TY - JOUR
T1 - Randomized calcineurin inhibitor cross over study to measure the pharmacokinetics of co-administered enteric-coated mycophenolate sodium
AU - Kaplan, Bruce
AU - Meier-Kriesche, Herwig Ulf
AU - Minnick, Paula
AU - Bastien, Marie Claude
AU - Sechaud, Romain
AU - Yeh, Ching Ming
AU - Balez, Sebastien
AU - Picard, Franck
AU - Schmouder, Robert
PY - 2005/8
Y1 - 2005/8
N2 - Enteric-coated mycophenolate sodium (EC-MPS) (myfortic®) is an advanced formulation delivering mycophenolic acid (MPA), designed to improve MPA-related upper gastrointestinal adverse events by delaying the release of MPA until the small intestine. A randomized, calcineurin inhibitor crossover, steady-state pharmacokinetic study in stable renal transplant patients receiving EC-MPS demonstrated increased MPA exposure of 19% higher, MPA Cmax,ss 19% lower and MPA Cmin,ss approximately twofold higher with tacrolimus, than cyclosporine microemulsion. No study drug-related adverse events were recorded, but mean blood glucose concentration was higher in patients receiving tacrolimus (p = 0.031). The dose changes in relation to MPA exposure in patients is dependent on the clinical situation and may not always be warranted. These observations should be taken into consideration when switching from one calcineurin inhibitor to another, but the final dosage should be based on both this pharmacokinetic data and the clinical situation.
AB - Enteric-coated mycophenolate sodium (EC-MPS) (myfortic®) is an advanced formulation delivering mycophenolic acid (MPA), designed to improve MPA-related upper gastrointestinal adverse events by delaying the release of MPA until the small intestine. A randomized, calcineurin inhibitor crossover, steady-state pharmacokinetic study in stable renal transplant patients receiving EC-MPS demonstrated increased MPA exposure of 19% higher, MPA Cmax,ss 19% lower and MPA Cmin,ss approximately twofold higher with tacrolimus, than cyclosporine microemulsion. No study drug-related adverse events were recorded, but mean blood glucose concentration was higher in patients receiving tacrolimus (p = 0.031). The dose changes in relation to MPA exposure in patients is dependent on the clinical situation and may not always be warranted. These observations should be taken into consideration when switching from one calcineurin inhibitor to another, but the final dosage should be based on both this pharmacokinetic data and the clinical situation.
KW - Calcineurin inhibitors
KW - Cyclosporine microemulsion
KW - Enteric-coated mycophenolate sodium
KW - Myfortic®
KW - Pharmacokinetics
KW - Tacrolimus
UR - http://www.scopus.com/inward/record.url?scp=22244431879&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=22244431879&partnerID=8YFLogxK
U2 - 10.1111/j.1399-0012.2005.00387.x
DO - 10.1111/j.1399-0012.2005.00387.x
M3 - Article
C2 - 16008604
AN - SCOPUS:22244431879
SN - 0902-0063
VL - 19
SP - 551
EP - 558
JO - Clinical Transplantation
JF - Clinical Transplantation
IS - 4
ER -