Nintedanib in patients with idiopathic pulmonary fibrosis and preserved lung volume.
Nintedanib in patients with idiopathic pulmonary fibrosis and preserved lung volume.
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DOI：
10.1136/thoraxjnl-2016-208710
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发表时间：
2017-04
期刊：
影响因子：
10
通讯作者：
du Bois RM
中科院分区：
文献类型：
--
作者：
Kolb M;Richeldi L;Behr J;Maher TM;Tang W;Stowasser S;Hallmann C;du Bois RM
对于特发性肺纤维化（IPF）的治疗何时开始尚无共识。有些医生不愿意治疗保留肺容量的病人。研究IPF和保留肺容量的患者是否与肺容量受损更严重的患者从尼达尼布中获得相同的益处。根据基线FVC %预测（≤90%,>90%）对两个重复的INPULSIS III期试验的合并数据进行事后亚组分析。基线时，274例患者FVC预测值达到90%，787例患者FVC预测值≤90%。在接受安慰剂治疗的患者中，FVC预测值为90%的患者和FVC预测值≤90%的患者（分别为- 224.6 mL/年和- 223.6 mL/年）FVC调整后的年下降率是一致的。这些亚组之间尼达尼布对FVC年下降率、圣乔治呼吸问卷总分从基线到首次急性加重的变化或时间的影响无统计学差异。在基线FVC预测值为90%和预测值≤90%的患者中，尼达尼布组FVC调整后的年下降率分别为- 91.5 mL/年（与安慰剂相比差异：133.1 mL/年（95% CI 68.0 ~ 198.2））和- 121.5 mL/年（与安慰剂相比差异：102.1 mL/年（95% CI 61.9 ~ 142.3））。与尼达尼布相关的不良事件在两个亚组中相似。IPF和保留肺容量（FVC >预测90%）的患者与肺容量受损更严重的患者具有相同的FVC下降率和从尼达尼布获得相同的获益。NCT01335464和NCT01335477。
There is no consensus as to when treatment for idiopathic pulmonary fibrosis (IPF) should be initiated. Some physicians prefer not to treat patients with preserved lung volume. To investigate whether patients with IPF and preserved lung volume receive the same benefit from nintedanib as patients with more impaired lung volume. Post hoc subgroup analyses of pooled data from the two replicate phase III INPULSIS trials by baseline FVC % predicted (≤90%, >90%). At baseline, 274 patients had FVC >90% predicted and 787 patients had FVC ≤90% predicted. In patients treated with placebo, the adjusted annual rate of decline in FVC was consistent between patients with FVC >90% predicted and FVC ≤90% predicted (−224.6 mL/year and −223.6 mL/year, respectively). There was no statistically significant difference between these subgroups in the effect of nintedanib on annual rate of decline in FVC, change from baseline in St George's Respiratory Questionnaire total score or time to first acute exacerbation. In patients with baseline FVC >90% predicted and ≤90% predicted, respectively, the adjusted annual rate of decline in FVC with nintedanib was −91.5 mL/year (difference vs placebo: 133.1 mL/year (95% CI 68.0 to 198.2)) and −121.5 mL/year (difference vs placebo: 102.1 mL/year (95% CI 61.9 to 142.3)). Adverse events associated with nintedanib were similar in both subgroups. Patients with IPF and preserved lung volume (FVC >90% predicted) have the same rate of FVC decline and receive the same benefit from nintedanib as patients with more impaired lung volume. NCT01335464 and NCT01335477.
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DOI：
10.1183/09059180.00008613
发表时间：
2014-03-01
期刊：
European respiratory review : an official journal of the European Respiratory Society
影响因子：
--
作者：
通讯作者：
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影响因子：
5.8
作者：
Hostettler KE;Zhong J;Papakonstantinou E;Karakiulakis G;Tamm M;Seidel P;Sun Q;Mandal J;Lardinois D;Lambers C;Roth M
通讯作者：
Roth M
影响因子：
158.5
作者：
Richeldi, Luca;Costabel, Ulrich;du Bois, Roland M.
通讯作者：
du Bois, Roland M.
影响因子：
24.3
作者：
Raghu, Ganesh;Million-Rousseau, Rachel;Behr, Juergen
通讯作者：
Behr, Juergen
DOI：
10.1164/rccm.2009-040gl
发表时间：
2011-03-15
影响因子：
24.7
作者：
Raghu, Ganesh;Collard, Harold R.;Schuenemann, Holger J.
通讯作者：
Schuenemann, Holger J.