A Randomized, Multicenter, Double-blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of a Quadruple Combination of Amlodipine, Losartan, Rosuvastatin, and Ezetimibe in Patients with Concomitant Essential Hypertension and Dyslipidemia,American Journal of Cardiovascular Drugs

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A Randomized, Multicenter, Double-blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of a Quadruple Combination of Amlodipine, Losartan, Rosuvastatin, and Ezetimibe in Patients with Concomitant Essential Hypertension and Dyslipidemia
American Journal of Cardiovascular Drugs ( IF 2.8 ) Pub Date : 2023-07-03 , DOI: 10.1007/s40256-023-00590-9
Min Chul Kim ₁ , Youngkeun Ahn ₁ , Moo Hyun Kim ₂ , Seok-Yeon Kim ₃ , Taek Jong Hong ₄ , Moo-Yong Rhee ₅ , Sang-Hyun Kim ₆ , Soon-Jun Hong ₇ , Hyungseop Kim ₈ , Weon Kim ₉ , In Ho Chae ₁₀ , Duk-Hyun Kang ₁₁ , Byeong-Keuk Kim ₁₂ , Hyo-Soo Kim ₁₃

Affiliation

Division of Cardiology, Department of Internal Medicine, Chonnam National University Hospital, Chonnam National University Medical School, Gwangju, Republic of Korea.
Department of Cardiology, Dong-A University Medical School, Pusan, Republic of Korea.
Department of Cardiology, Seoul Medical Center, Seoul, Republic of Korea.
Division of Cardiology, Department of Internal Medicine, Pusan National University Medical School, Pusan, Republic of Korea.
Cardiovascular Center, Dongguk University Ilsan Hospital, Goyang, Republic of Korea.
Division of Cardiology, Department of Internal Medicine, SMG-SNU Seoul Boramae Hospital, Seoul National University Medical School, Seoul, Republic of Korea.
Department of Cardiology, Cardiovascular Center, Korea University College of Medicine, Seoul, Republic of Korea.
Keimyung University Dongsan Medical Center, Daegu, Republic of Korea.
Division of Cardiovascular, Department of Internal Medicine, Kyung Hee University Hospital, Kyung Hee University Medical School, Seoul, Republic of Korea.
Cardiovascular Center, Seoul National University Bundang Hospital, Seoul National University Hospital, Seongnam, Republic of Korea.
Division of Cardiology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.
Division of Cardiology, Department of Internal Medicine, Severance Cardiovascular Hospital, Yonsei University College of Medicine, Seoul, Republic of Korea.
Department of Internal Medicine, Cardiovascular Center, Seoul National University Hospital, Seoul National University Medical School, 101, Daehak-ro, Jongro-gu, Seoul, 03080, Republic of Korea.

Background

Few data are available regarding the efficacy and safety of a single-pill combination (SPC) consisting of four medications in patients with concomitant hypertension and dyslipidemia.

Objective

We aimed to determine the efficacy and tolerability of a fixed-dose SPC consisting of 5 mg amlodipine, 100 mg losartan, 20 mg rosuvastatin, and 10 mg ezetimibe (A/L/R/E) in patients with concomitant hypertension and dyslipidemia.

Methods

This was a 14-week, randomized, multicenter, double-blind, placebo-controlled, phase III clinical trial. In total, 145 patients were randomized to receive A/L/R/E, A/L, or L/R/E. The primary endpoints were the average change in the low-density lipoprotein cholesterol (LDL-C) level in the A/L/R/E and A/L groups and the sitting systolic blood pressure (sitSBP) in the A/L/R/E and L/R/E groups. The numbers of patients with adverse drug reactions (ADRs) were compared as safety variables.

Results

The average percentage change in the LDL-C level as the least squares mean (LSM) from the baseline LDL-C level at the end of the 8-week treatment was − 59.0% in the A/L/R/E group and 0.2% in the A/L group (LSM difference − 59.2, 95% confidence interval [CI] − 68.1 to − 50.4; p < 0.0001). The average change in the sitSBP as the LSM was − 15.8 mmHg in the A/L/R/E group and −4.7 mmHg in the L/R/E group (LSM difference − 11.1, 95% CI − 16.8 to − 5.4; p = 0.0002). No ADRs occurred in the A/L/R/E group.

Conclusions

A/L/R/E as an SPC could be an effective treatment for patients with hypertension and dyslipidemia without significant safety issues.

Clinical Trials Registration

NCT04074551 (registered 30 August 2019).

Graphical Abstract

中文翻译：

一项随机、多中心、双盲、安慰剂对照研究，旨在评估氨氯地平、氯沙坦、瑞舒伐他汀和依折麦布四联疗法对合并原发性高血压和血脂异常患者的疗效和安全性

背景

关于由四种药物组成的单药组合 (SPC) 对于合并高血压和血脂异常的患者的疗效和安全性，目前的数据很少。

客观的

我们的目的是确定由 5 mg 氨氯地平、100 mg 氯沙坦、20 mg 瑞舒伐他汀和 10 mg 依折麦布 (A/L/R/E) 组成的固定剂量 SPC 对合并高血压和血脂异常的患者的疗效和耐受性。

方法

这是一项为期 14 周、随机、多中心、双盲、安慰剂对照的 III 期临床试验。总共 145 名患者被随机分配接受 A/L/R/E、A/L 或 L/R/E 治疗。主要终点是 A/L/R/E 组和 A/L 组中低密度脂蛋白胆固醇 (LDL-C) 水平的平均变化以及 A/L/R 组中的坐位收缩压 (sitSBP) /E 和 L/R/E 组。将发生药物不良反应（ADR）的患者数量作为安全变量进行比较。

结果

8 周治疗结束时，LDL-C 水平相对于基线 LDL-C 水平的最小二乘均值 (LSM) 平均百分比变化在 A/L/R/E 组中为 − 59.0%，在 A/L/R/E 组中为 0.2 A/L 组中的 %（LSM 差异 − 59.2，95% 置信区间 [CI] − 68.1 至 − 50.4；p < 0.0001）。LSM 下的 SITSBP 平均变化在 A/L/R/E 组中为 − 15.8 mmHg，在 L/R/E 组中为 −4.7 mmHg（LSM 差异 − 11.1，95% CI − 16.8 至 − 5.4；p = 0.0002）。A/L/R/E 组未发生 ADR。