Koren Michael J, Hunninghake Donald B
Jacksonville Center for Clinical Research, Jacksonville, Florida, USA.
J Am Coll Cardiol. 2004 Nov 2;44(9):1772-9. doi: 10.1016/j.jacc.2004.07.053.
This study sought to determine if an aggressive, focused low-density lipoprotein cholesterol (LDL-C)-lowering strategy was superior to usual care for coronary heart disease (CHD) patients enrolled in health maintenance organization or Veterans Administration settings.
Statin therapy benefits are well established. No prospective, randomized studies have tested strategies to optimize these benefits in a "real-world" setting.
A total of 2,442 CHD patients with hyperlipidemia were randomized to either an aggressive treatment arm using atorvastatin or usual care and followed for 51.5 months on average. Atorvastatin-group patients were titrated to LDL-C goals of <80 mg/dl (2.1 mmol/l) or a maximum atorvastatin dose of 80 mg/day. Usual-care patients received any treatment deemed appropriate by their regular physicians. End point assessments were complete in 958 atorvastatin-group and 941 usual-care patients. Partial assessments occurred in 259 patients in the atorvastatin group and 284 patients in the usual care group who did not complete four years of study participation because of adverse events, withdrawn consent, or follow-up loss. The primary efficacy parameter was time to first cardiovascular event.
A total of 289 (23.7%) patients in the atorvastatin group compared with 333 (27.7%) patients in the usual care group experienced a primary outcome (hazard ratio, 0.83; 95% confidence interval 0.71 to 0.97, p = 0.02). This reduction in morbidity was largely due to fewer non-fatal myocardial infarctions (4.3% vs. 7.7%, p = 0.0002). Levels of LDL-C were reduced more (34.3% vs. 23.3%, p < 0.0001) and National Cholesterol Education Program goals (LDL-C <100 mg/dl) more likely met at end-of-study visits (72.4% vs. 40.0%) in patients receiving atorvastatin compared with those receiving usual care.
An aggressive, focused statin therapy management strategy outperformed usual care in health maintenance organization and Veterans Administration clinic patients with CHD.
本研究旨在确定积极的、有针对性的降低低密度脂蛋白胆固醇（LDL-C）策略是否优于健康维护组织或退伍军人管理局环境中冠心病（CHD）患者的常规治疗。
他汀类药物治疗的益处已得到充分证实。尚无前瞻性随机研究在“现实世界”环境中测试优化这些益处的策略。
总共2442例患有高脂血症的冠心病患者被随机分为积极治疗组（使用阿托伐他汀）或常规治疗组，并平均随访51.5个月。阿托伐他汀组患者的LDL-C目标调整为<80mg/dl（2.1mmol/l）或阿托伐他汀最大剂量80mg/天。常规治疗组患者接受其常规医生认为合适的任何治疗。958例阿托伐他汀组患者和941例常规治疗组患者完成了终点评估。259例阿托伐他汀组患者和284例常规治疗组患者因不良事件、撤回同意或失访未完成四年研究参与，进行了部分评估。主要疗效参数是首次心血管事件发生时间。
阿托伐他汀组共有289例（23.7%）患者与常规治疗组333例（27.7%）患者发生主要结局（风险比，0.83；95%置信区间0.71至0.97，p = 0.02）。发病率的降低主要是由于非致命性心肌梗死减少（4.3%对7.7%，p = 0.0002）。与接受常规治疗的患者相比，接受阿托伐他汀治疗的患者在研究结束时LDL-C水平降低更多（34.3%对23.3%，p < 0.0001），更有可能达到国家胆固醇教育计划目标（LDL-C<100mg/dl）（72.4%对40.0%）。
在健康维护组织和退伍军人管理局诊所的冠心病患者中，积极的、有针对性的他汀类药物治疗管理策略优于常规治疗。
