Efficacy and safe of atorvastatin in the prevention of cardiovascular end points in subjects with type 2 diabetes - The Atorvastatin Study for Prevention of Coronary Heart Disease Endpoints in Non-Insulin-Dependent Diabetes Mellitus (ASPEN)
Efficacy and safe of atorvastatin in the prevention of cardiovascular end points in subjects with type 2 diabetes - The Atorvastatin Study for Prevention of Coronary Heart Disease Endpoints in Non-Insulin-Dependent Diabetes Mellitus (ASPEN)
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DOI：
10.2337/dc05-2415
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发表时间：
2006-07-01
期刊：
影响因子：
16.2
通讯作者：
Pocock, Stuart J.
中科院分区：
文献类型：
--
作者：
Knopp, Robert H.;D'Emden, Michael;Pocock, Stuart J.
目的：2型糖尿病患者心血管疾病(CVD)的风险增加。这项PUR研究旨在评估10毫克阿托伐他汀与安慰剂对CVD姿势的影响。研究设计与方法：在一项为期4年的双盲平行分组研究中，受试者被随机分配接受10 mg阿托伐他汀或安慰剂治疗。综合主要终点包括心血管死亡、非致命性心肌梗死、非致命性中风、再通、冠状动脉旁路手术、复苏的心脏骤停以及需要住院的恶化或不稳定心绞痛。结果：总共2,410名2型糖尿病患者被随机分为5组。与安慰剂组相比，阿托伐他汀组4年来低密度脂蛋白平均降低了29%(P<；0.0001)。当我们比较阿托伐他汀和安慰剂时，复合主要终点发生率分别为13.7%和15.0%(风险比0.90[95%可信区间0.73-1.12])。在1,905名既往无心肌梗死或介入治疗的受试者中，服用阿托伐他汀的受试者和服用安慰剂的受试者分别有10.4%和10.8%经历了主要终点(0.97[0.74-1.28])。在505名既往有心肌梗死或介入手术史的受试者中，服用阿托伐他汀的受试者中有26.2%的受试者和服用安慰剂的受试者中有30.8%的受试者经历了主要终点(0.82[0.59-1.15])。致命性和非致命性心肌梗死的相对风险降低总体上为27%(P=0。10)和19%(P=0.41)和36%(P=0。11.)对于既往无心肌梗死或介入手术的受试者，分别如此。结论：复合终点降低在统计学上没有显著意义。这一结果可能与总体研究设计、招募的受试者类型、主要终点的性质以及由于治疗指南的改变而需要的方案改变有关。出于这些原因，阿托伐他汀在非胰岛素依赖型糖尿病(ASPEN)中预防冠心病终点的研究结果没有证实治疗的益处，但并不影响大多数糖尿病患者有患冠心病的风险，应该将低密度脂蛋白胆固醇降低到目前推荐的目标这一迫切需要。
OBJECTIVE - Cardiovascular disease (CVD) risk is increased in type 2 diabetes. The pur-study was to assess the effect of 10 mg of atorvastatin versus placebo on CVD pose of this.. prevention in subjects with type 2 diabetes and LDL cholesterol levels below contemporary guideline targets.RESEARCH DESIGN AND METHODS - Subjects were randomly assigned to receive 10 mg of atorvastatin or placebo in a 4-year, double-blind, parallel-group study. The composite primary end point comprised cardiovascular death, nonfatal myocardial infarction nonfatal stroke, recanalization, coronary artery bypass surgery, resuscitated cardiac arrest, and worsening or unstable angina requiring hospitalization.RESULTS - A total of 2,410 subjects with type 2 diabetes were randomized. Mean LDL cholesterol reduction in the atorvastatin group over 4 years was 29% versus placebo (P < 0.0001). When we compared atorvastatin versus placebo, composite primary end point rates were 13.7 and 15.0%, respectively (hazard ratio 0.90 [95% CI 0.73-1.12]). in the subset of 1,905 subjects without prior myocardial infarction or interventional procedure, 10.4% of atorvastatin- and 10.8% of placebo-treated subjects experienced a primary end point (0.97 [0.74-1.28]). In the 505 subjects with prior myocardial infarction or interventional procedure, 26.2% of atorvastatin- and 30.8% of placebo-treated subjects experienced a primary end point (0.82 [0.59-1.15]). Relative risk reductions in fatal and nonfatal myocardial infarction were 27% overall (P = 0. 10) and 19% (P = 0.41) and 36% (P = 0. 11.) for subjects without and with prior myocardial infarction or interventional procedure, respectively.CONCLUSIONS - Composite end point reductions were not statistically significant. This result may relate to the overall study design, the types of subjects recruited, the nature of the primary end point, and the protocol changes required because of changing treatment guidelines. For these reasons, the results of the Atorvastatin Study for Prevention of Coronary Heart Disease Endpoints in N on-Insulin-Dependent Diabetes Mellitus (ASPEN) did not confirm the benefit of therapy but do not detract from the imperative that the majority of diabetic patients are at risk of coronary heart disease and deserve LDL cholesterol lowering to the currently recommended targets.