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随机分组时年龄在65 - 75岁患者的疗效与安全性分析:阿托伐他汀糖尿病协作研究(CARDS)

Analysis of efficacy and safety in patients aged 65-75 years at randomization: Collaborative Atorvastatin Diabetes Study (CARDS).

作者信息

Neil H Andrew W, DeMicco David A, Luo Don, Betteridge D John, Colhoun Helen M, Durrington Paul N, Livingstone Shona J, Fuller John H, Hitman Graham A

机构信息

Division of Public Health and Primary Health Care, University of Oxford, Old Road Campus, Headington, Oxford OX3 7LF, UK.

出版信息

Diabetes Care. 2006 Nov;29(11):2378-84. doi: 10.2337/dc06-0872.

DOI:10.2337/dc06-0872
PMID:17065671
Abstract

OBJECTIVE

Rates of cardiovascular disease are highest in the elderly. Lipid-lowering statin therapy reduces the proportional risk as effectively in older patients as in younger individuals; however, limited data are available for elderly patients with type 2 diabetes. We conducted a post hoc analysis to compare the efficacy and safety of atorvastatin among 1,129 patients aged 65-75 years at randomization with 1,709 younger patients in the Collaborative Atorvastatin Diabetes Study (CARDS).

RESEARCH DESIGN AND METHODS

CARDS was a randomized placebo-controlled trial of 10 mg/day atorvastatin for primary prevention of cardiovascular disease in patients aged 40-75 years with LDL cholesterol concentrations </=4.14 mmol/l followed for a median of 3.9 years. The primary end point was time to first occurrence of acute coronary heart disease events, coronary revascularizations, or stroke.

RESULTS

Atorvastatin treatment resulted in a 38% reduction in relative risk ([95% CI -58 to -8], P = 0.017) of first major cardiovascular events in older patients and a 37% reduction ([-57 to -7], P = 0.019) in younger patients. Corresponding absolute risk reductions were 3.9 and 2.7%, respectively (difference 1.2% [95% CI -2.8 to 5.3], P = 0.546); numbers needed to treat for 4 years to avoid one event were 21 and 33, respectively. All-cause mortality was reduced nonsignificantly by 22% ([-49 to 18], P = 0.245) and 37% ([-64 to 9], P = 0.98), respectively. The overall safety profile of atorvastatin was similar between age-groups.

CONCLUSIONS

Absolute and relative benefits of statin therapy in older patients with type 2 diabetes are substantial, and all patients warrant treatment unless specifically contraindicated.

摘要

目的

心血管疾病发病率在老年人中最高。降脂他汀类药物治疗在老年患者中降低比例风险的效果与年轻个体相同;然而,关于老年2型糖尿病患者的数据有限。我们进行了一项事后分析,以比较阿托伐他汀在1129例随机分组时年龄为65 - 75岁的患者与协作阿托伐他汀糖尿病研究(CARDS)中1709例年轻患者中的疗效和安全性。

研究设计与方法

CARDS是一项随机安慰剂对照试验,给予40 - 75岁、低密度脂蛋白胆固醇浓度≤4.14 mmol/l的患者每日10 mg阿托伐他汀用于心血管疾病的一级预防,随访中位时间为3.9年。主要终点是首次发生急性冠心病事件、冠状动脉血运重建或中风的时间。

结果

阿托伐他汀治疗使老年患者首次发生主要心血管事件的相对风险降低38%([95%可信区间 -58至 -8],P = 0.017),年轻患者降低37%([-57至 -7],P = 0.019)。相应的绝对风险降低分别为3.9%和2.7%(差异1.2% [95%可信区间 -2.8至5.3],P = 0.546);为避免发生一次事件需要治疗4年的人数分别为21和33。全因死亡率分别非显著降低22%([-49至18],P = 0.245)和37%([-64至9],P = 0.98)。阿托伐他汀的总体安全性在各年龄组之间相似。

结论

他汀类药物治疗对老年2型糖尿病患者的绝对和相对益处显著,所有患者均应接受治疗,除非有明确禁忌。

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