Fellström Bengt, Abedini Sadollah, Holdaas Hallvard, Jardine Alan G, Staffler Beatrix, Gimpelewicz Claudio
Department of Medical Science, Renal Unit, University Hospital, Uppsala, Sweden.
Clin Transplant. 2006 Nov-Dec;20(6):732-9. doi: 10.1111/j.1399-0012.2006.00555.x.
Concerns have recently been raised regarding a potential harmful effect of statins on renal function. This study investigated the effect of fluvastatin treatment on renal function in renal transplant recipients enrolled in the Assessment of Lescol in Renal Transplantation (ALERT) trial.
ALERT was a randomized, double-blind, placebo-controlled study of the effect of fluvastatin, 40-80 mg daily (n = 1050) or placebo (n = 1052) on cardiac and renal outcomes in renal transplant recipients over a follow-up period of five to six years. The incidence of graft loss, changes in serum creatinine, calculated creatinine clearance and proteinuria, and the incidence of renal adverse events (AEs) were assessed in both treatment groups.
Fluvastatin treatment in ALERT had no significant effect compared with placebo on renal function, assessed by serum creatinine (overall adjusted mean +/- SEM: fluvastatin, 175.4 +/- 2.20 micromol/L; placebo, 172.7 +/- 2.20 micromol/L; p = 0.39), creatinine clearance (fluvastatin, 55.3 +/- 0.30 mL/min; placebo, 55.8 +/- 0.30 mL/min; p = 0.26) or proteinuria (fluvastatin, 0.58 +/- 0.03 g/24 h; placebo, 0.53 +/- 0.03 g/24 h; p = 0.31). There were no significant differences between treatment groups when the 283 patients suffering graft loss were excluded from the analysis. Fluvastatin also had no detrimental effect on creatinine clearance or proteinuria in the subgroup of 340 diabetic patients without graft loss in ALERT. No notable differences in the rate of renal or musculoskeletal AEs were observed between fluvastatin and placebo groups.
Fluvastatin had no detrimental effect on renal function, or the risk of renal AEs, in renal transplant recipients with or without diabetes enrolled in ALERT. Fluvastatin treatment for the prevention of cardiac events may therefore be used without fear of jeopardizing renal function.
近期有人对他汀类药物对肾功能的潜在有害影响表示担忧。本研究在肾移植受者参与的氟伐他汀在肾移植中的评估（ALERT）试验中，调查了氟伐他汀治疗对肾功能的影响。
ALERT是一项随机、双盲、安慰剂对照研究，研究每日40 - 80毫克氟伐他汀（n = 1050）或安慰剂（n = 1052）对肾移植受者心脏和肾脏结局的影响，随访期为五到六年。评估了两个治疗组的移植物丢失发生率、血清肌酐变化、计算的肌酐清除率和蛋白尿，以及肾脏不良事件（AE）的发生率。
在ALERT中，与安慰剂相比，氟伐他汀治疗对肾功能无显著影响，根据血清肌酐评估（总体调整均值±标准误：氟伐他汀，175.4±2.20微摩尔/升；安慰剂，172.7±2.20微摩尔/升；p = 0.39）、肌酐清除率（氟伐他汀，55.3±0.30毫升/分钟；安慰剂，55.8±0.30毫升/分钟；p = 0.26）或蛋白尿（氟伐他汀，0.58±0.03克/24小时；安慰剂，0.53±0.03克/24小时；p = 0.31）。当将283例发生移植物丢失的患者排除在分析之外时，治疗组之间无显著差异。在ALERT中，氟伐他汀对340例无移植物丢失的糖尿病患者亚组的肌酐清除率或蛋白尿也无有害影响。氟伐他汀组和安慰剂组之间在肾脏或肌肉骨骼不良事件发生率方面未观察到显著差异。
在参与ALERT试验的有或无糖尿病的肾移植受者中，氟伐他汀对肾功能或肾脏不良事件风险无有害影响。因此，用于预防心脏事件的氟伐他汀治疗可放心使用，不用担心损害肾功能。
