Suppr超能文献

吡非尼酮治疗特发性肺纤维化:三项跨国3期试验汇总数据的分析

Pirfenidone for idiopathic pulmonary fibrosis: analysis of pooled data from three multinational phase 3 trials.

作者信息

Noble Paul W, Albera Carlo, Bradford Williamson Z, Costabel Ulrich, du Bois Roland M, Fagan Elizabeth A, Fishman Robert S, Glaspole Ian, Glassberg Marilyn K, Lancaster Lisa, Lederer David J, Leff Jonathan A, Nathan Steven D, Pereira Carlos A, Swigris Jeffrey J, Valeyre Dominique, King Talmadge E

机构信息

Cedars-Sinai Medical Center, Los Angeles, CA, USA

University of Turin, Turin, Italy.

出版信息

Eur Respir J. 2016 Jan;47(1):243-53. doi: 10.1183/13993003.00026-2015. Epub 2015 Dec 2.

Abstract

Pirfenidone is an antifibrotic agent that has been evaluated in three multinational phase 3 trials in patients with idiopathic pulmonary fibrosis (IPF). We analysed pooled data from the multinational trials to obtain the most precise estimates of the magnitude of treatment effect on measures of disease progression.All patients randomised to pirfenidone 2403 mg·day(-1) or placebo in the CAPACITY or ASCEND studies were included in the analysis. Pooled analyses of outcomes at 1 year were based on the pre-specified end-points and analytic methods described in the ASCEND study protocol.A total of 1247 patients were included in the analysis. At 1 year, pirfenidone reduced the proportion of patients with a ≥10% decline in per cent predicted forced vital capacity or death by 43.8% (95% CI 29.3-55.4%) and increased the proportion of patients with no decline by 59.3% (95% CI 29.0-96.8%). A treatment benefit was also observed for progression-free survival, 6-min walk distance and dyspnoea. Gastrointestinal and skin-related adverse events were more common in the pirfenidone group, but rarely led to discontinuation.Analysis of data from three phase 3 trials demonstrated that treatment with pirfenidone for 1 year resulted in clinically meaningful reductions in disease progression in patients with IPF.

摘要

吡非尼酮是一种抗纤维化药物,已在三项针对特发性肺纤维化(IPF)患者的跨国3期试验中进行了评估。我们分析了来自这些跨国试验的汇总数据,以获得对疾病进展指标治疗效果大小的最精确估计。纳入分析的所有患者均来自CAPACITY或ASCEND研究中随机接受2403mg·day⁻¹吡非尼酮或安慰剂治疗的患者。1年时结局的汇总分析基于ASCEND研究方案中预先设定的终点和分析方法。共有1247例患者纳入分析。1年时,吡非尼酮使预计用力肺活量下降≥10%或死亡的患者比例降低了43.8%(95%CI 29.3 - 55.4%),使无下降的患者比例增加了59.3%(95%CI 29.0 - 96.8%)。在无进展生存期、6分钟步行距离和呼吸困难方面也观察到了治疗益处。胃肠道和皮肤相关不良事件在吡非尼酮组中更常见,但很少导致停药。对三项3期试验数据的分析表明,吡非尼酮治疗1年可使IPF患者的疾病进展在临床上得到有意义的降低。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9462/4697914/5ba3e70074a4/ERJ-00026-2015.01.jpg

文献AI研究员

20分钟写一篇综述,助力文献阅读效率提升50倍。

立即体验

用中文搜PubMed

大模型驱动的PubMed中文搜索引擎

马上搜索

文档翻译

学术文献翻译模型,支持多种主流文档格式。

立即体验