Original Article
A Comparison of Tacrolimus (FK 506) and Cyclosporine for Immunosuppression in Liver Transplantation
N Engl J Med 1994; 331:1110-1115October 27, 1994
- Abstract
Background
Tacrolimus (FK 506), a macrolide compound isolated from a bacterium, is a potent immunosuppressant with activity in solid-organ transplants. Most immunosuppressive regimens for liver transplantation are based on cyclosporine.
Methods
We conducted an open-label, randomized, multicenter trial to compare the efficacy and safety of tacrolimus-based and cyclosporine-based immunosuppressive regimens for patients receiving a first liver transplant. A total of 478 adults and 51 children (≤ 12 years of age) were randomly assigned at the time of transplantation to receive tacrolimus (n = 263) or cyclosporine (n = 266) and were followed for one year. The primary end points were patient and graft survival at one year. The secondary end points were the incidence of acute rejection, corticosteroid-resistant rejection, and refractory rejection (continued rejection after two courses of corticosteroids and an intervening course of muromonab-CD3).
Results
According to Kaplan-Meier analysis, actuarial patient-survival rates at day 360 were 88 percent for both the tacrolimus and cyclosporine groups (P = 0.85; 95 percent confidence interval for the difference, -5.4 to 6.6 percent), and graft-survival rates were 82 percent and 79 percent, respectively (P = 0.55; 95 percent confidence interval for the difference, -4.8 to 9.7 percent). Acute rejection occurred in 154 patients in the tacrolimus group and 173 patients in the cyclosporine group (P<0.002), corticosteroid-resistant rejection occurred in 43 and 82 patients, respectively (P<0.001), and refractory rejection occurred in 6 and 32 patients, respectively (P<0.001). Tacrolimus was associated with a higher incidence of adverse events requiring withdrawal from the study, primarily nephrotoxicity and neurotoxicity; 37 patients in the tacrolimus group and 13 in the cyclosporine group discontinued the study because of adverse events (P<0.001).
Conclusions
After one year, immunosuppressive regimens based on tacrolimus and cyclosporine were comparable in terms of patient and graft survival. Tacrolimus was associated with significantly fewer episodes of acute, corticosteroid-resistant, or refractory rejection, but substantially more adverse events requiring discontinuation of the drug.
Media in This Article
Figure 1
Kaplan-Meier Estimates of Patient Survival (Panel A) and Graft Survival (Panel B) in the Tacrolimus and Cyclosporine Groups.Figure 2
Kaplan-Meier Estimates of Patients with Acute Rejection (Panel A) and Patients Requiring Muromonab-CD3 for Corticosteroid-Resistant Rejection (Panel B) in the Tacrolimus and Cyclosporine Groups.Article Activity
- Article
Over 3000 orthotopic liver transplantations are performed each year in the United States1. The success of this procedure is related in large part to the availability of potent immunosuppressive agents for preventing and treating acute rejection2,3. The use of regimens based on cyclosporine has resulted in one-year rates of graft survival that exceed 70 percent4. Graft rejection, however, remains a major cause of repeated transplantation and death4,5.
Tacrolimus (FK 506), a macrolide compound isolated from Streptomyces tsukubaensis, has potent immunosuppressive properties6,7. In the laboratory, tacrolimus inhibits the mixed-lymphocyte reaction, the formation of interleukin-2 by T lymphocytes, and the formation of other soluble mediators, including interleukin-3 and interferon gamma. As an immunosuppressive agent, tacrolimus is approximately 100 times more potent than cyclosporine8-12. In animals, it prevents graft rejection and prolongs graft survival in experimental liver, kidney, and heart transplantations13-18. The immunosuppressive properties of tacrolimus have been confirmed in people undergoing liver, kidney, and heart transplantations19-28. On the basis of these preliminary results, we conducted an open-label, multicenter, randomized trial to compare the efficacy and safety of tacrolimus-based and cyclosporine-based immunosuppressive regimens in patients undergoing primary liver transplantation.
Methods
Patient Eligibility
The study was conducted at 12 centers in the United States between August 1990 and October 1992. The protocol was approved by the institutional review board at each center, and the patients gave written informed consent before enrollment. Eligible patients had end-stage liver disease and were approved by the patient-selection committee at each center on the basis of specific criteria. Premenopausal women were required to have a negative pregnancy test at entry into the study and to use effective birth-control practices.
Patients were excluded if they were undergoing multiple-organ transplantation, had previously received a liver transplant, or were receiving an ABO-incompatible transplant. Pregnant or nursing women were excluded, as were patients with serious infections, vasculitis, or arteritis; patients requiring anticoagulants or thrombolytic agents (except those with Budd-Chiari syndrome); and patients with cancer, renal failure (defined as a serum creatinine concentration exceeding 2.0 mg per deciliter [180 μmol per liter], glomerular filtration rate below 30 ml per minute, or dependency on dialysis), stage IV hepatic encephalopathy, or seropositivity for the human immunodeficiency virus.
Treatment
Before liver transplantation, the patients were randomly assigned in blocks of four to the treatment groups according to a computer-generated code that the investigators did not know. Initially, patients randomly assigned to tacrolimus (Prograf, Fujisawa USA, Deerfield, Ill.) received a dose of 0.075 mg per kilogram of body weight in a 4-hour intravenous infusion every 12 hours until the medicine could be taken orally. Because of early reports of renal dysfunction with tacrolimus, the intravenous dose was subsequently reduced to 0.05 mg per kilogram and administered over a 12-hour period twice daily. Before the protocol was revised, 48 patients received the higher dose of tacrolimus. The first dose was started 6 to 24 hours after liver transplantation but was delayed for up to 48 hours if urinary output was ≤ 20 ml per hour. Oral tacrolimus was begun at a dose of 0.15 mg per kilogram every 12 hours. The dose was based on ideal body weight unless the patient's weight was less than ideal, in which case actual weight was used. The dose was adjusted in the event of adverse effects of the study drug, rejection, or a trough plasma level of less than 0.2 or more than 5 ng per milliliter. The maximal dose of tacrolimus allowed in the protocol was 0.6 mg per kilogram per day orally or 0.44 mg per kilogram per day intravenously. Plasma levels of tacrolimus were determined initially at a central laboratory and eventually at each clinical site. Plasma was separated at 37 °C and analyzed by enzyme-linked immunosorbent assay with liquid-liquid extraction29.
