Efficacy and Safety of Enteric-coated Mycophenolate Sodium versus Mycophenolate Mofetil in Renal Transplant Recipients: A Meta-analysis_Chinese Journal of Evidence-Based Medicine

Authors：

 LUKe-peng ^1,2 , ZHANGJing ¹ , LINLi-min ^1,2 , LIUQian ^1,2 ,  SONGHong-tao ¹

1. 沈阳药科大学药学院（沈阳 110016）;
2. Department of Pharmacy, Fuzhou General Hospital of Nanjing Military Command, Fuzhou 350025, China 2. Shenyang Pharmaceutical University, Shenyang 110016, China;

Corresponding author：

SONGHong-tao, Email: sohoto@vip.163.com

Keywords：

Mycophenolate mofetil; Enteric-coated mycophenolate sodium (EC-MPS); Renal transplantation; Immunosuppression; Meta-analysis; Randomized controlled trial

DOI：

10.7507/1672-2531.20150113

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Objective To systematically evaluate the efficacy and safety of enteric-coated mycophenolate sodium (EC-MPS) versus mycophenolate mofetil (MMF) in kidney transplant recipients. Methods We searched MEDLINE, EMbase, PubMed, the Cochrane Library (Issue 9, 2013), CBM, CNKI, VIP and WanFang Data from their inception to November 2013, to collect randomized controlled trials (RCTs) of EC-MPS versus MMF in kidney transplant recipients. References of included studies were also retrieved. Two reviewers independently screened studies according to the exclusion and inclusion criteria, extracted data, and assessed the risk of bias of included studies. Then, meta-analysis was performed using RevMan 5.1 software. Results A total of 8 RCTs involving 2 400 patients were included. The results of meta-analysis indicated that there were no significant differences between the two groups at the end of 4-week, 6-month, 12-month and 48-month follow-up in the acute rejection rate (4-weeks:RR=0.33, 95%CI 0.01 to 8.05; 6 months:RR=0.94, 95%CI 0.73 to 1.22; 12 months:RR=0.88, 95%CI 0.63 to 1.24; 4 years:RR=0.93, 95%CI 0.47 to 1.84). There were no significant differences between the two groups at the end of 6-month and 12-month follow-up in the chronic rejection rate (6 month:RR=0.66, 95%CI 0.27 to 1.58; 12 month:RR=0.57, 95%CI 0.29 to 1.15). There were no significant differences between the two groups at the end of 6-month, 12-month and 48-month follow-up in the graft loss or death rate (6-month:RR=0.79, 95%CI 0.41 to 1.50; 12-month:RR=0.76, 95%CI 0.40 to 1.43; 48-month:RR=1.38, 95%CI 0.59 to 3.23). As to the side effect, EC-MPS could significantly reduce the risk of pneumonia compared with MMF (RR=0.32, 95%CI 0.13 to 0.79). Conclusion Based on current evidences, EC-MPS is comparable with MMF for renal transplant patients in short-term effectiveness, and the incidence of pneumonia in the EC-MPS group is lower than the MMF group. Due to the limited quantity and quality of the studies, the conclusions should be validated by more high quality studies.

Citation： LUKe-peng, ZHANGJing, LINLi-min, LIUQian, SONGHong-tao. Efficacy and Safety of Enteric-coated Mycophenolate Sodium versus Mycophenolate Mofetil in Renal Transplant Recipients: A Meta-analysis. Chinese Journal of Evidence-Based Medicine, 2015, 15(6): 681-686. doi: 10.7507/1672-2531.20150113 Copy

