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 dyslipidemiaopen access
- Authors
- Jung, Hae Won; Kim, Chang-Yeon; Hong, Seung-Pyo; Bae, Han-Joon; Choi, Ji Yong; Ryu, Jae Kean; Lee, Jin-bae; Lee, Kyoung-Hoon; Han, Kyoo-Rok; Yang, Dong-Heon; Park, Chang-Gyu; Yu, Gheol-Woong; Rhee, Moo-Yong; Park, Sung-Ji; Hyon, Min-Su; Shin, Joon-Han; Hong, Bum-Kee; Jin, Han-Young; Lee, Sung-Yun; Seol, Sang-Hoon; Lee, Sang-Rok; Kim, Song-Yi; Lee, Kwang-Je; Cho, Eun-Joo; Nam, Chang-Wook; Park, Tae-Ho; Kim, Ung; Kim, Kee-Sik
- Issue Date
- Sep-2023
- Publisher
- WILEY
- Keywords
- amlodipine; atorvastatin; dyslipidemia; hypertension; rosuvastatin
- Citation
- JOURNAL OF CLINICAL HYPERTENSION, v.25, no.9, pp 828 - 844
- Pages
- 17
- Journal Title
- JOURNAL OF CLINICAL HYPERTENSION
- Volume
- 25
- Number
- 9
- Start Page
- 828
- End Page
- 844
- URI
- https://scholarworks.bwise.kr/sch/handle/2021.sw.sch/25498
- DOI
- 10.1111/jch.14715
- ISSN
- 1524-6175
1751-7176
- 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).
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Collections - College of Medicine > Department of Internal Medicine > 1. Journal Articles
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