Three-year results of a randomized, double-blind, controlled trial of mycophenolate mofetil versus azathioprine in cardiac transplant recipients

Howard Eisen, Jon Kobashigawa, Anne Keogh, Robert Bourge, Dale Renlund, Robert Mentzer, Edwin Alderman, Hannah Valantine, Georges Dureau, Donna Mancini, Richard Mamelok, Robert Gordon, Whedy Wang, Mandeep Mehra, Maria Rosa Constanzo, Manfred Hummel, Jay Johnson

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176 Scopus citations

Abstract

Background: This study reports the 36-month results of a randomized, double-blind, active-controlled trial of mycophenolate mofetil (MMF) vs azathioprine (AZA) in heart transplant patients. Methods: Patients were randomized at the time of transplant to receive MMF (1,500 mg twice a day, N = 327) or AZA (1.5 to 3 mg/kg in 4 daily doses, N = 323) in addition to cyclosporine and corticosteroids; 289 patients in each group received study drug. Data were analyzed in all randomized patients (enrolled) and in patients who received study medications (treated). Clinical and graft assessments continued for 36 months. Results: For the co-primary end-point, 53 of 289 (18.3%) AZA-treated patients either died or received another transplant compared with 34 of 289 (11.8%) MMF-treated patients (p < 0.01). Time to re-transplantation or patient death was significantly shorter for AZA- than MMF-treated patients (p = 0.029). In patients undergoing intravascular ultrasound, the change in mean maximal intimal thickness was less for the MMF group than for the AZA group (0.06 ± 0.03 mm vs 0.13 ± 0.03 mm, respectively; p = 0.056). No significant differences between treatments were observed in quantitative coronary angiographic measurements of transplant coronary vasculopathy. Congestive heart failure, atrial arrhythmia and leukopenia were more common in the AZA group, whereas diarrhea, esophagitis, Herpes simplex, Herpes zoster and cytomegalovirus (CMV) tissue invasion were more common in MMF-treated patients. Conclusion: MMF reduces mortality and graft loss up to 36 months after transplantation.

Original languageEnglish (US)
Pages (from-to)517-525
Number of pages9
JournalJournal of Heart and Lung Transplantation
Volume24
Issue number5
DOIs
StatePublished - May 1 2005

All Science Journal Classification (ASJC) codes

  • Surgery
  • Pulmonary and Respiratory Medicine
  • Cardiology and Cardiovascular Medicine
  • Transplantation

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