| Pharmacokinetics of aliskiren in patients with end-stage renal disease undergoing haemodialysis. | |
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MedLine Citation:
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PMID: 23018529 Owner: NLM Status: In-Data-Review |
Abstract/OtherAbstract:
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BACKGROUND AND OBJECTIVES: Aliskiren represents a novel class of orally active renin inhibitors. This study analyses the pharmacokinetics, tolerability and safety of single-dose aliskiren inpatients with end-stage renal disease (ESRD) undergoing haemodialysis. METHODS: Six ESRD patients and six matched healthy volunteers were enrolled in an open-label, parallel-group, single-sequence study. The ESRD patients underwent two treatment periods where 300 mg of aliskiren was administered 48 or 1 h before a standardized haemodialysis session (4 h, 1.4 m(2) high-flux filter, blood flow 300 mL/min, dialysate flow 500 mL/min). Washout was >10 days between both periods. Blood and dialysis samples were taken for up to 96 h postdose to determine aliskiren concentrations. RESULTS: Compared with the healthy subjects (1681 ± 1034 ng·h/mL), the area under the plasma concentration-time curve (AUC) from time zero to infinity was 61 % (haemodialysis at 48 h) and 41 % (haemodialysis at 1 h) higher in ESRD patients receiving single-dose aliskiren 300 mg. The maximum (peak) plasma drug concentration (481 ± 497 ng/mL in healthy subjects) was 17 % higher (haemodialysis at 48 h) and 16 % lower (haemodialysis at 1 h). In both treatment periods, dialysis clearance was below 2 % of oral clearance and the mean fraction eliminated from circulation was 10 and 12 % in period 1 and 2, respectively. Drug AUCs were similar in ESRD patients receiving aliskiren 1 or 48 h before dialysis. No severe adverse events occurred. CONCLUSION: The exposure of aliskiren is moderately higher in ESRD patients. Only a minor portion is removed by a typical haemodialysis session. Aliskiren exposure is not significantly affected by intermittent haemodialysis, suggesting that no dose adjustment is necessary in this population. |
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Authors:
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Dmytro Khadzhynov; Torsten Slowinski; Ina Lieker; Hans-Hellmut Neumayer; Diego Albrecht; Henk Johan Streefkerk; Sam Rebello; Harm Peters |
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Publication Detail:
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Type: Journal Article |
Journal Detail:
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Title: Clinical pharmacokinetics Volume: 51 ISSN: 0312-5963 ISO Abbreviation: Clin Pharmacokinet Publication Date: 2012 Oct |
Date Detail:
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Created Date: 2012-09-28 Completed Date: - Revised Date: - |
Medline Journal Info:
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Nlm Unique ID: 7606849 Medline TA: Clin Pharmacokinet Country: New Zealand |
Other Details:
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Languages: eng Pagination: 661-9 Citation Subset: IM |
Affiliation:
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Department of Nephrology, Charité Universitätsmedizin Berlin, Humboldt University, Charité Campus Mitte, Charitéplatz 1, 10117, Berlin, Germany. |
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From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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