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

• Published in: The Journal of Clinical Hypertension
• Main 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
• Format: Article
• Language: English
• Published: Wiley 2023-09-01
• Subjects: amlodipine; atorvastatin; dyslipidemia; hypertension; rosuvastatin
• Online Access: https://doi.org/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).