계명대학교 의학도서관 Repository

Randomized, multicenter, parallel, open, phase 4 study to compare the efficacy and safety of rosuvastatin/amlodipine polypill versus atorvastatin/amlodipine polypill in hypertension patient with dyslipidemia

Metadata Downloads
Author(s)
Hae Won JungChang-Yeon KimSeung-Pyo HongHan-Joon BaeJi Yong ChoiJae Kean RyuJin-Bae LeeKyoung-Hoon LeeKyoo-Rok HanDong-Heon YangChang-Gyu ParkGheol-Woong YuMoo-Yong RheeSung-Ji ParkMin-Su HyonJoon-Han ShinBum-Kee HongHan-Young JinSung-Yun LeeSang-Hoon SeolSang-Rok LeeSong-Yi KimKwang-Je LeeEun-Joo ChoChang-Wook NamTae-Ho Park 20, Ung KimKee-Sik Kim
Keimyung Author(s)
Nam, Chang Wook
Department
Dept. of Internal Medicine (내과학)
Journal Title
J Clin Hypertens (Greenwich)
Issued Date
2023
Volume
25
Issue
9
Keyword
amlodipineatorvastatindyslipidemiahypertensionrosuvastatin
Abstract
The authors performed this study to investigate the efficacy and safety of a rosuvastatin (RSV)/amlodipine (AML) polypill compared with those of atorvastatin (ATV)/AML polypill. We included 259 patients from 21 institutions in Korea. Patients were randomly assigned to 1 of 3 treatment groups: RSV 10 mg/AML 5 mg, RSV 20 mg/AML 5 mg, or ATV 20 mg /AML 5 mg. The primary endpoint was the efficacy of the RSV 10.20 mg/AML 5 mg via percentage changes in LDL-C after 8 weeks of treatment, compared with the ATV 20 mg /AML 5 mg. There was a significant difference in the mean percentage change of LDL-C at 8 weeks between the RSV 10 mg/AML 5 mg and the ATV 20 mg/AML 5 mg (full analysis set [FAS]: -7.08%, 95% CI: -11.79 to -2.38, p = .0034, per-protocol analysis set [PPS]: -6.97%, 95% CI: -11.76 to -2.19, p = .0046). Also, there was a significant difference in the mean percentage change of LDL-C at 8 weeks between the RSV 20 mg/AML 5 mg and the ATV 20 mg/AML 5 mg (FAS: -10.13%, 95% CI: -15.41 to -4.84, p = .0002, PPS: -10.96%, 95% CI: -15.98 to -5.93, p < .0001). There was no significant difference in the adverse events rates between RSV 10 mg/AML 5 mg, RSV 20 mg/AML 5 mg, and ATV 20 mg/AML 5 mg. In conclusion, while maintaining safety, RSV 10 mg/AML 5 mg and the RSV 20 mg/AML 5 mg more effectively reduced LDL-C compared with the ATV 20 mg /AML 5 mg (Clinical trial: NCT03951207).
Keimyung Author(s)(Kor)
남창욱
Publisher
School of Medicine (의과대학)
Type
Article
ISSN
1751-7176
Source
https://onlinelibrary.wiley.com/doi/10.1111/jch.14715
DOI
10.1111/jch.14715
URI
https://kumel.medlib.dsmc.or.kr/handle/2015.oak/45235
Appears in Collections:
1. School of Medicine (의과대학) > Dept. of Internal Medicine (내과학)
공개 및 라이선스
  • 공개 구분공개
파일 목록

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