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High incidence of rejection episodes and poor tolerance of sirolimus in a protocol with early steroid withdrawal and calcineurin inhibitor-free maintenance therapy in renal transplantation: experiences of a randomized prospective single-center study.
- Source :
-
Transplantation proceedings [Transplant Proc] 2012 Dec; Vol. 44 (10), pp. 2961-5. - Publication Year :
- 2012
-
Abstract
- Immunosuppressive maintenance therapy after kidney transplantation leads to various undesired side effects such as calcineurin inhibitor (CNI)-associated nephrotoxicity or elevated cardiovascular risk due to posttransplantation diabetes and hypertension. These effects show negative impacts on long-term allograft function as well as patient morbidity and mortality. Therefore, we used an immunosuppressive regimen with early corticosteroid withdrawal (ESW), maintenance therapy containing tacrolimus, sirolimus (SRL), and mycophenolate sodium for 3 months followed by a prospective randomized trial comparing a CNI free versus a low-dose CNI therapy. The primary endpoint was 6-month graft function. Among 75 patients, ESW was performed after 4 days in 65 patients. Over the following 3 months before randomization to CNI-free maintenance therapy, we experienced a high number (25%) of SRL discontinuations due to adverse events, including leukopenia, anemia, arthritis, and pneumonitis. In addition there were significantly more allograft rejection episodes in the CNI-free group (P = .017) during the study period leading to a switch from SRL to a CNI. Despite the higher rate of rejection episodes in the CNI-free groups, glomerular filtration rates (GFR) at 6 months were comparable between the study groups (P = .25). After 1 year only 9.2% (6/65) of all patients treated with SRL remained on this drug. Conclusion, there was an unacceptably high rate of SRL intolerance using an ESW and CNI-free immunosuppressive regimen combined with a significantly higher rate of rejection episodes.<br /> (Copyright © 2012 Elsevier Inc. All rights reserved.)
- Subjects :
- Adolescent
Adrenal Cortex Hormones adverse effects
Adult
Aged
Chi-Square Distribution
Drug Administration Schedule
Drug Substitution
Drug Therapy, Combination
Female
Glomerular Filtration Rate drug effects
Graft Rejection epidemiology
Graft Rejection immunology
Humans
Immunosuppressive Agents adverse effects
Incidence
Kidney Transplantation adverse effects
Male
Middle Aged
Mycophenolic Acid administration & dosage
Mycophenolic Acid analogs & derivatives
Prospective Studies
Sirolimus adverse effects
Switzerland epidemiology
Tacrolimus administration & dosage
Time Factors
Treatment Outcome
Young Adult
Adrenal Cortex Hormones administration & dosage
Calcineurin Inhibitors
Graft Rejection prevention & control
Graft Survival drug effects
Immunosuppressive Agents administration & dosage
Kidney Transplantation immunology
Sirolimus administration & dosage
Subjects
Details
- Language :
- English
- ISSN :
- 1873-2623
- Volume :
- 44
- Issue :
- 10
- Database :
- MEDLINE
- Journal :
- Transplantation proceedings
- Publication Type :
- Academic Journal
- Accession number :
- 23195006
- Full Text :
- https://doi.org/10.1016/j.transproceed.2012.07.142