The patients also received hydrocortisone (1000 mg intravenously) during or immediately after surgery, followed by methylprednisolone (100 mg intravenously or orally, decreasing by 20 mg daily over a period of five days). Treatment with oral prednisone (20 mg per day) or its equivalent was initiated in adults when tolerated, and the dose was tapered to 5 mg per day over a period of three months. Children received prednisone (10 mg per kilogram) or an equivalent dose of methylprednisolone intravenously, and the dose was decreased by 2 mg per kilogram per day over a period of five days. Thereafter, prednisone was continued at a dose of 0.3 mg per kilogram per day and gradually tapered to 0.1 mg per kilogram per day over a period of three months.
Immunosuppressive regimens based on cyclosporine (Sandimmune, Sandoz Pharmaceuticals, East Hanover, N.J.) varied among centers. At 10 centers, cyclosporine (1 mg per kilogram intravenously every 12 hours) and azathioprine (Imuran, Burroughs Wellcome, Research Triangle Park, N.C., at a daily dose of 2 mg per kilogram intravenously) were given preoperatively and corticosteroids were initiated during the procedure. At one center (University of Nebraska; 31 patients), preoperative cyclosporine was initiated at a dose of 2 mg per kilogram intravenously every 12 hours for one to two days, followed by a dose of 5 mg per kilogram orally every 12 hours, and steroids were begun intraoperatively. At another center (University of California, San Francisco; 27 patients), azathioprine at a dose of 2 mg per kilogram intravenously or orally once daily was begun preoperatively and continued for the duration of the study, Minnesota antilymphoblast globulin at a daily dose of 10 mg per kilogram was begun on the first postoperative day and continued for five days, steroids were begun intraoperatively, and cyclosporine was started on day 4. At all 12 centers, the adult maintenance dose of steroids in the cyclosporine group was a prednisone equivalent of 200 mg daily beginning the first day after transplantation, and the dose was tapered to 20 mg by day 6, 15 mg by day 60, 12.5 mg by day 180, and 10 mg by day 360. In children, prednisone or its equivalent was begun at a dose of 10 mg per kilogram per day on postoperative day 1, decreased by 2 mg per kilogram per day over a period of five days, and then adjusted at the investigator's discretion. Cyclosporine levels were measured according to the method used at each study site and were adjusted to maintain trough whole blood concentrations between 250 and 400 ng per milliliter as measured by a method specific for the parent compound or its equivalent.
Treatment of Rejection Episodes
All the patients had liver biopsies on days 7, 28, and 360 after transplantation and when rejection was suggested by a deterioration in liver function (changes in total bilirubin, aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, or γ-glutamyltransferase concentrations) or the appearance of clinical signs (fever, jaundice, pruritus, ascites, or hepatic tenderness). Whenever rejection was suggested, the diagnosis was confirmed by histologic findings on liver biopsy. The diagnosis required that biliary obstruction, hepatic vascular insufficiency, viral hepatitis, and cytomegalovirus be ruled out by ultrasonography, cholangiography, and when indicated, appropriate viral serologic analyses and cultures. In adults, the first episode of rejection was treated with one or two intravenous doses of 1000 mg of methylprednisolone followed by six days of prednisone or its equivalent, starting at a dose of 200 mg per day and tapering to a dose of 20 mg per day. Children received intravenous methylprednisolone at a dose of 20 mg per kilogram followed by six days of prednisone or its equivalent, starting at a dose of 10 mg per kilogram per day and tapering to a dose of 0.3 mg per kilogram per day.
When abnormal liver-function tests and clinical signs of rejection persisted after the completion of a course of corticosteroids, the possibility of corticosteroid-resistant rejection was considered. A liver biopsy showing evidence of rejection was required to confirm corticosteroid-resistant rejection. Muromonab-CD3 (OKT3, Orthoclone, Ortho Pharmaceuticals, Raritan, N.J.) was then given once daily at a dose of 5 mg per day intravenously in adults or 2.5 mg per day intravenously in children and continued for 10 to 14 days. Refractory rejection was defined as continued rejection, as documented by liver biopsy, after a course of corticosteroids, muromonab-CD3, and a second course of corticosteroids. Patients with refractory rejection could, at the discretion of the treating physicians, continue taking the study drug, switch to treatment with the alternative study drug, be treated with other investigational immunosuppressive agents, receive additional therapy outside the study, or undergo a second transplantation.
For each patient, a physical examination was performed and a complete medical history and 12-lead electrocardiogram were obtained just before transplantation and one year later. Routine laboratory tests including urinalysis, hematologic analysis, assessment of coagulation, and serum chemical analyses were performed before transplantation and 7, 14, 28, 180, and 360 days afterward. Specific viral studies were performed as determined at each site. The glomerular filtration rate was measured before transplantation and at days 28 and 360. Adverse events of new onset or increased severity were recorded for every patient during the entire study.
Statistical Analysis
The sample size was calculated to detect a 10 percent difference between tacrolimus and cyclosporine in the one-year rate of graft survival with 80 percent power at the 5 percent level of significance (by two-sided test). The primary end points were patient survival and graft survival at one year. Secondary end points included acute rejection, the use of muromonab-CD3 for corticosteroid-resistant rejection, and refractory rejection. All patients were followed for a minimum of 12 months after transplantation or until death. Analysis was by intention to treat and included all patients who underwent randomization and transplantation. Events were attributed to treatment beginning on the day after surgery. Patient and graft survival was estimated for each of the treatment groups with the Kaplan-Meier method30. Differences between the estimated survival curves for each treatment were analyzed with the Wilcoxon test. Confidence intervals were computed 12 months after transplantation31. Before data were pooled across sites, the potential interaction of treatment and study site was examined. Comparisons of laboratory-test results were based on group mean values over time and changes from base line.
Results
The patients were enrolled from August 1990 to October 1991; 529 patients were enrolled, underwent transplantation, and received at least one dose of the study drugs (263 received tacrolimus and 266 received cyclosporine). Of these, 30 patients receiving tacrolimus and 21 receiving cyclosporine were 12 years of age or younger. An additional 26 patients underwent randomization but were not enrolled because they did not meet the eligibility requirements after transplantation. One patient was randomly assigned to cyclosporine but treated with tacrolimus; this patient was included in the analysis. Eighty-eight percent of the 598 patients screened for the study were enrolled. No significant differences in base-line characteristics or the cause of liver failure were observed between treatment groups (Table 1Table 1
Base-Line Demographic and Clinical Characteristics of the 529 Patients Who Underwent Randomization and Liver Transplantation.).The median (±SD) duration of hospitalization after transplantation was 27.6 ±1.8 days in the tacrolimus group and 31.3 ±3.0 days in the cyclosporine group. By day 7, all but 7 of the patients treated with tacrolimus were receiving oral medication, whereas 137 of the patients treated with cyclosporine were still receiving medication intravenously. The cumulative total daily dose of corticosteroids administered for both prophylaxis and treatment of rejection was significantly lower (P<0.001) in the tacrolimus-treated patients (90 ±65 mg per kilogram) than in the cyclosporine-treated patients (131 ±61 mg per kilogram). Although the maintenance dose of corticosteroids was lower by design in the tacrolimus group, the amount of additional corticosteroids administered for the treatment of rejection was also lower in the tacrolimus group.
