Safety and tolerability of N-acetylcysteine (NAC) with pirfenidone in IPF: PANORAMA
J Behr, E Bendstrup, B Crestani, A Günther, H Olschewski, M Sköld, A Wells, W Wuyts, D Koschel, M Kreuter, B Wallaert, H Tang, J Beck, C Albera · Pneumologie · 2016 · Heft 02
Bibliografische Angaben
Zusammenfassung
Background: In Europe, NAC and pirfenidone are often combined in IPF clinical practice but the safety of this combination is unknown. Method: In this randomised, double-blind, placebo (PBO)-controlled, phase 2 study, European patients on a stable dose of 1602 – 2403 mg/day pirfenidone were randomised to 24 weeks of NAC (1800 mg/day) or PBO. Adverse events (AEs) and functional parameters (spirometry, 6MWD, and SOBQ) were collected up to 28 days after end of treatment. Results: 122 patients (98.4% White; 85.2% male; mean age 67.1 years) were randomised (NAC: 60; PBO: 62). Mean ± SD baseline % FVC and % DLCO were N…
