1. 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.
- Author
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Jung HW, Kim CY, Hong SP, Bae HJ, Choi JY, Ryu JK, Lee JB, Lee KH, Han KR, Yang DH, Park CG, Yu GW, Rhee MY, Park SJ, Hyon MS, Shin JH, Hong BK, Jin HY, Lee SY, Seol SH, Lee SR, Kim SY, Lee KJ, Cho EJ, Nam CW, Park TH, Kim U, and Kim KS
- Subjects
- Humans, Rosuvastatin Calcium adverse effects, Atorvastatin adverse effects, Amlodipine adverse effects, Cholesterol, LDL, Double-Blind Method, Treatment Outcome, Hypertension drug therapy, Hypertension chemically induced, Dyslipidemias drug therapy, Leukemia, Myeloid, Acute chemically induced
- 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.)
- Published
- 2023
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