A randomized, double-blind clinical trial to evaluate the efficacy and safety of a fixed-dose combination of amlodipine/rosuvastatin in patients with dyslipidemia and hypertension

被引：18

作者：

Kim, Woohyeun ^{[1
]}

Chang, Kiyuk ^{[2
]}

Cho, Eun Joo ^{[3
]}

Ahn, Jeong-Cheon ^{[4
]}

Yu, Cheol Woong ^{[5
]}

Cho, Kyoung-Im ^{[6
]}

Kim, Yong-Jin ^{[7
]}

Kang, Duk-Hyun ^{[8
]}

Kim, Seok-Yeon ^{[9
]}

Lee, Sang-Hak ^{[10
]}

Kim, Ung ^{[11
]}

Kim, Shin-Jae ^{[12
]}

Ahn, Young Keun ^{[13
]}

Lee, Chang Hoon ^{[14
]}

Shin, Jin Ho ^{[15
]}

Kim, Mikyung ^{[16
]}

Park, Chang Gyu ^{[1
]}

机构：

[1] Korea Univ, Guro Hosp, Cardiovasc Ctr, Seoul, South Korea

[2] Seoul St Marys Hosp, Div Cardiol, Seoul, South Korea

[3] St Pauls Hosp, Div Cardiol, Seoul, South Korea

[4] Korea Univ, Ansan Hosp, Div Cardiol, Ansan, South Korea

[5] Korea Univ, Anam Hosp, Div Cardiol, Seoul, South Korea

[6] Maryknoll Med Ctr, Div Cardiol, Busan, South Korea

[7] Seoul Natl Univ Hosp, Cardiovasc Ctr, Seoul, South Korea

[8] Asan Med Ctr, Inst Heart, Valvular Heart Dis Ctr, Seoul, South Korea

[9] Seoul Med Ctr, Dept Cardiol, Seoul, South Korea

[10] Severance Cardiovasc Hosp, Div Cardiol, Seoul, South Korea

[11] Yeungnam Univ, Div Cardiol, Med Ctr, Daegu, South Korea

[12] Ulsan Univ Hosp, Div Cardiol, Ulsan, South Korea

[13] Natl Univ Hosp, Heart Ctr Chonnam, Gwangju, South Korea

[14] Vet Hlth Serv Med Ctr, Div Cardiol, Seoul, South Korea

[15] Hanyang Univ Hosp, Div Cardiol, Seoul, South Korea

[16] Yuhan Corp, Yuhan Res Inst, Yongin, South Korea

来源：

JOURNAL OF CLINICAL HYPERTENSION | 2020年 / 22卷 / 02期

关键词：

amlodipine; dyslipidemia; hypertension; rosuvastatin; single-pill combination; BLOOD-PRESSURE; SYSTEMATIC ANALYSIS; GLOBAL BURDEN; METAANALYSIS; PREVALENCE; STATINS; AMLODIPINE/ATORVASTATIN; MANAGEMENT; ADHERENCE; THERAPY;

D O I：

10.1111/jch.13774

中图分类号：

R6 [外科学];

学科分类号：

1002 ; 100210 ;

摘要：

This multicenter, randomized, double-blind, parallel-group phase III clinical trial aimed to investigate the efficacy and safety of a rosuvastatin + amlodipine combination compared with that of rosuvastatin or amlodipine monotherapy in hypertensive patients with dyslipidemia. A total of 106 patients of 15 institutions in Korea were randomly assigned to 1 of 3 treatment groups: rosuvastatin 20 mg + amlodipine 10 mg, amlodipine 10 mg, or rosuvastatin 20 mg. After 8 weeks of treatment, the mean +/- SD of change in mean sitting systolic blood pressure (msSBP) was -22.82 +/- 12.99 mm Hg in the rosuvastatin + amlodipine group, the most decreased among the treatment groups. The percentage of patients whose msSBP decreased >= 20 mm Hg or msDBP decreased >= 10 mm Hg was also highest in this group (74.29%). The mean +/- SD percentage change in low-density lipoprotein cholesterol (LDL-C) level from baseline after 8 weeks was -52.53% +/- 11.21% in the rosuvastatin + amlodipine group, the most decreased among the treatment groups. More patients in the rosuvastatin + amlodipine group achieved their target LDL-C goal at 8 weeks, compared with the other treatment groups (97.14%). No serious adverse events or adverse drug reactions were observed in all groups. In hypertensive patients with dyslipidemia, combination treatment with rosuvastatin 20 mg + amlodipine 10 mg effectively reduced blood pressure and LDL-C levels while maintaining safety.

引用

页码：261 / 269

页数：9

共 39 条

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