Demographic and clinical characteristics of incident users
Characteristics | Overall incident users | Non-triple users | IMT users | |||||||||
Overall n=13 451 | BDP/FOR n=6122 | BUD/FOR n=2703 | Other ICS/LABA* n=4626 | Overall n=7448 | BDP/FOR n=3601 | BUD/FOR n=1432 | Other ICS/LABA* n=2415 | Overall n=5162 | BDP/FOR n=2427 | BUD/FOR n=1056 | Other ICS/LABA* n=1679 | |
Demographic characteristics | ||||||||||||
Age at index, years, mean (SD)† | 68.7 (10.8) | 68.7 (10.8) | 68.6 (10.8) | 68.8 (10.7) | 68.5 (11.1) | 68.6 (11.1) | 68.3 (11.2) | 68.6 (10.9) | 67.6 (11.3) | 67.8 (11.3) | 67.5 (11.3) | 67.4 (11.1) |
Female, n (%) | 6046 (45.0) | 2818 (46.0) | 1214 (44.9) | 2014 (43.5) | 3436 (46.1) | 1683 (46.7) | 664 (46.4) | 1089 (45.1) | 2361 (45.7) | 1130 (46.6) | 460 (43.6) | 771 (45.9) |
Patient region, n (%) | ||||||||||||
North East | 1262 (9.4) | 320 (5.2) | 624 (23.1) | 318 (6.9) | 564 (7.6) | 153 (4.3) | 273 (19.1) | 138 (5.7) | 425 (8.2) | 96 (4.0) | 211 (20.0) | 118 (7.0) |
North West | 2649 (19.7) | 1284 (21.0) | 439 (16.3) | 926 (20.0) | 1445 (19.4) | 718 (19.9) | 218 (15.2) | 509 (21.1) | 984 (19.1) | 472 (19.5) | 157 (14.9) | 355 (21.2) |
Yorkshire and The Humber | 530 (3.9) | 273 (4.5) | 57 (2.1) | 200 4.3) | 266 (3.6) | 142 (3.9) | 34 (2.4) | 90 (3.7) | 193 (3.7) | 103 (4.2) | 26 (2.5) | 64 (3.8) |
East Midlands | 412 (3.1) | 288 (4.7) | 72 (2.7) | 52 (1.1) | 260 (3.5) | 190 (5.3) | 46 (3.2) | 24 (1.0) | 143 (2.8) | 96 (4.0) | 30 (2.8) | 17 (1.0) |
West Midlands | 2397 (17.8) | 1312 (21.4) | 362 (13.4) | 723 (15.6) | 1394 (18.7) | 840 (23.3) | 192 (13.4) | 362 (15.0) | 988 (19.1) | 587 (24.2) | 140 (13.3) | 261 (15.6) |
East of England | 663 (4.9) | 297 (4.9) | 133 (4.9) | 233 (5.0) | 365 (4.9) | 160 (4.4) | 77 (5.4) | 128 (5.3) | 260 (5.0) | 114 (4.7) | 65 (6.2) | 81 (4.8) |
South West | 1567 (11.7) | 617 (10.1) | 295 (10.9) | 655 (14.2) | 912 (12.3) | 389 (10.8) | 179 (12.5) | 344 (14.3) | 633 (12.3) | 259 (10.7) | 124 (11.7) | 250 (14.9) |
South Central | 1623 (12.1) | 926 (15.1) | 173 (6.4) | 524 (11.3) | 876 (11.8) | 524 (14.6) | 92 (6.4) | 260 (10.8) | 600 (11.6) | 361 (14.9) | 67 (6.3) | 172 (10.3) |
London | 1435 (10.7) | 531 (8.7) | 360 (13.3) | 544 (11.8) | 861 (11.6) | 319 (8.9) | 217 (15.2) | 325 (13.5) | 585 (11.3) | 217 (8.9) | 161 (15.3) | 207 (12.3) |
South East Coast | 909 (6.8) | 273 (4.5) | 187 (6.9) | 449 (9.7) | 502 (6.7) | 166 (4.6) | 103 (7.2) | 233 (9.7) | 350 (6.8) | 122 (5.0) | 75 (7.1) | 153 (9.1) |
