Mortality benefit with antifibrotics in idiopathic pulmonary fibrosis: real world evidence or bias?

Mortality benefit with antifibrotics in idiopathic pulmonary fibrosis: real world evidence or bias?
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抗纤维化药物治疗特发性肺纤维化的死亡率获益:现实世界的证据还是偏见?

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发表时间:
2021
影响因子:
24.3
通讯作者:
D. Assayag
D. Assayag
中科院分区:
医学1区
文献类型:
--
作者:
S. Suissa;D. Assayag

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我们饶有兴趣地阅读了Behr等人[1]对特发性肺纤维化(IPF)患者的INSIGHTS-IPF登记研究进行的分析,特别是抗纤维化治疗对死亡率的有效性。研究表明,与非使用者相比,抗纤维化药物(即吡非尼酮和尼达尼布)使用者的死亡风险显著降低(风险比0.63,95% CI 0.45-0.87; p=0.005)。在常规临床实践背景下,全因死亡率降低37%对于一项观察性研究来说是非常显著的,尽管平均随访时间较短,仅为1.2年,并且此类研究中固有的适应症预期会产生混淆。 我们认为,抗纤维化治疗降低死亡率的报道更可能是不朽时间偏倚的结果[2]。来自INSIGHTS-IPF登记研究的研究受到永久时间偏倚的影响,这大大夸大了吡非尼酮和尼达尼布在IPF患者中降低死亡率37%的有效性。https://bit.ly/2Xp7XTr
We read with interest the analysis conducted by Behr et al. [1] of the INSIGHTS-IPF registry of patients with idiopathic pulmonary fibrosis (IPF), particularly of the effectiveness of antifibrotic treatment on mortality. It showed that users of antifibrotics, namely pirfenidone and nintedanib, have a significantly lower risk of death (hazard ratio 0.63, 95% CI 0.45–0.87; p=0.005) compared with non-users. This 37% reduction in all-cause mortality is quite remarkable for an observational study in the context of regular clinical practice, despite the short mean duration of follow-up of 1.2 years and the expected confounding by indication inherent in such studies. We believe that this reported reduction in mortality with antifibrotic treatment is more likely the result of immortal time bias [2]. Study from the INSIGHTS-IPF registry is affected by immortal time bias, which greatly exaggerates the reported effectiveness of pirfenidone and nintedanib on lowering mortality by 37% in patients with IPF. https://bit.ly/2Xp7XTr
DOI: 10.1056/nejmoa1908142
发表时间: 2019-12-12
影响因子: 158.5
作者:
Dransfield, M. T.;Voelker, H.;Connett, J. E.
通讯作者: Connett, J. E.