同时使用口服抗凝剂与口服二甲酶-4抑制剂和严重出血事件
Thanh Phuong Pham Nguyen1,2,3,4, Charles E Leonard1,2,3,5, Colleen M Brensinger1,2,3
1Center for Real-World Effectiveness and Safety of Therapeutics, University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania, USA.
Clinical pharmacology and therapeutics
|September 12, 2024
概括
这项研究调查了当将口服抗凝剂 (OAC) 与二二酶-4抑制剂 (DPP-4is) 结合使用时存在严重出血风险. 虽然由于统计限制而不能证实先前的信号,但某些组合仍然需要谨慎.
科学领域:
- 药物监督 药物监督 药物监督
- 心血管药理学心血管药理学
- 药品安全 药品安全
背景情况:
- 之前的查发现了萨克萨格利普丁 (DPP-4抑制剂) 和口服抗凝剂 (OAC) 的潜在严重出血风险.
- 了解DPP-4抑制剂和OAC之间的药物相互作用对于患者的安全至关重要.
研究的目的:
- 确认或驳斥特定OAC,DPP-4抑制剂和严重出血事件之间的关联.
- 评估DPP-4抑制剂和OACs在大量美国医疗保险人口中同时使用的安全性.
主要方法:
- 雇员自控病例系列 (SCCS) 和病例交叉 (CCO) 设计,使用2016-2020年的医疗保险数据.
- 使用SCCS的条件Poisson回归和CCO的多变量条件逻辑回归,用lisinopril作为负对照.
- 计算的比率比率 (RRRs) 和比率比率比率 (RORs) 来评估出血风险.
主要成果:
- 针对严重出血的调整后的RRRs有所不同,华法林/利西诺普利尔 + 林格利平丁显示出显著的升高 (3.49 [1.29-9.48]).
- 调整后的ROR也显示出变化,阿皮克萨班/利西诺普利尔 + 林格利普丁表明潜在的增加 (2.99 [0.74-12.11]).
- 统计学上的不准确性限制了先前识别的出血信号的确认.
结论:
- 一些OAC和DPP-4抑制剂的同时使用可能会带来出血风险,尽管这项研究并未最终证实.
- 数字上升的风险估计表明,对于特定的药物组合,需要谨慎.
- 需要进一步的研究来澄清这些药物相互作用的安全性.
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