A Randomized Active-Controlled Trial of Mycophenolate Mofetil in Heart Transplant Recipients1

Kobashigawa, Jon A.; Miller, Leslie W.; Renlund, Dale G.; Mentzer, Robert M.; Alderman, Edwin L.; Bourge, Robert C.; Costanzo, María Rosa; Eisen, Howard J.; Dureau, G; Ratkovec, Ranae; Hummel, Manfred; Ipe, David; Johnson, Jessica; Keogh, Anne; Mamelok, Richard D.; Mancini, Donna; Smart, Frank W.; Valantine, Hannah A.

doi:10.1097/00007890-199808270-00016

Cited by 557 publications

(302 citation statements)

References 13 publications

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“…6 Compared with azathioprine, MMF seems to be a more powerful immunosuppressive drug. 7 It has been used in the setting of kidney, 7 liver, 17 heart, 18 and lung 19 transplantation and in the treatment of autoimmune diseases, such as Wegener' s granulomatosis, microscopic polyangiitis, immunoglobulin A nephropathy, 20 and other glomerular diseases. 21 In the setting of OLT, the use of MMF seems to allow a reduction in cyclosporine or tacrolimus dose and therefore decreased toxicity.…”

Section: Discussionmentioning

confidence: 99%

Conversion of liver transplant recipients on cyclosporine with renal impairment to mycophenolate mofetil

et al. 1999

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The management of liver transplant recipients with renal function impairment remains controversial because cyclosporine withdrawal from triple immunosuppression regimens may be followed by graft rejection. A nonnephrotoxic and powerful immunosuppressant such as mycophenolate mofetil (MMF) could allow a reduction of cyclosporine dosage or its withdrawal and an improvement in renal function in these patients. Eleven patients with serum creatinine levels greater than 1.5 mg/dL, normal graft function, and a rejection-free period of at least 1 year started MMF at a dose of 2000 mg/d (reduced in case of adverse events) while cyclosporine dosage was slowly reduced. At last follow-up (63 ؎ 5 weeks), 7 patients remained free of cyclosporine (6 of those patients are also free of steroids), 2 patients reduced their cyclosporine dose, and 2 patients developed mild acute rejection that responded to a switch to tacrolimus therapy. Serum creatinine and urea levels in the 7 patients free of cyclosporine decreased from 2.22 ؎ 0.13 to 1.90 ؎ 0.19 mg/dL (P ‫؍‬ .05) and 0.95 ؎ 0.10 to 0.60 ؎ 0.10 g/L (P F .001), respectively. Creatinine clearance increased from 38.16 ؎ 5.60 to 47.01 ؎ 6.76 mL/min (P ‫؍‬ .005). Control of arterial hypertension also improved. Tolerance to MMF was good, but 6 patients required dose reductions, mainly because of asymptomatic anemia. In conclusion, in liver transplant recipients with stable graft function, MMF may allow cyclosporine dose reduction or discontinuation, thus improving renal function and the control of arterial hypertension. This change of treatment must be carefully monitored because of the frequent need for MMF dose reduction and the risk for rejection.

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Section: Discussionmentioning

confidence: 99%

Conversion of liver transplant recipients on cyclosporine with renal impairment to mycophenolate mofetil

et al. 1999

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“…The use of MMF as part of immunosuppressive therapy in heart transplantation also prevents the occurrence of acute rejection (5). The combination of mycophenolic acid (MPA), in the form of MMF, with cyclosporine and corticosteroids has proven to be one of the most successful strategies used in transplantation, allowing improved long-term patient and graft survival in Caucasian as well as African-American renal transplant populations (6)(7)(8).…”

Section: Introductionmentioning

confidence: 99%

Enteric-Coated Mycophenolate Sodium can be Safely Administered in Maintenance Renal Transplant Patients: Results of a 1-Year Study

Budde

Curtis

Knoll

et al. 2004

American Journal of Transplantation

240

157

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With the objective of enhancing upper gastrointestinal (GI) tolerability, enteric-coated mycophenolate sodium (EC-MPS, myfortic0.47; p = = NS). Neutropenia (< <1500 cells/mm 3 ) within the first 3 months (coprimary endpoint) was low in both groups (EC-MPS 0.6%; MMF 3.1%; p = = NS). Although the overall incidence of infections was similar, the number of serious infections was significantly lower in EC-MPS patients (8.8% vs. 16.0%; p < < 0.05). Similar rates of efficacy failure (EC-MPS 2.5%; MMF 6.1%; p = = NS), biopsy-proven acute rejection (EC-MPS 1.3%; MMF 3.1%; p = = NS) and biopsy-proven chronic rejection (EC-MPS 3.8%; MMF 4.9%; p = = NS) were observed in both groups. In conclusion, renal maintenance patients can be converted from MMF to EC-MPS without compromising the safety and efficacy profile associated with MMF.

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“…29 The randomized trial that formed the basis of this IVUS core laboratory data showed that MMF, an immunosuppressive agent that inhibits cellular proliferation, was more efficacious than Aza in reducing rejection episodes and improving survival among heart transplant recipients. 19 The present study is an expansion of the IVUS results from that clinical trial. The IVUS data demonstrate that the MMF-treated patients showed a trend for lower maximal MIT per patient compared with the Aza-treated patients (p-value was borderline, most likely due to small sample size).…”

Section: Discussionmentioning

confidence: 99%

“…19 One hundred ninety patients with evaluable baseline and 1-year IVUS studies were analyzed. All patients received cyclosporine and prednisone and were randomized to receive either MMF or azathioprine (Aza).…”

Section: Patient Populationmentioning

confidence: 99%

Vascular Remodeling 1 Year After Cardiac Transplantation

Tanaka

Chhabra

et al. 2007

The Journal of Heart and Lung Transplantation

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Background:The belief that vascular remodeling and intimal hyperplasia are causes of luminal narrowing in cardiac allograft vasculopathy (CAV) is controversial. This study evaluated the relationship of vascular remodeling and intimal hyperplasia to luminal narrowing 1 year after orthotopic heart transplantation. Methods:Intravascular ultrasound imaging was performed on 190 cardiac transplant recipients at baseline and again 1 year after transplantation as part of a randomized trial of mycophenolate mofetil (MMF) and azathioprine (Aza). Studies 1 year apart were matched at 625 sites. All sites were classified into positive, non-significant and negative remodeling patterns, depending on a change of Ϯ10% in external elastic membrane area. Of the 190 patients, 99 were randomized to receive MMF, and 91 to receive Aza. Results:A total of 625 sites were observed. Of these, 52% had no remodeling, 25%

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A Randomized Active-Controlled Trial of Mycophenolate Mofetil in Heart Transplant Recipients1

Abstract: Substitution of MMF for azathioprine may reduce mortality and rejection in the first year after cardiac transplantation.

Cited by 557 publications

References 13 publications

Conversion of liver transplant recipients on cyclosporine with renal impairment to mycophenolate mofetil

Conversion of liver transplant recipients on cyclosporine with renal impairment to mycophenolate mofetil

Enteric-Coated Mycophenolate Sodium can be Safely Administered in Maintenance Renal Transplant Patients: Results of a 1-Year Study

Vascular Remodeling 1 Year After Cardiac Transplantation

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