ROsulord® sAfety for Patients with Dyslipidemia Study: A Non-interventional, Multicenter, Prospective, Observational Study in South Korea.
| Autor: | Kim DY; Department of Cardiology, Ajou University Hospital, Suwon, Gyeonggi-do, Republic of Korea., Kim SH; Department of Cardiology, Konkuk University School of Medicine, Seoul, Republic of Korea., Kim EJ; Department of Cardiology, Korea University Guro Hospital, Seoul, Republic of Korea., Han SJ; Department of Cardiology, Hallym University Sacred Heart Hospital, Anyang, Gyeonggi-do, Republic of Korea., Park JY; Department of Cardiology, Nowon Eulji Medical Center, Eulji University, Seoul, Republic of Korea., Youn JC; Division of Cardiology, Department of Internal Medicine, Seoul St. Mary's Hospital, Seoul, Republic of Korea., Kim HS; Catholic Research Institute for Intractable Cardiovascular Disease, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea., Jeong JE; Chong Kun Dang Pharmaceutical Corporation, Seoul, Republic of Korea., Ryu KH; Department of Cardiology, Hebron Medical Center, #102, St.68K, Phum Prey Sala, Sangkat Kakab2, Khan Pou Senchey, Phnom Penh, Cambodia. khryumd@hanmail.net. |
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| Jazyk: | angličtina |
| Zdroj: | Cardiology and therapy [Cardiol Ther] 2024 Nov 23. Date of Electronic Publication: 2024 Nov 23. |
| DOI: | 10.1007/s40119-024-00391-4 |
| Abstrakt: | 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. Competing Interests: Declarations. Conflict of Interest: Do Young Kim, Sung Hea Kim, Eung-Ju Kim, Sang-Jin Han, Ji-Yeong Park, Jong- Chan Youn, Kyu-Hyung Ryu, Hee-Seok Kim, and Ji-Eun Jeong declare that they have no competing interests. Ethical Approval: The ROAD study was an observational study that was conducted in local clinics and general hospitals. Approval for the study was provided by the respective Institutional Review Boards (IRBs) of institutions with IRBs (Kyung Hee University Hospital IRB No: 2015-11-304). This study was conducted in accordance with the Helsinki Declaration of 1964 and its later amendments. All participants provided written informed consent to participate in the study. An Independent Data Monitoring Committee (IDMC) was responsible for monitoring both data integrity and drug safety throughout the study. (© 2024. The Author(s).) |
| Databáze: | MEDLINE |
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