Reboxetine Plus Oxybutynin for OSA Treatment,Chest

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Reboxetine Plus Oxybutynin for OSA Treatment
Chest ( IF 9.5 ) Pub Date : 2021-09-20 , DOI: 10.1016/j.chest.2021.08.080
Elisa Perger ₁ , Luigi Taranto Montemurro ₂ , Debora Rosa ₃ , Stefano Vicini ₁ , Mariapaola Marconi ₃ , Lucia Zanotti ₃ , Paolo Meriggi ₄ , Ali Azarbarzin ₂ , Scott A Sands ₂ , Andrew Wellman ₂ , Carolina Lombardi ₁ , Gianfranco Parati ₁

Affiliation

Background

The recent discovery that a combination of noradrenergic and antimuscarinic drugs improved upper airway muscle function during sleep and reduced OSA severity has revitalized interest in pharmacologic therapies for OSA.

Research Question

Would 1 week of reboxetine plus oxybutynin (Reb-Oxy) be effective on OSA severity?

Study Design and Methods

A randomized, placebo-controlled, double-blind, crossover trial was performed comparing 4 mg reboxetine plus 5 mg oxybutynin (Reb-Oxy) vs placebo in patients with OSA. After a baseline in-laboratory polysomnogram (PSG), patients underwent PSGs after 7 nights of Reb-Oxy and 7 nights of placebo to compare apnea-hypopnea index (AHI), which was the primary outcome. Response rate was based on the percentage of subjects with a ≥ 50% reduction in AHI from baseline. Secondary outcomes included Epworth Sleepiness Scale (ESS) score and psychomotor vigilance test (PVT) values. Home oximetry evaluated overnight oxygen desaturation index (ODI) throughout treatment.

Results

Sixteen subjects aged 57 [51-61] years (median [interquartile range]) with a BMI of 30 [26-36] kg/m² completed the study. Reb-Oxy lowered AHI from 49 [35-57] events per hour at baseline to 18 [13-21] events per hour (59% median reduction) compared with 39 [29-48] events per hour (6% median reduction) with placebo (P < .001). Response rate for Reb-Oxy was 81% vs 13% for placebo (P < .001). Although ESS scores were not significantly lowered, PVT median reaction time decreased from 250 [239-312] ms at baseline to 223 [172-244] ms on Reb-Oxy vs 264 [217-284] ms on placebo (P < .001). Home oximetry illustrated acute and sustained improvement in the oxygen desaturation index on Reb-Oxy vs placebo.

Interpretation

The administration of Reb-Oxy greatly decreased OSA severity and increased vigilance. These results highlight potential possibilities for pharmacologic treatment of OSA.

Clinical Trial Registration

ClinicalTrials.gov; No.: NCT04449133; URL: www.clinicaltrials.gov

中文翻译：

瑞波西汀加奥昔布宁治疗 OSA

背景

最近发现，去甲肾上腺素能药物和抗毒蕈碱药物的组合可以改善睡眠期间的上呼吸道肌肉功能并降低 OSA 的严重程度，这重新激发了人们对 OSA 药物治疗的兴趣。

研究问题

1 周瑞波西汀加奥昔布宁 (Reb-Oxy) 对 OSA 严重程度有效吗？

研究设计和方法

进行了一项随机、安慰剂对照、双盲、交叉试验，比较 4 mg 瑞波西汀加 5 mg 奥昔布宁 (Reb-Oxy) 与安慰剂治疗 OSA 患者的效果。在进行基线实验室多导睡眠图 (PSG) 后，患者在 7 晚 Reb-Oxy 和 7 晚安慰剂后接受 PSG，以比较呼吸暂停低通气指数 (AHI)，这是主要结果。有效率基于 AHI 较基线降低 ≥ 50% 的受试者百分比。次要结局包括 Epworth 嗜睡量表 (ESS) 评分和精神运动警惕性测试 (PVT) 值。家庭血氧测定法评估整个治疗过程中的过夜氧饱和度指数 (ODI)。

结果

16 名年龄 57 [51-61] 岁（中位[四分位距]）、BMI 为 30 [26-36] kg/m ²的受试者完成了研究。 Reb-Oxy 将 AHI 从基线时每小时 49 [35-57] 次事件降低至每小时 18 [13-21] 次事件（中值减少 59%），而每小时 39 [29-48] 次事件（中值减少 6%）与安慰剂（ P < .001）。 Reb-Oxy 的反应率为 81%，安慰剂为 13% ( P < .001)。尽管 ESS 评分没有显着降低，但 Reb-Oxy 组的 PVT 中位反应时间从基线时的 250 [239-312] 毫秒降至 223 [172-244] 毫秒，而安慰剂组为 264 [217-284] 毫秒（ P < .001））。家庭血氧测定显示，与安慰剂相比，Reb-Oxy 的氧饱和度指数得到了急性和持续的改善。