Journal article
Three-Year Results of a Randomized, Double-Blind, Controlled Trial of Mycophenolate Mofetil Versus Azathioprine in Cardiac Transplant Recipients
The Journal of heart and lung transplantation, v 24(5), pp 517-525
2005
PMID: 15896747
Featured in Collection : UN Sustainable Development Goals @ Drexel
Abstract
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.
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.
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.
MMF reduces mortality and graft loss up to 36 months after transplantation.
Metrics
Details
- Title
- Three-Year Results of a Randomized, Double-Blind, Controlled Trial of Mycophenolate Mofetil Versus Azathioprine in Cardiac Transplant Recipients
- Creators
- Howard J. Eisen - Drexel UniversityJon Kobashigawa - Center of Mathematical Sciences, Zhejiang UniversityAnne Keogh - St Vincent's Hospital SydneyRobert Bourge - University of Alabama at BirminghamDale Renlund - University of UtahRobert Mentzer - University of Wisconsin–MadisonEdwin Alderman - Stanford UniversityHannah Valantine - Stanford UniversityGeorges Dureau - Hospices Civils de LyonDonna Mancini - Columbia UniversityRichard Mamelok - LEK ConsultingRobert Gordon - Hoffmann‐La Roche, Nutley, New Jersey.Whedy Wang - Hoffmann‐La Roche, Nutley, New Jersey.Mandeep Mehra - Ochsner Medical CenterMaria Rosa Constanzo - Rush University Medical CenterManfred Hummel - Deutsches Herzzentrum BerlinJay Johnson - Center of Mathematical Sciences, Zhejiang UniversityMycophenolate Mofetil Cardiac Study InvestigatorsJamila Danielle Johnson - Bennett S. LeBow College of Business (1999-)
- Publication Details
- The Journal of heart and lung transplantation, v 24(5), pp 517-525
- Publisher
- Elsevier
- Resource Type
- Journal article
- Language
- English
- Academic Unit
- Bennett S. LeBow College of Business
- Web of Science ID
- WOS:000229250300002
- Scopus ID
- 2-s2.0-21044458269
- Other Identifier
- 991019169416904721
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InCites Highlights
Data related to this publication, from InCites Benchmarking & Analytics tool:
- Collaboration types
- Industry collaboration
- Domestic collaboration
- International collaboration
- Web of Science research areas
- Cardiac & Cardiovascular Systems
- Respiratory System
- Surgery
- Transplantation