Dokumentenart: | Artikel | ||||
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Titel eines Journals oder einer Zeitschrift: | Transplantation | ||||
Verlag: | LIPPINCOTT WILLIAMS & WILKINS | ||||
Ort der Veröffentlichung: | PHILADELPHIA | ||||
Band: | 94 | ||||
Nummer des Zeitschriftenheftes oder des Kapitels: | 5 | ||||
Seitenbereich: | S. 492-498 | ||||
Datum: | 2012 | ||||
Institutionen: | Medizin > Abteilung für Nephrologie | ||||
Identifikationsnummer: |
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Stichwörter / Keywords: | CORTICOSTEROID-FREE REGIMENS; STANDARD TRIPLE REGIMEN; LONG-TERM; MYCOPHENOLATE-MOFETIL; RHEUMATOID-ARTHRITIS; CYCLOSPORINE MICROEMULSION; KIDNEY-TRANSPLANTATION; FREE IMMUNOSUPPRESSION; RANDOMIZED-TRIAL; ADVERSE EVENTS; Tacrolimus; Renal transplant; Immunosuppression; Steroid; Long term | ||||
Dewey-Dezimal-Klassifikation: | 600 Technik, Medizin, angewandte Wissenschaften > 610 Medizin | ||||
Status: | Veröffentlicht | ||||
Begutachtet: | Ja, diese Version wurde begutachtet | ||||
An der Universität Regensburg entstanden: | Ja | ||||
Dokumenten-ID: | 63367 |
Zusammenfassung
Background. Long-term use of corticosteroids is associated with considerable morbidity, including cardiovascular and metabolic adverse effects. Methods. This study evaluated the long-term efficacy and safety of two steroid-free regimens compared with a triple immunosuppressive therapy in renal transplant recipients. This was a 3-year follow-up to a 6-month, open-label, randomized, multicenter ...
Zusammenfassung
Background. Long-term use of corticosteroids is associated with considerable morbidity, including cardiovascular and metabolic adverse effects. Methods. This study evaluated the long-term efficacy and safety of two steroid-free regimens compared with a triple immunosuppressive therapy in renal transplant recipients. This was a 3-year follow-up to a 6-month, open-label, randomized, multicenter study. Results. Data from 3 years were available for 421 (93.3%) of 451 patients in the original intent-to-treat population (143 tacrolimus/basiliximab [Tac/Bas], 139 tacrolimus/mycophenolate mofetil [Tac/MMF], and 139 tacrolimus/MMF/steroids [triple therapy]). In the time interval from 6 months to 3 years after transplantation, the incidence of biopsy-proven acute rejection was low and similar (Tac/Bas, 2.1%; Tac/MMF, 2.2%; triple therapy, 2.2%); Most rejection episodes occurred during the first 6 months of the study. Graft survival was high (Kaplan-Meier estimates: 92.7%, 92.5%, and 92.5%), as was patient survival (93.1%, 96.4%, and 97.0%). There were 10 graft losses (n=2, 4, and 4) and 12 patient deaths (n=5, 2, and 5). Renal function was well preserved throughout the study and similar between groups. There was a trend toward improved cardiovascular risk factors in the Tac/Bas group, including reduced total and low-density lipoprotein cholesterol and lower new-onset insulin use. There were no between-group differences in the incidence or type of adverse events. Conclusion. Higher rates of acute rejection early in treatment were seen with the steroid-free regimens, but this did not translate into poorer long-term outcomes, such as graft and patient survival and renal function. A trend for a more favorable cardiovascular risk profile was observed for steroid-free immunosuppression with Tac/Bas.
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