Abstract：
UNASSIGNED: Our study aims to characterize the ocular safety profiles of phosphodiesterase type 5 (PDE5) inhibitors and explore the differences among different PDE5 inhibitors.
UNASSIGNED: We analyzed reports on ocular adverse events associated with sildenafil, vardenafil and tadalafil submitted to the FDA Adverse Event Reporting System (FAERS) database from the first quarter of 2004 to the first quarter of 2023. Disproportionality analysis was conducted to evaluate reporting risk profiles.
UNASSIGNED: Among 61,211 reports qualifying for analysis, 5,127 involved sildenafil, 832 vardenafil, and 3,733 tadalafil. All PDE5 inhibitors showed increased reporting odds ratios (ROR) for ocular adverse events, with vardenafil highest (ROR 4.47) followed by sildenafil and tadalafil. Key ocular adverse events included cyanopsia, optic ischemic neuropathy, visual field defects, unilateral blindness and blindness. Sildenafil showed the highest disproportionality for cyanopsia (ROR 1148.11) while vardenafil and tadalafil showed the highest disproportionality for optic ischemic neuropathy. Time-to-onset analysis also revealed significant differences, with sildenafil having a later median time-to-onset compared to vardenafil and tadalafil.
UNASSIGNED: This comprehensive pharmacovigilance study reveals distinct patterns of ocular adverse events associated with PDE5 inhibitors. These findings contribute to a better understanding of the safety profiles of PDE5 inhibitors and may guide healthcare professionals in clinical decision-making.
UNASSIGNED: We analyzed reports on ocular adverse events associated with sildenafil, vardenafil and tadalafil submitted to the FDA Adverse Event Reporting System (FAERS) database from the first quarter of 2004 to the first quarter of 2023. Disproportionality analysis was conducted to evaluate reporting risk profiles.
UNASSIGNED: Among 61,211 reports qualifying for analysis, 5,127 involved sildenafil, 832 vardenafil, and 3,733 tadalafil. All PDE5 inhibitors showed increased reporting odds ratios (ROR) for ocular adverse events, with vardenafil highest (ROR 4.47) followed by sildenafil and tadalafil. Key ocular adverse events included cyanopsia, optic ischemic neuropathy, visual field defects, unilateral blindness and blindness. Sildenafil showed the highest disproportionality for cyanopsia (ROR 1148.11) while vardenafil and tadalafil showed the highest disproportionality for optic ischemic neuropathy. Time-to-onset analysis also revealed significant differences, with sildenafil having a later median time-to-onset compared to vardenafil and tadalafil.
UNASSIGNED: This comprehensive pharmacovigilance study reveals distinct patterns of ocular adverse events associated with PDE5 inhibitors. These findings contribute to a better understanding of the safety profiles of PDE5 inhibitors and may guide healthcare professionals in clinical decision-making.
摘要：
■5型磷酸二酯酶（PDE5）抑制剂通常用于勃起功能障碍和肺动脉高压。虽然PDE5抑制剂在其预期的治疗领域显示出显著的疗效，人们对其潜在的眼部不良事件感到担忧.我们的研究旨在表征PDE5抑制剂的眼部安全性，并探讨PDE5抑制剂之间眼部不良事件的差异。
■我们分析了与西地那非相关的眼部不良事件的报告，伐地那非和他达拉非从2004年第一季度到2023年第一季度提交给FDA不良事件报告系统（FAERS）数据库。进行不相称性分析以评估报告风险概况。
■在符合分析条件的61,211份报告中，5,127涉及西地那非，832伐地那非,和3,733他达拉非.所有PDE5抑制剂显示眼部不良事件的报告比值比（ROR）增加，伐地那非最高（ROR4.47），其次是西地那非和他达拉非。关键的眼部不良事件包括氰视，视神经缺血性神经病,视野缺陷,单侧失明和失明。西地那非对色盲的比例最高（ROR1148.11），而伐地那非和他达拉非对视神经缺血性病变的比例最高。发病时间分析也显示出显著差异，与伐地那非和他达拉非相比，西地那非的中位发病时间较晚。
这项全面的药物警戒研究揭示了与西地那非相关的眼部不良事件的不同模式，伐地那非,还有他达拉非.这些发现有助于更好地了解PDE5抑制剂的安全性，并可能指导医疗保健专业人员进行临床决策。
■我们分析了与西地那非相关的眼部不良事件的报告，伐地那非和他达拉非从2004年第一季度到2023年第一季度提交给FDA不良事件报告系统（FAERS）数据库。进行不相称性分析以评估报告风险概况。
■在符合分析条件的61,211份报告中，5,127涉及西地那非，832伐地那非,和3,733他达拉非.所有PDE5抑制剂显示眼部不良事件的报告比值比（ROR）增加，伐地那非最高（ROR4.47），其次是西地那非和他达拉非。关键的眼部不良事件包括氰视，视神经缺血性神经病,视野缺陷,单侧失明和失明。西地那非对色盲的比例最高（ROR1148.11），而伐地那非和他达拉非对视神经缺血性病变的比例最高。发病时间分析也显示出显著差异，与伐地那非和他达拉非相比，西地那非的中位发病时间较晚。
这项全面的药物警戒研究揭示了与西地那非相关的眼部不良事件的不同模式，伐地那非,还有他达拉非.这些发现有助于更好地了解PDE5抑制剂的安全性，并可能指导医疗保健专业人员进行临床决策。