Table 2Table 2
Primary and Secondary End Points after One Year of Follow-up. shows the number of patients who died or underwent a second transplantation or in whom rejection occurred during the one-year follow-up. Kaplan-Meier estimates of one-year patient and graft survival were not significantly different between treatment groups (Figure 1Figure 1Kaplan-Meier Estimates of Patient Survival (Panel A) and Graft Survival (Panel B) in the Tacrolimus and Cyclosporine Groups.). Actuarial rates of patient survival at day 360 were 88 percent for both treatment groups (P = 0.85; 95 percent confidence interval for the difference, -5.4 to 6.6 percent), and graft-survival rates at day 360 were 82 percent for the tacrolimus group and 79 percent for the cyclosporine group (P = 0.55; 95 percent confidence interval for the difference, -4.8 to 9.7 percent). Sixty-four patients, 31 in the tacrolimus group and 33 in the cyclosporine group, died during the study or after being withdrawn from it. A total of 52 patients (24 given tacrolimus and 28 given cyclosporine) underwent a second transplantation for primary nonfunction of the liver graft (11 given tacrolimus and 10 given cyclosporine), vascular or biliary complications (8 given tacrolimus and 10 given cyclosporine), rejection (5 given tacrolimus and 4 given cyclosporine), or recurrent hepatitis (4 given cyclosporine). Analysis of treatment according to study site revealed no significant differences between treatment groups in patient or graft survival across centers at 6 and 12 months, except at the Mayo Clinic, where significantly better patient survival (P = 0.018) and graft survival (P = 0.008) were reported at one year in the tacrolimus group.Kaplan-Meier estimates of the fraction of patients who had an episode of acute rejection verified by biopsy showed a significant (P<0.002) difference between treatment groups (Figure 2AFigure 2
Kaplan-Meier Estimates of Patients with Acute Rejection (Panel A) and Patients Requiring Muromonab-CD3 for Corticosteroid-Resistant Rejection (Panel B) in the Tacrolimus and Cyclosporine Groups.). By day 360, 154 tacrolimus-treated patients and 173 cyclosporine-treated patients had had an episode of acute rejection (Table 2). The Kaplan-Meier estimate of the fraction of patients who required muromonab-CD3 showed significantly (P<0.001) lower usage among the tacrolimus-treated patients (Figure 2B). By day 360, 43 tacrolimus-treated patients and 82 cyclosporine-treated patients required muromonab-CD3 (P<0.001) (Table 2).Kaplan-Meier estimates, which took into account censoring of data at the time patients were withdrawn from the study, showed that, by day 360, 6 of the tacrolimus-treated patients (3 percent) and 32 of the cyclosporine-treated patients (15 percent) had discontinued therapy because of refractory rejection (P<0.001). Of the 32 cyclosporine-treated patients with refractory rejection, 22 were switched to tacrolimus, 5 continued to take cyclosporine, 2 underwent a second transplantation, and 3 began to receive another immunosuppressive agent. Of the 22 who were switched to tacrolimus, 19 were alive with their original graft, 2 had undergone a second transplantation (1 of whom died), and 1 had died during the one-year follow-up. Three tacrolimus-treated patients with refractory rejection were switched to cyclosporine and were alive at the one-year follow-up, including one patient who had a second transplantation. Two others continued to take tacrolimus, and one underwent a second transplantation after the completion of the study.
Table 3Table 3
Reasons for Withdrawal from the Study. shows the reasons for withdrawal from the trial. Thirty-seven patients in the tacrolimus group and 13 in the cyclosporine group were withdrawn from the study (P<0.001) at the discretion of the physician because of adverse events, most commonly nephrotoxicity and neurotoxicity in both groups. Detailed information on adverse events is given in Table 4Table 4
Incidence of Adverse Events with Tacrolimus and Cyclosporine..The mean serum creatinine concentration was 1.0 ±0.4 mg per deciliter (88 ±35 μmol per liter) before transplantation and 1.5 ±0.5 mg per deciliter (133 ±44 μmol per liter) at the one-year follow-up in both groups. During this same period, the mean glomerular filtration rate decreased from 85.5 ±27.8 to 59.2 ±21.5 ml per minute in the tacrolimus group and from 93.0 ±35.0 to 62.6 ±28.4 ml per minute in the cyclosporine group. Twenty-seven patients in the tacrolimus group and 17 in the cyclosporine group required dialysis or ultrafiltration during the study. For the majority of the patients (81 percent of the tacrolimus group and 88 percent of the cyclosporine group), dialysis was initiated during the first 28 days of treatment. Among the 63 percent of the patients in the tacrolimus group and 70 percent of the patients in the cyclosporine group who had dialysis and were alive at one year, none required long-term dialysis.
Hyperkalemia was reported more frequently in the tacrolimus group, although mean serum potassium values were within the normal range in both groups. Hyperglycemia was reported more frequently in the tacrolimus group than in the cyclosporine group, but the incidence gradually decreased after transplantation. Among the patients who were not dependent on insulin before transplantation, 11 of those receiving tacrolimus and 5 of those receiving cyclosporine continued to require insulin therapy by day 360. Neoplasms were diagnosed in 5 patients receiving tacrolimus and 19 receiving cyclosporine; all but 5 cases were detected more than one month after transplantation. Four deaths, all in the cyclosporine group, were attributed to laryngeal cancer, renal-cell carcinoma, hepatic adenoma, or large B-cell lymphoma.
Discussion
We compared a regimen of tacrolimus and low-dose corticosteroids with the best cyclosporine-based regimen at each institution. This design helped ensure that the liver-transplantation results in the control group would be comparable to the highest success rate at the institution. After one year of follow-up, the rates of patient and graft survival were comparable between treatment groups but were substantially higher than comparable survival rates reported by the United Network for Organ Sharing or the University of Pittsburgh with cyclosporine-based therapy1,32. The higher rates of patient and graft survival may reflect the exclusion of high-risk patients and the use of the best available cyclosporine regimen at each site.
