CareLit Fachartikel

Pre-specified subgroup analyses of pooled data from the INPULSIS™ trials of nintedanib in idiopathic pulmonary fibrosis

U Costabel, L Richeldi, A Azuma, Y Inoue, HR Collard, I Tschoepe, S Stowasser, M Selman · Pneumologie · 2015 · Heft 02

Dokument
1144932
CareLit-ID
Jahr
2015
Publikation
PDF
nein
Metadaten
DOI
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Bibliografische Angaben

Zeitschrift
Pneumologie
Autor:innen
U Costabel, L Richeldi, A Azuma, Y Inoue, HR Collard, I Tschoepe, S Stowasser, M Selman
Ausgabe
Heft 02 / 2015
Seiten
–
Erschienen: 2015-02-04 00:00:00
ISSN
0934-8387
DOI
10.1055/s-0035-1544828

Zusammenfassung

Background: The two replicate randomized, double-blind, placebo-controlled, 52-week Phase III INPULSIS™ trials assessed the efficacy and safety of nintedanib 150 mg twice daily in patients with IPF. Nintedanib significantly reduced the annual rate of decline in forced vital capacity (FVC) in mL/year, the primary endpoint, in both trials (p < 0.001 for both), consistent with slowing disease progression. Statistically significant differences in favour of nintedanib on the key secondary endpoints (time to first acute exacerbation and change from baseline in St George's Respiratory Questionnaire [SGRQ] total score o…

Schlagworte

Baseline Inpulsis Trials Nintedanib Endpoints Pre-Specified Subgroup Analyses Pooled Patients Primary Secondary Pneumologie