title: A controlled trial comparing two doses of cyclosporine in conjunction with mycophenolate mofetil and corticosteroids.
abstract: It is unknown whether the addition of mycophenolate mofetil (MMF) to cyclosporine (CsA) and prednisone after renal transplantation (RTx) allows for a reduced dose of CsA, to minimize the incidence of CsA-related side effects and to reduce costs. Therefore, 313 renal allograft recipients were randomized for treatment with MMF (1000 mg twice a day), prednisone, and either conventional- or low-dose CsA during the first 3 mo after RTx. The target trough levels were 300 and 150 ng/ml, respectively, during the first 3 mo and 150 ng/ml in both groups thereafter. A total of 313 patients were included: 161 patients received a conventional dose and 152 received a low dose of CsA. During the first 6 mo after RTx, graft failure or patient death occurred in 19 of 161 patients (12%) in the conventional-dose group and in 11 of 152 patients (7%) in the low-dose group (not significant). Biopsy-proven acute rejection occurred in 36 of 161 patients (22%) in the conventional-dose group and in 29 of 152 patients (19%) in the low-dose group (not significant). The incidence of delayed graft function was similar in both groups (31 of 161 [19%] versus 28 of 152 [18%]; not significant). Serum creatinine did not differ between the conventional- and the low-dose groups: 151 +/- 56 micromol/L versus 142 +/- 49 micromol/L at 3 mo and 141 +/- 60 micromol/L versus 136 +/- 49 micromol/L at 6 mo. There were no differences between the groups regarding BP, lipid metabolism, and infectious complications. In the low-dose group, an estimated $500 per patient was saved on the costs of CsA. In conclusion, the addition of MMF to CsA and prednisone after RTx allows the use of a lower-than-conventional dose of CsA, without increasing the risk of rejection.
authors.affiliation: Department of Nephrology, University Hospital of Nijmegen, The Netherlands.
authors.forename: Ruud G L DE
authors.initials: RGL
authors.lastname: Sévaux
authors.affiliation: Department of Nephrology, University Hospital of Rotterdam, The Netherlands.
authors.forename: Peter J H Smak
authors.initials: PJHS
authors.lastname: Gregoor
authors.affiliation: Department of Nephrology, University Hospital of Utrecht, The Netherlands.
authors.forename: Ronald J
authors.initials: RJ
authors.lastname: Hené
authors.affiliation: Department of Nephrology, University Hospital of Nijmegen, The Netherlands.
authors.forename: Andries J
authors.initials: AJ
authors.lastname: Hoitsma
authors.affiliation: Department of Nephrology, University Hospital of Utrecht, The Netherlands.
authors.forename: Pieter
authors.initials: P
authors.lastname: Vos
authors.affiliation: Department of Nephrology, University Hospital of Rotterdam, The Netherlands.
authors.forename: Willem
authors.initials: W
authors.lastname: Weimar
authors.affiliation: Department of Nephrology, University Hospital of Rotterdam, The Netherlands.
authors.forename: Teun VAN
authors.initials: TV
authors.lastname: Gelder
authors.affiliation: Department of Nephrology, University Hospital of Nijmegen, The Netherlands.
authors.forename: Lukas B
authors.initials: LB
authors.lastname: Hilbrands
mesh_terms: D000305:Adrenal Cortex Hormones / Q000627:therapeutic use*; D000328:Adult; D001706:Biopsy; D001794:Blood Pressure; D016572:Cyclosporine / Q000008:administration & dosage* / Q000097:blood / Q000191:economics / Q000627:therapeutic use; D004305:Dose-Response Relationship, Drug; D016527:Drug Costs; D005260:Female; D006084:Graft Rejection / Q000453:epidemiology / Q000473:pathology; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage* / Q000097:blood / Q000191:economics / Q000627:therapeutic use; D015994:Incidence; D007668:Kidney / Q000503:physiopathology; D016030:Kidney Transplantation / Q000401:mortality; D008297:Male; D008875:Middle Aged; D009173:Mycophenolic Acid / Q000031:analogs & derivatives / Q000627:therapeutic use*; D012449:Safety; D017211:Treatment Failure
chemical_list: D000305:Adrenal Cortex Hormones; D007166:Immunosuppressive Agents; D016572:Cyclosporine; D009173:Mycophenolic Acid