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

• DOI: 10.1097/tp.0b013e3181613e65
• Publication Date: 2009-03-05T15:12:33Z
• Authors: Matthew P. Welber...; Chas G. Newstead; Niaz Ahmad; Andrew J. P. Lewi...; Stephen Tibble; J Peter A. Lodge; Stephen G. Pollard; Richard J. Baker
• Keywords: Sirolimus; Basiliximab; Tolerability; Regimen

Vascular disease and chronic allograft nephropathy have prompted re-evaluation of steroids calcineurin inhibitors (CNIs) in renal transplantation. Sirolimus (SRL) can facilitate early CNI withdrawal. We report on the Early Steroid Elimination Leeds (ECSEL) study, which was terminated due to poor tolerability SRL. Basiliximab/methylprednisolone induction used, then 2 months tacrolimus (TAC) mycophenolate mofetil (MMF) treatment. A total 51 patients were randomized continue TAC/MMF or switch SRL/MMF. In ECSEL1, switched at (n=10). ECSEL2, SRL introduced 4–6 TAC tapered (n=13). Median overall follow up 701 days. All 10 ECSEL1 13 (77%) ECSEL2 discontinued adverse events, including leucopenia, rash, mucosal ulceration, arthralgia, possible pneumonitis. Mean end-of-study creatinine comparable all groups. should be used with caution complete steroid withdrawal, resultant intolerable event profile.