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Abstract：
Recent studies focused on exploring phosphodiesterase type 5 inhibitors (PDE5Is)-related hearing impairment. This study aimed to comprehensively explore real-world hearing impairment associated with PDE5Is based on the US Food and Drug Administration Adverse Event Reporting System (FAERS). The characteristics and correlation of PDE5Is-related hearing impairment reported in the FAERS database from the fourth quarter of 2003 to the second quarter of 2023 were analyzed using disproportionality analysis. The Standardized Medical Dictionary for Regulatory Activities (MedDRA) Queries (SMQs) were used to analyze the adverse events (AEs) of hearing impairment. A total of 1,438 reported cases of hearing impairment were associated with four PDE5Is, revealing statistically significant reporting odds ratio (ROR), proportional reporting ratio (PRR), and information component (IC) with the SMQ. The average age of all patients was more than 55 years, over 70% of AEs were reported in men. Most of the reported cases were from the United States. Reports for all the drugs indicated an increase since 2008, except for avanafil. This study showed that the disability rates of PDE5Is were 8.14-40%, the rates of initial or prolonged hospitalization were 6.21-10.24%, and the rates of required intervention were 3.31-9.45%. The pharmacovigilance study identified a potential risk of hearing impairment associated with PDE5Is, indicating the need for continuous monitoring and appropriate management.
摘要：
最近的研究集中在探索5型磷酸二酯酶抑制剂（PDE5Is）相关的听力障碍。本研究旨在基于美国食品和药物管理局不良事件报告系统（FAERS）全面探索与PDE5Is相关的真实世界听力障碍。从2003年第四季度到2023年第二季度，FAERS数据库中报告的PDE5Is相关听力损害的特征和相关性使用不成比例分析进行了分析。使用规范活动标准化医学词典（MedDRA）查询（SMQs）分析听力障碍的不良事件（AE）。共有1,438例报告的听力障碍病例与4例PDE5Is相关，揭示统计上显著的报告优势比(ROR)，比例报告比率(PRR)，以及带有SMQ的信息组件(IC)。所有患者的平均年龄超过55岁，超过70%的AE在男性中报告。报告的大多数病例来自美国。自2008年以来，所有药物的报告均有所增加，但阿瓦那非除外。这项研究表明，PDE5Is的致残率为8.14-40%，初次或长期住院率为6.21-10.24%，所需干预率为3.31-9.45%。药物警戒研究确定了与PDE5Is相关的听力损害的潜在风险，表明需要持续监测和适当管理。
