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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
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BMC Nephrology

ISSN: 1471-2369

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