Table II.
Baseline Characteristics of Study Population Prior to Randomization to Double‐Blind Treatment Groups (Week 0) and Prior to Entry Into Single‐Blind Phase (at the End of Week 8)
| Prior to Randomization to Double‐Blind Treatment Groups | |||||
|---|---|---|---|---|---|
| Characteristic | AML 5 mg+ ATV 10 mg(n=207) | AML 5 mg (n=201) | ATV io mg(n=200) | Placebo(n=239) | Prior to Single‐Blind, Open‐Label(n=782) |
| Gender (n [%]) | |||||
| Male | 135 (65.2) | 117(58.2) | 111 (55.5) | 151 (63.2) | 471 (60.2) |
| Female | 72 (34.8) | 84 (41.8) | 89 (44.5) | 88 (36.8) | 311 (39.8) |
| Age (yr) (M [SD]) | 55.6 (9.9) | 56.2 (10.3) | 55.1 (9.3) | 55.3 (9.2) | 55.5 (9.7) |
| Race (n [%]) | |||||
| White | 173 (83.6) | 169 (84.1) | 167 (83.5) | 193 (80.8) | 655 (83.8) |
| Black | 24 (11.6) | 18 (9.0) | 22 (11.0) | 27(11.3) | 82 (10.5) |
| Asian | 6 (2.9) | 4 (2.0) | 2 (1.0) | 3 (1.3) | 13 (1.7) |
| Other | 4 (1.9) | 10 (5.0) | 9 (4.5) | 16 (6.7) | 32 (4.1) |
| Weight (kg) (M [SD]) | |||||
| Male | 95.0 (17.2) | 93.3 (18.5) | 96.1 (18.1) | 94.0 (16.7) | – |
| Female | 81.4 (17.2) | 81.2 (17.8) | 83.4 (17.4) | 82.2 (17.2) | – |
| Duration of primary | |||||
| diagnoses (yr) | |||||
| (M [range]) | |||||
| Hypertension | 5.9 (0.0–41.1) | 5.9 (0.0–37.7) | 5.6 (0.0–49.2) | 7.6 (0.0–51.5) | – |
| Dyslipidemia | 4.5 (0.0–30.7) | 4.2 (0.0–31.9) | 4.2 (0.0–25.5) | 4.6 (0.0–25.7) | – |
| CV risk group (n [%])* | |||||
| I | 14 (6.8) | 18 (9.0) | 11 (5.5) | 9 (3.8) | 49 (6.3) |
| II | 155 (74.9) | 143 (71.1) | 160 (80.0) | 189 (79.1) | 598 (76.5) |
| III | 38 (18.4) | 40 (19.9) | 29 (14.5) | 41 (17.2) | 135 (17.3) |
| Eligibility parameters | |||||
| (M [SD])* | |||||
| LDL‐C (mg/dL) | 163.9 (25.0) | 164.3 (26.0) | 161.7 (24.6) | 163.3 (24.8) | 133.6 (39.2) |
| Systolic BP (mm Hg) | 146.6 (12.3) | 147.6 (10.0) | 147.1 (10.9) | 146.7 (10.8) | 137.1 (14.0) |
| Diastolic BP (mm Hg) | 92.1 (7.2) | 92.6 (6.9) | 91.4 (7.7) | 92.4 (6.2) | 85.9 (9.0) |
| Framingham 10‐yr risk | 15.9 (8) | 15.0 (7.3) | 14.5 (6.7) | 15.1 (7.1) | 11.0(6.7) |
| of CHD(%) | |||||
| (M [SD]) | |||||
| Drug therapy before | |||||
| enrollment (n [%]) | |||||
| Antihypertensive only | 54 (26.1) | 57 (28.4) | 46 (23.0) | 65 (27.2) | – |
| Lipid‐lowering only | 4 (1.9) | 6 (3.0) | 2 (1.0) | 6 (2.5) | – |
| Both | 17 (8.2) | 22 (10.9) | 18 (9.0) | 20 (8.4) | – |
| None | 132 (63.8) | 116(57.7) | 134 (67.0) | 148 (61.9) | – |
| AML=amlodipine; ATV=atorvastatin; M=mean; CV=cardiovascular; LDL‐C=low‐density lipoprotein cholesterol; BP=blood pressure; CHD=coronary heart disease; *no statistically significant differences among treatment groups for these parameters | |||||