10 September 2024: Patients taking sulthiame (brand name Ospolot), a drug currently in use for epilepsy, experienced a reduction in their symptoms of obstructive sleep apnoea (OSA) according to results of a clinical trial presented at the European Respiratory Society (ERS) Congress in Vienna Austria [1].
Patients with OSA often snore loudly, their breathing starts and stops during the night, and they may wake up several times. Not only does this cause tiredness, but it can also increase the risk of high blood pressure, stroke, heart disease and type 2 diabetes. OSA is very common, but many people do not realise they have the condition.
The new research was presented by Professor Jan Hedner from Sahlgrenska University Hospital and the University of Gothenburg in Sweden. He said: “The standard treatment for obstructive sleep apnoea is sleeping with a machine that blows air through a face mask to keep the airways open. Unfortunately, many people find these machines hard to use over the long term, so there is a need to find alternative treatments. We also a need better understanding of the underlying mechanisms in OSA to help clinicians give more personalised treatment.”
The trial was a double-blind, randomised, placebo-controlled trial. It involved 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. Polysomnography measures breathing, levels of oxygen in the blood, heart rhythm, eye movements, brain and muscle activity during a night of sleep.
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 (dummy pill). Sulthiame is a drug that targets the respiratory system by inhibiting an enzyme called carbonic anhydrase and stimulating the upper airway muscles.
Professor Hedner said:
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. This suggests that sulthiame could be an effective treatment for OSA, especially for those who find they cannot use the existing mechanical treatments. 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.”
References
[1] Abstract no: OA5433 “Late Breaking Abstract – A randomized, double-blind, placebo controlled, dose-finding trial of sulthiame in obstructive sleep apnea”, by Jan Hedner et al; Presented in session, “Emerging insights in prognostic aspects and positive airway pressure treatment for obstructive sleep apnoea” at 14:15–15:30 CEST on Tuesday 10 September 2024. [https://live.ersnet.org/programme/session/93028]
