Effectiveness and Safety of Very-Low-Dose Rosuvastatin-Ezetimibe Therapy in Korean Patients with Dyslipidaemia: A Multicentre Prospective Observational Study.

IF 2.7 3区 医学 Q2 PHARMACOLOGY & PHARMACY
Clinical Drug Investigation Pub Date : 2025-10-01 Epub Date: 2025-09-16 DOI:10.1007/s40261-025-01482-3
Ji Woong Roh, Moon-Hwa Park, Ji-Won Son, SungA Bae
{"title":"Effectiveness and Safety of Very-Low-Dose Rosuvastatin-Ezetimibe Therapy in Korean Patients with Dyslipidaemia: A Multicentre Prospective Observational Study.","authors":"Ji Woong Roh, Moon-Hwa Park, Ji-Won Son, SungA Bae","doi":"10.1007/s40261-025-01482-3","DOIUrl":null,"url":null,"abstract":"<p><strong>Background and objectives: </strong>Dyslipidaemia is a key modifiable risk factor for atherosclerotic cardiovascular disease. However, achieving recommended low-density lipoprotein cholesterol (LDL-C) target levels is challenging owing to dose-dependent adverse effects and limited tolerability of high-dose statins. This study evaluated the real-world efficacy and safety of combining very-low-dose rosuvastatin (2.5 mg) with ezetimibe (10 mg) in adult patients with dyslipidaemia across different cardiovascular risk strata.</p><p><strong>Methods: </strong>This multicentre prospective study in South Korea enrolled 2,388 patients. Participants were stratified into low-, moderate-, or high-risk groups on the basis of the 2019 European Society of Cardiology and European Atherosclerosis Society guidelines. Lipid profiles and safety outcomes were assessed at baseline and after 12 weeks. The primary and secondary outcomes were LDL-C and non-high-density lipoprotein cholesterol (non-HDL-C) target level achievements, respectively, and adverse events were monitored.</p><p><strong>Results: </strong>After 12 weeks, LDL-C target levels were achieved by 82.6% of low-risk (< 116 mg/dL), 73.9% of moderate-risk (< 100 mg/dL), and 50.4% of high-risk (< 70 mg/dL) patients. Non-HDL-C target level achievement followed a similar trend. Combination therapy with ezetimibe and low-dose statin resulted in significant LDL-C reductions, compared with statins alone. Adverse events were infrequent (0.6%), and only 0.2% of patients discontinued treatment owing to medication-related concerns.</p><p><strong>Conclusions: </strong>Very-low-dose rosuvastatin-ezetimibe combination therapy significantly lowered LDL-C levels and improved lipid profiles across various risk groups, demonstrating a favourable safety profile. These findings support its use as an effective, well-tolerated option for managing dyslipidaemia. Longer-term studies are warranted to evaluate sustained lipid control and cardiovascular outcomes.</p>","PeriodicalId":10402,"journal":{"name":"Clinical Drug Investigation","volume":" ","pages":"803-813"},"PeriodicalIF":2.7000,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Clinical Drug Investigation","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1007/s40261-025-01482-3","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2025/9/16 0:00:00","PubModel":"Epub","JCR":"Q2","JCRName":"PHARMACOLOGY & PHARMACY","Score":null,"Total":0}
引用次数: 0

Abstract

Background and objectives: Dyslipidaemia is a key modifiable risk factor for atherosclerotic cardiovascular disease. However, achieving recommended low-density lipoprotein cholesterol (LDL-C) target levels is challenging owing to dose-dependent adverse effects and limited tolerability of high-dose statins. This study evaluated the real-world efficacy and safety of combining very-low-dose rosuvastatin (2.5 mg) with ezetimibe (10 mg) in adult patients with dyslipidaemia across different cardiovascular risk strata.

Methods: This multicentre prospective study in South Korea enrolled 2,388 patients. Participants were stratified into low-, moderate-, or high-risk groups on the basis of the 2019 European Society of Cardiology and European Atherosclerosis Society guidelines. Lipid profiles and safety outcomes were assessed at baseline and after 12 weeks. The primary and secondary outcomes were LDL-C and non-high-density lipoprotein cholesterol (non-HDL-C) target level achievements, respectively, and adverse events were monitored.