The tacrolimus-based regimen was significantly better than the cyclosporine-based regimen at preventing acute, corticosteroid-resistant, and refractory rejection. Fewer tacrolimus-treated patients had refractory rejection requiring withdrawal from the study and the use of an alternative immunosuppressive agent despite the administration of lower doses of corticosteroids and avoidance of the use of azathioprine. The low number of second transplantations for refractory rejection may have been due, in part, to the effectiveness of tacrolimus in treating patients in the cyclosporine group who had refractory rejection.
Nephrotoxicity, neurotoxicity, impaired glucose metabolism, hypertension, infection, and gastrointestinal disturbances were common in both treatment groups. The majority of adverse events occurred early, and the incidence decreased over time, often in association with a reduction in the dose of tacrolimus or cyclosporine. Fourteen percent of the patients treated with tacrolimus discontinued treatment because of adverse events, as compared with 5 percent of the patients treated with cyclosporine. Standard cyclosporine-based therapy was available to patients given tacrolimus who had adverse events, whereas tacrolimus, as an experimental drug at the time, was not available to patients given cyclosporine who had adverse events.
A high incidence of nephrotoxicity has been reported with both tacrolimus and cyclosporine33-39. In our study, although nephrotoxicity was reported more often with tacrolimus, the mean glomerular filtration rate and serum creatinine concentration were similar in the two groups. Nephrotoxicity is related in part to the dose of the drug and its levels in plasma, and the decrease in nephrotoxicity over time may reflect both a decrease in the dose of tacrolimus and a more rapid conversion to oral therapy as experience with the medication increased. Although hyperkalemia was reported in both groups, it was clinically manageable with a decrease in the dose of tacrolimus or treatment with sodium polystyrene sulfonate or fludrocortisone. The higher incidence of diarrhea, nausea, and vomiting with tacrolimus is troublesome but not surprising, since tacrolimus is a macrolide, a class of drugs frequently associated with gastrointestinal upset.
Recently, a multicenter European study comparing tacrolimus and cyclosporine in a randomized, open-label trial had similar results40. Analysis of data on 545 recipients of a primary liver transplant 12 months after transplantation showed that the rates of patient and graft survival were not significantly different between groups but that tacrolimus was associated with significantly fewer episodes of acute, refractory acute, and chronic rejection. The most serious adverse events -- renal impairment, disturbances of glucose metabolism, and neurologic complications -- were more common in the group receiving tacrolimus.
In summary, we found that a regimen of tacrolimus and low-dose corticosteroids was comparable to regimens based on cyclosporine in its ability to prevent rejection after liver transplantation. Tacrolimus was more effective than cyclosporine in preventing acute, corticosteroid-resistant, and refractory rejection but was associated with an increased incidence of adverse events.
Supported by Fujisawa USA Inc., Deerfield, Ill.
Dr. Klintmalm assumes full responsibility for the overall content and integrity of the manuscript.
Source Information
Address reprint requests to Dr. Goran B. Klintmalm at Baylor University Medical Center, 3500 Gaston Ave., Dallas, TX 75246.
Members of the U.S. Multicenter FK506 Liver Study Group are listed in the Appendix.
Appendix
The members of the U.S. Multicenter FK506 Liver Study Group are as follows: R.W. Busuttil and S. McDiarmid (UCLA, Los Angeles); G.B. Klintmalm and R. Goldstein (Baylor University Medical Center, Dallas); C.M. Miller and M. Schwartz (Mt. Sinai Medical Center, New York); B.W. Shaw (University of Nebraska, Omaha); J.P. Roberts and M.F. Hebert (University of California, San Francisco); C.O. Esquivel and P. Nakazato (California Pacific Medical Center, San Francisco); R.H. Wiesner and R.A.F. Krom (Mayo Clinic, Rochester, Minn.); M. Kalayoglu and A.M. D'Alessandro (University of Wisconsin, Madison); J.W. Marsh and M.G. Peters (Washington University School of Medicine, St. Louis); J. Burdick and A. Klein (Johns Hopkins Hospital, Baltimore); W.D. Lewis and R. Jenkins (New England Deaconess Hospital, Boston); J.R. Thistlethwaite and J.C. Emond (University of Chicago, Chicago); W.J. Jusko and R. D'Ambrosio (State University of New York, Buffalo); and D. Buell and W.E. Fitzsimmons (Fujisawa, USA, Deerfield, Ill.).
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- Citing Articles (358)
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Russell H. Wiesner. 2011. Immunosuppression: The Global Picture. , 1096-1109.
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Peter Neuhaus, Jochen Klupp, Jan M. Langrehr, Ulf Neumann, Astrid Gebhardt, Johann Pratschke, Stefan G. Tullius, R??diger Lohmann, Cornelia Radke, Nada Rayes, Ruth Neuhaus, Wolf O. Bechstein. (2000) QUADRUPLE TACROLIMUS-BASED INDUCTION THERAPY INCLUDING AZATHIOPRINE AND ALG DOES NOT SIGNIFICANTLY IMPROVE OUTCOME AFTER LIVER TRANSPLANTATION WHEN COMPARED WITH STANDARD INDUCTION WITH TACROLIMUS AND STEROIDS: RESULTS OF A PROSPECTIVE, RANDOMIZED TRIAL. Transplantation 69:11, 2343-2353
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Edward Gane. (2000) Pre- and post-transplant treatment of hepatitis C. Journal of Gastroenterology and Hepatology 15:5 (Suppl.), E187-E193
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Thomas A. Gonwa. (2000) Transplantation. American Journal of Kidney Diseases 35:4, S153-S159
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Patricia A. Sheiner, Joseph F. Magliocca, Carol A. Bodian, Leona Kim-Schluger, Gulum Altaca, James V. Guarrera, Sukru Emre, Thomas M. Fishbein, Stephen R. Guy, Myron E. Schwartz, Charles M. Miller. (2000) LONG-TERM MEDICAL COMPLICATIONS IN PATIENTS SURVIVING ???5 YEARS AFTER LIVER TRANSPLANT. Transplantation781-789
