Table S1.
Time to subsequent event adjusted for inhaled corticosteroid use and exacerbation history
| Subsequent event | Index on-treatment exacerbation
|
|||
|---|---|---|---|---|
| Moderate
|
Severe (requiring hospitalization) | |||
| Treated with antibiotics only | Treated with systemic corticosteroids only | Treated with antibiotics and systemic corticosteroids | ||
| No of patients in the exacerbation analysis | N=3,028 | N=791 | N=2,577 | N=1,359 |
| Moderate to severe exacerbation, n (%) | 1,631 (53.9) | 450 (56.9) | 1,610 (62.5) | 700 (51.5) |
| HR versus antibiotics only (95% CI), P-value | – | 1.21 (1.09–1.34), 0.0004 | 1.33 (1.24–1.43), <0.0001 | 1.06 (0.97–1.16), 0.18 |
| HR versus hospitalized (95% CI), P-value | 0.94 (0.86–1.03), 0.18 | 1.14 (1.01–1.28), 0.03 | 1.25 (1.15–1.37), <0.0001 | – |
| Severe exacerbation, n (%) | 355 (11.7) | 135 (17.1) | 478 (18.5) | 483 (35.5) |
| HR versus antibiotics only (95% CI), P-value | – | 1.59 (1.30–1.94), <0.0001 | 1.63 (1.42–1.87), <0.0001 | 4.31 (3.76–4.95), <0.0001 |
| HR versus hospitalized (95% CI), P-value | 0.23 (0.20–0.27), <0.0001 | 0.37 (0.31–0.45), <0.0001 | 0.38 (0.33–0.43), <0.0001 | – |
| No of patients in the hospitalization, death, and discontinuation analysis | N=3,070 | N=820 | N=2,660 | N=1,486 |
| Hospitalization (all-cause), n (%) | 772 (25.1) | 242 (29.5) | 838 (31.5) | 758 (51.0) |
| HR versus antibiotics only (95% CI), P-value | – | 1.29 (1.11–1.49), 0.0007 | 1.32 (1.20–1.45), <0.0001 | 3.35 (3.03–3.70), <0.0001 |
| HR versus hospitalized (95% CI), P-value | 0.30 (0.27–0.33), <0.0001 | 0.38 (0.33–0.44), <0.0001 | 0.39 (0.36–0.44), <0.0001 | – |
| Death (all-cause), n (%) | 164 (5.3) | 64 (7.8) | 209 (7.9) | 240 (16.2) |
| HR versus antibiotics only (95% CI), P-value | – | 1.50 (1.12–2.00), 0.0059 | 1.47 (1.20–1.80), 0.0002 | 3.53 (2.90–4.31), <0.0001 |
| HR versus hospitalized (95% CI), P-value | 0.28 (0.23–0.35), <0.0001 | 0.43 (0.32–0.56), <0.0001 | 0.42 (0.35–0.50), <0.0001 | – |
| Death due to COPD, n (%) | 45 (1.5) | 26 (3.2) | 85 (3.2) | 106 (7.1) |
| HR versus antibiotics only (95% CI), P-value | – | 2.23 (1.38–3.62), 0.0011 | 2.15 (1.50–3.09), <0.0001 | 5.54 (3.91–7.86), <0.0001 |
| HR versus hospitalized (95% CI), P-value | 0.18 (0.13–0.26), <0.0001 | 0.40 (0.26–0.62), <0.0001 | 0.39 (0.29–0.52), <0.0001 | – |
| Discontinuation, n (%) | 435 (14.2) | 162 (19.8) | 509 (19.1) | 434 (29.2) |
| HR versus antibiotics only (95% CI), P-value | – | 1.46 (1.22–1.75), <0.0001 | 1.38 (1.21–1.56), <0.0001 | 2.52 (2.21–2.88), <0.0001 |
| HR versus hospitalized (95% CI), P-value | 0.40 (0.35–0.45), <0.0001 | 0.58 (0.48–0.69), <0.0001 | 0.55 (0.48–0.62), <0.0001 | – |
Notes: Time at risk of subsequent exacerbation started the day after the end of the first exacerbation and ended at treatment stop. Time at risk of subsequent hospitalization, discontinuation, or death started the day after the start of the first exacerbation and ended at treatment stop +30 days (or death) (for hospitalization), treatment stop (for discontinuation), or at last known date alive or death (for death).