Randomized Controlled Trial Exploring Safety and Tolerability of Sulthiame in Sleep Apnea, Hedner, 2020

https://www.atsjournals.org/doi/10.1164/rccm.202109-2043OC


Rational: Current therapies in obstructive sleep apnea (OSA) are limited by insufficient efficacy, compliance or tolerability. An effective pharmacological treatment in OSA is warranted. Carbonic anhydrase (CA) inhibition has been shown to ameliorate OSA. Objective: To explore safety and tolerability of the CA inhibitor sulthiame (STM) in OSA. Methods: A four week double-blind, randomized, placebo-controlled dose guiding trial in patients with moderate/severe OSA not tolerating positive airway pressure treatment. Measurements and results: Intermittent paresthesia was reported by 79, 67 and 18% of patients receiving 400 mg STM (N=34), 200 mg STM (N=12) or placebo (N=22), respectively. Dyspnea was reported only after 400 mg STM (18%). Six patients in the higher dose group withdrew due to an adverse event. There were no serious adverse events. STM reduced the apnea-hypopnea index (AHI) from 55.3 to 33.1 events/h ( 41.0%) in the 400 mg group and from 61.2 to 40.7 events/h ( 32.1%) after 200 mg (p<0.001, respectively). Corresponding placebo values were 53.9 and 50.9 events/h ( 5.4 %). The AHI reduction threshold of ≥50% was reached in 40% after 400 mg, 25% after 200 mg and 5% following placebo. Mean overnight oxygen saturation improved by 1.1% after 400 mg and 200 mg (p<0.001 and p=0.034, respectively). Patient related outcomes were unchanged. Conclusions: STM showed a satisfactory safety profile in moderate/severe OSA. STM reduced OSA by more than 20 events/h, one of the strongest reductions reported in a drug trial in OSA. Larger scale clinical studies of STM in OSA are justified.



Decent study/results.
Posting because many pmecfs report sleep apnea e.g.

https://www.s4me.info/threads/mild-sleep-apnea.12019/