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. 2015 Sep;24(137):420–427. doi: 10.1183/16000617.0042-2015

TABLE 1.

Real-life experience with pirfenidone in observational studies

First author [ref.] Country Patients n Patient characteristics Efficacy outcome Adverse events Treatment discontinuation due to adverse events %
GI Skin
Bonella [18] Germany 45 Age: 69±7 years Baseline FVC (% pred): 61±15 Baseline DLCO (% pred): 48±14 Stable lung function in 28 (70%) out of 40 patients; subjective improvement in cough in 12 (33%) out of 36 patients 17 (38) 10 (22) 13
Okuda [19] Japan 76 Age: 70.5±8.3 years Baseline FVC (% pred): 65.3±16.1 Baseline DLCO (% pred): 55.9±17.8 Reduction in FVC and DLCO decline 18 (24)# 19 (25) 18
Arai [20] Japan 41 Age: 70 (65.5–75.5) years Baseline VC (% pred): 66.7 (54.8–77.8) Significant reduction in VC decline in patients with severity grades I–II (Japanese Respiratory Society criteria) 24 (59)+ 5 (12)§ 15
Oltmanns [21] Germany 63 Age: 68±7 years Baseline FVC (% pred): 70±19 Baseline DLCO (% pred): 40±14 Stable lung function in 62% of patients N/A N/A 13
Chaudhuri [22] UK 40 Age: 65.8 (48–80) years Baseline FVC (% pred): 77.3 (range 46–146) Baseline DLCO (% pred): 42.4 (14–81) Reduction in FVC and DLCO decline at 9 months 87 10 15
Loeh [23] Germany and Italy 197 Age: 69.8±0.6 years Baseline FVC (% pred): 65±18.8 Baseline DLCO (% pred): 39.8±17 Decrease in annual decline in FVC; greater effect was observed in progressive IPF N/A N/A N/A
Harari [24] Italy 128 Age: 69±7 years Baseline FVC (% pred): 75±18 Baseline DLCO (% pred): 47±15 Decrease in annual decline in FVCƒ; greater effect in patients with more severe disease (GAP II–III and FVC at baseline ≤75% pred) N/A N/A N/A

Data are presented as mean±sd, mean (range) or n (%), unless otherwise stated. GI: gastrointestinal; FVC: forced vital capacity; DLCO: diffusing capacity of the lung for carbon monoxide; VC: vital capacity; N/A: not applicable; GAP: GAP severity index (a simple point-scoring system based on gender (G), age (A) and two lung physiology (P) variables (FVC and DLCO). #: gastric distress (n=9) and nausea (n=9); : photosensitivity (n=14) and rash (n=5); +: anorexia and/or nausea; §: photosensitivity; ƒ: relative change in FVC. Reproduced and modified from [25] with permission from the publisher.