A systematic review and meta-analysis of the clinical benefits and adverse reactions of anti-fibrotics in non-IPF progressive fibrosing ILD

IF 2.4 4区医学 Q2 CARDIAC & CARDIOVASCULAR SYSTEMS

Heart & Lung Pub Date : 2024-07-31 DOI:10.1016/j.hrtlng.2024.07.010

Woon Hean Chong MD, Dipika Agrawal MD, Ze Ying Tan MD, Sridhar Venkateswaran MD, Adeline Yit Ying Tan MD, Ching Yee Tan MD, Norris Chun Ang Ling MD, Noel Stanley Wey Tut Tay MD

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引用次数: 0

Abstract

Background

Anti-fibrotics can reduce restrictive impairment in idiopathic pulmonary fibrosis (IPF). However, its effectiveness in non-IPF progressive fibrosing interstitial lung disease (non-IPF PF-ILD) remains uncertain.

Objective

We assess the efficacy and safety of anti-fibrotics pirfenidone and nintedanib versus placebo among non-IPF PF-ILD adult patients.

Methods

Meta-analysis was performed using PubMed, SCOPUS, and Cochrane databases to identify randomized controlled trials (RCTs). At respective centers, non-IPF PF-ILD was defined as clinical and radiological findings inconsistent with IPF and greater than 5 % forced vital capacity (FVC) decline, worsening radiological fibrosis or respiratory symptoms.

Results

Among seven RCTs involving 1,816 non-IPF PF-ILD patients, anti-fibrotics significantly reduced decline in FVC from baseline in milliliters (MD -66.80milliliters; P < 0.01) and percent predicted (MD -1.80 %; P < 0.01) compared to placebo. However, severity of FVC decline was less than 10 % (P = 0.33) in both groups. No significant difference in the decline of 6MWD from baseline in meters (P = 0.19) while on anti-fibrotics, although those on pirfenidone had less decline in 6MWD (MD -25.12 m; P < 0.01) versus placebo. The rates of all-cause mortality (P = 0.34), all-cause hospitalization (P = 0.44), and hospitalization for respiratory etiology (P = 0.06) were comparable in both groups. Adverse events of nausea/vomiting (54.2 % vs. 20.3 %; P < 0.01), diarrhea (65.2 % vs. 27.6 %; P = 0.02), anorexia/weight loss (23.0 % vs. 7.7 %; P < 0.01), neurological disorders (20.8 % vs. 12.6 %; P < 0.01), and events requiring therapy discontinuation were higher (18.4 % vs. 9.9 %; P < 0.01) in the anti-fibrotic group. Other adverse events of skin (P = 0.18) and respiratory disorders (P = 0.20) were equal.

Conclusion

The advent of anti-fibrotics offers alternative treatment to reduce lung function decline.

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抗纤维化药物对非 IPF 进行性纤维化 ILD 的临床疗效和不良反应的系统综述和荟萃分析。

背景：抗纤维化药物可减轻特发性肺纤维化（IPF）的限制性损伤。然而，其对非 IPF 进行性纤维化间质性肺病（non-IPF PF-ILD）的疗效仍不确定：我们评估了抗纤维化药物吡非尼酮和宁替达尼与安慰剂在非 IPF PF-ILD 成年患者中的疗效和安全性：利用PubMed、SCOPUS和Cochrane数据库进行Meta分析，以确定随机对照试验（RCT）。在各研究中心，非 IPF PF-ILD 的定义是：临床和放射学检查结果与 IPF 不一致、用力呼吸容量（FVC）下降超过 5%、放射学纤维化或呼吸道症状恶化：在涉及1816名非IPF PF-ILD患者的七项研究中，与安慰剂相比，抗纤维化药物显著降低了FVC从基线下降的毫升数（MD -66.80毫升；P < 0.01）和预测百分比（MD -1.80%；P < 0.01）。不过，两组患者的 FVC 下降幅度均小于 10 %（P = 0.33）。与安慰剂相比，服用吡非尼酮的患者 6MWD 的下降幅度较小（MD -25.12 m；P <0.01），但服用抗纤维化药物的患者 6MWD 从基线下降的米数无明显差异（P = 0.19）。两组患者的全因死亡率（P = 0.34）、全因住院率（P = 0.44）和因呼吸系统病因住院率（P = 0.06）相当。恶心/呕吐（54.2% 对 20.3%；P < 0.01）、腹泻（65.2% 对 27.6%；P = 0.02）、厌食/体重减轻（23.0% 对 7.7%；P < 0.01）、神经系统紊乱（20.8 % vs. 12.6 %；P < 0.01）和需要中断治疗的事件在抗纤维化组更高（18.4 % vs. 9.9 %；P < 0.01）。皮肤（P = 0.18）和呼吸系统疾病（P = 0.20）等其他不良事件的发生率相同：抗纤维化药物的出现为减少肺功能衰退提供了替代治疗方法。

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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来源期刊

Heart & Lung 医学-呼吸系统

CiteScore

4.60

自引率

3.60%

发文量

184

审稿时长

35 days

期刊介绍： Heart & Lung: The Journal of Cardiopulmonary and Acute Care, the official publication of The American Association of Heart Failure Nurses, presents original, peer-reviewed articles on techniques, advances, investigations, and observations related to the care of patients with acute and critical illness and patients with chronic cardiac or pulmonary disorders. The Journal''s acute care articles focus on the care of hospitalized patients, including those in the critical and acute care settings. Because most patients who are hospitalized in acute and critical care settings have chronic conditions, we are also interested in the chronically critically ill, the care of patients with chronic cardiopulmonary disorders, their rehabilitation, and disease prevention. The Journal''s heart failure articles focus on all aspects of the care of patients with this condition. Manuscripts that are relevant to populations across the human lifespan are welcome.