Systematic review and network meta-analysis of approved medicines for the treatment of idiopathic pulmonary fibrosis.

IF 2.4 Journal of Drug Assessment Pub Date : 2019-04-12 eCollection Date: 2019-01-01 DOI:10.1080/21556660.2019.1597726
Aristeidis Skandamis, Chara Kani, Sophia L Markantonis, Kyriakos Souliotis
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引用次数: 25

Abstract

Background: Clinical practice guidelines for the treatment of idiopathic pulmonary fibrosis (IPF) currently recommend pirfenidone and nintedanib. However, there is a lack of evidence from head-to-head comparisons. Objectives: To perform a systematic review and network meta-analysis (NMA) to access the efficacy and tolerability of two new treatments for IPF, pirfenidone and nintedanib. Methods: Randomized controlled trials (RCTs) selection (CENTRAL, MEDLINE, Embase), data extraction, risk of bias analysis, and GRADE assessment were carried out by two authors separately. Direct estimates were calculated using standard pairwise meta-analysis. A Bayesian mixed treatment comparison approach for NMA estimates, with 95% confidence intervals (CI), was used to compare the treatments, calculating odds ratios (OR) and number needed to treat (NNTB) or harm (NNTH). Results: The NMA on 10 randomized controlled trials showed that each drug had a positive effect on percentage of forced vital capacity (FVC) decline ≥ 10% (pirfenidone OR = 0.54 [95% CI = 0.37-0.80], NNTB = 9 [95% CI = 7-22]; nintedanib OR = 0.59 [95% CI = 0.41-0.84], NNTB = 9 [95% CI = 6-23]), but no significant differences were noted when comparing pirfenidone and nintedanib with respect to acute exacerbations, mortality, and serious adverse events (FVC decline OR = 0.91 [95% CI = 0.45-2.03]) or dropouts (OR = 0.75 [95% CI = 0.33-1.27]). Nintedanib showed an effect on dropouts, OR = 1.61 (1.13-2.28) and NNTH = 14 (8-61). Conclusions: Based on RCTs of 12 month duration in patients with IPF, a positive effect on FVC decline was noted for both treatments and on dropouts for nintedanib, but no significant differences were noted between treatments.

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特发性肺纤维化治疗批准药物的系统评价和网络荟萃分析。
背景:特发性肺纤维化(IPF)治疗的临床实践指南目前推荐吡非尼酮和尼达尼布。然而,缺乏正面比较的证据。目的:进行系统评价和网络荟萃分析(NMA),以获得两种新治疗IPF的疗效和耐受性,吡非尼酮和尼达尼布。方法:随机对照试验(rct)选择(CENTRAL、MEDLINE、Embase)、数据提取、偏倚风险分析和GRADE评价由2位作者分别进行。使用标准两两元分析计算直接估计值。采用贝叶斯混合治疗比较方法对NMA估计进行比较,采用95%置信区间(CI),计算优势比(OR)和治疗(NNTB)或危害(NNTH)所需的数量。结果:10项随机对照试验的NMA结果显示,各药物对强制肺活量(FVC)下降百分比均有积极影响≥10%(吡非尼酮OR = 0.54 [95% CI = 0.37 ~ 0.80], NNTB = 9 [95% CI = 7 ~ 22];尼达尼布OR = 0.59 [95% CI = 0.41-0.84], NNTB = 9 [95% CI = 6-23]),但在比较吡非尼酮和尼达尼布在急性加重、死亡率和严重不良事件(FVC下降OR = 0.91 [95% CI = 0.45-2.03])或辍学率(OR = 0.75 [95% CI = 0.33-1.27])方面没有显著差异。尼达尼布对辍学率有影响,OR = 1.61 (1.13-2.28), NNTH = 14(8-61)。结论:基于为期12个月的IPF患者的随机对照试验,两种治疗方法对FVC下降和尼达尼布的退出均有积极作用,但两种治疗方法之间没有显著差异。
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来源期刊
Journal of Drug Assessment
Journal of Drug Assessment PHARMACOLOGY & PHARMACY-
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