Urbinati Stefano, Romanazzi Serena, Gambetti Simona
U.O.C di Cardiologia, Ospedale Bellaria, Bologna.
G Ital Cardiol (Rome). 2009 Dec;10(11-12 Suppl 3):28S-32S.
Major clinical evidence obtained in the last 15-20 years with statins is reviewed. A tight correlation between LDL cholesterol and occurrence of major cardiovascular events has been observed. Moreover, favorable effects have been shown also in subjects with normal cholesterol blood levels and high levels of high-sensitivity C-reactive protein (hsCRP), a predictive marker of cardiovascular events. In two studies involving patients with acute coronary artery disease the prognosis was better in subjects with cholesterol levels < 70 mg/dl or hsCRP < 2 mg/I. These studies provide the background for the JUPITER trial, a double-blind randomized controlled "globalized" study with rosuvastatin 20 mg in primary prevention, including 17 802 normal cholesterolemic males and females with increased risk for hsCRP > 2 mg/I. The combined primary endpoint included myocardial infarction, stroke, arterial revascularization, hospitalization for unstable angina, or death from cardiovascular causes. Rosuvastatin reduced LDL cholesterol levels by 50% and hsCRP levels by 37%. The trial was stopped after a median follow-up period of 1.9 years, due to a significant superiority of rosuvastatin on the incidence of major cardiovascular events. Moreover, long-term adherence to randomized treatment was excellent, and safety was consistent in the two groups. Eligible patients were more than one fourth of the outpatients attending a cardiology clinic; median age of 66 is 5-6 years lower than age of patients admitted to Italian intensive cardiac care units for acute coronary disease, suggesting the usefulness of a primary prevention program with rosuvastatin in this clinical setting. Practical and healthcare planning implications deriving from this study are currently under evaluation by scientific societies and healthcare authorities.
回顾了过去15至20年使用他汀类药物获得的主要临床证据。已观察到低密度脂蛋白胆固醇与主要心血管事件的发生之间存在紧密关联。此外，对于胆固醇血液水平正常但高敏C反应蛋白（hsCRP）水平较高（心血管事件的预测指标）的受试者，也显示出了有益效果。在两项涉及急性冠状动脉疾病患者的研究中，胆固醇水平<70mg/dl或hsCRP<2mg/I的受试者预后更好。这些研究为JUPITER试验提供了背景，该试验是一项双盲随机对照的“全球化”研究，在一级预防中使用瑞舒伐他汀20mg，纳入了17802名胆固醇正常但hsCRP>2mg/I风险增加的男性和女性。联合主要终点包括心肌梗死、中风、动脉血运重建、因不稳定型心绞痛住院或心血管原因导致的死亡。瑞舒伐他汀使低密度脂蛋白胆固醇水平降低了50%，hsCRP水平降低了37%。由于瑞舒伐他汀在主要心血管事件发生率方面具有显著优势，该试验在中位随访期1.9年后停止。此外，长期坚持随机治疗的情况良好，两组的安全性一致。符合条件的患者占心脏病门诊患者的四分之一以上；66岁的中位年龄比因急性冠状动脉疾病入住意大利重症心脏监护病房的患者年龄低5至6岁，这表明在这种临床环境中使用瑞舒伐他汀进行一级预防计划是有用的。科学协会和卫生当局目前正在评估这项研究产生的实际和医疗规划影响。
