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


CONCLUSIONS
MMF reduces mortality and graft loss up to 36 months after transplantation.
Eisen
Howard J
HJ
Division of Cardiology, Drexel University College of Medicine, Philadelphia, Pennsylvania 19102-1192, USA. heisen@drexelmed.edu
Kobashigawa
Jon
J
Keogh
Anne
A
Bourge
Robert
R
Renlund
Dale
D
Mentzer
Robert
R
Alderman
Edwin
E
Valantine
Hannah
H
Dureau
Georges
G
Mancini
Donna
D
Mamelok
Richard
R
Gordon
Robert
R
Wang
Whedy
W
Mehra
Mandeep
M
Constanzo
Maria Rosa
MR
Hummel
Manfred
M
Johnson
Jay
J
D001379:Azathioprine / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D006085:Graft Survival / Q000187:drug effects / Q000276:immunology; D016027:Heart Transplantation / Q000276:immunology*; D006801:Humans; D007166:Immunosuppressive Agents / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D009173:Mycophenolic Acid / Q000031:analogs & derivatives* / Q000627:therapeutic use; D014181:Transplantation Immunology / Q000276:immunology
D007166:Immunosuppressive Agents; D009173:Mycophenolic Acid; D001379:Azathioprine