Table 1.
Characteristics of the real-world patients with diabetes and initiating statin therapy and of the participants of the HPS-DM11 and CARDS12 trials
| Study population | HPS-DM11 | Real-world patients with diabetes (all) | CARDS12 (see online supplementary appendix) | Real-world patients with diabetes and without CVD* |
|---|---|---|---|---|
| Years of recruitment or cohort entry | 1994–1997 | 2005–2008 | 1997–2001 | 2005–2008 |
| Number of patients | 5963 | 56 963 | 2838 | 41 552 |
| Mean age in years (SD) | 62.1 (8.9) | 61.9 (12.4) | 61.5 (8.3) | 59.5 (12.0) |
| Min | 40 | 8 | 40 | 8 |
| Max | 80 | 98 | 75 | 96 |
| Age in years, N (%) | ||||
| <40 | 2384 (4) | 2266 (5) | ||
| 40–80 | 50 347 (88) | 37 622 (91) | ||
| ≥80 | 4232 (7) | 1664 (4) | ||
| Men, N (%) | 4147 (70) | 31 912 (56) | 972 (68) | 22 605 (54) |
| Cardiovascular disease, N (%) | 3051 (51) | 15 411 (27) | 0† | 0 |
| Coronary heart disease, N (%) | 1981 (33) | 11 054 (19) | 0† | 0 |
| Previous myocardial infarction, N (%) | 1125 (19) | 3742 (7) | 0† | 0 |
| Stroke, N (%) | NA | 3713 (7) | 0† | 0 |
| Peripheral arterial disease, N (%) | NA | 2046 (4) | 0† | 0 |
| Type I diabetes, N (%) | 615 (10) | 4463 (8) | 0 | 3644 (9) |
| Diabetes duration in years (SD) | 9.3 (8.9)‡ | 7.6 (8.5) | 7.9 (6.4) | 7.1 (8.2) |
| Diabetes duration ≤ 0.5 years, N (%) | NA | 7514 (13) | 0† | 5638 (14) |
| Retinopathy, N (%) | NA | 4569 (8) | 426 (30) | 3051 (7) |
| Microalbuminuria/macroalbuminuria, N (%) | NA | 124 (<1) | 172 (12) | 84 (<1) |
| Nephropathy, N (%) | 0† | 441 (<1) | 0† | 232 (<1) |
For the CARDS trial, only data for the arm treated with statins (N=1428) are presented.
*According to previous cardiovascular disease (CVD) status at baseline.
†Assumed on the basis of trial eligibility criteria.
‡Data for patients with type 2 diabetes.
CARDS, Collaborative Atorvastatin Diabetes Study; HPS-DM, Heart Protection Study-diabetes mellitus; NA, data not available.