학술논문
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.
Document Type
Article
Author
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
Source
Subject
Language
ISSN
1524-6175
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). [ABSTRACT FROM AUTHOR]