Stanek Eric J, Sarawate Chaitanya, Willey Vincent J, Charland Scott L, Cziraky Mark J
Kos Pharmaceuticals, Inc., Cranbury, NJ, USA.
Curr Med Res Opin. 2007 Mar;23(3):553-63. doi: 10.1185/030079906x167660.
Current prevention guidelines support efforts to achieve optimal high-density lipoprotein (HDL-C) and triglyceride (TG) values, in addition to low-density lipoprotein (LDL-C) in order to reduce cardiovascular (CV) events. The study objective was to evaluate the risk of CV events in patients attaining versus not attaining combined (LDL-C, HDL-C, and TG) optimal lipid values.
METHODS/RESULTS: This retrospective cohort analysis was conducted using a 1.1 million member managed care database. Eligible patients had a full lipid panel between 10/1/99 and 9/30/00, were naive to lipid therapy, and had health plan eligibility 12 months pre- and post-index (baseline) lipid laboratory value. Optimal lipid values (LDL-C, HDL-C, and TG) were established using the National Cholesterol Education Program Adult Treatment Panel (NCEP ATP III) guidelines, and patients were placed into one of four groups: none, one, two, or three lipid components non-optimal at baseline. The presence of cardiovascular risk, disease, and events were determined by selected International Classification of Diseases, 9th Revision, Clinical Modification (ICD-9 CM) and Current Procedural Terminology (CPT codes). The definition of a CV event included: diagnosis of ischemic heart disease, peripheral arterial disease, stroke/TIA, or revascularization procedure. Odds ratios (OR) for a CV event associated with attainment of each optimal lipid fraction were determined by multivariate logistic regression. The study cohort included 30,348 patients, with a mean follow-up of 27 +/- 8 months. Mean age was 66 +/- 12 years; 16,549 (54%) were male; and 17,289 (57%) patients had coronary heart disease (CHD) or CHD risk equivalent. There were 5955 CV events that occurred in 4059 (13%) study patients. The presence of a single non-optimal lipid value slightly increased CV event risk [OR: 1.06; 95% CI: 0.95-1.18], whereas two or all three non-optimal lipid values significantly increased the risk of a CV event [OR: 1.22; 95% CI: 1.08-1.37; and 1.45; 95% CI: 1.24-1.68, respectively].
As with all large observational databases there are potential limitations including: patient selection bias (e.g., more interventions in patients with greater illness, lack of mortality data, and frequency of lipid monitoring), unknown confounding variables, and potential coding errors.
Not attaining optimal combined lipid values, independently and significantly, increased the risk of CV events in this large at-risk population with approximately 68,283 patient years of follow-up. The combination of non-attainment of optimal LDL-C with non-attainment of optimal HDL-C or TG values, or both, increased the adjusted risk of CV events by 22-45%. Thus, therapeutic strategies should focus on assessment and management of multiple lipid abnormalities, and not on single lipid risk factor modification.
当前的预防指南支持努力实现最佳的高密度脂蛋白(HDL-C)和甘油三酯(TG)水平,同时降低低密度脂蛋白(LDL-C)水平,以减少心血管(CV)事件。本研究的目的是评估达到与未达到联合(LDL-C、HDL-C和TG)最佳血脂水平的患者发生CV事件的风险。
方法/结果:本回顾性队列分析使用了一个拥有110万成员的管理式医疗数据库。符合条件的患者在1999年10月1日至2000年9月30日期间进行了完整的血脂检测,未接受过血脂治疗,并且在索引(基线)血脂实验室值前后12个月均符合健康计划资格。根据国家胆固醇教育计划成人治疗小组(NCEP ATP III)指南确定最佳血脂水平(LDL-C、HDL-C和TG),患者被分为四组之一:基线时无、一个、两个或三个血脂成分未达最佳水平。通过选定的国际疾病分类第九版临床修订本(ICD-9 CM)和当前程序术语(CPT代码)确定心血管风险、疾病和事件的存在。CV事件的定义包括:缺血性心脏病、外周动脉疾病、中风/短暂性脑缺血发作或血运重建手术的诊断。通过多变量逻辑回归确定与达到每个最佳血脂分数相关的CV事件的比值比(OR)。研究队列包括30348名患者,平均随访27±8个月。平均年龄为66±12岁;16549名(54%)为男性;17289名(57%)患者患有冠心病(CHD)或CHD风险等同疾病。4059名(13%)研究患者发生了5955次CV事件。存在单一未达最佳水平的血脂值会轻微增加CV事件风险[OR:1.06;95%置信区间:0.95-1.18],而两个或所有三个未达最佳水平的血脂值会显著增加CV事件风险[OR分别为:1.22;95%置信区间:1.08-1.37;以及1.45;95%置信区间:1.24-1.68]。
与所有大型观察性数据库一样,存在潜在局限性,包括:患者选择偏倚(例如,病情较重的患者接受更多干预、缺乏死亡率数据以及血脂监测频率)、未知的混杂变量和潜在的编码错误。
在这个约有68283患者年随访的高危大人群中,未达到最佳联合血脂水平独立且显著地增加了CV事件的风险。未达到最佳LDL-C水平与未达到最佳HDL-C或TG水平,或两者兼而有之,会使CV事件的调整风险增加22%-45%。因此,治疗策略应侧重于评估和管理多种血脂异常,而不是单一血脂危险因素的改善。