Clinical outcomes during the first three months posttransplant in renal allograft recipients managed by C2 monitoring of cyclosporine microemulsion
| Autor: | Lorenzo Toselli, Per Pfeffer, Raymond Dandavino, Steven J. Chadban, Matthias Büchler, L. Pallardó, Maria Scolari, Francesco Paolo Schena, Edward S. Cole, César Agost Carreno, Eric Thervet, Helen Pilmore, John K. Connolly |
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| Rok vydání: | 2003 |
| Předmět: |
Adult
Graft Rejection Reoperation medicine.medical_specialty Time Factors medicine.medical_treatment Azathioprine Gastroenterology chemistry.chemical_compound Internal medicine Multicenter trial medicine Humans Transplantation Homologous Adverse effect Transplantation Creatinine medicine.diagnostic_test business.industry Incidence Graft Survival Immunosuppression Ciclosporin Kidney Transplantation Surgery Survival Rate Treatment Outcome Intestinal Absorption chemistry Therapeutic drug monitoring Cyclosporine Emulsions Drug Monitoring business Immunosuppressive Agents Follow-Up Studies medicine.drug |
| Zdroj: | Transplantation. 76:903-908 |
| ISSN: | 0041-1337 |
| Popis: | Background. MO2ART (monitoring of 2-hr absorption in renal transplantation) is the first prospective, multicenter trial of cyclosporine (CsA) blood level 2 hr postdose (C 2 ) monitoring in de novo kidney recipients receiving CsA microemulsion (ME) (Neoral; Novartis, Basel, Switzerland). Efficacy and safety results from the first 3 months are presented here. Methods. MO2ART is a 12-month, open-label, randomized study involving 296 patients. In all patients, the dose of CsA-ME was adjusted to achieve protocol-defined C 2 targets of 1.6 to 2.0 μg/mL for the first month, with subsequent tapering. Randomization into two target groups occurred at 3 months. All patients received steroids and mycophenolate mofetil (89%) or azathioprine. For patients with delayed graft function, the protocol permitted reduced C 2 targets and prophylactic administration of antibodies. Results. At 3 months, overall incidence of biopsy-proven acute rejection was 11.5%. Median serum creatinine was 132 μmol/L. Patient and graft survival were 96.6% and 91.2%, respectively. C 2 levels greater than 1.6 μg/mL were achieved within 5 days by 60.6% of patients with immediate graft function and 19.5% of patients with delayed graft function. Prophylactic antibodies were used in 15% of the total population. Twenty-four patients (8.1%) experienced serious adverse events with a suspected relation to CsA, and 26 patients (8.8%) discontinued the study because of adverse events (n=15) or after a switch in immunosuppression after rejection episodes (n=11). Conclusions. Patient management by C 2 monitoring resulted in a low incidence of biopsy-proven acute rejection in standard risk de novo kidney recipients, 85% of whom did not receive prophylactic antibodies. CsA-ME with C 2 monitoring provides excellent short-term efficacy and safety among de novo renal transplant patients. |
| Databáze: | OpenAIRE |
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