EFFECT OF LOVASTATIN ON EARLY CAROTID ATHEROSCLEROSIS AND CARDIOVASCULAR EVENTS
EFFECT OF LOVASTATIN ON EARLY CAROTID ATHEROSCLEROSIS AND CARDIOVASCULAR EVENTS
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DOI：
10.1161/01.cir.90.4.1679
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发表时间：
1994-10-01
期刊：
影响因子：
37.8
通讯作者：
YOUNG, B
中科院分区：
文献类型：
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作者：
FURBERG, CD;ADAMS, HP;YOUNG, B
HMG辅酶a还原酶抑制剂（或称他汀类药物）是一类新的降脂化合物，与老的降脂药物相比，它的应用前景更加广阔。它们不仅在降低低密度脂蛋白胆固醇方面更有效，而且耐受性也更好。没有关于他汀类药物对低密度脂蛋白胆固醇水平中度升高但无症状性心血管疾病的男性和女性的早期颈动脉粥样硬化和临床事件的影响的数据。方法和结果洛伐他汀（20 ~ 40mg /d）或其安慰剂与华法林（1mg /d）或其安慰剂在一项双盲随机临床试验中进行评估。本报告仅限于该试验的洛伐他汀部分。建议所有人每天服用阿司匹林（81毫克/天）。纳入919名无症状男性和女性，年龄40 - 79岁，b超诊断为早期颈动脉粥样硬化，LDL胆固醇在第60 - 90百分位数之间。12个颈动脉壁平均最大内膜-内侧厚度（IMT）的3年变化是主要结局；单次最大IMT的变化和主要心血管事件的发生率是次要结局。洛伐他汀组低密度脂蛋白胆固醇下降28%，从基线时的156.6 mg/dL降至6个月时的113.1 mg/dL (P < 0.0001)，洛伐他汀-安慰剂组基本不变。在未使用华法林的参与者中，与安慰剂组相比，洛伐他汀组12个月后平均最大IMT出现回归；3年差异有统计学意义（P = .001）。洛伐他汀对单次最大IMT的改变有较大的有利作用，但无统计学意义（P = 0.12）。5名洛伐他汀治疗的参与者出现了主要的心血管事件——冠心病死亡率、非致死性心肌梗死或中风——而洛伐他汀安慰剂组有14名（P = 0.04）。1名接受洛伐他汀治疗的受试者死亡，8名接受洛伐他汀安慰剂治疗的受试者死亡（P = 0.02）。结论：在LDL胆固醇中度升高的男性和女性中，洛伐他汀可以逆转颈动脉IMT的进展，并降低主要心血管事件和死亡率的风险。正在进行的大规模临床试验的结果可能进一步确定他汀类药物的临床益处。
Background HMG CoA reductase inhibitors (or statins), a new class of lipid-lowering compounds, have raised expectations for more widespread use than that of the older lipid-lowering drugs. Not only are they more effective in lowering LDL cholesterol, but they are better tolerated as well. No data exist concerning the effect of statins on early carotid atherosclerosis and clinical events in men and women who have moderately elevated LDL cholesterol levels but are free of symptomatic cardiovascular disease.Methods and Results Lovastatin (20 to 40 mg/d) or its placebo was evaluated in a double-blind, randomized clinical trial with factorial design along with warfarin (1 mg/d) or its placebo. This report is limited to the lovastatin component of the trial. Daily aspirin (81 mg/d) was recommended for everyone. Enrollment included 919 asymptomatic men and women, 40 to 79 years old, with early carotid atherosclerosis as defined by B-mode ultrasonography and LDL cholesterol between the 60th and 90th percentiles. The 3-year change in mean maximum intimal-medial thickness (IMT) in 12 walls of the carotid arteries was the primary outcome; change in single maximum IMT and incidence of major cardiovascular events were secondary outcomes. LDL cholesterol fell 28%, from 156.6 mg/dL at baseline to 113.1 mg/dL at 6 months (P < .0001), in the lovastatin groups and was largely unchanged in the lovastatin-placebo groups. Among participants not on warfarin, regression of the mean maximum IMT was seen after 12 months in the lovastatin group compared with the placebo group; the 3-year difference was statistically significant (P = .001). A larger favorable effect of lovastatin was observed for the change in single maximum IMT but was not statistically significant (P = .12). Five lovastatin-treated participants suffered major cardiovascular events-coronary heart disease mortality, nonfatal myocardial infarction, or stroke - versus 14 in the lovastatin-placebo groups (P = .04). One lovastatin-treated participant died, compared with eight on lovastatin-placebo (P = .02).Conclusions In men and women with moderately elevated LDL cholesterol, lovastatin reverses progression of IMT in the carotid arteries and appears to reduce the risk of major cardiovascular events and mortality. Results from ongoing large-scale clinical trials may further establish the clinical benefit of statins.