Efficacy and safety of tacrolimus <i>versus</i> cyclosporine after renal transplantation: a meta-analysis_Chinese Journal of Evidence-Based Medicine

Authors：

ZHANG Wenrui ¹ , GAO Yuan ¹ , BU Ning ¹ , ZHAO Min ¹ , WANG Ge ¹ , RUAN Zhen ¹ ,  SHA Baoyong ² ,  GAO Wei ¹

1. Department of Anesthesiology and Surgery, The First Affiliated Hospital of Xi’an Jiaotong University, Xi’an, 710061, P.R.China;
2. Institute of Basic Medical Science, Xi’an Medical University, Xi’an, 710021, P.R.China;

Corresponding author：

SHA Baoyong, Email: 121915839@qq.com; GAO Wei, Email: 545359725@qq.com

Keywords：

Tacrolimus; Cyclosporine A; Renal transplantation; Systematic review; Meta-analysis; Randomized controlled trial

DOI：

10.7507/1672-2531.201902011

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Objectives To systematically review the efficacy and safety of tacrolimus (TAC) and cyclosporine A (CsA) for patients after renal transplantation.Methods PubMed, EMbase, Web of Science, The Cochrane Library, CBM, WanFang Data and CNKI databases were electronically searched to collect randomized controlled trials (RCTs) on the efficacy and safety of TAC vs. CsA after renal transplantation from inception to December, 2018. Two reviewers independently screened literature, extracted data and assessed the risk of bias of included studies, then, meta-analysis was performed by using RevMan 5.3 software.Results A total of 12 RCTs involving 3 130 patients were included. The results of meta-analysis showed that: compared with CsA, the TAC had lower incidence of acute rejection at 6 months after renal transplantation (RR=0.61, 95%CI 0.50 to 0.74, P<0.000 01), and had higher glomerular filtration rate (GFR) (MD=4.20, 95%CI 1.07 to 7.34, P=0.009), lower incidence of dyslipidemia (RR=0.46, 95%CI 0.27 to 0.80, P<0.006), higher incidence of diabetes (RR=1.36, 95%CI 1.12 to 1.65, P=0.002) at 12 months after renal transplantation. There was no significant difference between two groups in the incidence of hypertension after renal transplantation (RR=0.90, 95%CI 0.69 to 1.17,P=0.43).Conclusions Current evidence shows that, compared with CsA, TAC can significantly improve renal function, reduce the risk of acute rejection and dyslipidemia, but it can increase the risk of diabetes. Due to limited quality and quantity of the included studies, more high-quality studies are needed to verify above conclusions.

Citation： ZHANG Wenrui, GAO Yuan, BU Ning, ZHAO Min, WANG Ge, RUAN Zhen, SHA Baoyong, GAO Wei. Efficacy and safety of tacrolimus versus cyclosporine after renal transplantation: a meta-analysis. Chinese Journal of Evidence-Based Medicine, 2019, 19(9): 1063-1069. doi: 10.7507/1672-2531.201902011 Copy

