Journal article
Similar Efficacy and Safety of Enteric-coated Mycophenolate Sodium (EC-MPS, Myfortic) Compared With Mycophenolate Mofetil (MMF) in De Novo Heart Transplant Recipients: Results of a 12-Month, Single-blind, Randomized, Parallel-group, Multicenter Study
The Journal of heart and lung transplantation, v 25(8), pp 935-941
2006
PMID: 16890114
Featured in Collection : UN Sustainable Development Goals @ Drexel
Abstract
Enteric-coated mycophenolate sodium (EC-MPS, myfortic) is an advanced formulation that delays the release of mycophenolic acid (MPA). Its efficacy and safety has been proven in several clinical trials in renal transplantation.
In a single-blind, multicenter trial, a total of 154 de novo heart transplant patients were randomized to either EC-MPS 1,080 mg twice daily or mycophenolate mofetil (MMF) 1,500 mg twice daily. Eligible patients included men or women aged 18 to 65 years, undergoing primary heart transplantation, who were treated with cyclosporine microemulsion and corticosteroids as basic immunosuppression. The primary study objective was to investigate the incidence of biopsy-proven and treated acute rejection, graft loss or death (defined as treatment failure) for EC-MPS vs MMF during the first 6 months of treatment in de novo heart transplant recipients. Secondary objectives included assessment of the overall safety and tolerability of EC-MPS vs MMF in the study population.
The primary efficacy variable, treatment failure at 6 months, was similar for both treatments: 52.6% for EC-MPS and 57.9% for MMF (2-sided 95% confidence interval [CI]: −21.0% to 10.4%). At 12 months, treatment failure was 57.7% for EC-MPS and 60.5% for MMF (2-sided 95% CI: −18.4 to 12.7), and death and graft loss rate was 5.1% vs 9.2% for EC-MPS and MMF at 12 months, respectively (2-sided 95% CI: −12.2 to 4.1). The overall safety profile was similar for both groups. Significantly more patients on MMF had two or more study medication dose reductions during the treatment period.
These 6- and 12-month results show that EC-MPS is therapeutically similar to MMF in de novo heart transplant recipients and has a comparable safety profile.
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Details
- Title
- Similar Efficacy and Safety of Enteric-coated Mycophenolate Sodium (EC-MPS, Myfortic) Compared With Mycophenolate Mofetil (MMF) in De Novo Heart Transplant Recipients: Results of a 12-Month, Single-blind, Randomized, Parallel-group, Multicenter Study
- Creators
- Jon A. Kobashigawa - University of California, Los AngelesDale G. Renlund - University of UtahGino Gerosa - University of PaduaLuis Almenar - Hospital La Fe, Valencia, SpainHoward J. Eisen - Drexel UniversityAnne M. Keogh - St Vincent's Hospital SydneyHans B. Lehmkuhl - Deutsches Herzzentrum der CharitéUgolino Livi - Department of Cardiovascular Sciences, Azienda Ospedale, Udine, ItalyHeather Ross - Toronto General HospitalJavier Segovia - Hospital Universitario Puerta de Hierro MajadahondaNizar Yonan - Wythenshawe HospitalERL2401 Heart Study Investigators
- Publication Details
- The Journal of heart and lung transplantation, v 25(8), pp 935-941
- Publisher
- Elsevier
- Resource Type
- Journal article
- Language
- English
- Web of Science ID
- WOS:000239795800008
- Scopus ID
- 2-s2.0-33746473566
- Other Identifier
- 991019330915704721
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InCites Highlights
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- Collaboration types
- Domestic collaboration
- International collaboration
- Web of Science research areas
- Cardiac & Cardiovascular Systems
- Respiratory System
- Surgery
- Transplantation