Table 5.
Effect of tolvaptan at baseline and during inhibition of the nitric oxide system on brachial systolic- and diastolic blood pressure (SBP and DBP), and pulse rate in a randomized, placebo-controlled, double-blind, crossover study of 19 healthy subjects
|
Periods |
Baseline |
L-NMMA |
Post infusion |
p (GLM-within) | ||
|---|---|---|---|---|---|---|
| 0-90 min | 90-120 min | 120-150 min | 150-180 min | 180-210 min | ||
|
SBP (mmHG) | ||||||
| Placebo |
112 ± 8 |
113 ± 9 |
115 ± 8* |
115 ± 9* |
116 ± 10* |
0.170 |
| Tolvaptan |
112 ± 11 |
115 ± 9* |
116 ± 9* |
116 ± 10* |
114 ± 9 |
|
| p (GLM between) 0.876 | ||||||
| p (paired t-test, between) |
0.833 |
0.117 |
0.272 |
0.929 |
0.430 |
|
|
DBP (mmHg) | ||||||
| Placebo |
61 ± 5 |
68 ± 6*** |
67 ± 6*** |
67 ± 5* |
65 ± 7 |
0.688 |
| Tolvaptan |
63 ± 5 |
69 ± 7*** |
68 ± 6*** |
67 ± 6 |
66 ± 7 |
|
| p(GLM between) 0.606 | ||||||
| p (paired t-test, between) |
0.049 |
0.467 |
0.259 |
0.907 |
0.454 |
|
|
Pulse rate (BPM) | ||||||
| Placebo |
57 ± 10 |
52 ± 9*** |
53 ± 9*** |
55. ± 11*** |
58 ± 12*** |
0.889 |
| Tolvaptan |
55 ± 10 |
50 ± 9*** |
51 ± 9*** |
53 ± 10*** |
56 ± 11* |
|
| p (GLM between) 0.527 | ||||||
| p (paired t-test, between) | 0.016 | 0.022 | 0.007 | 0.013 | 0.003 | |
Data are shown as mean with ± SD or medians with ± interquartile range. General linear model (GLM) with repeated measures was performed for comparison within the group and intervention as between subjects factor. Post-hoc Bonferoni test (*) was used for comparison of infusion period 90–150 min vs baseline and post infusion period 150–210 vs baseline. Paired t-test or Wilcoxon signed rank test was used for comparison between treatment group at baseline vs during infusion period 90–150 min, and at baseline vs post infusion period 150–210 min. *p < 0.05; **p < 0.001;*** p < 0.0001.