Studies included | Country | Sample size (P/C) | Age (mean±SD, years) | Males (%, P/C) | Study period (weeks) | Intervention | Primary outcome | ||
Pirfenidone | Controls | Pirfenidone | Controls | ||||||
Azuma et al, 200522 | Western | 72/35 | 64.0±7.1 | 64.3±7.6 | 62 (86.1%)/33 (94.3%) | 36 | Pirfenidone 1800 mg/day | Placebo pills | Change in the lowest SpO2 during 6MWT |
Taniguchi et al, 201023 | Asian | 108/55/104* | 65.4±6.2/63.9±7.5* | 64.7±7.3 | 85 (78.7%)/47 (85.4%)/81 (77.9%)* | 52 | Pirfenidone 1800 or 1200 mg/day* | Placebo pills | Change from baseline to week 52 in predicted FVC |
Noble et al, 2011 (PIPF 004)12 | Western | 174/87/174* | 65.7±8.2/68.0±7.6* | 66.3±7.5 | 118 (67.8%)/65 (74.7%)/128 (73.6%)* | 72 | Pirfenidone 2403 or 1197 mg/day* | Placebo pills | Change from baseline to week 72 in predicted FVC |
Noble et al, 2011 (PIPF 006)12 | Western | 171/177 | 66.8±7.9 | 67.0±7.8 | 123 (71.9%)/124 (70.1%) | 52 | Pirfenidone 2403 mg/day | Placebo pills | Change from baseline to week 72 in predicted FVC |
Kind et al 201424 | Western | 278/277 | 68.4±6.7 | 67.8±7.3 | 222 (80.0%)/213 (76.9%) | 48 | Pirfenidone 2403 mg/day | Placebo pills | Change from baseline to week 52 in predicted FVC |
Huang et al, 201511 | Asian | 38/38 | 59.0±5.9 | 61.6±6.4 | 33 (86.8%)/38 (100.0%) | 48 | Pirfenidone 1800 mg/day | Placebo pills | Change from baseline to week 48 in predicted FVC |
Furuya et al, 201721 | Asian | 20/27 | 76 (66–82) | 73 (64–84) | 18 (90.0%)/24 (88.9%) | 52 | Pirfenidone 1200–1800 mg/day | Placebo pills | 3 month survival and adverse events |
Nathan et al, 201914 | Western | 90/80 | 70 (46–80) | 69 (40–80)† | 74 (82.2%)/59 (73.8%) | 52 | Pirfenidone 1800 mg/day | Placebo pills | Change from baseline to week 52 in predicted FVC |
Vianello et al, 201925 | Western | 11/9 | 62 (52–78) | 74 (50–87)† | 9 (81.8%)/6 (66.7%) | 52 | Pirfenidone 2403 mg/day | Placebo pills | Change from baseline to week 52 in predicted FVC |
*Data for two trial groups and one control group.
†Range of age.
C, control group; FVC, forced vital capacity; 6MWT, 6 min walk test; NA, not available; P, pirfenidone group.