A Prospective Randomized Trial of Tacrolimus and Prednisone Versus Tacrolimus, Prednisone, and Mycophenolate Mofetil in Primary Adult Liver Transplant Recipients

Jain, Ashokkumar; Hamad, Imad; Rakela, Jorge; Dodson, Forrest; Kramer, David J.; Demetris, Jake; McMichael, John; Starzl, Thomas E.; Fung, John J.

doi:10.1097/00007890-199811270-00024

Cited by 83 publications

(53 citation statements)

References 10 publications

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“…[16][17][18][19][20] The aim of the present study is to examine the impact of MMF therapy in HCV-positive liver transplant recipients administered tacrolimus (TAC)-based immunosuppression. 21,22 One hundred six patients on this trial underwent LT for end-stage liver disease secondary to HCV infection. The diagnosis of HCV was made on the basis of qualitative analysis of reverse-transcriptase polymerase chain reaction.…”

mentioning

confidence: 99%

A prospective randomized trial of mycophenolate mofetil in liver transplant recipients with hepatitis C

Jain

2002

Liver Transplantation

129

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Hepatitis C is the most common indication for liver transplantation (LT) in the United States. Recurrence of hepatitis C virus (HCV) infection post-LT remains a problem for which there is no completely satisfactory treatment. The aim of the present study is to evaluate mycophenolate mofetil (MMF), which has both immunosuppressive and antiviral properties, to determine whether it is associated with a difference in the rate of HCV recurrence and also examine its impact on patient and graft survival. Between August 1995 and May 1998, a total of 106 patients who were HCV positive before LT were randomized to tacrolimus (

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mentioning

confidence: 99%

A prospective randomized trial of mycophenolate mofetil in liver transplant recipients with hepatitis C

Jain

2002

Liver Transplantation

129

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“…15 A large randomized trial compared the effects of a double therapy regimen of tacrolimus and a corticosteroid to triple therapy with tacrolimus, corticosteroid, and MMF 2 g/d in 200 adult recipients of a primary orthotopic liver transplant. 16 Although patient and graft survival were comparable in both double-drug and triple-drug treatment groups, there was a trend toward a reduced incidence of acute rejection episodes, a reduction in the mean maintenance and cumulative doses of corticosteroids, and better preservation of renal function among patients in the MMF treatment group. 16 …”

Section: Efficacy In Solid Organ Transplantationmentioning

confidence: 88%

“…16 Although patient and graft survival were comparable in both double-drug and triple-drug treatment groups, there was a trend toward a reduced incidence of acute rejection episodes, a reduction in the mean maintenance and cumulative doses of corticosteroids, and better preservation of renal function among patients in the MMF treatment group. 16 …”

Section: Efficacy In Solid Organ Transplantationmentioning

confidence: 88%

Mycophenolate mofetil for the prevention and treatment of graft-versus-host disease following stem cell transplantation: preliminary findings

