Effect of fluvastatin on cardiac outcomes in renal transplant recipients:: a multicentre, randomised, placebo-controlled trial
Effect of fluvastatin on cardiac outcomes in renal transplant recipients:: a multicentre, randomised, placebo-controlled trial
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DOI：
10.1016/s0140-6736(03)13638-0
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发表时间：
2003-06-14
期刊：
影响因子：
168.9
通讯作者：
Pedersen, TR
中科院分区：
文献类型：
--
作者：
Holdaas, H;Fellström, B;Pedersen, TR
背景肾移植受者患早产儿心血管疾病的风险增加。尽管他汀类药物在普通人群中降低了心血管风险，但其在肾移植受者中的有效性和安全性尚未确定。方法采用多中心、随机、双盲、安慰剂对照试验，对2102例总胆固醇为4.0~9.0 mmol/L的肾移植受者，随机分为氟伐他汀组(n=1050)和安慰剂组(n=1052)，随访5~6年。主要终点是发生重大不良心脏事件，定义为心脏性死亡、非致命性心肌梗死(MI)或冠状动脉介入治疗。次要终点是个体心脏事件、合并心源性死亡或非致命性心肌梗死、脑血管事件、非心血管死亡、全因死亡、移植物丢失或血肌酐增加一倍。根据治疗意向进行分析。平均随访5.1年后发现，氟伐他汀使低密度脂蛋白胆固醇浓度降低了32%。尽管氟伐他汀组的心脏死亡或非致死性心肌梗死(70vs104，0.65[0.48-0.88]p=0.005)比安慰剂组少(风险比0.83[95%Cl0.64-1.06]，p=0.005)，但氟伐他汀对主要终点的风险降低并不显著。冠状动脉介入治疗和其他次要终点在两组之间没有显著差异。尽管心脏病死亡和非致死性心肌梗死似乎减少了，但氟伐他汀通常并不能降低冠状动脉介入治疗的发生率或死亡率。氟伐他汀在其他人群中的总体疗效与他汀类药物相似。
Background Renal transplant recipients are at increased risk of premature cardiovascular disease. Although statins reduce cardiovascular risk in the general population, their efficacy and safety in renal transplant recipients have not been established. We investigated the effects of fluvastatin on cardiac and renal endpoints in this population.Methods We did a multicentre, randomised, double-blind, placebo-controlled trial in 2102 renal transplant recipients with total cholesterol 4.0-9.0 mmol/L. We randomly assigned patients fluvastatin (n=1050) or placebo (n=1052) and follow up was for 5-6 years. The primary endpoint was the occurrence of a major adverse cardiac event, defined as cardiac death, nonfatal myocardial infarction (MI), or coronary intervention procedure. Secondary endpoints were individual cardiac events, combined cardiac death or non-fatal MI, cerebrovascular events, non-cardiovascular death, all-cause mortality, and graft loss or doubling of serum creatinine. Analysis was by intention to treat.Findings After a mean follow-up of 5.1 years, fluvastatin lowered LDL cholesterol concentrations by 32%. Risk reduction with fluvastatin for the primary endpoint (risk ratio 0.83 [95% Cl 0.64-1.06], p=0.139) was not significant, although there were fewer cardiac deaths or non-fatal MI (70 vs 104, 0.65 [0.48-0.88] p=0.005) in the fluvastatin group than in the placebo group. Coronary intervention procedures and other secondary endpoints did not differ significantly between groups.Interpretation Although cardiac deaths and non-fatal MI seemed to be reduced, fluvastatin did not generally reduce rates of coronary intervention procedures or mortality. Overall effects of fluvastatin were similar to those of statins in other populations.