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Table 1 Baseline characteristics in the prespecified study period and post hoc extension study period

From: Real-world effectiveness of early intervention with fixed-dose tiotropium/olodaterol vs tiotropium in Japanese patients with COPD: a high-dimensional propensity score–matched cohort analysis

Variable Prespecified study period
(1 April 2015 to 31 March 2019)
Post hoc extension period
(1 April 2015 to 31 March 2020)
hdPS-matched cohort Unmatched cohort hdPS-matched cohort Unmatched cohort
Tio
n = 1302
Tio/Olo
n = 1302
Tio
n = 5352
Tio/Olo
n = 1436
Tio
n = 1723
Tio/Olo
n = 1723
Tio
n = 6505
Tio/Olo
n = 1860
Age at cohort entry, mean (SD), years 75.1 (8.9) 75.2 (8.5) 75.6 (8.9) 75.2 (8.4) 75.6 (8.8) 75.4 (8.5) 75.6 (8.9) 75.4 (8.5)
Male, n (%) 1140 (87.6) 1148 (88.2) 4573 (85.4) 1273 (88.6) 1524 (88.5) 1520 (88.2) 5543 (85.2) 1649 (88.7)
Year of cohort entry, n (%)         
 2015 + 2016 86 (6.6) 97 (7.5) 2196 (41.0) 99 (6.9) 86 (5.0) 84 (4.9) 2227 (34.2) 84 (4.5)
 2017 586 (45.0) 581 (44.6) 1815 (33.9) 617 (43.0) 527 (30.6) 528 (30.6) 1860 (28.6) 546 (29.4)
 2018 594 (45.6) 590 (45.3) 1282 (24.0) 679 (47.3) 566 (32.8) 569 (33.0) 1415 (21.8) 605 (32.5)
 2019 36 (2.8) 34 (2.6) 59 (1.1) 41 (2.9) 519 (30.1) 517 (30.0) 955 (14.7) 595 (32.0)
Hospital size by bed number, n (%)         
 < 199 beds 144 (11.1) 129 (9.9) 706 (13.2) 138 (9.6) 175 (10.2) 162 (9.4) 885 (13.6) 171 (9.2)
 200–499 beds 685 (52.6) 709 (54.5) 3031 (56.6) 760 (52.9) 924 (53.6) 929 (53.9) 3640 (56.0) 980 (52.7)
 ≥ 500 beds 472 (36.3) 462 (35.5) 1575 (29.4) 536 (37.3) 622 (36.1) 630 (36.6) 1937 (29.8) 707 (38.0)
Blood eosinophil count %, mean (SD)a 2.69 (2.56)b 2.89 (2.71)b 3.07 (3.13)c 2.93 (2.84)c 2.94 (3.28)d 2.99 (2.83)d 3.05 (3.28)e 2.93 (2.79)e
Respiratory events and medications, n (%)         
 All-cause hospitalization 524 (40.2) 535 (41.1) 2013 (37.6) 617 (43.0) 742 (43.1) 745 (43.2) 2507 (38.5) 846 (45.5)
 Hospitalization due to respiratory condition 475 (36.5) 485 (37.3) 1798 (33.6) 560 (39.0) 660 (38.3) 670 (38.9) 2240 (34.4) 762 (41.0)
 Cough and cold preparations 366 (28.1) 364 (28.0) 1240 (23.2) 436 (30.4) 485 (28.1) 477 (27.7) 1489 (22.9) 552 (29.7)
 Oral/injected corticosteroids 220 (16.9) 219 (16.8) 711 (13.3) 263 (18.3) 289 (16.8) 291 (16.9) 860 (13.2) 337 (18.1)
 COPD exacerbations 181 (13.9) 166 (12.7) 530 (9.9) 192 (13.4) 221 (12.8) 220 (12.8) 643 (9.9) 256 (13.8)
 COPD exacerbations + oral/injected corticosteroids 131 (10.1) 130 (10.0) 384 (7.2) 148 (10.3) 163 (9.5) 183 (10.6) 466 (7.2) 205 (11.0)
Other concomitant therapy, n (%)         
 Antihypertensives/diuretics 443 (34.0) 457 (35.1) 1738 (32.5) 520 (36.2) 635 (36.9) 629 (36.5) 2175 (33.4) 708 (38.1)
 Antithrombotic agents (including aspirin/DOAC) 382 (29.3) 391 (30.0) 1523 (28.5) 460 (32.0) 528 (30.6) 531 (30.8) 1909 (29.3) 601 (32.3)
 Antiepileptics/psycholeptics/psychoanaleptics (hypnotics/sedatives)f 325 (25.0) 315 (24.2) 1188 (22.2) 371 (25.8) 439 (25.5) 431 (25.0) 1475 (22.7) 497 (26.7)
 Hypnotics/sedatives (N5B)g 207 (15.9) 206 (15.8) 768 (14.3) 244 (17.0) 292 (17.0) 294 (17.1) 960 (14.8) 330 (17.7)
 Lipid-lowering agents 182 (14.0) 189 (14.5) 698 (13.0) 208 (14.5) 268 (15.6) 259 (15.0) 893 (13.7) 290 (15.6)
 Antirheumatics, non-steroidal 172 (13.2) 171 (13.1) 653 (12.2) 215 (15.0) 240 (13.9) 227 (13.2) 771 (11.9) 269 (14.5)
Comorbidities before cohort entry, n (%)         
 Hypertension 237 (18.2) 253 (19.4) 1069 (20.0) 288 (20.1) 339 (19.7) 354 (20.5) 1332 (20.5) 394 (21.2)
 Pneumonia 246 (18.9) 244 (18.7) 911 (17.0) 286 (19.9) 339 (19.7) 344 (20.0) 1119 (17.2) 399 (21.5)
 Heart failure 200 (15.4) 203 (15.6) 821 (15.3) 229 (15.9) 265 (15.4) 274 (15.9) 1017 (15.6) 297 (16.0)
 Any cancer (except non-melanoma skin cancer) 147 (11.3) 145 (11.1) 469 (8.8) 178 (12.4) 208 (12.1) 204 (11.8) 580 (8.9) 236 (12.7)
 Gastroesophageal reflux disease 141 (10.8) 142 (10.9) 672 (12.6) 165 (11.5) 198 (11.5) 211 (12.2) 796 (12.2) 235 (12.6)
 Type 2 diabetes mellitus 131 (10.1) 126 (9.7) 481 (9.0) 151 (10.5) 184 (10.7) 188 (10.9) 594 (9.1) 215 (11.6)
 Chronic bronchitis 65 (5.0) 74 (5.7) 264 (4.9) 86 (6.0) 79 (4.6) 89 (5.2) 314 (4.8) 100 (5.4)
  1. COPD chronic obstructive pulmonary disease, DOAC direct oral anticoagulant, hdPS high-dimensional propensity score, n number of patients, SD standard deviation, Tio tiotropium, Tio/Olo tiotropium/olodaterol
  2. aBlood eosinophil count was not included in the hdPS models
  3. bData only included for 50 (3.8%) patients in the tiotropium group and 68 (5.2%) patients in the tiotropium/olodaterol group
  4. cData only included for 178 (3.3%) patients in the tiotropium group and 76 (5.3%) patients in the tiotropium/olodaterol group
  5. dData only included for 63 (3.7%) patients in the tiotropium group and 81 (4.7%) patients in the tiotropium/olodaterol group
  6. eData only included for 211 (3.2%) patients in the tiotropium group and 85 (4.6%) patients in the tiotropium/olodaterol group
  7. fIncludes hypnotics/sedatives
  8. gNot included in the hdPS models