Vogelsang¹,

Arai²

2001

Bone Marrow Transplant

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Summary:The therapeutic benefits of allogeneic stem cell transplantation in patients with hematologic disorders are limited by the significant morbidity and mortality of graft-versus-host disease (GVHD). Current agents for the prevention and treatment of GVHD have limited efficacy and often result in toxic side-effects. Mycophenolate mofetil (MMF) is a new immunosuppressant with a selective mechanism of action. When employed following solid organ transplantation, MMF reduces the incidence and severity of acute rejection episodes. By selectively targeting activated lymphocytes, the active metabolite of MMF, mycophenolic acid (MPA), appears to augment the actions of standard immunosuppressant agents without adding overlapping toxicities. Studies of combination regimens that include MMF report that this agent permits a dose reduction of cyclosporine, tacrolimus, or corticosteroid, without increasing the incidence of acute rejection in solid organ transplants. Reports on the efficacy of MMF following stem cell transplantation in animal studies were mixed. However, the use of a non-myeloablative conditioning regimen with a post-graft immunosuppressive regimen of MMF and cyclosporine was able to sustain stable mixed chimeras in 60% to 80% of dogs who received hematopoietic grafts from DLA-identical littermates. MMF has demonstrated activity in preliminary clinical trials for GVHD prophylaxis, and treatment of acute or chronic GVHD. Larger clinical trials are warranted to determine the optimum dose and route of MMF administration for GVHD, as well as the comparative safety and efficacy of MMF-containing regimens. Allogeneic stem cell transplantation (SCT) has significant therapeutic benefits for many patients with hematologic disorders. Unfortunately, the benefits of the stem cell graft are limited by the significant morbidity and mortality of graftversus-host disease (GVHD). 1 In related donor, histocompatible-matched, and unmanipulated allografts, acute GVHD develops in approximately 30% to 60% of SCT recipients; when the donor and recipient are unrelated or histoincompatible, the prevalence is higher, from 40% to 90%. 2,3 Mortality, as a direct or indirect consequence of acute GVHD, may be as high as 50%. 2 In addition, chronic GVHD develops in 35% to 50% of long-term survivors. 2 Current post-transplantation therapies to prevent or treat GVHD are only partially effective. Furthermore, these immunosuppressive regimens often result in significant toxicities. With cyclosporine therapy, the prevalence of nephrotoxicity can be as high as 75%. 4 Long-term use of glucocorticoids increases the risk of hyperglycemia, infections, avascular necrosis of bone, and osteoporosis. 2,4 The therapeutic index for methotrexate (MTX) is extremely low, and the occurrence of hyperbilirubinemia, bone marrow suppression, or mucositis is common. 4,5 There is an obvious need for new immunosuppressive strategies that provide greater control of GVHD with less toxicity. Mycophenolate mofetil (MMF) is an immunosuppressant presently used for the ...

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“…The immunosuppression regimen consisted of tacrolimus, mycophenolate mofetil and prednisone. This combination has been previously studied in OLT with favorable graft and patient survival without predisposition to the development of NAFLD (30)(31)(32)(33). Rapid taper of immunosuppression resulted in mild rejection in two patients, without significant improvement in hepatic steatosis.…”

Section: Discussionmentioning

confidence: 99%

De Novo Non-Alcoholic Fatty Liver Disease Following Orthotopic Liver Transplantation

Poordad¹,

Gish²,

Wakil³

et al. 2003

American Journal of Transplantation

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Non-alcoholic fatty liver disease (NAFLD) is an increasingly recognized clinico-pathologic entity typically associated with obesity, type II diabetes and hyperlipidemia. It has been noted to recur after orthotopic liver transplantation (OLT). We report four patients who developed de novo NAFLD within 3 months of OLT without the typical predisposing factors of diabetes mellitus or obesity. Three of the four patients underwent OLT for hepatitis C-related cirrhosis, and the other for alcoholic cirrhosis. Examination of the liver explants revealed no evidence of steatosis. No surreptitious alcohol use or a drug-induced process could be identified in these patients. Treatment of recurrent hepatitis C infection in one patient with interferon and ribavirin led to sustained suppression of the viral RNA to undetectable levels, but no improvement in histology or liver enzymes. All four patients had histologic evidence of preservation injury on the initial post-OLT biopsies, but the significance of this finding in relationship to the development of NAFLD is unknown. NAFLD can develop without any of the known predisposing conditions after transplantation, and this raises further questions about the pathogenesis of this condition.

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A Prospective Randomized Trial of Tacrolimus and Prednisone Versus Tacrolimus, Prednisone, and Mycophenolate Mofetil in Primary Adult Liver Transplant Recipients

Abstract: Patient and graft survival rates were similar in both groups. There was a trend to a lower incidence of rejection, reduced nephrotoxicity, and a lesser amount of maintenance corticosteroids in triple-drug therapy compared with double-drug therapy.

Cited by 83 publications

References 10 publications

A prospective randomized trial of mycophenolate mofetil in liver transplant recipients with hepatitis C

A prospective randomized trial of mycophenolate mofetil in liver transplant recipients with hepatitis C

Mycophenolate mofetil for the prevention and treatment of graft-versus-host disease following stem cell transplantation: preliminary findings

De Novo Non-Alcoholic Fatty Liver Disease Following Orthotopic Liver Transplantation

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