1.	Banham GD, Flint SM, Torpey N, et al. Belimumab in kidney transplantation: an experimental medicine, randomised, placebo-controlled phase 2 trial. Lancet, 2018, 391(10140): 2619-2630.
2.	Parajuli S, Mandelbrot DA, Aziz F, et al. Characteristics and outcomes of kidney transplant recipients with a functioning graft for more than 25 years. Kidney Dis (Basel), 2018, 4(4): 255-261.
3.	Skulratanasak P, Mahamongkhonsawata J, Chayakulkeereeb M, et al. BK virus infection in Thai kidney transplant recipients: a single-center experience. Transplant Proc, 2018, 50(4): 1077-1079.
4.	Zabana Y, Rodríguez L, Lobatón T, et al. Relevant infections in inflammatory bowel disease, their relationship with immunosuppressive therapy and their effects on disease mortality. J Crohns Colitis, 2019, 13(7): 828-837.
5.	周易, 姚雷雨, 于哲, 等. BK多瘤病毒在肾移植受者中的感染特征. 南方医科大学学报, 2019, 39(1): 126-130.
6.	齐隽, 闵志廉, 常继伟, 等. 肾移植后免疫抑制用药方案与移植肾长期存活的关系. 中华器官移植杂志, 2000, 21(5): 288-290.
7.	Carr WW. Topical calcineurin inhibitors for atopic dermatitis: review and treatment recommendations. Paediatr Drugs, 2013, 15(4): 303-310.
8.	李阳波, 卢奕, 许亚宏, 等. 肾移植术后免疫抑制剂联合应用的方案优化研究. 西南国防医药, 2017, 27(2): 146-148.
9.	薛武军. 器官移植免疫抑制治疗策略. 实用器官移植电子杂志, 2015, 3(5): 268-271.
10.	卢一平. 肾移植受者糖尿病、高血压和血脂异常防治策略. 中华移植杂志(电子版), 2010, (3): 182-186.
11.	Charpentier B, Rostaing L, Berthoux F, et al. A three-arm study comparing immediate tacrolimus therapy with antithymocyte globulin induction therapy followed by tacrolimus or cyclosporine A in adult renal transplant recipients1. Transplantation, 2003, 75(6): 1625-1626.
12.	Hardinger KL, Bohl DL, Schnitzler MA, et al. A randomized, prospective, pharmacoeconomic trial of tacrolimus versus cyclosporine in combination with thymoglobulin in renal transplant recipients. Transplantation, 2005, 80(1): 41-46.
13.	Ekberg H, Bernasconi C, Nöldeke J, et al. Cyclosporine, tacrolimus and sirolimus retain their distinct toxicity profiles despite low doses in the Symphony study. Nephrol Dial Transplant, 2010, 25(6): 2004-2010.
14.	Park JB, Kim SJ, Oh HY, et al. Steroid withdrawal in living donor renal transplant recipients using tacrolimus and cyclosporine: a randomized prospective study. Transpl Int, 2006, 19(6): 478-484.
15.	Silva HT Jr, Yang HC, Abouljoud M, et al. One-year results with extended-release tacrolimus/MMF, tacrolimus/MMF and cyclosporine/MMF in de novo kidney transplant recipients. Am J Transplant, 2007, 7(3): 595-608.
16.	Torres A, Hernández D, Moreso F, et al. Randomized controlled trial assessing the impact of tacrolimus versus cyclosporine on the incidence of posttransplant diabetes mellitus. Kidney Int Rep, 2018, 3(6): 1304-1315.
17.	Trompeter R, Filler G, Webb NJ, et al. Randomized trial of tacrolimus versus cyclosporin microemulsion in renal transplantation. Pediatr Nephrol, 2002, 17(3): 141-149.
18.	Vincenti F, Friman S, Scheuermann E, et al. Results of an international, randomized trial comparing glucose metabolism disorders and outcome with cyclosporine versus tacrolimus. Am J Transplant, 2007, 7(6): 1506-1514.
19.	White SA, Jain S, Williams ST, et al. Randomized trial comparing neoral and tacrolimus immunousuppression for recipients of renal transplants procured from different donor groups. Transplant Proc, 2000, 32(3): 600.
20.	Wissing KM, Abramowicz D, Weekers L, et al. Prospective randomized study of conversion from tacrolimus to cyclosporine A to improve glucose metabolism in patients with posttransplant diabetes mellitus after renal transplantation. Am J Transplant, 2018, 18(7): 1726-1734.
21.	Yang HC, Holman MJ, Langhoff E, et al. Tacrolimus/" low-dose” mycophenolate mofetil versus microemulsion cyclosporine/" low-dose” mycophenolate mofetil after kidney transplantation—1-year follow-up of a prospective, randomized clinical trial. Transplant Proc, 1999, 31(1-2): 1121-1124.
22.	陈国栋, 陈立中, 王长希, 等. 他克莫司与环孢素A在高致敏肾移植受者中的应用比较. 中华器官移植杂志, 2008, 29(4): 222-224.
23.	戴澄, 王平, 张新涛, 等. 移植肾急性排斥反应彩色多普勒超声诊断的临床价值. 中国组织工程研究与临床康复, 2009, 13(53): 10427-10430.
24.	Westall GP, Paraskeva MA, Snell GI. Antibody-mediated rejection. Curr Opin Organ Transplant, 2015, 20(5): 492-497.
25.	Ishimura T, Fujisawa M, Isotani S, et al. Transforming growth factor-beta1 expression in early biopsy specimen predicts long-term graft function following pediatric renal transplantation. Clin Transplant, 2001, 15(3): 185-191.
26.	He X, Johnston A. Risk factors for allograft failure in United Kingdom renal transplant recipients treated with cyclosporine A. Transplantation, 2005, 79(8): 953-957.
27.	Henry ML. Cyclosporine and tacrolimus (FK506): a comparison of efficacy and safety profiles. Clin Transplant, 1999, 13(3): 209-220.
28.	Liu JY, You RX, Guo M, et al. Tacrolimus versus cyclosporine as primary immunosuppressant after renal transplantation: a meta-analysis and economics evaluation. Am J Ther, 2016, 23(3): e810-e824.

