Muscle-Related Adverse Events Associated With PCSK9 Inhibitors in a Veteran Population.

Joseph Cencetti, Callie Abramowitz, Heather Spoonhower
{"title":"Muscle-Related Adverse Events Associated With PCSK9 Inhibitors in a Veteran Population.","authors":"Joseph Cencetti, Callie Abramowitz, Heather Spoonhower","doi":"10.12788/fp.0357","DOIUrl":null,"url":null,"abstract":"Background\nStatins and PCSK9 inhibitors (PCSK9i) are used to lower low-density lipoprotein cholesterol and reduce cardiovascular events, yet some patients are unable to tolerate statin therapy due to muscle-related adverse events (AEs). The effect of PCSK9i on muscle-related AEs is not well studied, and available data show inconsistent incidence rates.\n\n\nMethods\nThe primary study outcome was to determine the percentage of patients who developed muscle-related PCSK9i AEs. A secondary outcome was to analyze data based on 4 subgroups: tolerated a full PCSK9i dose; tolerated alternative PCSK9i following initial intolerance; required a PCSK9i dose reduction, or discontinued PCSK9i. In addition, the percentage of statin- and/or ezetimibe-intolerant patients in these 4 groups was determined. Another secondary outcome was the management strategies taken for patients who were on a reduced (monthly) dose of PCSK9i who did not reach their low-density lipoprotein cholesterol goal. Statin intolerance was defined as intolerable skeletal muscle AEs on at least 3 different statins. We conducted a single-center, retrospective review of patients prescribed a PCSK9i between December 1, 2017, and September 1, 2021, at a patient aligned care team clinic at the Wilkes-Barre Veterans Affairs Medical Center.\n\n\nResults\nThe study included 137 veterans. Twenty-four patients (17.5%) developed a muscle-related AE while on a PCSK9i. In predefined subgroups studied, statin intolerance ranged from 68.1% to 100%, ezetimibe intolerance ranged from 41.6% to 83.3%, and both statin and ezetimibe intolerance ranged from 36.3% to 83.3%.\n\n\nConclusions\nIn this study, muscle-related PCSK9i AEs occurred at a similar incidence rate to that reported in previous clinical trials and exceeded the incidence rate reported in the prescribing information for alirocumab and evolocumab. It also appears that patients who have a prior muscle-related intolerance to a statin and/or ezetimibe have a higher likelihood of developing a muscle-related AE to a PCSK9i.","PeriodicalId":94009,"journal":{"name":"Federal practitioner : for the health care professionals of the VA, DoD, and PHS","volume":null,"pages":null},"PeriodicalIF":0.0000,"publicationDate":"2023-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"1","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Federal practitioner : for the health care professionals of the VA, DoD, and PHS","FirstCategoryId":"0","ListUrlMain":"https://doi.org/10.12788/fp.0357","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
引用次数: 1

Abstract

Background Statins and PCSK9 inhibitors (PCSK9i) are used to lower low-density lipoprotein cholesterol and reduce cardiovascular events, yet some patients are unable to tolerate statin therapy due to muscle-related adverse events (AEs). The effect of PCSK9i on muscle-related AEs is not well studied, and available data show inconsistent incidence rates. Methods The primary study outcome was to determine the percentage of patients who developed muscle-related PCSK9i AEs. A secondary outcome was to analyze data based on 4 subgroups: tolerated a full PCSK9i dose; tolerated alternative PCSK9i following initial intolerance; required a PCSK9i dose reduction, or discontinued PCSK9i. In addition, the percentage of statin- and/or ezetimibe-intolerant patients in these 4 groups was determined. Another secondary outcome was the management strategies taken for patients who were on a reduced (monthly) dose of PCSK9i who did not reach their low-density lipoprotein cholesterol goal. Statin intolerance was defined as intolerable skeletal muscle AEs on at least 3 different statins. We conducted a single-center, retrospective review of patients prescribed a PCSK9i between December 1, 2017, and September 1, 2021, at a patient aligned care team clinic at the Wilkes-Barre Veterans Affairs Medical Center. Results The study included 137 veterans. Twenty-four patients (17.5%) developed a muscle-related AE while on a PCSK9i. In predefined subgroups studied, statin intolerance ranged from 68.1% to 100%, ezetimibe intolerance ranged from 41.6% to 83.3%, and both statin and ezetimibe intolerance ranged from 36.3% to 83.3%. Conclusions In this study, muscle-related PCSK9i AEs occurred at a similar incidence rate to that reported in previous clinical trials and exceeded the incidence rate reported in the prescribing information for alirocumab and evolocumab. It also appears that patients who have a prior muscle-related intolerance to a statin and/or ezetimibe have a higher likelihood of developing a muscle-related AE to a PCSK9i.
退伍军人中PCSK9抑制剂相关的肌肉相关不良事件
他汀类药物和PCSK9抑制剂(PCSK9i)用于降低低密度脂蛋白胆固醇和减少心血管事件,然而一些患者由于肌肉相关不良事件(ae)而无法耐受他汀类药物治疗。PCSK9i对肌肉相关ae的影响尚未得到很好的研究,现有数据显示发病率不一致。方法主要研究结果是确定发生肌肉相关PCSK9i ae的患者百分比。次要结局是分析基于4个亚组的数据:耐受全剂量PCSK9i;初始不耐受后可耐受替代PCSK9i;需要减少PCSK9i剂量,或停用PCSK9i。此外,确定了这4组中他汀类药物和/或依折替米贝不耐受患者的百分比。另一个次要结果是对未达到低密度脂蛋白胆固醇目标的减少(每月)PCSK9i剂量的患者所采取的管理策略。他汀类药物不耐受被定义为对至少3种不同他汀类药物的骨骼肌不良反应。我们对2017年12月1日至2021年9月1日期间在Wilkes-Barre退伍军人事务医疗中心的患者对齐护理团队诊所使用PCSK9i的患者进行了单中心回顾性评价。结果该研究包括137名退伍军人。24例患者(17.5%)在使用PCSK9i时发生了肌肉相关AE。在预先确定的亚组研究中,他汀类药物不耐受范围从68.1%到100%,依泽替米贝不耐受范围从41.6%到83.3%,他汀类药物和依泽替米贝不耐受范围从36.3%到83.3%。结论在本研究中,肌肉相关PCSK9i ae的发生率与以往临床试验报道的发生率相似,并且超过了alirocumab和evolocumab处方信息中报道的发生率。此外,既往对他汀类药物和/或依zetimibe有肌肉相关不耐受的患者发生PCSK9i肌肉相关AE的可能性更高。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
求助全文
约1分钟内获得全文 求助全文
来源期刊
自引率
0.00%
发文量
0
×
引用
GB/T 7714-2015
复制
MLA
复制
APA
复制
导出至
BibTeX EndNote RefMan NoteFirst NoteExpress
×
提示
您的信息不完整,为了账户安全,请先补充。
现在去补充
×
提示
您因"违规操作"
具体请查看互助需知
我知道了
×
提示
确定
请完成安全验证×
copy
已复制链接
快去分享给好友吧!
我知道了
右上角分享
点击右上角分享
0
联系我们:info@booksci.cn Book学术提供免费学术资源搜索服务,方便国内外学者检索中英文文献。致力于提供最便捷和优质的服务体验。 Copyright © 2023 布克学术 All rights reserved.
京ICP备2023020795号-1
ghs 京公网安备 11010802042870号
Book学术文献互助
Book学术文献互助群
群 号:481959085
Book学术官方微信