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Within-Trial Evaluation of Medical Resources, Costs, and Quality of Life Among Patients With Type 2 Diabetes Participating in the Exenatide Study of Cardiovascular Event Lowering (EXSCEL).
Diabetes Care ( IF 14.8 ) Pub Date : 2019-12-05 , DOI: 10.2337/dc19-0950
Shelby D Reed 1 , Yanhong Li 2 , Helen A Dakin 3 , Frauke Becker 3 , Jose Leal 3 , Stephanie M Gustavson 4 , Bernt Kartman 5 , Eric Wittbrodt 4 , Robert J Mentz 2 , Neha J Pagidipati 2 , M Angelyn Bethel 6 , Alastair M Gray 3 , Rury R Holman 6 , Adrian F Hernandez ,
Affiliation  

OBJECTIVE To compare medical resource use, costs, and health utilities for 14,752 patients with type 2 diabetes who were randomized to once-weekly exenatide (EQW) or placebo in addition to usual diabetes care in the Exenatide Study of Cardiovascular Event Lowering (EXSCEL). RESEARCH DESIGN AND METHODS Medical resource use data and responses to the EuroQol 5-Dimension (EQ-5D) instrument were collected at baseline and throughout the trial. Medical resources and medications were assigned values by using U.S. Medicare payments and wholesale acquisition costs, respectively. Secondary analyses used English costs. RESULTS Patients were followed for an average of 3.3 years, during which time those randomized to EQW experienced 0.41 fewer inpatient days (7.05 vs. 7.46 days; relative rate ratio 0.91; P = 0.05). Rates of outpatient medical visits were similar, as were total inpatient and outpatient costs. Mean costs for nonstudy diabetes medications over the study period were ∼$1,600 lower with EQW than with placebo (P = 0.01). Total within-study costs, excluding study medication, were lower in the EQW arm than in the placebo arm ($28,907 vs. $30,914; P ≤ 0.01). When including the estimated cost of EQW, total mean costs were significantly higher in the EQW group than in the placebo group ($42,697 vs. $30,914; P < 0.01). With English costs applied, mean total costs, including exenatide costs, were £1,670 higher in the EQW group than the placebo group (£10,874 vs. £9,204; P < 0.01). There were no significant differences in EQ-5D health utilities between arms over time. CONCLUSIONS Medical costs were lower in the EQW arm than the placebo arm, but total costs were significantly higher once the cost of branded exenatide was incorporated.

中文翻译:

参加心血管事件降低(EXSCEL)的艾塞那肽研究的2型糖尿病患者的医疗资源,成本和生活质量的试验内评估。

目的比较心血管疾病降低艾塞那肽研究(EXSCEL)中除常规糖尿病治疗外,随机分配每周一次艾塞那肽(EQW)或安慰剂治疗的14752名2型糖尿病患者的医疗资源使用,成本和卫生服务。研究设计和方法在基线和整个试验过程中收集了医疗资源使用数据和对EuroQol 5-Dimension(EQ-5D)仪器的响应。通过分别使用美国Medicare付款和批发采购成本为医疗资源和药物分配了价值。次要分析使用英语成本。结果患者平均随访3.3年,在此期间,随机分组接受EQW治疗的患者住院天数减少了0.41天(7.05比7.46天;相对比率0.91; P = 0.05)。门诊就诊率和住院及门诊总费用相似。研究期间非研究型糖尿病药物的平均费用比安慰剂组低约1600美元(P = 0.01)。EQW组的研究内总费用(不包括研究药物)低于安慰剂组(28,907美元对30,914美元; P≤0.01)。包括EQW的估计成本在内,EQW组的总平均成本显着高于安慰剂组(42,697美元对30,914美元; P <0.01)。加上英语费用,EQW组的平均总费用(包括艾塞那肽费用)比安慰剂组高1,670英镑(10,874英镑对9,204英镑; P <0.01)。随着时间的推移,武器之间的EQ-5D健康效用没有显着差异。结论EQW组的医疗费用低于安慰剂组,
更新日期:2020-01-21
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