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

IF 3.6 4区医学 Q2 PHARMACOLOGY & PHARMACY

Clinical therapeutics Pub Date : 2025-08-25 DOI:10.1016/j.clinthera.2025.07.023

Soohyung Park, Eun Jin Park, Moon-Hwa Park, Wonsang Chu, Dae-In Lee, Seung-Young Roh, Cheol Ung Choi, Dong Oh Kang

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引用次数: 0

Abstract

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.

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四药联合治疗高血压和血脂异常的疗效和安全性：一项前瞻性、多中心、观察性研究。

目的：单丸联合（SPC）治疗可以减轻高血压和血脂异常患者的药物负担，可能改善药物依从性和临床结果。本研究旨在评估氯沙坦、氨氯地平、瑞舒伐他汀和依zetimibe （L/ a /R/E）联合四药固定剂量SPC （QFDC）治疗这些患者的疗效和安全性。方法：在2021年9月至2023年9月期间，2150名患者（平均年龄：61.58±12.41岁，男性：56.33%）纳入了这项在韩国137家医院进行的前瞻性、多中心、观察性研究。患者接受六种QFDC方案之一的治疗，联合氯沙坦（50/ 100mg）、氨氯地平（5mg）、瑞舒伐他汀（5/10/20 mg）和依折替米贝（10mg）。主要终点是达到目标血压（BP）的患者百分比结果：在1965名符合条件的患者（疗效分析集）中，73.15%（95%置信区间[CI] 71.19-75.11）在QFDC治疗12周后达到目标血压。同样，71.11% （95% CI 68.33-73.89）达到目标LDL-C水平。此外，57.11% （95% CI 54.08-60.15）患者达到了目标血压和LDL-C水平。从基线到12周的平均变化为收缩压-13.69±17.04 mmHg, LDL-C -37.55±34.93 mg/dL（均P < 0.0001），基线水平较高的亚组（BP≥140/90 mmHg或LDL-C≥100 mg/dL）降低幅度更大。未见严重不良事件或药物不良反应。结论：L/A/R/E QFDC方案对于并发高血压和血脂异常患者是一种有效且安全的治疗选择。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Clinical therapeutics 医学-药学

CiteScore

6.00

自引率

3.10%

发文量

154

审稿时长

9 weeks

期刊介绍： Clinical Therapeutics provides peer-reviewed, rapid publication of recent developments in drug and other therapies as well as in diagnostics, pharmacoeconomics, health policy, treatment outcomes, and innovations in drug and biologics research. In addition Clinical Therapeutics features updates on specific topics collated by expert Topic Editors. Clinical Therapeutics is read by a large international audience of scientists and clinicians in a variety of research, academic, and clinical practice settings. Articles are indexed by all major biomedical abstracting databases.