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Clinical Trial
. 2023 Sep;25(9):828-844.
doi: 10.1111/jch.14715. Epub 2023 Aug 16.

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

Hae Won Jung  1 , Chang-Yeon Kim  1 , Seung-Pyo Hong  1 , Han-Joon Bae  1 , Ji Yong Choi  1 , Jae Kean Ryu  1 , Jin-Bae Lee  1 , Kyoung-Hoon Lee  2 , Kyoo-Rok Han  3 , Dong-Heon Yang  4 , Chang-Gyu Park  5 , Gheol-Woong Yu  6 , Moo-Yong Rhee  7 , Sung-Ji Park  8 , Min-Su Hyon  9 , Joon-Han Shin  10 , Bum-Kee Hong  11 , Han-Young Jin  12 , Sung-Yun Lee  13 , Sang-Hoon Seol  14 , Sang-Rok Lee  15 , Song-Yi Kim  16 , Kwang-Je Lee  17 , Eun-Joo Cho  18 , Chang-Wook Nam  19 , Tae-Ho Park  20 , Ung Kim  21 , Kee-Sik Kim  1
Affiliations
Clinical Trial

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

Hae Won Jung et al. J Clin Hypertens (Greenwich). 2023 Sep.

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).

Keywords: amlodipine; atorvastatin; dyslipidemia; hypertension; rosuvastatin.

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Conflict of interest statement

The authors declare no conflicts of interest.

Figures

FIGURE 1
FIGURE 1
progress of clinical trial. RAS, renin angiotensin system.
FIGURE 2
FIGURE 2
Enrollment flow chart for analysis. AML, amlodipine; ATV, atorvastatin; FAS, full analysis set; PPS, per‐protocol set; RSV, rosuvastatin.
FIGURE 3
FIGURE 3
The percent changes in LDL‐C at baseline, week 4, and week 8 in FAS population (A) and PPS population (B). AML, amlodipine; ATV, atorvastatin; FAS, full analysis set; LD L‐C, low‐density lipoprotein cholesterol; PPS, per‐protocol set; RSV, rosuvastatin.
FIGURE 4
FIGURE 4
The proportion of patients who satisfied the LDL‐C target goal according to risk classification. AML, amlodipine; ATV, atorvastatin; FAS, full analysis set; LDL‐C, low‐density lipoprotein cholesterol; PPS, per‐protocol set; RSV, rosuvastatin.
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