Table S5.
Results during the 2 year outcome period for the initiation sample, unmatched cohorts, no treatment change
| Outcome | Extrafine BDP (n=413) |
Fluticasone (n=180) |
Adjusted odds, hazard, or rate ratio for extrafine BDP (95% CI) |
|---|---|---|---|
| Coprimary outcome measures | |||
| COPD treatment success (0 exacerbations) | 170 (41.2) | 79 (43.9) | OR 0.93 (0.64–1.37)b |
| Exacerbations over 2 years | RR 0.89 (0.66–1.20)c | ||
| 0 | 170 (41.2) | 79 (43.9) | |
| 1 | 98 (23.7) | 40 (22.2) | |
| 2–3 | 83 (20.1) | 36 (20.0) | |
| 4–6 | 46 (11.1) | 8 (4.4) | |
| ≥7 | 16 (3.9) | 17 (9.4) | |
| Secondary outcome measures | |||
| Time to first exacerbation, median (95% CI), days | HR 1.05 (0.82–1.34)d P-valuea |
||
|
| |||
| Disaggregated outcome measures | |||
| 1 oral corticosteroid course | 53 (12.8) | 22 (12.2) | 0.75 |
| ≥2 oral corticosteroid courses | 42 (10.2) | 15 (8.3) | |
| 1 lower respiratory infection + antibiotic Rx | 86 (20.8) | 35 (19.4) | 0.68 |
| ≥2 lower respiratory infections + antibiotic Rx | 76 (18.4) | 29 (16.1) | |
| ≥1 hospitalization for COPD or lower respiratory | 3 (0.7) | 1 (0.6) | 0.82 |
| Daily ICS dose (μg/d), median (IQR) | 219 (110–356) | 390 (138–740) | <0.001 |
| Daily SABA dose (μg/d), median (IQR) | 712 (329–1,315) | 712 (274–1,452) | 0.70 |
| Increase in ICS dose by ≥50% | 43 (10.4) | 18 (10.0) | 0.88 |
| Continuing LABA from baseline | 53 (12.8) | 46 (25.6) | |
| Confirmed pneumonia diagnosis | 1 (0.2) | 1 (0.6) | Not applicable |
Notes: Data are n (%) unless otherwise indicated.
Conditional logistic regression. Adjusted for baseline
adjusted for: age, antibiotics use (with a lower respiratory read code within a ±5 day window) (categorized), prescriptions for theophylline (Yes/No) and time between first coded diagnosis at practice and the index date (categorized)
adjusted for: age, rhinitis diagnosis (Yes/No), antibiotics use (with a lower respiratory read code within a ±5 day window) (categorized), acute use of oral steroids (categorized), number of lower respiratory-related consultations (categorized), beta blockers (Yes/No), prescriptions for theophylline (Yes/No) and Year of first coded diagnosis at practice (categorized)
adjusted for: age, antibiotics use (with a lower respiratory read code within a ±5 day window) (categorized), number of COPD consultations (categorized), prescriptions for theophylline (Yes/No) and inpatient admissions for COPD (Yes/No).
Abbreviations: HR, hazard ratio; OR, odds ratio; RR, rate ratio; BDP, beclomethasone dipropionate; CI, confidence interval; COPD, chronic obstructive pulmonary disease; ICS, inhaled corticosteroid; IQR, interquartile range; LABA, long-acting β2-agonist; Rx, treatment; SABA, short-acting β2-agonist.