Yuet Wei C, Ebert Didi, Jann Michael
Department of Pharmacy Clinical Services, JPS Health Network, 1500 S. Main Street, Fort Worth, TX 76104, USA.
Department of Family Medicine, University of North Texas Health Science Center, Fort Worth, TX, USA.
Ther Adv Drug Saf. 2021 Mar 8;12:2042098620959271. doi: 10.1177/2042098620959271. eCollection 2021.
Neurocognitive adverse events have been observed with the widespread use of 3-hydroxy-3-methylglutaryl-CoA reductase inhibitors or "statins," which reduce low-density lipoprotein cholesterol (LDL-C) levels and subsequently cardiovascular risk. The United States Food and Drug Association directed manufacturers of proprotein convertase subtilisin-kexin type 9 (PCSK9) inhibitors to monitor for neurocognitive adverse events due to their potent effects on LDL-C reduction, which is a proposed mechanism for neuronal cell dysfunction. Other proposed mechanisms for PCSK9 inhibitor-associated neurocognitive adverse events include N-methyl-d-aspartate receptor modulation, dysregulation of lipid and glucose metabolism, and patient-specific risk factors for cognitive impairment. The purpose of this narrative review article is to describe the proposed mechanisms, incidence of neurocognitive adverse events from phase II and III trials for PCSK9 inhibitors, neurocognitive assessments utilized in clinical trials, and clinical implications. Given the increasing prevalence of PCSK9 inhibitor use and the neurocognitive adverse events observed with prior lipid-lowering therapies, clinicians should be aware of the risks associated with PCSK9 inhibitors, especially when therapy is indicated for patients at high risk for cardiovascular events. Overall, the incidence of PCSK9 inhibitor-associated neurocognitive appears to be uncommon. However, additional prospective studies evaluating cognitive impairment may be beneficial to determine the long-term safety of these agents.
随着3-羟基-3-甲基戊二酰辅酶A还原酶抑制剂(即“他汀类药物”)的广泛使用,已观察到神经认知不良事件,这类药物可降低低密度脂蛋白胆固醇(LDL-C)水平,进而降低心血管疾病风险。美国食品药品监督管理局要求前蛋白转化酶枯草溶菌素9型(PCSK9)抑制剂的制造商监测神经认知不良事件,因为这类药物对降低LDL-C有显著效果,而这被认为是导致神经元细胞功能障碍的一种机制。PCSK9抑制剂相关神经认知不良事件的其他潜在机制包括N-甲基-D-天冬氨酸受体调节、脂质和葡萄糖代谢失调以及患者特有的认知障碍风险因素。这篇叙述性综述文章的目的是描述潜在机制、PCSK9抑制剂II期和III期试验中神经认知不良事件的发生率、临床试验中使用的神经认知评估方法以及临床意义。鉴于PCSK9抑制剂的使用日益普遍,以及先前降脂治疗中观察到的神经认知不良事件,临床医生应意识到PCSK9抑制剂相关的风险,尤其是在为心血管事件高危患者进行治疗时。总体而言,PCSK9抑制剂相关神经认知不良事件的发生率似乎并不常见。然而,更多评估认知障碍的前瞻性研究可能有助于确定这些药物的长期安全性。