Baseline and on-treatment characteristics of randomized subjects
| All subjects | Primary prevention | Secondary prevention | |||||||
|---|---|---|---|---|---|---|---|---|---|
| Atorvastatin | Placebo | Atorvastatin | Placebo | Atorvastatin | Placebo | ||||
| n | 1,211 | 1,199 | 959 | 946 | 252 | 253 | |||
| Age (years) | 61.1 ± 8.1 | 61.0 ± 8.2 | 60.5 ± 8.3 | 60.4 ± 8.3 | 63.1 ± 7.2 | 63.2 ± 7.4 | |||
| ≥65 | 448 (37) | 422 (35) | 332 (35) | 305 (32) | 116 (46) | 117 (46) | |||
| Men | 796 (66) | 803 (67) | 593 (62) | 594 (63) | 203 (81) | 209 (83) | |||
| Race | |||||||||
| Caucasian | 1,018 (84) | 1,011 (84) | 805 (84) | 792 (84) | 213 (85) | 219 (87) | |||
| Black | 81 (6.7) | 74 (6.2) | 73 (7.6) | 68 (7.2) | 8 (3.2) | 6 (2.4) | |||
| BMI (kg/m2) | 28.9 ± 3.7 | 28.8 ± 3.8 | 28.9 ± 3.7 | 28.8 ± 3.7 | 28.9 ± 3.7 | 28.9 ± 3.8 | |||
| Current smokers | 147 (12) | 153 (13) | 119 (12) | 132 (14) | 28 (11) | 21 (8) | |||
| Median duration of diabetes (years) | 8.0 | 8.0 | 8.0 | 8.0 | 8.0 | 10.0 | |||
| Blood pressure (mmHg) | |||||||||
| Systolic | 133.1 ± 16.8 | 133.4 ± 16.4 | 133.0 ± 17.0 | 133.0 ± 16.7 | 133.6 ± 16.0 | 134.9 ± 15.3 | |||
| Diastolic | 76.9 ± 9.1 | 76.3 ± 9.0 | 77.1 ± 8.8 | 76.7 ± 8.8 | 76.0 ± 10.0 | 74.9 ± 9.6 | |||
| History of hypertension | 671 (55) | 657 (55) | 498 (52) | 499 (53) | 173 (69) | 158 (63) | |||
| History of hyperlipidemia | 343 (28) | 369 (31) | 265 (28) | 275 (29) | 78 (31) | 94 (37) | |||
| Glomerular filtration rate (ml/min per 1.73 m2) | 65.7 ± 11.5 | 65.8 ± 11.9 | 66.1 ± 11.4 | 66.7 ± 11.8 | 64.0 ± 11.6 | 62.6 ± 11.9 | |||
| CVD history | |||||||||
| Myocardial infarction | 208 (17) | 187 (16) | 0 | 0 | 208 (83) | 187 (74) | |||
| Interventional procedure | 145 (12) | 170 (14) | 0 | 0 | 145 (58) | 170 (67) | |||
| Angina | 200 (17) | 195 (16) | 55 (6) | 47 (5) | 145 (58) | 148 (58) | |||
| Peripheral arterial disease | 101 (8) | 107 (9) | 64 (7) | 53 (6) | 37 (15) | 54 (21) | |||
| Cerebrovascular disease | 61 (5) | 62 (5) | 38 (4) | 32 (3) | 23 (9) | 30 (12) | |||
| Arrhythmia | 108 (9) | 119 (10) | 67 (7) | 77 (8) | 41 (16) | 42 (17) | |||
| LDL cholesterol (mg/dl) | |||||||||
| Baseline | 113 ± 25 | 114 ± 26 | 114 ± 26 | 114 ± 26 | 112 ± 24 | 113 ± 25 | |||
| End of treatment (% change) | −30.29 | −1.09 | −30.48 | −0.48 | −29.65 | −3.31 | |||
| P value (% change) | <0.0001 | <0.0001 | <0.0001 | ||||||
| Total cholesterol (mg/dl) | |||||||||
| Baseline | 194 ± 31 | 194 ± 31 | 195 ± 31 | 195 ± 31 | 188 ± 26 | 191 ± 29 | |||
| End of treatment (% change) | −19.70 | −1.41 | −19.78 | −1.38 | −19.47 | −1.45 | |||
| P value (% change) | <0.0001 | <0.0001 | <0.0001 | ||||||
| HDL cholesterol (mg/dl) | |||||||||
| Baseline | 47 ± 14 | 47 ± 13 | 48 ± 14 | 47 ± 13 | 42 ± 11 | 44 ± 12 | |||
| End of treatment (% change) | 2.17 | −0.18 | 1.93 | −0.33 | 2.98 | 0.52 | |||
| P value (% change) | 0.0005 | 0.002 | 0.143 | ||||||
| Triglycerides (mg/dl) | |||||||||
| Baseline | 147 (101–208) | 145 (102–213) | 145 (99–205) | 144.5 (103–211) | 151.5 (104–219) | 147 (99–219) | |||
| End of treatment (% change) | −3.90 | 10.01 | −4.72 | 7.24 | −0.79 | 20.44 | |||
| P value (% change) | <0.0001 | <0.0001 | 0.0005 | ||||||
| A1C (%) | 7.6 ± 1.2 | 7.5 ± 1.3 | 7.6 ± 1.2 | 7.6 ± 1.3 | 7.6 ± 1.3 | 7.4 ± 1.2 | |||
| Baseline | 7.8 ± 1.4 | 7.7 ± 1.4 | 7.8 ± 1.4 | 7.7 ± 1.4 | 7.9 ± 1.5 | 7.8 ± 1.4 | |||
| End of treatment | |||||||||
Data are means ± SD, n (%), mean, or median (interquartile range). End of treatment lipid changes are from a last-observation-carried-forward analysis. To convert from mg/dl to mmol/l for cholesterol, divide by 38.67; for triglycerides, divide by 88.57.