Treatment with atorvastatin to the National Cholesterol Educational Program goal versus 'usual' care in secondary coronary heart disease prevention - The GREek Atorvastatin and Coronary-heart-disease Evaluation (GREACE) Study
Treatment with atorvastatin to the National Cholesterol Educational Program goal versus 'usual' care in secondary coronary heart disease prevention - The GREek Atorvastatin and Coronary-heart-disease Evaluation (GREACE) Study
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DOI：
10.1185/030079902125000787
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发表时间：
2002-01-01
影响因子：
2.3
通讯作者：
Kontopoulos, AG
中科院分区：
文献类型：
--
作者：
Athyros, VG;Papageorgiou, AA;Kontopoulos, AG
背景。-阿托伐他汀在降低血浆低密度脂蛋白胆固醇（LDL-C）水平方面非常有效。然而，有没有长期生存的研究，评估这statin.Patients -方法：阿托伐他汀的发病率和死亡率（总冠状动脉）的患者与建立冠心病（CHD），1600例连续患者的影响进行评估，阿托伐他汀或“通常”的医疗护理。阿托伐他汀的剂量从10 mg/天滴定至80 mg/天，以达到国家胆固醇教育计划（NCEP）LDL-C < 100 mg/dl（2.6 mmol/l）的目标。所有患者随访平均3年。主要结果测量：研究的主要终点定义为死亡，非致命性心肌梗死，不稳定型心绞痛，充血性心力衰竭，血运重建（冠状动脉发病率）和中风。次要终点为降血脂药物的安全性和有效性以及阿托伐他汀的成本-效果。这种他汀类药物使总胆固醇降低了36%，LDL-C降低了46%，甘油三酯降低了31%，非高密度脂蛋白胆固醇（非HDL-C）降低了44%，而HDL-C升高了7%;所有这些变化都是显著的。接受阿托伐他汀治疗的患者分别有95%（n = 759）和97%（n = 776）达到NCEP LDL-C和非HDL-C治疗目标。在整个研究期间，只有14%的“常规”治疗患者接受了任何降血脂药物，其中3%达到了NCEP LDL-C治疗目标。使用阿托伐他汀获得的每质量调整生命年的成本估计为8350美元。在这项研究中，196例（24.5%）接受“常规”治疗的CHD患者发生CHD复发事件或死亡，而接受阿托伐他汀治疗的CHD患者为96例（12%）;风险比（RR）为0.49，置信区间（CI）为0.27-0.73，p < 0.0001。详细地说，与“常规”治疗相比，阿托伐他汀降低了总死亡率（RR 0.57，CI 0.39-0.78，p = 0.0021），冠心病死亡率（RR 0.53，CI 0.29-0.74，p = 0.0017）、冠状动脉发病率（RR 0.46，CI 0.25-0.71，p < 0.0001）和卒中（RR 0.53，CI 0.30-0.82，p = 0.034）。所有患者亚组（女性、糖尿病、动脉高血压、年龄60 - 75岁、充血性心力衰竭、近期不稳定型心绞痛或既往血运重建）均从阿托伐他汀治疗中获益。阿托伐他汀组的患者，因为副作用退出是低的（0.75%）和类似的“通常”的护理group.Conclusions：长期治疗冠心病患者阿托伐他汀达到NCEP血脂目标显着降低总的和冠状动脉死亡率，冠状动脉发病率和中风，相比，患者接受“通常”的医疗护理。阿托伐他汀治疗耐受性良好，具有成本效益。
Background.-Atorvastatin is very effective in reducing plasma low-density lipoprotein cholesterol (LDL-C) levels. However, there is no long-term survival study that evaluated this statin.Patients - Methods: To assess the effect of atorvastatin on morbidity and mortality (total and coronary) of patients with established coronary heart disease (CHD), 1600 consecutive patients were randomised either to atorvastatin or to 'usual' medical care. The dose of atorvastatin was titrated from 10 to 80 mg/day, in order to reach the National Cholesterol Education Program (NCEP) goal of LDL-C < 100 mg/dl (2.6 mmol/l). All patients were followed up for a mean period of 3 years.Main Outcome Measures: Primary endpoints of the study were defined as death, non-fatal myocardial infarction, unstable angina, congestive heart failure, revascularisation (coronary morbidity) and stroke. Secondary endpoints were the safety and efficacy of the hypolipidaemic drugs as well as the cost-effectiveness of atorvastatin.Results: The mean dosage of atorvastatin was 24 mg/day. This statin reduced total cholesterol by 36%, LDL-C by 46%, triglycerides by 31%, and non-high-density lipoprotein cholesterol (non-HDL-C) by 44%, while it increased HDL-C by 7%; all these changes were significant. The NCEP LDL-C and non-HDL-C treatment goals were reached by 95% (n = 759) and 97% (n = 776), respectively, of patients on atorvastatin. Only 14% of the 'usual' care patients received any hypolipidaemic drugs throughout the study and 3% of them reached the NCEP LDL-C treatment goal. The cost per quality-adjusted life-year gained with atorvastatin was estimated at $US 8350. During this study 196 (24.5%) CHD patients on 'usual' care had a CHD recurrent event or died vs. 96 (12%) CHD patients on atorvastatin; risk ratio (RR) 0.49, confidence interval (CI) 0.27-0.73, p < 0.0001. In detail, atorvastatin reduced, in comparison to 'usual' care, total mortality (RR 0.57, CI 0.39-0.78, p = 0.0021), coronary mortality (RR 0.53, CI 0.29-0.74, p = 0.0017), coronary morbidity (RR 0.46, CI 0.25-0.71, p < 0.0001), and stroke (RR 0.53, CI 0.30-0.82, p = 0.034). All subgroups of patients (women, those with diabetes mellitus, arterial hypertension, age 60 to 75 years, congestive heart failure, recent unstable angina or prior revascularisation) benefited from treatment with atorvastatin. Withdrawal of patients because of side-effects from the atorvastatin group was low (0.75%) and similar to that of the 'usual' care group (0.4%).Conclusions: Long-term treatment of CHD patients with atorvastatin to achieve NCEP lipid targets significantly reduces total and coronary mortality, coronary morbidity and stroke, in comparison to patients receiving 'usual' medical care. Treatment with atorvastatin is well tolerated and cost-effective.