Socioeconomic status, IMD, n (%) | ||||||||||||
Quintile 1 | 2110 (15.7) | 1024 (16.7) | 371 (13.7) | 715 (15.5) | 1234 (16.6) | 615 (17.1) | 212 (14.8) | 407 (16.9) | 819 (15.9) | 393 (16.2) | 161 (15.3) | 265 (15.8) |
Quintile 2 | 2325 (17.3) | 1047 (17.1) | 438 (16.2) | 840 (18.2) | 1300 (17.5) | 629 (17.5) | 238 (16.6) | 433 (18.0) | 903 (17.5) | 428 (17.6) | 180 (17.1) | 295 (17.6) |
Quintile 3 | 2587 (19.2) | 1157 (18.9) | 546 (20.2) | 884 (19.1) | 1476 (19.8) | 684 (19.0) | 318 (22.2) | 474 (19.7) | 1016 (19.7) | 465 (19.2) | 211 (20.0) | 340 (20.3) |
Quintile 4 | 2939 (21.9) | 1293 (21.1) | 621 (23.0) | 1025 (22.2) | 1567 (21.1) | 756 (21.0) | 304 (21.2) | 507 (21.0) | 1148 (22.2) | 532 (21.9) | 246 (23.3) | 370 (22.0) |
Quintile 5 | 3483 (25.9) | 1600 (26.1) | 725 (26.8) | 1158 (25.1) | 1867 (25.1) | 917 (25.5) | 359 (25.1) | 591 (24.5) | 1276 (24.7) | 609 (25.1) | 258 (24.4) | 409 (24.4) |
Clinical characteristics | ||||||||||||
BMI at index, kg/m2, mean (SD) | ||||||||||||
n | 11 312 | 5292 | 2272 | 3748 | 6180 | 3058 | 1195 | 1927 | 4144 | 2002 | 847 | 1295 |
Mean (SD) | 27.8 (6.9) | 27.8 (6.8) | 27.7 (6.8) | 27.8 (7.1) | 27.9 (6.9) | 27.9 (6.8) | 27.7 (6.7) | 28.0 (7.3) | 27.7 (6.9) | 27.8 (6.8) | 27.3 (6.7) | 27.9 (7.0) |
Smoking status at index, n (%) | ||||||||||||
Current smoker | 7149 (53.2) | 3248 (53.1) | 1464 (54.2) | 2437 (52.7) | 3911 (52.5) | 1884 (52.3) | 755 (52.7) | 1272 (52.7) | 2810 (54.4) | 1295 (53.4) | 565 (53.5) | 950 (56.6) |
Former smoker | 5951 (44.2) | 2717 (44.4) | 1172 (43.4) | 2062 (44.6) | 3298 (44.3) | 1609 (44.7) | 626 (43.7) | 1063 (44.0) | 2165 (41.9) | 1040 (42.9) | 455 (43.1) | 670 (39.9) |
Non-smoker | NR‡ | NR‡ NR‡ | NR‡ NR‡ | NR‡ NR‡ | NR‡ NR‡ | NR‡ NR‡ | NR‡ NR‡ | NR‡ NR‡ | NR‡ NR‡ | NR‡ NR‡ | NR‡ NR‡ | NR‡ NR‡ |
Unknown | NR‡ | |||||||||||
FEV1/FVC ratio, FEV1 %, mean (SD) | ||||||||||||
n | 10 408 | 4664 | 2076 | 3668 | 5775 | 2759 | 1091 | 1925 | 4020 | 1888 | 794 | 1338 |
Mean (SD) | 58.6 (13.4) | 58.5 (13.4) | 59.3 (13.8) | 58.3 (13.3) | 59.9 (12.8) | 59.8 (12.8) | 61.2 (12.9) | 59.4 (12.8) | 59.0 (12.7) | 59.2 (12.8) | 59.5 (13.5) | 58.5 (12.3) |
% predicted FEV1, mean (SD)§ | ||||||||||||
n | 9979 | 4619 | 2009 | 3351 | 5468 | 2710 | 1037 | 1721 | 3766 | 1829 | 765 | 1172 |
Mean (SD) | 58.9 (18.4) | 59.1 (18.4) | 58.5 (18.5) | 59.0 (18.2) | 60.9 (18.3) | 60.9 (18.3) | 60.4 (18.4) | 61.1 (18.2) | 59.9 (18.4) | 60.1 (18.2) | 58.6 (18.9) | 60.4 (18.3) |
