1 research outputs found
Withdrawal of cyclosporine or prednisone six months after kidney transplantation in patients on triple drug therapy: a randomized, prospective, multicenter study
Uncertainty exists regarding the necessity of continuing triple therapy
consisting of mycophenolate mofetil (MMF), cyclosporine (CsA), and
prednisone (Pred) after kidney transplantation (RTx). At 6 mo after RTx,
212 patients were randomized to stop CsA (n = 63), stop Pred (n = 76), or
continue triple drug therapy (n = 73). The MMF dose was 1000 mg twice
daily, target CsA trough levels were 150 ng/ml, and Pred dose was 0.10
mg/kg per d. Follow-up was until 24 mo after RTx. Biopsy-proven acute
rejection occurred in 14 (22%) of 63 patients after CsA withdrawal
compared with 3 (4%) of 76 in the Pred withdrawal group (P = 0.001) and 1
(1.4%) of 73 in the control group (P = 0.0001). Biopsy-proven chronic
rejection was present in one patient in the control group, in nine
patients after CsA withdrawal (P = 0.006 versus control group); and in
four patients after discontinuation of Pred (NS). Graft loss occurred in
two versus one patient after CsA or Pred withdrawal, respectively, and in
two patients in the control group (NS). Patients who successfully withdrew
CsA had a significantly lower serum creatinine during follow-up. Pred
withdrawal resulted in a reduction in mean arterial pressure, and the
total cholesterol/HDL ratio increased. In conclusion, rapid CsA withdrawal
at 6 mo after RTx results in a significantly increased incidence of
biopsy-proven acute and chronic rejection. Pred withdrawal was safe and
resulted in a reduction in mean arterial pressure. However, patient and
graft survival and renal function 2 yr after RTx were not different among
groups