在现实世界,当代心力衰竭人口中,有资格获得 vericiguat
Giuseppe Vergaro1,2, Alberto Aimo1,2, Francesco Gentile1,2
1Interdisciplinary Center for Health Sciences, Scuola Superiore Sant'Anna, Piazza Martiri della Libertà, 33, 56124, Pisa, Italy.
ESC heart failure
|July 11, 2024
概括
对于心力衰竭患者,Vericiguat的适用性在现实世界中是有限的. 只有9%的人符合VICTORIA试验的标准,但高达19%的人符合监管标准,影响了治疗机会.
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.
- 现实世界的证据 现实世界的证据
背景情况:
- 韦里西瓜特是一种可溶性瓜尼酸环酶刺激剂,可改善心力衰竭 (HF) 降低射出分数 (HFrEF) 的存活率.
- 关于捐赠者资格的现实数据很少,需要更新的评估超出过时的注册表.
- 评估当前和未来的HF队列中的资格对于理解治疗准入至关重要.
研究的目的:
- 为了前性地评估心力衰竭患者在现实环境中是否有资格接受输送治疗.
- 根据临床试验标准,HF指南和监管机构标签来比较资格.
- 确定意大利国家卫生系统对药物成本的潜在覆盖.
主要方法:
- 在五所大学医院,从346名连续HF患者收集前性数据.
- 根据VICTORIA试验标准,HF指南建议和FDA/EMA标签标准对资格的评估.
- 意大利监管机构对可退款标准的评估,考虑到SGLT2抑制剂的使用.
主要成果:
- 57%的患者有HFrEF,68%的患者有LVEF<45%,76%的患者有NYHAII-IV类症状.
- 只有9%的人符合VICTORIA试验资格;13%的人符合HF指南建议.
- 在意大利,高达19%的药物符合FDA或EMA标签标准;药物成本覆盖率估计为8-10%.
结论:
- 在现实世界中,受理器的资格是狭窄的,特别是在VICTORIA试验标准的基础上.
- 根据HF指南和监管标签,更广泛的患者群体可能有资格参加.
- 意大利有限的药物成本覆盖率突出显示了符合条件的患者获得医疗服务的潜在障碍.
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