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What have we learned about primary liver transplantation under tacrolimus immunosuppression? - Long-term follow-up of the first 1000 patients

Jain, A and Reyes, J and Kashyap, R and Rohal, S and Abu-Elmagd, K and Starzl, T and Fung, J (1999) What have we learned about primary liver transplantation under tacrolimus immunosuppression? - Long-term follow-up of the first 1000 patients. Annals of Surgery, 230 (3). 441 - 449. ISSN 0003-4932

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Objective: To summarize the long-term efficacy and safety of tacrolimus in orthotopic liver transplant (OLT) recipients, as well as to examine the factors that influence long-term morbidity and mortality rates. Background: Tacrolimus (FK506, Prograf) was introduced as primary immunosuppression for primary liver transplantation in 1989; many subsquent trials have verified the association of tacrolimus with decreased rates of acute rejection and steroid-resistant rejection after OLT. Cumulative experience with tacrolimus has also defined its short- and intermediate-term toxicity. Methods: One thousand consecutive patients undergoing primary OLT at a single center from August 1989 to December 1992, under tacrolimus immunosuppression, were followed until January 1999. Patients were categorized by age. Mean follow-up was 93.4 ± 11 months after OLT. Patient survival, graft survival (with corresponding causes of death and retransplantation), and rejection rates (and corresponding doses of immunosuppression) were examined as efficacy parameters. Hypertension, renal function, incidence of malignancies, incidence of diabetes, and other toxicities were examined as safety parameters. Results: Actual 6-year overall patient survival rate was 68.1% and graft survival rate was 62.5%, with significant differences in the patterns of survival among the different age groups. After the first post-OLT year, infection, recurrence of disease, de novo malignancies, and cardiovascular events were the main causes of graft loss and death during the long-term follow-up. Graft loss related to either acute or chronic rejection was rare. The rate of acute rejection beyond 2 years was approximately 3% per year, and most were steroid-responsive. Approximately 70% of the patients were receiving tacrolimus monotherapy beyond year 1; at the latest follow-up, 74.2% were maintained on tacrolimus alone. In 6.1% of the survivors, end- stage renal disease developed during the follow-up period, requiring either dialysis or kidney transplantation. Hyperkalemia and hypertension was observed in approximately one third of the patients. Insulin-dependent diabetes mellitus (including patients who had diabetes before the transplant) was observed in 14% in year 1, dropping to 11% in year 7. In 82 patients, de novo malignancies developed; in 41 patients, lymphoproliferative disorders developed during the entire follow-up period. Conclusions: Long-term patient and graft survival rates are excellent under tacrolimus immunosuppression. Pediatric patients have a better long-term outcome than adults, in part because of the limited recurrence of the original disease, which was the most common cause of late graft loss (other than patient death, most commonly the result of late de novo malignancies and cardiovascular events). Graft loss from late rejection was rare.


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Item Type: Article
Status: Published
CreatorsEmailPitt UsernameORCID
Jain, A
Reyes, J
Kashyap, R
Rohal, S
Abu-Elmagd, K
Starzl, Ttes11@pitt.eduTES11
Fung, J
Centers: Other Centers, Institutes, Offices, or Units > Thomas E. Starzl Transplantation Institute
Date: 1 September 1999
Date Type: Publication
Journal or Publication Title: Annals of Surgery
Volume: 230
Number: 3
Page Range: 441 - 449
DOI or Unique Handle: 10.1097/00000658-199909000-00016
Institution: University of Pittsburgh
Refereed: Yes
ISSN: 0003-4932
Other ID: uls-drl:31735062120096, Starzl CV No. 2103
Date Deposited: 08 Apr 2010 17:36
Last Modified: 18 Oct 2017 17:55


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