患有排泄功能障碍风险的男性中SGLT2抑制剂和尿路感染:VigiBase分析
Zhiyu Qian1,2, Jonathan Song1,2, Alyssa Jones1,2
1Department of Urological Surgery, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.
Urology practice
|September 6, 2024
概括
-葡萄糖共运输体-2 (SGLT2) 抑制剂与男性尿路感染 (UTIs) 和复杂的UTIs风险增加有关. 老年男性面临更高的复杂尿路感染的风险,可能是由于排泄功能障碍.
科学领域:
- 药监和药物安全 药监和药物安全
- 泌尿病学和脏病学
- 内分泌学和糖尿病管理
背景情况:
- -葡萄糖共运输体-2 (SGLT2) 抑制剂被广泛用于治疗2型糖尿病.
- 男性患者,特别是老年人,由于潜在的排泄功能障碍,可能会增加尿路感染 (UTI) 的风险.
- 了解与男性SGLT2抑制剂相关的特定风险对于安全处方至关重要.
研究的目的:
- 调查SGLT2抑制剂使用与男性尿路感染和复杂尿路感染风险之间的关联.
- 为了特别评估老年男性 (≥65岁) 中的这种风险,他们更容易受到排泄功能障碍的影响.
主要方法:
- 使用全球VigiBase报告 (19672022) 采用药监督案例非案例研究设计.
- 使用不成比例分析,包括报告几率比率 (ROR) 和经验贝叶斯估计器 (EBE) 来评估风险.
- 在65岁时进行了年龄分层和敏感性分析,将SGLT2抑制剂与其他糖尿病药物进行了比较.
主要成果:
- 在使用SGLT2抑制剂的男性中,观察到尿路感染 (ROR 6.75) 和复杂尿路感染 (ROR 8.09) 的风险增加.
- 在65岁及以上的男性中,复杂尿路感染的风险特别明显 (ROR 8.79).
- 敏感性分析证实了重要的关联,表明了一致的安全信号.
结论:
- 在男性人群中,SGLT2抑制剂与尿路感染和复杂尿路感染的风险增加有关.
- 年长的男性,可能与良性前列腺增生相关的排泄功能障碍,表现出更明显的复杂尿路感染的风险.
- 处方者在开始使用SGLT2抑制剂时应考虑均衡的风险-益处评估,特别是在敏感的男性人群中.
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