Secondary prevention by raising HDL cholesterol and reducing triglycerides in patients with coronary artery disease - The bezafibrate infarction prevention (BIP) study
Secondary prevention by raising HDL cholesterol and reducing triglycerides in patients with coronary artery disease - The bezafibrate infarction prevention (BIP) study
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DOI：
10.1161/01.cir.102.1.21
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发表时间：
2000-07-04
期刊：
影响因子：
37.8
通讯作者：
Henkin, J
中科院分区：
文献类型：
--
作者：
Schlesinger, Z;Vered, Z;Henkin, J
背景：低高密度脂蛋白胆固醇（HDL-C）水平、高甘油三酯水平或两者兼有的冠心病患者发生心血管事件的风险增加，但升高HDL-C或降低甘油三酯的临床影响仍有待证实。方法和结果：在一项双盲试验中，3090例既往心肌梗死或稳定型心绞痛，总胆固醇180 - 250mg /dL， HDL-C小于或等于45mg /dL，甘油三酯小于或等于300mg /dL，低密度脂蛋白胆固醇小于或等于180mg /dL的患者被随机分为每天400mg贝扎布特或安慰剂组；他们的平均随访时间为6.2年。主要终点是致死性或非致死性心肌梗死或猝死。贝扎菲特使HDL-C增加18%，甘油三酯降低21%。贝扎非特组的主要终点频率为13.6%，安慰剂组为15.0% （P=0.26）。6.2年后，主要终点的累积概率降低7.3%,（P=0.24）。在高基线甘油三酯亚组（大于或等于200mg /dL）的事后分析中，贝扎布特降低主要终点累积概率为39.5% （P=0.02）。总死亡率和非心脏死亡率相似，不良事件和癌症分布均匀。结论：贝扎菲特对提高HDL-C水平和降低甘油三酯安全有效。观察到主要终点发生率降低的总体趋势。基线甘油三酯高（大于或等于200mg /dL）患者的主要终点降低需要进一步确认。
Background-Coronary heart disease patients with low high-density lipoprotein cholesterol (HDL-C) levels, high triglyceride levels, or both are at an increased risk of cardiovascular events, but the clinical impact of raising HDL-C or decreasing triglycerides remains to be confirmed.Methods and Results-In a double-blind trial, 3090 patients with a previous myocardial infarction or stable angina, total cholesterol of 180 to 250 mg/dL, HDL-C less than or equal to 45 mg/dL, triglycerides less than or equal to 300 mg/dL, and low-density lipoprotein cholesterol less than or equal to 180 mg/dL were randomized to receive either 400 mg of bezafibrate per day or a placebo; they were followed for a mean of 6.2 years. The primary end point was fatal or nonfatal myocardial infarction or sudden death. Bezafibrate increased HDL-C by 18% and reduced triglycerides by 21%. The frequency of the primary end point was 13.6% on bezafibrate versus 15.0% on placebo (P=0.26). After 6.2 years, the reduction in the cumulative probability of the primary end point was 7.3%, (P=0.24). In a post hoc analysis in the subgroup with high baseline triglycerides (greater than or equal to 200 mg/dL), the reduction in the cumulative probability of the primary end point by bezafibrate was 39.5% (P=0.02). Total and noncardiac mortality rates were similar, and adverse events and cancer were equally distributed.Conclusions-Bezafibrate was safe and effective in elevating HDL-C levels and lowering triglycerides. An overall trend in a reduction of the incidence of primary end points was observed. The reduction in the primary end point in patients with high baseline triglycerides (greater than or equal to 200 mg/dL) requires further confirmation.