Atorvastatin, Cardiovascular Events, and Disability-free Survival in Older Adults.

Methods

We conducted a double-blind, randomized, placebo-controlledtrial at general medical practices across Australia.

我们在澳大利亚的普通医疗实践中进行了一项双盲、随机、安慰剂对照试验。

Community-dwelling adults at least 70 years of age with no history of cardiovascular disease, diabetes, or dementia were randomly assigned in a 1:1 ratio to receive atorvastatin at a dose of 40 mg once daily or identical placebo.

至少70岁的社区居住成年人，没有心血管疾病、糖尿病或痴呆的病史，被随机分配以1:1的比例接受每日一次40毫克的阿托伐他汀或相同的安慰剂。

The two primary end points were a composite of death from cardiovascular causes, nonfatal myocardial infarction or stroke, or coronary revascularization (to assess effects on major cardiovascular events) and a composite of death from any cause, dementia, or persistent physical disability (to assess effects on disability-free survival).

两个主要终点是一个复合终点，包括心血管原因的死亡、非致命性心肌梗死或中风，或冠状动脉再血管化（以评估对主要心血管事件的影响），以及一个复合终点，包括任何原因的死亡、痴呆或持续性身体残疾（以评估对无残疾生存期的影响）。

Analyses were performed according to a hierarchical testing plan.

分析是根据层次测试计划进行的。

Results

A total of 9971 participants were enrolled: 4984 were assigned to receive atorvastatin and 4987 to receive placebo.

共有9971名参与者被纳入研究：4984人被分配接受阿托伐他汀，4987人被分配接受安慰剂。

The mean (±SD) age of the participants was 74.7±4.5 years, and 51.9% were women.

参与者的平均（±标准差）年龄为74.7±4.5岁，女性占51.9%。

After a median of 5.9 years, a primary cardiovascular event had occurred in 297 participants (10.9 events per 1000 person-years) in the atorvastatin group and in 412 participants (15.5 events per 1000 person-years) in the placebo group (hazard ratio, 0.70; 95% confidence interval[CI], 0.61 to 0.82; P<0.001).

在中位数5.9年后，阿托伐他汀组有297名参与者（每1000人年10.9事件）和安慰剂组有412名参与者（每1000人年15.5事件）发生了主要心血管事件（风险比，0.70；95%置信区间[CI]，0.61至0.82；P<0.001）。

Death from any cause, dementia, or persistent physical disability occurred in 637 participants (21.6 events per 1000 person-years) in the atorvastatin group and in 676 participants (23.0 events per 1000 person-years) in the placebo group (hazard ratio, 0.94; 95% CI, 0.84 to 1.05; P = 0.25).

在阿托伐他汀组的637名参与者中（每1000人年21.6事件），以及在安慰剂组的676名参与者中（每1000人年23.0事件），发生了任何原因的死亡、痴呆或持续的身体残疾（风险比，0.94；95%置信区间，0.84至1.05；P = 0.25）。

Serious adverse events occurred in 131 participants (2.7%) in the atorvastatin group and in 129 (2.7%) in the placebo group, with musculoskeletal, hepatobiliary, and diabetes-related adverse events occurring more commonly in the atorvastatin group.

在阿托伐他汀组的131名参与者（2.7%）和安慰剂组的129名参与者（2.7%）中发生了严重不良事件，其中肌肉骨骼、肝胆和糖尿病相关的不良事件在阿托伐他汀组中更为常见。

Conclusions

Treatment with atorvastatin led to a lower risk of major cardiovascular events than placebo at a median of 5.9 years but did not result in longer disability-free survival among community-dwelling older adults without clinical cardiovascular disease.

在中位数为5.9年的随访中，与安慰剂相比，阿托伐他汀治疗降低了主要心血管事件的风险，但在没有临床心血管疾病的社区居住的老年人中，并没有导致更长的无残疾生存期。

(Funded by the National Health and Medical Research Council and others; STAREE ClinicalTrials.gov number, NCT02099123.).

该项目由国家健康与医学研究委员会和其他机构资助；STAREE临床试验注册号为NCT02099123。