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

Cardiol Ther. 2024 Nov 23. doi: 10.1007/s40119-024-00391-4. Online ahead of print.

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.

Keywords: Cardiovascular disease; Dyslipidemia; Lipids; Myopathy; Rosuvastatin.