A six-hour extrapolated sampling strategy for monitoring mycophenolic acid in renal transplant patients in the Indian subcontinent.

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dc.contributor.authorFleming, D Hen_US
dc.contributor.authorMathew, B Sen_US
dc.contributor.authorJohn, G Ten_US
dc.contributor.authorChandy, S Jen_US
dc.contributor.authorManivannan, Jen_US
dc.contributor.authorJeyaseelan, Ven_US
dc.date.accessioned2006-10-15en_US
dc.date.accessioned2009-06-02T10:30:47Z
dc.date.available2006-10-15en_US
dc.date.available2009-06-02T10:30:47Z
dc.date.issued2006-10-15en_US
dc.description.abstractBACKGROUND: Therapeutic drug monitoring for mycophenolic acid (MPA) is increasingly being advocated. The present therapeutic range relates to the 12-hour area under the serum concentration time profile (AUC).However, this is a cumbersome, tedious, cost restricting procedure. Is it possible to reduce this sampling period? AIM: To compare the AUC from a reduced sampling strategy with the full 12-hour profile for MPA. SETTINGS AND DESIGN: Clinical Pharmacology Unit of a tertiary care hospital in South India. Retrospective, paired data. MATERIALS AND METHODS: Thirty-four 12-hour profiles from post-renal transplant patients on Cellcept were evaluated. Profiles were grouped according to steroid and immunosuppressant co-medication and the time after transplant. MPA was estimated by high performance liquid chromatography with UV detection. From the 12-hour profiles the AUC up to only six hours was calculated by the trapezoidal rule and a correction factor applied. These two AUCs were then compared. STATISTICAL ANALYSIS: Linear regression, intra-class correlations (ICC) and a two-tailed paired t-test were applied to the data. RESULTS: Comparing the 12-hour AUC with the paired 6-hour extrapolated AUC, the ICC and linear regression(r2) were very good for all three groups. No statistical difference was found by a two-tailed paired t-test. No bias was seen with a Bland Altman plot or by calculation. CONCLUSION: For patients on Cellcept with prednisolone +/- cyclosporine the 6-hour corrected is an accurate measure of the full 12-hour AUC.en_US
dc.description.affiliationClinical Pharmacology Unit, Christian Medical College, Vellore, Tamil Nadu, India. clinpharm@cmcvellore.ac.inen_US
dc.identifier.citationFleming DH, Mathew BS, John GT, Chandy SJ, Manivannan J, Jeyaseelan V. A six-hour extrapolated sampling strategy for monitoring mycophenolic acid in renal transplant patients in the Indian subcontinent. Journal of Postgraduate Medicine. 2006 Oct-Dec; 52(4): 248-52en_US
dc.identifier.urihttps://imsear.searo.who.int/handle/123456789/115574
dc.language.isoengen_US
dc.source.urihttps://www.jpgmonline.comen_US
dc.subject.meshAdolescenten_US
dc.subject.meshAdulten_US
dc.subject.meshArea Under Curveen_US
dc.subject.meshDrug Monitoring --methodsen_US
dc.subject.meshHumansen_US
dc.subject.meshImmunosuppressive Agents --blooden_US
dc.subject.meshIndiaen_US
dc.subject.meshKidney Transplantationen_US
dc.subject.meshMiddle Ageden_US
dc.subject.meshMycophenolic Acid --blooden_US
dc.subject.meshTime Factorsen_US
dc.titleA six-hour extrapolated sampling strategy for monitoring mycophenolic acid in renal transplant patients in the Indian subcontinent.en_US
dc.typeComparative Studyen_US
dc.typeJournal Articleen_US
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