Table 1. Study cohort mean SeSBP/SeDBP at baseline and Week 52/ET, by subgroup and treatment regimen at Week 52/ET.
| Mean SeBP± s.e.m., mm Hg | AML 5 mg/ OM 40 mg | AML 10 mg/OM 40 mg | AML 10 mg/OM 40 mg/HCTZ 12.5 mg | AML 10 mg/OM 40 mg/HCTZ 25 mg | All treatment regimensa |
|---|---|---|---|---|---|
| Age | |||||
| <65 years | |||||
| N | 436 | 306 | 223 | 328 | 1340 |
| Baseline | 155.8±0.6/100.4±0.2 | 159.4±0.7/101.4±0.3 | 163.1±0.9/102.7±0.4 | 169.7±0.9/103.8±0.3 | 161.2±0.4/101.9±0.1 |
| Week 52/ET | 127.0±0.6/81.5±0.4 | 130.3±0.7/82.8±0.5 | 129.8±0.9/82.3±0.6 | 135.9±0.8/84.4±0.5 | 130.3±0.4/82.6±0.2 |
| ⩾65 years | |||||
| N | 89 | 72 | 63 | 91 | 331 |
| Baseline | 166.3±1.7/99.9±0.5 | 166.4±1.6/99.9±0.4 | 173.7±2.0/100.4±0.4 | 184.2±1.6/100.9±0.6 | 173.1±0.9/100.2±0.2 |
| Week 52/ET | 130.6±1.8/78.3±0.9 | 133.8±1.6/80.4±1.0 | 134.1±1.9/76.5±1.0 | 140.2±1.8/79.7±0.8 | 134.8±0.9/78.7±0.5 |
| Race | |||||
| Black | |||||
| N | 84 | 90 | 82 | 147 | 409 |
| Baseline | 156.1±1.4/100.7±0.6 | 158.1±1.3/100.9±0.5 | 161.1±1.6/102.4±0.5 | 172.3±1.4/103.6±0.5 | 163.3±0.8/102.2±0.3 |
| Week 52/ET | 132.8±1.7/84.0±1.1 | 130.6±1.4/83.4±0.8 | 129.6±1.8/82.8±1.0 | 135.9±1.4/83.7±0.8 | 132.6±0.8/83.5±0.5 |
| Non-Black | |||||
| N | 441 | 288 | 204 | 272 | 1262 |
| Baseline | 157.9±0.7/100.2±0.2 | 161.5±0.8/101.2±0.3 | 167.2±1.0/102.1±0.4 | 173.2±1.0/102.9±0.3 | 163.7±0.4/101.3±0.1 |
| Week 52/ET | 126.7±0.6/80.4±0.4 | 131.1±0.7/82.0±0.5 | 131.2±0.9/80.3±0.6 | 137.3±0.8/83.3±0.5 | 130.7±0.4/81.3±0.2 |
| Diabetes status | |||||
| Yes | |||||
| N | 36 | 30 | 44 | 109 | 227 |
| Baseline | 163.6±3.3/99.8±0.6 | 159.5±2.1/100.1±0.7 | 166.4±2.2/101.2±0.7 | 173.3±1.5/101.6±0.5 | 168.2±1.1/101.0±0.3 |
| Week 52/ET | 130.7±3.2/80.2±1.5 | 132.8±2.8/82.2±1.1 | 132.1±2.3/79.3±1.2 | 136.8±1.4/81.9±0.7 | 134.0±1.1/81.0±0.5 |
| No | |||||
| N | 489 | 348 | 242 | 310 | 1444 |
| Baseline | 157.2±0.6/100.3±0.2 | 160.8±0.7/101.2±0.2 | 165.3±1.0/102.4±0.3 | 172.7±1.0/103.7±0.3 | 162.8±0.4/101.6±0.1 |
| Week 52/ET | 127.4±0.6/81.1±0.4 | 130.8±0.7/82.4±0.5 | 130.5±0.9/81.3±0.6 | 136.8±0.8/84.0±0.5 | 130.7±0.4/82.0±0.2 |
Abbreviations: AML, amlodipine; ET, early termination; HCTZ, hydrochlorothiazide; OM, olmesartan medoxomil; SeBP, seated BP; SeDBP, seated diastolic BP; SeSBP, seated systolic BP.
Data are expressed as mean±standard error of the mean (s.e.m.). Baseline for vital signs was defined as the average of the visit values from the randomization visit (Week 0) and the visit before the randomization visit (Week −1). Only patients with baseline and Week 52/ET blood pressure (BP) measurements are included. Each BP visit value is the mean of three measurements. Age was calculated using the date the patient was randomized.
aThe no. of treatment regimens may not add to all patients due to some patients receiving non-protocol drug combinations, as noted in the Materials and methods section.