Efficacy and safty of a quadruple combination of amlodipine, losartan, rosuvastatin, and ezetimibe in ASCVD patients with poor medication adherence (AMOREMIO study)

Abstract Background Poor medication adherence in ASCVD patients significantly contributes to adverse clinical outcomes, increasing cardiovascular risks and healthcare burdens. Fixed-dose combination therapy (FDCT) offers a simplified treatment approach to improve adherence and optimize therapeutic outcomes. Objective The AMOREMIO study represents the first investigation into the efficacy of a quadruple fixed-dose combination therapy (FDQC) of amlodipine, losartan, rosuvastatin, and ezetimibe in ASCVD patients with poor adherence after switching from free combination therapy (FCT). Methods This multicenter, post-marketing, observational study included ASCVD patients with hypertension (MSSBP 140–179 mmHg) and/or dyslipidemia. Total 550 patients were enrolled to this study. Poor adherence was identified through clinical evidence or self-reports. Patients switched from FCT to FDQC were followed for 12 weeks with primary endpoints of blood pressure (MSSBP, MSDBP) and LDL-C changes. Paired T-tests were conducted to compare pre- and post-treatment values within the FDQC group. Results Switching to FDQC therapy resulted in significant improvements in systolic and diastolic blood pressure, LDL-C levels, and uric acid reduction. Logistic regression revealed higher odds of achieving SBP 140 mmHg (OR 3.08; p0.001) and LDL-C 70 mg/dL (OR 3.70; p0.001) after the switch. Patient satisfaction scores were markedly higher due to reduced pill burden. Conclusion Transitioning to FDQC therapy significantly improves adherence and achieves better blood pressure and lipid control, addressing barriers of complex therapeutic regimens. This study highlights the importance of simplified strategies for improving outcomes in high-risk ASCVD patients.