Baseline Characteristics of the Treatment Groups
As shown in Table 2, 12,054 patients were included in the analysis; 6,563 patients were randomized to roflumilast 250 to 500 mg total daily dose, and 5,491 were randomized to placebo. Baseline patient characteristics in the comparisons between roflumilast and placebo were similar for age, sex, COPD severity, and concomitant cardiovascular and pulmonary medications. Similar proportions of the patients in the roflumilast and placebo treatment groups had cardiovascular risk factors of hypertension, diabetes, hyperlipidemia, or ischemic heart disease at baseline (Table 2). 
Primary Cardiovascular Events (Composite) for Controlled Trials
The disposition of deaths and nonfatal cardiovascular deaths by the adjudication process is shown in Figure 1 according to treatment ED with Viagra Canada assignment. A total of 78 cardiovascular deaths and 51 nonfatal MACEs.
Table 2—Baseline Characteristics of the COPD Population
| Characteristic | Roflumilast(n = 6,563) | Placebo (n = 5,491) |
| Age, y | 64 (25-93) | 64 (40-92) |
| Male sex | 4,743 (72.3) | 3,979 (72.5) |
| BMI, kg/m2 | 26.0 ± 5.2 | 26.0 ± 5.5 |
| White race | 5,872 (89.5) | 4,851 (88.3) |
| Smoking status | ||
| Current | 2,800 (42.7) | 2,279 (41.5) |
| Former | 3,752 (57.2) | 3,194 (58.2) |
| COPD severity | ||
| GOLD stage IV (very severe) | 958 (14.6) | 883 (16.1) |
| GOLD stage III (severe) | 3,589 (54.7) | 3,117 (56.8) |
| GOLD stage II (moderate) | 1,999 (30.5) | 1,474 (26.8) |
| Cardiovascular comorbid diseases | ||
| Hypertension | 2,566 (39.1) | 2,199 (40.0) |
| Dyslipidemia | 1,133 (17.3) | 1,042 (19.0) |
| Ischemic heart disease | 1,129 (17.2) | 924 (16.8) |
| Diabetes mellitus | 672 (10.2) | 608 (11.1) |
| COPD medications | ||
| Inhaled short-acting b-agonists | 5,344 (81) | 4,767 (87) |
| Inhaled long-acting b-agonists | 768 (12) | 771 (14) |
| Inhaled corticosteroids | 1,248 (19) | 1,196 (22) |
| Cardiovascular medications | ||
| Antiplatelet agents | 583 (8.9) | 543 (9.9) |
| Ь-Adrenergic blocking drugs | 382 (5.8) | 327 (6.0) |
| HMG-CoA reductase | 563 (8.6) | 570 (10.4) |
| inhibitors (statins) | ||
| Renin-angiotensin blocking drugs | 1,640 (25.0) | 1,421 (25.9) |
Data are presented as median (range), mean ± SD, or No. (%). GOLD = Global Initiative for Chronic Obstructive Lung Disease; HMG-CoA= 5-hydroxy-3-methylglutaryl-coenzyme A.