Interim analysis of nintedanib in an open-label extension of the INPULSIS® trials (INPULSIS®-ON)
M Kreuter, B Crestani, T Ogura, K Pelling, C Coeck, M Quaresma, M Kaye · Pneumologie · 2016 · Heft 02
Bibliografische Angaben
Zusammenfassung
Introduction: The INPULSIS® trials assessed the efficacy and safety of nintedanib 150 mg twice daily in patients with idiopathic pulmonary fibrosis. Nintedanib significantly reduced the annual rate of decline in forced vital capacity (FVC) compared with placebo in both trials. Patients who completed the 52-week treatment period and follow-up visit 4 weeks later (n = 807) could receive open-label nintedanib in an extension trial. Aim: To assess the long-term efficacy and safety of nintedanib. Methods: Patients treated with placebo in the INPULSIS® trials initiated treatment with nintedanib in the extension; patie…