Poor Tolerance of Sirolimus in a Steroid Avoidance Regimen for Renal Transplantation

Vascular disease and chronic allograft nephropathy have prompted re-evaluation of steroids and calcineurin inhibitors (CNIs) in renal transplantation. Sirolimus (SRL) can facilitate early CNI withdrawal. We report on the Early CNI and Steroid Elimination in Leeds (ECSEL) study, which was terminated...

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Published in:	Transplantation Vol. 85; no. 4; pp. 636 - 639
Main Authors:	WELBERRY SMITH, Matthew P, NEWSTEAD, Chas G, AHMAD, Niaz, LEWINGTON, Andrew J. P, TIBBIE, Stephen, LODGE, J. Peter A, POLLARD, Stephen G, BAKER, Richard J
Format:	Journal Article
Language:	English
Published:	Hagerstown, MD Lippincott 27-02-2008
Subjects:	Adrenal Cortex Hormones - therapeutic use Adult Antibacterial agents Antibiotics. Antiinfectious agents. Antiparasitic agents Antibodies, Monoclonal - therapeutic use Biological and medical sciences Drug Therapy, Combination Drug Tolerance Female Fundamental and applied biological sciences. Psychology Fundamental immunology Humans Immunosuppressive Agents - adverse effects Immunosuppressive Agents - therapeutic use Kidney Diseases - classification Kidney Diseases - surgery Kidney Transplantation - immunology Male Medical sciences Methylprednisolone - therapeutic use Middle Aged Pharmacology. Drug treatments Recombinant Fusion Proteins - therapeutic use Sirolimus - adverse effects Sirolimus - therapeutic use Surgery (general aspects). Transplantations, organ and tissue grafts. Graft diseases Surgery of the urinary system Tissue, organ and graft immunology Antineoplastic agent Steroid Corticosteroid Sirolimus Tolerance Lactone Homotransplantation Macrolide Kidney Macrocycle Antibiotic Treatment Urinary system Surgery Graft Protein synthesis inhibitor Immunosuppressive agent Antibacterial agent Therapeutic protocol Avoidance Kidney transplantation
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Summary:	Vascular disease and chronic allograft nephropathy have prompted re-evaluation of steroids and calcineurin inhibitors (CNIs) in renal transplantation. Sirolimus (SRL) can facilitate early CNI withdrawal. We report on the Early CNI and Steroid Elimination in Leeds (ECSEL) study, which was terminated early due to poor tolerability of SRL. Basiliximab/methylprednisolone induction was used, then 2 months of tacrolimus (TAC) and mycophenolate mofetil (MMF) treatment. A total of 51 patients were randomized to continue TAC/MMF or switch to SRL/MMF. In ECSEL1, patients were switched at 2 months (n=10). In ECSEL2, SRL was introduced at months 4-6 and TAC was tapered (n=13). Median overall follow up was 701 days. All 10 ECSEL1 and 10 of 13 (77%) ECSEL2 patients discontinued SRL due to adverse events, including leucopenia, rash, mucosal ulceration, arthralgia, and possible pneumonitis. Mean end-of-study creatinine was comparable in all groups. Sirolimus should be used with caution in complete CNI and steroid withdrawal, due to the resultant intolerable adverse event profile.
Bibliography:	ObjectType-Article-2 SourceType-Scholarly Journals-1 ObjectType-Feature-1 content type line 23
ISSN:	0041-1337 1534-6080
DOI:	10.1097/TP.0b013e3181613e65