Controlled Trial of Tacrolimus Versus Cyclosporin

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Randomized

Controlled Trial of Tacrolimus Versus

Microemulsified Cyclosporin

(TMC) in Liver Transplantation: Poststudy

Surveillance to 3 Years

Authors:

O'Grady, J. G.; Hardy, P.; Burroughs, A.

K.; Elbourne, D.

Source:

American Journal

of Transplantation, Volume 7, Number 1,

January 2007, pp. 137-141(5)

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 C0 monitoring.