听力系统不良事件与sacubitril/valsartan:使用FDA不良事件报告系统数据库的活性比较器受限不成比例性分析
Atefeh Jafari1,2, Niaz Chalabianloo3, Flory T Muanda1,2,3,4
1Department of Epidemiology & Biostatistics, Western University, London, ON, Canada.
Expert opinion on drug safety
|September 29, 2025
概括
与利西诺普里尔和洛萨坦相比,萨库比特里尔/瓦尔萨坦可能会增加听力损失和前体障碍的风险. 需要进一步的研究来证实这些听觉不良事件.
科学领域:
- 药物监督 药物监督 药物监督
- 心脏病学 心脏病学
- 耳鼻喉科 耳鼻喉科 耳鼻喉科
背景情况:
- 萨库比特里尔/瓦尔沙坦是心力衰竭的关键治疗方法,其喷射分数减少.
- 新出现的数据表明,sacubitril/valsartan与耳毒性之间存在潜在的联系,包括听力和前置系统问题.
- 这些听觉不良事件被低估了,并没有被充分理解.
研究的目的:
- 为了比较sacubitril/valsartan与lisinopril和losartan的听觉不良事件报告.
- 为了调查与这些药物相关的听力障碍,前体障碍和低音的风险.
主要方法:
- 美国FDA不良事件报告系统 (FAERS) 数据 (2015Q3-2023Q3) 的回顾性不成比例分析.
- 使用的监管活动医学词典 (MedDRA) 术语用于听觉不良事件.
- 采用后勤回归和贝叶斯方法来计算调整后报赔率比率 (aROR).
主要成果:
- 萨库比特里尔/瓦尔萨坦与报告听力损伤 (aROR 2.35) 和前置障碍 (aROR 2.58) 的几率比率相比,与利西诺普里尔相关.
- 与lisinopril相比,在使用sacubitril/valsartan时观察到显著增加低音度风险 (aROR 15.03).
- 当将萨库比特里尔/瓦尔萨坦与洛萨坦进行比较时,发现了类似的风险增加,贝叶斯分析证实了这一点.
结论:
- 萨库比特里尔/瓦尔萨坦可能与听觉不良事件的风险比利西诺普里尔和洛萨坦更大.
- 这些发现表明sacubitril/valsartan的潜在耳毒作用.
- 建议进行进一步的药理流行病学研究以验证这些关联.
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