吲达帕胺诱发横纹肌溶解症的真实证据:对电子健康记录的回顾性分析。

IF 2.4 4区 医学 Q3 PHARMACOLOGY & PHARMACY Pharmacoepidemiology and Drug Safety Pub Date : 2024-11-01 DOI:10.1002/pds.70053
Raseel Alroba, Almaha Alfakhri, Hisham Badreldin, Adel Alrwisan, Ohoud Almadani
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引用次数: 0

摘要

目的:以往的研究和药物警戒监测活动表明,吲达帕胺的使用与横纹肌溶解症之间可能存在关联。本研究旨在调查使用吲达帕胺与横纹肌溶解症之间的潜在因果关系:使用电子健康记录数据进行病例对照研究,研究时间为 2016 年 7 月 1 日至 2022 年 12 月 31 日。根据年龄、性别和日期将发生横纹肌溶解症的患者(病例)与四名对照者进行配对。我们通过三个风险期(当前使用、近期使用和曾经使用)研究了吲达帕胺暴露的几率。研究结果通过 CK 水平超过 1000 U/L(即横纹肌溶解事件)来确定。随后,利用多变量条件逻辑回归分析评估了吲达帕胺暴露与横纹肌溶解发生可能性的因果关系,同时考虑了潜在的混杂变量:研究对象包括 2965 例病例和 11 860 例对照。条件逻辑回归分析的结果表明,目前使用吲达帕胺的患者与吲达帕胺暴露之间没有关联,其几率比(OR)为 0.6(95% 置信区间(CI):0.39-1.05)。病例中近期使用吲达帕胺的几率低于对照组(OR 0.2;95% CI:0.14-0.47)。最后,曾使用吲达帕胺的几率为 0.1(95% CI:0.07-0.23):在这项研究中,我们没有发现使用吲达帕胺与横纹肌溶解症之间存在关联,而与暴露时间无关。
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Real-World Evidence of Indapamide-Induced Rhabdomyolysis: A Retrospective Analysis of Electronic Health Records.

Purpose: Previous research and pharmacovigilance monitoring activities have suggested a potential association between indapamide use and rhabdomyolysis. This study aims to investigate the potential causal relationship between the use of indapamide and rhabdomyolysis.

Methods: A case-control study conducted using electronic health records data, between July 1, 2016 and December 31, 2022. Patients who have rhabdomyolysis event (cases) were matched to four controls bases on age, gender, and date. We examined the odds for indapamide exposure through three risk periods: current use, recent use, and former. The study outcome was ascertained through the presence of CK level over 1000 U/L (i.e., rhabdomyolysis event). Subsequently, a multivariable conditional logistic regression analysis was utilized to assess the causal association of indapamide exposure on the likelihood of developing rhabdomyolysis, while accounting for potential confounding variables.

Results: The study population consisted of 2965 cases and 11 860 controls. The results of the conditional logistic regression analysis indicated a lack of association between exposure to indapamide for the current users with an odds ratio (OR) of 0.6 (95% confidence intervals (CI): 0.39-1.05). The odds of recent indapamide use among cases was lower than controls (OR 0.2; 95% CI: 0.14-0.47). Lastly, the OR for former use of indapamide was 0.1 (95% CI: 0.07-0.23).

Conclusions: In this study, we did not find association between indapamide use and rhabdomyolysis regardless timing of exposure.

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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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