Pirfenidone in Idiopathic Pulmonary Fibrosis: Real-World Observation on Efficacy and Safety, Focus on Patients Undergoing Antithrombotic and Anticoagulant

Pharmaceuticals Pub Date : 2024-07-11 DOI:10.3390/ph17070930
Nicolò Reccardini, Maria Chernovsky, F. Salton, P. Confalonieri, L. Mondini, Mariangela Barbieri, A. Romallo, Marta Maggisano, C. Torregiani, P. Geri, Michael Hughes, C. Campochiaro, M. Confalonieri, A. Scarda, Umberto Zuccon, B. Ruaro
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Abstract

Idiopathic pulmonary fibrosis (IPF) is a rare and progressive interstitial lung disease characterized by irreversible distortion of lung architecture and subsequent loss of pulmonary function. Pirfenidone is an antifibrotic agent associated with increased progression-free survival and overall survival rates, but it carries multiple side effects. The aim of the study was to examine the efficacy and safety profile of pirfenidone in a real-life context, with a focus on the concomitant use of antithrombotic and/or anticoagulant treatments. The clinical and functional data (forced vital capacity [FVC], forced expiratory volume in 1 s [FEV1], diffusing lung capacity for carbon monoxide [DLCO], and 6 min walking test distance [6MWD]) of all IPF patients treated with pirfenidone and referred to our two centers between 2019 and 2022 were retrospectively analyzed at baseline, 6 and 12 months after the start of treatment. A total of 55 IPF subjects undergoing pirfenidone treatment were included in the analysis (45.5% females, median [IQR] age at disease onset 68.0 [10.0] years, median [IQR] age at baseline 69.0 [10.8] years). Compared to baseline, at 12 months, FVC (86.0% vs. 80.0%; p = 0.023) and DLCO (44.0% vs. 40.0%; p = 0.002) were significantly reduced, while FEV1 (p = 0.304) and 6MWD (p = 0.276) remained stable; no significant change was recorded at 6 months. Most of the reported adverse events were mild or moderate. Gastrointestinal intolerance (9.1%) was the main cause of treatment discontinuation. A total of 5% of patients reported at least one minor bleeding event, although all episodes occurred in those receiving concomitant antithrombotic or anticoagulant. Overall, this real-life experience confirms the efficacy and safety profile of pirfenidone in the case of the concomitant use of antithrombotic and/or anticoagulant drugs.
吡非尼酮治疗特发性肺纤维化:对疗效和安全性的实际观察,重点关注接受抗血栓和抗凝治疗的患者
特发性肺纤维化(IPF)是一种罕见的进行性间质性肺部疾病,其特点是肺部结构不可逆转的扭曲和随后的肺功能丧失。吡非尼酮是一种抗纤维化药物,可提高无进展生存率和总生存率,但它有多种副作用。该研究旨在考察吡非尼酮在现实生活中的疗效和安全性,重点关注同时使用抗血栓和/或抗凝治疗的情况。我们回顾性分析了2019年至2022年期间转诊到我们两个中心的所有接受吡非尼酮治疗的IPF患者在基线、治疗开始后6个月和12个月的临床和功能数据(用力肺活量[FVC]、1秒用力呼气容积[FEV1]、一氧化碳弥散肺活量[DLCO]和6分钟步行测试距离[6MWD])。共有55名接受吡非尼酮治疗的IPF受试者被纳入分析(女性占45.5%,发病年龄中位数[IQR]为68.0 [10.0]岁,基线年龄中位数[IQR]为69.0 [10.8]岁)。与基线相比,12 个月时,FVC(86.0% 对 80.0%;p = 0.023)和 DLCO(44.0% 对 40.0%;p = 0.002)显著降低,而 FEV1(p = 0.304)和 6MWD (p = 0.276)保持稳定;6 个月时无显著变化。大多数报告的不良反应为轻度或中度。胃肠道不耐受(9.1%)是导致停药的主要原因。共有 5% 的患者报告了至少一次轻微出血事件,不过所有出血事件都发生在同时服用抗血栓或抗凝剂的患者身上。总之,这一实际经验证实了吡非尼酮在同时使用抗血栓和/或抗凝药物情况下的疗效和安全性。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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