Table 1.
Baseline characteristics of the propensity score matched cohorts.
| Characteristics | Patients with collection of promethazine (N = 1,645) |
Patients with collection of melatonin (N = 1,645) |
|---|---|---|
| Age, years | 73.5 (66.1–79.5) | 72.5 (65.3–79.7) |
| Gender, female | 993 (6.4) | 953 (57.9) |
| Tobacco exposure#: | ||
| Never smoking | 40 (2.4) | 50 (3.0) |
| Previous smoking | 863 (52.5) | 864 (52.5) |
| Active smoking | 609 (37.0) | 584 (35.5) |
| Unknown tobacco exposure | 133 (8.1) | 147 (8.9) |
| MRC# | 3 (2–3) | 3 (2–3) |
| BMI# | 25 (22–29) | 25 (22–29) |
| FEV1% GOLD stages#: | ||
| GOLD I Mild COPD FEV1% ≥ 80% | 86 (5.2) | 62 (3.8) |
| GOLD II Moderate COPD 50% ≤ FEV1% < 80% | 683 (41.5) | 666 (4.5) |
| GOLD II Severe COPD 30% ≤ FEV1% < 50% | 712 (43.3) | 750 (45.6) |
| GOLD IV Very severe COPD FEV1% < 30% | 164 (1.0) | 167 (1.1) |
| Comorbidities: | ||
| Charlson comorbidity index | 5 (3–6) | 5 (3–6) |
| Hypertension | 772 (46.9) | 726 (44.1) |
| Hypercholesterolemia | 339 (2.6) | 301 (18.3) |
| Atrial fibrillation | 373 (22.7) | 368 (22.4) |
| Diabetes | 286 (17.4) | 293 (17.8) |
| Osteoporosis or osteopenia | 546 (33.2) | 512 (31.1) |
| Renal insufficiency | 111 (6.7) | 110 (6.7) |
| Liver insufficiency | 83 (5.0) | 74 (4.5) |
| Malignancy within five years prior to inclusion | 453 (27.5) | 432 (26.3) |
| Atopy or allergy | 141 (8.6) | 136 (8.3) |
| Depression | 191 (11.6) | 164 (1.0) |
| Exacerbations requiring admission within the last year prior to inclusion |
1,302 (79.1) | 1,303 (79.2) |
| Medical treatment for respiratory disease within the last year prior to inclusion: |
||
| Inhaled corticosteroid (ICS) | 1,551 (94.3) | 1,544 (93.9) |
| Long-acting β2-agonist (LABA) | 1,436 (87.3) | 1,346 (81.8)* |
| Long-acting muscarinic receptor antagonist (LAMA) | 1,389 (84.4) | 1,272 (77.3)* |
| Short acting β2-agonist (SABA) | 1,253 (76.2) | 1,146 (69.7)* |
| Short acting muscarinic receptor antagonist (SAMA) | 253 (15.4) | 139 (8.4)* |
| Medical treatment with sleep agents and opioids within the last year prior to inclusion: |
||
| Anxiolytics: Benzodiazepines (ATC code N05BA) | 404 (24.6) | 355 (21.6)* |
| Hypnotics and sedatives: Benzodiazepine derivatives and related substances (ATC codes N05CD and N05CF) | 532 (32.3) | 692 (42.1)* |
| Opioids (N02A) | 744 (45.2) | 767 (46.6) |
Note: Propensity score matched patients with collection of promethazine and melatonin.
Patients were propensity score matched 1:1 by age, gender, tobacco exposure, MRC, BMI, FEV1% GOLD stages, collection of inhaled corticosteroids (ICS), collection of inhaled long-acting muscarinic receptor antagonist (LAMA) and Charlson comorbidity index.
Characteristics are presented as medians and absolute numbers as relevant with interquartile ranges and percentages in parenthesis.
#in case of missing data, values were imputed.
*indicates statistical significance p < 0.05 by regression analysis.