Effect of baseline emphysema on reduction in FVC decline with nintedanib in the INPULSIS™ trials
M Pfeifer, V Cottin, H Taniguchi, L Richeldi, HR Collard, M Kaye, DM Hansell, Z Bailes, R Schlenker-Herceg, G Raghu · Pneumologie · 2015 · Heft 02
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Zusammenfassung
Background: The INPULSIS™ trials were two replicate randomized, placebo-controlled, 52-week Phase III trials that assessed the efficacy and safety of nintedanib 150 mg twice daily in patients with IPF. In both trials, nintedanib slowed disease progression by significantly reducing the annual rate of decline in forced vital capacity (FVC), the primary endpoint, compared with placebo. Methods: A post-hoc subgroup analysis of the effect of nintedanib on the primary endpoint in patients with or without emphysema at baseline, as assessed on qualitative central assessment of chest high-resolution computed tomography (…
