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Mycophenolate Mofetil versus Azathioprine for Prevention of Chronic Allograft Dysfunction in Renal Transplantation: The MYSS Follow-Up Randomized, Controlled Clinical Trial

Giuseppe Remuzzi^*,, Paolo Cravedi^*,, Marco Costantini^*, Mariadomenica Lesti^*, Maria Ganeva^*,, Giulia Gherardi^*, Bogdan Ene-Iordache^*, Eliana Gotti, Donato Donati, Maurizio Salvadori^||, Silvio Sandrini^¶, Giuseppe Segoloni^**, Stefano Federico, Paolo Rigotti, Vito Sparacino, Piero Ruggenenti^*, for the MYSS Follow-Up Study Group

^* Clinical Research Center for Rare Diseases, "Aldo e Cele Daccò," Mario Negri Institute for Pharmacological Research, Villa Camozzi, Ranica, and Department of Medicine and Transplantation, Azienda Ospedaliera, Ospedali Riuniti, Bergamo, Italy; Department of Medical Information Services, University Hospital "St. George," Plovdiv, Bulgaria; Unit of Nephrology and Dialysis, Azienda Ospedaliera Universitaria "Ospedale Regionale di Circolo e Fondazione Macchi," Varese, Italy; ^|| Unit of Nephrology and Dialysis, Azienda Ospedaliera Careggi Monna Tessa, Firenze, Italy; ^¶ Unit of Nephrology, Dialysis and Transplantation, Azienda Ospedaliera Spedali Civili, Brescia, Italy; ^** Unit of Nephrology, Dialysis and Transplantation, Azienda Ospedaliera S.G. Battista, Torino, Italy; Department of Nephrology, Università Federico II, Napoli, Italy; Department of Surgery and Medical Science, Ospedale Giustinianeo, Padova, Italy; and Unit of Renal Transplantation, Ospedale Civico, Palermo, Italy

Address correspondence to: Dr. Piero Ruggenenti, Department of Renal Medicine, "Mario Negri" Institute for Pharmacological Research, Negri Bergamo Laboratories, Via Gavazzeni, 11-24125 Bergamo, Italy. Phone: +39-035-319-888; Fax: +39-035-319-331; E-mail: manuelap{at}marionegri.it

Received for publication October 26, 2006. Accepted for publication March 16, 2007.

The Mycophenolate Steroids Sparing (MYSS) study found that in renal transplant recipients who were on immunosuppressive therapy with the cyclosporine microemulsion Neoral, mycophenolate mofetil (MMF) was not better than azathioprine in preventing acute rejection at 21 mo after transplantation and was 15 times more expensive. The MYSS Follow-up Study, an extension of MYSS, was aimed at comparing long-term outcome of 248 MYSS patients according to their original randomization to MMF (1 g twice daily) or azathioprine (75 to 100 mg/d). Primary outcome was estimated GFR at 5 yr after transplantation. Mean 5-yr GFR difference between azathioprine and mycophenolate was 4.67 ml/min per 1.73 m² (95% confidence interval [CI] –0.43 to 9.77 ml/min per 1.73 m²; P = 0.07). GFR from month 6 (mean ± SEM: 54.3 ± 1.6 versus 53.9 ± 1.5 ml/min per 1.73 m²; P = 0.83) to month 72 after transplantation (49.5 ± 2.2 versus 47.3 ± 2.4 ml/min per 1.73 m²; P = 0.50); GFR slopes (mean ± SEM: –1.10 ± 0.56 versus –1.23 ± 0.31 ml/min per 1.73 m² per year; P = 0.83); and 72-mo patient mortality (4.0 versus 4.0% [P = 0.95]; HR 0.96; 95% CI 0.28 to 3.31; P = 0.95), graft loss (6.8 versus 6.1% [P = 0.82]; HR 0.89; 95% CI 0.32 to 2.46; P = 0.83), incidence of persistent proteinuria (25.0 versus 27.4%; P = 0.72), late (>6 mo after transplantation) rejections (25.3 versus 21.2%; P = 0.53), and adverse events were similar on azathioprine (n = 124) and MMF (n = 124), respectively. Outcomes in the two groups were comparable also among patients with or without steroid therapy, considered separately. In kidney transplantation, the long-term risk/benefit profile of MMF and azathioprine therapy in combination with cyclosporine Neoral is similar. In view of the cost, standard immunosuppression regimens for kidney transplantation should perhaps include azathioprine rather than MMF.

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