| Autor: |
Cawello, W., Kuhlmann, U., Schweer, H., Samadi, N., Gerloff, J., Wilberz, S., Seyberth, H.W., Lange, H. |
| Předmět: |
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| Zdroj: |
Clinical Drug Investigation; 1999, Vol. 18 Issue 4, p279-285, 7p |
| Abstrakt: |
Aim: The objective of this study was to evaluate the pharmacokinetics of prostaglandin E(PGE) and its metabolites after infusion of alprostadil in patients undergoing haemodialysis. Methods: In a single-blind, randomised, 2-way crossover study including eight patients with end-stage renal disease undergoing haemodialysis, alprostadil (60µg PGE) and placebo were administered by an intravenous infusion over 2 hours in parallel to dialysis. A specific highly sensitive analytical method was used to detect plasma levels of PGE and its metabolites. Results: Endogenous plasma levels of PGE were approximately 1 ng/L and did not change during dialysis. Plasma concentrations of unchanged drug increased to 11 ng/L, followed by a rapid drop to baseline levels after the end of the infusion. Comparing PGE plasma concentrations measured in the arterial inlet and venous outlet line of the dialyser, no significant extraction of PGE was found, which was also reflected by measurements from dialysis fluid. Plasma concentrations of metabolites 13,14-dihydro-prostaglandin E (PGE) and 15-keto-13,14-dihydro-prostaglandin E (15-keto-PGE) confirm the results described for the unchanged drug, indicating that no significant extraction occurs during dialysis. The pharmacokinetic profiles of PGE and its metabolites in patients undergoing dialysis are similar to those previouslyreported for healthy volunteers, with endogenous plasma levels of about 1 ng/L (PGE and PGE) and 10 ng/L (15-keto-PGE) and maximal plasma concentrations after a 2-hour infusion of about 11, 13 and 330 ng/L (PGE, PGE and 15-keto-PGE, respectively). Conclusions: There is no extraction of unchanged PGE and its metabolites during an intravenous infusion of alprostadil in parallel with haemodialysis. A dose adjustment for patients undergoing dialysis is not necessary. The pharmacokinetics of PGE and its metabolites are similar in patients undergoing dialysis compared with those in healthy volunteers. [ABSTRACT FROM AUTHOR] |
| Databáze: |
Complementary Index |
| Externí odkaz: |
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