Sterling Rock Falls Clinic, 101 East Miller Road, Sterling, IL, 61081, USA.
J Clin Lipidol. 2007 Jul;1(3):182-90. doi: 10.1016/j.jacl.2007.05.004. Epub 2007 Jun 2.
3-Hydroxy-3-methylglutaryl-coenzyme A reductase inhibitors (statins) are the first-line treatment for dyslipidemia and the results of large statin trials have a significant impact on guidelines for cardiovascular disease (CVD) management, such as those set by the National Cholesterol Education Program Adult Treatment Panel. The benefit of statin therapy in CVD prevention has traditionally been demonstrated in clinical trials by the superior efficacy of statins vs placebo in lowering low-density lipoprotein cholesterol (LDL-C) and preventing hard coronary heart disease (CHD) outcomes including myocardial infarction and CHD death. However, due to earlier and improved treatment of CVD, the clinical manifestations of atherosclerosis are changing and other forms of CVD are now thought to predominate (such as revascularization and stroke). These changes in how CVD manifests in the patient population may have consequences for selection of endpoints when designing future clinical trials. Recent statin trials have also demonstrated the early and improved clinical benefit of lowering LDL-C beyond traditional goals with intensive statin therapy vs more moderate lipid-lowering therapy. This review assesses the impact of early statin trials on current CVD management guidelines, summarizes results of recent landmark statin trials, and evaluates the potential implications of these studies for future clinical trials and CVD management guidelines.
3-羟基-3-甲基戊二酰辅酶 A 还原酶抑制剂(他汀类药物)是治疗血脂异常的一线药物,大型他汀类药物试验的结果对心血管疾病(CVD)管理指南有重大影响,例如国家胆固醇教育计划成人治疗专家组制定的指南。他汀类药物治疗在 CVD 预防中的益处传统上通过临床试验来证明,与安慰剂相比,他汀类药物在降低低密度脂蛋白胆固醇(LDL-C)和预防硬冠状动脉心脏病(CHD)结局方面(如心肌梗死和 CHD 死亡)具有更好的疗效。然而,由于 CVD 的早期和改善治疗,动脉粥样硬化的临床表现正在发生变化,现在认为其他形式的 CVD 更为常见(如血运重建和中风)。这些在患者人群中 CVD 表现方式的变化可能会对未来临床试验设计时选择终点产生影响。最近的他汀类药物试验还表明,与更温和的降脂治疗相比,强化他汀类药物治疗在降低 LDL-C 方面的早期和改善的临床益处超过了传统目标。本综述评估了早期他汀类药物试验对当前 CVD 管理指南的影响,总结了最近具有里程碑意义的他汀类药物试验的结果,并评估了这些研究对未来临床试验和 CVD 管理指南的潜在影响。