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2.	Budde K,Curtis J,Knoll G,et al.Enteric-coated mycophenolate sodium can be safely administered in maintenance renal transplant patients:results of a 1-year study.Am J Transplant,2004,4(2):237-243.
3.	Ciancio G,Gaynor JJ,Zarak A,et al.Randomized trial of mycophenolate mofetil versus enteric-coated mycophenolate sodium in primary renal transplantation with tacrolimus and steroid avoidance:four-year analysis.Transplantation,2011,91(11):1198-1205.
4.	Ciancio G,Burke GW,Gaynor JJ,et al.Randomized trial of mycophenolate mofetil versus enteric-coated mycophenolate sodium in primary renal transplant recipients given tacrolimus and daclizumab/thymoglobulin:One year follow-up.Transplantation,2008,86(1):67-74.
5.	Ortega F,Sanchez-Fructuoso A,Cruzado JM,et al.Gastrointestinal quality of life improvement of renal transplant recipients converted from mycophenolate mofetil to enteric-coated mycophenolate sodium drugs or agents:mycophenolate mofetil and enteric-coated mycophenolate sodium.Transplantation,2011,92(4):426-432.
6.	Langone AJ,Chan L,Bolin P,et al.Enteric-coated mycophenolate sodium versus mycophenolate mofetil in renal transplant recipients experiencing gastrointestinal intolerance:a multicenter,double-blind,randomized study.Transplantation,2011,91(4):470-478.
7.	Salvadori M,Holzer H,de Mattos A,et al.Enteric-coated mycophenolate sodium is therapeutically equivalent to mycophenolate mofetil in de novo renal transplant patients.Am J Transplantation,2004,4(2):231-236.
8.	Granger DK.Enteric-coated mycophenolate sodium:results of two pivotal global multicenter trials.Transplantation Proc,2001,33(7-8):3241-3244.
9.	Salvadori M.Therapeutic equivalence of mycophenolate sodium versus mycophenolate mofetil in de novo renal transplant recipients.Transplantation Proc,2001,33(7-8):3245-3247.
10.	Cooper M,Deering KL,Slakey DP,et al.Comparing outcomes associated with dose manipulations of enteric-coated mycophenolate sodium versus mycophenolate mofetil in renal transplant recipients.Transplantation,2009,88(4):514-520.
11.	Sollinger HW,Sundberg AK,Leverson G,et al.Mycophenolate mofetil versus enteric-coated mycophenolate sodium:a large single-center comparison of dose adjustments and outcomes in kidney transplant recipients.Transplantation,2010,89(4):446-451.
12.	Gozdowska J,Urbanowicz A,Baczkowska T,et al.Safety and tolerance of sodium mycophenolate in patients after renal transplantation-an observational study.Transplant Proc,2009,41(8):3016-3018.
13.	Hardinger KL.Hebbar S,Bloomer T,et al.Adverse drug reaction driven immunosuppressive drug manipulations:A single-center comparison of enteric-coated mycophenolate sodium vs.mycophenolate mofetil.Clin Transplant,2008,22(5):555-561.
14.	Salvadori M,Holzer H,de Mattos A,et al.Enteric-coated mycophenolate sodium is therapeutically equivalent to mycophenolate mofetil in de novo renal transplant patients.Am J Transplant,2004,4(2):231-236.
15.	Pelletier RP,Henry ML,Rajab A,et al.Clinical outcomes of renal transplant recipients treated with enteric-coated mycophenolic acid vs mycophenolate mofetil as a swith agent using a primary steroid-free rapamune and microemulsion cyclosporine protocol.Clin Transplant,2007,21(21):532-535.
16.	Pocivalnik M,Kirsch AH,Hassler EM,et al.Fever and pneumonitis induced by enteric-coated mycophenolate sodium in a patient after kidney transplantation.Transplant International,2013,26(7):e54-e57.
17.	Loock J,Lamprecht P,Gross WL.Acute inflammatory syndrome with elevated procalcitonin induced by mycophenolate sodium.J Rheumatol,2012,39(3):658-659.
18.	Maes B,Oellerich M,Ceuppens JL,et al.A new acute inflammatory syndrome related to the introduction of mycophenolate mofetil in patients with Wegener's granulomatosis.Nephrol Dial Transplant,2002,17(5):923-926.
19.	Hochegger K,Gruber J,Lhotta K.Acute inflammatory syndrome induced by mycophenolate mofetil in a patient following kidney transplantation.Am J Transplant,2006,6(4):852-854.
20.	Budde K,Bauer S,Hambach P,et al.Pharmacokinetic and pharmacodynamic comparison of enteric-coated mycophenolate sodium and mycophenolate mofetil in maintenance renal transplant patients.Am J Transplant,2007,7(4):888-898.
21.	阮钧,徐卓群,胡礼炳,等.肾移植术后肺炎的诊断和治疗.江苏医药,2006,32(8):794.

