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依泽替米贝和辛伐他汀治疗高胆固醇血症减少动脉粥样硬化进展试验(ENHANCE)结果报告前后处方模式的变化,以及对降低低密度脂蛋白胆固醇的预期影响。

Changes in prescription patterns before and after reporting of the Ezetimibe and Simvastatin in Hypercholesterolemia Enhances Atherosclerosis Regression trial (ENHANCE) results and expected effects on low-density lipoprotein-cholesterol reduction.

机构信息

CGH Medical Center and University of Illinois College of Medicine, 101 East Miller Road, Sterling, IL 61081, USA.

出版信息

J Clin Lipidol. 2012 Mar-Apr;6(2):180-91. doi: 10.1016/j.jacl.2011.11.007. Epub 2011 Dec 7.

DOI:10.1016/j.jacl.2011.11.007
PMID:22385552
Abstract

BACKGROUND

Recent trends suggest a decreased use of ezetimibe/simvastatin combination and coadministered ezetimibe plus statin therapies.

OBJECTIVE

This analysis evaluated changes in prescription patterns for ezetimibe/simvastatin, ezetimibe plus statins, and statin therapies and expected effects on low-density lipoprotein cholesterol (LDL-C) lowering during 2007 to 2008.

METHODS

Prescription pattern changes were assessed by the use of patient-level data from the IMS Health Longitudinal Rx database during two time periods, July 14, 2007 to January 13, 2008 (n = 8,813,674) and January 14, 2008 to July 13, 2008 (n = 9,131,030), 6 months before and after reporting of the results of The Ezetimibe and Simvastatin in Hypercholesterolemia Enhances Atherosclerosis Regression trial (ENHANCE) trial on January 14, 2008. Expected LDL-C reductions were estimated using data from previous controlled clinical trials.

RESULTS

During 6 months post-ENHANCE, greater proportions of patients were switched from ezetimibe/simvastatin and ezetimibe plus statins to other lipid-lowering therapies by health care providers than 6 months pre-ENHANCE (21.1% vs 6.0% and 46.9% vs 38.5%, differences: -15.06% [95% confidence interval -15.14%, -14.97%] and -8.43% [95% confidence interval -8.70%, -8.17%], respectively). Greater proportions of these patients switched to statin monotherapy in the later than earlier period. Prescription patterns were similar for statins during both time periods, although fewer patients switched to ezetimibe/simvastatin and ezetimibe plus statin therapies post-ENHANCE. In both time periods, greater proportions of patients on ezetimibe/simvastatin and ezetimibe plus statins switched to less-than-equivalent LDL-C lowering efficacy doses of statins than those on statin therapy. On the basis of previous clinical data for these therapies, smaller LDL-C reductions would be expected in patients who switched from ezetimibe/simvastatin and ezetimibe plus statins to statins, despite a trend toward switching to greater statin doses in the later time period.

CONCLUSIONS

More patients switched from ezetimibe/simvastatin and ezetimibe plus statin to statin monotherapy 6 months after the reporting of the ENHANCE trial, the majority of which were prescribed less potent, LDL-C-lowering therapies. On the basis of the known LDL-C lowering efficacies for these therapies, such changes would be expected to increase LDL-C levels in these patients and may reduce the proportion of patients who achieve guideline-recommended LDL-C goals.

摘要

背景

最近的趋势表明,依折麦布/辛伐他汀联合用药和联合应用依折麦布加他汀的治疗方法的使用有所减少。

目的

本分析评估了依折麦布/辛伐他汀、依折麦布加他汀和他汀类药物治疗方案的处方模式变化,并预计在 2007 年至 2008 年期间降低低密度脂蛋白胆固醇 (LDL-C) 的效果。

方法

使用 IMS Health Longitudinal Rx 数据库中的患者水平数据,在两个时间段评估处方模式变化:2007 年 7 月 14 日至 2008 年 1 月 13 日(n=8813674)和 2008 年 1 月 14 日至 2008 年 7 月 13 日(n=9131030),这是在 2008 年 1 月 14 日报告依折麦布和辛伐他汀在高胆固醇血症中增强动脉粥样硬化消退试验 (ENHANCE)试验结果后的 6 个月。使用先前对照临床试验的数据估计预期 LDL-C 降低。

结果

在 ENHANCE 试验报告后的 6 个月内,与报告前 6 个月相比,卫生保健提供者更倾向于将患者从依折麦布/辛伐他汀和依折麦布加他汀转换为其他降脂治疗(21.1%比 6.0%和 46.9%比 38.5%,差异:-15.06%[95%置信区间 -15.14%,-14.97%]和-8.43%[95%置信区间 -8.70%,-8.17%])。在后期,更多的这些患者转为他汀类药物单药治疗。在两个时期,他汀类药物的处方模式相似,尽管报告后患者转换为依折麦布/辛伐他汀和依折麦布加他汀治疗的比例较低。在两个时期,与他汀类药物治疗相比,依折麦布/辛伐他汀和依折麦布加他汀治疗的患者中,更多的患者转换为 LDL-C 降低效果较低的他汀类药物剂量。基于这些治疗方法的先前临床数据,尽管在后期趋势显示向更大剂量的他汀类药物转换,但从依折麦布/辛伐他汀和依折麦布加他汀转换为他汀类药物的患者的 LDL-C 降低幅度预计会较小。

结论

在 ENHANCE 试验报告后 6 个月,更多的患者从依折麦布/辛伐他汀和依折麦布加他汀转换为他汀类药物单药治疗,其中大部分患者被处方为效力较低、降低 LDL-C 的治疗药物。基于这些治疗方法已知的 LDL-C 降低效果,这种变化预计会增加这些患者的 LDL-C 水平,并可能降低达到指南推荐 LDL-C 目标的患者比例。

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