Table 1.
Patient characteristics at study enrollment according to treatment group. The S and S+E groups were randomized and the E group represents a parallel study.
| Characteristic | All patients (n=67) | S (n=16) | S+E (n=18) | E (n=33) |
|---|---|---|---|---|
| Age - yr | 62±10 | 59±10 | 62±8 | 65±10 |
| Ankle Brachial Index (ABI) | 0.69±0.14 | 0.72±0.14 | 0.62±0.15 | 0.72±0.12 |
| Body Mass Index, kg/m2 | 29±6 | 30±7 | 28±6 | 30±5 |
| Male sex – (%) | 37 (55) | 11 (69) | 10 (56) | 16 (48) |
| Prior lower extremity revascularization – (%) | 13 (19) | 2 (13) | 4 (22) | 7 (21) |
| Leg of interest – (%) | 8 (12) | 2 (13) | 3 (17) | 3 (9) |
| Race – (%) | ||||
| White | 51 (76) | 13 (81) | 14 (78) | 24 (73) |
| Black | 11 (16) | 2 (13) | 3 (17) | 6 (18) |
| American Indian | 5 (7) | 1 (6) | 1 (5) | 3 (9) |
| Risk Factors – (%) | ||||
| Tobacco Use | 33 (50) | 8 (50) | 13 (72) | 12 (36) |
| Diabetes mellitus | 20 (30) | 5 (31) | 5 (28) | 10 (30) |
| Hypertension | 56 (84) | 13 (81) | 14 (78) | 29 (88) |
| History of CAD | 38 (57) | 8 (50) | 10 (56) | 20 (61) |
| Hypercholesterolemia | 51 (76) | 9 (56) | 11 (61) | 31 (94) |
| Medications – (%) | ||||
| Aspirin/Clopidogrel | 49(73) | 11 (69) | 13 (72) | 25 (76) |
| ACE-Inhibitor | 33 (49) | 8 (50) | 5 (28) | 20 (61) |
| ARB | 8 (12) | 2 (13) | 4 (22) | 2 (6) |
| β-Blocker | 25 (37) | 6 (38) | 6 (33) | 13 (39) |
| Cilastazol | 8 (12) | 2 (13) | 2 (11) | 4 (12) |
S - simvastatin only, S+E - simvastatin+ezetimibe, E - open label ezetimibe added to ongoing statin. Plus-minus values are means ±SD. ACE - angiotensin converting enzyme, ARB - angiotensin receptor blocker. Body-mass index - weight in kilograms divided by the square of the height in meters. There were no differences in any demographics parameters between S and S+E.