Consistent effect of nintedanib on decline in FVC in patients across subgroups based on HRCT diagnostic criteria: results from the INPULSIS® trials in idiopathic pulmonary fibrosi…
M Pfeifer, G Raghu, A Wells, AG Nicholson, L Richeldi, KR Flaherty, F Le Maulf, S Stowasser, R Schlenker-Herceg, DM Hansell · Pneumologie · 2016 · Heft 02
Bibliografische Angaben
Zusammenfassung
Background: The randomized, placebo-controlled, 52-week INPULSIS® trials assessed efficacy and safety of nintedanib 150 mg bid in patients with IPF. Nintedanib significantly reduced annual rate of FVC decline vs. placebo (primary endpoint) in both trials). Key secondary endpoints were time to first acute exacerbation and change from baseline in SGRQ total score, both over 52 weeks. Methods: If a surgical lung biopsy was unavailable, HRCT criteria A + B + C; or A + C; or B + C had to be met (A = definite honeycombing with basal and peripheral predominance, B = presence of reticular abnormality and traction bronch…