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Joshua Miller, Robert Mendez, John D. Pirsch, Stephen C. Jensik. (2000) SAFETY AND EFFICACY OF TACROLIMUS IN COMBINATION WITH MYCOPHENOLATE MOFETIL (MMF) IN CADAVERIC RENAL TRANSPLANT RECIPIENTS1. Transplantation875-880
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Greg L. Plosker, Rachel H. Foster. (2000) Tacrolimus. Drugs 59:2, 323-389
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Timothy Gayowski, Nina Singh, Lois Keyes, Cheryl F. Wannstedt, Marilyn M. Wagener, Hugo Vargas, Tomacz Laskus, Jorge Rakela, John J. Fung, Ignazio R. Marino. (2000) LATE-ONSET RENAL FAILURE AFTER LIVER TRANSPLANTATION: ROLE OF POSTTRANSPLANT ALCOHOL USE1. Transplantation383
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Eric M. Yoshida, Andrzej K. Buczkowski, Sandra M. Sirrs, Tom G. Elliott, Charles H. Scudamore, Adeera Levin, Hugh D. Tildesley, David N. Landsberg. (2000) Post-transplant diabetic ketoacidosis - A possible consequence of immunosuppression with calcineurin inhibiting agents: A case series. Transplant International 13:1, 69-72
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Philip W. Lowry, Amy L. Weaver, William J. Tremaine, William J. Sandborn. (1999) Combination therapy with oral tacrolimus (FK506) and azathioprine or 6-mercaptopurine for treatment-refractory Crohn's disease perianal fistulae. Inflammatory Bowel Diseases 5:4, 239-245
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Andrew Klein. (1999) Tacrolimus rescue in liver transplant patients with refractory rejection or intolerance or malabsorption of cyclosporine. Liver Transplantation and Surgery 5:6, 502-508
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Luis A. Fernandez, Roger Lehmann, Livio Luzi, Alberto Battezzati, Maria C. Angelico, Camillo Ricordi, Andreas Tzakis, Rodolfo Alejandro. (1999) THE EFFECTS OF MAINTENANCE DOSES OF FK506 VERSUS CYCLOSPORIN A ON GLUCOSE AND LIPID METABOLISM AFTER ORTHOTOPIC LIVER TRANSPLANTATION1. Transplantation 68:10, 1532-1541
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Alex S. Befeler, Thomas D. Schiano, Trevor W. Lissoos, Hari S. Conjeevaram, Allen S. Anderson, J. Michael Millis, Mario Albertucci, Alfred L. Baker. (1999) SUCCESSFUL COMBINED LIVER-HEART TRANSPLANTATION IN ADULTS: REPORT OF THREE PATIENTS AND REVIEW OF THE LITERATURE. Transplantation 68:9, 1423-1427
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Drew J. Winston, Preston F. Foster, Kenneth A. Somberg, Ronald W. Busuttil, Marlon F. Levy, Patricia A. Sheiner, K. Rajender Reddy, Nick Fotheringham, Mitzi Armstrong, Eileen Logan. (1999) RANDOMIZED, PLACEBO-CONTROLLED, DOUBLE-BLIND, MULTICENTER TRIAL OF EFFICACY AND SAFETY OF GRANULOCYTE COLONY-STIMULATING FACTOR IN LIVER TRANSPLANT RECIPIENTS1. Transplantation 68:9, 1298-1304
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Leslie M. Shaw, David W. Holt, Paul Keown, Raman Venkataramanan, Randall W. Yatscoff. (1999) Current opinions on therapeutic drug monitoring of immunosuppressive drugs. Clinical Therapeutics 21:10, 1632-1652
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Ashokkumar Jain, Jorge Reyes, Randeep Kashyap, Susan Rohal, Kareem Abu-Elmagd, Thomas Starzl, John Fung. (1999) Annals of Surgery 230:3, 441
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Zhongquan Qi, Mecislovas Simanaitis, Henrik Ekberg. (1999) Malononitrilamides and tacrolimus additively prevent acute rejection in rat cardiac allografts. Transplant Immunology 7:3, 169-175
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Erik Letko, Kailash Bhol, Vakur Pinar, C. Stephen Foster, A. Razzaque Ahmed. (1999) Tacrolimus (FK 506). Annals of Allergy, Asthma & Immunology 83:3, 179-190
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Russell H. Wiesner, Kenneth P. Batts, Ruud A. F. Krom. (1999) Evolving concepts in the diagnosis, pathogenesis, and treatment of chronic hepatic allograft rejection. Liver Transplantation and Surgery 5:5, 388-400
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Justin D Harmon, Phillip C Ginsberg, Marcella M Nachmann, Cosme Manzarbeita, Richard C Harkaway. (1999) Stuttering priapism in a liver transplant patient with toxic levels of fk506. Urology 54:2, 366
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Dimitrios Vassilopoulos, Charles Camisa, Robert M. Strauss. (1999) SELECTED DRUG COMPLICATIONS AND TREATMENT CONFLICTS IN THE PRESENCE OF COEXISTENT DISEASES. Rheumatic Disease Clinics of North America 25:3, 745-777
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Piyawat Komolmit, Mervyn H Davies. (1999) Tacrolimus in liver transplantation. Expert Opinion on Investigational Drugs 8:8, 1239-1254
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Jon W. Jones, E.Tuncay Üstüner, Marty Zdichavsky, Jean Edelstein, Xiaoping Ren, Claudio Maldonado, Mokunda Ray, Anthony W. Jevans, Warren C. Breidenbach, Scott A. Gruber, John H. Barker. (1999) Long-term survival of an extremity composite tissue allograft with FK506–mycophenolate mofetil therapy. Surgery 126:2, 384-388
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Rolland C. Dickson, Gregory Y. Lauwers, Charles B. Rosen, Rachel Cantwell, David R. Nelson, Johnson Y.N. Lau. (1999) THE UTILITY OF NONINVASIVE SEROLOGIC MARKERS IN THE MANAGEMENT OF EARLY ALLOGRAFT REJECTION IN LIVER TRANSPLANTATION RECIPIENTS1. Transplantation 68:2, 247-253
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Rowen K. Zetterman. (1999) Caring for the liver transplant recipient. Current Gastroenterology Reports 1:3, 175-176
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Rafik M. Ghobrial, Douglas G. Farmer, Angeles Baquerizo, Steven Colquhoun, Hugo R. Rosen, Hasan Yersiz, James F. Markmann, Kenneth E. Drazan, Curtis Holt, David Imagawa, Leonard I. Goldstein, Paul Martin, Ronald W. Busuttil. (1999) Orthotopic Liver Transplantation for Hepatitis C. Annals of Surgery 229:6, 824
