A randomized trial of rosuvastatin in the prevention of venous thromboembolism.
A randomized trial of rosuvastatin in the prevention of venous thromboembolism.
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DOI：
10.1056/nejmoa0900241
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发表时间：
2009-04-30
期刊：
影响因子：
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通讯作者：
Ridker PM
中科院分区：
文献类型：
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作者：
Glynn RJ;Danielson E;Fonseca FA;Genest J;Gotto AM Jr;Kastelein JJ;Koenig W;Libby P;Lorenzatti AJ;MacFadyen JG;Nordestgaard BG;Shepherd J;Willerson JT;Ridker PM
关于动脉和静脉血栓形成是否有共同的途径，以及对一种疾病过程的已知疗效的治疗是否对另一种疾病过程具有一致的益处，仍存在争议。观察性研究已经得出了他汀类药物治疗对静脉血栓栓塞风险影响的可变估计值，缺乏随机证据。症状性静脉血栓栓塞是预防使用他汀类药物的理由：一项评价瑞舒伐他汀的干预试验（JUPITER）的预定终点。我们将17，802名低密度脂蛋白（LDL）胆固醇水平低于130 mg/dL且高敏C反应蛋白水平≥ 2.0 mg/L的表面健康男性和女性随机分配至瑞舒伐他汀组（20 mg/d）或安慰剂组。意向性治疗分析随访首次发生肺栓塞或深静脉血栓的参与者。在中位随访1.9年（最长5.0年）期间，94名受试者发生了症状性静脉血栓栓塞，瑞舒伐他汀组34名，安慰剂组60名。瑞舒伐他汀组和安慰剂组的静脉血栓栓塞发生率分别为0.18和0.32/100人-年随访（瑞舒伐他汀的风险比为0.57; 95%置信区间[CI]为0.37 - 0.86; P=0.007），无诱因静脉血栓栓塞的相应发生率为0.10和0.17（风险比0.61; 95% CI，0.35 - 1.09; P=0.089），诱发静脉血栓栓塞为0.08和0.16（风险比0.52; 95% CI，0.28 - 0.96; P=0.033）。肺栓塞的相应发生率为0.09和0.12（风险比0.77; 95% CI，0.41 - 1.45; P=0.42），而深静脉血栓形成的发生率仅为0.09和0.20（风险比0.45; 95% CI，0.25 - 0.79; P=0.004）。在检查的所有亚组中观察到一致的效应。治疗组间出血率无差异。在这项针对表面健康人群的试验中，瑞舒伐他汀显著降低了症状性静脉血栓栓塞的发生率。（ClinicalTrials.gov编号，NCT 00239681。）
Controversies persist on whether arterial and venous thrombosis share common pathways and whether treatments of known efficacy for one disease process have consistent benefits for the other. Observational studies have yielded variable estimates of the effect of statin therapy on risk of venous thromboembolism, and randomized evidence is lacking. Symptomatic venous thromboembolism was a pre-specified endpoint of Justification for the Use of Statins in Prevention: an Intervention Trial Evaluating Rosuvastatin (JUPITER). We randomly assigned 17,802 apparently healthy men and women with low-density lipoprotein (LDL) cholesterol levels of less than 130 mg/dL and high-sensitivity C-reactive protein levels of 2.0 mg/L or higher to rosuvastatin, 20 mg/d, or placebo. Intention-to-treat analyses followed participants for the first occurrence of pulmonary embolism or deep vein thrombosis. During a median follow-up of 1.9 years (maximum 5.0), symptomatic venous thromboembolism occurred in 94 participants, 34 in the rosuvastatin group and 60 in the placebo group. The rates of venous thromboembolism were 0.18 and 0.32 per 100 person-years of follow-up in the rosuvastatin and placebo groups, respectively (hazard ratio for rosuvastatin 0.57; 95% confidence interval [CI], 0.37 to 0.86; P=0.007), with corresponding rates of 0.10 and 0.17 for unprovoked venous thromboembolism (hazard ratio 0.61; 95% CI, 0.35 to 1.09; P=0.089) and 0.08 and 0.16 for provoked venous thromboembolism (hazard ratio 0.52; 95% CI, 0.28 to 0.96; P=0.033). Corresponding rates of pulmonary embolism were 0.09 and 0.12 (hazard ratio 0.77; 95% CI, 0.41 to 1.45; P=0.42), whereas rates of deep vein thrombosis only were 0.09 and 0.20 (hazard ratio 0.45; 95% CI, 0.25 to 0.79; P=0.004). Consistent effects were observed in all subgroups examined. No differences were seen between treatment groups in rates of bleeding. In this trial of apparently healthy persons, rosuvastatin significantly reduced the occurrence of symptomatic venous thromboembolism. (ClinicalTrials.gov number, NCT00239681.)