Marrett Elizabeth, Zhao Changgeng, Zhang Ning Jackie, Zhang Qiaoyi, Ramey Dena R, Tomassini Joanne E, Tershakovec Andrew M, Neff David R
Merck & Co, Inc., Whitehouse Station, NJ, USA.
College of Health and Public Affairs, University of Central Florida, Orlando, FL, USA.
Vasc Health Risk Manag. 2014 Apr 25;10:237-46. doi: 10.2147/VHRM.S54886. eCollection 2014.
Guidelines endorse statin therapy for lowering low-density lipoprotein cholesterol (LDL-C) to recommended levels, in patients with cardiovascular disease (CVD) risk, if needed, after lifestyle changes. Atorvastatin is a common statin with greater LDL-C lowering efficacy than most other statins; its availability in generic form will likely increase its use. This study assessed attainment of guideline-recommended LDL-C levels in high-risk CVD patients treated with atorvastatin monotherapy.
Analyses of two retrospective US cohorts of patients who received a prescription for atorvastatin monotherapy between January 1, 2008 and December 31, 2010 (index date defined as first prescription date) in the GE Centricity Electronic Medical Record (EMR) (N=10,693) and Humana Medicare (N=16,798) databases. Eligible patients were ≥18 years, diagnosed with coronary heart disease or atherosclerotic vascular disease, with ≥1 LDL-C measurement between 3 months and 1 year postindex date, and continuously enrolled for 1 year prior to and following the index date.
Of the eligible patients, 21.8%, 29.6%, 29.9%, and 18.7% (GE Centricity EMR) and 25.4%, 32.9%, 27.8%, and 14.0% (Humana Medicare) received 10, 20, 40, and 80 mg doses of atorvastatin, respectively. The mean ± standard deviation (SD) follow-up LDL-C levels were 2.1±0.8 mmol/L (83±30 mg/dL) and 2.3±0.8 mmol/L (88±31 mg/dL) for the GE Centricity EMR and Humana Medicare cohorts, respectively. Regardless of dose, only 28.3%-34.8% of patients had LDL-C levels <1.8 mmol/L (<70 mg/dL), and 72.0%-78.0% achieved LDL-C <2.6 mmol/L (<100 mg/dL) in both cohorts. As many as 41% and 13% of patients had LDL-C levels ≥0.5 mmol/L (≥20 mg/dL) above LDL-C 1.8 mmol/L (70 mg/dL) and 2.6 mmol/L (100 mg/dL), respectively, in both cohorts; these percentages were generally similar across atorvastatin doses.
In this real-world US setting, a large number of high-risk CVD patients did not attain guideline-recommended LDL-C levels with atorvastatin monotherapy. More than 65% of the patients had LDL-C levels >1.8 mmol/L (>70 mg/dL), and of these, 30%-40% had LDL-C levels ≥0.5 mmol/L (≥20 mg/dL) above this, regardless of dose. This suggests that more effective lipid-lowering strategies, such as statin uptitration, switching to a higher efficacy statin, and/or combination therapy, may be required to achieve optimal LDL-C lowering in high-risk patients.
指南支持在心血管疾病(CVD)风险患者中,必要时在改变生活方式后使用他汀类药物治疗,将低密度脂蛋白胆固醇(LDL-C)降至推荐水平。阿托伐他汀是一种常见的他汀类药物,其降低LDL-C的疗效高于大多数其他他汀类药物;其仿制药的可获得性可能会增加其使用。本研究评估了接受阿托伐他汀单药治疗的高危CVD患者达到指南推荐的LDL-C水平的情况。
对两个美国回顾性队列进行分析,这些患者在2008年1月1日至2010年12月31日期间(索引日期定义为首次处方日期)在GE Centricity电子病历(EMR)(N = 10,693)和Humana Medicare(N = 16,798)数据库中接受了阿托伐他汀单药治疗的处方。符合条件的患者年龄≥18岁,诊断为冠心病或动脉粥样硬化性血管疾病,在索引日期后3个月至1年之间有≥1次LDL-C测量值,并且在索引日期之前和之后连续登记1年。
在符合条件的患者中,GE Centricity EMR队列中分别有21.8%、29.6%、29.9%和18.7%,Humana Medicare队列中分别有25.4%、32.9%、27.8%和14.0%接受了10、20、40和80mg剂量的阿托伐他汀。GE Centricity EMR队列和Humana Medicare队列的平均±标准差(SD)随访LDL-C水平分别为2.1±0.8mmol/L(83±30mg/dL)和2.3±0.8mmol/L(88±31mg/dL)。无论剂量如何,两个队列中只有28.3%-34.8%的患者LDL-C水平<1.8mmol/L(<70mg/dL),72.0%-78.0%的患者LDL-C<2.6mmol/L(<100mg/dL)。在两个队列中,分别有多达41%和13%的患者LDL-C水平比LDL-C 1.8mmol/L(70mg/dL)和2.6mmol/L(100mg/dL)高出≥0.5mmol/L(≥20mg/dL);这些百分比在阿托伐他汀各剂量组中总体相似。
在这种美国的实际情况中,大量高危CVD患者接受阿托伐他汀单药治疗未达到指南推荐的LDL-C水平。超过65%的患者LDL-C水平>1.8mmol/L(>70mg/dL),其中30%-40%的患者LDL-C水平比此值高出≥0.5mmol/L(≥20mg/dL),无论剂量如何。这表明可能需要更有效的降脂策略,如增加他汀类药物剂量、换用更高疗效的他汀类药物和/或联合治疗,以在高危患者中实现最佳的LDL-C降低。