使用PCSK9抑制剂的认知功能:在现实世界中进行24个月的随访观察前性研究-MEMOGAL研究
Jose Seijas-Amigo1,2,3, Mª José Mauriz-Montero4, Pedro Suarez-Artime5
1Cardiology Department, Complejo Hospitalario Universidad de Santiago de Compostela, Travesía da Choupana s/n, 15706, Santiago de Compostela (A Coruña), Spain. jose.seijas@rai.usc.es.
概括
单克隆抗体PCSK9抑制剂 (PCSK9i) 在现实研究中没有对认知功能产生负面影响. 延迟回忆记忆略有改善,PCSK9i药物或LDL-C水平之间没有观察到差异.
科学领域:
- 心脏病学 心脏病学
- 神经学 神经学
- 药理学 药理学是指药理学的学科.
背景情况:
- PCSK9抑制剂 (PCSK9i) 的认知安全性是在临床试验中确立的,但需要在现实世界中进行验证.
- 需要实践观察性研究来确认PCSK9i治疗的神经认知安全性.
研究的目的:
- 在现实环境中评估患者启动PCSK9抑制剂的认知功能.
- 分析认知功能领域的差异,并根据LDL-C水平和PCSK9i类型 (alirocumab与evolocumab) 确定子组.
主要方法:
- 从2020年5月到2023年2月,多中心,准实验性设计涉及12家西班牙医院.
- 用蒙特利尔认知评估 (MoCA) 工具评估认知功能.
- 患者的随访时间中位数为99周,分组分析基于LDL-C水平和PCSK9i类型.
主要成果:
- 在24个月内,全球MoCA得分或大多数认知领域没有显著变化.
- 在延迟召回记忆方面,统计学显著改善 (平均变化+0.44,p=0.001).
- 在alirocumab和evolocumab之间没有发现认知差异,也没有在实现不同的LDL-C水平的子组之间发现.
结论:
- 单克隆抗体PCSK9抑制剂在24个月内似乎不会影响全球神经认知功能或特定的认知领域.
- 观察到延迟召回记忆的轻微改善,表明没有不良的认知影响.
- 认知安全在不同的LDL-C水平之间以及在现实环境中在阿利罗库马布和埃沃洛库马布之间保持.
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