Reassessment of pioglitazone and bladder cancer based on FAERS database.

IF 3 3区医学 Q2 PHARMACOLOGY & PHARMACY

Expert Opinion on Drug Safety Pub Date : 2024-09-20 DOI:10.1080/14740338.2024.2390000

Hai-Yan Chen, Hui Zhao, Jun-Jie Yang, Qian Zhang, Ming-Ming Yan, Xiao-Yan Qiu

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引用次数: 0

Abstract

Background: The association between pioglitazone (PLZ) and bladder cancer (BC) remains controversial in several randomized control trials, meta-analyses of multiple prospective studies, and large-scale observational studies.

Research design and methods: Adverse event (AE) data from 1 January 2004 to 31 March 2024 were extracted from the Food and Drug Administration Adverse Event Reporting System (FAERS) database. Disproportionality analysis were applied to quantify the signals of PLZ related BC.

Results: In total, 17,627,524 AE reports were recorded in the FAERS database, of which 1366 were PLZ-related BCs. More male than female patients were reported. The median age of patients was 70 years old. The peak in the annual report occurred in 2011. A total of 602 AEs reported time to onset (TTO) and the median TTO was 1023 days. In this study, BC and BC recurrence were strong signal, whereas BC stage 0 (with cancer in situ), stage ii and iii were weak signals.

Conclusions: This study comprehensively demostrated the PLZ-induced risk of BC in patients with diabetes mellitus using the FAERS database. The results demonstrated that the patients treated with PLZ were more likely to develop BC. The male and aging attributed more cases to BC-related reports of PLZ treated patients.

查看原文本刊更多论文

基于 FAERS 数据库对吡格列酮与膀胱癌的重新评估。

背景：在多项随机对照试验、多项前瞻性研究的荟萃分析以及大规模观察性研究中，吡格列酮与膀胱癌（BC）之间的关系仍存在争议：从美国食品和药物管理局不良事件报告系统（FAERS）数据库中提取了2004年1月1日至2024年3月31日期间的不良事件（AE）数据。应用比例失调分析量化与PLZ相关的BC信号：结果：FAERS数据库共记录了17,627,524份AE报告，其中1366份是与PLZ相关的BC。男性患者多于女性患者。患者的中位年龄为70岁。年度报告的高峰期出现在 2011 年。共有 602 例 AE 报告了发病时间（TTO），中位 TTO 为 1023 天。在这项研究中，乳腺癌和乳腺癌复发是强信号，而乳腺癌0期（原位癌）、Ⅱ期和Ⅲ期是弱信号：本研究利用FAERS数据库全面展示了PLZ诱发糖尿病患者BC的风险。结果表明，接受PLZ治疗的患者更容易罹患乳腺癌。接受PLZ治疗的患者中，与BC相关的病例报告中，男性和老年占多数。

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

Expert Opinion on Drug Safety 医学-药学

CiteScore

5.90

自引率

3.20%

发文量

审稿时长

6-12 weeks

期刊介绍： Expert Opinion on Drug Safety ranks #62 of 216 in the Pharmacology & Pharmacy category in the 2008 ISI Journal Citation Reports. Expert Opinion on Drug Safety (ISSN 1474-0338 [print], 1744-764X [electronic]) is a MEDLINE-indexed, peer-reviewed, international journal publishing review articles on all aspects of drug safety and original papers on the clinical implications of drug treatment safety issues, providing expert opinion on the scope for future development.