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European Journal of Clinical Pharmacology

, Volume 27, Issue 2, pp 159–163 | Cite as

Clinical pharmacological studies with the vasodilator endralazine in patients with renal impairment

  • H. L. Elliott
  • P. A. Meredith
  • L. Sloan
  • J. L. Reid
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Summary

The influence of renal impairment on the pharmacokinetics of endralazine was studied in 12 patients; 4 patients on regular haemodialysis therapy (creatinine clearance less than 5 ml/min) and 8 patients with varying degrees of renal impairment (creatinine clearance 11–52 ml/min). Following an oral dose of 10 mg endralazine the mean terminal elimination half-life (βt1/2) in the dialysis sub-group was prolonged at 7.1 h (range 3.3 to 14 h), compared to 3.6 h in the other renal patients (and compared to 2.3 h in hypertensive patients with normal renal function). After one week's therapy with 10 mg B.D. endralazine in the 8 patients with moderate renal impairment there was a significant increase in βt1/2 to 8.6 h but there was no significant change in the area under the drug concentration-time curve and no evidence of drug accumulation. In this study those patients with the poorest renal function had the longest βt1/2 after acute dosing. There was a significant correlation between creatinine clearance and acute βt1/2 but there was considerable variability in individual patients and, even with severe degrees of renal impairment, major dose adjustments do not appear necessary.

Key words

endralazine renal impairment pharmacokinetics 

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Copyright information

© Springer-Verlag 1984

Authors and Affiliations

  • H. L. Elliott
    • 1
  • P. A. Meredith
    • 1
  • L. Sloan
    • 1
  • J. L. Reid
    • 1
  1. 1.Department of Materia MedicaStobhill General HospitalGlasgowScotland

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