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...
Saved in:
| Main Authors: | , , , , , , , , , |
|---|---|
| Format: | Article (Journal) |
| Language: | English |
| Published: |
2010 Feb 11
|
| In: |
Clinical journal of the American Society of Nephrology
Year: 2010, Volume: 5, Issue: 3, Pages: 503-511 |
| ISSN: | 1555-905X |
| Online Access: |
|
| 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
| LEADER | 00000caa a2200000 c 4500 | ||
|---|---|---|---|
| 001 | 1841069426 | ||
| 003 | DE-627 | ||
| 005 | 20230710144246.0 | ||
| 007 | cr uuu---uuuuu | ||
| 008 | 230403s2010 xx |||||o 00| ||eng c | ||
| 024 | 7 | |a 10.2215/CJN.06050809 |2 doi | |
| 035 | |a (DE-627)1841069426 | ||
| 035 | |a (DE-599)KXP1841069426 | ||
| 035 | |a (OCoLC)1389806774 | ||
| 040 | |a DE-627 |b ger |c DE-627 |e rda | ||
| 041 | |a eng | ||
| 084 | |a 33 |2 sdnb | ||
| 100 | 1 | |a Glander, Petra |d 1966- |e VerfasserIn |0 (DE-588)120842998 |0 (DE-627)70503108X |0 (DE-576)292412185 |4 aut | |
| 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 |
| 264 | 1 | |c 2010 Feb 11 | |
| 300 | |a 9 | ||
| 336 | |a Text |b txt |2 rdacontent | ||
| 337 | |a Computermedien |b c |2 rdamedia | ||
| 338 | |a Online-Ressource |b cr |2 rdacarrier | ||
| 500 | |a Gesehen am 03.04.2023 | ||
| 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 | |
| 700 | 1 | |a Sommerer, Claudia |d 1971- |e VerfasserIn |0 (DE-588)121857654 |0 (DE-627)705680002 |0 (DE-576)292921829 |4 aut | |
| 700 | 1 | |a Arns, Wolfgang |e VerfasserIn |4 aut | |
| 700 | 1 | |a Ariatabar, Toofan |e VerfasserIn |4 aut | |
| 700 | 1 | |a Kramer, Stefan |e VerfasserIn |4 aut | |
| 700 | 1 | |a Vogel, Eva-Maria |e VerfasserIn |4 aut | |
| 700 | 1 | |a Shipkova, Maria |d 1966- |e VerfasserIn |0 (DE-588)124332919 |0 (DE-627)085792411 |0 (DE-576)294123970 |4 aut | |
| 700 | 1 | |a Fischer, Wolfgang |e VerfasserIn |4 aut | |
| 700 | 1 | |a Zeier, Martin |e VerfasserIn |0 (DE-588)1026480302 |0 (DE-627)726772356 |0 (DE-576)371826438 |4 aut | |
| 700 | 1 | |a Budde, Klemens |e VerfasserIn |0 (DE-588)1111064571 |0 (DE-627)865478902 |0 (DE-576)475913329 |4 aut | |
| 773 | 0 | 8 | |i Enthalten in |a American Society of Nephrology |t Clinical journal of the American Society of Nephrology |d Washington, DC : American Society of Nephrology, 2006 |g 5(2010), 3, Seite 503-511 |h Online-Ressource |w (DE-627)50595091X |w (DE-600)2216582-4 |w (DE-576)30683281X |x 1555-905X |7 nnas |
| 773 | 1 | 8 | |g volume:5 |g year:2010 |g number:3 |g pages:503-511 |g extent:9 |a Pharmacokinetics and pharmacodynamics of intensified versus standard dosing of mycophenolate sodium in renal transplant patients |
| 951 | |a AR | ||
| 992 | |a 20230403 | ||
| 993 | |a Article | ||
| 994 | |a 2010 | ||
| 998 | |g 1026480302 |a Zeier, Martin |m 1026480302:Zeier, Martin |d 910000 |d 910100 |d 50000 |e 910000PZ1026480302 |e 910100PZ1026480302 |e 50000PZ1026480302 |k 0/910000/ |k 1/910000/910100/ |k 0/50000/ |p 9 | ||
| 998 | |g 121857654 |a Sommerer, Claudia |m 121857654:Sommerer, Claudia |d 910000 |d 910100 |e 910000PS121857654 |e 910100PS121857654 |k 0/910000/ |k 1/910000/910100/ |p 2 | ||
| 999 | |a KXP-PPN1841069426 |e 4301292683 | ||
| BIB | |a Y | ||
| SER | |a journal | ||
| JSO | |a {"note":["Gesehen am 03.04.2023"],"relHost":[{"pubHistory":["1.2006 -"],"titleAlt":[{"title":"CJASN"}],"note":["Gesehen am 04.08.2025"],"part":{"text":"5(2010), 3, Seite 503-511","extent":"9","pages":"503-511","volume":"5","issue":"3","year":"2010"},"title":[{"title_sort":"Clinical journal of the American Society of Nephrology","title":"Clinical journal of the American Society of Nephrology","subtitle":"CJASN"}],"physDesc":[{"extent":"Online-Ressource"}],"language":["eng"],"type":{"bibl":"periodical","media":"Online-Ressource"},"corporate":[{"role":"aut","display":"American Society of Nephrology"}],"id":{"eki":["50595091X"],"zdb":["2216582-4"],"issn":["1555-905X"]},"origin":[{"dateIssuedKey":"2006","publisher":"American Society of Nephrology","dateIssuedDisp":"2006-","publisherPlace":"Washington, DC"}],"disp":"American Society of NephrologyClinical journal of the American Society of Nephrology","recId":"50595091X"}],"physDesc":[{"extent":"9 S."}],"language":["eng"],"type":{"bibl":"article-journal","media":"Online-Ressource"},"person":[{"role":"aut","given":"Petra","family":"Glander","display":"Glander, Petra"},{"role":"aut","given":"Claudia","family":"Sommerer","display":"Sommerer, Claudia"},{"display":"Arns, Wolfgang","role":"aut","given":"Wolfgang","family":"Arns"},{"family":"Ariatabar","given":"Toofan","role":"aut","display":"Ariatabar, Toofan"},{"given":"Stefan","role":"aut","family":"Kramer","display":"Kramer, Stefan"},{"display":"Vogel, Eva-Maria","family":"Vogel","role":"aut","given":"Eva-Maria"},{"given":"Maria","role":"aut","family":"Shipkova","display":"Shipkova, Maria"},{"role":"aut","given":"Wolfgang","family":"Fischer","display":"Fischer, Wolfgang"},{"display":"Zeier, Martin","given":"Martin","role":"aut","family":"Zeier"},{"role":"aut","given":"Klemens","family":"Budde","display":"Budde, Klemens"}],"title":[{"title_sort":"Pharmacokinetics and pharmacodynamics of intensified versus standard dosing of mycophenolate sodium in renal transplant patients","title":"Pharmacokinetics and pharmacodynamics of intensified versus standard dosing of mycophenolate sodium in renal transplant patients"}],"name":{"displayForm":["Petra Glander, Claudia Sommerer, Wolfgang Arns, Toofan Ariatabar, Stefan Kramer, Eva-Maria Vogel, Maria Shipkova, Wolfgang Fischer, Martin Zeier, and Klemens Budde"]},"recId":"1841069426","id":{"doi":["10.2215/CJN.06050809"],"eki":["1841069426"]},"origin":[{"dateIssuedKey":"2010","dateIssuedDisp":"2010 Feb 11"}]} | ||
| SRT | |a GLANDERPETPHARMACOKI2010 | ||