Table 1.
Patient Demographics and Baseline Characteristics
| Characteristic | UMEC/VI (n=6536) | TIO/OLO (n=2067) |
|---|---|---|
| Age, years, mean (SD)a | 69.5 (10.6) | 70.0 (10.3) |
| Female, n (%) | 2857 (43.7) | 973 (47.1) |
| BMI, mean (SD)a,b | 27.2 (6.2) | 27.3 (6.4) |
| Patient region, n (%) | ||
| East Midlands | 72 (1.1) | 20 (1.0) |
| East of England | 172 (2.7) | 52 (2.5) |
| London | 493 (7.6) | 103 (5.0) |
| North East | 124 (1.9) | 207 (10.1) |
| North West | 1480 (22.8) | 542 (26.4) |
| South Central | 718 (11.1) | 460 (22.4) |
| South East Coast | 423 (6.5) | 126 (6.1) |
| South West | 1323 (20.4) | 333 (16.2) |
| West Midlands | 1075 (16.6) | 103 (5.0) |
| Yorkshire and the Humber | 601 (9.3) | 109 (5.3) |
| FEV1% predicted in baseline period, n (%)c | ||
| GOLD grade 1: FEV1% predicted ≥80% | 747 (14.7) | 240 (14.5) |
| GOLD grade 2: FEV1% predicted ≥50– < 80% | 3039 (59.9) | 1002 (60.7) |
| GOLD grade 3: FEV1% predicted ≥30– < 50% | 1156 (22.8) | 355 (21.5) |
| GOLD grade 4: FEV1% predicted < 30% | 135 (2.7) | 54 (3.3) |
| GOLD 2019 group, n (%)d | ||
| A | 2555 (42.1) | 786 (40.9) |
| B | 2249 (37.0) | 705 (36.7) |
| C | 652 (10.7) | 194 (10.1) |
| D | 618 (10.2) | 238 (12.4) |
| MRC Dyspnea Scale score, n (%)e | ||
| 1f | 611 (9.3) | 215 (10.4) |
| 2 | 2596 (39.7) | 765 (37.0) |
| 3 | 2043 (31.3) | 640 (31.0) |
| 4 | 734 (11.2) | 266 (12.9) |
| 5f | 90 (1.4) | 37 (1.8) |
| Unknown | 462 (7.1) | 144 (7.0) |
| Smoking status, n (%)a | ||
| Current smoker | 3690 (56.5) | 1160 (56.1) |
| Former smoker | 2721 (41.6) | 854 (41.3) |
| Non-smoker | 117 (1.8) | NRg |
| Unknown | 8 (0.1) | NRg |
| Comorbidities, n (%)h | ||
| Rheumatoid/osteoarthritis | 2211 (33.8) | 734 (35.5) |
| Depression | 2100 (32.1) | 682 (33.0) |
| Diabetes | 1383 (21.2) | 431 (20.9) |
| Anxiety | 1326 (20.3) | 396 (19.2) |
| Gastroesophageal reflux disease | 1222 (18.7) | 393 (19.0) |
| Stroke | 739 (11.3) | 234 (11.3) |
| Acute myocardial infarction | 716 (11.0) | 244 (11.8) |
| Congestive heart failure | 629 (9.6) | 193 (9.3) |
| Dementia/cognitive impairment | 487 (7.5) | 192 (9.3) |
| Bronchiectasis | 176 (2.7) | 65 (3.1) |
| Lung cancer | 62 (0.9) | 19 (0.9) |
| Current asthma diagnosis, n (%)i | 518 (8.1) | 194 (9.6) |
| Historical asthma diagnosis, n (%)j | 1106 (17.2) | 356 (17.5) |
| Moderate-to-severe exacerbations, n (%)k | 2014 (30.8) | 668 (32.3) |
| Respiratory therapies received in baseline period, n (%) | ||
| No use | 702 (10.7) | 141 (6.8) |
| Any use | 5834 (89.3) | 1926 (93.2) |
| LAMAl | 3669 (56.1) | 1240 (60.0) |
| SABA (not overlapping SAMA)l | 5220 (79.9) | 1765 (85.4) |
| SAMA (not overlapping SABA)l | 123 (1.9) | 29 (1.4) |
| SAMA/SABA (FDC and open)l | 158 (2.4) | NRg |
| Xanthinel | 14 (0.2) | NRg |
Notes: aAt index; bUMEC/VI: n=6438; TIO/OLO: n=2036; cUMEC/VI: n=5077; TIO/OLO: n=1651; dA composite measure of COPD severity using AECOPD events in the prior 12 months and MRC grade in the prior 24 months; eMost recent score in the 24 months prior to index; f1Not troubled by breathlessness except on strenuous exercise; f5Too breathless to leave the house; gResults based on small numbers of patients (n < 5) were suppressed, as well as the next-smallest value to protect primary suppression; hAt any time in the patients history; iAt any time in the 24 months pre-index (inclusive); j≥24 months pre-index; kBased on a validated algorithm, defined as the presence of one of the following events: i. Antibiotic and OCS prescriptions for 5–14 days with the same start date; ii. ≥2 symptoms of breathlessness, cough, sputum volume or purulence and an antibiotic or OCS prescription on the same day; iii. Lower respiratory tract infection code; iv. Exacerbation specific medical code; lPercentages calculated for the full cohort.
Abbreviations: AECOPD, acute exacerbations of COPD; BMI, body mass index; COPD, chronic obstructive pulmonary disease; FDC, fixed-dose combination; FEV1, forced expiratory volume in 1 second; GOLD, Global Initiative for Chronic Obstructive Lung Disease; LAMA, long-acting muscarinic antagonist; MRC, Medical Research Council; NR, not reported; OCS, oral corticosteroid; OLO, olodaterol; SABA, short-acting β2-agonist; SD, standard deviation; SAMA, short-acting muscarinic antagonist; TIO, tiotropium bromide; UMEC; umeclidinium; VI, vilanterol.