Efficacy and Safety of Rosuvastatin/Amlodipine FDC in Patients With Hypertension and Dyslipidemia: A Multicenter, Prospective, Observational Study

Abstract

Background: A fixed-dose combination of rosuvastatin and amlodipine (Ros/Aml) offers a simplified approach to simultaneously address hypertension and dyslipidemia. While pivotal trials have demonstrated the efficacy and safety of this regimen, real-world evidence on its clinical outcomes related to major adverse cardiovascular and cerebrovascular events (MACCE) had been limited. Methods: This multicenter, prospective, non-interventional study was conducted across 39 sites in South Korea (2020–2024) to evaluate the 12-month effectiveness and safety of Ros/Aml in adults with coexisting hypertension and dyslipidemia. The primary endpoint was the incidence of MACCE. Secondary endpoints included changes in blood pressure, lipid profiles, and safety outcomes. Results: A total of 5018 patients were enrolled, with 5009 (99.82%) included in the Safety and Efficacy Sets. The mean age was 66.80 years, and 60.39% were male. In the efficacy set, the 12-month MACCE incidence was 0.54% [95% CI: 0.36–0.78], with no significant differences among four dose groups. Ros/Aml significantly reduced systolic and diastolic blood pressure at 6 and 12 months (both P < 0.001), and LDL-C levels (P < 0.0001). Adverse drug reactions were reported in 3.11% of patients; with only 0.06% experiencing serious ADRs and no ADR-related deaths occurred, suggesting a tolerable safety profile. Conclusions: In this large real-world study, Ros/Aml demonstrated a favorable safety profile and was effective in reducing MACCE risk, blood pressure, and lipid levels over 12 months. These findings in patients with hypertension and dyslipidemia support its use as a viable strategy for integrated cardiovascular risk management in clinical practice.