RT Journal Article
SR Electronic
T1 Safety of nintedanib added to pirfenidone treatment for idiopathic pulmonary fibrosis
JF European Respiratory Journal
JO Eur Respir J
FD European Respiratory Society
SP 1800230
DO 10.1183/13993003.00230-2018
VO 52
IS 2
A1 Kevin R. Flaherty
A1 Charlene D. Fell
A1 J. Terrill Huggins
A1 Hilario Nunes
A1 Robert Sussman
A1 Claudia Valenzuela
A1 Ute Petzinger
A1 John L. Stauffer
A1 Frank Gilberg
A1 Monica Bengus
A1 Marlies Wijsenbeek
YR 2018
UL http://erj.ersjournals.com/content/52/2/1800230.abstract
AB We assessed safety and tolerability of treatment with pirfenidone (1602–2403 mg·day−1) and nintedanib (200–300 mg·day−1) in patients with idiopathic pulmonary fibrosis (IPF).This 24-week, single-arm, open-label, phase IV study (ClinicalTrials.gov identifier NCT02598193) enrolled patients with IPF with forced vital capacity % pred ≥50% and diffusing capacity of the lung for carbon monoxide % pred ≥30%. Before initiating nintedanib, patients had received pirfenidone for ≥16 weeks and tolerated a stable dose of ≥1602 mg·day−1 for ≥28 days. The primary end-point was the proportion of patients who completed 24 weeks of combination treatment on pirfenidone (1602–2403 mg·day−1) and nintedanib (200–300 mg·day−1). Investigators recorded treatment-emergent adverse events (TEAEs), attributing them to pirfenidone, nintedanib, both or neither.89 patients were enrolled; 73 completed 24 weeks of treatment (69 meeting the primary end-point) and 16 discontinued treatment prematurely (13 due to TEAEs). 74 patients had 418 treatment-related TEAEs, of which diarrhoea, nausea and vomiting were the most common. Two patients had serious treatment-related TEAEs.Combined pirfenidone and nintedanib use for 24 weeks was tolerated by the majority of patients with IPF and associated with a similar pattern of TEAEs expected for either treatment alone. These results encourage further study of combination treatment with pirfenidone and nintedanib in patients with IPF.Combined pirfenidone and nintedanib was tolerated by the majority of patients with IPF, encouraging further study http://ow.ly/1Iq030kaZuD