Kim, Woohyeun; Chang, Kiyuk; Cho, Eun Joo; Ahn, Jeong-Cheon; Yu, Cheol Woong; Cho, Kyoung-Im; Kim, Yong-Jin; Kang, Duk-Hyun; Kim, Seok-Yeon; Lee, Sang-Hak; Kim, Ung; Kim, Shin-Jae; Ahn, Young Keun; Lee, Chang Hoon; Shin, Jin Ho; Kim, Mikyung; Park, Chang Gyu
Journal of clinical hypertension (Greenwich, Conn.)
2020Jan ; 105 ( 2 ) :.
PMID : 32003938
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Kim, Woohyeun - Cardiovascular Center, Korea University Guro Hospital, Seoul, Korea.
Chang, Kiyuk - Division of Cardiology, Seoul St. Mary's Hospital, Seoul, Korea.
Cho, Eun Joo - Division of Cardiology, St. Paul's Hospital, Seoul, Korea.
Ahn, Jeong-Cheon - Division of Cardiology, Korea University Ansan Hospital, Ansan, Korea.
Yu, Cheol Woong - Division of Cardiology, Korea University Anam Hospital, Seoul, Korea.
Cho, Kyoung-Im - Division of Cardiology, Maryknoll Medical Center, Busan, Korea.
Kim, Yong-Jin - Cardiovascular Center, Seoul National University Hospital, Seoul, Korea.
Kang, Duk-Hyun - Valvular Heart Disease Center, Asan Medical Center Heart Institute, Seoul, Korea.
Kim, Seok-Yeon - Department of Cardiology, Seoul Medical Center, Seoul, Korea.
Lee, Sang-Hak - Division of Cardiology, Severance Cardiovascular Hospital, Seoul, Korea.
Kim, Ung - Division of Cardiology, Yeungnam University Medical Center, Daegu, Korea.
Kim, Shin-Jae - Division of Cardiology, Ulsan University Hospital, Ulsan, Korea.
Ahn, Young Keun - Heart Center of Chonnam, National University Hospital, Gwangju, Korea.
Lee, Chang Hoon - Division of Cardiology, Veterans Health Service Medical Center, Seoul, Korea.
Shin, Jin Ho - Division of Cardiology, Hanyang University Hospital, Seoul, Korea.
Kim, Mikyung - Yuhan Research Institute, Yuhan Corporation, Yongin, Korea.
Park, Chang Gyu - Cardiovascular Center, Korea University Guro Hospital, Seoul, Korea.
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 ??0?mm Hg or msDBP decreased ??0?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. CI - ??2020 Wiley Periodicals, Inc.
keyword
amlodipine;dyslipidemia;hypertension;rosuvastatin;single-pill combination
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