Table S6.
Unadjusted and adjusted results during the 2 year outcome period for the step-up sample, unmatched cohorts, no treatment change
| Outcome | Extrafine BDP (n=178) |
Fluticasone (n=240) |
Adjusted odds, hazard, or rate ratio for extrafine BDP (95% CI) |
|---|---|---|---|
| Coprimary outcome measures | |||
| COPD treatment success (0 exacerbations) | 65 (36.5) | 86 (35.8) | OR 0.80 (0.50–1.29)b |
| Exacerbations over 2 years | RR 0.97 (0.74–1.26)c | ||
| 0 | 65 (36.5) | 86 (35.8) | |
| 1 | 43 (24.2) | 37 (15.4) | |
| 2–3 | 39 (21.9) | 55 (22.9) | |
| 4–6 | 19 (10.7) | 37 (15.4) | |
| ≥7 | 12 (6.7) | 25 (10.4) | |
| Secondary outcome measures | |||
| Time to first exacerbation, median (95% CI), days | HR 1.10 (0.85–1.42)d P-valuea |
||
|
| |||
| Disaggregated outcome measures | |||
| 1 oral corticosteroid course | 27 (15.2) | 37 (15.4) | 0.005 |
| ≥2 oral corticosteroid courses | 26 (14.6) | 66 (27.5) | |
| 1 lower respiratory infection + antibiotic Rx | 48 (27.0) | 46 (19.2) | 0.091 |
| ≥2 lower respiratory infections + antibiotic Rx | 29 (16.3) | 54 (22.5) | |
| ≥1 hospitalization for COPD or lower respiratory | 7 (3.9) | 3 (1.3) | 0.076 |
| Daily ICS dose (μg/d), median (IQR) | 411 (219–575) | 740 (432–1,027) | <0.001 |
| Daily SABA dose (μg/d), median (IQR) | 822 (329–1,315) | 1,096 (438–1,781) | 0.002 |
| Increase in ICS dose by ≥50% | 4 (2.2) | 12 (5.0) | 0.15 |
| Continuing LABA from baseline | 61 (34.3) | 121 (50.4) | 0.001 |
| Confirmed pneumonia diagnosis | 2 (1.1) | 2 (0.8) | 0.76 |
Notes: Data are n (%) unless otherwise indicated.
Conditional logistic regression. Adjusted for baseline
adjusted for: asthma diagnosis (Yes/No), GERD diagnosis and/or therapy (Yes/No), cardiac disease diagnosis and/or therapy (Yes/No), acute use of oral steroids (categorized), number of primary care consultations (categorized), prior LABA use (Yes/No) and time between first coded diagnosis at practice and the index date (categorized)
adjusted for: antibiotics use (with a lower respiratory read code within a ±5 day window) (categorized), acute use of oral steroids (categorized), number of COPD consultations (categorized), average daily ICS dose (categorized), prescriptions for paracetamol (Yes/No), prior LABA use (Yes/No) and time between first coded diagnosis at practice and IPD (categorized)
adjusted for: GERD diagnosis and/or therapy (Yes/No), antibiotics use (with a lower respiratory read code within a ±5 day window) (categorized 0–1/2+ to meet proportional hazards requirement), acute use of oral steroids (categorized 0–1/2+ to meet proportional hazards requirement), prior LABA use (Yes/No) and number of primary care consultations (categorized).
Abbreviations: HR, hazard ratio; OR, odds ratio; RR, rate ratio; BDP, beclomethasone dipropionate; CI, confidence interval; COPD, chronic obstructive pulmonary disease; GERD, gastroesophageal reflux disease; ICS, inhaled corticosteroid; IQR, interquartile range; LABA, long-acting β2-agonist; Rx, treatment; SABA, short-acting β2-agonist.