Category, n (%) | ||||||||||||
GOLD 1: FEV1 % predicted ≥80% | 1410 (14.1) | 674 (14.6) | 269 (13.4) | 467 (13.9) | 895 (16.4) | 446 (16.5) | 160 (15.4) | 289 (16.8) | 573 (15.2) | 269 (14.7) | 109 (14.25) | 195 (16.6) |
GOLD 2: FEV1 % predicted ≥50%–<80% | 5359 (53.7) | 2480 (53.7) | 1072 (53.4) | 1807 (53.9) | 3053 (55.8) | 1530 (56.5) | 576 (55.5) | 947 (55.0) | 2037 (54.1) | 1025 (56.0) | 391 (51.11) | 621 (53.0) |
GOLD 3: FEV1 % predicted ≥30%–<50% | 2749 (27.6) | 1248 (27.0) | 566 (28.2) | 935 (27.9) | 1309 (23.9) | 631 (23.3) | 257 (24.8) | 421 (24.5) | 998 (26.5) | 466 (25.5) | 221 (28.89) | 311 (26.5) |
GOLD 4: FEV1 % predicted <30% | 461 (4.6) | 217 (4.7) | 102 (5.1) | 142 (4.2) | 211 (3.9) | 103 (3.8) | 44 (4.2) | 64 (3.7) | 158 (4.2) | 69 (3.8) | 44 (5.75) | 45 (3.8) |
MRC Dyspnoea Scale score, n (%) | ||||||||||||
1† | 1748 (13.0) | 817 (13.4) | 345 (12.8) | 586 (12.7) | 1120 (15.0) | 536 (14.9) | 227 (15.9) | 357 (14.8) | 782 (15.2) | 353 (14.5) | 179 (17.0) | 250 (14.9) |
2 | 4803 (35.7) | 2200 (35.9) | 969 (35.9) | 1634 (35.3) | 2595 (34.8) | 1263 (35.1) | 499 (34.9) | 833 (34.5) | 1467 (28.4) | 724 (29.8) | 293 (27.8) | 450 (26.8) |
3 | 2927 (21.8) | 1306 (21.3) | 586 (21.7) | 1035 (22.4) | 1329 (17.8) | 635 (17.6) | 248 (17.3) | 446 (18.5) | 662 (12.8) | 311 (12.8) | 131 (12.4) | 220 (13.1) |
4 | 1028 (7.6) | 454 (7.4) | 203 (7.5) | 371 (8.0) | 403 (5.4) | 203 (5.6) | 68 (4.8) | 132 (5.5) | 190 (3.7) | 100 (4.1) | 33 (3.1) | 57 (3.4) |
5¶ | 157 (1.2) | 84 (1.4) | 22 (0.8) | 51 (1.1) | 56 (0.8) | 36 (1.0) | 7 (0.5) | 13 (0.5) | 29 (0.6) | 16 (0.7) | 6 (0.6) | 7 (0.4) |
Unknown | 2788 (20.7) | 1261 (20.6) | 578 (21.4) | 949 (20.5) | 1945 (26.1) | 928 (25.8) | 383 (26.8) | 634 (26.5) | 2032 (39.4) | 923 (38.0) | 414 (39.2) | 695 (41.4) |
Number of comorbidities, mean (SD) | 1.9 (1.5) | 1.8 (1.5) | 1.8 (1.5) | 1.9 (1.5) | 1.9 (1.5) | 1.9 (1.5) | 1.8 (1.5) | 1.9 (1.5) | 1.8 (1.5) | 1.8 (1.5) | 1.7 (1.5) | 1.8 (1.5) |
Comorbidities, n (%) | ||||||||||||
Depression | 5647 (42.0) | 2509 (41.0) | 1170 (43.3) | 1968 (42.5) | 3123 (41.9) | 1474 (40.9) | 611 (42.7) | 1038 (43.0) | 2097 (40.6) | 966 (39.8) | 422 (40.0) | 709 (42.2) |
Anxiety | 3648 (27.1) | 1681 (27.5) | 725 (26.8) | 1242 (26.6) | 2041 (27.4) | 995 (27.6) | 379 (26.5) | 667 (27.6) | 1365 (26.4) | 639 (26.3) | 262 (24.8) | 464 (27.6) |
