[논문]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)

Park, Jin-Sun; Shin, Joon-Han; Hong, Taek-Jong; Seo, Hong-Seog; Shim, Wan-Joo; Baek, Sang-Hong; Jeong, Jin-Ok; Ahn, Youngkeun; Kang, Woong-Chol; Kim, Young-Hak; Kim, Sang-Hyun; Hyon, Min-Su; Choi, Dong-Hoon; Nam, Chang-Wook; Park, Tae-Ho; Lee, Sang-Chol; Kim, Hyo-Soo

doi:10.2147/DDDT.S112873

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) 원문보기

Drug design, development and therapy, v.10, 2016년, pp.2599 - 2609

Park, Jin-Sun (Department of Cardiology, Ajou University School of Medicine, Suwon) , Shin, Joon-Han (Department of Cardiology, Ajou University School of Medicine, Suwon) , Hong, Taek-Jong (Division of Cardiology, Pusan National University Hospital, Busan) , Seo, Hong-Seog (Division of Cardiology, Korea University Guro Hospital, Korea University College of Medicine) , Shim, Wan-Joo (Division of Cardiology, Korea University Anam Hospital) , Baek, Sang-Hong (Cardiovascular Division, Catholic University of Korea, Seoul St Mary’s Hospital, Seoul) , Jeong, Jin-Ok (Division of Cardiology, Chungnam National University Hospital, Daejeon) , Ahn, Youngkeun (Division of Cardiology, Chonnam National University Hospital, Gwangju) , Kang, Woong-Chol (Division of Cardiology, Gachon University Gil Hospital, Incheon) , Kim, Young-Hak (Division of Cardiology, Asan Medical Center, College of Medicine, University of Ulsan) , Kim, Sang-Hyun (Division of Cardiology, Seoul Metropolitan Government Seoul National University Boramae Medical Center) , Hyon, Min-Su (Division of Cardiology, Soonchunhyang University Hospital) , Choi, Dong-Hoon (Division of Cardiology, Yonsei University Severance Hospital, Seoul) , Nam, Chang-Wook (Department of I) , Park, Tae-Ho , Lee, Sang-Chol , Kim, Hyo-Soo

Abstract ▼ AI-Helper

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.

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