Abstract

Treatment of hypertension in hemodialysis (HD) patients is characterised by lack of evidence for both the blood pressure (BP) target goal and the recommended drug class to use. Telmisartan, an Angiotensin receptor blocker (ARB) that is metabolised in the liver and not excreted via HD extracorporeal circuit might be particularly suitable for HD patients. We designed and conducted a randomised, placebo-controlled, double-blind and cross-over trial for treatment of dialysis–associated hypertension with telmisartan 80 mg once daily or placebo on top of standard antihypertensive treatment excluding other Renin-Angiotensin-System (RAS) blockers. In 29 patients after randomization we analysed BP after a treatment period of 8 weeks, while 13 started with telmisartan and 16 with placebo; after 8 weeks 11 continued with telmisartan and 12 with placebo after cross-over, respectively. Patients exhibited a significant reduction of systolic pre-HD BP from 141.9±21.8 before to 131.3±17.3 mmHg after the first treatment period with telmisartan or placebo. However, no average significant influence of telmisartan was observed compared to placebo. The latter may be due to a large inter-individual variability of BP responses reaching from a 40 mmHg decrease under placebo to 40 mmHg increase under telmisartan. Antihypertensive co-medication was changed for clinical reasons in 7 out of 21 patients with no significant difference between telmisartan and placebo groups. Our starting hypothesis, that telmisartan on top of standard therapy lowers systolic office BP in HD patients could not be confirmed. In conclusion, this small trial indicates that testing antihypertensive drug efficacy in HD patients is challenging due to complicated standardization of concomitant medication and other confounding factors, e.g. volume status, salt load and neurohormonal activation, that influence BP control in HD patients.Trial Registration Clinicaltrialsregister.eu 2005-005021-60

Highlights

  • The prevalence of arterial hypertension in patients with chronic kidney disease stage 5 (CKD 5) receiving haemodialysis (HD) treatment ranges between 60 to 80% [1]

  • The pharmacokinetics including the elimination of the Angiotensin receptor blockers (ARB) olmesartan, was not influenced by HD in a previous report, but the drug reduced oxidative stress compared to amlodipin [8,9,10]

  • End-points Course of systolic office blood pressure (BP) pre HD in either placebo or telmisartan starting group is given in Fig. 2a and 2b, respectively

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Summary

Introduction

The prevalence of arterial hypertension in patients with chronic kidney disease stage 5 (CKD 5) receiving haemodialysis (HD) treatment ranges between 60 to 80% [1]. Therapeutic compounds which inhibit the Renin-AngiotensinSystem (RAS), e.g. ACE inhibitors (ACE-I) or Angiotensin receptor blockers (ARB) have proven protective cardiovascular effects [6;7]. Such evidence, while widely recognized in the general hypertensive population and in patients with increased cardiovascular risk, could not be affirmed in CKD 5 patients on maintenance HD treatment, since data are scarce in that field. No controlled study has been conducted so far targeting BP in HD patients by using telmisartan This relates probably to the difficulties of clinical management of dialysis-associated hypertension. We tested an approach using a doubleblind, randomized, cross-over controlled design to study the effect of telmisartan compared to placebo on top of a standard antihypertensive medication without treatment of other RAS blockers in HD patients

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