Gastro-oesophageal reflux disease | 3119 (23.2) | 1445 (23.6) | 603 (22.3) | 1071 (23.2) | 1791 (24.1) | 871 (24.2) | 319 (22.3) | 601 (24.9) | 1159 (22.5) | 563 (23.2) | 218 (20.6) | 378 (22.5) |
Acute myocardial infarction | 1565 (11.6) | 705 (11.5) | 294 (10.9) | 566 (12.2) | 845 (11.4) | 407 (11.3) | 165 (11.5) | 273 (11.3) | 556 (10.8) | 253 (10.4) | 119 (11.3) | 184 (11.0) |
Congestive heart failure | 1788 (13.3) | 785 (12.8) | 350 (13.0) | 653 (14.1) | 970 (13.0) | 447 (12.4) | 182 (12.7) | 341 (14.1) | 631 (12.2) | 272 (11.2) | 129 (12.2) | 230 (13.7) |
Stroke | 1655 (12.3) | 743 (12.1) | 335 (12.4) | 577 (12.5) | 914 (12.3) | 440 (12.2) | 174 (12.2) | 300 (12.4) | 607 (11.8) | 290 (12.0) | 122 (11.6) | 195 (11.6) |
Bronchiectasis | 483 (3.6) | 221 (3.6) | 91 (3.4) | 171 (3.7) | 273 (3.7) | 136 (3.8) | 50 (3.5) | 87 (3.6) | 162 (3.1) | 75 (3.1) | 34 (3.2) | 53 (3.2) |
Dementia/cognitive impairment | 1481 (11.0) | 686 (11.2) | 255 (9.4) | 540 (11.7) | 841 (11.3) | 414 (11.5) | 135 (9.4) | 292 (12.1) | 527 (10.2) | 249 (10.3) | 93 (8.8) | 185 (11.0) |
Rheumatoid/osteoarthritis | 5498 (40.9) | 2490 (40.7) | 1108 (41.0) | 1900 (41.1) | 3093 (41.5) | 1486 (41.3) | 583 (40.7) | 1024 (42.4) | 2018 (39.1) | 950 (39.1) | 389 (36.8) | 679 (40.4) |
Current asthma diagnosis, n (%)§ | 2797 (20.8) | 1429 (23.3) | 509 (18.8) | 859 (18.6) | 1884 (25.3) | 1002 (27.8) | 316 (22.1) | 566 (23.4) | 1436 (27.8) | 768 (31.6) | 244 (23.1) | 424 (25.3) |
Historical asthma diagnosis, n (%)§ | 3545 (26.4) | 1701 (27.8) | 684 (25.3) | 1160 (25.1) | 2168 (29.1) | 1085 (30.1) | 403 (28.1) | 680 (28.2) | 1466 (28.4) | 741 (30.5) | 270 (25.6) | 455 (27.1) |
AECOPD in the 12 months prior to index | ||||||||||||
Moderate-to-severe | ||||||||||||
Patients with ≥1 AECOPD, n (%) | 5717 (42.5) | 2543 (41.5) | 1085 (40.1) | 2089 (45.2) | 2886 (38.8) | 1379 (38.3) | 517 (36.1) | 990 (41.0) | 1920 (37.2) | 892 (36.8) | 367 (34.8) | 661 (39.4) |
Mean AECOPD per patient‡ (SD) | 0.7 (1.0) | 0.7 (1.0) | 0.6 (0.9) | 0.7 (1.0) | 0.6 (0.9) | 0.6 (0.9) | 0.5 (0.9) | 0.6 (0.9) | 0.5 (0.8) | 0.5 (0.9) | 0.5 (0.8) | 0.6 (0.9) |
Moderate | ||||||||||||
Patients with ≥1 AECOPD, n (%) | 4686 (34.8) | 2079 (34.0) | 888 (32.9) | 1719 (37.2) | 2424 (32.6) | 1140 (31.7) | 444 (31.0) | 840 (34.8) | 1576 (30.5) | 730 (30.1) | 294 (27.8) | 552 (32.9) |
Mean AECOPD per patient‡ (SD) | 0.5 (0.9) | 0.5 (0.9) | 0.5 (0.8) | 0.5 (0.9) | 0.5 (0.8) | 0.5 (0.9) | 0.4 (0.8) | 0.5 (0.8) | 0.4 (0.8) | 0.4 (0.8) | 0.4 (0.7) | 0.5 (0.8) |