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Kenneth Cox, William Berquist, Ricardo Castillo. (1999) Paediatric liver transplantation: Indications, timing and medical complications. Journal of Gastroenterology and Hepatology 14:5s, S61-S66
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Ramón Charco, Carme Cantarell, Victor Vargas, Luis Capdevila, Jose Luis Lázaro, Ernest Hidalgo, Enrique Murio, Carlos Margarit. (1999) Serum cholesterol changes in long-term survivors of liver transplantation: A comparison between cyclosporine and tacrolimus therapy. Liver Transplantation and Surgery 5:3, 204-208
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Weston W. Bush. (1999) Overview of Transplantation Immunology and the Pharmacotherapy of Adult Solid Organ Transplant Recipients: Focus on Immunosuppression. AACN Clinical Issues: Advanced Practice in Acute and Critical Care 10:2, 253-269
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CHRISTIAN A. Seiier, EBERHARD L. Renner, ABRAHAM Czerniak, DOMENICO Didonna, MARKUS W.Büchler, JÜRG Reichen. (1999) Early acute cellular rejection: no effect on late hepatic allograft function in man. Transplant International 12:3, 195-201
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Michael D. Green, Marian G. Michaels. (1999) TACROLIMUS: EFFECTS AND SIDE EFFECTS. The Pediatric Infectious Disease Journal 18:4, 372-373
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David O. Taylor, Mark L. Barr, Branislav Radovancevic, Dale G. Renlund, Robert M. Mentzer Jr, Frank W. Smart, David E. Tolman, O.H. Frazier, James B. Young, Paul VanVeldhuisen. (1999) A randomized, multicenter comparison of tacrolimus and cyclosporine immunosuppressive regimens in cardiac transplantation: decreased hyperlipidemia and hypertension with tacrolimus11This study was sponsored by a grant from Fujisawa USA, Deerfield, Illinois.22The authors were working on behalf of the Tacrolimus US Heart Transplant Multicenter Study Group. Other members of the Study Group included (principal investigator listed first): UTAH Cardiac Transplant Program, Salt Lake City, Utah: David O. Taylor, MD, Dale G. Renlund, MD, Abdallah G. Kfoury, MD; St. Luke’s Episcopal Hospital/Texas Heart Institute, Houston, Texas: O. H. Frazier, MD, Branislav Radovancevic, MD, Edward K. Massin, MD; University of Wisconsin Hospitals and Clinics, Madison, Wisconsin: Robert M. Mentzer, Jr., MD, Charles C. Canver, MD, Robert B. Love, MD; Ochsner Medical Foundation, New Orleans, Louisiana: Frank W. Smart, MD, Hector O. Ventura, MD, Dwight D. Stapleton, MD, Mandeep Mehra, MD; University of Southern California, Los Angeles, California: Mark L. Barr, MD, Vaugh A. Starnes, MD; Medical College of Virginia, Richmond, Virginia: David E. Tolman, MD, Albert Guerraty, MD, David Salter, MD; Cleveland Clinic Foundation, Cleveland, Ohio: James B. Young, MD; Data Management and Statistical Coordinating Center-The EMMES Corporation, Potomac, Maryland: Paul VanVeldhuisen, MS, Anne Lindblad, PhD, Anita Yaffe, MSN, MPH.. The Journal of Heart and Lung Transplantation 18:4, 336-345
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Mary F. Hebert, Nancy L. Ascher, John R. Lake, Jean Emond, Bev Nikolai, T. Juhani Linna, John P. Roberts. (1999) FOUR-YEAR FOLLOW-UP OF MYCOPHENOLATE MOFETIL FOR GRAFT RESCUE IN LIVER ALLOGRAFT RECIPIENTS1. Transplantation 67:5, 707-712
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Hongsi Jiang, Shozo Sakuma, Yasutomo Fujii, Yuka Akiyama, Toshikazu Ogawa, Kouichi Tamura, Masakazu Kobayashi, Takashi Fujitsu. (1999) Tacrolimus versus cyclosporin A: a comparative study on rat renal allograft survival. Transplant International 12:2, 92-99
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Ashokkumar B. Jain, Randeep Kashyap, Jorge Rakela, Thomas E. Starzl, John J. Fung. (1999) Primary adult liver transplantation under tacrolimus: More than 90 months actual follow-up survival and adverse events. Liver Transplantation 5:2, 144-150
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David K. Imagawa. (1999) Novel therapeutic approaches in chronic rejection. Current Opinion in Organ Transplantation 4:1, 35
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Takeji Uno, Teruhisa Kazui, Yoshinari Suzuki, Hisakuni Hashimoto, Koichi Suzuki, Bashar A. H. Muhammad. (1999) Pharmacokinetic advantages of a newly developed tacrolimus oil-in-water-type emulsion via the enteral route. Lipids 34:3, 249-254
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Ashok Jain, Ajai Khanna, Ernesto P. Molmenti, Nitin Rishi, John J. Fung. (1999) IMMUNOSUPPRESSIVE THERAPY. Surgical Clinics of North America 79:1, 59-76
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Bruno M Meiser, Matthias Pfeiffer, Dorothe Schmidt, Hermann Reichenspurner, Peter Ueberfuhr, Daniela Paulus, Wolfgang von Scheidt, Eckart Kreuzer, Dietrich Seidel, Bruno Reichart. (1999) Combination therapy with tacrolimus and mycophenolate mofetil following cardiac transplantation: importance of mycophenolic acid therapeutic drug monitoring. The Journal of Heart and Lung Transplantation 18:2, 143-149
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Jorge Reyes, George V. Mazariegos. (1999) PEDIATRIC TRANSPLANTATION. Surgical Clinics of North America 79:1, 163-189
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William F. Finn, George A. Porter. (1999) Urinary Biomarkers: Recommendations of the Joint European/United States Workshop for Future Research. Renal Failure 21:3-4, 445-451
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Mercè Brunet, Leonor Pou, Cecelia Manzanares, Gonzalo Palacios, Jacint Corbella. (1998) Multicenter Comparison of First- and Second-Generation IMx Tacrolimus Microparticle Enzyme Immunoassays in Liver and Kidney Transplantation. Therapeutic Drug Monitoring 20:6, 676-679
