阿托伐他汀用于接受血液透析的2型糖尿病患者。

Atorvastatin in patients with type 2 diabetes mellitus undergoing hemodialysis.

作者信息

Wanner Christoph, Krane Vera, März Winfried, Olschewski Manfred, Mann Johannes F E, Ruf Günther, Ritz Eberhard

机构信息

Division of Nephrology, Department of Medicine, University of Würzburg, Würzburg, Germany.

出版信息

N Engl J Med. 2005 Jul 21;353(3):238-48. doi: 10.1056/NEJMoa043545.

DOI:10.1056/NEJMoa043545

PMID:16034009

Abstract

BACKGROUND

Statins reduce the incidence of cardiovascular events in persons with type 2 diabetes mellitus. However, the benefit of statins in such patients receiving hemodialysis, who are at high risk for cardiovascular disease and death, has not been examined.

METHODS

We conducted a multicenter, randomized, double-blind, prospective study of 1255 subjects with type 2 diabetes mellitus receiving maintenance hemodialysis who were randomly assigned to receive 20 mg of atorvastatin per day or matching placebo. The primary end point was a composite of death from cardiac causes, nonfatal myocardial infarction, and stroke. Secondary end points included death from all causes and all cardiac and cerebrovascular events combined.

RESULTS

After four weeks of treatment, the median level of low-density lipoprotein cholesterol was reduced by 42 percent among patients receiving atorvastatin, and among those receiving placebo it was reduced by 1.3 percent. During a median follow-up period of four years, 469 patients (37 percent) reached the primary end point, of whom 226 were assigned to atorvastatin and 243 to placebo (relative risk, 0.92; 95 percent confidence interval, 0.77 to 1.10; P=0.37). Atorvastatin had no significant effect on the individual components of the primary end point, except that the relative risk of fatal stroke among those receiving the drug was 2.03 (95 percent confidence interval, 1.05 to 3.93; P=0.04). Atorvastatin reduced the rate of all cardiac events combined (relative risk, 0.82; 95 percent confidence interval, 0.68 to 0.99; P=0.03, nominally significant) but not all cerebrovascular events combined (relative risk, 1.12; 95 percent confidence interval, 0.81 to 1.55; P=0.49) or total mortality (relative risk, 0.93; 95 percent confidence interval, 0.79 to 1.08; P=0.33).

CONCLUSIONS

Atorvastatin had no statistically significant effect on the composite primary end point of cardiovascular death, nonfatal myocardial infarction, and stroke in patients with diabetes receiving hemodialysis.

摘要

背景

他汀类药物可降低2型糖尿病患者心血管事件的发生率。然而，他汀类药物对接受血液透析的此类患者（心血管疾病和死亡风险高）的益处尚未得到研究。

方法

我们对1255例接受维持性血液透析的2型糖尿病患者进行了一项多中心、随机、双盲、前瞻性研究，这些患者被随机分配接受每日20毫克阿托伐他汀或匹配的安慰剂。主要终点是心源性死亡、非致命性心肌梗死和中风的复合终点。次要终点包括全因死亡以及所有心脏和脑血管事件的总和。

结果

治疗四周后，接受阿托伐他汀治疗的患者中，低密度脂蛋白胆固醇的中位数水平降低了42%，而接受安慰剂治疗的患者中，该水平降低了1.3%。在中位随访期四年中，469例患者（37%）达到主要终点，其中226例被分配接受阿托伐他汀治疗，243例接受安慰剂治疗（相对风险，0.92；95%置信区间，0.77至1.10；P = 0.37）。阿托伐他汀对主要终点的各个组成部分没有显著影响，只是接受该药物治疗的患者中致命性中风的相对风险为2.03（95%置信区间，1.05至3.93；P = 0.04）。阿托伐他汀降低了所有心脏事件的总和（相对风险，0.82；95%置信区间，0.68至0.99；P = 0.03，名义上显著），但未降低所有脑血管事件的总和（相对风险，1.12；95%置信区间，0.81至1.55；P = 0.49）或总死亡率（相对风险，0.93；95%置信区间，0.79至1.08；P = 0.33）。