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糖尿病患者血压和低密度脂蛋白胆固醇目标值较低的成本效益:原发性糖尿病动脉粥样硬化研究(SANDS)。

Cost-effectiveness of lower targets for blood pressure and low-density lipoprotein cholesterol in diabetes: the Stop Atherosclerosis in Native Diabetics Study (SANDS) .

机构信息

Phoenix Indian Medical Center, 4212 N 16th Street, Phoenix, AZ 85016, USA.

出版信息

J Clin Lipidol. 2010 May-Jun;4(3):165-72. doi: 10.1016/j.jacl.2010.01.008.

Abstract

BACKGROUND

The Stop Atherosclerosis in Native Diabetics Study (SANDS) reported cardiovascular benefit of aggressive versus standard treatment targets for both low-density lipoprotein cholesterol (LDL-C) and blood pressure (BP) in diabetic individuals.

OBJECTIVE

In this analysis, we examined within trial cost-effectiveness of aggressive targets of LDL-C ≤70 mg/dL and systolic BP ≤115 mmHg versus standard targets of LDL-C ≤100 mg/dL and systolic BP ≤130 mmHg.

DESIGN

Randomized, open label blinded-to-endpoint 3-year trial.

DATA SOURCES

SANDS clinical trial database, Quality of Wellbeing survey, Centers for Medicare and Medicaid Services, Wholesale Drug Prices.

TARGET POPULATION

American Indians ≥ age 40 years with type 2 diabetes and no previous cardiovascular events.

TIME HORIZON

April 2003 to July 2007.

PERSPECTIVE

Health payer.

INTERVENTIONS

Participants were randomized to aggressive versus standard groups with treatment algorithms defined for both.

OUTCOME MEASURES

Incremental cost-effectiveness.

RESULTS OF BASE-CASE ANALYSIS: Compared with the standard group, the aggressive group had slightly lower costs of medical services (-$116) but a 54% greater cost for BP medication ($1,242) and a 116% greater cost for lipid-lowering medication ($2,863), resulting in an increased cost of $3,988 over 3 years. Those in the aggressively treated group gained 0.0480 quality-adjusted life-years (QALY) over the standard group. When a 3% discount rate for costs and outcomes was used, the resulting cost per QALY was $82,589.

RESULTS OF SENSITIVITY ANALYSIS

The use of a 25%, 50%, and 75% reduction in drug costs resulted in a cost per QALY of $61,329, $40,070, and $18,810, respectively.

LIMITATIONS

This study was limited by use of a single ethnic group and by its 3-year duration.

CONCLUSIONS

Within this 3-year study, treatment to lower BP and LDL-C below standard targets was not cost-effective because of the cost of the additional medications required to meet the lower targets. With the anticipated availability of generic versions of the BP and lipid-lowering drugs used in SANDS, the cost-effectiveness of this intervention should improve. Published by Elsevier Inc on behalf of the National Lipid Association.

摘要

背景

《原发性糖尿病患者降脂研究》(SANDS)报告称,对于糖尿病患者,积极控制低密度脂蛋白胆固醇(LDL-C)和血压(BP)的治疗目标比标准治疗目标更具心血管获益。

目的

在本分析中,我们研究了 LDL-C≤70mg/dL 和收缩压≤115mmHg 的积极目标与 LDL-C≤100mg/dL 和收缩压≤130mmHg 的标准目标之间的试验内成本效益。

设计

随机、开放标签、以终点为盲的 3 年试验。

数据来源

SANDS 临床试验数据库、生活质量调查、医疗保险和医疗补助服务中心、批发药品价格。

目标人群

年龄≥40 岁、患有 2 型糖尿病且无既往心血管事件的美国印第安人。

时间范围

2003 年 4 月至 2007 年 7 月。

视角

健康支付方。

干预措施

参与者被随机分配到积极组和标准组,两组均有明确的治疗方案。

结果指标

增量成本效益。

基础分析结果

与标准组相比,积极组的医疗服务成本略低(-116 美元),但降压药物的成本增加了 54%(1242 美元),降脂药物的成本增加了 116%(2863 美元),3 年内总成本增加了 3988 美元。积极治疗组的质量调整生命年(QALY)比标准组增加了 0.0480。当对成本和结果使用 3%的贴现率时,每 QALY 的成本为 82589 美元。

敏感性分析结果

当药物成本降低 25%、50%和 75%时,每 QALY 的成本分别为 61329 美元、40070 美元和 18810 美元。

局限性

本研究的局限性在于仅使用了一个种族群体和 3 年的研究时间。

结论

在这项为期 3 年的研究中,由于达到较低目标所需的额外药物的成本,将血压和 LDL-C 降低至低于标准目标的治疗并不具有成本效益。随着 SANDS 中使用的降压和降脂药物的仿制药的预期可用性,该干预措施的成本效益应该会提高。由 Elsevier Inc 代表国家脂质协会出版。

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