Baseline parameters of the study cohort characteristics of the entire patient population, patients who had suffered at least one subsequent SAE and patients who died during follow-up
| Entire cohort | At least one subsequent exacerbation | Death | ||
| At the time of the index date | No. of patients | 9257 | 3492 | 1193 |
| Age at cohort entry (years; mean (SD)) | 58.24 (15.74) | 60.28 (12.71) | 70.95 (11.66) | |
| Charlson Comorbidity Index; mean (SD) | 2.25 (1.60) | 2.34 (1.61) | 3.13 (1.93) | |
| Female (%) | 7013 (75.8) | 2774 (79.4) | 815 (68.3) | |
| One year prior to the index date | ICS therapy (%) | 7201 (77.8) | 2775 (79.5) | 986 (82.6) |
| SABA therapy (%) | 6366 (68.8) | 2380 (68.2) | 865 (72.5) | |
| LABA therapy (%) | 6878 (74.3) | 2684 (76.9) | 961 (80.6) | |
| LAMA therapy (%) | 531 (5.7) | 214 (6.1) | 133 (11.1) | |
| SABA therapy without ICS therapy (%) | 917 (9.9) | 267 (7.6) | 91 (7.6) | |
| More than 3 SABA therapy (%) | 2836 (30.6) | 1054 (30.2) | 522 (43.8) | |
| Any therapy but ICS therapy (%) | 1106 (11.9) | 337 (9.7) | 125 (10.5) | |
| Any therapy AND ICS therapy (%) | 8151 (88.1) | 3155 (90.3) | 1068 (89.5) | |
| Comorbidity in year prior to the index date (%) | Cardiovascular diseases (%) | 3949 (42.7) | 1646 (47.1) | 798 (66.9) |
| Heart failure (%) | 1051 (11.4) | 395 (11.3) | 334 (28.0) | |
| Myocardial infarction (%) | 200 (2.2) | 71 (2.0) | 58 (4.9) | |
| Anxiety (%) | 2375 (25.7) | 983 (28.2) | 308 (25.8) | |
| Depressive episode (%) | 1788 (19.3) | 779 (22.3) | 204 (17.1) | |
| Cerebrovascular disease (%) | 1689 (18.2) | 715 (20.5) | 318 (26.7) | |
| Diabetes (%) | 1486 (16.1) | 583 (16.7) | 292 (24.5) | |
| Peripheral vascular disease (%) | 793 (8.6) | 319 (9.1) | 175 (14.7) | |
| Cancer (not lung) (%) | 572 (6.2) | 238 (6.8) | 129 (10.8) | |
| Liver disease (%) | 289 (3.1) | 121 (3.5) | 41 (3.4) | |
| Schizophrenia (%) | 237 (2.6) | 91 (2.6) | 44 (3.7) | |
| Renal disease (%) | 198 (2.1) | 68 (1.9) | 62 (5.2) | |
| Rheumatoid arthritis (%) | 191 (2.1) | 81 (2.3) | 32 (2.7) | |
| Dementia (%) | 88 (1.0) | 32 (0.9) | 29 (2.4) | |
| Metastatic cancer (%) | 38 (0.4) | 16 (0.5) | 24 (2.0) | |
| Peptic ulcer (%) | 34 (0.4) | 17 (0.5) | NA | |
| Hemiplegia or paraplegia (%) | 27 (0.3) | 10 (0.3) | NA | |
| At least one moderate exacerbation (%) | 3134 (33.9) | 1309 (37.5) | 420 (35.2) | |
For age, data on the Charlson index are shown as mean and SD. For all other variables, data are shown as the number of patients and percentages.
ICS, inhaled corticosteroid; LABA, long-acting beta agonist; LAMA, long-acting muscarinic antagonist; SABA, short-acting beta agonist; SAE, severe acute exacerbation; SAMA, short-acting muscarinic antagonist.