Comparing Outcomes Associated With Dose Manipulations of Enteric-Coated Mycophenolate Sodium Versus Mycophenolate Mofetil in Renal Transplant Recipients
| Autor: | Matthew Cooper, Qing Harshaw, Kathleen L. Deering, Stephen Arcona, F. Rasetto, Douglas P. Slakey, Sander Florman, Erin L. McCann |
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| Rok vydání: | 2009 |
| Předmět: |
Graft Rejection
Male medicine.medical_specialty Urinary system Urology Mycophenolic acid Cohort Studies Risk Factors Humans Medicine Aged Proportional Hazards Models Retrospective Studies Transplantation Univariate analysis Dose-Response Relationship Drug business.industry Proportional hazards model Incidence (epidemiology) Retrospective cohort study Middle Aged Mycophenolic Acid Kidney Transplantation Surgery Gastrointestinal Tract Female Tablets Enteric-Coated business Complication Immunosuppressive Agents medicine.drug |
| Zdroj: | Transplantation. 88:514-520 |
| ISSN: | 0041-1337 |
| DOI: | 10.1097/tp.0b013e3181b0e65e |
| Popis: | Background This study assessed the incidence of reported gastrointestinal (GI) complications in patients treated with enteric-coated mycophenolate sodium (EC-MPS) versus mycophenolate mofetil (MMF) and to examine the impact of dose manipulations on biopsy-proven acute rejection (BPAR). Methods A retrospective study was conducted in 379 renal transplant recipients initiated on EC-MPS or MMF through 3-months posttransplant between the years of 2001 to 2007. Descriptive univariate analyses were used for comparisons of baseline characteristics and outcome measures between the cohorts. A Cox proportional hazards model was used to evaluate the time to a first BPAR event. Results GI complications occurred at an incidence of 52.8% and 48.9% in the EC-MPS and MMF cohorts, respectively (NS). Patients requiring dose manipulations due to GI complications were 19.7% with EC-MPS and 25.3% with MMF (NS). The mean equimolar dose reduction below 2000 mg was 930+/-292.13 mg with EC-MPS and 933+/-173.95 mg with MMF (NS). Patients treated with EC-MPS experienced significantly fewer BPAR episodes than those treated with MMF (14% EC-MPS vs. 23.1% MMF; P =0.0221). Conclusions In this study, EC-MPS had a similar incidence of GI complications and dose manipulations compared with MMF. Despite similar GI complication rates and dose manipulations, treatment with EC-MPS seemed to result in a lower incidence of BPAR. Based on these observations, more studies need to be conducted to evaluate risks for BPAR relating to mycophenolic acid product. |
| Databáze: | OpenAIRE |
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