Signals mining and analysis of adverse drug events of pioglitazone based on FAERS database

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Author: LI Ping ^1# LIU Yan ^2# YANG Tianyi ³ ZHAO Qiyao ¹ LI Jiaoyue ¹ LUO Yunpeng ¹ DAI Jinlin ¹ HUANG Zifan ¹  ZHANG Li ⁴  YANG Xiaohui ¹

Affiliation: 1. Department of Nephrology and Endocrinology, Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing 100700, China 2. Key Laboratory of Chinese Internal Medicine of Ministry of Education, Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing 10070, China 3. Rutgers University, New Brunswick, New Jersey 08901, USA 4. Department of Scientific Research, Dongfang Hospital, Beijing University of Chinese Medicine, Beijing 100078, China

Keywords: Pioglitazone Thiazolidinediones Adverse drug event FAERS database Signal mining Pharmacovigilance

DOI: 10.12173/j.issn.1005-0698.202407064

Reference: LI Ping, LIU Yan, YANG Tianyi, ZHAO Qiyao, LI Jiaoyue, LUO Yunpeng, DAI Jinlin, HUANG Zifan, ZHANG Li, YANG Xiaohui.Signals mining and analysis of adverse drug events of pioglitazone based on FAERS database[J]. Yaowu Liuxingbingxue Zazhi, 2024, 33(12): 1365-1374. DOI: 10.12173/j.issn.1005-0698.202407064.[Article in Chinese]  Copied

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Abstract

Objective To mine adverse drug event (ADE) signals of pioglitazone, and to provide references for the safe clinical use of the medication.

Methods The reporting odds ratio(ROR) method and the Bayesian confidence propagation neural network (BCPNN) method were utilized to analyze pioglitazone ADE reports from the U. S. Food and Drug Administration Adverse Event Reporting System (FAERS) database, spanning from the first quarter of 2013 to the second quarter of 2024.

Results After data cleaning, a total of 16 904 pioglitazone ADE reports were retrieved. The ADE reports primarily involved individuals over the age of 45, with a male predominance, and were mainly reported from the United States. After screening, 180 ADE signals were identified, affecting 27 system-organ classes (SOC). Out of these, 34 ADE signals were classified as medium to high risk, with 9 ADE signals not mentioned in the product labeling, including ureteral cancer, urethral cancer, gallbladder tumors, malignant tumors of the renal pelvis, pericardial tamponade, left ventricular dysfunction, pulmonary edema, cystitis, and somniloquy.

Conclusion In addition to closely monitoring weight gain, systemic edema, and heart failure, clinical attention should be given to left ventricular dysfunction, pulmonary edema, cystitis, and pericardial tamponade ADEs that are not mentioned in the instructions, to ensure the safety of pioglitazone use in clinical practice.

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