Kulbertus H, Scheen A J
Service de Diabétologie, Nutrition et Maladies métaboliques et deMédecine Interne Générale, CHU Liège.
Rev Med Liege. 2002 Dec;57(12):809-13.
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.
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。