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在管理式医疗环境下,新开始使用他汀类药物单药治疗的高危患者的治疗模式变化。

Treatment pattern changes in high-risk patients newly initiated on statin monotherapy in a managed care setting.

机构信息

University of North Carolina Hospital, 160 Dental Circle CB 7075, 6033 Burnett-Womack, Chapel Hill, NC 27599-7075, USA.

出版信息

J Clin Lipidol. 2013 Sep-Oct;7(5):399-407. doi: 10.1016/j.jacl.2013.06.002. Epub 2013 Jun 18.

Abstract

BACKGROUND

For high-risk patients who do not achieve guideline-recommended LDL-C levels, more intensive treatment including statin-uptitration to higher doses or potency, as well as combination therapy may be considered. A better understanding of statin treatment patterns in real-world clinical practice may contribute to improved lipid-lowering management in these patients.

OBJECTIVE

We determined treatment pattern changes among patients with high risk of cardiovascular disease who were not at low-density lipoprotein cholesterol (LDL-C) goal on statin monotherapy.

METHODS

Treatment pattern changes were evaluated among patients newly initiated on statins between January 1, 2006, and August 31, 2009, in the HealthCore Integrated Research Database. Rates and mean time to first and second treatment changes were examined in patients with claims for coronary heart disease (CHD), atherosclerotic vascular disease (AVD), and diabetes mellitus during 12 months before index, who were not at LDL-C <70 mg/dL at their first-eligible LDL-C test (≥ 4 weeks after index). Therapy change was assessed for 12 months after the LDL-C result.

RESULTS

Of 11,473 eligible subjects, 61.3% had diabetes, 26.6% had CHD and AVD, and 12.1% had CHD and AVD and diabetes. At index, patients were prescribed medium-potency levels of statins, including simvastatin (44.7%), atorvastatin (31.5%), and other statins (23.8%). Mean ± SD LDL-C before statin initiation was 138 ± 34 mg/dL, and at the first-eligible LDL-C result after index, it was 101 ± 25 mg/dL. During follow-up, 7444 subjects (64.9%) experienced a first treatment change, with mean time to change of 93.8 ± 92 days, whereas 4029 (36.1%) had no treatment change. Discontinuation of index therapy occurred in 46.9% of subjects and medication switches or titration in 18.0% (index statin titration, switch to other statins, other lipid-lowering therapies [LLT], including ezetimibe). Of the discontinuers, 27.4% restarted LLT. Of subjects with a first treatment change who did not discontinue, 48.9% experienced a second therapy change. Results were similar between the 3 high-risk groups.

CONCLUSIONS

In this managed-care setting, among patients with high risk of cardiovascular disease who were not at LDL-C goal, statins were usually started at medium-potency doses without being titrated up, whereas nearly one-half had a discontinuation of LLT within 12 months. These treatment patterns indicate the need for better patient and provider education as well as other system-wide modifications to improve medication adherence.

摘要

背景

对于未达到指南推荐的 LDL-C 水平的高危患者,可能需要更强化的治疗,包括将他汀类药物剂量增至更高水平或加大药物效力,以及联合治疗。更好地了解真实世界临床实践中的他汀类药物治疗模式可能有助于改善这些患者的降脂管理。

目的

我们旨在确定在他汀类药物单药治疗时 LDL-C 水平未达标的高危心血管疾病患者的治疗模式变化。

方法

2006 年 1 月 1 日至 2009 年 8 月 31 日,在 HealthCore 综合研究数据库中评估了新开始使用他汀类药物的患者的治疗模式变化。在索引前 12 个月内有冠心病(CHD)、动脉粥样硬化性血管疾病(AVD)和糖尿病(DM)理赔记录的患者中,评估了在首次合格 LDL-C 检测(索引后≥4 周)时 LDL-C<70mg/dL 而未达到 LDL-C<70mg/dL 的患者的治疗变化。在 LDL-C 结果后 12 个月评估了治疗变化。

结果

在 11473 名合格患者中,61.3%患有糖尿病,26.6%患有 CHD 和 AVD,12.1%患有 CHD 和 AVD 以及糖尿病。在索引时,患者接受了中等效力的他汀类药物治疗,包括辛伐他汀(44.7%)、阿托伐他汀(31.5%)和其他他汀类药物(23.8%)。他汀类药物起始前的平均±SD LDL-C 为 138±34mg/dL,而在索引后的首次合格 LDL-C 结果中为 101±25mg/dL。在随访期间,7444 名患者(64.9%)发生了首次治疗变化,平均治疗变化时间为 93.8±92 天,而 4029 名患者(36.1%)没有治疗变化。46.9%的患者停止了指数治疗,18.0%的患者(指数他汀类药物剂量调整、换用其他他汀类药物、其他降脂治疗[LLT],包括依折麦布)进行了药物转换或剂量调整。在停药患者中,27.4%重新开始 LLT。在未停药的首次治疗变化患者中,48.9%发生了第二次治疗变化。结果在 3 个高危组中相似。

结论

在这个管理式医疗环境中,在 LDL-C 目标不达标的高危心血管疾病患者中,他汀类药物通常以中等效力的剂量起始,而不进行滴定,而近一半的患者在 12 个月内停止了 LLT。这些治疗模式表明,需要更好地对患者和医生进行教育,以及进行其他系统级别的修改,以提高药物依从性。

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