Minimization of immunosuppressive therapy after renal transplantation: Results of a randomized controlled trial
(2005) In American Journal of Transplantation 5(1). p.87-95- Abstract
- Modern immunosuppressive regimens reduce the acute rejection rate by combining a cornerstone immunosuppressant like tacrolimus or cyclosporine with adjunctive agents like corticosteroids, mycophenolate mofetil (MMF) or azathioprine, often associated with untoward side effects. A 6-month randomized study was conducted in 47 European centers. Triple therapy with tacrolimus (trough levels 5-15 ng/mL), corticosteroids (dosage 10 mg/day) and MMF (1 g/day) was administered for 3 months. From day 92, patients either continued with triple therapy (control, n = 277), or stopped steroids (n = 279), or stopped MMF (n = 277). Surrogate markers for long-term benefits were changes in lipid profiles and occurrence of hematological, gastrointestinal and... (More)
- Modern immunosuppressive regimens reduce the acute rejection rate by combining a cornerstone immunosuppressant like tacrolimus or cyclosporine with adjunctive agents like corticosteroids, mycophenolate mofetil (MMF) or azathioprine, often associated with untoward side effects. A 6-month randomized study was conducted in 47 European centers. Triple therapy with tacrolimus (trough levels 5-15 ng/mL), corticosteroids (dosage 10 mg/day) and MMF (1 g/day) was administered for 3 months. From day 92, patients either continued with triple therapy (control, n = 277), or stopped steroids (n = 279), or stopped MMF (n = 277). Surrogate markers for long-term benefits were changes in lipid profiles and occurrence of hematological, gastrointestinal and infectious complications. The 6-month acute rejection incidence (biopsy-proven) was similar in all groups (17.0% vs. 15.1% vs. 14.8%, p = 0.744), although the incidence after month 3 was higher in the steroid stop group than in the two other groups. Mean reductions in total cholesterol (18.9 mg/dL [0.49 mmol/L]) and LDL-cholesterol (8.1 mg/dL [0.21 mmol/L]) between months 4 and 6 were greater in the steroid stop group (p < 0.001). Leukopenia (p = 0.0082), serious CMV infection (p = 0.024), anemia (p = NS) and diarrhea (p = NS) were less frequent in the MMF stop group. In a study population of immunologically low-risk patients' withdrawal of corticosteroids or MMF from a tacrolimus-based therapy at 3 months was feasible. A longer follow-up will be needed to confirm the expected advantages for the long-term outcome and to assess the long-term safety of this minimization of immunosuppressive therapy. (Less)
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https://lup.lub.lu.se/record/897740
- author
- organization
- publishing date
- 2005
- type
- Contribution to journal
- publication status
- published
- subject
- keywords
- tacrolimus, MMF withdrawal, minimization of immunosuppression, transplantation, kidney, corticosteroid withdrawal, cardiovascular risk, cholesterol
- in
- American Journal of Transplantation
- volume
- 5
- issue
- 1
- pages
- 87 - 95
- publisher
- Wiley-Blackwell
- external identifiers
-
- wos:000225790600011
- pmid:15636615
- scopus:19944427631
- ISSN
- 1600-6135
- DOI
- 10.1111/j.1600-6143.2004.00638.x
- language
- English
- LU publication?
- yes
- id
- c7c1bcd8-d0bd-4d4e-817d-cbc79296c5b6 (old id 897740)
- date added to LUP
- 2016-04-01 12:23:45
- date last changed
- 2022-01-27 03:10:51
@article{c7c1bcd8-d0bd-4d4e-817d-cbc79296c5b6,
abstract = {{Modern immunosuppressive regimens reduce the acute rejection rate by combining a cornerstone immunosuppressant like tacrolimus or cyclosporine with adjunctive agents like corticosteroids, mycophenolate mofetil (MMF) or azathioprine, often associated with untoward side effects. A 6-month randomized study was conducted in 47 European centers. Triple therapy with tacrolimus (trough levels 5-15 ng/mL), corticosteroids (dosage 10 mg/day) and MMF (1 g/day) was administered for 3 months. From day 92, patients either continued with triple therapy (control, n = 277), or stopped steroids (n = 279), or stopped MMF (n = 277). Surrogate markers for long-term benefits were changes in lipid profiles and occurrence of hematological, gastrointestinal and infectious complications. The 6-month acute rejection incidence (biopsy-proven) was similar in all groups (17.0% vs. 15.1% vs. 14.8%, p = 0.744), although the incidence after month 3 was higher in the steroid stop group than in the two other groups. Mean reductions in total cholesterol (18.9 mg/dL [0.49 mmol/L]) and LDL-cholesterol (8.1 mg/dL [0.21 mmol/L]) between months 4 and 6 were greater in the steroid stop group (p < 0.001). Leukopenia (p = 0.0082), serious CMV infection (p = 0.024), anemia (p = NS) and diarrhea (p = NS) were less frequent in the MMF stop group. In a study population of immunologically low-risk patients' withdrawal of corticosteroids or MMF from a tacrolimus-based therapy at 3 months was feasible. A longer follow-up will be needed to confirm the expected advantages for the long-term outcome and to assess the long-term safety of this minimization of immunosuppressive therapy.}},
author = {{Vanrenterghem, Y and van Hooff, JP and Squifflet, JP and Salmela, K and Rigotti, P and Jindal, RM and Pascual, J and Ekberg, Henrik and Sicilia, LS and Boletis, JN and Grinyo, JM and Rodriguez, MA}},
issn = {{1600-6135}},
keywords = {{tacrolimus; MMF withdrawal; minimization of immunosuppression; transplantation; kidney; corticosteroid withdrawal; cardiovascular risk; cholesterol}},
language = {{eng}},
number = {{1}},
pages = {{87--95}},
publisher = {{Wiley-Blackwell}},
series = {{American Journal of Transplantation}},
title = {{Minimization of immunosuppressive therapy after renal transplantation: Results of a randomized controlled trial}},
url = {{http://dx.doi.org/10.1111/j.1600-6143.2004.00638.x}},
doi = {{10.1111/j.1600-6143.2004.00638.x}},
volume = {{5}},
year = {{2005}},
}