Pirfenidone and nintedanib for pulmonary fibrosis in clinical practice: Tolerability and adverse drug reactions
Pirfenidone and nintedanib for pulmonary fibrosis in clinical practice: Tolerability and adverse drug reactions
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DOI：
10.1111/resp.13024
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发表时间：
2017-08-01
期刊：
影响因子：
6.9
通讯作者：
Criner, Gerard J.
中科院分区：
文献类型：
--
作者：
Galli, Jonathan A.;Pandya, Aloknath;Criner, Gerard J.
背景和目的吡非尼酮和尼达尼布在非临床试验患者中的真实耐受性尚不清楚。许多肺纤维化患者有显著的医学共病或基线特征，排除他们从clinical trial participation.MethodsWe进行了一项回顾性图表回顾性研究，从2014年9月至2016年2月，受试者处方尼达尼布或吡非尼酮治疗肺纤维化（任何病因）。共纳入186例受试者：129例接受吡非尼酮治疗，57例接受尼达尼布处方治疗，随访平均观察期为吡非尼酮5217周，尼达尼布4115周。主要结果是药物停药作为一个结果的不良事件。结果受试者在基线时有显着的呼吸功能障碍，63%需要家庭氧疗和一氧化碳（DLCO）的平均弥散量为36 +/- 14%的预测。吡非尼酮组20.9%的受试者和尼达尼布组26.3%的受试者因不良事件停药。吡非尼酮和尼达尼布的停药率与相应的大型临床试验（分别为ASCEND/CAPACITY和INPULSIS 1和2）无显著差异。吡非尼酮组发生频率最高的不良事件为恶心（26.4%）、皮疹/光敏性（14.7%）和消化不良/胃食管反流病（GERD）（12.4%）。腹泻（52.6%）和恶心（29.8%）最常报告与nintedanib therapeutic.Conclusion肺纤维化患者治疗nintedanib或吡非尼酮在常规临床实践中的药物耐受性和不良事件的特征与临床试验中招募的受试者相媲美，尽管有更大程度的呼吸损害和高患病率的共病医疗条件。
Background and objectiveThe real-world tolerability of pirfenidone and nintedanib in non-clinical trial patients is unknown. Many patients with pulmonary fibrosis have significant medical co-morbidities or baseline characteristics that exclude them from clinical trial participation.MethodsWe conducted a retrospective chart review study on subjects prescribed nintedanib or pirfenidone for pulmonary fibrosis treatment (any aetiology) from September 2014 to February 2016. A total of 186 subjects were included: 129 received pirfenidone and 57 were prescribed nintedanib and followed up for mean observation periods of 5217weeks for pirfenidone and 4115weeks for nintedanib. The primary outcome was drug discontinuation as a result of an adverse event.Results Subjects had significant respiratory impairment at baseline, 63% required home oxygen therapy and mean diffusion capacity of carbon monoxide (DLCO) was 36 +/- 14% predicted. Drug discontinuation as a result of an adverse event occurred in 20.9% of subjects on pirfenidone and 26.3% on nintedanib. Drug discontinuation rates for both pirfenidone and nintedanib did not significantly differ from corresponding large clinical trials (ASCEND/CAPACITY and INPULSIS 1 and 2, respectively). Adverse events that occurred with highest frequency on pirfenidone were nausea (26.4%), rash/photosensitivity (14.7%) and dyspepsia/gastroesophageal reflux disease (GERD) (12.4%). Diarrhoea (52.6%) and nausea (29.8%) were reported most often with nintedanib therapy.Conclusion Patients with pulmonary fibrosis treated with nintedanib or pirfenidone in routine clinical practice had drug tolerability and adverse event profiles comparable with subjects enrolled in clinical trials despite having a greater degree of respiratory impairment and a high prevalence of co-morbid medical conditions.