DOSE OPTIMIZATION OF MYCOPHENOLATE MOFETIL WHEN ADMINISTERED WITH A LOW DOSE OF TACROLIMUS IN CADAVERIC RENAL TRANSPLANT RECIPIENTS
| Autor: | Gunnar Tydén, Lars Bäckman, D Taube, Karl-Heinz Dietl, John L. R. Forsythe, Ulrich Kunzendorf, Uwe Heemann, José M. Morales, J.P. van Hooff, S. Schleibner, Yves Vanrenterghem, Ferdinand Mühlbacher, Kerstin Claesson, David Talbot, Henrik Ekberg, Jean-Paul Squifflet, Walter Land |
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| Rok vydání: | 2001 |
| Předmět: |
Adult
Graft Rejection Male medicine.medical_specialty Time Factors Gastrointestinal Diseases medicine.drug_class medicine.medical_treatment Gastroenterology Tacrolimus Mycophenolic acid Adrenal Cortex Hormones Internal medicine Cadaver Humans Medicine Adverse effect Kidney transplantation Transplantation Chemotherapy Leukopenia Dose-Response Relationship Drug business.industry Graft Survival Middle Aged Mycophenolic Acid medicine.disease Kidney Transplantation Survival Analysis Surgery Treatment Outcome surgical procedures operative Corticosteroid Drug Therapy Combination Female medicine.symptom business Immunosuppressive Agents medicine.drug |
| Zdroj: | Transplantation. 72:63-69 |
| ISSN: | 0041-1337 |
| Popis: | BACKGROUND: Supplementation of immunosuppressive therapy with mycophenolate mofetil (MMF) has been found to reduce the rate of acute rejection in renal transplantation. We report a dose-finding study for MMF when administered in combination with low-dose tacrolimus and corticosteroid prophylaxis in cadaveric renal transplant recipients. METHODS: Two hundred thirty-two patients at 16 centers were enrolled in this randomized, parallel-group study. The three treatment groups were tacrolimus and corticosteroids (MMF-0 group, n=82); tacrolimus, corticosteroids, and 1 g of MMF daily (MMF-1 g group, n=79); and tacrolimus, corticosteroids, and 2 g of MMF daily (MMF-2 g group, n=71). Study duration was 6 months, and patients were followed up for patient and graft survival for 12 months. RESULTS: At 6 months posttransplantation, daily doses of 1 g and 2 g of MMF were associated with significantly lower rates of acute rejection compared with tacrolimus alone. The Kaplan-Meier rates were 48.5%, 24.9%, and 22.9%, respectively, for the three treatment groups when acute rejection was determined by clinical criteria (P=0.007). At month 12, patient survival rates were 100%, 97.5%, and 97.2% and graft survival rates were 90.2%, 92.4%, and 93.0% for the MMF-0 group, MMF-1 g group, and the MMF-2 g group, respectively. Gastrointestinal adverse events and leukopenia were higher in the MMF groups, especially in the MMF-2 g group (P |
| Databáze: | OpenAIRE |
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