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. Issue 2 (31st January 2020)

• Record Type: Journal Article
• Authors: 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
• Is Part Of: Journal of clinical hypertension. Volume 22:Issue 2(2020)
• Page Start: 261
• Page End: 269
• Publication Date: 2020-01-31
• Subjects: amlodipine -- dyslipidemia -- hypertension -- rosuvastatin -- single‐pill combination; Hypertension -- Periodicals; 616.132
• DOI: 10.1111/jch.13774
• Languages: English
• ISSNs: 1524-6175

Abstract

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.