Table 1.
Characteristics of the Patients.*
| Characteristic | Simvastatin (N = 433) |
Placebo (N = 452) |
|---|---|---|
| Age — yr | 62.2±8.5 | 62.3±8.4 |
| Female sex — no. (%) | 184 (42.5) | 203 (44.9) |
| FEV1 after bronchodilator use — liters (% of predicted value)† | 1.2±0.6 (41.5±17.8) | 1.2±0.6 (41.6±17.6) |
| FEV1:FVC — %† | 44.4±12.6 | 44.3±13.5 |
| GOLD stage — no./total no. (%)‡ | ||
| 2 | 142/430 (33.0) | 145/449 (32.3) |
| 3 | 142/430 (33.0) | 163/449 (36.3) |
| 4 | 146/430 (34.0) | 141/449 (31.4) |
| Smoking history — pack-yr | 50.0±26.1 | 51.2±28.7 |
| Current smoking — no. (%) | 133 (30.7) | 143 (31.6) |
| COPD medication — no. (%) | ||
| Inhaled glucocorticoids only | 14 (3.2) | 12 (2.7) |
| Long-acting muscarinic antagonist only | 29 (6.7) | 35 (7.7) |
| Long-acting beta2-agonist only | 10 (2.3) | 10 (2.2) |
| Inhaled glucocorticoids and long-acting muscarinic antagonist | 5 (1.2) | 9 (2.0) |
| Inhaled glucocorticoids and long-acting beta2-agonist | 71 (16.4) | 89 (19.7) |
| Long-acting muscarinic antagonist and long-acting beta2-agonist | 25 (5.8) | 23 (5.1) |
| Inhaled glucocorticoids, long-acting muscarinic antagonist, and long-acting beta2-agonist | 223 (51.5) | 228 (50.4) |
| None | 56 (12.9) | 46 (10.2) |
| Entry criteria — no. (%) | ||
| Acute COPD exacerbation requiring hospitalization or ED visit within previous 12 mo | 216 (49.9) | 238 (52.7) |
| Systemic glucocorticoid or antibiotic use within previous 12 mo | 367 (84.8) | 382 (84.5) |
| Use of supplemental oxygen within previous 12 mo | ||
| All patients who met this criterion | 198 (45.7) | 222 (49.1) |
| Patients who met only this criterion | 48 (11.1) | 53 (11.7) |
*
Plus–minus differences are means ±SD. There were no significant differences between the simvastatin and placebo groups, and there was no imbalance regarding race between the two groups. COPD denotes chronic obstructive pulmonary disease, ED emergency department, FEV1 forced expiratory volume in 1 second, and FVC forced vital capacity.
†
Spirometric measurements were available for 430 patients in the simvastatin group and 449 in the placebo group.
‡
The Global Initiative for Chronic Obstructive Lung Disease (GOLD) staging system is used to assess the severity of lung disease, with stage 4 indicating the most severe disease.