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Efficacy and safety of fixed-dose combination therapy with olmesartan medoxomil and rosuvastatin in Korean patients with mild to moderate hypertension and dyslipidemia: an 8-week, multicenter, randomized, double-blind, factorial-design study (OLSTA-D RCT: OLmesartan rosuvaSTAtin from Daewoong)

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Author(s)
Jin-Sun ParkJoon-Han ShinTaek-Jong HongHong-Seog SeoWan-Joo ShimSang-Hong BaekJin-Ok JeongYoungkeun AhnWoong-Chol KangYoung-Hak KimSang-Hyun KimMin-Su HyonDong-Hoon ChoiChang-Wook NamTae-Ho ParkSang-Chol LeeHyo-Soo Kim
Keimyung Author(s)
Nam, Chang Wook
Department
Dept. of Internal Medicine (내과학)
Journal Title
Drug Design, Development and Therapy
Issued Date
2016
Volume
10
Keyword
fixed-dose combination therapyolmesartan medoxomilrosuvastatinhypertensiondyslipidemia
Abstract
The pill burden of patients with hypertension and dyslipidemia can result in poor medication compliance. This study aimed to evaluate the efficacy and safety of fixed-dose combination (FDC) therapy with olmesartan medoxomil (40 mg) and rosuvastatin (20 mg) in Korean patients with mild to moderate hypertension and dyslipidemia. This multicenter, randomized, double-blind, factorial-design study included patients aged ≥20 years with mild to moderate essential hypertension and dyslipidemia. Patients were randomly assigned to receive FDC therapy (40 mg olmesartan medoxomil, 20 mg rosuvastatin), 40 mg olmesartan medoxomil, 20 mg rosuvastatin, or a placebo. The percentage change from baseline in low-density lipoprotein cholesterol levels was compared between FDC therapy and olmesartan medoxomil, and the change from baseline in diastolic blood pressure was compared between FDC therapy and rosuvastatin 8 weeks after treatment. A total of 162 patients were included. The least square mean percentage change (standard error) from baseline in low-density lipoprotein cholesterol levels 8 weeks after treatment was significantly greater in the FDC than in the olmesartan medoxomil group (−52.3% [2.8%] vs −0.6% [3.5%], P<0.0001), and the difference was −51.7% (4.1%) (95% confidence interval: −59.8% to −43.6%). The least square mean change (standard error) from baseline in diastolic blood pressure 8 weeks after treatment was significantly greater in the FDC group than in the rosuvastatin group (−10.4 [1.2] mmHg vs 0.1 [1.6] mmHg, P<0.0001), and the difference was −10.5 (1.8) mmHg (95% confidence interval: −14.1 to −6.9 mmHg). There were 50 adverse events in 41 patients (22.7%) and eight adverse drug reactions in five patients (2.8%). The study found that FDC therapy with olmesartan medoxomil and rosuvastatin is an effective, safe treatment for patients with hypertension and dyslipidemia. This combination may improve medication compliance in patients with a large pill burden.
Keimyung Author(s)(Kor)
남창욱
Publisher
School of Medicine
Citation
Jin-Sun Park et al. (2016). Efficacy and safety of fixed-dose combination therapy with olmesartan medoxomil and rosuvastatin in Korean patients with mild to moderate hypertension and dyslipidemia: an 8-week, multicenter, randomized, double-blind, factorial-design study (OLSTA-D RCT: OLmesartan rosuvaSTAtin from Daewoong). Drug Design, Development and Therapy, 10, 2599–2609. doi: 10.2147/DDDT.S112873
Type
Article
ISSN
1177-8881
DOI
10.2147/DDDT.S112873
URI
https://kumel.medlib.dsmc.or.kr/handle/2015.oak/32397
Appears in Collections:
1. School of Medicine (의과대학) > Dept. of Internal Medicine (내과학)
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