Results: After 12 weeks, LDL-C target levels were achieved by 82.6% of low-risk (< 116 mg/dL), 73.9% of moderate-risk (< 100 mg/dL), and 50.4% of high-risk (< 70 mg/dL) patients. Non-HDL-C target level achievement followed a similar trend. Combination therapy with ezetimibe and low-dose statin resulted in significant LDL-C reductions, compared with statins alone. Adverse events were infrequent (0.6%), and only 0.2% of patients discontinued treatment owing to medication-related concerns.

Conclusions: Very-low-dose rosuvastatin-ezetimibe combination therapy significantly lowered LDL-C levels and improved lipid profiles across various risk groups, demonstrating a favourable safety profile. These findings support its use as an effective, well-tolerated option for managing dyslipidaemia. Longer-term studies are warranted to evaluate sustained lipid control and cardiovascular outcomes.

极低剂量瑞舒伐他汀-依折替米治疗韩国血脂异常患者的有效性和安全性:一项多中心前瞻性观察研究
背景和目的:血脂异常是动脉粥样硬化性心血管疾病的关键可改变危险因素。然而,由于剂量依赖性副作用和高剂量他汀类药物耐受性有限,实现推荐的低密度脂蛋白胆固醇(LDL-C)目标水平具有挑战性。本研究评估了极低剂量瑞舒伐他汀(2.5 mg)与依折替米贝(10 mg)联合治疗不同心血管风险层的成人血脂异常患者的实际疗效和安全性。方法:这项在韩国进行的多中心前瞻性研究纳入了2388例患者。根据2019年欧洲心脏病学会和欧洲动脉粥样硬化学会指南,将参与者分为低、中、高风险组。在基线和12周后评估脂质谱和安全性结果。主要和次要结局分别是LDL-C和非高密度脂蛋白胆固醇(non-HDL-C)目标水平的实现,并监测不良事件。结果:12周后,82.6%的低危(< 116 mg/dL)、73.9%的中危(< 100 mg/dL)和50.4%的高危(< 70 mg/dL)患者达到了LDL-C目标水平。非hdl - c目标水平的实现也遵循了类似的趋势。与单用他汀类药物相比,依折替贝和低剂量他汀类药物联合治疗可显著降低LDL-C。不良事件很少发生(0.6%),只有0.2%的患者因药物相关问题而停止治疗。结论:极低剂量瑞舒伐他汀-依zetimibe联合治疗可显著降低各种风险组的LDL-C水平并改善脂质谱,显示出良好的安全性。这些发现支持它作为一种有效的、耐受性良好的治疗血脂异常的选择。长期研究需要评估持续的脂质控制和心血管结果。
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
CiteScore
5.90
自引率
3.10%
发文量
108
审稿时长
6-12 weeks
期刊介绍: Clinical Drug Investigation provides rapid publication of original research covering all phases of clinical drug development and therapeutic use of drugs. The Journal includes: -Clinical trials, outcomes research, clinical pharmacoeconomic studies and pharmacoepidemiology studies with a strong link to optimum prescribing practice for a drug or group of drugs. -Clinical pharmacodynamic and clinical pharmacokinetic studies with a strong link to clinical practice. -Pharmacodynamic and pharmacokinetic studies in healthy volunteers in which significant implications for clinical prescribing are discussed. -Studies focusing on the application of drug delivery technology in healthcare. -Short communications and case study reports that meet the above criteria will also be considered. Additional digital features (including animated abstracts, video abstracts, slide decks, audio slides, instructional videos, infographics, podcasts and animations) can be published with articles; these are designed to increase the visibility, readership and educational value of the journal’s content. In addition, articles published in Clinical Drug Investigation may be accompanied by plain language summaries to assist readers who have some knowledge, but non in-depth expertise in, the area to understand important medical advances.
×
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:604180095
Book学术官方微信