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[普伐他汀对老年高危人群的前瞻性研究(PROSPER研究)]

[The PROSPER Study (PROspective study of pravastatin in the elderly at risk)].

作者信息

Kulbertus H, Scheen A J

机构信息

Service de Diabétologie, Nutrition et Maladies métaboliques et deMédecine Interne Générale, CHU Liège.

出版信息

Rev Med Liege. 2002 Dec;57(12):809-13.

PMID:12632840
Abstract

Statins reduce coronary and cerebrovascular mortality and morbidity in middle-aged individuals. Until recently, their efficacy and safety in elderly people had not yet been firmly established. PROSPER was a controlled, randomised study involving 2,804 men and 3,000 women aged 70-82, with a history of, or risk factors for cardiovascular disease. Their baseline cholesterol level was 135-350 mg/dl; they were randomised to either 40 mg pravastatin per day, or matching placebo. Average follow-up was 3.2 years. The primary endpoint was a composite of coronary death, non-fatal myocardial infarction, and fatal or non-fatal stroke. Pravastatin lowered LDL-cholesterol (-34%), and reduced the incidence of the primary endpoint (-15%; CI 95%: 3-26%; p = 0.014). Coronary death and non-fatal myocardial infarction risk was also reduced (-19%; p = 0.006), and mortality from coronary disease fell by 24% (p = 0.043). The risk for stroke, however, was unaffected (p = 0.8), whereas the incidence of transient ischemic attacks was reduced by 25%, which was (marginally) insignificant (p = 0.051). Pravastatin had no effect on cognitive functions or incapacity. New cancers were more frequent amongst pravastatin-treated individuals (+25%; p = 0.020). However incorporation of this new data in a meta-analysis of all pravastatin and all statin trials revealed no overall increase of cancer risk.

摘要

他汀类药物可降低中年个体的冠状动脉和脑血管疾病死亡率及发病率。直到最近,其在老年人中的疗效和安全性仍未得到确切证实。PROSPER是一项对照随机研究,涉及2804名男性和3000名年龄在70 - 82岁、有心血管疾病病史或危险因素的女性。他们的基线胆固醇水平为135 - 350mg/dl;被随机分为每日服用40mg普伐他汀或匹配的安慰剂组。平均随访时间为3.2年。主要终点是冠状动脉死亡、非致命性心肌梗死以及致命或非致命性中风的综合指标。普伐他汀降低了低密度脂蛋白胆固醇(-34%),并降低了主要终点的发生率(-15%;95%置信区间:3 - 26%;p = 0.014)。冠状动脉死亡和非致命性心肌梗死风险也有所降低(-19%;p = 0.006),冠心病死亡率下降了24%(p = 0.043)。然而,中风风险未受影响(p = 0.8),而短暂性脑缺血发作的发生率降低了25%,这一结果(勉强)无统计学意义(p = 0.051)。普伐他汀对认知功能或失能无影响。接受普伐他汀治疗的个体中新发癌症更为常见(+25%;p = 0.020)。然而,将这些新数据纳入所有普伐他汀和所有他汀类药物试验的荟萃分析后发现,癌症风险并无总体增加。

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[The PROSPER Study (PROspective study of pravastatin in the elderly at risk)].[普伐他汀对老年高危人群的前瞻性研究(PROSPER研究)]
Rev Med Liege. 2002 Dec;57(12):809-13.
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Pravastatin in elderly individuals at risk of vascular disease (PROSPER): a randomised controlled trial.普伐他汀用于有血管疾病风险的老年人(PROSPER):一项随机对照试验。
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Effect of pravastatin on cardiovascular events and mortality in 1516 women with coronary heart disease: results from the Long-Term Intervention with Pravastatin in Ischemic Disease (LIPID) study.普伐他汀对1516例冠心病女性患者心血管事件及死亡率的影响:缺血性疾病普伐他汀长期干预研究(LIPID研究)结果
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Low-density lipoprotein cholesterol (LDL-C) levels and LDL-C goal attainment among elderly patients treated with rosuvastatin compared with other statins in routine clinical practice.在常规临床实践中,与其他他汀类药物相比,瑞舒伐他汀治疗的老年患者的低密度脂蛋白胆固醇(LDL-C)水平及LDL-C达标情况。
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Atorvastatin: gold standard for prophylaxis of myocardial ischemia and stroke - comparison of the clinical benefit of statins on the basis of randomized controlled endpoint studies.阿托伐他汀:预防心肌缺血和中风的金标准——基于随机对照终点研究对比他汀类药物的临床获益
Eur J Med Res. 2004 Jan 26;9(1):1-17.
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Long-term effectiveness and safety of pravastatin in 9014 patients with coronary heart disease and average cholesterol concentrations: the LIPID trial follow-up.普伐他汀对9014例冠心病及胆固醇浓度正常患者的长期有效性和安全性:血脂干预试验随访
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Preventing the next event in the elderly: the PROSPER perspective.预防老年人的下一次发病:PROSPER研究的视角
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Prevention of coronary heart disease with pravastatin in men with hypercholesterolemia. West of Scotland Coronary Prevention Study Group.普伐他汀预防高胆固醇血症男性冠心病。苏格兰西部冠心病预防研究组。
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Statins for the primary prevention of cardiovascular disease.他汀类药物用于心血管疾病的一级预防。
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