계명대학교 의학도서관 Repository

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

Metadata Downloads
Author(s)
Min Chul KimYoungkeun AhnMoo Hyun KimSeok-Yeon KimTaek Jong HongMoo-Yong RheeSang-Hyun KimSoon-Jun HongHyungseop KimWeon KimIn Ho ChaeDuk-Hyun KangByeong-Keuk KimHyo-Soo Kim
Keimyung Author(s)
Kim, Hyung Seop
Department
Dept. of Internal Medicine (내과학)
Journal Title
Am J Cardiovasc Drugs
Issued Date
2023
Volume
23
Issue
4
Abstract
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).
Keimyung Author(s)(Kor)
김형섭
Publisher
School of Medicine (의과대학)
Type
Article
ISSN
1179-187X
Source
https://link.springer.com/article/10.1007/s40256-023-00590-9
DOI
10.1007/s40256-023-00590-9
URI
https://kumel.medlib.dsmc.or.kr/handle/2015.oak/45166
Appears in Collections:
1. School of Medicine (의과대학) > Dept. of Internal Medicine (내과학)
공개 및 라이선스
  • 공개 구분공개
  • 엠바고Forever
파일 목록
  • 관련 파일이 존재하지 않습니다.

Items in Repository are protected by copyright, with all rights reserved, unless otherwise indicated.