Patient and graft survival in the European Multicentre Liver Study--FK 506 vs cyclosporin A.
A prospective randomised study was conducted to evaluate the efficacy and safety of FK 506 administered with corticosteroids compared with a cyclosporin A-based immunosuppressive regimen in patients undergoing primary liver transplantation. 545 patients were recruited in eight European centres, of whom 267 were randomised to FK 506 therapy and 273 to cyclosporin A-based therapy. The estimated Kaplan-Meier patient and graft survival figures of 82.9% and 77.5% respectively in the FK 506 group were higher than the comparable figures in the cyclosporin A group (77.5% and 72.6%, respectively). These differences did not reach statistical significance. Retransplantation rates, time to first rejection episode and number of rejection episodes were all lower (P < 0.001) in the FK 506 group. The infection rates were comparable between the two groups. During the study, the dose of FK 506 was reduced; this did not compromise efficacy and reduced the associated toxicity. FK 506 provides effective immunosuppression in patients undergoing primary liver transplantation and is associated with a lower incidence of rejection.
The Liver and Hepatobiliary Unit, The Queen Elizabeth Hospital, Queen Elizabeth Medical Centre, Edgbaston, Birmingham, United Kingdom.
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McMaster
D000293:Adolescent; D000328:Adult; D000368:Aged; D000900:Anti-Bacterial Agents / Q000627:therapeutic use; D016572:Cyclosporine / Q000009:adverse effects / Q000627:therapeutic use*; D004359:Drug Therapy, Combination; D005260:Female; D006085:Graft Survival; D006801:Humans; D007166:Immunosuppressive Agents / Q000009:adverse effects / Q000627:therapeutic use*; D007239:Infections / Q000188:drug therapy / Q000453:epidemiology; D016031:Liver Transplantation / Q000276:immunology / Q000401:mortality / Q000502:physiology*; D008297:Male; D008875:Middle Aged; D011183:Postoperative Complications / Q000453:epidemiology; D015996:Survival Rate; D016559:Tacrolimus / Q000009:adverse effects / Q000627:therapeutic use*; D013997:Time Factors
D000900:Anti-Bacterial Agents; D007166:Immunosuppressive Agents; D016572:Cyclosporine; D016559:Tacrolimus