西地那非是一种选择性的磷酸二酯酶-5（PDE5）抑制剂，广泛用于治疗勃起功能障碍（ED）。然而，包括不良事件（AEs）在内的西地那非安全性需进行全面评价。本回顾性药物监测研究旨在通过分析来自FDA不良事件报告系统（FAERS）数据库的数据来评估与西地那非相关的AEs。采用病例/非病例设计，并采用多个算法，包括报告比（ROR）、比例报告比（PRR）、贝叶斯置信传播神经网络（BCPNN）和多项目伽马泊松收缩器（MGPS），以测量指示与西地那非相关的AEs存在的信号。在339,230份报告中，有33,692份明确提及使用了西地那非。大多数AEs发生在60岁以上的男性患者中。美国报告的AEs占最高比例。包括“生殖系统和乳房疾患”（SOC: 10038604）、“恶性、良性和未指明的肿瘤”（SOC: 10038738）、“血管疾患”（SOC: 10047065）和“血液和淋巴系统疾患”（SOC: 10005329）在内的重要系统器官类别（SOC）发生了AEs。与西地那非相关的值得注意的优先术语（PTs）包括“视力模糊”、“潮红”、“突发性听力丧失”、“疼痛勃起”和“持续勃起”。还发现了一些意外的AEs，例如“恶性黑色素瘤”、“肺动脉高压”、“原位恶性黑色素瘤”、“肺动脉高压”、“转移性恶性黑色素瘤”、“III期恶性黑色素瘤”、“II期恶性黑色素瘤”、“获得性血友病”、“主动脉夹层破裂”和“颅内动脉夹层”。这些发现强调了监测和了解与西地那非相关的潜在风险的重要性。进一步研究需要验证这些关联并解决以前未被认识到的安全性问题。©2023 American Society of Andrology and European Academy of Andrology.

Sildenafil, a selective inhibitor of phosphodiesterase type 5 (PDE5), is widely used for the treatment of erectile dysfunction (ED). However, the safety profile of sildenafil, including adverse event (AEs), requires comprehensive evaluation.This retrospective pharmacovigilance study aimed to evaluate AEs linked to sildenafil by analyzing data sourced from the FDA Adverse Event Reporting System (FAERS) database. A case/non-case design was utilized, and various algorithms including the reporting odds ratio (ROR), the proportional reporting ratio (PRR), the Bayesian confidence propagation neural network (BCPNN), and the multiitem gamma Poisson shrinker (MGPS) were employed to measure the signals indicating the presence of sildenafil-related AEs.Among 339,230 reports, 33,692 specifically mentioned sildenafil use. Most of AEs occurred in males over 60 years old. The United States accounted for the highest proportion of reported AEs. Severe outcomes, including death, disability, and life-threatening events, were reported. Significant system organ class (SOC) included "Reproductive system and breast disorders" (SOC: 10038604), "Neoplasms benign, malignant and unspecified" (SOC: 10038738), "Vascular disorders" (SOC: 10047065), and "Blood and lymphatic system disorders" (SOC: 10005329). Noteworthy preferred terms (PTs) associated with sildenafil included "Vision blurred," "Flushing," "sudden hearing loss," "Painful erection," and "Priapism." Unexpected AEs, such as "Malignant melanoma," "Pulmonary hypertension," "Malignant melanoma in situ," "Pulmonary arterial hypertension," "Metastatic malignant melanoma," "Malignant melanoma stage III," "Malignant melanoma stage II," "Acquired hemophilia," "Aortic dissection rupture," and "Intracranial artery dissection" were also identified.These findings emphasize the importance of monitoring and understanding the potential risks associated with sildenafil. Further investigation is warranted to validate these associations and address previously unrecognized safety concerns.© 2023 American Society of Andrology and European Academy of Andrology.