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Sulthiame may be the next treatment for OSA

Presented by
Dr Jan Hedner, University of Gothenburg, Sweden
ATS 2024
Phase 2, STM-042/K
In patients with obstructive sleep apnoea (OSA), sulthiame was associated with improvements in the apnoea-hypopnoea index (AHI), oxygenation, daytime sleepiness, sleep quality, and blood pressure. According to the authors of the current dosefinding study, sulthiame is therefore a promising candidate for pharmacological treatment in patients with OSA.

“The carbonic anhydrase inhibitor sulthiame decreased OSA activity in a proof-of-concept study called STM-026/K [1],” said Dr Jan Hedner (University of Gothenburg, Sweden). The current multicentre, double-blind, phase 2 dose-finding study called STM-042/K (NCT05236842) randomised 298 patients with OSA to 15 weeks of sulthiame treatment at 3 different dose levels: 100 mg, 200 mg, or 300 mg, or to a placebo [2].

At week 15, the relative change from baseline in apnoea/hypopnoea with ≥4% O2 desaturation (AHI4) was largest in the 300 mg dose group (-47.1%), followed by the 200 mg (-36.8%), and the 100 mg dose group (-26.2%). “All sulthiame dose groups performed significantly better than placebo, with a peak efficacy in the 200–300 mg range and with similar efficacy in moderate and severe OSA,” added Dr Hedner. Changes in number of 3% desaturations (ODI3%) and mean O2 saturation from baseline to week 15 showed similar doserelated effects. Furthermore, improvements in sleep quality and reductions in daytime sleepiness and blood pressure were mostly observed in the 200 mg and 300 mg arms.

According to Dr Hedner, sulthiame was well tolerated, with paraesthesia, headache, dyspnoea, and nausea being the most frequently reported treatment-emergent adverse events.


  1. Hedner J, et al. Am J Respir Crit Care Med. 2022;15:1461-1469.
  2. Hedner J, et al. 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). Late-breaking abstracts: science that will impact clinical care. ATS 2024, 17–22 May, San Diego, USA.

Medical writing support was provided by Robert van den Heuvel.

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