Table 3.
Exclusion criteria stratified for inhaler device (multiple counting)
| Category | Explicit criterion | Code category/unit used in KVB | Explicit code/threshold used in KVB | Not included/excluded HandiHaler ® | Not included/excluded Respimat ® | |
|---|---|---|---|---|---|---|
| Inclusion criteria | Gender | Gender | Male/female | Male/female | 0 | 0 |
| Age | Age | years | ≥40 | 769 (1.8%) | 169 (3.1%) | |
| Clinical diagnosis | COPD | ICD‐10‐GM | J44 | 7156 (17.0%) | 1086 (20.0%) | |
| Exclusion criteria | Concomitant cardiovascular disease | Myocardial infarction within the last 6 months | ICD‐10‐GM | I21, I22, I25.20 | 4535 (10.8%) | 528 (9.7%) |
| Hospitalization for heart failure within 12 months | ICD‐10‐GM | I50.14 | 564 (1.3%) | 62 (1.1%) | ||
| Unstable or life threatening arrhythmia requiring intervention or change in drug therapy within 12 months | ICD‐10‐GM | I44.2, I45.9, I46, I47.0, I47.2, I49.0 | 1306 (3.1%) | 158 (2.9%) | ||
| Other significant lung diseases | Active tuberculosis | ICD‐10‐GM | A15, A16, A17, A18, A19 | 1507 (3.6%) | 200 (3.7%) | |
| Asthma | ICD‐10‐GM | J45, J46 | 23 701 (56.2%) | 3140 (57.7%) | ||
| Cystic fibrosis | ICD‐10‐GM | E84 | 46 (0.1%) | 3 (0.1%) | ||
| Clinically evident bronchiectasis (not excluded for radiographic evidence of bronchiectasis if they were not being treated for this condition) | ICD‐10‐GM | J47 | 712 (1.7%) | 101 (1.9%) | ||
| Interstitial lung disease | ICD‐10‐GM | J60‐J70, J80, J82, J84 | 0 | 0 | ||
| Pulmonary thromboembolism | ICD‐10‐GM | I26 | 2159 (5.1%) | 252 (4.6%) | ||
| Cancer | Malignancies (other than treated basal cell carcinoma) requiring therapy within the last 5 years (resection, radiation, chemotherapy or biological treatments) | ICD‐10‐GM | C00–C97 except C44 | 11 458 (27.2%) | 1376 (25.3%) | |
| Others | Known moderate to severe renal impairment (as judged by the investigator) | ICD‐10‐GM | N18.3, N18.4, N18.5 | 2592 (6.1%) | 257 (4.7%) | |
| Drug abuse within 12 months | ICD‐10‐GM | F11.2, F12.2, F13.2, F19.0 | 261 (0.6%) | 42 (0.8%) | ||
| Alcohol abuse within 12 months | ICD‐10‐GM | F10, K70, Z72.0 | 3883 (9.2%) | 521 (9.6%) | ||
| Known narrow angle glaucoma | ICD‐10‐GM | H40.2 | 266 (0.6%) | 34 (0.6%) | ||
| Known hypersensitivity to anticholinergic drugs, lactose or other components of the HandiHaler® or Respimat® inhalation solution delivery system | ICD‐10‐GM | E73.‐ | 250 (0.6%) | 34 (0.6%) | ||
| Symptomatic bladder neck obstruction | ICD‐10‐GM | N32.0 | 523 (1.2%) | 52 (1.0%) | ||
| Child‐bearing potential not on contraceptives | ATC Age | No G03A ≤ 45 years | 856 (2.0%) | 165 (3.0%) | ||
| Unstable COPD | Plans for lung transplantation or lung volume reduction surgery | ICD‐10‐GM | Z94.2, Z94.3, T86.3, T86.81, U55.2, U55.3 | 23 (0.1%) | 5 (0.1%) | |
| Total | 42 151 (67.9%) | 5443 (70.0%) |
KVB, Kassenärztliche Vereinigung Bayerns database.