• 主题
高级搜索  >
历史搜索 清空历史
首页> 外文期刊>BMJ Open Respiratory Research >Safety and survival data in patients with idiopathic pulmonary fibrosis treated with nintedanib: pooled data from six clinical trials
【24h】

Safety and survival data in patients with idiopathic pulmonary fibrosis treated with nintedanib: pooled data from six clinical trials

机译：Nintedanib治疗的特发性肺纤维化患者的安全性和生存数据：来自六个临床试验的汇总数据

获取原文
       
页面导航
  • 摘要
  • 著录项
  • 相似文献
  • 相关主题

摘要

Introduction Nintedanib slows disease progression in patients with idiopathic pulmonary fibrosis (IPF) by reducing the rate of decline in forced vital capacity, with an adverse event profile that is manageable for most patients. We used data from six clinical trials to characterise the safety and tolerability profile of nintedanib and to investigate its effects on survival.Methods Data from patients treated with ≥1?dose of nintedanib 150?mg two times per day or placebo in the 52-week TOMORROW trial and/or its open-label extension; the two 52-week INPULSIS trials and/or their open-label extension, INPULSIS-ON; and a Phase IIIb trial with a placebo-controlled period of ≥6 months followed by open-label nintedanib were pooled. All adverse events, irrespective of causality, were included in descriptive analyses. Parametric survival distributions were fit to pooled Kaplan-Meier survival data from the trials and extrapolated to estimate long-term survival.Results There were 1126 patients in the pooled nintedanib group and 565 patients in the pooled placebo group. The mean duration of nintedanib treatment was 28 months. No new safety signals were observed. Incidence rates of bleeding, liver enzyme elevations and cardiovascular events were consistent with those observed in the INPULSIS trials. Diarrhoea was reported at a lower event rate in the pooled nintedanib group than in nintedanib-treated patients in the INPULSIS trials (76.5 vs 112.6 events per 100 patient exposure-years) and infrequently led to permanent treatment discontinuation (3.6 events per 100 patient exposure-years). Based on the Weibull distribution, mean (95%?CI) survival was estimated as 11.6 (9.6, 14.1) years in nintedanib-treated patients and 3.7 (2.5, 5.4) years in placebo-treated patients.Conclusions Based on pooled data from six clinical trials, the adverse event profile of nintedanib was manageable for most patients. Exploratory analyses based on extrapolation of survival data suggest that nintedanib extends life expectancy in patients with IPF.
机译：简介Nintedanib通过降低强迫肺活量下降的速率来减慢特发性肺纤维化（IPF）患者的疾病进展，而不良反应可为大多数患者控制。我们使用来自六项临床试验的数据来表征nintedanib的安全性和耐受性特征，并研究其对生存的影响。方法每天两次两次或≥52 mg剂量的nintedanib 150 mg或安慰剂治疗的患者在52周内的数据TOMORROW试用版和/或其开放标签扩展名;两项52周的INPULSIS试验和/或其开放标签扩展名INPULSIS-ON;合并安慰剂对照期≥6个月的IIIb期试验，然后进行开放标签的nintedanib。描述性分析中包括所有不良事件，无论其是否因果关系。参数生存分布与试验中合并的Kaplan-Meier生存数据相符，并据此推断长期生存率。结果联合nintedanib组有1126例患者，安慰剂组有565例。 nintedanib治疗的平均持续时间为28个月。没有观察到新的安全信号。出血，肝酶升高和心血管事件的发生率与INPULSIS试验中观察到的一致。在INPULSIS试验中，nintedanib组合并腹泻的事件发生率低于nintedanib治疗组的患者（每100名患者暴露年76.5比112.6事件），很少导致永久性停药（每100名患者暴露3.6事件-年份）。根据Weibull分布，接受nintedanib治疗的患者的平均（95％？CI）生存期估计为11.6（9.6，14.1）年，而接受安慰剂治疗的患者的平均生存期为3.7（2.5，5.4）年。临床试验中，对于大多数患者而言，nintedanib的不良事件情况是可以控制的。基于生存数据推断的探索性分析表明，nintedanib延长了IPF患者的预期寿命。

著录项

相似文献

  • 外文文献
  • 中文文献
  • 专利
获取原文

客服邮箱：kefu@zhangqiaokeyan.com

京公网安备：11010802029741号 ICP备案号：京ICP备15016152号-6 六维联合信息科技 (北京) 有限公司©版权所有

  • 客服微信

  • 服务号