Pravastatin reduces carotid intima-media thickness progression in an asymptomatic hypercholesterolemic Mediterranean population: The carotid atherosclerosis Italian ultrasound study

Pravastatin reduces carotid intima-media thickness progression in an asymptomatic hypercholesterolemic Mediterranean population: The carotid atherosclerosis Italian ultrasound study
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DOI:
10.1016/s0002-9343(96)00333-6
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发表时间:
1996-12-01
影响因子:
5.9
通讯作者:
Ventura, A
Ventura, A
中科院分区:
医学2区
文献类型:
--
作者:
Mercuri, M;Bond, G;Ventura, A

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意大利颈动脉粥样硬化超声研究(CAIUS)是在一个地中海国家的305名无症状患者中进行的,目的是检测降脂对颈动脉内膜中层厚度(IMT)进展的影响。患者和方法:入选标准包括高胆固醇血症(基线平均值:低密度脂蛋白[LDL] = 4.68 mmol/L,高密度脂蛋白[HDL] = 1.37 mmol/L),颈动脉中至少有一个1.3 < IMT < 3.5 mm。患者(平均年龄55岁,53%为男性)被分配至普伐他汀组(40 mg/天,n = 151)或安慰剂组(n不等于154)。在基线时使用超声成像定量IMT,此后每半年进行一次,持续3年。计算每次患者访视的12个最大IMT(MMaxIMT)的平均值,并用于确定每例患者的纵向进展斜率。在MMaxIMT进展的意向治疗组的差异被选为先验的主要endpoint.Results:五个严重的心血管事件(1致命的心肌梗死),和7脱落的癌症登记。在普伐他汀组中,LDL在3个月后下降了-0.22,而安慰剂组为-0.01,此后基本保持不变(在36个月时分别为-0.23和+0.01)。MMaxIMT的进展为0.009 +/- 0.0027与-0.0043 +/- 0.0028 mm/年(x +/- SE,P
The Carotid Atherosclerosis Italian Ultrasound Study (CAIUS) was performed to test the effects of lipid lowering on the progression of carotid intima-media thickness (IMT) in 305 asymptomatic patients from a Mediterranean country. PATIENTS AND METHODS: Eligibility included hypercholesterolemia (baseline means: low-density lipoprotein [LDL] = 4.68 mmol/L, high-density lipoprotein [HDL] = 1.37 mmol/L), and at least one 1.3 < IMT < 3.5 mm in the carotid arteries. Patients (mean age 55 years, 53% male) were assigned to pravastatin (40 mg/day, n = 151) or placebo (n not equal 154). Ultrasound imaging was used to quantify IMT at baseline, and semiannually thereafter for up to 3 years. The mean of the 12 maximum IMTs (MMaxIMT), was calculated for each patient visit, and used to determine each patient's longitudinal progression slope. The intention-to-treat group difference in the MMaxIMT progression was chosen a priori as the primary end point.RESULTS: Five serious cardiovascular events (1 fatal myocardial infarction), and 7 drop-outs for cancer were registered. In the pravastatin group, LDL decreased -0.22 after 3 months versus -0.01 in the placebo group, and remained substantially unchanged afterward (-0.23 versus +0.01 at 36 months, respectively). Progression of the MMaxIMT was 0.009 +/- 0.0027 versus -0.0043 +/- 0.0028 mm/year (x +/- SE, P