A Comparative Analysis of ADRs under Obeticholic Acid and Ursodeoxycholic Acid in Cholestatic Liver Diseases Using the FAERS Database.

IF 1.7 Q3 PHARMACOLOGY & PHARMACY Drug Research Pub Date : 2024-11-01 Epub Date: 2024-09-23 DOI:10.1055/a-2401-4700

Meng Zhu, Linghui Tao, Feiye Zhu, Yongsheng Zhang

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Abstract

Background: The objective of this study was to compare the safety profiles of OCA and UDCA for the treatment of PBC using the FDA Adverse Event Reporting System database.

Methods: We extracted reports for OCA from 2016 to 2023 and UDCA from 2004 to 2023. Demographic details, adverse events (AEs), and concomitant medications were analyzed using descriptive statistics and signal detection methods.

Results: The most common for OCA were pruritus (1345 cases, ROR 20.96) and fatigue (528 cases, ROR 3.46). UDCA was more frequently associated with hepatocellular carcinoma (22 cases, ROR 16.37) and type I hypersensitivity reactions (11 cases, ROR 12.77). OCA was also linked to a higher frequency of constipation (161 cases, ROR 3.92) and increased blood alkaline phosphatase levels (145 cases, ROR 44.27).

Conclusion: This study reveals distinct safety profiles for OCA and UDCA in the treatment of PBC. OCA is associated with a higher frequency of pruritus, fatigue, constipation, and increased blood alkaline phosphatase levels, while UDCA is linked to hepatocellular carcinoma and type I hypersensitivity reactions. These findings support personalized treatment approaches based on individual patient characteristics.

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利用 FAERS 数据库比较分析胆汁淤积性肝病中 Obeticholic Acid 和 Ursodeoxycholic Acid 的 ADRs。

研究背景本研究的目的是利用美国食品药品管理局不良事件报告系统数据库，比较OCA和UDCA治疗PBC的安全性：我们提取了 2016 年至 2023 年的 OCA 报告和 2004 年至 2023 年的 UDCA 报告。使用描述性统计和信号检测方法分析了人口统计学细节、不良事件（AEs）和伴随药物：OCA最常见的不良反应是瘙痒（1345例，ROR为20.96）和疲劳（528例，ROR为3.46）。UDCA 更常见于肝细胞癌（22 例，ROR 16.37）和 I 型超敏反应（11 例，ROR 12.77）。OCA 也与较高的便秘频率（161 例，ROR 3.92）和血液碱性磷酸酶水平升高（145 例，ROR 44.27）有关：本研究显示，OCA 和 UDCA 在治疗 PBC 时具有不同的安全性。结论：本研究揭示了 OCA 和 UDCA 在治疗 PBC 时不同的安全性特征，OCA 与较高频率的瘙痒、疲劳、便秘和血液碱性磷酸酶水平升高有关，而 UDCA 则与肝细胞癌和 I 型超敏反应有关。这些研究结果支持根据患者个体特征采取个性化治疗方法。

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

Drug Research PHARMACOLOGY & PHARMACY-

CiteScore

3.50

自引率

0.00%

发文量

期刊介绍： Drug Research (formerly Arzneimittelforschung) is an international peer-reviewed journal with expedited processing times presenting the very latest research results related to novel and established drug molecules and the evaluation of new drug development. A key focus of the publication is translational medicine and the application of biological discoveries in the development of drugs for use in the clinical environment. Articles and experimental data from across the field of drug research address not only the issue of drug discovery, but also the mathematical and statistical methods for evaluating results from industrial investigations and clinical trials. Publishing twelve times a year, Drug Research includes original research articles as well as reviews, commentaries and short communications in the following areas: analytics applied to clinical trials chemistry and biochemistry clinical and experimental pharmacology drug interactions efficacy testing pharmacodynamics pharmacokinetics teratology toxicology.