부산대학교 도서관

In the Phase III INPULSIS.sup.® trials, 52 weeks' treatment with nintedanib reduced decline in forced vital capacity (FVC) versus placebo in patients with idiopathic pulmonary fibrosis (IPF). Patients who completed the INPULSIS.sup.® trials could receive nintedanib in an open-label extension trial (INPULSIS.sup.®-ON). Patients with FVC 50 % predicted at the start of INPULSIS.sup.®-ON, the absolute mean change in FVC from baseline to week 48 of INPULSIS.sup.®-ON was -62.3 and -87.9 mL, respectively (n = 24 and n = 558, respectively). No new safety signals were identified in INPULSIS.sup.®-ON compared with INPULSIS.sup.®. The decline in FVC in INPULSIS.sup.®-ON in both subgroups by baseline FVC % predicted was similar to that in INPULSIS.sup.®, suggesting that nintedanib may have a similar effect on disease progression in patients with advanced disease as in less advanced disease.
Author(s): Wim A. Wuyts[sup.1] , Martin Kolb[sup.2] , Susanne Stowasser[sup.3] , Wibke Stansen[sup.3] , John T. Huggins[sup.4] , Ganesh Raghu[sup.5] Author Affiliations: (1) Unit for Interstitial Lung Diseases, Department of [...]