1. Banham GD, Flint SM, Torpey N, et al. Belimumab in kidney transplantation: an experimental medicine, randomised, placebo-controlled phase 2 trial. Lancet, 2018, 391(10140): 2619-2630.
2. Parajuli S, Mandelbrot DA, Aziz F, et al. Characteristics and outcomes of kidney transplant recipients with a functioning graft for more than 25 years. Kidney Dis (Basel), 2018, 4(4): 255-261.
3. Skulratanasak P, Mahamongkhonsawata J, Chayakulkeereeb M, et al. BK virus infection in Thai kidney transplant recipients: a single-center experience. Transplant Proc, 2018, 50(4): 1077-1079.
4. Zabana Y, Rodríguez L, Lobatón T, et al. Relevant infections in inflammatory bowel disease, their relationship with immunosuppressive therapy and their effects on disease mortality. J Crohns Colitis, 2019, 13(7): 828-837.
5. 周易, 姚雷雨, 于哲, 等. BK多瘤病毒在肾移植受者中的感染特征. 南方医科大学学报, 2019, 39(1): 126-130.
6. 齐隽, 闵志廉, 常继伟, 等. 肾移植后免疫抑制用药方案与移植肾长期存活的关系. 中华器官移植杂志, 2000, 21(5): 288-290.
7. Carr WW. Topical calcineurin inhibitors for atopic dermatitis: review and treatment recommendations. Paediatr Drugs, 2013, 15(4): 303-310.
8. 李阳波, 卢奕, 许亚宏, 等. 肾移植术后免疫抑制剂联合应用的方案优化研究. 西南国防医药, 2017, 27(2): 146-148.
9. 薛武军. 器官移植免疫抑制治疗策略. 实用器官移植电子杂志, 2015, 3(5): 268-271.
10. 卢一平. 肾移植受者糖尿病、高血压和血脂异常防治策略. 中华移植杂志(电子版), 2010, (3): 182-186.
11. Charpentier B, Rostaing L, Berthoux F, et al. A three-arm study comparing immediate tacrolimus therapy with antithymocyte globulin induction therapy followed by tacrolimus or cyclosporine A in adult renal transplant recipients1. Transplantation, 2003, 75(6): 1625-1626.
12. Hardinger KL, Bohl DL, Schnitzler MA, et al. A randomized, prospective, pharmacoeconomic trial of tacrolimus versus cyclosporine in combination with thymoglobulin in renal transplant recipients. Transplantation, 2005, 80(1): 41-46.
13. Ekberg H, Bernasconi C, Nöldeke J, et al. Cyclosporine, tacrolimus and sirolimus retain their distinct toxicity profiles despite low doses in the Symphony study. Nephrol Dial Transplant, 2010, 25(6): 2004-2010.
14. Park JB, Kim SJ, Oh HY, et al. Steroid withdrawal in living donor renal transplant recipients using tacrolimus and cyclosporine: a randomized prospective study. Transpl Int, 2006, 19(6): 478-484.
15. Silva HT Jr, Yang HC, Abouljoud M, et al. One-year results with extended-release tacrolimus/MMF, tacrolimus/MMF and cyclosporine/MMF in de novo kidney transplant recipients. Am J Transplant, 2007, 7(3): 595-608.
