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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)

Authors
 Jin-Sun Park  ;  Joon-Han Shin  ;  Taek-Jong Hong  ;  Hong-Seog Seo  ;  Wan-Joo Shim  ;  Sang-Hong Baek  ;  Jin-Ok Jeong  ;  Youngkeun Ahn  ;  Woong-Chol Kang  ;  Young-Hak Kim  ;  Sang-Hyun Kim  ;  Min-Su Hyon  ;  Dong-Hoon Choi  ;  Chang-Wook Nam  ;  Tae-Ho Park  ;  Sang-Chol Lee  ;  Hyo-Soo Kim 
Citation
 DRUG DESIGN DEVELOPMENT AND THERAPY, Vol.10 : 2599-2609, 2016 
Journal Title
 DRUG DESIGN DEVELOPMENT AND THERAPY 
Issue Date
2016
MeSH
Antihypertensive Agents/administration & dosage ; Antihypertensive Agents/adverse effects ; Antihypertensive Agents/therapeutic use* ; Double-Blind Method ; Drug Combinations ; Dyslipidemias/drug therapy* ; Female ; Humans ; Hypertension/drug therapy* ; Male ; Middle Aged ; Olmesartan Medoxomil/administration & dosage ; Olmesartan Medoxomil/adverse effects ; Olmesartan Medoxomil/therapeutic use* ; Republic of Korea ; Rosuvastatin Calcium/administration & dosage ; Rosuvastatin Calcium/adverse effects ; Rosuvastatin Calcium/therapeutic use*
Keywords
dyslipidemia ; fixed-dose combination therapy ; hypertension ; olmesartan medoxomil ; rosuvastatin
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.
Files in This Item:
T201603069.pdf Download
DOI
10.2147/DDDT.S112873
Appears in Collections:
1. College of Medicine (의과대학) > Dept. of Internal Medicine (내과학교실) > 1. Journal Papers
Yonsei Authors
Choi, Dong Hoon(최동훈) ORCID logo https://orcid.org/0000-0002-2009-9760
URI
https://ir.ymlib.yonsei.ac.kr/handle/22282913/151921
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