Low-dose tacrolimus ELITE after renal transplant?
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Low-dose tacrolimus ELITE after renal transplant? Immunosuppression with a regimen containing lowdose tacrolimus appears to be associated with better renal function, higher allograft survival rate and less acute rejection than regimens containing lower doses of ciclosporin or sirolimus, or standard-dose ciclosporin in renal transplant recipients, according to results from the ELITE study* .1 In an accompanying editorial, Dr Alan B Leichtman from the University of Michigan Medical School, Ann Arbor, Michigan, USA says that this data is "compelling" but questions whether it can provide guidance for the treatment of the general kidneytransplant population.2 In this 12-month, open-label, multicentre study, researchers determined whether a mycophenolate mofetil-based regimen with lower doses of adjunctive immunosuppressants would maintain acceptable efficacy and a more favourable tolerability profile than a regimen containing a standard-dose immunosuppressant.1 1645 renal transplant recipients (aged 18–75 years) were randomised to receive one of four regimens containing standard-dose ciclosporin [Neoral or Sandimmune] (n = 390 ) or daclizumab [Zenapax] induction with lower doses of ciclosporin (399), tacrolimus [Prograf] (401) or sirolimus [Rapamune] (399). All regimens contained mycophenolate mofetil and corticosteroids. Low-dose tacrolimus recipients had a higher mean calculated glomerular filtration rate (65.4 mL/min) than those receiving standard-dose ciclosporin (57.1 mL/min), low-dose sirolimus (56.7 mL/min) and low-dose ciclosporin (59.4 mL/min), 12 months after transplantation (p ≤ 0.001). Low-dose tacrolimus was also associated with a lower rate of acute rejection than the other three groups (p < 0.001), and a significantly higher rate of allograft survival than standard-dose ciclosporin and low-dose sirolimus (p < 0.01). Serious adverse events (AEs) were reported more frequently in the low-dose sirolimus group (53.2% of patients) than in the other groups (43.4–44.3%), but the rate of one or more AEs was similar between groups. According to Dr Leichtman, this study does not determine whether limiting the initial tacrolimus dose would "result in long-term conserved efficacy and reduced toxic effects". He believes it remains unknown if this approach would "improve long-term function of renal allografts and the overall health and quality of life for kidney-transplant recipients".2 * funded by Hoffmann-La Roche. 1. Ekberg H, et al. Reduced exposure to calcineurin inhibitors in renal transplantation. New England Journal of Medicine 357: 2562-2575, No. 25, 20 Dec 2007. 2. Leichtman AB. Balancing efficacy and toxicity in kidney-transplant immunosuppression. New England Journal of Medicine 357: 2625-2627, No. 25, 20 Dec 2007. 801099345
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Reactions 12 Jan 2008 No. 1184
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