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

被引:173
作者
Eisen, HJ
Kobashigawa, J
Keogh, A
Bourge, R
Renlund, D
Mentzer, R
Alderman, E
Valantine, H
Dureau, G
Mancini, D
Mamelok, R
Gordon, R
Wang, WD
Mehra, M
Constanzo, MR
Hummel, M
Johnson, J
机构
[1] Drexel Univ, Coll Med, Div Cardiol, Philadelphia, PA 19102 USA
[2] Univ Calif Los Angeles, Los Angeles, CA 90024 USA
[3] St Vincents Hosp, Sydney, NSW 2010, Australia
[4] Univ Alabama Birmingham, Birmingham, AL 35233 USA
[5] Univ Utah, Salt Lake City, UT 84112 USA
[6] Univ Wisconsin, Madison, WI 53706 USA
[7] Stanford Univ, Palo Alto, CA 94304 USA
[8] Lyon Hop, Hospices Civils, Lyon, France
[9] Columbia Univ, Coll Phys & Surg, New York, NY USA
[10] Mamelok Consulting, Palo Alto, CA USA
[11] Hoffmann La Roche Inc, Nutley, NJ 07110 USA
[12] Alton Ochsner Med Fdn & Ochsner Clin, New Orleans, LA 70121 USA
[13] Rush Presbyterian St Lukes Med Ctr, Chicago, IL USA
[14] Deutsch Herzzentrum Berlin, Berlin, Germany
关键词
D O I
10.1016/j.healun.2005.02.002
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
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 an 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 retransplantation 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. Copyright (c) 2005 by the International Society for Heart and Lung Transplantation.
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收藏
页码:517 / 525
页数:9
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