleep-disordered breathing. He also highlighted the growing interest in non-CPAP therapies, such as neurostimulation and strength training, as part of the evolving treatment landscape.

“Sulthiame is already available to treat pediatric epilepsy, but phase 3 trials are needed to confirm the drug's beneficial respiratory effects in a larger group of patients with OSA,” Hedner said of the new study findings.²

People with OSA often snore loudly, stop breathing throughout the night and wake up repeatedly, which not only leads to fatigue but also increases the risk of developing high blood pressure, stroke, heart disease and type 2 diabetes. OSA is a widespread condition, but many people are unaware they have it.

“Many people know that they or their partner snore,” said Sofia Siza, MD, director of the ERS Conference on Sleep-Disordered Breathing and professor of Pulmonary and Sleep Medicine at the University of Crete School of Medicine in Greece, who was not involved in the study. “If snoring is accompanied by other symptoms, such as frequent waking during the night or feeling tired or sleepy during the day, it's time to see a doctor. It's crucial to diagnose and treat obstructive sleep apnea, as it increases the risk of serious health problems, including high blood pressure, heart disease and metabolic disorders.”

Although treatments for OSA exist, they don't work for everyone, highlighting the need for more individualized diagnosis and treatment options. Siza added that this study is one of the first to show promising results that drug therapy, specifically sulthiame, can be effective for certain OSA patients. Further research is needed to evaluate the long-term effects and potential side effects of sulthiame and similar treatments, including their effectiveness in lowering blood pressure and preventing cardiovascular disease in OSA patients.

References

1. Schwarz E, Testelmans D. Prognostic aspects of obstructive sleep apnea and new insights into positive airway pressure therapy. ERS Congress 2024 Webinar. Presented September 10, 2024. https://k4.ersnet.org/prod/v2/Front/Program/Session?e=549&session=17922
2. Hedner J, et al. A randomized, double-blind, placebo-controlled, dose-ranging study of sulthiame in obstructive sleep apnea. Presented at: ERS ​​Congress 2024, September 10, 2024, Vienna, Austria. https://k4.ersnet.org/prod/v2/Front/Program/Session?e=549&session=17922
3. Santoro C. Jan Hedner, PhD, is investigating the benefits of sulthiame, a new tool in the treatment of SDB. AJMC^®. May 21, 2024. Accessed September 10, 2024. https://www.ajmc.com/view/dr-jan-hedner-explores-benefit-of-sulthiame-new-avenue-in-sdb-treatment