Efficacy and Safety of Quadruple-Drug Fixed-Dose Single-Pill Combination Therapy for Hypertension and Dyslipidemia: A Prospective, Multicenter, Observational Study.

Purpose: Single-pill combination (SPC) therapy can reduce the pill burden in patients with hypertension and dyslipidemia, potentially improving medication adherence and clinical outcomes. This study aimed to evaluate the efficacy and safety of a quadruple-drug fixed-dose SPC (QFDC) therapy combining losartan, amlodipine, rosuvastatin, and ezetimibe (L/A/R/E) in these patients.

Methods: Between September 2021 and September 2023, 2,150 patients (mean age: 61.58 ± 12.41 years; male: 56.33%) were enrolled in this prospective, multicenter, observational study conducted across 137 hospitals in South Korea. Patients were treated with one of six QFDC regimens, which combined losartan (50/100 mg), amlodipine (5 mg), rosuvastatin (5/10/20 mg), and ezetimibe (10 mg). The primary endpoint was the percentage of patients who achieved a target blood pressure (BP) of <140/90 mmHg and low-density lipoprotein cholesterol (LDL-C) levels of <100 mg/dL 12 weeks post-treatment.

Findings: Among the 1,965 eligible patients (efficacy analysis set), 73.15% (95% confidence interval [CI] 71.19-75.11) achieved the target BP after 12 weeks of QFDC therapy. Similarly, 71.11% (95% CI 68.33-73.89) reached the target LDL-C level. Additionally, 57.11% (95% CI 54.08-60.15) achieved both target BP and LDL-C levels. The mean changes from baseline to 12 weeks were -13.69 ± 17.04 mmHg for systolic BP and -37.55 ± 34.93 mg/dL for LDL-C (both P < 0.0001), with greater reductions noted in subgroups with higher baseline levels (BP ≥140/90 mmHg or LDL-C ≥100 mg/dL). No serious adverse events or adverse drug reactions were reported.

Implications: The L/A/R/E QFDC regimen is an effective and safe treatment option for patients with concurrent hypertension and dyslipidemia.