Minimization of immunosuppressive therapy after renal transplantation: results of a randomized controlled trial.
(2005) American Journal of Transplantation — Vol. 5, n° 1, p. 87-95 (2005)
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- 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.
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Vanrenterghem, Y., van Hooff, J. P., Squifflet, J.-P., Salmela, K., Rigotti, P., Jindal, R. M., Pascual, J., Ekberg, H., Sicilia, L. S., Boletis, J. N., Grinyo, J. M., & Rodriguez, M. A. (2005). Minimization of immunosuppressive therapy after renal transplantation: results of a randomized controlled trial. American Journal of Transplantation, 5(1), 87-95. https://doi.org/10.1111/j.1600-6143.2004.00638.x (Original work published 2005)