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  • Title: Tolerance of enteric-coated mycophenolate sodium in combination with calcineurin inhibitor in kidney transplant recipients: Polish experience.
    Author: Gozdowska J, Urbanowicz AL, Galazka Z, Chmura A, Durlik M.
    Journal: Transplant Proc; 2011 Oct; 43(8):2946-9. PubMed ID: 21996197.
    Abstract:
    INTRODUCTION: Enteric-coated mycophenolate sodium (EC-MPS) was developed to reduce the incidence of gastrointestinal adverse effects. This multicenter observational study was designed to evaluate the safety profile and drug tolerance in kidney transplant recipients. METHODS: Three hundred adult kidney recipients (median age 48 years) were enrolled over 3 years to receive EC-MPS de novo (n=175), as a switch from azathioprine (n=62) or mycophenolate mofetil MMF (n=63); in combination with calcineurin inhibitor. Drug doses, serum creatinine, estimated glomerular filtration rate (eGFR), as well as drug tolerance, patient and physician evaluation of therapy (on a 4-point scale) were recorded at enrollment and followed over 28 weeks. We modeled the probability of the highest level (ie, best result) of the categorical outcome variable. RESULTS: Two hundred seventy-three patients completed the study (91%). In the pooled study group (1) best drug tolerance was expected more frequently with tacrolimus versus cyclosporine (odds ratio [OR] 2.12, P<.05); (2) best physician evaluation, with earlier EC-MPS introduction (OR for 4-week delay: 0.99, P<.03) and higher eGFR (OR for 5 mL/min increase: 1.21, P<.01). Among the EC-MPS de novo administrations group: (1) best drug tolerance was expected more frequently with coadministered tacrolimus versus cyclosporine (OR 3.14, P<.02); (2) best patient evaluation, with higher eGFR (OR for 1 mL/min increase: 1.04, P<.04); and (3) best physician evaluation, with higher eGFR (OR for 1 mL/min increase: 1.04, P<.001) and earlier EC-MPS introduction (OR for 4-week delay: 0.99, P<.03). In the conversion from MMF to EC-MPS group: (1) best drug tolerance was expected less frequently with coadministered cyclosporine versus tacrolimus (OR 0.05, P<.04) and more frequently with younger recipients (OR .001, P<.04); (2) best physician evaluation was expected more frequently with lower EC-MPS dose (OR for 360-mg dose increase: 0.4, P<.01) and with higher eGFR (OR for 5 mL/min increase: 1.42, P<.002). Adverse events were reported among 49/300 patients (16 serious adverse events). CONCLUSIONS: EC-MPS was tolerated better by younger kidney recipients, when combined with tacrolimus versus cyclosporine, and when introduced earlier after transplantation. EC-MPS tolerance decreased gradually with renal function deterioration.
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