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急性冠状动脉综合征患者辛伐他汀早期强化与晚期保守治疗的比较:A-Z试验的Z阶段

Early intensive vs a delayed conservative simvastatin strategy in patients with acute coronary syndromes: Phase Z of the A to Z trial

作     者:De Lemos J.A. Blazing M.A. Wiviott S.D. 任付先 

作者机构:Cardiology Division Univ. Texas Southwestern Med. Ctr. 5 323 Harry Hines Blvd Dallas TX 75390-9047 United States Dr. 

出 版 物:《世界核心医学期刊文摘(心脏病学分册)》 (Digest of the World Core Medical Journals(Cardiology))

年 卷 期:2005年第1卷第2期

页      面:4-5页

学科分类:1002[医学-临床医学] 100201[医学-内科学(含:心血管病、血液病、呼吸系病、消化系病、内分泌与代谢病、肾病、风湿病、传染病)] 10[医学] 

主  题:A-Z试验 早期强化 致命性心肌梗死 他汀类药物 双盲试验 心血管事件 终点事件 低密度脂蛋白 肌病 安慰剂 

摘      要:Context: Limited data are available evaluating how the timing and intensity of statin therapy following an acute coronary syndrome (ACS) event affect clinical outcome. Objective: To compare early initiation of an intensive statin regimen with delayed initiation of a less intensive regimen in patients with ACS. Design , Setting, and Participants: International, randomized, double blind trial of p atients with ACS receiving 40 mg/d of simvastatin for 1 month followed by 80 mg/ d thereafter (n=2265) compared with ACS patients receiving placebo for 4 months followed by 20 mg/d of simvastatin (n=2232), who were enrolled in phase Z of the A to Z trial between December 29, 1999, and January 6, 2003. Main Outcome Measu re: The primary end point was a composite of cardiovascular death, nonfatal myoc ardial infarction, readmission for ACS, and stroke. Follow up was for at least 6 months and up to 24 months. Results Among the patients in the placebo plus sim vastatin group, the median low density lipoprotein (LDL) cholesterol level achi eved while taking placebo was 122mg/dL (3.16 mmol/L) at 1 month and was 77mg/dL (1.99 mmol/L) at 8 months while taking 20 mg/d of simvastatin. Among the patient s in the simvastatin only group, the median LDL cholesterol level achieved at 1 month while taking 40 mg/d of simvastatin was 68mg/dL (1.76 mmol/L) and was 63 m g/dL (1.63 mmol/L) at 8 months while taking 80 mg/d of simvastatin. A total of 3 43 patients (16.7%) in the placebo plus simvastatin group experienced the prima ry end point compared with 309 (14.4%) in the simvastatin only group (40 mg/80 mg) (hazard ratio [HR], 0.89; 95%confidence interval [Cl] 0.76-1.04; P=.14 ). C ardiovascular death occurred in 109 (5.4%) and 83 (4.1 %) patients in the 2 gr oups (HR, 0.75; 95%Cl, 0.57-1.00; P=.05) but no differences were observed in other individual components of the primary end po int. No difference was evident during the first 4 months between the groups for the primary end point (HR, 1.0

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