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• W2317259733 abstract "Knight and Morris (1) recently published a systematic review on steroid withdrawal (SW) strategies after kidney transplantation. Their main conclusions are similar to ours, in another systematic review on the same topic made in the Cochrane Collaboration (2). The incidence of acute rejection after steroid withdrawal is increased, without any impact on renal survival. Knight and Morris did not observe any different outcomes related to the calcineurin inhibitor used, showing similar acute rejection rates with cyclosporine A (CsA) and tacrolimus (1). Focusing on studies addressing outcomes after SW between 3 and 6 months after kidney transplantation (3), the use of CsA seemed to be associated with a higher incidence in acute rejection comparing SW versus controls. SW in tacrolimus trials was not associated with increased acute rejection. The outcome “overall acute rejection” included both clinically suspected plus biopsy-proven cases and was extracted from two controlled trials (4–6). Considering overall acute rejection, the difference between using CsA and tacrolimus lost significance when interaction analysis proposed by Altman and Bland (7) was applied (P=0.438). However, the effect of SW on biopsy-proven acute rejection was only significant only if CsA is used, not with tacrolimus (P for the interaction=0.005). The critique of limited evidence for this significant interaction is not adequate, because we have found enough evidence to reject the null hypotheses of no interaction. As Knight and Morris underline, this difference is based in only one trial, the largest trial assessing safety and efficacy of SW at 3 months in a tacrolimus-mycophenolate mofetil (MMF) regimen (5, 6). In this trial, assessing outcomes up to 3 years after transplantation, patients were initially treated with tacrolimus, MMF, and steroids and randomized to stop MMF or steroids after 3 months. Biopsy-proven acute rejection was not different between patients with or without steroids after 3 months (relative risk 0.82, 95% confidence interval 0.57–1.18). In contrast, when pooling data from three CsA trials, biopsy-proven acute rejection increased significantly after SW (relative risk 1.61, 95% confidence interval 1.20–2.17, P=0.0018), without any heterogeneity among the three trials. In our view, these data confirm that SW is safer in tacrolimus than in CsA-based protocols in terms of acute rejection risk. Julio, Pascual1 Ana Royuela2,3 Javier Zamora2,3 1 Servicio de Nefrología Hospital del Mar Parc de Salut Mar Universitat Autonoma de Barcelona Barcelona, Spain 2Unidad de Bioestadística Clínica Hospital Ramon y Cajal IRYCIS Madrid, Spain 3CIBER Epidemiología y Salud Pública (CIBERESP) Madrid, Spain" @default.
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• W2317259733 date "2011-03-15" @default.
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• W2317259733 title "Authors' Reply: Cyclosporine A Versus Tacrolimus in Steroid Withdrawal Strategies" @default.
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• W2317259733 doi "https://doi.org/10.1097/tp.0b013e318208e719" @default.
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