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首页> 外文期刊>Pulmonary Circulation >An Observational Study of Inhaled-Treprostinil Respiratory-Related Safety in Patients with Pulmonary Arterial Hypertension:
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An Observational Study of Inhaled-Treprostinil Respiratory-Related Safety in Patients with Pulmonary Arterial Hypertension:

机译：肺动脉高压患者吸入曲前列环素呼吸相关安全性的观察研究：

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Inhaled treprostinil (Tyvaso) has been shown to be a safe and effective addition to pulmonary arterial hypertension (PAH) oral therapies; however, the respiratory-related safety profile of inhaled treprostinil required further elucidation in the setting of routine clinical care. The objectives of this study were to characterize respiratory-related adverse events (AEs) associated with current or recent treatment with inhaled treprostinil and to compare the incidence of respiratory-related AEs in PAH patients treated with inhaled treprostinil with that in patients treated with other Food and Drug Administration (FDA)–approved PAH therapies. This was a long-term, prospective, observational study. All respiratory-related AEs were recorded during the study. The number of PAH patients enrolled was 1,333, 666 treated with inhaled treprostinil and 667 controls (treated with an FDA-approved PAH therapy other than inhaled treprostinil), for a total of 958 and 1,094 patient-years of exposure, respectively. In the inhaled-treprostinil group, 1,281 respiratory-related AEs were reported in 403 patients (61%), and in the control group, 1,295 respiratory-related AEs were reported in 388 patients (58%). Cough, throat irritation, nasal discomfort, and hemoptysis were the most common respiratory-related AEs (occurring in ≥2% of patients in either treatment group) that demonstrated a higher number of events per patient-year of exposure in the inhaled-treprostinil group than in the control group (risk ratio [95% confidence interval]: 1.487 [1.172–1.887], 3.777 [2.050–6.956], 2.039 [1.072–3.879], and 1.957 [1.024–3.741], respectively). Overall, inhaled treprostinil was well tolerated by PAH patients in routine clinical care, with respiratory-related AEs consistent with the known safety profile (trial registration: clinicaltrials.gov identifier: NCT01266265).
机译：事实证明，吸入曲前列尼（Tyvaso）是安全有效的除肺动脉高压（PAH）口服疗法外的另一种疗法。然而，吸入曲前列环素的与呼吸有关的安全性需要在常规临床护理中进一步阐明。这项研究的目的是表征与当前或近期吸入曲前列环素治疗相关的呼吸道相关不良事件（AE），并比较吸入曲前列环素治疗的PAH患者与其他食品治疗的患者的呼吸道相关AEs发生率和药物管理局（FDA）批准的PAH疗法。这是一项长期的，前瞻性的观察性研究。在研究期间记录了所有与呼吸有关的AE。入组的PAH患者分别为1,333，666接受吸入曲前列环素治疗和667对照（接受FDA批准的PAH疗法而非吸入曲前列环素治疗），分别暴露了958和1,094个患者年。吸入曲前列素组中，有403例患者报告了1,281例呼吸相关的AE（61％），而对照组中，388例患者中报告了1,295例呼吸相关的AE（58％）。咳嗽，喉咙不适，鼻腔不适和咯血是最常见的与呼吸有关的AE（在任一治疗组中≥2％的患者中发生），在吸入曲前列素组中，每患者年暴露事件的发生率更高比对照组（风险比[95％置信区间]：1.487 [1.172-1.887]，3.777 [2.050-6.956]，2.039 [1.072-3.879]和1.957 [1.024-3.741]）。总体而言，PAH患者在常规临床护理中对曲前列环素的吸入耐受良好，且与呼吸有关的AE与已知的安全性相一致（试验注册：clinicaltrials.gov标识符：NCT01266265）。

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