| Pharmacokinetics and pharmacodynamics of mycophenolic acid after enteric-coated mycophenolate versus mycophenolate mofetil in patients with progressive IgA nephritis. | |
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MedLine Citation:
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PMID: 17526858 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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Mycophenolic acid can be administered orally using mycophenolate mofetil or enteric-coated mycophenolate. In renal transplant patients on immunosuppressant combination therapy, the overall mycophenolic acid exposure after oral dosing with mycophenolate mofetil and enteric-coated mycophenolate is similar. This study compared pharmacokinetics and pharmacodynamics of mycophenolic acid after equivalent doses of enteric-coated mycophenolate (360 mg twice daily) or mycophenolate mofetil (500 mg twice daily) in 7 patients with progressive IgA nephritis (glomerular filtration rate 20-35 mL/min) using a randomized crossover design. The pharmacokinetics of mycophenolic acid concentrations and pharmacodynamics (using inosine 5'-monophosphate dehydrogenase activity as a bio-marker) were sequentially monitored for 12 hours. After enteric-coated mycophenolate treatment, the mycophenolic acid peak concentration (Cmax = 12.8 vs 6.0 microg/mL, P < .05) and the overall exposure were significantly higher (AUC = 60.9 vs 40.7 microg.h/mL, P < .05), and the apparent clearance was significantly lower (CL/F = 7.9 vs 10.7 L/h, P < .05) as compared to that after mycophenolate mofetil. Paradoxically, inosine 5'-monophosphate dehydrogenase activity was not significantly different. In conclusion, the steady-state mycophenolic acid exposure was higher during treatment with enteric-coated mycophenolate as compared to mycophenolate mofetil, which might be explained by more extensive enterohepatic recycling of mycophenolic acid after administration of enteric-coated mycophenolate, whereas inosine 5'-monophosphate dehydrogenase suppression was not different. |
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Authors:
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David Czock; Franz Maximilian Rasche; Alexander Carius; Petra Glander; Klemens Budde; Steffen Bauer; Frieder Keller; Lutz von Müller |
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Publication Detail:
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Type: Comparative Study; Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't Date: 2007-05-25 |
Journal Detail:
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Title: Journal of clinical pharmacology Volume: 47 ISSN: 0091-2700 ISO Abbreviation: J Clin Pharmacol Publication Date: 2007 Jul |
Date Detail:
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Created Date: 2007-06-22 Completed Date: 2007-08-20 Revised Date: 2013-05-29 |
Medline Journal Info:
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Nlm Unique ID: 0366372 Medline TA: J Clin Pharmacol Country: United States |
Other Details:
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Languages: eng Pagination: 850-9 Citation Subset: IM |
Affiliation:
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University Hospital Ulm, Medical Department I, Division of Nephrology, Robert-Koch-Str. 8, 89070 Ulm, Germany. |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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Area Under Curve Cross-Over Studies Female Glomerulonephritis, IGA / physiopathology* Humans IMP Dehydrogenase / metabolism Immunosuppressive Agents / administration & dosage, pharmacokinetics*, pharmacology*, therapeutic use Linear Models Male Metabolic Clearance Rate Middle Aged Mycophenolic Acid / administration & dosage, analogs & derivatives*, pharmacokinetics, pharmacology, therapeutic use Prodrugs / administration & dosage, pharmacokinetics*, pharmacology*, therapeutic use Renal Insufficiency / physiopathology Tablets, Enteric-Coated Therapeutic Equivalency |
| Chemical | |
Reg. No./Substance:
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0/Immunosuppressive Agents; 0/Prodrugs; 0/Tablets, Enteric-Coated; 24280-93-1/Mycophenolic Acid; 9242ECW6R0/mycophenolate mofetil; EC 1.1.1.205/IMP Dehydrogenase |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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