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比较使用“正确药物、正确剂量、正确时间:利用基因组数据个体化治疗(RIGHT)10K 华法林队列”的对华法林敏感患者与对华法林不敏感患者的结局和成本。

Comparing outcomes and costs among warfarin-sensitive patients versus warfarin-insensitive patients using The Right Drug, Right Dose, Right Time: Using genomic data to individualize treatment (RIGHT) 10K warfarin cohort.

机构信息

Robert D and Patricia E Kern Center for the Science of Health Care Delivery, Mayo Clinic, Rochester, MN, United States of America.

Division of Health Care Policy and Research, Department of Health Sciences Research, Mayo Clinic, Rochester, MN, United States of America.

出版信息

PLoS One. 2020 May 19;15(5):e0233316. doi: 10.1371/journal.pone.0233316. eCollection 2020.

DOI:10.1371/journal.pone.0233316
PMID:32428022
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7237006/
Abstract

Oral anticoagulant (OAC) therapy has been the main treatment approach for stroke prevention for decades. Warfarin is the most widely prescribed OAC in the United States, but is difficult to manage due to variability in dose requirements across individuals. Pharmacogenomics may mitigate risk concerns related to warfarin use by fostering the opportunity to facilitate individualized medicine approaches to warfarin treatment (e.g., genome-guided dosing). While various economic evaluations exist examining the cost-effectiveness of pharmacogenomics testing for warfarin, few observational studies exist to support these studies, with even fewer using genotype as the main exposure of interest. We examined a cohort of individuals initiating warfarin therapy between 2004 and 2017 and examined bleeding and cost outcomes for the year following initiation using Mayo Clinic's billing and administrative data, as well the Mayo Clinic Rochester Cost Data Warehouse. Analyses included descriptive summaries, comparison of characteristics across exposure groups, reporting of crude outcomes, and multivariate analyses. We included N = 1,143 patients for analyses. Just over a third of our study population (34.9%) carried a warfarin-sensitive phenotype. Sensitive individuals differed in their baseline characteristics by being of older age and having a higher number of comorbid conditions; myocardial infarction, diabetes, and cancer in particular. The occurrence of bleeding events was not significantly different across exposure groups. No significant differences across exposure groups existed in either the likelihood of incurring all-cause healthcare costs or in the magnitude of those costs. Warfarin-sensitive individuals were no more likely to utilize cardiovascular-related healthcare services; however, they had lower total and inpatient cardiovascular-related costs compared to warfarin-insensitive patients. No significant differences existed in any other categories of costs. We found limited evidence that warfarin-sensitive individuals have different healthcare spending than warfarin-insensitive individuals. Additional real-world studies are needed to support the traditional economic evaluations currently existing in the literature.

摘要

口服抗凝剂(OAC)治疗已成为预防中风的主要治疗方法已有数十年。在美国,华法林是最广泛使用的 OAC,但由于个体之间剂量需求的差异,难以管理。药物基因组学可能通过促进华法林治疗的个体化医学方法(例如,基因组指导剂量)来减轻与华法林使用相关的风险。虽然存在各种经济评估来检查药物基因组学检测对华法林的成本效益,但很少有观察性研究支持这些研究,甚至更少的研究使用基因型作为主要关注的暴露。我们检查了一组在 2004 年至 2017 年间开始接受华法林治疗的个体,并使用梅奥诊所的计费和行政数据以及梅奥诊所罗切斯特成本数据仓库,检查了起始治疗后一年的出血和成本结果。分析包括描述性总结、暴露组之间特征的比较、未调整结果的报告以及多变量分析。我们共纳入了 1143 名患者进行分析。我们研究人群中有略超过三分之一(34.9%)的患者携带华法林敏感表型。敏感个体在年龄较大和合并症较多方面存在差异,特别是心肌梗死、糖尿病和癌症;在出血事件的发生方面,各组之间没有显著差异。各组之间在是否发生全因医疗保健费用或费用大小方面没有显著差异。华法林敏感个体使用心血管相关医疗服务的可能性没有增加;然而,与华法林不敏感患者相比,他们的总心血管相关费用和住院费用较低。在其他费用类别中没有发现显著差异。我们发现,华法林敏感个体的医疗支出与华法林不敏感个体没有显著差异。需要更多的真实世界研究来支持当前文献中存在的传统经济评估。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7848/7237006/dc4a55f82003/pone.0233316.g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7848/7237006/dc4a55f82003/pone.0233316.g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7848/7237006/dc4a55f82003/pone.0233316.g001.jpg

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本文引用的文献

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Genet Med. 2020 Mar;22(3):475-486. doi: 10.1038/s41436-019-0667-y. Epub 2019 Oct 8.
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Cohort Profile: The Right Drug, Right Dose, Right Time: Using Genomic Data to Individualize Treatment Protocol (RIGHT Protocol).队列简介:正确的药物、正确的剂量、正确的时间:利用基因组数据个体化治疗方案(RIGHT方案)。
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现实世界中心血管相关药物遗传学检测对参保人群的影响。
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