效果非常高强度的他汀类药物治疗对冠状动脉粥样硬化的回归:小行星审判。

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尼森,尼科尔斯SJ, Sipahi我,利比P,里奇伦JS,巴兰坦厘米,达维尼翁J,埃贝尔R, Fruchart JC, Tardif JC, Schoenhagen P, Crowe T,该隐V, Wolski K, Goormastic M, Tuzcu EM

效果非常高强度的他汀类药物治疗对冠状动脉粥样硬化的回归:小行星审判。

《美国医学协会杂志》上。2006年4月5日,295 (13):1556 - 65。Epub 2006年3月13日。

PubMed ID

16533939 (在PubMed

]

文摘

背景:前血管内超声(治疗作用试验已经证明放缓或停止与他汀类药物治疗动脉粥样硬化的进展却没有令人信服的证据显示回归使用动脉粥样化体积百分比(奶油水果蛋白饼),最严格IVUS疾病进展和回归。目的:评估非常密集的他汀类药物治疗能否回归冠状动脉粥样硬化由IVUS成像。设计和设置:前瞻性、非盲盲端点试验(研究探讨普伐对冠状动脉粥样化血管内Ultrasound-Derived负担的影响(小行星))进行了53个社区和三级医疗中心在美国,加拿大,欧洲,澳大利亚。电动IVUS回落是用来评估冠状动脉粥样化负担在基线和治疗后24个月。每一对基线和随访IVUS评估蒙蔽的方式进行了分析。病人:2002年11月至2003年10月,507年患者基线IVUS检查和接收至少1研究药物的剂量。后24个月,349例可评价的连环IVUS检查。干预:所有患者接受密集的与普伐他汀治疗40毫克/天。主要结果测量:两个主要功效指定参数:奶油水果蛋白饼的变化和名义粉瘤体积的变化10毫米亚节疾病严重程度最大的基线。次要疗效变量,改变规范化整个动脉,动脉粥样化总额也指定。 RESULTS: The mean (SD) baseline low-density lipoprotein cholesterol (LDL-C) level of 130.4 (34.3) mg/dL declined to 60.8 (20.0) mg/dL, a mean reduction of 53.2% (P<.001). Mean (SD) high-density lipoprotein cholesterol (HDL-C) level at baseline was 43.1 (11.1) mg/dL, increasing to 49.0 (12.6) mg/dL, an increase of 14.7% (P<.001). The mean (SD) change in PAV for the entire vessel was -0.98% (3.15%), with a median of -0.79% (97.5% CI, -1.21% to -0.53%) (P<.001 vs baseline). The mean (SD) change in atheroma volume in the most diseased 10-mm subsegment was -6.1 (10.1) mm3, with a median of -5.6 mm3 (97.5% CI, -6.8 to -4.0 mm3) (P<.001 vs baseline). Change in total atheroma volume showed a 6.8% median reduction; with a mean (SD) reduction of -14.7 (25.7) mm3, with a median of -12.5 mm3 (95% CI, -15.1 to -10.5 mm3) (P<.001 vs baseline). Adverse events were infrequent and similar to other statin trials. CONCLUSIONS: Very high-intensity statin therapy using rosuvastatin 40 mg/d achieved an average LDL-C of 60.8 mg/dL and increased HDL-C by 14.7%, resulting in significant regression of atherosclerosis for all 3 prespecified IVUS measures of disease burden. Treatment to LDL-C levels below currently accepted guidelines, when accompanied by significant HDL-C increases, can regress atherosclerosis in coronary disease patients. Further studies are needed to determine the effect of the observed changes on clinical outcome. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT00240318.

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