Table 5. Baseline characteristics.
| Intensive therapy group (n = 2,550) n (%) | Standard therapy group (n = 2,557) n (%) | |
|---|---|---|
| Sex, Male | 1,213 (47.6%) | 1,219 (47.7%) |
| Age (mean ± SD) | 63.0 ± 10.8 | 63.2 ± 10.4 |
| Body mass index (kg/m2) (mean ± SD) | 25.69 ± 4.25 | 25.59 ± 4.36 |
| Anti-hyperlipidemia medicine§ | ||
| None | 1,122 (44.0%) | 1,053 (41.2%) |
| One drug | 1,421 (55.7%) | 1,501 (58.7%) |
| Two drugs | 7 (0.3%) | 3 (0.1%) |
| Smoking† | 465 (18.2%) | 490 (19.2%) |
| Family history of CAD | 326 (12.8%) | 318 (12.4%) |
| Family history of cerebrovascular disease | 497 (19.5%) | 531 (20.8%) |
| Duration of diabetes (yr, mean ± SD) | 12.8 ± 8.6 | 13.0 ± 9.0 |
| Diabetic complication | ||
| Retinopathy | 2,543 (99.7%) | 2,546 (99.6%) |
| Neuropathy | 756 (29.6%) | 764 (29.9%) |
| Nephropathy | 1,320 (51.8%) | 1,270 (49.7%) |
| Hypertension | 1,769 (69.4%) | 1,791 (70.0%) |
| PAD | 117 (4.6%) | 98 (3.8%) |
| Funduscopy | ||
| Simple retinopathy | 1,706 (66.9%) | 1,692 (66.2%) |
| Preproliferative retinopathy | 424 (16.6%) | 480 (18.8%) |
| Proliferative retinopathy | 396 (15.5%) | 368 (14.4%) |
| Hemoglobin A1c (%)6 [mean ± SD (n)] | 7.77 ± 1.27 (2,550) | 7.77 ± 1.25 (2,557) |
| LDL-C (mg/dL)‖ [mean ± SD (n)] | ||
| Beginning of the run-in period§§ | ||
| Patients who had not received lipid-lowering therapy previously | 143.1 ± 23.5 (714) | 140.4 ± 22.9 (666) |
| Patients who had received previous therapy | 120.5 ± 22.1 (917) | 120.9 ± 23.5 (958) |
| Beginning of the treatment period | ||
| Patients who had not received lipid-lowering therapy previously | 98.4 ± 25.8 (1,101) | 97.7 ± 24.6 (1,033) |
| Patients who had received previous therapy | 112.3 ± 25.8 (1,398) | 112.0 ± 25.0 (1,460) |
| All | 106.2 ± 26.7 (2,499) | 106.0 ± 25.8 (2,493) |
| SBP (mmHg)†† [mean ± SD (n)] | 134.7 ± 16.9 (2,526) | 134.5 ± 16.2 (2,536) |
| DBP (mmHg)†† [mean ± SD (n)] | 74.9 ± 11.6 (2,526) | 74.7 ± 11.1 (2,536) |
CAD, coronary artery disease; PAD, peripheral artery disease; LDL-C, low-density lipoprotein cholesterol; SBP, systolic blood pressure; DBP, diastolic blood pressure.
§
Values were calculated at the beginning of the run-in period.
†
The categories of “Past Smoker” and “Non Smoker” were combined as “Not Current Smoker.”
‡
Values were calculated at the time of consent.
‖
Values were calculated using the Friedewald equation; LDL-C=total cholesterol (TC)∓[high-density lipoprotein cholesterol (HDL-C) + triglyceride (TG)/5].
§§
Values were measured at each study center. Only data obtained by the Friedewald equation were used for totaling.
††
Values were calculated at the beginning of the treatment.