Table 1 Sample Derivation, Demographics, and Pre-Index Clinical Characteristics and Costs
Sample Derivation | |||||||
|---|---|---|---|---|---|---|---|
Total number of patients with ≥ 1 TIO prescription during study period | 85,153 | ||||||
Reason for exclusion, n (%) | |||||||
< 40 years old as of index date | 3347 (3.9) | ||||||
Absence of continuous health plan eligibility | 19,743 (23.2) | ||||||
Absence of ≥ 1 claim with diagnosis code for COPD | 29,216 (34.3) | ||||||
Presence of FSC in the pre-index period | 20,510 (24.1) | ||||||
Presence of exclusionary comorbid conditions | 14,448 (17.0) | ||||||
Absence of index TIO prescription date during enrollment period | 219 (0.26) | ||||||
Absence of COPD-related exacerbation in the pre-index period | 61,619 (72.4) | ||||||
Absence of ipratropium/ipratropium-albuterol in the pre-index period | 22,691 (26.7) | ||||||
Presence of a COPD-related exacerbation or hospital/emergency room visit in 30-day outcome-free period | 6317 (7.4) | ||||||
Follow-up ending during the 30-day outcome-free period | 10,779 (12.7) | ||||||
Final sample, N | 3333 | ||||||
Total | TIO | TIO+FSC | P -value | ||||
N = 3333 | n = 2481 | n = 852 | |||||
Demographics | |||||||
Mean age, years (SD) | 65.7 | (10.9) | 66.1 | (10.9) | 64.6 | (11.0) | 0.0008 |
Male, n (%) | 1565 | (47.0%) | 1166 | (47.0%) | 399 | (46.8%) | 0.9332 |
Region, n (%) | |||||||
East | 970 | (29.1%) | 711 | (28.7%) | 259 | (30.4%) | |
Midwest | 1283 | (38.5%) | 938 | (37.8%) | 345 | (40.5%) | |
South | 560 | (16.8%) | 404 | (16.3%) | 156 | (18.3%) | |
West | 520 | (15.6%) | 428 | (17.3%) | 92 | (10.8%) | |
Comorbidity in pre-index period | |||||||
Charlson index (mean, SD) | 1.98 | (2.1) | 1.91 | (2.1) | 2.18 | (2.3) | 0.0018 |
Presence of asthma (%) | 1084 | (32.5%) | 757 | (30.5%) | 327 | (38.4%) | < .0001 |
COPD severity in pre-index period | |||||||
Mean (SD) short-acting beta-agonist canisters | 2.38 | (5.1) | 2.43 | (5.0) | 2.22 | (5.4) | 0.3197 |
Mean (SD) oral corticosteroid prescriptions | 2.03 | (2.8) | 2.09 | (2.9) | 1.87 | (2.3) | 0.0253 |
Mean (SD) ipratropium or ipratropium/albuterol canisters | 5.01 | (6.9) | 5.12 | (6.9) | 4.72 | (6.9) | 0.1451 |
Mean (SD) classes of maintenance medication* | 0.48 | (0.7) | 0.52 | (0.7) | 0.37 | (0.6) | < .0001 |
Use of home oxygen therapy, n (%) | 1049 | (31.5%) | 801 | (32.3%) | 248 | (29.1%) | 0.0849 |
Presence of intensive care unit stay for COPD, n (%) | 110 | (3.3%) | 81 | (3.3%) | 29 | (3.4%) | 0.8447 |
Hospital visits for COPD | |||||||
n (%) | 695 | (20.9%) | 467 | (18.8%) | 228 | (26.8%) | < .0001 |
Mean (SD) | 0.24 | (0.5%) | 0.22 | (0.5%) | 0.31 | (0.5%) | 0.0002 |
Emergency room visits for COPD | |||||||
n (%) | 769 | (23.1%) | 570 | (23.0%) | 199 | (23.4%) | 0.8193 |
Mean (SD) | 0.30 | (0.7%) | 0.31 | (0.7%) | 0.29 | (0.6%) | 0.3304 |
Hospital or emergency room visits for COPD | |||||||
n, (%) | 1289 | (38.7%) | 917 | (37.0%) | 372 | (43.7%) | 0.0005 |
Mean (SD) | 0.55 | (0.9) | 0.53 | (0.9) | 0.59 | (0.8) | 0.0813 |
Mean (SD) number of physician visits for COPD | 3.23 | (3.6) | 3.33 | (3.6) | 2.93 | (3.4) | 0.0041 |
Exacerbations in pre-index period | |||||||
All, mean (SD) | 1.49 | (0.8) | 1.50 | (0.8) | 1.45 | (0.7) | 0.1441 |
Severe | |||||||
n (%) | 535 | (16.1%) | 360 | (14.5%) | 175 | (20.5%) | < .0001 |
Mean (SD) | 0.18 | (0.4) | 0.16 | (0.4) | 0.22 | (0.4) | 0.0007 |
Moderate | |||||||
n (%) | 3021 | (90.6%) | 2274 | (91.7%) | 747 | (87.7%) | 0.0006 |
Mean (SD) | 1.31 | (0.8) | 1.34 | (0.9) | 1.23 | (0.8) | 0.0014 |
Pre-index costs, mean (SD) | |||||||
Total COPD-related costs | $9108 | (18,434) | $8825 | (18,786) | $9932 | (17,355) | 0.1164 |
COPD-related pharmacy costs | $1444 | (1625) | $1494 | (1681) | $1296 | (1441) | 0.0009 |
COPD-related medical costs | $7665 | (18,220) | $7331 | (18,536) | $8636 | (17,242) | 0.0618 |