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Leonor Pou, Mercè Brunet, Itxarone Bilbao, Hernan Andreu, Ines Andres, Rosa Lopez, Carles Margarit, Antonio Rimola, Jacint Corbella. (1998) Therapeutic Drug Monitoring of Tacrolimus in Liver Transplantation, Phase III FK506 Multicenter Spanish Study Group: A Two-Year Follow-Up. Therapeutic Drug Monitoring 20:6, 602-606
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Robert A. Fisher, John M. Ham, Amadeo Marcos, Mitchell L. Shiffman, Velimir A. Luketic, Pam M. Kimball, Arun J. Sanyal, Luke Wolfe, Amy Chodorov, Marc P. Posner. (1998) A PROSPECTIVE RANDOMIZED TRIAL OF MYCOPHENOLATE MOFETIL WITH NEORAL OR TACROLIMUS AFTER ORTHOTOPIC LIVER TRANSPLANTATION1,2. Transplantation 66:12, 1616-1621
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Olivier Boillot, Jean-Paul Viale, Pierre Gratadour, Pierre Meeus, Pierre Souraty, Yannick Le Derf, Isabelle Mechet, Jean-Yves Scoazec, Francoise Berger, Pierre Paliard. (1998) REVERSAL OF EARLY ACUTE REJECTION WITH INCREASED DOSES OF TACROLIMUS IN LIVER TRANSPLANTATION. Transplantation 66:9, 1182-1185
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A. B. Jain, I. Hamad, J. Rakela, F. Dodson, D. Kramer, J. Demetris, J. McMichael, T. E. Starzl, J. J. Fung. (1998) A PROSPECTIVE RANDOMIZED TRIAL OF TACROLIMUS AND PREDNISONE VERSUS TACROLIMUS, PREDNISONE, AND MYCOPHENOLATE MOFETIL IN PRIMARY ADULT LIVER TRANSPLANT RECIPIENTS. Transplantation 66:10, 1395-1398
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Stephan Kr??henb??hl, Andrea Menafoglio, Emile Giostra, Augusto Gallino. (1998) SERIOUS INTERACTION BETWEEN MIBEFRADIL AND TACROLIMUS1. Transplantation 66:8, 1113-1115
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K. Fellermann, D. Ludwig, M. Stahl, T. David-Walek, E.F. Stange. (1998) Steroid-unresponsive acute attacks of inflammatory bowel disease: immunomodulation by tacrolimus (FK506). The American Journal of Gastroenterology 93:10, 1860-1866
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Russell H. Wiesner, A. Jake Demetris, Steven H. Belle, Eric C. Seaberg, John R. Lake, Rowen K. Zetterman, James Everhart, Katherine M. Detre. (1998) Acute hepatic allograft rejection: Incidence, risk factors, and impact on outcome. Hepatology 28:3, 638-645
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Renata Fabia, Marlon F Levy, Giuliano Testa, Samuel Obiekwe, Robert M Goldstein, Bo S Husberg, Thomas A Gonwa, Goran B Klintmalm. (1998) Colon carcinoma in patients undergoing liver transplantation. The American Journal of Surgery 176:3, 265-269
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Ewa Chelmicka-Schorr, Katherine Wiegmann, Robert Wollmann, Barry G.W. Arnason, Duk Hwan Kim. (1998) Immunoaugmenting Effect of FK 506 on Experimental Allergic Encephalomyelitis in Lewis Rats. Journal of Autoimmunity 11:4, 329-334
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H. Bertz, J. Laubenberger, G. Steinfurth, J. Finke. (1998) SINUS VENOUS THROMBOSIS. Transplantation 66:2, 241-244
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Vincent J. Canzanello, Stephen C. Textor, Sandra J. Taler, Lora L. Schwartz, Michael K. Porayko, Russell H. Wiesner, Ruud A.F. Krom. (1998) Late hypertension after liver transplantation: A comparison of cyclosporine and tacrolimus (FK 506). Liver Transplantation and Surgery 4:4, 328-334
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Ruggiero Francavilla, Nedim Hadzic, James Underhill, Nigel Heaton, Mohamed Rela, Giorgina Mieli-Vergani, Peter Donaldson. (1998) ROLE OF HLA COMPATIBILITY IN PEDIATRIC LIVER TRANSPLANTATION. Transplantation 66:1, 53-58
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Simon M. Gabe, Ingvar Bjarnason, Zahra Tolou–Ghamari, J.Michael Tredger, Philip G. Johnson, G.Robin Barclay, Roger Williams, David B.A. Silk. (1998) The effect of tacrolimus (FK506) on intestinal barrier function and cellular energy production in humans. Gastroenterology 115:1, 67-74
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R. Charco, E. Murio, A. Edo, J. Balsclls, J. L. Lazaro, I. Bilbao, E. Hidalgo, C. Margarit. (1998) Early use of tacrolimus as rescue therapy for refractory liver allograft rejection. Transplant International 11:s1, S313-S317
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C. Margarit, A. Rimola, I. Gonzalez-Pinto, V. Cuervas-Mons, A. Edo, H. Andreu, E. Moreno-Gonzalez, J. L. Calleja. (1998) Efficacy and safety of oral low-dose tacrolimus treatment in liver transplantation. Transplant International 11:s1, S260-S266
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Yi-Min Ku, David I. Min. (1998) An Abbreviated Area-Under-the-Curve Monitoring for Tacrolimus in Patients With Liver Transplants. Therapeutic Drug Monitoring 20:2, 219-223
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Wolfgang Fischbach, Volker Groß, Jürgen Schölmerich, Christian Ell, Peter Layer, Wolfgang E. Fleig. (1998) Update Gastroenterologie 1997—Teil II. Medizinische Klinik 93:3, 146-164
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Thomas B. Strouse, Suzie M. El-Saden, Nancy E.M. Glaser, Curley Bonds, Natalie Ayars, Ronald W. Busuttil. (1998) Immunosuppressant Neurotoxicity in Liver Transplant Recipients: Clinical Challenges for the Consultation-Liaison Psychiatrist. Psychosomatics 39:2, 124-133
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Holly L. Casele, Steven A. Laifer. (1998) ASSOCIATION OF PREGNANCY COMPLICATIONS AND CHOICE OF IMMUNOSUPPRESSANT IN LIVER TRANSPLANT PATIENTS1. Transplantation 65:4, 581-583
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James F. Whiting, Annie Fecteau, Jill Martin, Pablo A. Bejarano, Douglas W. Hanto. (1998) USE OF LOW-DOSE OKT3 AS INDUCTION THERAPY IN LIVER TRANSPLANTATION. Transplantation 65:4, 577-580
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Hilla Knobler, Alex Stagnaro-Green, Sylvan Wallenstein, Myron Schwartz, Sheila H. Roman. (1998) Higher Incidence of Diabetes in Liver Transplant Recipients With Hepatitis C. Journal of Clinical Gastroenterology 26:1, 30-33
