title: Tacrolimus monitoring in renal transplantation: a comparison between high-performance liquid chromatography and immunoassay.
abstract: It is recommended that specific methods of tacrolimus monitoring rather than immunoassays, which overestimate tacrolimus levels, should be used in transplant recipients. Direct comparison of these techniques, however, has not been conducted in renal transplantation. In this study, 40 renal transplant recipients with tacrolimus monitoring by microparticle enzyme immunoassay (MEIA; target trough level 10 to 15 ng/mL) were compared with 40 patients monitored by high-performance liquid chromatography with tandem mass spectrometry (HPLC-MS; target trough level 8 to 13 ng/mL). All patients received anti CD25 antibody induction and mycophenolate mofetil in a steroid-sparing protocol. No differences were seen between MEIA and HPLC-MS groups in patient demographics. All patients were followed for 6 months. Patient survival was 100% in both groups; graft survival was 100% in the MEIA group and 97.5% in the HPLC-MS group. The groups did not differ in the number of dose changes required in the first 6 months or in the number of patients displaying tacrolimus levels within target range at 3 and 6 months. Delayed graft function occurred in 14 patients in the MEIA group and 12 patients in the HPLC-MS group (P = NS). Biopsy-proven acute rejection occurred in four patients in the MEIA group and one patient in the HPLC-MS group (P < .2). No differences were seen for the following parameters at 3 or 6 months: biopsy-proven tacrolimus nephrotoxicity, serum creatinine or estimated creatinine clearance, systolic or diastolic blood pressure, cholesterol, cytomegalovirus disease, posttransplant diabetes, or tremor. This study suggests that renal transplantation with HPLC-MS monitoring of tacrolimus is safe and effective.
authors.affiliation: Renal and Transplant Units, St. Mary's Hospital, Paddington, London, United Kingdom. richardborrows@doctors.org.uk
authors.forename: R
authors.initials: R
authors.lastname: Borrows
authors.forename: G
authors.initials: G
authors.lastname: Chusney
authors.forename: M
authors.initials: M
authors.lastname: Loucaidou
authors.forename: S
authors.initials: S
authors.lastname: Singh
authors.forename: A
authors.initials: A
authors.lastname: James
authors.forename: J
authors.initials: J
authors.lastname: Stichbury
authors.forename: J
authors.initials: J
authors.lastname: Van Tromp
authors.forename: T
authors.initials: T
authors.lastname: Cairns
authors.forename: M
authors.initials: M
authors.lastname: Griffith
authors.forename: N
authors.initials: N
authors.lastname: Hakim
authors.forename: A
authors.initials: A
authors.lastname: McLean
authors.forename: A
authors.initials: A
authors.lastname: Palmer
authors.forename: V
authors.initials: V
authors.lastname: Papalois
authors.forename: D
authors.initials: D
authors.lastname: Taube
mesh_terms: D001794:Blood Pressure; D002851:Chromatography, High Pressure Liquid / Q000379:methods; D016903:Drug Monitoring / Q000379:methods; D006084:Graft Rejection / Q000453:epidemiology; D006085:Graft Survival; D006801:Humans; D007124:Immunoenzyme Techniques; D007166:Immunosuppressive Agents / Q000493:pharmacokinetics; D016030:Kidney Transplantation / Q000276:immunology* / Q000401:mortality; D013058:Mass Spectrometry; D016019:Survival Analysis; D016559:Tacrolimus / Q000493:pharmacokinetics*
chemical_list: D007166:Immunosuppressive Agents; D016559:Tacrolimus