16. Torres A, Hernández D, Moreso F, et al. Randomized controlled trial assessing the impact of tacrolimus versus cyclosporine on the incidence of posttransplant diabetes mellitus. Kidney Int Rep, 2018, 3(6): 1304-1315.
17. Trompeter R, Filler G, Webb NJ, et al. Randomized trial of tacrolimus versus cyclosporin microemulsion in renal transplantation. Pediatr Nephrol, 2002, 17(3): 141-149.
18. Vincenti F, Friman S, Scheuermann E, et al. Results of an international, randomized trial comparing glucose metabolism disorders and outcome with cyclosporine versus tacrolimus. Am J Transplant, 2007, 7(6): 1506-1514.
19. White SA, Jain S, Williams ST, et al. Randomized trial comparing neoral and tacrolimus immunousuppression for recipients of renal transplants procured from different donor groups. Transplant Proc, 2000, 32(3): 600.
20. Wissing KM, Abramowicz D, Weekers L, et al. Prospective randomized study of conversion from tacrolimus to cyclosporine A to improve glucose metabolism in patients with posttransplant diabetes mellitus after renal transplantation. Am J Transplant, 2018, 18(7): 1726-1734.
21. Yang HC, Holman MJ, Langhoff E, et al. Tacrolimus/" low-dose” mycophenolate mofetil versus microemulsion cyclosporine/" low-dose” mycophenolate mofetil after kidney transplantation—1-year follow-up of a prospective, randomized clinical trial. Transplant Proc, 1999, 31(1-2): 1121-1124.
22. 陈国栋, 陈立中, 王长希, 等. 他克莫司与环孢素A在高致敏肾移植受者中的应用比较. 中华器官移植杂志, 2008, 29(4): 222-224.
23. 戴澄, 王平, 张新涛, 等. 移植肾急性排斥反应彩色多普勒超声诊断的临床价值. 中国组织工程研究与临床康复, 2009, 13(53): 10427-10430.
24. Westall GP, Paraskeva MA, Snell GI. Antibody-mediated rejection. Curr Opin Organ Transplant, 2015, 20(5): 492-497.
25. Ishimura T, Fujisawa M, Isotani S, et al. Transforming growth factor-beta1 expression in early biopsy specimen predicts long-term graft function following pediatric renal transplantation. Clin Transplant, 2001, 15(3): 185-191.
26. He X, Johnston A. Risk factors for allograft failure in United Kingdom renal transplant recipients treated with cyclosporine A. Transplantation, 2005, 79(8): 953-957.
27. Henry ML. Cyclosporine and tacrolimus (FK506): a comparison of efficacy and safety profiles. Clin Transplant, 1999, 13(3): 209-220.
28. Liu JY, You RX, Guo M, et al. Tacrolimus versus cyclosporine as primary immunosuppressant after renal transplantation: a meta-analysis and economics evaluation. Am J Ther, 2016, 23(3): e810-e824.

Chinese Journal of Evidence-Based Medicine

Efficacy and safety of tacrolimus versus cyclosporine after renal transplantation: a meta-analysis

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