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Table 2 Effect of tolvaptan at baseline and during inhibition of the nitric oxide system on GFR (51-CrEDTA-clearance), urinary output (OU), free water clearance (C H2O ), urinary aquaporin2 excretion rate (u-AQP2), urinary ENaC γ excretion rate (u-ENaC γ ) and fractional excretion of sodium (FE Na ) in a randomized, double-blind, placebo-controlled, crossover study of 19 healthy subjects

From: Effect of vasopressin antagonism on renal handling of sodium and water and central and brachial blood pressure during inhibition of the nitric oxide system in healthy subjects

Periods Baseline L-NMMA Post infusion P (GLM-within)
   90-120 min 120-150 min 150-180 min 180-210 min
51 Cr-EDTA-clearance (ml/min/1.73 m2)
Placebo 99 ± 5 93 ± 10*** 92 ± 8*** 94 ± 8*** 97 ± 9 0.522
Tolvaptan 97 ± 9 91 ± 12*** 93 ± 9*** 90 ± 12*** 94 ± 12
p (GLM between) 0.527
p (paired t-test, between) 0.403 0.533 0.583 0.118 0.197  
UO (ml/min)
Placebo 7.4 ± 1.3 3.0 ± 1.2*** 4.2 ± 1.3*** 4.9 ± 1.2*** 6.3 ± 1.1 <0.0001
Tolvaptan 8.9 ± 1.7 4.3 ± 1.8*** 4.2 ± 1.8*** 4.9 ± 1.3*** 5.7 ± 1.6
p (GLM between) 0.230
p (paired t-test, between) 0.009 0.026 0.965 0.861 0.124  
C H2O (ml/min)
Placebo 4.6 ± 1.1 2.9 ± 1.0*** 3.9 ± 1.2*** 4.6 ± 1.0*** 5.9 ± 1.0 <0.0001
Tolvaptan 5.8 ± 1.1 4.4 ± 1.8* 4.0 ± 1.6* 3.9 ± 1.2 5.2 ± 1.4
p(GLM between) 0.185
p (paired t-test, between) 0.002 0.009 0.756 0.063 0.097  
u-AQP2 (ng/min)
Placebo 1.30 ± 0.27 1.04 ± 0.36* 0.99 ± 0.19*** 1.06 ± 0.24*** 1.11 ± 0.20 0.444
Tolvaptan 1.32 ± 0.28 1.08 ± 0.39 1.04 ± 0.23*** 1.17 ± 0.32*** 1.10 ± 0.21
p (GLM between) 0.614
p (paired t-test, between) 0.771 0.427 0.382 0.044 0.665  
u-ENaC γ (pg/min)
Placebo 476 - 367 - 442**  
(398; 640) (296; 756) (308; 605)
Tolvaptan 320 - 430 *** - 567***  
(281; 379) (361; 492) (322; 537)
p (Wilcoxon’s signed rank test, between) <0.001   0.355   0.227  
FE Na
Placebo 1.17 ± 0.62 0.77 ± 0.35* 0.78 ± 0.37* 1.12 ± 0.41 1.07 ± 0.35 0.945
Tolvaptan 1.29 ± 0.45 0.89 ± 0.34* 0.87 ± 0.32* 1.22 ± 0.30 1.18 ± 0.30
p (GLM between) 0.328
p (paired t-test, between) 0.326 0.073 0.073 0.198 0.200  
  1. Data are shown as mean with ± SD or medians with 25th and 75th percentiles in parentheses. General linear model (GLM) with repeated measures was performed for comparison within the group and intervention as between subject 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 and during infusion period 90–150 min, and at baseline and post infusion period 150 – 210 min. *p < 0.05; **p < 0.001;***p < 0.0001.