Unadjusted 1-year risks of study outcomes for baseline statin users and non-users*†
| Outcome | Crude analysis, n (%) | Bivariate frailty model (statin users vs non-users) | ||||
|---|---|---|---|---|---|---|
| Statin users (N=276) | Statin non-users (N=348) | p Value | HR | 95% CI | p Value | |
| Disease-progression composite outcome‡ | 103 (37.3) | 152 (43.7) | 0.0737 | 0.79 | 0.61 to 1.02 | 0.0686 |
| First disease-progression outcome to occur§ | ||||||
| All-cause mortality | 13 (4.7) | 19 (5.5) | ||||
| Absolute FVC decrease ≥10% | 32 (11.6) | 52 (14.9) | ||||
| 6MWD decrease ≥50 m | 62 (22.5) | 92 (26.4) | ||||
| Mortality | ||||||
| All-cause | 18 (6.5) | 24 (6.9) | 0.8528 | 0.91 | 0.49 to 1.68 | 0.7557 |
| IPF-related | 15 (5.4) | 23 (6.6) | 0.5423 | 0.71 | 0.33 to 1.54 | 0.3814 |
| FVC change | ||||||
| Absolute decrease ≥10% | 43 (15.6) | 70 (20.1) | 0.1440 | 0.67 | 0.46 to 0.99 | 0.0417 |
| Relative decrease ≥10% | 77 (27.9) | 108 (31.0) | 0.3943 | 0.77 | 0.57 to 1.03 | 0.0814 |
| Absolute decrease ≥5% | 109 (39.5) | 147 (42.2) | 0.4881 | 0.81 | 0.63 to 1.04 | 0.0958 |
| Relative decrease ≥5% | 134 (48.6) | 191 (54.9) | 0.1157 | 0.76 | 0.61 to 0.95 | 0.0174 |
| Death or absolute FVC decrease ≥10% | 57 (9.1) | 90 (14.4) | 0.1277 | 0.71 | 0.51 to 0.99 | 0.0437 |
| Death or 6MWD decrease ≥50 m | 99 (15.9) | 142 (22.8) | 0.2086 | 0.85 | 0.66 to 1.10 | 0.2157 |
| 6MWD decrease ≥50 m | 69 (25.0) | 97 (27.9) | 0.4918 | 0.85 | 0.62 to 1.16 | 0.3046 |
| Hospitalisation | ||||||
| All-cause | 47 (17.0) | 72 (20.7) | 0.2477 | 0.78 | 0.54 to 1.13 | 0.1818 |
| Respiratory-related¶ | 30 (10.9) | 59 (17.0) | 0.0309 | 0.64 | 0.41 to 1.00 | 0.0496 |
*Only confirmed cases included, defined as those for whom follow-up assessment was repeated ≥6 weeks following initial assessment and criteria for outcome were met.
†Patients with missing baseline data were excluded from relevant analyses.
‡Only first event considered in analyses.
§Number of patients who experienced each outcome as their first disease-progression event.
¶Hospitalisation in which the primary reason for admission was determined to be respiratory-related by a blinded clinical investigator.
6MWD, 6-minute walk distance; IPF, idiopathic pulmonary fibrosis.