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


O'Grady, JG; Hardy, P; Burroughs, AK; Elbourne, D; (2007) Randomized controlled trial of tacrolimus versus microemulsified cyclosporin (TMC) in liver transplantation: Poststudy surveillance to 3 years. American journal of transplantation, 7 (1). pp. 137-141. ISSN 1600-6135 DOI: https://doi.org/10.1111/j.1600-6143.2006.01576.x

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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.

Item Type: Article
Keywords: tacrolimus, cyclosporin, liver transplantation, graft survival, MULTICENTER, FK506
Faculty and Department: Faculty of Epidemiology and Population Health > Dept of Medical Statistics
Research Centre: Centre for Global Non-Communicable Diseases (NCDs)
PubMed ID: 17109723
Web of Science ID: 242779400020
URI: http://researchonline.lshtm.ac.uk/id/eprint/10540

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