The Prevalent New-User Design to Study Drug-Drug Interactions: The Example of Sulfonylureas and Warfarin Interaction on the Risk of Severe Hypoglycemia.

IF 2.4 4区 医学 Q3 PHARMACOLOGY & PHARMACY
Wanqi Wang, Ying Cui, Oriana Hoi Yun Yu, Samy Suissa, Antonios Douros
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Abstract

Purpose: The optimal design for pharmacoepidemiologic drug-drug interactions (DDIs) studies is unclear. Using the association between concomitant use of sulfonylureas and warfarin and the risk of severe hypoglycemia as a case study, a DDI with little or no clinical impact, we tested whether the prevalent new-user design can be applied in the area.

Methods: Among all patients initiating sulfonylureas in the UK's Clinical Practice Research Datalink (1998-2020), we identified those adding-on warfarin while on a sulfonylurea. For each co-exposed patient, we defined a prescription-based exposure set including other sulfonylurea users not adding-on warfarin (comparators). Within each exposure set, we matched each co-exposed patient to five comparators on time-conditional propensity scores (TCPS) and followed them using an as-treated approach. Cox proportional hazards models estimated hazard ratios (HRs) and 95% confidence intervals (CIs) of severe hypoglycemia associated with concomitant use of sulfonylureas and warfarin compared to use of sulfonylureas alone. Sensitivity analyses addressed the impact of different potential sources of bias.

Results: The study cohort included 17 890 patients co-exposed to sulfonylureas and warfarin and 88 749 matched comparators. After TCPS matching, patient characteristics were well-balanced between groups. Compared to use of sulfonylureas alone, concomitant use of sulfonylureas and warfarin was not associated with the risk of severe hypoglycemia (HR, 1.04; 95% CI, 0.92-1.17). Sensitivity analyses were consistent with the primary analysis (HRs ranging from 1.01 to 1.15, all not statistically significant).

Conclusions: Our study suggests that the prevalent new-user design could be used for the assessment of clinical effects of DDIs.

研究药物相互作用的普遍新用户设计:以磺脲类药物和华法林相互作用对严重低血糖风险的影响为例。
目的:药物流行病学药物间相互作用(DDIs)研究的最佳设计尚不明确。我们以同时使用磺脲类药物和华法林与严重低血糖风险之间的关联(这是一种对临床影响很小或没有影响的 DDI)为案例,检验了新用户设计是否可用于该领域:在英国临床实践研究数据链(1998-2020 年)中所有开始使用磺脲类药物的患者中,我们确定了那些在使用磺脲类药物的同时加用华法林的患者。对于每位共同暴露的患者,我们定义了一个基于处方的暴露集,其中包括未加用华法林的其他磺脲类药物使用者(比较者)。在每个暴露集内,我们根据时间条件倾向分数 (TCPS) 将每位共同暴露患者与五位比较者进行匹配,并采用治疗方法对他们进行随访。Cox 比例危险模型估算了与单独使用磺脲类药物相比,同时使用磺脲类药物和华法林引起严重低血糖的危险比 (HR) 和 95% 置信区间 (CI)。敏感性分析探讨了不同潜在偏倚来源的影响:研究队列包括17 890名同时使用磺脲类药物和华法林的患者,以及88 749名匹配的比较者。经过 TCPS 匹配后,各组患者的特征非常均衡。与单独使用磺脲类药物相比,同时使用磺脲类药物和华法林与严重低血糖风险无关(HR,1.04;95% CI,0.92-1.17)。敏感性分析结果与主要分析结果一致(HR 从 1.01 到 1.15 不等,均无统计学意义):我们的研究表明,普遍的新用户设计可用于评估 DDIs 的临床效果。
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来源期刊
CiteScore
4.80
自引率
7.70%
发文量
173
审稿时长
3 months
期刊介绍: The aim of Pharmacoepidemiology and Drug Safety is to provide an international forum for the communication and evaluation of data, methods and opinion in the discipline of pharmacoepidemiology. The Journal publishes peer-reviewed reports of original research, invited reviews and a variety of guest editorials and commentaries embracing scientific, medical, statistical, legal and economic aspects of pharmacoepidemiology and post-marketing surveillance of drug safety. Appropriate material in these categories may also be considered for publication as a Brief Report. Particular areas of interest include: design, analysis, results, and interpretation of studies looking at the benefit or safety of specific pharmaceuticals, biologics, or medical devices, including studies in pharmacovigilance, postmarketing surveillance, pharmacoeconomics, patient safety, molecular pharmacoepidemiology, or any other study within the broad field of pharmacoepidemiology; comparative effectiveness research relating to pharmaceuticals, biologics, and medical devices. Comparative effectiveness research is the generation and synthesis of evidence that compares the benefits and harms of alternative methods to prevent, diagnose, treat, and monitor a clinical condition, as these methods are truly used in the real world; methodologic contributions of relevance to pharmacoepidemiology, whether original contributions, reviews of existing methods, or tutorials for how to apply the methods of pharmacoepidemiology; assessments of harm versus benefit in drug therapy; patterns of drug utilization; relationships between pharmacoepidemiology and the formulation and interpretation of regulatory guidelines; evaluations of risk management plans and programmes relating to pharmaceuticals, biologics and medical devices.
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