Pharmacokinetics and pharmacodynamics of intensified versus standard dosing of mycophenolate sodium in renal transplant patients
BACKGROUND AND OBJECTIVES: Adequate early mycophenolic acid (MPA) exposure is an important determinant for effective rejection prophylaxis. This pharmacokinetic study investigated whether an intensified dosing regimen of enteric-coated mycophenolate sodium (EC-MPS) could achieve higher mycophenolic...
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| Main Authors: | , , , , , , , , , |
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| Format: | Article (Journal) |
| Language: | English |
| Published: |
2010 Feb 11
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| In: |
Clinical journal of the American Society of Nephrology
Year: 2010, Volume: 5, Issue: 3, Pages: 503-511 |
| ISSN: | 1555-905X |
| Online Access: |
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| Author Notes: | Petra Glander, Claudia Sommerer, Wolfgang Arns, Toofan Ariatabar, Stefan Kramer, Eva-Maria Vogel, Maria Shipkova, Wolfgang Fischer, Martin Zeier, and Klemens Budde |
MARC
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| 245 | 1 | 0 | |a Pharmacokinetics and pharmacodynamics of intensified versus standard dosing of mycophenolate sodium in renal transplant patients |c Petra Glander, Claudia Sommerer, Wolfgang Arns, Toofan Ariatabar, Stefan Kramer, Eva-Maria Vogel, Maria Shipkova, Wolfgang Fischer, Martin Zeier, and Klemens Budde |
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| 520 | |a BACKGROUND AND OBJECTIVES: Adequate early mycophenolic acid (MPA) exposure is an important determinant for effective rejection prophylaxis. This pharmacokinetic study investigated whether an intensified dosing regimen of enteric-coated mycophenolate sodium (EC-MPS) could achieve higher mycophenolic acid (MPA) exposure early after transplantation versus a standard dosing regimen. - DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS: De novo kidney transplant recipients (n = 75) who were treated with basiliximab induction and cyclosporine were randomly assigned to receive EC-MPS as either standard dosing (1440 mg/d; n = 37) or intensified dosing (days 0 through 14: 2880 mg/d; days 15 through 42: 2160 mg/d; followed by 1440 mg/d; n = 38). Full 12-hour pharmacokinetic and pharmacodynamic profiles were taken at six time points during the first 3 months. Exploratory analysis of inosine monophosphate dehydrogenase (IMPDH) activity was also performed for better understanding of the pharmacokinetic-pharmacodynamic relationship between MPA exposure and IMPDH activity in the early posttransplantation period. Preliminary efficacy parameters, safety, and tolerability were assessed. - RESULTS: Exposure to MPA was significantly higher on days 3 and 10 after transplantation in the intensified versus standard EC-MPS group, with 52.9 versus 22.2% (P < 0.05) of patients reaching MPA exposure >40 mg/h per L in the first week. The intensified regimen resulted in significantly lower IMPDH activity on day 3 after transplantation, and the overall safety was comparable for both groups. - CONCLUSIONS: These pharmacokinetic and safety data support further research on the hypothesis that early adequate MPA exposure could improve clinical outcome. | ||
| 650 | 4 | |a Administration, Oral | |
| 650 | 4 | |a Adult | |
| 650 | 4 | |a Antibodies, Monoclonal | |
| 650 | 4 | |a Area Under Curve | |
| 650 | 4 | |a Basiliximab | |
| 650 | 4 | |a Chi-Square Distribution | |
| 650 | 4 | |a Cyclosporine | |
| 650 | 4 | |a Drug Therapy, Combination | |
| 650 | 4 | |a Feasibility Studies | |
| 650 | 4 | |a Female | |
| 650 | 4 | |a Germany | |
| 650 | 4 | |a Graft Rejection | |
| 650 | 4 | |a Graft Survival | |
| 650 | 4 | |a Humans | |
| 650 | 4 | |a Immunosuppressive Agents | |
| 650 | 4 | |a IMP Dehydrogenase | |
| 650 | 4 | |a Kidney Transplantation | |
| 650 | 4 | |a Male | |
| 650 | 4 | |a Middle Aged | |
| 650 | 4 | |a Mycophenolic Acid | |
| 650 | 4 | |a Pilot Projects | |
| 650 | 4 | |a Prospective Studies | |
| 650 | 4 | |a Recombinant Fusion Proteins | |
| 650 | 4 | |a Tablets, Enteric-Coated | |
| 650 | 4 | |a Time Factors | |
| 650 | 4 | |a Treatment Outcome | |
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| 700 | 1 | |a Budde, Klemens |e VerfasserIn |0 (DE-588)1111064571 |0 (DE-627)865478902 |0 (DE-576)475913329 |4 aut | |
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