在接受心脏康复的患者中,Icosapent乙烯的适用性:现实世界的队列研究
Filippo Brucato1, Chiara Tognola2, Antonella Moreo2
1School of Medicine and Surgery, University of Milano-Bicocca, Milan, Italy.
International journal of cardiology
|November 27, 2025
概括
在心脏康复中,超过10%的心血管患者满足了Icosapent ethyl (IPE) 试验标准. 然而,只有不到1%的人符合意大利AIFA的标准,这表明对高甘油三的治疗机会存在差距.
科学领域:
- 心脏病学 心脏病学
- 药理学 药理学是指药理学的学科.
- 公共卫生 公共卫生
背景情况:
- 心血管疾病 (CVD) 患者的高甘油 (TG) 持续存在,尽管最佳的降脂疗法,表明残留风险.
- 伊科萨乙烯 (IPE) 是一种处方级的omega-3脂肪酸,已被证明可以减少特定患者群体的心血管事件.
- 在现实环境中评估IPE资格对于优化治疗策略至关重要.
研究的目的:
- 评估接受心脏康复治疗的患者中符合Icosapent乙烯 (IPE) 治疗的比例.
- 根据REDUCE-IT临床试验标准与意大利药物管理局 (AIFA) 标准对比资格.
- 确定在高TG患者的临床实践中实施IPE的障碍.
主要方法:
- 对1129名心脏康复计划中的急性或慢性冠状动脉综合征患者的回顾性分析.
- 在入院和出院时评估禁食甘油三 (TG) 和LDL胆固醇水平.
- 应用REDUCE-IT (TG 135-499 mg/dL,LDL 40-100 mg/dL,他类药物治疗) 和AIFA (TG ≥200 mg/dL,LDL <70 mg/dL,BMI ≥27 kg/m2,他类药物+ezetimibe,年龄18-80岁) 的IPE资格标准.
主要成果:
- 在康复期间,TG水平的中位数显著下降,从117 mg/dL降至99 mg/dL (p < 0.001),而LDL则从106.7 mg/dL降至62.8 mg/dL (p < 0.001).
- 10.4%的患者 (n=117) 满足了IPE的REDUCE-IT资格标准.
- 只有0.53%的患者 (n=6) 符合更严格的AIFAIPE资格标准.
结论:
- 根据临床试验标准,在心脏康复中相当一部分心血管患者在理论上有资格接受IPE.
- 严格的AIFA资格标准对IPE在常规临床实践中的实施构成重大障碍.
- 现实世界的数据强调需要重新评估当前的指导方针,以改善获得有效的TG降低疗法,如IPE.
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