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Minimization of imm...
Minimization of immunosuppressive therapy after renal transplantation: Results of a randomized controlled trial
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Vanrenterghem, Y (author)
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van Hooff, JP (author)
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Squifflet, JP (author)
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Salmela, K (author)
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Rigotti, P (author)
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Jindal, RM (author)
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Pascual, J (author)
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- Ekberg, Henrik (author)
- Lund University,Lunds universitet,Enheten för forskning kring njurfunktion och njursjukdom,Kirurgi,Forskargrupper vid Lunds universitet,Renal Research Unit,Surgery,Lund University Research Groups
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Sicilia, LS (author)
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Boletis, JN (author)
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Grinyo, JM (author)
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Rodriguez, MA (author)
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(creator_code:org_t)
- Elsevier BV, 2005
- 2005
- English.
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In: American Journal of Transplantation. - : Elsevier BV. - 1600-6135. ; 5:1, s. 87-95
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Abstract
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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.
Subject headings
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Kirurgi (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Surgery (hsv//eng)
Keyword
- tacrolimus
- MMF withdrawal
- minimization of immunosuppression
- transplantation
- kidney
- corticosteroid withdrawal
- cardiovascular risk
- cholesterol
Publication and Content Type
- art (subject category)
- ref (subject category)
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- By the author/editor
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Vanrenterghem, Y
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van Hooff, JP
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Squifflet, JP
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Salmela, K
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Rigotti, P
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Jindal, RM
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show more...
-
Pascual, J
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Ekberg, Henrik
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Sicilia, LS
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Boletis, JN
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Grinyo, JM
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Rodriguez, MA
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show less...
- About the subject
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- MEDICAL AND HEALTH SCIENCES
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MEDICAL AND HEAL ...
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and Clinical Medicin ...
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and Surgery
- Articles in the publication
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American Journal ...
- By the university
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Lund University