冠心病低危患者早期他汀干预临床意义介绍.ppt

JUPITER研究一级预防 FDA专家委员会 2009年12月投票结果 JUPITER – 总结与展望 JUPITER 研究纳入了LDL-C水平正常或低于正常、但CPR水平升高而评价为心血管风险增加的人群，这部分人群根据现行的治疗指南不需要接受他汀类药物治疗。 研究发现，和安慰剂组相比，接受瑞舒伐他汀20mg治疗组的主要终点重大心血管事件（由下列组分构成：心血管死亡、心梗、卒中、不稳定性心绞痛、动脉血管成形术）减少了44% （p 0.00001） 和安慰剂相比，接受瑞舒伐他汀20mg治疗可使患者总体死亡率降低20% (p=0.02), 这是在无明确CHD病史的人群中应用他汀类所获得的独特的研究结果 在JUPITER研究中，近9000名参加者接受瑞舒伐他汀20mg长期治疗的耐受性良好 比较两治疗组间的肌肉无力、肿瘤、血液学异常、胃肠道、肝肾功能，均无差异 来自JUPITER研究的结果强调了采用强效他汀类治疗对心血管疾病风险升高患者的重要意义。 Ridker P et al. N Eng J Med 2008;359: 2195-2207 * Slide 18. CIMT progression rate: marker of increased risk for events CIMT measurement is tracked across time to assess for changes in atherosclerosis extent during pharmacotherapy; slower rates of progression have been associated with lower risk from CHD in the Cholesterol Lowering Atherosclerosis Study (CLAS). In CLAS, there was a direct relationship between CIMT progression and clinical events; a 3-fold greater CIMT progression rate was associated with a 3-fold higher risk for events. These data helped establish CIMT as a valid surrogate endpoint for clinical events. Reference: Hodis HN, Mack WJ, LaBree L, et al. The role of carotid arterial intima-media thickness in predicting clinical coronary events. Ann Intern Med 1998;128:262-269. * * * The participants in METEOR are lower risk than previous IMT trials in that they had no clinical disease (ie no CAD, no carotid plaque and no PVD) and low rates of risk factors (smoking, hypertension). Regression has been reported in other IMT trials, However, these trials included subjects at much higher CV risk (e.g. those with familial hypercholesteraemia in ASAP).. In addition, some of these trials use weaker methodology eg. ARBITER measured only the common carotid IMT, ACAPS reported regression but no formal test for regression was performed. References Crouse JR, Grobbee D, O’Leary D, et al. Measuring effects on intima media thickness: An evaluation of 瑞舒伐他汀 in subclinical atherosclerosis — The rationale and methodology of the METEOR study. Cardio