Table 6.
Mean level ± SD at end of period |
Mean differences (95% CI) |
P-value | ||||
---|---|---|---|---|---|---|
N | Baseline | 5 weeks |
5 weeks minus baseline |
Double difference (rostafuroxin minus placebo) |
||
Systolic pressure, mm Hg | ||||||
Placebo | 203 | 149.8 ± 7.2 | 144.5 ± 12.5 | -5.35 (-6.97 to -3.74) | ||
Rostafuroxin | ||||||
0.05 mg | 42 | 150.5 ± 7.3 | 144.5 ± 12.6 | -6.00 (-9.86 to -2.13) | -1.20 (-6.28 to 3.87) | 0.64 |
0.15 mg | 40 | 150.5 ± 8.4 | 143.9 ± 12.4 | -6.60 (-9.91 to -3.29) | -3.08 (-8.03 to 1.88) | 0.22 |
0.5 mg | 40 | 153.0 ± 8.7 | 147.4 ± 11.5 | -5.65 (-9.42 to -1.88) | 0.96 (-4.74 to 6.66) | 0.74 |
1.5 mg | 43 | 151.0 ± 7.9 | 147.4 ± 15.2 | -3.68 (-7.87 to 0.51) | 1.59 (-3.77 to 6.95) | 0.56 |
5.0 mg | 42 | 149.6 ± 7.1 | 145.3 ± 14.0 | -4.31 (-8.55 to -0.07) | 2.45 (-3.05 to 7.95) | 0.38 |
All doses | 207 | 150.9 ± 7.9 | 145.7 ± 13.2 | -5.22 (-6.92 to -3.53) | 0.13 (-2.21 to 2.47) | 0.91 |
Diastolic pressure, mm Hg | ||||||
Placebo | 203 | 92.0 ± 7.2 | 89.4 ± 8.7 | -2.63 (-3.77 to -1.50) | ||
Rostafuroxin | ||||||
0.05 mg | 42 | 92.9 ± 7.2 | 89.9 ± 8.3 | -3.01 (-4.90 to -1.11) | 0.52 (-2.65 to 3.70) | 0.75 |
0.15 mg | 40 | 92.3 ± 7.5 | 88.5 ± 8.5 | -3.82 (-6.12 to -1.51) | -1.94 (-5.52 to 1.65) | 0.28 |
0.5 mg | 40 | 95.9 ± 6.6 | 92.0 ± 7.8 | -3.96 (-6.67 to -1.25) | -1.20 (-5.32 to 2.92) | 0.56 |
1.5 mg | 43 | 94.2 ± 8.3 | 92.9 ± 9.4 | -1.33 (-3.77 to 1.12) | -0.21 (-3.26 to 2.84) | 0.89 |
5.0 mg | 42 | 94.0 ± 6.5 | 90.7 ± 9.2 | -3.33 (-6.32 to -0.35) | 0.68 (-3.15 to 4.51) | 0.72 |
All doses | 207 | 93.9 ± 7.3 | 90.8 ± 8.7 | -3.06 (-4.15 to -1.98) | -0.43 (-2.00 to 1.13) | 0.59 |
Mean differences were estimated with a paired and unpaired t-tests for within-group and between-group differences, respectively. The double difference is the net treatment effect defined as the difference placebo minus baseline subtracted from the difference rostafuroxin minus baseline (parallel-group analysis). Abbreviations: N = number of patients; SD, standard deviation; CI, confidence interval.