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Table 2 Effect of tolvaptan 60 mg at baseline, during, and after systemic inhibition of NO synthesis on GFR (51 CrEDTA-clearance), urinary output (UO), free water clearance (CH2O), urinary aquaporin-2 excretion rate (u-AQP2), fractional excretion of sodium (FENa), and urinary ENaCγ excretion rate (u-ENaCγ) in a randomized, placebo-controlled, double-blind, crossover study of 18 ADPKD patients

From: Effect of tolvaptan on renal handling of water and sodium, GFR and central hemodynamics in autosomal dominant polycystic kidney disease during inhibition of the nitric oxide system: a randomized, placebo-controlled, double blind, crossover study

Periods Baseline L-NMMA Post infusion p (GLM-within)
0–90 min 90–120 min 120–150 min 150–180 min 180–210 min
51Cr-EDTA-clearance (ml/min/ 1.73 m2)
 Placebo 73 ± 20 66 ± 22 72 ± 24 76 ± 17 73 ± 19 0.154
 Tolvaptan 60 mg 72 ± 19 67 ± 19 70 ± 19 68 ± 19 67 ± 19
 p (GLM between) 0.684      
 p (paired t-test, between) 0.740 0.758 0.643 0.005 0.016  
UO (ml/min)
 Placebo 5.6 ± 1.4 2.9 ± 1.2*** 2.8 ± 1.2*** 3.6 ± 1.4*** 5.1 ± 1.7 < 0.0001
 Tolvaptan 60 mg 11.1 ± 1.8 7.0 ± 2.2*** 6.3 ± 1.9*** 7.1 ± 1.7*** 7.0 ± 2.0***
 p (GLM between) < 0.0001      
 p (paired t-test, between) < 0.0001 < 0.0001 < 0.0001 < 0.0001 0.009  
CH2O (ml/min)
 Placebo 3.0 ± 1.2 1.2 ± 0.8*** 1.1 ± 0.7*** 1.8 ± 0.9* 2.9 ± 1.4 < 0.0001
 Tolvaptan 60 mg 8.4 ± 1.7 4.8 ± 1.6*** 4.3 ± 1.4*** 4.8 ± 1.0*** 4.7 ± 1.2***
 p (GLM between) < 0.0001      
 p (paired t-test, between) < 0.0001 < 0.0001 < 0.0001 < 0.0001 0.012  
u-AQP2 (ng/min)
 Placebo 1.28 ± 0.37 0.87 ± 0.25*** 0.85 ± 0.28*** 0.94 ± 0.35* 1.12 ± 0.40 < 0.0001
 Tolavptan 60 mg 1.15 ± 0.32 0.87 ± 0.23* 0.82 ± 0.22*** 0.93 ± 0.23* 0.89 ± 0.26*
 p (GLM between) < 0.0001      
 p (paired t-test, between) 0.075 0.931 0.702 0.887 0.015  
FENa (%)
 Placebo 1.39 (1.18; 2.33) 0.91* (0.84; 1.50) 0.78* (0.56; 0.97) 0.51*** (0.28; 0.78) 1.10 (0.88; 1.50)  
 Tolvaptan 60 mg 1.18 (0.83; 1.6) 0.86 (0.69; 1.11) 0.75 (0.45; 1.12) 0.44* (0.30; 0.81) 1.21 (0.81; 1.74)
 p (Wilcoxon’s signed rank test, between) 0.122 0.948 0.777 0.948 0.267
ENaCγ (ng/min)
 Placebo 0.78 (0.67; 0.79) 0.61 (0.45; 0.70) 0.60 (0.43; 0.76) 0.65 (0.37; 0.70) 0.73 (0.63; 0.91)  
 Tolvaptan 60 mg 0.75 (0.65; 1.0) 0.59 (0.52; 0.93) 0.66 (0.51; 0.81) 0.68 (0.56; 0.77) 0.69 (0.59; 0.86)
 p (Wilcoxon’s signed rank test, between) 0.711 0.112 0.306 0.248 0.744
  1. Data are given as mean ± SD or median with 25th and 75th percentiles in parentheses. General linear model (GLM) with repeated measures was performed for comparison within and between groups. Post-hoc Bonferoni test (*) was used for comparison of infusion period (90–150 min) vs baseline period (0–90 min) and post infusion period (150–210 min) vs baseline period
  2. Paired t-test or Wilcoxon’s signed rank test was performed for comparison between tolvaptan and placebo treatment at baseline period (0–90 min), L-NMMA infusion period (90–150 min) and post infusion period (150–210 min)
  3. *p<; 0.05; ***p < 0.0001