title: Additive beneficial effects of valsartan combined with rosuvastatin in the treatment of hypercholesterolemic hypertensive patients.
abstract: OBJECTIVE
  We compared the efficacy and safety of valsartan and rosuvastatin combination therapy with each treatment alone in hypercholesterolemic hypertensive patients.
  
  
  METHODS
  Patients who met inclusion criteria were randomized to receive 1 of the following 2-month drug regimens: valsartan 160 mg plus rosuvastatin 20 mg, valsartan 160 mg plus placebo, or rosuvastatin 20 mg plus placebo. The primary efficacy variables were change in sitting diastolic blood pressure (sitDBP) and sitting systolic blood pressure (sitSBP), and percentage change in low-density lipoprotein-cholesterol (LDL-C) in the combination, valsartan, and rosuvastatin groups. Adverse events (AEs) during the study were analyzed.
  
  
  RESULTS
  A total of 354 patients were screened and 123 of them were finally randomized. Changes of sitDBP by least squares mean (LSM) were -11.1, -7.2, and -3.6 mm Hg, respectively, and was greater in the combination, as compared to both valsartan (p=0.02) and rosuvastatin (p<0.001). Changes of sitSBP by LSM were -13.2, -10.8, and -4.9 mm Hg, and was greater in the combination, as compared to rosuvastatin (p=0.006) and not valsartan (p=0.42). Percentage changes of LDL-C by LSM were -52, -4, and -47% in each group, and was greater in the combination, as compared to valsartan (p<0.001), similar to rosuvastatin (p=0.16). Most AEs were mild and resolved by the end of the study.
  
  
  CONCLUSIONS
  Combination treatment with valsartan and rosuvastatin exhibited an additive blood pressure-lowering effect with acceptable tolerability, as compared to valsartan monotherapy. Its lipid lowering effect was similar to rosuvatatin monotherapy.
authors.affiliation: Division of Cardiology and Cardiovascular Research Institute, Department of Internal Medicine, Severance Hospital, Yonsei University College of Medicine, Seoul, Korea.
authors.forename: Ji-Yong
authors.initials: JY
authors.lastname: Jang
authors.affiliation: Division of Cardiology and Cardiovascular Research Institute, Department of Internal Medicine, Severance Hospital, Yonsei University College of Medicine, Seoul, Korea.
authors.forename: Sang-Hak
authors.initials: SH
authors.lastname: Lee
authors.affiliation: Division of Cardiology, Department of Internal Medicine, Daedong Hospital, Busan, Korea.
authors.forename: Byung Soo
authors.initials: BS
authors.lastname: Kim
authors.affiliation: Division of Cardiology, Cardiovascular Center, Korea University Guro Hospital, Korea University College of Medicine, Seoul, Korea.
authors.forename: Hong Seog
authors.initials: HS
authors.lastname: Seo
authors.affiliation: Division of Cardiology, Department of Internal Medicine, Kyung Hee University Medical Center, Seoul, Korea.
authors.forename: Woo-Shik
authors.initials: WS
authors.lastname: Kim
authors.affiliation: Department of Cardiology, Heart Research Center of Chonnam National University Hospital, Gwangju, Korea.
authors.forename: Youngkeun
authors.initials: Y
authors.lastname: Ahn
authors.affiliation: Department of Cardiology, Soon Chun Hyang University Bucheon Hospital, Bucheon, Korea.
authors.forename: Nae-Hee
authors.initials: NH
authors.lastname: Lee
authors.affiliation: Department of Cardiology, Gachon University Gil Medical Center, Incheon, Korea.
authors.forename: Kwang Kon
authors.initials: KK
authors.lastname: Koh
authors.affiliation: Division of Cardiology, Dankook University College of Medicine, Cheonan, Korea.
authors.forename: Tae-Soo
authors.initials: TS
authors.lastname: Kang
authors.affiliation: Division of Cardiology, Department of Internal Medicine, Hallym University Sacred Heart Hospital, Anyang, Korea.
authors.forename: Sang-Ho
authors.initials: SH
authors.lastname: Jo
authors.affiliation: Division of Cardiology, Department of Internal Medicine, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul, Korea.
authors.forename: Bum-Kee
authors.initials: BK
authors.lastname: Hong
authors.affiliation: Division of Cardiology, Department of Internal Medicine, Konyang University Hospital, Daejeon, Korea.
authors.forename: Jang-Ho
authors.initials: JH
authors.lastname: Bae
authors.affiliation: Department of Cardiology, Ajou University Medical Center, Suwon, Korea.
authors.forename: Hyoung-Mo
authors.initials: HM
authors.lastname: Yang
authors.affiliation: Division of Cardiology, Pusan National University Hospital, Busan, Korea.
authors.forename: Kwang Soo
authors.initials: KS
authors.lastname: Cha
authors.affiliation: Division of Cardiology, Department of Internal Medicine, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, Korea.
authors.forename: Bum Soo
authors.initials: BS
authors.lastname: Kim
authors.affiliation: Division of Cardiology, Department of Internal Medicine, Gyeongsang National University Hospital and Gyeongsang National University School of Medicine, Jinju, Korea.
authors.forename: Choong Hwan
authors.initials: CH
authors.lastname: Kwak
authors.affiliation: Department of Cardiology, Myongji Hospital Cardiovascular Center, Goyang, Korea.
authors.forename: Deok-Kyu
authors.initials: DK
authors.lastname: Cho
authors.affiliation: Division of Cardiology, Department of Internal Medicine, Yeungnam University Hospital, Daegu, Korea.
authors.forename: Ung
authors.initials: U
authors.lastname: Kim
authors.affiliation: Division of Cardiology, Department of Internal Medicine, SMG-SNU Boramae Medical Center, Seoul National University College of Medicine, Seoul, Korea.
authors.forename: Joo-Hee
authors.initials: JH
authors.lastname: Zo
authors.affiliation: Division of Cardiology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.
authors.forename: Duk-Hyun
authors.initials: DH
authors.lastname: Kang
authors.affiliation: Division of Cardiology, Department of Internal Medicine, Ewha Womans University Mokdong Hospital, Seoul, Korea.
authors.forename: Wook Bum
authors.initials: WB
authors.lastname: Pyun
authors.affiliation: Department of Cardiology, Pusan National University Yangsan Hospital, Yangsan, Korea.
authors.forename: Kook Jin
authors.initials: KJ
authors.lastname: Chun
authors.affiliation: Division of Cardiology, Department of Internal Medicine, Inje University Ilsan Paik Hospital, Goyang, Korea.
authors.forename: June
authors.initials: J
authors.lastname: Namgung
authors.affiliation: Division of Cardiology, Department of Internal Medicine, Kosin University Gospel Hospital, Busan, Korea.
authors.forename: Tae-Joon
authors.initials: TJ
authors.lastname: Cha
authors.affiliation: Clinical Development Department, LG Life Sciences Ltd., Seoul, Korea.
authors.forename: Jae-Hyeon
authors.initials: JH
authors.lastname: Juhn
authors.affiliation: Clinical Development Department, LG Life Sciences Ltd., Seoul, Korea.
authors.forename: YeiLi
authors.initials: Y
authors.lastname: Jung
authors.affiliation: Division of Cardiology and Cardiovascular Research Institute, Department of Internal Medicine, Severance Hospital, Yonsei University College of Medicine, Seoul, Korea.
authors.forename: Yangsoo
authors.initials: Y
authors.lastname: Jang
keywords: Blood pressure; Controlled clinical trials, randomized; Drug therapy, combination; Rosuvastatin; Valsartan