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Comparison of cyclosporine microemulsion and tacrolimus in 39 recipients of living donor liver transplantation.
Liver Transpl 2005; 11(11):1395-402LT

Abstract

New immunosuppressive agents and regimens should be evaluated specifically in living donor liver transplant patients due to potential clinical and pharmacokinetic differences between deceased donor and living donor transplant recipients. The analysis presented here is the first direct comparison of clinical outcomes using cyclosporine microemulsion (CsA-ME) with monitoring of blood concentration at 2 hours postdose (C2) and tacrolimus-based immunosuppression in living donor liver transplantation. The analysis was conducted on the data provided by the 39 recipients of a living donor transplant out of the 495 patients enrolled in a 6-month, randomized, prospective, multicenter, open-label study (LIS2T). Patients were randomized to CsA-ME (C2 monitoring) or tacrolimus (monitoring of predose trough drug blood level [C0)]) and were administered corticosteroids with or without azathioprine. Twenty-three living-donor patients received CsA-ME and 16 received tacrolimus. By month 6, 9% of patients receiving CsA-ME and 19% of those receiving tacrolimus had lost their graft or died (not significant [NS]). Nine episodes of biopsy-proven acute rejection were reported: 4 in the CsA-ME group (17%) and 5 in the tacrolimus cohort (31%, NS). There were no significant differences in any safety parameter between groups. The most frequently reported serious adverse events were infections, which occurred in 14 patients in the CsA-ME group (61%) and 13 patients in the tacrolimus arm (81%, NS). Twelve patients in the CsA-ME arm (52%) and 5 in the tacrolimus arm (31%, NS) discontinued the study prematurely. In conclusion, CsA-ME C2 monitoring or tacrolimus both offer effective protection against rejection in living donor liver transplants while maintaining a good safety profile.

Authors+Show Affiliations

Organ Transplant Unit, Kyoto University, Kyoto, Japan. koichi@kuhp.kyoto-u.ac.jpNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

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

Language

eng

PubMed ID

16237691

Citation

Tanaka, Koichi, et al. "Comparison of Cyclosporine Microemulsion and Tacrolimus in 39 Recipients of Living Donor Liver Transplantation." Liver Transplantation : Official Publication of the American Association for the Study of Liver Diseases and the International Liver Transplantation Society, vol. 11, no. 11, 2005, pp. 1395-402.
Tanaka K, Lake J, Villamil F, et al. Comparison of cyclosporine microemulsion and tacrolimus in 39 recipients of living donor liver transplantation. Liver Transpl. 2005;11(11):1395-402.
Tanaka, K., Lake, J., Villamil, F., Levy, G., Marotta, P., Mies, S., ... Moench, C. (2005). Comparison of cyclosporine microemulsion and tacrolimus in 39 recipients of living donor liver transplantation. Liver Transplantation : Official Publication of the American Association for the Study of Liver Diseases and the International Liver Transplantation Society, 11(11), pp. 1395-402.
Tanaka K, et al. Comparison of Cyclosporine Microemulsion and Tacrolimus in 39 Recipients of Living Donor Liver Transplantation. Liver Transpl. 2005;11(11):1395-402. PubMed PMID: 16237691.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Comparison of cyclosporine microemulsion and tacrolimus in 39 recipients of living donor liver transplantation. AU - Tanaka,Koichi, AU - Lake,John, AU - Villamil,Federico, AU - Levy,Gary, AU - Marotta,Paul, AU - Mies,Sergio, AU - de Hemptinne,Bernard, AU - Moench,Christian, PY - 2005/10/21/pubmed PY - 2006/3/8/medline PY - 2005/10/21/entrez SP - 1395 EP - 402 JF - Liver transplantation : official publication of the American Association for the Study of Liver Diseases and the International Liver Transplantation Society JO - Liver Transpl. VL - 11 IS - 11 N2 - New immunosuppressive agents and regimens should be evaluated specifically in living donor liver transplant patients due to potential clinical and pharmacokinetic differences between deceased donor and living donor transplant recipients. The analysis presented here is the first direct comparison of clinical outcomes using cyclosporine microemulsion (CsA-ME) with monitoring of blood concentration at 2 hours postdose (C2) and tacrolimus-based immunosuppression in living donor liver transplantation. The analysis was conducted on the data provided by the 39 recipients of a living donor transplant out of the 495 patients enrolled in a 6-month, randomized, prospective, multicenter, open-label study (LIS2T). Patients were randomized to CsA-ME (C2 monitoring) or tacrolimus (monitoring of predose trough drug blood level [C0)]) and were administered corticosteroids with or without azathioprine. Twenty-three living-donor patients received CsA-ME and 16 received tacrolimus. By month 6, 9% of patients receiving CsA-ME and 19% of those receiving tacrolimus had lost their graft or died (not significant [NS]). Nine episodes of biopsy-proven acute rejection were reported: 4 in the CsA-ME group (17%) and 5 in the tacrolimus cohort (31%, NS). There were no significant differences in any safety parameter between groups. The most frequently reported serious adverse events were infections, which occurred in 14 patients in the CsA-ME group (61%) and 13 patients in the tacrolimus arm (81%, NS). Twelve patients in the CsA-ME arm (52%) and 5 in the tacrolimus arm (31%, NS) discontinued the study prematurely. In conclusion, CsA-ME C2 monitoring or tacrolimus both offer effective protection against rejection in living donor liver transplants while maintaining a good safety profile. SN - 1527-6465 UR - https://www.unboundmedicine.com/medline/citation/16237691/Comparison_of_cyclosporine_microemulsion_and_tacrolimus_in_39_recipients_of_living_donor_liver_transplantation_ L2 - https://doi.org/10.1002/lt.20508 DB - PRIME DP - Unbound Medicine ER -