People taking the drug had fewer pauses in their breathing and higher levels of oxygen in their blood during sleep.
RT’s Three Key Takeaways:
- Symptom Reduction: Sulthiame reduced sleep apnea episodes by up to 39.9% in the highest dose group, with a close to 50% reduction in respiratory pauses using one measurement method (AHI4).
- Improved Oxygenation: Patients taking sulthiame experienced higher blood oxygen levels during sleep.
- Mild Side Effects: The drug was well-tolerated, with most side effects being mild or moderate, such as pins and needles, headaches, and fatigue.
Patients taking sulthiame, a drug currently in use for epilepsy, experienced a reduction in their symptoms of obstructive sleep apnea (OSA), according to results of a clinical trial presented at the European Respiratory Society (ERS) Congress in Vienna, Austria.
The trial was a double-blind, randomized, placebo-controlled trial involving 298 people with OSA being treated at 28 different centres in Spain, France, Belgium, Germany, and the Czech Republic. All the patients could not tolerate or refused to use continuous positive airway pressure (CPAP) machines or mouthpieces designed to keep the airways open.
The patients were assessed with polysomnography at the start of the trial and after four weeks and 12 weeks in the study. The patients were divided into four groups: 74 people took 100 mg of sulthiame daily, 74 took 200 mg, 75 took 300 mg and the remaining 75 took a placebo.
Sulthiame is a drug that targets the respiratory system by inhibiting an enzyme called carbonic anhydrase and stimulating the upper airway muscles.
Sulthiame Reduces Breathing Pauses, Improves Blood Oxygen
The people taking sulthiame had fewer pauses in their breathing and higher levels of oxygen in their blood during sleep. A measure of the frequency of respiratory pauses during sleep, called AHI3a, was 17.8% lower for patients taking the lowest dose, 34.8% lower for patients on the medium dose and 39.9% lower for patients on the highest dose.
When researchers used another measure called AHI4, the effect of the treatment was close to a 50% reduction of respiratory pauses with more profound lowering of oxygen levels. OSA patients who had been feeling sleepy during the daytime also felt less so when they took sulthiame.
Side effects experienced by the people taking sulthiame, such pins and needles, headache, fatigue, and nausea, were generally mild or moderate.
“People taking sulthiame in the trial had a reduction in OSA symptoms such as stopping breathing during the night and feeling sleepy during the day. Their average levels of oxygen in the blood were also improved with the treatment,” says professor Jan Hedner, MD, PhD, from Sahlgrenska University Hospital and the University of Gothenburg in Sweden, who presented the research, in release. “This suggests that sulthiame could be an effective treatment for OSA, especially for those who find they cannot use the existing mechanical treatments.
Promising Results, With Further Research Needed
“Although sulthiame is already available as a treatment for childhood epilepsy, we still need to carry out a phase III study to confirm the beneficial respiratory effects of this drug in a larger group of patients with OSA,” says Hedner in a release
Professor Sophia Schiza, MD, PhD, head of the ERS assembly on sleep-disordered breathing, professor of respiratory and sleep medicine in the School of Medicine at the University of Crete, Greece, who was not involved in the research, says in a release, “Because obstructive sleep apnea increases the risk of serious health problems such as high blood pressure, heart and metabolic disease, it’s vital that we diagnose and treat the condition. Treatments are available, but because they don’t work for everyone, we need more ways to treat the disease, based on individualized diagnostic and treatment approaches.
“This is one of the first studies to suggest that a drug treatment could help some patients, and the results are promising. We need to continue testing sulthiame and other treatments to understand their long-term effects, including any side effects. For example, we’d like to see whether treatment can help with lowering blood pressure and preventing cardiovascular disease for people with OSA.”