Long-term cardiac outcomes in renal transplant recipients receiving fluvastatin:: The ALERT extension study
Long-term cardiac outcomes in renal transplant recipients receiving fluvastatin:: The ALERT extension study
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DOI：
10.1111/j.1600-6143.2005.01105.x
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发表时间：
2005-12-01
影响因子：
8.8
通讯作者：
Jardine, AG
中科院分区：
文献类型：
--
作者：
Holdaas, H;Fellström, B;Jardine, AG
肾移植受者（RTR）患早发心血管疾病的风险增加。ALERT研究是第一项评估他汀类药物治疗对肾移植后心脏结局影响的试验。在5-6年ALERT研究中最初随机分配至氟伐他汀或安慰剂组的患者在原始研究的2年扩展期内接受开放标签氟伐他汀XL 80 mg/天治疗。主要终点是至首次主要心脏不良事件（MACE）的时间。在完成ALERT的1787例患者中，1652例（92%）在扩展期接受了随访。平均总随访时间为6.7年。末次随访时平均LDL-胆固醇为98 mg/dL（2.5 mmol/L），而研究前水平为159 mg/dL（4.1 mmol/L）。随机接受氟伐他汀治疗的患者的主要不良心脏事件风险降低（风险比[HR] 0.79，95%CI 0.63-0.99，p = 0.036），心源性死亡或明确的非致命性心肌梗死减少29%（HR 0.71，95%CI 0.55-0.93，p = 0.014）。总死亡率和移植物丢失在两组之间没有显著差异。氟伐他汀可安全有效地降低LDL-胆固醇，并降低RTR中MACE的风险。在其他患者组中，氟伐他汀的降脂和心血管获益与他汀类药物相当，支持在RTR中使用氟伐他汀。
Renal transplant recipients (RTR) have an increased risk of premature cardiovascular disease. The ALERT study is the first trial to evaluate the effect of statin therapy on cardiac outcomes following renal transplantation. Patients initially randomized to fluvastatin or placebo in the 5-6 year ALERT study were offered open-label fluvastatin XL 80 mg/day in a 2-year extension to the original study. The primary endpoint was time to first major adverse cardiac event (MACE). Of 1787 patients who completed ALERT, 1652 (92%) were followed in the extension. Mean total follow-up was 6.7 years. Mean LDL-cholesterol was 98 mg/dL (2.5 mmol/L) at last follow-up compared to a pre-study level of 159 mg/dL (4.1 mmol/L). Patients randomized to fluvastatin had a reduced risk of MACE (hazards ratio [HR] 0.79, 95% CI 0.63-0.99, p = 0.036), and a 29% reduction in cardiac death or definite non-fatal MI (HR 0.71, 95% CI 0.55-0.93, p = 0.014). Total mortality and graft loss did not differ significantly between groups. Fluvastatin produces a safe and effective reduction in LDL-cholesterol associated with reduced risk of MACE in RTR. The lipid-lowering and cardiovascular benefits of fluvastatin are comparable to those of statins in other patient groups, and support use of fluvastatin in RTR.