Abstract：
Aneurysm and arterial dissection have been reported as adverse drug events, associated with angiogenesis inhibitors and fluoroquinolones. Specifically, several cases of severe arterial disease following cGMP-specific phosphodiesterase type 5 (PDE5) inhibitors usage have recently been reported. It is necessary to ascertain the risks of serious adverse events caused by PDE5 inhibitors. We aimed to evaluate the association of aneurysm and artery dissection with PDE5 inhibitors using VigiBase, which is a World Health Organization database of spontaneously reported adverse events, for explorative hypothesis-generating analysis. We performed disproportionality analysis using a dataset from inception in 1967 to December 2022 and calculated reporting odds ratios (ROR) between PDE5 inhibitors and arterial diseases. We extracted 195,839 reports on PDE5 inhibitors with 254 reports of arterial disease as adverse events from VigiBase. Disproportionality analysis showed disproportional signals for PDE5 inhibitors (ROR, 2.30;95% confidence intervals, 2.04-2.61);disproportional signals were detected in analyses restricting the lesion site to the aorta or cerebral arteries. From stratified analysis, disproportional signals were noted in females, as well as males, generally recognized as a risk factor for artery diseases. This real-world data analysis suggests that PDE5 inhibitors may play a role in the development of lethal arterial disease. J. Med. Invest. 71 : 134-140, February, 2024.
摘要：
动脉瘤和动脉夹层已被报告为不良药物事件，与血管生成抑制剂和氟喹诺酮类药物有关。具体来说,最近有报道称,使用cGMP特异性磷酸二酯酶5型(PDE5)抑制剂后出现几例严重动脉疾病.有必要确定PDE5抑制剂引起的严重不良事件的风险。我们旨在使用VigiBase评估动脉瘤和动脉夹层与PDE5抑制剂的关系，这是世界卫生组织自发报告的不良事件的数据库，用于探索性假设生成分析。我们使用从1967年开始到2022年12月的数据集进行了不成比例分析，并计算了PDE5抑制剂与动脉疾病之间的报告优势比（ROR）。我们从VigiBase中提取了195,839份关于PDE5抑制剂的报告和254份关于动脉疾病的报告作为不良事件。不成比例分析显示PDE5抑制剂的不成比例信号(ROR，2.30；95%置信区间，2.04-2.61）；在将病变部位限制在主动脉或脑动脉的分析中检测到不成比例的信号。从分层分析来看，在女性中注意到不成比例的信号，和男性一样，一般认为是动脉疾病的危险因素。这种真实世界的数据分析表明PDE5抑制剂可能在致死性动脉疾病的发展中起作用。J.Med.投资。71:134-140,二月,2024.
