Exploring signals of myopathy associated with statin and contraindicated comedications in the realworld

IF 2.1 4区医学 Q3 PHARMACOLOGY & PHARMACY

Fundamental & Clinical Pharmacology Pub Date : 2023-10-11 DOI:10.1111/fcp.12959

Sewon Park, Ju Won Lee, Dal Ri Nam, Sun-Young Jung

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引用次数: 0

Abstract

Background

Using statins in combination with other drugs was reported to increase the risk of myopathy. However, there was a sparse number of studies on the incidence of adverse events (AEs) associated with the concomitant use of statin and contraindicated drugs in the real world.

Objectives

This study aimed to identify the risk of concomitant use of statins with contraindicated drugs by exploring signals related to statin–drug interactions.

Methods

We performed a disproportionality analysis for drugs and AEs by applying the case/non-case study using the KIDS-KAERS database (KIDS-KD), 2016–2020. A case was defined as an individual case safety reports (ICSRs) including “rhabdomyolysis/myopathy.” A non-case was defined as an ICSR, including all other AEs. We applied Ω shrinkage measure model, chi-square statics model, additive model, multiplicative model, and combination risk ratio model to detect signals of myopathy due to statin with concomitant drugs including antiviral agents, immunosuppressants, and antifungals.

Results

Among 1 011 234 ICSRs, 2708 were cases, with 861 cases of statin monotherapy and 1248 of concomitant uses of statin. The adjusted reporting odds ratios were 3.27 (95% confidence interval [CI]: 3.11–3.43), 8.70 (95% CI: 8.04–9.40), and 1.83 (95% CI: 1.73–1.94), respectively. Several combinations of signals were detected through an additive model or multiplicative model.

Conclusion

Signals of an increased risk of myopathy associated with the use of statins with concomitant drugs, including contraindicated drugs, were confirmed in a real-world setting.

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探讨现实世界中与他汀类药物和禁忌症相关的肌病信号。

背景：据报道，他汀类药物与其他药物联合使用会增加肌病的风险。然而，在现实世界中，关于与他汀类药物和禁忌症药物同时使用相关的不良事件（AE）发生率的研究数量很少。目的：本研究旨在通过探索他汀类药物相互作用的相关信号，确定他汀类药物与禁忌症药物同时使用的风险。方法：我们使用KIDS-KAERS数据库（KIDS-KD），2016-2020，通过应用病例/非病例研究，对药物和AE进行了不均衡性分析。一个病例被定义为包括“横纹肌溶解症/肌病”在内的个别病例安全性报告（ICSRs）。非病例则被定义为ICSR，包括所有其他AE。我们应用Ω收缩测量模型、卡方静态模型、加法模型、乘法模型和组合风险比模型来检测他汀类药物与抗病毒药物、免疫抑制剂和抗真菌药物联合引起的肌病信号。结果：在1 011 234例ICSRs，2708例为病例，861例为他汀类药物单药治疗，1248例为同时使用他汀类药物。调整后的报告比值比分别为3.27（95%置信区间[CI]:3.11-3.43）、8.70（95%置信指数：8.04-9.40）和1.83（95%置信度：1.73-1.94）。通过加法模型或乘法模型来检测信号的几种组合。结论：在现实世界中，他汀类药物与包括禁忌症药物在内的联合用药导致肌病风险增加的信号得到了证实。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Fundamental & Clinical Pharmacology 医学-药学

CiteScore

5.30

自引率

6.90%

发文量

111

审稿时长

6-12 weeks

期刊介绍： Fundamental & Clinical Pharmacology publishes reports describing important and novel developments in fundamental as well as clinical research relevant to drug therapy. Original articles, short communications and reviews are published on all aspects of experimental and clinical pharmacology including: Antimicrobial, Antiviral Agents Autonomic Pharmacology Cardiovascular Pharmacology Cellular Pharmacology Clinical Trials Endocrinopharmacology Gene Therapy Inflammation, Immunopharmacology Lipids, Atherosclerosis Liver and G-I Tract Pharmacology Metabolism, Pharmacokinetics Neuropharmacology Neuropsychopharmacology Oncopharmacology Pediatric Pharmacology Development Pharmacoeconomics Pharmacoepidemiology Pharmacogenetics, Pharmacogenomics Pharmacovigilance Pulmonary Pharmacology Receptors, Signal Transduction Renal Pharmacology Thrombosis and Hemostasis Toxicopharmacology Clinical research, including clinical studies and clinical trials, may cover disciplines such as pharmacokinetics, pharmacodynamics, pharmacovigilance, pharmacoepidemiology, pharmacogenomics and pharmacoeconomics. Basic research articles from fields such as physiology and molecular biology which contribute to an understanding of drug therapy are also welcomed.