Severe | ||||||||||||
Patients with ≥1 AECOPD, n (%) | 1596 (11.9) | 711 (11.6) | 307 (11.4) | 578 (12.5) | 680 (9.1) | 353 (9.8) | 107 (7.5) | 220 (9.1) | 472 (9.1) | 224 (9.2) | 96 (9.1) | 152 (9.1) |
Mean AECOPD per patient‡ (SD) | 0.1 (0.4) | 0.1 (0.4) | 0.1 (0.4) | 0.2 (0.3) | 0.1 (0.4) | 0.1 (0.4) | 0.1 (0.3) | 0.1 (0.4) | 0.1 (0.3) | 0.1 (0.3) | 0.1 (0.3) | 0.1 (0.3) |
GOLD 2019 group, n (%) | ||||||||||||
A | 3832 (34.7) | 1830 (36.3) | 799 (36.4) | 1203 (31.7) | 2327 (40.6) | 1168 (41.7) | 469 (43.0) | 690 (37.5) | 1449 (43.2) | 720 (44.5) | 310 (45.3) | 419 (39.9) |
B | 2283 (20.7) | 1041 (20.6) | 463 (21.1) | 779 (20.5) | 1038 (18.1) | 511 (18.3) | 190 (17.4) | 337 (18.3) | 525 (15.7) | 262 (16.2) | 102 (14.9) | 161 (15.3) |
C | 1763 (16.0) | 754 (15.0) | 355 (16.2) | 654 (17.3) | 930 (16.2) | 403 (14.4) | 189 (17.3) | 338 (18.4) | 552 (16.5) | 237 (14.7) | 123 (18.0) | 192 (18.3) |
D | 3155 (28.6) | 1419 (28.1) | 580 (26.4) | 1156 (30.5) | 1436 (25.1) | 717 (25.6) | 242 (22.2) | 477 (25.9) | 827 (24.7) | 398 (24.6) | 150 (21.9) | 279 (26.6) |
Eosinophil count, 109 cells/L, mean (SD) | ||||||||||||
n | 7200 | 3261 | 1474 | 2465 | 4101 | 1975 | 799 | 1327 | 2879 | 1349 | 601 | 929 |
Mean (SD) | 0.24 (0.16) | 0.24 (0.16) | 0.23 (0.16) | 0.24 (0.16) | 0.24 (0.16) | 0.24 (0.16) | 0.23 (0.16) | 0.24 (0.16) | 0.24 (0.16) | 0.23 (0.16) | 0.23 (0.16) | 0.24 (0.16) |
Values of ‘n’ are indicated in italics to differentiate from the Mean (SD).
*Included fluticasone propionate/salmeterol, fluticasone propionate/formoterol fumarate and fluticasone furoate/vilanterol.
†Not troubled by breathlessness except on strenuous exercise.
‡Included all patients with or without ≥1 AECOPD; results based on small numbers of patients (n<5) were suppressed, as well as related values to protect primary suppression.
§Current and historical asthma were not mutually exclusive.
¶Too breathless to leave the house or breathless when dressing/undressing.
AECOPD, acute exacerbation of chronic obstructive pulmonary disease; BDP, beclomethasone dipropionate; BMI, body mass index; BUD, budesonide; FEV1, forced expiratory volume in 1 s; FOR, formoterol; FVC, forced vital capacity; GOLD, Global Initiative for Chronic Obstructive Lung Disease; ICS, inhaled corticosteroids; IMD, Index of Multiple Deprivation; IMT, initial maintenance therapy; LABA, long-acting β2-agonist; MRC, Medical Research Council; NR, not reported; SD, standarad deviation.