Pre-menopausal | Post-menopausal | |||||||
Placebo | Sirolimus | Between-group difference 95% CI | p-value | Placebo | Sirolimus | Between-group difference 95% CI | p-value | |
Subjects | 27 | 32 | 16 | 14 | ||||
Rate of decline of FEV1 mL·month−1 | −17±3 | −1±2 | 9.38–22.28 | <0.0001 | −3±3 | 6±3 | 0.73–17.45 | 0.04 |
Rate of decline of FVC mL·month−1 | −17±4 | 6±4 | 11.93–33.21 | 0.0001 | −3±4 | 16±6 | 4.52–33.28 | 0.03 |
Rate of decline of DLCO mL·mmHg−1·min−1·month−1 | −0.07±0.04 | −0.02±0.03 | −0.048–0.148 | 0.4 | −0.04±0.02 | 0.03±0.03 | −0.00–0.14 | 0.04 |
Serum VEGF-D slope pg·mL−1·month−1 | −15±20 | −99±18 | 31.24–136.56 | 0.003 | 22±27 | −54±31 | −3.93–156.93 | 0.07 |
Change in 6MWD m | 31±10 | 24±10 | −21.73–35.35 | 0.63 | 18±16 | 23±21 | −46.72–55.56 | 0.69 |
Change in VAS | −2.8±3.8 | 7±3.2 | 0.04–19.54 | 0.07 | −1.5±3.4 | 3.7±4.6 | −6.04–16.58 | 0.55 |
Change in FPI | −0.04±0.05 | 0.10±0.07 | −0.03–0.31 | 0.26 | −0.07±0.06 | 0.10±0.11 | −0.08–0.42 | 0.14 |
Data are presented as n or mean±se, unless otherwise stated. FEV1: forced expiratory volume in 1 s; FVC: forced vital capacity; DLCO: diffusion capacity of the lung for carbon monoxide; VEGF: vascular endothelial growth factor; 6MWD: 6-min walk distance; VAS: visual analogue scale; FPI: functional performance inventory.