大剂量阿托伐他汀对常用量辛伐他汀对心肌梗死后二级预防:理想的研究:一项随机对照试验。
文章的细节
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引用
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皮德森TR, Faergeman O, Kastelein JJ,奥尔森AG) Tikkanen MJ,河中沙洲,拉森ML, Bendiksen FS,林达尔C, Szarek M,蔡J
大剂量阿托伐他汀对常用量辛伐他汀对心肌梗死后二级预防:理想的研究:一项随机对照试验。
《美国医学协会杂志》上。2005年11月16日,294 (19):2437 - 45。doi: 10.1001 / jama.294.19.2437。
- PubMed ID
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16287954 (在PubMed]
- 文摘
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背景:证据表明更密集的降低低密度脂蛋白胆固醇(低密度脂蛋白)比一般临床应用将进一步受益稳定冠状动脉疾病。目的:比较2的影响策略的脂质降低心血管疾病风险的患者先前心肌梗死(MI)。设计、设置和参与者:理想的研究、前瞻性、随机、非盲、盲端点评价试验在190年进行动态心脏病护理和专业实践在欧洲北部1999年3月至2005年3月的平均随访4.8年,共招收了8888名80岁或更年轻的患者急性心肌梗死史。干预:病人被随机分配接受高剂量阿托伐他汀(80毫克/天;n = 4439),或常用量辛伐他汀(20毫克/天;n = 4449)。主要结果测量:发生的一个主要冠状动脉事件,定义为冠心病死亡,证实非致死性急性心肌梗死、心脏骤停复苏。结果:治疗期间,意味着低密度脂蛋白水平是104 (SE、0.3 mg / dL)辛伐他汀组和81 (SE、0.3 mg / dL)的阿托伐他汀组。一个主要冠脉事件发生在463年辛伐他汀的患者(10.4%)和411年阿托伐他汀的患者(9.3%)(危险比[HR], 0.89;95%置信区间,0.78 - -1.01;P = . 07)。 Nonfatal acute MI occurred in 321 (7.2%) and 267 (6.0%) in the 2 groups (HR, 0.83; 95% CI, 0.71-0.98; P = .02), but no differences were seen in the 2 other components of the primary end point. Major cardiovascular events occurred in 608 and 533 in the 2 groups, respectively (HR, 0.87; 95% CI, 0.77-0.98; P = .02). Occurrence of any coronary event was reported in 1059 simvastatin and 898 atorvastatin patients (HR, 0.84; 95% CI, 0.76-0.91; P<.001). Noncardiovascular death occurred in 156 (3.5%) and 143 (3.2%) in the 2 groups (HR, 0.92; 95% CI, 0.73-1.15; P = .47). Death from any cause occurred in 374 (8.4%) in the simvastatin group and 366 (8.2%) in the atorvastatin group (HR, 0.98; 95% CI, 0.85-1.13; P = .81). Patients in the atorvastatin group had higher rates of drug discontinuation due to nonserious adverse events; transaminase elevation resulted in 43 (1.0%) vs 5 (0.1%) withdrawals (P<.001). Serious myopathy and rhabdomyolysis were rare in both groups. CONCLUSIONS: In this study of patients with previous MI, intensive lowering of LDL-C did not result in a significant reduction in the primary outcome of major coronary events, but did reduce the risk of other composite secondary end points and nonfatal acute MI. There were no differences in cardiovascular or all-cause mortality. Patients with MI may benefit from intensive lowering of LDL-C without an increase in noncardiovascular mortality or other serious adverse reactions.Trial Registration ClinicalTrials.gov Identifier: NCT00159835.
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