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Outcomes of Late Corticosteroid Withdrawal after Renal Transplantation in Patients Exposed to Tacrolimus and/or Mycophen...
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 Material Information
Title: Outcomes of Late Corticosteroid Withdrawal after Renal Transplantation in Patients Exposed to Tacrolimus and/or Mycophenolate Mofetil: A Meta-Analysis of Randomized Controlled Trials.
Physical Description: Conference Papers
Creator: Ayad K. Ali
Conference: AAPS Annual Meeting and Exposition
Publisher: Springer and the American Association of Pharmaceutical Scientists
Place of Publication: USA
Publication Date: 2011
 Notes
Abstract: Purpose: To evaluate the clinical benefits and risks of late corticosteroid withdrawal in renal transplant patients treated with tacrolimus (TAC), or mycophenolate mofetil (MMF), or both. Methods: We conducted searches of the published literature through Pubmed and Google Scholar. Nine randomized trials were identified that enrolled kidney transplant patients who were randomized to corticosteroid maintenance or late withdrawal under concomitant immunosuppression by TAC (n=1), MMF (n=6), or both(n=2). An unweighted random effects model is used to combine results from individual trials. SAS 9.2 (SAS Institute Inc, Cary, NC) is used to conduct the analyses. Results: Nine studies randomized 1,907 patients. Compared to maintenance corticosteroid (CS) therapy, late CS withdrawal was associated with statistically not significant 34% increase in the risk of acute graft rejection (95% Confidence Interval CI, 0.47-3.82); 35% and 5% reductions in the risk of graft failure and patient's all-cause mortality (95%CI, 0.26-1.60; 0.23-3.93, respectively); and 4% increase in the risk of post transplant diabetes mellitus (95%CI, 0.45-2.41). Late CS withdrawal was associated with statistically significant reduction in total cholesterol levels (mean difference, 18.05 mg/dl; 95%CI, 7.12-29.0), but did not reduce serum creatinine levels (-0.0007 mg/dl; 95%CI, -0.17 to 0.17). Stopping CS therapy was associated with better growth outcomes in children compared to continuing CS treatment. Conclusion : Although late CS withdrawal under TAC- and/or MMF-lead immunosuppression after kidney transplantation could provide benefits in terms of total cholesterol, patient and graft survival, and pediatric growth; the strategy did not reduce the risk of acute graft rejection, posttransplant diabetes mellitus, and deterioration in serum creatinine levels. Additional large scale studies are required to further evaluate the long-term clinical outcomes associated with late CS withdrawal and to assess the CS-sparing effects of TAC and MMF in kidney transplant patients.
Acquisition: Collected for University of Florida's Institutional Repository by the UFIR Self-Submittal tool. Submitted by Ayad K Ali.
Publication Status: Published
General Note: Suggested Citation: Ali AK, Guo J, Ahn H-C, Shuster J, Dharnidharka V. Outcomes of Late Corticosteroid Withdrawal after Renal Transplantation in Patients Exposed to Tacrolimus and/or Mycophenolate Mofetil: A Meta-Analysis of Randomized Controlled Trials. The AAPS Journal. 2011;13(S2) Abstract No. T3377.
 Record Information
Source Institution: University of Florida Institutional Repository
Holding Location: University of Florida
Rights Management: All rights reserved by the source institution.
System ID: IR00000825:00001

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Outcomes of Late Corticosteroid Withdrawal after Renal Transplantation in Patients Exposed to Tacrolimus and/or Mycophenolate Mofetil: A Meta-Analysis of Randomized Controlled Trials. A. Ali, J. Guo, H-C. Ahn, J. Shuster, V. Dharnidharka University of Florida Purpose. To evaluate the clinical benefits and risks of late corticosteroid withdrawal in renal transplant patients treated with tacroli mus (TAC), or mycophenolate mofetil (MMF), or both. Methods. We conducted searches of the published literature through Pubmed and Google Scholar. Nine randomized trials were identified that enrolled kidney transplant patients who were randomized to corticosteroid maintenance or late withdrawal under concomitant immunosuppression by TAC (n=1), MMF (n=6), or both(n=2). An unweighted random effects model is used to combine results from individual trials. SAS 9.2 (SAS Institute Inc, Cary, NC) is used to conduct the analyses. Results. Nine studies randomized 1,907 patients. Compared to maintenance corticosteroid (CS) therapy, late CS withdrawal was associated with statistically not significant 34% increase in the risk of acute graft rejection (95% Confidence Interval [CI], 0.47-3.82); 35% and 5% reductions in the risk of graft failure and patient's all-cause mortality (95%CI, 0.26-1.60; 0.23-3.93, respectively); and 4% increase in the risk of post transplant diabetes mellitus (95%CI, 0.452.41). Late CS withdrawal was associated with statistically significant reduction in total cholesterol levels (mean difference, 18.05 mg/dl; 95%CI, 7.12-29.0 ), but did not reduce serum creatinine levels (-0.0007 mg/dl; 95%CI, -0.17 to 0.17). Stopping CS therapy was associated with better growth outcomes in children compared to continuing CS treatment. Conclusion. Although late CS withdrawal under TACand/or MMF-lead immunosuppression after kidney transplantation could provide benefits in terms of total cholesterol, patient and graft survival, and pediatric growth; the strategy did not reduce the risk of acute graft rejection, posttransplant diabetes me llitus, and deterioration in serum creatinine levels. Additional large scale studies are required to further evaluate the long-term clinical outcomes associated with late CS withdrawal and to assess the CS-sparing effects of TAC and MMF in kidney transplant patients.