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Minimization of Immunosuppressive Therapy After Renal Transplantation: Results of a Randomized Controlled Trial
Author(s) -
Vanrenterghem Yves,
Van Hooff Johannes P.,
Squifflet JeanPaul,
Salmela Kaija,
Rigotti Paolo,
Jindal Rahul M.,
Pascual Julio,
Ekberg Henrik,
Sicilia Luis Sanchez,
Boletis John N.,
Grinyo Josep M.,
Rodriguez Manuel Arias
Publication year - 2005
Publication title -
american journal of transplantation
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.89
H-Index - 188
eISSN - 1600-6143
pISSN - 1600-6135
DOI - 10.1111/j.1600-6143.2004.00638.x
Subject(s) - medicine , azathioprine , tacrolimus , gastroenterology , transplantation , leukopenia , population , incidence (geometry) , immunosuppression , randomized controlled trial , surgery , chemotherapy , disease , physics , environmental health , optics
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.