Effect of statin therapy on C-reactive protein levels - The Pravastatin Inflammation/CRP Evaluation (PRINCE): A randomized trial and cohort study
Effect of statin therapy on C-reactive protein levels - The Pravastatin Inflammation/CRP Evaluation (PRINCE): A randomized trial and cohort study
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DOI：
10.1001/jama.286.1.64
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发表时间：
2001-07-04
影响因子：
120.7
通讯作者：
Ridker, PM
中科院分区：
文献类型：
--
作者：
Albert, MA;Danielson, E;Ridker, PM
背景：炎症生物标志物C反应蛋白（CRP）的血浆水平可预测心血管风险，回顾性研究表明，3 - 羟基 - 3 - 甲基戊二酰辅酶A还原酶抑制剂（他汀类药物）可能在很大程度上独立于低密度脂蛋白胆固醇（LDL - C）降低CRP。然而，直接评估他汀类药物这种抗炎作用的前瞻性试验数据尚未获得。
目的：检验普伐他汀具有抗炎作用（以CRP降低为证据）这一假设。
设计、地点和参与者：基于社区的前瞻性随机双盲试验，包括1702名无心血管疾病既往史的男性和女性（一级预防队列），以及开放标签研究，包括1182名已知患有心血管疾病的患者（二级预防队列），这些患者至少提供了基线和12周的血液样本。该研究于2000年2月至12月在美国的诊所进行。
干预措施：双盲一级预防试验的参与者被随机分配接受40mg/d的普伐他汀（n = 865）或安慰剂（n = 837），持续24周。二级预防队列的参与者接受40mg/d的开放标签普伐他汀，持续24周。
主要观察指标：从基线到24周CRP水平的变化。
结果：在一级预防试验中，与安慰剂相比，普伐他汀使中位CRP水平降低了16.9%（P<......（此处原文似乎不完整）
Context Plasma levels of the inflammatory biomarker C-reactive protein (CRP) predict cardiovascular risk, and retrospective studies suggest that 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitors (stations) may lower CRP in a manner largely independent of low-density lipoprotein cholesterol (LDL-C). However, prospective trial data directly evaluating this anti-inflammatory effect of statins are not available.Objective to test the hypothesis that pravastation has anti-inflammatory effects as evidenced by CRP reduction.Design, Setting, and Participants Community-based, prospective, randomized, double-blind trial including 1702 men and women with no prior history of cardiovascular disease (primary prevention cohort) and open-label study including 1182 patients with known cardiovascular disease (secondary prevention cohort) who provided at least baseline and 12-week blood samples. The study was conducted in US office-based practices from February to December 2000.Interventions Participants in the double-blind primary prevention trial were randomly assigned to receive 40 mg/d of pravastatin (n=865) or placebo (n=837) for 24 weeks. Participants in the secondary prevention cohort received 40 mg/d of open-label pravastatin for 24 weeks.Main Outcome Measure Change in CRP levels from baseline to 24 weeks.Results In the primary prevention trial, compared with placebo, pravastatin reduced median CRP levels by 16.9% (P