Favorable results of concomitant tacrolimus and sirolimus therapy in Taiwanese renal transplant recipients at 12 months
Journal
Journal of the Formosan Medical Association
Journal Volume
107
Journal Issue
7
Pages
533-539
Date Issued
2008
Author(s)
Abstract
Background/Purpose: Combined therapy of sirolimus and cyclosporine has been found to exacerbate cyclosporine-related nephrotoxicity and to imperil graft renal function. We hypothesized that tacrolimus could bring about better renal function than cyclosporine when used in combination with sirolimus and corticosteroids for de novo renal transplantation. Methods: A two-arm randomized study was conducted to test the hypothesis. Patients who gave written informed consent and received renal transplantation were randomized to take sirolimus in combination with either tacrolimus or cyclosporine. The primaiy endpoint of this study was renal function, and the secondary endpoints were acute rejection, graft and patient survival, metabolic side effects and infectious complications. Results: A total of 41 Taiwanese renal transplant patients were randomized to receive cyclosporine (CsA group, n = 20) or tacrolimus (TAC group, n = 21) in combination with sirolimus and corticosteroids. The average estimated glomerular filtration rate (eGFR) was 52.77 ± 3.86 mL per minute for the TAC group at 6 months, and 46.42 ± 3.95 mL per minute for the CsA group (p> 0.05). At 12 months, the average eGFR was 52.04 ± 4.38 mL per minute for the TAC group, and 46.79 ± 4.38 mL per minute for the CsA group (p> 0.05). The biopsy-proven acute rejection rate of the TAC group was 4.76% (1/21), and that of the CsA group was 5.00% (1/20) at 12 months. The 12-month graft survival rates for the TAC and CsA groups were 100% and 90% (p = 0.142), respectively. Conclusion: Our study demonstrated that concomitant tacrolimus and sirolimus therapy resulted in a favorable outcome in Taiwanese renal transplant patients at 12 months. Large-scale clinical trials will be needed to further address the issue of which calcineurin inhibitor, cyclosporine or tacrolimus, provides better renal function and graft survival for renal transplant patients. ?2008 Elsevier & Formosan Medical Association.
SDGs
Other Subjects
cholesterol; corticosteroid; cyclosporin A; fibric acid derivative; HLA antigen; hydroxymethylglutaryl coenzyme A reductase inhibitor; insulin; rapamycin; tacrolimus; valganciclovir; acute graft rejection; adult; alanine aminotransferase blood level; article; aspartate aminotransferase blood level; bacterial pneumonia; clinical article; clinical trial; controlled clinical trial; controlled study; Cytomegalovirus; deep vein thrombosis; diabetes mellitus; drug blood level; drug substitution; drug withdrawal; female; glomerulus filtration rate; graft failure; graft infection; graft recipient; graft survival; hemolytic uremic syndrome; hirsutism; HLA matching; human; hypercholesterolemia; hyperlipidemia; hypothesis; informed consent; kidney biopsy; kidney failure; kidney function; kidney graft; kidney graft rejection; kidney transplantation; Legionella; loading drug dose; male; medical research; outcome assessment; peritoneal dialysis; peritonitis; pyrexia idiopathica; randomized controlled trial; rapidly progressive glomerulonephritis; side effect; Taiwan; treatment outcome; urinary tract infection; urine incontinence
Publisher
Scientific Communications International Ltd
Type
journal article