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Five-year follow-up of a trial comparing Tacrolimus and cyclosporine microemulsion in liver transplantation.
Transplant Proc 2005; 37(4):1713-5TP

Abstract

We evaluate 5-year results of a prospective randomized trial that compared cyclosporine microemulsion (CsA-me) and Tacrolimus (Tac) for primary immunosuppression. One hundred one adult patients undergoing liver transplantation were randomized to receive Tac (n = 50) or CsA-me (n = 51). The most frequent indication for the procedure was cirrhosis due to virus C followed by alcoholism. Survival rates at 1, 3, and 5 years were 86%, 75%, and 72%, respectively; there was no significant difference between CsA-me versus Tac arms. Acute rejection occurred in 30 cases (30%), independent of the type of primary immunosuppression. Serious adverse events were reported significantly more among patients under CsA-me (48 episodes) than under Tac (32 episodes). Nineteen patients were switched to the other calcineurin inhibitor. The switch was much more frequent from CsA-me to Tac (n = 15; 29.4%), mainly because of lack of efficacy (n = 10; 19.6%). There were no cases of chronic rejections in the Tac arm. Four patients were switched from Tac to CsA-me for side effects; only 1 remains alive, after treatment was changed from CsA-me to an antimetabolite. There were no statistical differences in renal dysfunction, diabetes, hypertension, neurologic disorders, new-onset malignancies, or infections. There were no differences in survival or rejection among the intention-to-treat groups. Serious adverse events, total patients with switch of calcineurin inhibitor, as well as switches due to lack of efficacy, were statistically more frequent under CsA-me. Tacrolimus seems to be a more appropriate drug to be used for primary immunosuppression in liver transplantation.

Authors+Show Affiliations

Liver Transplantation Unit, Hospital 12 de Octubre, Madrid, Spain. igpinto@hotmail.comNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Comparative Study
Journal Article
Randomized Controlled Trial

Language

eng

PubMed ID

15919441

Citation

González-Pinto, I M., et al. "Five-year Follow-up of a Trial Comparing Tacrolimus and Cyclosporine Microemulsion in Liver Transplantation." Transplantation Proceedings, vol. 37, no. 4, 2005, pp. 1713-5.
González-Pinto IM, Rimola A, Margarit C, et al. Five-year follow-up of a trial comparing Tacrolimus and cyclosporine microemulsion in liver transplantation. Transplant Proc. 2005;37(4):1713-5.
González-Pinto, I. M., Rimola, A., Margarit, C., Cuervas-Mons, V., Abradelo, M., Alvarez-Laso, C., ... Sánchez-Turrión, V. (2005). Five-year follow-up of a trial comparing Tacrolimus and cyclosporine microemulsion in liver transplantation. Transplantation Proceedings, 37(4), pp. 1713-5.
González-Pinto IM, et al. Five-year Follow-up of a Trial Comparing Tacrolimus and Cyclosporine Microemulsion in Liver Transplantation. Transplant Proc. 2005;37(4):1713-5. PubMed PMID: 15919441.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Five-year follow-up of a trial comparing Tacrolimus and cyclosporine microemulsion in liver transplantation. AU - González-Pinto,I M, AU - Rimola,A, AU - Margarit,C, AU - Cuervas-Mons,V, AU - Abradelo,M, AU - Alvarez-Laso,C, AU - Londoño,M C, AU - Bilbao,I, AU - Sánchez-Turrión,V, PY - 2005/5/28/pubmed PY - 2005/9/24/medline PY - 2005/5/28/entrez SP - 1713 EP - 5 JF - Transplantation proceedings JO - Transplant. Proc. VL - 37 IS - 4 N2 - We evaluate 5-year results of a prospective randomized trial that compared cyclosporine microemulsion (CsA-me) and Tacrolimus (Tac) for primary immunosuppression. One hundred one adult patients undergoing liver transplantation were randomized to receive Tac (n = 50) or CsA-me (n = 51). The most frequent indication for the procedure was cirrhosis due to virus C followed by alcoholism. Survival rates at 1, 3, and 5 years were 86%, 75%, and 72%, respectively; there was no significant difference between CsA-me versus Tac arms. Acute rejection occurred in 30 cases (30%), independent of the type of primary immunosuppression. Serious adverse events were reported significantly more among patients under CsA-me (48 episodes) than under Tac (32 episodes). Nineteen patients were switched to the other calcineurin inhibitor. The switch was much more frequent from CsA-me to Tac (n = 15; 29.4%), mainly because of lack of efficacy (n = 10; 19.6%). There were no cases of chronic rejections in the Tac arm. Four patients were switched from Tac to CsA-me for side effects; only 1 remains alive, after treatment was changed from CsA-me to an antimetabolite. There were no statistical differences in renal dysfunction, diabetes, hypertension, neurologic disorders, new-onset malignancies, or infections. There were no differences in survival or rejection among the intention-to-treat groups. Serious adverse events, total patients with switch of calcineurin inhibitor, as well as switches due to lack of efficacy, were statistically more frequent under CsA-me. Tacrolimus seems to be a more appropriate drug to be used for primary immunosuppression in liver transplantation. SN - 0041-1345 UR - https://www.unboundmedicine.com/medline/citation/15919441/Five_year_follow_up_of_a_trial_comparing_Tacrolimus_and_cyclosporine_microemulsion_in_liver_transplantation_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0041-1345(05)00396-9 DB - PRIME DP - Unbound Medicine ER -