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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

Authors
 Hae Won Jung  ;  Chang-Yeon Kim  ;  Seung-Pyo Hong  ;  Han-Joon Bae  ;  Ji Yong Choi  ;  Jae Kean Ryu  ;  Jin-Bae Lee  ;  Kyoung-Hoon Lee  ;  Kyoo-Rok Han  ;  Dong-Heon Yang  ;  Chang-Gyu Park  ;  Gheol-Woong Yu  ;  Moo-Yong Rhee  ;  Sung-Ji Park  ;  Min-Su Hyon  ;  Joon-Han Shin  ;  Bum-Kee Hong  ;  Han-Young Jin  ;  Sung-Yun Lee  ;  Sang-Hoon Seol  ;  Sang-Rok Lee  ;  Song-Yi Kim  ;  Kwang-Je Lee  ;  Eun-Joo Cho  ;  Chang-Wook Nam  ;  Tae-Ho Park  ;  Ung Kim  ;  Kee-Sik Kim 
Citation
 JOURNAL OF CLINICAL HYPERTENSION, Vol.25(9) : 828-844, 2023-09 
Journal Title
JOURNAL OF CLINICAL HYPERTENSION
ISSN
 1524-6175 
Issue Date
2023-09
MeSH
Amlodipine / adverse effects ; Atorvastatin / adverse effects ; Cholesterol, LDL ; Double-Blind Method ; Dyslipidemias* / drug therapy ; Humans ; Hypertension* / chemically induced ; Hypertension* / drug therapy ; Leukemia, Myeloid, Acute* / chemically induced ; Rosuvastatin Calcium / adverse effects ; Treatment Outcome
Keywords
amlodipine ; atorvastatin ; dyslipidemia ; hypertension ; rosuvastatin
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). © 2023 The Authors. The Journal of Clinical Hypertension published by Wiley Periodicals LLC.
Files in This Item:
T999202634.pdf Download
DOI
10.1111/jch.14715
Appears in Collections:
1. College of Medicine (의과대학) > Dept. of Internal Medicine (내과학교실) > 1. Journal Papers
Yonsei Authors
Hong, Bum Kee(홍범기) ORCID logo https://orcid.org/0000-0002-6456-0184
URI
https://ir.ymlib.yonsei.ac.kr/handle/22282913/198434
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