Acarbose心血管评估试验中冠心病和糖耐量受损患者的医疗资源和费用比较。

IF 3 2区 医学 Q2 ENDOCRINOLOGY & METABOLISM Journal of Diabetes Pub Date : 2023-11-01 DOI:10.1111/1753-0407.13473
Liam Mc Morrow, Frauke Becker, Ruth L. Coleman, Hertzel C. Gerstein, Lars Rydén, Stefan Schöder, Alastair M. Gray, Jose Leal, Rury R. Holman, for the ACE Study Group
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引用次数: 0

摘要

背景:阿卡波糖心血管评估(ACE)试验(ISRCTN91899513)在中国6522名冠心病和糖耐量受损患者中评估了与安慰剂相比的α-葡萄糖苷酶抑制剂阿卡波糖,并显示糖尿病发病率降低。我们评估了试验内医疗资源的使用和成本,以及质量调整生命年(QALYs)。方法:在ACE试验中前瞻性地收集资源使用数据。住院、药物和门诊就诊均采用中国单位成本进行估价。药物使用以用药天数为单位进行测量,参与者对整个试验中的心血管和糖尿病药物进行汇总。使用EuroQol-5维度-3水平问卷获取与健康相关的生活质量。回归分析用于比较资源使用、成本和QALYs,考虑区域差异。成本和QALYs按每年3%的折扣计算。结果:试验期间阿卡波糖组的住院率高出6%(比率1.06,p = .009),但总住院天数没有显著差异(比率1.04,p = .30)。阿卡波糖每位参与者的总成本(包括研究药物)明显更高(¥[元]56 480,6213英镑),与安慰剂(48日元)相比 079,5289英镑;平均比率1.18,p 结论:阿卡波糖与安慰剂相比,由于研究药物成本,参与者的成本更高,并且报告的QALYs没有统计学上的显著差异。这些更高的试验内成本可能在未来被阿卡波糖相关的糖尿病发病率降低带来的节约所抵消。
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Comparison of medical resources and costs among patients with coronary heart disease and impaired glucose tolerance in the Acarbose Cardiovascular Evaluation trial

Background

The Acarbose Cardiovascular Evaluation (ACE) trial (ISRCTN91899513) evaluated the alpha-glucosidase inhibitor acarbose, compared with placebo, in 6522 patients with coronary heart disease and impaired glucose tolerance in China and showed a reduced incidence of diabetes. We assessed the within-trial medical resource use and costs, and quality-adjusted life years (QALYs).

Methods

Resource use data were collected prospectively within the ACE trial. Hospitalizations, medications, and outpatient visits were valued using Chinese unit costs. Medication use was measured in drug days, with cardiovascular and diabetes drugs summed across the trial by participant. Health-related quality of life was captured using the EuroQol-5 Dimension-3 Level questionnaire. Regression analyses were used to compare resource use, costs, and QALYs, accounting for regional variation. Costs and QALYs were discounted at 3% yearly.

Results

Hospitalizations were 6% higher in the acarbose arm during the trial (rate ratio 1.06, p = .009), but there were no significant differences in total inpatient days (rate ratio 1.04, p = .30). Total costs per participant, including study drug, were significantly higher for acarbose (¥ [Yuan] 56 480, £6213), compared with placebo (¥48 079, £5289; mean ratio 1.18, p < 0.001). QALYs reported by participants in the acarbose arm (3.96 QALYs) were marginally higher than in the placebo arm (3.95 QALYs), but the difference was not statistically significant (0.01 QALYs; p = .58).

Conclusions

Acarbose, compared with placebo, participants cost more due to study drug costs and reported no statistically significant difference in QALYs. These higher within-trial costs could potentially be offset in future by savings from the acarbose-related lower incidence of diabetes.

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来源期刊
Journal of Diabetes
Journal of Diabetes ENDOCRINOLOGY & METABOLISM-
CiteScore
6.50
自引率
2.20%
发文量
94
审稿时长
>12 weeks
期刊介绍: Journal of Diabetes (JDB) devotes itself to diabetes research, therapeutics, and education. It aims to involve researchers and practitioners in a dialogue between East and West via all aspects of epidemiology, etiology, pathogenesis, management, complications and prevention of diabetes, including the molecular, biochemical, and physiological aspects of diabetes. The Editorial team is international with a unique mix of Asian and Western participation. The Editors welcome submissions in form of original research articles, images, novel case reports and correspondence, and will solicit reviews, point-counterpoint, commentaries, editorials, news highlights, and educational content.
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