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Table 7 24-h ambulatory blood pressure at the end of the baseline period and at 5 weeks after randomization

From: Main results of the Ouabain and Adducin for Specific Intervention on Sodium in Hypertension Trial (OASIS-HT): a randomized placebo-controlled phase-2 dose-finding study of rostafuroxin

  

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

189

137.8 ± 10.7

135.6 ± 12.2

-2.28 (-3.78 to -0.77)

  

   Rostafuroxin

      

0.05 mg

39

137.3 ± 11.3

132.5 ± 11.2

-4.74 (-8.00 to -1.48)

-1.16 (-5.38 to 3.06)

0.59

0.15 mg

36

134.9 ± 10.9

137.3 ± 11.2

+2.36 (-0.62 to 5.34)

3.16 (-1.32 to 7.63)

0.16

0.5 mg

38

137.4 ± 9.6

136.7 ± 9.9

-0.76 (-4.44 to 2.92)

2.63 (-2.44 to 7.70)

0.30

1.5 mg

40

137.8 ± 11.8

138.0 ± 10.3

+0.21 (-3.10 to 3.51)

2.12 (-2.74 to 6.98)

0.39

5.0 mg

36

136.2 ± 11.7

135.6 ± 11.9

-0.52 (-4.32 to 3.27)

1.33 (-4.00 to 6.66)

0.62

All doses

189

136.8 ± 11.0

136.0 ± 11.0

-0.74 (-2.24 to 0.77)

1.54 (-0.59 to 3.66)

0.16

Diastolic pressure, mm Hg

     

   Placebo

189

86.2 ± 7.8

84.0 ± 8.7

-2.28 (-3.28 to -1.28)

  

   Rostafuroxin

      

0.05 mg

39

84.1 ± 7.2

82.4 ± 8.4

-1.65 (-3.25 to -0.06)

1.62 (-0.74 to 3.97)

0.18

0.15 mg

36

84.2 ± 8.4

84.6 ± 9.1

+0.41 (-1.46 to 2.28)

1.62 (-1.23 to 4.47)

0.26

0.5 mg

38

87.6 ± 8.8

85.7 ± 8.3

-1.89 (-4.15 to 0.37)

0.68 (-2.65 to 4.01)

0.68

1.5 mg

40

85.6 ± 8.4

85.4 ± 7.4

-0.28 (-1.96 to 1.40)

1.64 (-1.21 to 4.50)

0.25

5.0 mg

36

85.0 ± 9.0

85.4 ± 8.4

+0.36 (-2.34 to 3.07)

2.85 (-0.86 to 6.57)

0.13

All doses

189

85.3 ± 8.4

84.7 ± 8.3

-0.63 (-1.52 to 0.26)

1.65 (0.31 to 2.98)

0.02

  1. Mean differences were estimated with 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.