European Respiratory Society International Congress

European Respiratory Society International Congress

Source:

Hedner JA, et al. Different treatment modalities and impact of comorbidities on sleep-disordered breathing. Presented at: European Respiratory Society International Congress; Sept. 5-8, 2021 (virtual meeting).

Disclosures: Hedner reports no relevant financial disclosures.
October 08, 2021
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Sulthiame safe in patients with moderate to severe obstructive sleep apnea

Source:

Hedner JA, et al. Different treatment modalities and impact of comorbidities on sleep-disordered breathing. Presented at: European Respiratory Society International Congress; Sept. 5-8, 2021 (virtual meeting).

Disclosures: Hedner reports no relevant financial disclosures.
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In patients with moderate to severe obstructive sleep apnea, carbonic anhydrase inhibition with sulthiame was safe and improved outcomes in the short term, researchers reported at the European Respiratory Society International Congress.

Researchers conducted a phase 2b, randomized, placebo-controlled, parallel-group, dose-guiding trial that enrolled 68 patients with OSA who did not tolerate positive airway pressure (mean age, 61 years; 69% men; apnea-hypopnea index, 15 events per hour; Epworth Sleepiness Scale score, 6; BMI < 35 kg/m2). Patients were randomly assigned to receive sulthiame (Bayer) 200 mg (n = 12), 400 mg (n = 34) or placebo (n = 22) for 4 weeks. Researchers assessed polysomnography, vital signs and biochemistry.

Paper that says diagnosis sleep apnea
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The primary outcome was the safety and tolerability of treatment with sulthiame.

Overall, sulthiame demonstrated acceptable tolerability, according to the researchers. Paresthesia was the most common adverse event and occurred in 79% of the sulthiame 400 mg group, 67% of the 200 mg group and 18% of the placebo group, according to the results.

Nine patients, all in the sulthiame 400 mg group, discontinued treatment due to adverse events.

In addition, researchers observed a 41% decrease in the apnea-hypopnea index (55 to 33 events per hour) among patients in the sulthiame 400 mg group, a 32% decrease (61 to 41 events per hour) in the 200 mg group and an 8% decrease (54 to 51 events per hour) in the placebo group, according to the results.

In an unadjusted responder analysis, 59% of patients assigned sulthiame 200 mg or 400 mg reached a 30% efficacy threshold, 49% reached a 40% efficacy threshold, 35% reached a 50% efficacy threshold and 19% reached a 60% efficacy threshold.

Results also showed a 1.1% increase in mean overnight oxygen saturation among patients assigned sulthiame 400 mg and 200 mg (P < .001), according to the results.

“Large-scale studies of sulthiame in OSA are warranted,” Jan A. Hedner, MD, PhD, professor of respiratory medicine at the Centre for Sleep and Wake Disorders at the Sahlgrenska Academy at Gothenburg University, Sweden, and colleagues concluded.