title: 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).
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.
authors: Department of Cardiology, Ajou University School of Medicine, Suwon.
authors: Jin-Sun
authors: JS
authors: Park
authors: Department of Cardiology, Ajou University School of Medicine, Suwon.
authors: Joon-Han
authors: JH
authors: Shin
authors: Division of Cardiology, Pusan National University Hospital, Busan.
authors: Taek-Jong
authors: TJ
authors: Hong
authors: Division of Cardiology, Korea University Guro Hospital, Korea University College of Medicine.
authors: Hong-Seog
authors: HS
authors: Seo
authors: Division of Cardiology, Korea University Anam Hospital.
authors: Wan-Joo
authors: WJ
authors: Shim
authors: Cardiovascular Division, Catholic University of Korea, Seoul St Mary's Hospital, Seoul.
authors: Sang-Hong
authors: SH
authors: Baek
authors: Division of Cardiology, Chungnam National University Hospital, Daejeon.
authors: Jin-Ok
authors: JO
authors: Jeong
authors: Division of Cardiology, Chonnam National University Hospital, Gwangju.
authors: Youngkeun
authors: Y
authors: Ahn
authors: Division of Cardiology, Gachon University Gil Hospital, Incheon.
authors: Woong-Chol
authors: WC
authors: Kang
authors: Division of Cardiology, Asan Medical Center, College of Medicine, University of Ulsan.
authors: Young-Hak
authors: YH
authors: Kim
authors: Division of Cardiology, Seoul Metropolitan Government Seoul National University Boramae Medical Center.
authors: Sang-Hyun
authors: SH
authors: Kim
authors: Division of Cardiology, Soonchunhyang University Hospital.
authors: Min-Su
authors: MS
authors: Hyon
authors: Division of Cardiology, Yonsei University Severance Hospital, Seoul.
authors: Dong-Hoon
authors: DH
authors: Choi
authors: Department of Internal Medicine, Keimyung University Dongsan Medical Center, Daegu.
authors: Chang-Wook
authors: CW
authors: Nam
authors: Division of Cardiology, Dong-A University Hospital, Busan.
authors: Tae-Ho
authors: TH
authors: Park
authors: Cardiovascular Imaging Center, Samsung Medical Center, Sungkyunkwan University School of Medicine.
authors: Sang-Chol
authors: SC
authors: Lee
authors: Department of Internal Medicine, Cardiovascular Center, Seoul National University Hospital, Seoul, Korea.
authors: Hyo-Soo
authors: HS
authors: Kim
mesh_terms: D000959:Antihypertensive Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D004311:Double-Blind Method; D004338:Drug Combinations; D050171:Dyslipidemias / Q000188:drug therapy*; D005260:Female; D006801:Humans; D006973:Hypertension / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D000068557:Olmesartan Medoxomil / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D056910:Republic of Korea; D000068718:Rosuvastatin Calcium / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*
chemical_list: D000959:Antihypertensive Agents; D004338:Drug Combinations; D000068557:Olmesartan Medoxomil; D000068718:Rosuvastatin Calcium
keywords: dyslipidemia; fixed-dose combination therapy; hypertension; olmesartan medoxomil; rosuvastatin