Comparison of azathioprine and mycophenolate mofetil for the prevention ofacute rejection in recipients of pancreas transplantation

The study was performed to compare the efficacy and side effects of azathio prine (AZA) and mycophenolate mofetil (MMF) in conjunction with cyclosporin e or tocrolimus and steroids for the prevention of acute pancreas rejection during the first 6 months of pancreas transplantation. In this case-contro lled study, MMF is compared with historical controls of AZA in the preventi on of acute pancreas rejection. The primary measures of treatment efficacy were patient and pancreas survival rate at 6 months after transplantation, Secondary efficacy measures were the occurrence of biopsy-proven pancreas r ejections and the use of antilymphocyte preparations for rejection treatmen t. A total of 111 pancreas transplant patients (57 in the AZA group and 54 in the MMF group) were evaluated, The 6-month patient survival rate was 96% in the AZA group versus 97% in the MMF group (p = 0.57). The 6-month pancr eas graft survival rate was 88% in the AZA group versus 91% in the MMF grou p (p = 0.29). However, biopsy-proven rejection episodes during the first 6 months of transplantation were significantly lower with MMF (46%) than with AZA (69%) (p = 0.01). In addition, patients in the AZA group received a gr eater number of MI courses of antilymphocyte therapy as a rejection treatme nt (p = 0.004). Overall, the frequency of adverse events was similar, altho ugh the MMF group experienced higher incidences of gastrointestinal adverse events. In conclusion, compared with AZA, MMF significantly reduces the ra te of biopsy-proven pancreas rejection during the first 6 months of transpl antation and is well tolerated, except for gastrointestinal adverse events. (C) 2001 the American College of Clinical Pharmacology.