Rapamycin at Six Years Can Exhibit Normal Renal Function Without Proteinuria or Neoplasia After Renal Transplantation. A Single-Center Experience N. Nungaray, M. Arriola, M.J. Gutierrez, E. Oliva, E. Hernández, E. Gonzalez, A. Andres, and J.M. Morales ABSTRACT Currently, long-term experience with Rapamune (RAPA) after renal transplantation is scarce. We present our experience with RAPA in patients who were included in clinical trials. Between 1996 and 1999, 27 renal transplant patients received RAPA alone or in combination with cyclosporine (CyA). We study 15 of them (9 males, 6 females; mean age 36 years) who are currently functioning with a mean follow-up of 6 years (range, 5.2– 8 years). The presence of delayed graft function was 40% and acute rejection 26.6%, all of them controlled with steroids. Notably, no patients experienced an acute rejection episode after the first year. Among 15 patients, 12 received steroids, RAPA and CyA; and 3 received steroids, RAPA, azathioprine (AZA) or mycophenolate mofetil (MMF) for immunosuppression. At the end of follow-up, the situation was the opposite: 12 patients received steroids (2.5–5 mg/d) and RAPA associated with or without AZA/MMF, and 3 were maintained with steroids, RAPA and CyA. Renal function was excellent in the entire group: mean SCr 1.1 mg/dL (range, 0.7–1.8) with mean RAPA blood levels (HPLC) of 11 ng/dL (range 8 –16). Hyperlipidemia was universal with all patients (100%) receiving statins maintaining acceptable levels of cholesterol (mean 209  28 mg/dL) and tryglyc- erides (mean 154  76 mg/dL). Arterial hypertension present in 12 of 15 (80%) patients was controlled with a mean of 1.5 drugs. Notably, no patient presented with proteinuria, neoplasia, posttransplant diabetes, or cardiovascular events. In conclusion, these single- center results suggest that Rapamune may be useful in the long-run after renal transplan- tation. The presence of normal renal function and the absence of proteinuria and neoplasia in these renal transplant patients may have important clinical implications. R APAMYCIN (RAPA) is a new non-nephrotoxic immunosuppressive agent with a different mechanism of action. RAPA inhibits m-TOR, thereby blocking signal-3 by preventing cytokine receptors from activating the cell cycle. 1 RAPA is effective alone 2 or in combination with anticalcineurin drugs, 3 preventing acute rejection. How- ever, long-term experience with RAPA at the moment is scarce. 4 The aim of the present study was to describe results in patients treated with rapamycin (RAPA) in our hospital for more than 5 years. PATIENTS AND METHODS Between 1996 and 1999, a total of 27 renal transplant patients were included in clinical trials to receive RAPA alone or with cyclospor- ine (CyA) as base immunosuppression. During follow-up, 3 pa- tients died, 3 returned to dialysis, and 6 were switched to other medications. The remaining 15, who were chronically maintained on RAPA, had a mean follow-up of 6 years (range, 5.2– 8 year) and were the subjects of this study. At the end of follow-up we carefully studied the most important data concerning immunosuppressive therapy, renal function, pro- teinuria, neoplasia, and cardiovascular risk factors, such as hyper- lipidemia, diabetes, arterial hypertension, and also cardiovascular events (angina, myocardial infarction, or cerebrovascular accident). From the Renal Transplant Unit, Nephrology Department, Hospital 12 de Octubre, Madrid, Spain. Address reprint requests to J.M. Morales, Renal Transplant Unit, Nephrology Department, Hospital 12 de Octubre, Carretera de Andalucia Km 5.400, 28041-Madrid, Spain. E-mail: jmorales@ h12o.es © 2005 by Elsevier Inc. All rights reserved. 0041-1345/05/$–see front matter 360 Park Avenue South, New York, NY 10010-1710 doi:10.1016/j.transproceed.2005.09.125 Transplantation Proceedings, 37, 3727–3728 (2005) 3727