Chen Hai-Yan, Zhao Hui, Yang Jun-Jie, Zhang Qian, Yan Ming-Ming, Qiu Xiao-Yan
Department of Pharmacy, Affiliated Dongyang Hospital of Wenzhou Medical University, Dongyang, Zhejiang, P. R. China.
Clinical Pharmacy Department, Huashan Hospital, Fudan University, Shanghai, P. R. China.
Expert Opin Drug Saf. 2024 Sep 20:1-8. doi: 10.1080/14740338.2024.2390000.
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.
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.
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.
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.
在多项随机对照试验、多个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（PLZ）与膀胱癌（BC）之间的关联仍存在争议。
从美国食品药品监督管理局不良事件报告系统（FAERS）数据库中提取2004年1月1日至2024年3月31日的不良事件（AE）数据。应用不成比例分析来量化PLZ相关膀胱癌的信号。
FAERS数据库中总共记录了17,627,524份AE报告，其中1366份是与PLZ相关的膀胱癌报告。报告的男性患者多于女性患者。患者的中位年龄为70岁。年度报告的峰值出现在2011年。共有602份AE报告了发病时间（TTO），中位TTO为1023天。在本研究中，膀胱癌和膀胱癌复发是强烈信号，而0期（原位癌）、ii期和iii期膀胱癌是弱信号。
本研究使用FAERS数据库全面证明了PLZ在糖尿病患者中诱发膀胱癌的风险。结果表明，接受PLZ治疗的患者更有可能患膀胱癌。男性和老龄化导致PLZ治疗患者的膀胱癌相关报告病例更多。
