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.
RCT Entities:
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.
Authors: Oscar Kenneth Serrano; Raja Kandaswamy; Kristen Gillingham; Srinath Chinnakotla; Ty B Dunn; Erik Finger; William Payne; Hassan Ibrahim; Aleksandra Kukla; Richard Spong; Naim Issa; Timothy L Pruett; Arthur Matas Journal: Transplantation Date: 2017-10 Impact factor: 4.939
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Authors: Greg A Knoll; Madzouka B Kokolo; Ranjeeta Mallick; Andrew Beck; Chieny D Buenaventura; Robin Ducharme; Rashad Barsoum; Corrado Bernasconi; Tom D Blydt-Hansen; Henrik Ekberg; Claudia R Felipe; John Firth; Lorenzo Gallon; Marielle Gelens; Denis Glotz; Jan Gossmann; Markus Guba; Ahmed Ali Morsy; Rebekka Salgo; Earnst H Scheuermann; Helio Tedesco-Silva; Stefan Vitko; Christopher Watson; Dean A Fergusson Journal: BMJ Date: 2014-11-24
Authors: Marit S van Sandwijk; Aiko P J de Vries; Stephan J L Bakker; Ineke J M Ten Berge; Stefan P Berger; Yassine R Bouatou; Johan W de Fijter; Sandrine Florquin; Jaap J Homan van der Heide; Mirza M Idu; Christina Krikke; Karlijn A M I van der Pant; Marlies E Reinders; Jan Ringers; Neelke C van der Weerd; Frederike J Bemelman; Jan-Stephan S Sanders Journal: Transplant Direct Date: 2018-05-15
Authors: Ilaria Gandolfini; Cynthia Harris; Michael Abecassis; Lisa Anderson; Oriol Bestard; Giorgia Comai; Paolo Cravedi; Elena Cremaschi; J Andrew Duty; Sander Florman; John Friedewald; Gaetano La Manna; Umberto Maggiore; Thomas Moran; Giovanni Piotti; Carolina Purroy; Marta Jarque; Vinay Nair; Ron Shapiro; Jessica Reid-Adam; Peter S Heeger Journal: Kidney Int Rep Date: 2017-06-21