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ROsulord® 对血脂异常患者的安全性研究:韩国一项非干预性、多中心、前瞻性观察性研究。

ROsulord® sAfety for Patients with Dyslipidemia Study: A Non-interventional, Multicenter, Prospective, Observational Study in South Korea.

作者信息

Kim Do Young, Kim Sung Hea, Kim Eung-Ju, Han Sang-Jin, Park Ji-Yeong, Youn Jong-Chan, Kim Hee-Seok, Jeong Ji-Eun, Ryu Kyu-Hyung

机构信息

Department of Cardiology, Ajou University Hospital, Suwon, Gyeonggi-do, Republic of Korea.

Department of Cardiology, Konkuk University School of Medicine, Seoul, Republic of Korea.

出版信息

Cardiol Ther. 2025 Mar;14(1):17-29. doi: 10.1007/s40119-024-00391-4. Epub 2024 Nov 23.

DOI:10.1007/s40119-024-00391-4
PMID:39579293
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11893939/
Abstract

INTRODUCTION

The ROsulord® sAfety for patients with Dyslipidemia study (ROAD study) in the Republic of Korea investigated the safety and efficacy of rosuvastatin in routine clinical practice.

METHODS

This non-interventional, multicenter, prospective, observational study was conducted over a period of approximately 4.6 years and involved 14,243 participants. During this study, we assessed the adverse events, changes in laboratory test results, and efficacy endpoints associated with rosuvastatin use.

RESULTS

The findings revealed a notably low adverse event rate of 1.63%, indicating a favorable safety profile for rosuvastatin in the management of dyslipidemia. Importantly, no clinically significant incidences of statin-associated myopathy, hepatotoxicity, or diabetes were observed during the study period. Moreover, this study demonstrated significant improvements in lipid profiles among patients receiving rosuvastatin treatment, with a reduction in total cholesterol, low-density lipoprotein cholesterol, and triglyceride levels. These improvements contributed to a lower cardiovascular risk in the study population.

CONCLUSION

Overall, these findings suggest that rosuvastatin is safe and effective in managing dyslipidemia in real-world clinical settings, providing clinicians with valuable insights into the benefits and risks associated with statin therapy in this patient population.

摘要

引言

韩国的瑞舒伐他汀对血脂异常患者的安全性研究(ROAD研究)调查了瑞舒伐他汀在常规临床实践中的安全性和有效性。

方法

这项非干预性、多中心、前瞻性观察性研究历时约4.6年,涉及14243名参与者。在本研究中,我们评估了与使用瑞舒伐他汀相关的不良事件、实验室检查结果变化和疗效终点。

结果

研究结果显示不良事件发生率低至1.63%,表明瑞舒伐他汀在血脂异常管理中具有良好的安全性。重要的是,在研究期间未观察到与他汀类药物相关的肌病、肝毒性或糖尿病的临床显著发生率。此外,本研究表明接受瑞舒伐他汀治疗的患者血脂水平有显著改善,总胆固醇、低密度脂蛋白胆固醇和甘油三酯水平降低。这些改善有助于降低研究人群的心血管风险。

结论

总体而言,这些发现表明瑞舒伐他汀在现实临床环境中治疗血脂异常是安全有效的,为临床医生提供了关于该患者群体他汀类药物治疗相关益处和风险的宝贵见解。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e351/11893939/f44742a89c19/40119_2024_391_Fig3_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e351/11893939/0e66377cbaaf/40119_2024_391_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e351/11893939/11dcc30b44e5/40119_2024_391_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e351/11893939/f44742a89c19/40119_2024_391_Fig3_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e351/11893939/0e66377cbaaf/40119_2024_391_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e351/11893939/11dcc30b44e5/40119_2024_391_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e351/11893939/f44742a89c19/40119_2024_391_Fig3_HTML.jpg

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