Hildemann Steven, Karmann Barbara, Pittrow David, Barho Christian, Darius Harald, Bode Christoph
Medical Department, essex Pharma, Munich, Germany.
Curr Med Res Opin. 2008 Jun;24(6):1659-68. doi: 10.1185/03007990802134755. Epub 2008 May 2.
To determine (a) the proportion of patients at high risk of cardiovascular events who achieve low-density lipoprotein cholesterol (LDL-C) goals as recommended by the National Cholesterol Education Program Adult Treatment Panel (NCEP ATP III) guidelines, and (b) the predictors of poor LDL-C control.
Two open-label, prospective, non-randomised, observational studies (study 1 with n=19 194 patients, predominantly with coronary artery disease (CHD); study 2 with n=19 484 patients, pre-dominantly with diabetes mellitus (DM)). Patients received, usually after statin pretreatment, ezetimibe 10 mg plus simvastatin as fixed-dose combinations over 3 months. Bivariate and multivariate regression analysis was performed to identify factors associated with poor LDL-C control.
At study end, 38% (up from 4.7% at baseline) of CHD and 35% (up from 3.3% at baseline) of diabetic patients achieved the target LDL value <100 mg/dl (2.6 mmol/l) after treatment with a fixed-dose ezetimibe-simvastatin combination. In both studies, concomitant atherosclerotic disease was associated with good control. Conversely, factors associated with poor control were, among others, high baseline LDL-C values, pretreatment with certain statins, and (in the DM study) high HbA(1c), and high body mass index.
Under real world, general practice conditions, a substantial proportion of high-risk patients with CHD and/or DM met LDL-C target levels on dual cholesterol inhibition with ezetimibe/simvastatin. A limited number of easily recognisable factors allow physicians to identify high risk patients whose LDL-C is likely to be difficult to control. Early identification of this patient group may have profound clinical benefits in general practice by enabling specific early interventions such as counselling on physical activity, dietary support and/or follow up visits to the GP.
确定（a）心血管事件高危患者中达到美国国家胆固醇教育计划成人治疗专家组（NCEP ATP III）指南推荐的低密度脂蛋白胆固醇（LDL-C）目标的患者比例，以及（b）LDL-C控制不佳的预测因素。
两项开放标签、前瞻性、非随机观察性研究（研究1有19194例患者，主要患有冠状动脉疾病（CHD）；研究2有19484例患者，主要患有糖尿病（DM））。患者通常在接受他汀类药物预处理后，服用依泽替米贝10毫克加辛伐他汀的固定剂量组合，持续3个月。进行双变量和多变量回归分析以确定与LDL-C控制不佳相关的因素。
研究结束时，冠心病患者中有38%（从基线时的4.7%上升），糖尿病患者中有35%（从基线时的3.3%上升）在用依泽替米贝 - 辛伐他汀固定剂量组合治疗后达到目标LDL值<100毫克/分升（2.6毫摩尔/升）。在两项研究中，合并动脉粥样硬化疾病与良好控制相关。相反，与控制不佳相关的因素包括高基线LDL-C值、某些他汀类药物的预处理，以及（在糖尿病研究中）高糖化血红蛋白（HbA1c）和高体重指数。
在现实世界的全科医疗条件下，相当一部分患有冠心病和/或糖尿病的高危患者在接受依泽替米贝/辛伐他汀双重胆固醇抑制治疗时达到了LDL-C目标水平。少数易于识别的因素使医生能够识别出LDL-C可能难以控制的高危患者。早期识别这一患者群体可能通过实施特定的早期干预措施，如体育活动咨询、饮食支持和/或全科医生随访，在全科医疗中带来深远的临床益处。
