Clinical Drug Investigation

, Volume 21, Issue 1, pp 59–66 | Cite as

Pharmacokinetics of Valsartan in Hypertensive Patients on Long-Term Haemodialysis

  • Michael F. Leidig
  • Christian Delles
  • Christian Kuchenbecker
  • Rainer-Ainer-Max Lederle
  • Gottfried Weidinger
  • Roland E. Schmieder
Clinical Pharmacokinetics

Abstract

Background

Previous studies have indicated no relationship between renal function (creatinine clearance) and the pharmacokinetics of valsartan in patients with moderately impaired renal function. There are no pharmacokinetic data available for valsartan in patients on long-term haemodialysis.

Objective

To examine the pharmacokinetics of valsartan 80mg in hypertensive patients on long-term haemodialysis. Secondary objectives were to evaluate the efficacy and tolerability of valsartan in this patient group.

Design

Multicentre, nonblind, parallel-group study.

Participants

20 hypertensive patients with no renal impairment and 20 hypertensive patients on long-term haemodialysis.

Methods

All patients were treated with valsartan 80mg once daily for 15 days. After the first dose of valsartan and at the end of the treatment period, plasma concentrations of valsartan were determined over 24 hours.

Results

Significant differences in the area under the concentration-time curve from zero to 24 hours (AUC24h) at steady state were found between the patients on haemodialysis and those with normal renal function. In contrast, no differences were found for AUC24h during first-dose pharmacokinetics or for maximum plasma concentration and elimination half-life during first-dose and steady-state pharmacokinetics. Blood pressure decreased significantly in both groups, but the reduction in systolic blood pressure was greater in patients on haemodialysis (18mm Hg) than in the control group (6mm Hg). Valsartan 80mg was well tolerated in patients undergoing haemodialysis.

Conclusions

The pharmacokinetic characteristics of valsartan are altered in patients on haemodialysis under steady-state conditions, but not after single-dose administration. The increased bioavailability at steady state was still in the range of the bioavailability for the approved dose of up to 160mg in patients with or without renal impairment. Valsartan 80 mg/day was well tolerated in this patient population.

Keywords

Hypertensive Patient Renal Impairment Valsartan Normal Renal Function Polycystic Kidney Disease 

Notes

Acknowledgements

This study was supported in part by a grant from Novartis Pharma GmbH.

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Copyright information

© Adis International Limited 2001

Authors and Affiliations

  • Michael F. Leidig
    • 1
  • Christian Delles
    • 1
  • Christian Kuchenbecker
    • 2
  • Rainer-Ainer-Max Lederle
    • 3
  • Gottfried Weidinger
    • 4
  • Roland E. Schmieder
    • 1
  1. 1.Department of Medicine IV/NephrologyUniversity of Erlangen-NürnbergNürnbergGermany
  2. 2.Physician in Private PracticeWeimarGermany
  3. 3.Physician in Private PracticeDortmundGermany
  4. 4.Novartis Pharma GmbHNürnbergGermany

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