Randomized controlled trial of tacrolimus versus microemulsified cyclosporin (TMC) in liver transplantation: poststudy surveillance to 3 years

Am J Transplant. 2007 Jan;7(1):137-41. doi: 10.1111/j.1600-6143.2006.01576.x. Epub 2006 Nov 15.

Abstract

The 1-year results of the tacrolimus versus microemulsified cyclosporin (TMC) study found a benefit with tacrolimus immunosuppression after primary liver transplants in adults with respect to freedom from graft loss and immunological failure. The integrity of the randomization process was preserved for a further 2 years for poststudy surveillance. The data after 3 years confirms the significant difference between tacrolimus and cyclosporin with tacrolimus less likely to meet the composite primary endpoint (log rank p = 0.01; relative risk 0.75; 95% CI 0.60-0.95; p = 0.016). However, freedom from death or retransplantation no longer achieves statistical significance (relative risk 0.79; 95% CI 0.62-1.02; p = 0.065). A total of 62.1% of patients randomized to tacrolimus were alive at 3 years with their original graft and still on their allocated study medication, as compared with only 41.6% in the cyclosporin limb (p < 0.001). No difference was detected between tacrolimus and cyclosporin in hepatitis-C-positive patients with the available data. The TMC study confirms after 3 years of follow-up the benefits of tacrolimus-based immunosuppression over cyclosporin using C(0) monitoring.

Publication types

  • Comparative Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Cyclosporine / therapeutic use*
  • Emulsions
  • Female
  • Follow-Up Studies
  • Graft Rejection / immunology
  • Graft Survival / drug effects
  • Humans
  • Immunosuppression Therapy / methods
  • Liver Transplantation / adverse effects
  • Liver Transplantation / methods*
  • Liver Transplantation / mortality
  • Male
  • Middle Aged
  • Survival Rate
  • Tacrolimus / therapeutic use*

Substances

  • Emulsions
  • Cyclosporine
  • Tacrolimus