A Randomized, Multicenter, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and the Tolerability of a Triple Combination of Amlodipine/Losartan/Rosuvastatin in Patients With Comorbid Essential Hypertension and Hyperlipidemia
- Authors
- Lee, Hae-Young; Kim, Seok-Yeon; Choi, Kee-Joon; Yoo, Byung-Su; Cha, Dong-Hun; Jung, Hae Ok; Ryu, Dong-Ryeol; Choi, Joon Hyouk; Lee, Kwang Je; Park, Tae Ho; Oh, Ju Hyeon; Kim, Sang Min; Choi, Ji-Yong; Kim, Kye Hun; Shim, Jaemin; Kim, Woo-Shik; Choi, Si -Wan; Park, Dae-Gyun; Song, Pil-Sang; Hong, Taek-Jong; Rhee, Moo-Yong; Rha, Seung-Woon; Park, Seung Woo
- Issue Date
- 12월-2017
- Publisher
- ELSEVIER
- Keywords
- angiotensin receptor blocker; calcium channel blocker; HMG-CoA reductase inhibitor; hypercholesterolemia; hypertension
- Citation
- CLINICAL THERAPEUTICS, v.39, no.12, pp.2366 - 2379
- Indexed
- SCIE
SCOPUS
- Journal Title
- CLINICAL THERAPEUTICS
- Volume
- 39
- Number
- 12
- Start Page
- 2366
- End Page
- 2379
- URI
- https://scholar.korea.ac.kr/handle/2021.sw.korea/81431
- DOI
- 10.1016/j.clinthera.2017.10.013
- ISSN
- 0149-2918
- Abstract
- Purpose: The objective of this study was to evaluate the efficacy and tolerability of a triple combination of amlodipine/losartan/rosuvastatin in patients with hypertension and hypercholesterolemia. Methods: A randomized, multicenter, double-blind, placebo-controlled study was conducted. Eligible patients with hypertension and a sitting diastolic blood pressure (SiDBP) of >90 mm Hg and LDL-C levels <250 mg/dL were screened. After a 4-week run-in period with therapeutic lifestyle changes and losartan potassium 100 mg once daily, patients who met both blood pressure criteria (80 mm Hg <= SiDBP < 110 mm Hg) and the LDL-C level criteria (defined in the National Cholesterol Education Program Adult Treatment Panel III cardiovascular risk categories) were randomized to 1 of 3 groups and treated once daily for 8 weeks: losartan potassium 100 mg + rosuvastatin 20 mg treatment (L/R 100/20) group, amlodipine camsylate 5 mg + losartan potassium 100 mg treatment (A/L 5/100) group, and amlodipine S mg + losartan potassium 100 mg + rosuvastatin 20 mg (A/L/R 5/100/20) group. The primary efficacy variables were the percent change in LDL-C in the A/L/R 5/100/20 and A/L 5/100 groups and the mean change of SiDBP in the A/L/R 5/100/20 and L/R 100/20 groups after 8 weeks of treatment, relative to baseline values. Findings: A total of 146 patients were enrolled and the demographic characteristics were similar among the 3 treatment groups. After 8 weeks of treatment, the mean (SD) percent change in LDL-C was significantly greater in the A/L/R group than in the A/L group (-48.40% [2.77%] vs -6.70% [3.00%]; P < 0.0001). Moreover, the mean change in SiDBP was significantly greater in the A/L/R group than in the L/R group (-9.75 [0.92] mm Hg vs -1.73 [1.03] mm Hg; P < 0.0001). SiDBP and LDL-C reductions in the A/L/R group were comparable to reductions in the A/L and L/R groups, respectively. Ten adverse events were reported in 7 patients (4.83%), and 1 patient from the A/L group (0.69%) experienced 2 adverse drug reactions (tachycardia and face edema), which were mild and resolved without specific treatment. There were no clinically significant tolerability issues during the treatment period. Implications: Triple combination therapy with amlodipine/losartan/rosuvastatin can be an effective therapeutic strategy in patients with hypertension combined with dyslipidemia. These findings will form the foundation of the future development of a single pill triple combination. (C) 2017 Elsevier HS Journals, Inc. All rights reserved.
- Files in This Item
- There are no files associated with this item.
- Appears in
Collections - College of Medicine > Department of Medical Science > 1. Journal Articles
- Graduate School > Department of Biomedical Sciences > 1. Journal Articles
Items in ScholarWorks are protected by copyright, with all rights reserved, unless otherwise indicated.