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Robert M. Mentzer, M. Salik Jahania, Robert D. Lasley. (1998) TACROLIMUS AS A RESCUE IMMUNOSUPPRESSANT AFTER HEART AND LUNG TRANSPLANTATION1. Transplantation 65:1, 109-113
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Thomas E. Starzl. (1998) The mother lode of liver transplantation, with particular reference to our new journal. Liver Transplantation and Surgery 4:1, 1-14
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Devin E. Eckhoff, Brendan M. McGuire, Luc R. Frenette, Juan L. Contreras, Sharon L. Hudson, J. Stevenson Bynon. (1998) TACROLIMUS (FK506) AND MYCOPHENOLATE MOFETIL COMBINATION THERAPY VERSUS TACROLIMUS IN ADULT LIVER TRANSPLANTATION1. Transplantation180-187
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HIDEKI NAKAGAWA. (1998) Latter period II phase test on concentration setting of the FK506 ( tacrolimus ) salve for atopic dermatitis ( Part 1 ).. Nishi Nihon Hifuka 60:5, 685-698
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Mark D. Stegall, Michael E. Wachs, Gregory Everson, Tracy Steinberg, Bahri Bilir, Roshan Shrestha, Frederick Karrer, Igal Kam. (1997) PREDNISONE WITHDRAWAL 14 DAYS AFTER LIVER TRANSPLANTATION WITH MYCOPHENOLATE. Transplantation 64:12, 1755-1760
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Mark D. Stegall, Marta Simon, Michael E. Wachs, Lawrence Chan, Charles Nolan, Igal Kam. (1997) MYCOPHENOLATE MOFETIL DECREASES REJECTION IN SIMULTANEOUS PANCREAS-KIDNEY TRANSPLANTATION WHEN COMBINED WITH TACROLIMUS OR CYCLOSPORINE1. Transplantation 64:12, 1695-1700
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Miguel A. Vazquez. (1997) New Advances in Immunosuppression Therapy for Renal Transplantation. The American Journal of the Medical Sciences 314:6, 415-435
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Bruce G. Gold. (1997) FK506 and the role of immunophilins in nerve regeneration. Molecular Neurobiology 15:3, 285-306
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Etienne Marc Sokal, Henedina Antunes, Claire Beguin, Monique Bodeus, Pierre Wallemacq, Jean de Ville de Goyet, Raymond Reding, Magda Janssen, Jean Paul Buts, Jean Bernard Otte. (1997) Early Signs And Risk Factors For The Increased Incidence Of Epstein-Barr Virus-Related Posttransplant Lymphoproliferative Diseases In Pediatric Liver Transplant Recipients Treated With Tacrolimus. Transplantation 64:10, 1438-1442
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Victoria F. Hughes, Andrew K. Trull, Alexander Gimson, Peter J. Friend, Neville Jamieson, Al??na Duncan, Derek G.D. Wight, A. Toby Prevost, Graeme J.M. Alexander. (1997) Randomized Trial To Evaluate The Clinical Benefits Of Serum??-Glutathione S-Transferase Concentration Monitoring After Liver Transplantation1. Transplantation 64:10, 1446-1452
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Takenori Ochiai, Kaichi Isono. (1997) Advances in the development of immunosuppressive agents in organ transplantation. Surgery Today 27:10, 883-891
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Masaaki Kimikawa, David H. Sachs, Robert B. Colvin, Amelia Bartholomew, Tatsuo Kawai, A. Benedict Cosimi. (1997) MODIFICATIONS OF THE CONDITIONING REGIMEN FOR ACHIEVING MIXED CHIMERISM AND DONOR-SPECIFIC TOLERANCE IN CYNOMOLGUS MONKEYS1. Transplantation 64:5, 709-716
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Ivo W. Graziadei, Russell H. Wiesner, Paul J. Marotta, Michael K. Porayko, Linda J. Dahlke, Sharon M. Wilson, Jeffery L. Steers, Ruud A.F. Krom. (1997) NEORAL COMPARED TO SANDIMMUNE IS ASSOCIATED WITH A DECREASE IN HISTOLOGIC SEVERITY OF REJECTION IN PATIENTS UNDERGOING PRIMARY LIVER TRANSPLANTATION1. Transplantation 64:5, 726-731
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Johann Pratschke, Ruth Neuhaus, Stefan G. Tullius, Gary W. Haller, Sven Jonas, Thomas Steinmueller, Wolf-Otto Bechstein, Peter Neuhaus. (1997) TREATMENT OF CYCLOSPORINE-RELATED ADVERSE EFFECTS BY CONVERSION TO TACROLIMUS AFTER LIVER TRANSPLANTATION. Transplantation 64:6, 938-940
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A. David Mayer, Jan Dmitrewski, Jean-Paul Squifflet, Tatjana Besse, Bernd Grabensee, Barbara Klein, Friedrich W. Eigler, Uwe Heemann, Rudolf Pichlmayr, Matthias Behrend, Yves Vanrenterghem, Jan Donck, Johannes van Hooff, Maarten Christiaans, Jose M. Morales, Amado Andres, Robert W.G. Johnson, Colin Short, Bernd Buchholz, Nikola Rehmert, Walter Land, Stefan Schleibner, John L.R. Forsythe, David Talbot, Hans-H. Neumayer, Ingeborg Hauser, Bo-G??ran Ericzon, Christina Brattstr??m, Kerstin Claesson, Ferdinand M??hlbacher, Erich Pohanka. (1997) MULTICENTER RANDOMIZED TRIAL COMPARING TACROLIMUS (FK506) AND CYCLOSPORINE IN THE PREVENTION OF RENAL ALLOGRAFT REJECTION1. Transplantation 64:3, 436-443
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Ashok Jain, Raman Venkataramanan, John J. Fung, J. Carlton Gartner, Jackie Lever, Vijayan Balan, Vijay Warty, Thomas E. Starzl. (1997) PREGNANCY AFTER LIVER TRANSPLANTATION UNDER TACROLIMUS1. Transplantation 64:4, 559-565
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Linda S. Sher, Carlos A. Cosenza, Jacques Michel, Leonard Makowka, Charles M. Miller, Myron E. Schwartz, Ronald Busuttil, Sue McDiarmid, James F. Burdick, Andrew S. Klein, Carlos Esquivel, Goran Klintmalm, Marlon Levy, John P. Roberts, John R. Lake, Munci Kalayoglu, Anthony M. D'Alessandro, Robert D. Gordon, Andrei C. Stieber, Byers W. Shaw, J. Richard Thistlethwaite, Peter Whittington, Russell H. Wiesner, Michael Porayko, J. Steve Bynon, Devin E. Eckhoff, Richard B. Freeman, Richard J. Rohrer, W. David Lewis, J. Wallis Marsh, Marion Peters, John Powelson, A. Benedict Cosimi. (1997) EFFICACY OF TACROLIMUS AS RESCUE THERAPY FOR CHRONIC REJECTION IN ORTHOTOPIC LIVER TRANSPLANTATION. Transplantation 64:2, 258-263
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