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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

Authors
 Woohyeun Kim  ;  Kiyuk Chang  ;  Eun Joo Cho  ;  Jeong-Cheon Ahn  ;  Cheol Woong Yu  ;  Kyoung-Im Cho  ;  Yong-Jin Kim  ;  Duk-Hyun Kang  ;  Seok-Yeon Kim  ;  Sang-Hak Lee  ;  Ung Kim  ;  Shin-Jae Kim  ;  Young Keun Ahn  ;  Chang Hoon Lee  ;  Jin Ho Shin  ;  Mikyung Kim  ;  Chang Gyu Park 
Citation
 JOURNAL OF CLINICAL HYPERTENSION, Vol.22(2) : 261-269, 2020-02 
Journal Title
JOURNAL OF CLINICAL HYPERTENSION
ISSN
 1524-6175 
Issue Date
2020-02
MeSH
Amlodipine / therapeutic use* ; Antihypertensive Agents / therapeutic use* ; Blood Pressure / drug effects ; Double-Blind Method ; Drug Therapy, Combination ; Dyslipidemias* / drug therapy ; Dyslipidemias* / epidemiology ; Humans ; Hypertension* / drug therapy ; Republic of Korea / epidemiology ; Rosuvastatin Calcium / therapeutic use* ; Treatment Outcome
Keywords
amlodipine ; dyslipidemia ; hypertension ; rosuvastatin ; single-pill combination
Abstract
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.
Files in This Item:
T9992020479.pdf Download
DOI
10.1111/jch.13774
Appears in Collections:
1. College of Medicine (의과대학) > Dept. of Internal Medicine (내과학교실) > 1. Journal Papers
Yonsei Authors
Lee, Sang Hak(이상학) ORCID logo https://orcid.org/0000-0002-4535-3745
URI
https://ir.ymlib.yonsei.ac.kr/handle/22282913/190254
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