MRC / BHF银行心脏保护研究在20536年与辛伐他汀的胆固醇降低高危个体:随机安慰剂对照试验。

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MRC / BHF银行心脏保护研究在20536年与辛伐他汀的胆固醇降低高危个体:随机安慰剂对照试验。

柳叶刀》。2002年7月6日,360 (9326):7-22。doi: 10.1016 / s0140 - 6736 (02) 09327 - 3。

PubMed ID
12114036 (在PubMed
]
文摘

背景:在通常的低密度脂蛋白胆固醇在西方人群范围,降低血液浓度降低心血管疾病的风险。在这样的人群,因此,降低低密度脂蛋白胆固醇可降低血管疾病的发展,很大程度上不考虑初始胆固醇浓度。方法:20536名英国成年人(年龄在40 - 80岁)与冠状动脉疾病、其他闭塞的动脉疾病或糖尿病患者被随机分配接受每天40毫克辛伐他汀(平均合规:85%)或匹配的安慰剂(平均non-study他汀类药物使用:17%)。第一次出现的特定事件,分析和比较所有placebo-allocated simvastatin-allocated和参与者。这些“意向处理”比较评估的影响大约三分之二(85% - 17%)预定的5年期间服用他汀类药物治疗期间,取得了平均差的低密度脂蛋白胆固醇1.0更易/ L(约三分之二的每日40毫克辛伐他汀)的实际使用效果。主要结果死亡率(整体分析)和致命或非致命的血管事件(子类别分析),与子公司的评估癌症和其他主要的发病率。结果:全因死亡率显著降低(1328[12.9%]死亡10269分配辛伐他汀与1507(14.7%)在10267分配安慰剂;p = 0.0003),由于高度显著的18% (SE 5)比例减少冠状动脉死亡率(587年(5.7%)和707年(6.9%);p = 0.0005),一个略微显著减少其他血管性死亡(194年(1.9%)和230年(2.2%);p = 0.07),减少与非血管死亡(547年(5.3%)和570年(5.6%); p=0.4). There were highly significant reductions of about one-quarter in the first event rate for non-fatal myocardial infarction or coronary death (898 [8.7%] vs 1212 [11.8%]; p<0.0001), for non-fatal or fatal stroke (444 [4.3%] vs 585 [5.7%]; p<0.0001), and for coronary or non-coronary revascularisation (939 [9.1%] vs 1205 [11.7%]; p<0.0001). For the first occurrence of any of these major vascular events, there was a definite 24% (SE 3; 95% CI 19-28) reduction in the event rate (2033 [19.8%] vs 2585 [25.2%] affected individuals; p<0.0001). During the first year the reduction in major vascular events was not significant, but subsequently it was highly significant during each separate year. The proportional reduction in the event rate was similar (and significant) in each subcategory of participant studied, including: those without diagnosed coronary disease who had cerebrovascular disease, or had peripheral artery disease, or had diabetes; men and, separately, women; those aged either under or over 70 years at entry; and--most notably--even those who presented with LDL cholesterol below 3.0 mmol/L (116 mg/dL), or total cholesterol below 5.0 mmol/L (193 mg/dL). The benefits of simvastatin were additional to those of other cardioprotective treatments. The annual excess risk of myopathy with this regimen was about 0.01%. There were no significant adverse effects on cancer incidence or on hospitalisation for any other non-vascular cause. INTERPRETATION: Adding simvastatin to existing treatments safely produces substantial additional benefits for a wide range of high-risk patients, irrespective of their initial cholesterol concentrations. Allocation to 40 mg simvastatin daily reduced the rates of myocardial infarction, of stroke, and of revascularisation by about one-quarter. After making allowance for non-compliance, actual use of this regimen would probably reduce these rates by about one-third. Hence, among the many types of high-risk individual studied, 5 years of simvastatin would prevent about 70-100 people per 1000 from suffering at least one of these major vascular events (and longer treatment should produce further benefit). The size of the 5-year benefit depends chiefly on such individuals' overall risk of major vascular events, rather than on their blood lipid concentrations alone.

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