1. Higgins JP,Greens.Cochrane Handbook for Systematic Reviews of Intervention (Version 5.1.0).Available at:http://www.cochrane-handbook.org.
2. Budde K,Curtis J,Knoll G,et al.Enteric-coated mycophenolate sodium can be safely administered in maintenance renal transplant patients:results of a 1-year study.Am J Transplant,2004,4(2):237-243.
3. Ciancio G,Gaynor JJ,Zarak A,et al.Randomized trial of mycophenolate mofetil versus enteric-coated mycophenolate sodium in primary renal transplantation with tacrolimus and steroid avoidance:four-year analysis.Transplantation,2011,91(11):1198-1205.
4. Ciancio G,Burke GW,Gaynor JJ,et al.Randomized trial of mycophenolate mofetil versus enteric-coated mycophenolate sodium in primary renal transplant recipients given tacrolimus and daclizumab/thymoglobulin:One year follow-up.Transplantation,2008,86(1):67-74.
5. Ortega F,Sanchez-Fructuoso A,Cruzado JM,et al.Gastrointestinal quality of life improvement of renal transplant recipients converted from mycophenolate mofetil to enteric-coated mycophenolate sodium drugs or agents:mycophenolate mofetil and enteric-coated mycophenolate sodium.Transplantation,2011,92(4):426-432.
6. Langone AJ,Chan L,Bolin P,et al.Enteric-coated mycophenolate sodium versus mycophenolate mofetil in renal transplant recipients experiencing gastrointestinal intolerance:a multicenter,double-blind,randomized study.Transplantation,2011,91(4):470-478.
7. Salvadori M,Holzer H,de Mattos A,et al.Enteric-coated mycophenolate sodium is therapeutically equivalent to mycophenolate mofetil in de novo renal transplant patients.Am J Transplantation,2004,4(2):231-236.
8. Granger DK.Enteric-coated mycophenolate sodium:results of two pivotal global multicenter trials.Transplantation Proc,2001,33(7-8):3241-3244.
9. Salvadori M.Therapeutic equivalence of mycophenolate sodium versus mycophenolate mofetil in de novo renal transplant recipients.Transplantation Proc,2001,33(7-8):3245-3247.
10. Cooper M,Deering KL,Slakey DP,et al.Comparing outcomes associated with dose manipulations of enteric-coated mycophenolate sodium versus mycophenolate mofetil in renal transplant recipients.Transplantation,2009,88(4):514-520.
11. Sollinger HW,Sundberg AK,Leverson G,et al.Mycophenolate mofetil versus enteric-coated mycophenolate sodium:a large single-center comparison of dose adjustments and outcomes in kidney transplant recipients.Transplantation,2010,89(4):446-451.
12. Gozdowska J,Urbanowicz A,Baczkowska T,et al.Safety and tolerance of sodium mycophenolate in patients after renal transplantation-an observational study.Transplant Proc,2009,41(8):3016-3018.
13. Hardinger KL.Hebbar S,Bloomer T,et al.Adverse drug reaction driven immunosuppressive drug manipulations:A single-center comparison of enteric-coated mycophenolate sodium vs.mycophenolate mofetil.Clin Transplant,2008,22(5):555-561.
14. Salvadori M,Holzer H,de Mattos A,et al.Enteric-coated mycophenolate sodium is therapeutically equivalent to mycophenolate mofetil in de novo renal transplant patients.Am J Transplant,2004,4(2):231-236.
15. Pelletier RP,Henry ML,Rajab A,et al.Clinical outcomes of renal transplant recipients treated with enteric-coated mycophenolic acid vs mycophenolate mofetil as a swith agent using a primary steroid-free rapamune and microemulsion cyclosporine protocol.Clin Transplant,2007,21(21):532-535.
16. Pocivalnik M,Kirsch AH,Hassler EM,et al.Fever and pneumonitis induced by enteric-coated mycophenolate sodium in a patient after kidney transplantation.Transplant International,2013,26(7):e54-e57.
17. Loock J,Lamprecht P,Gross WL.Acute inflammatory syndrome with elevated procalcitonin induced by mycophenolate sodium.J Rheumatol,2012,39(3):658-659.
18. Maes B,Oellerich M,Ceuppens JL,et al.A new acute inflammatory syndrome related to the introduction of mycophenolate mofetil in patients with Wegener's granulomatosis.Nephrol Dial Transplant,2002,17(5):923-926.
19. Hochegger K,Gruber J,Lhotta K.Acute inflammatory syndrome induced by mycophenolate mofetil in a patient following kidney transplantation.Am J Transplant,2006,6(4):852-854.
20. Budde K,Bauer S,Hambach P,et al.Pharmacokinetic and pharmacodynamic comparison of enteric-coated mycophenolate sodium and mycophenolate mofetil in maintenance renal transplant patients.Am J Transplant,2007,7(4):888-898.
21. 阮钧,徐卓群,胡礼炳,等.肾移植术后肺炎的诊断和治疗.江苏医药,2006,32(8):794.

Chinese Journal of Evidence-Based Medicine

Efficacy and Safety of Enteric-coated Mycophenolate Sodium versus Mycophenolate Mofetil in Renal Transplant Recipients: A Meta-analysis

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