Korean Circulation Journal

The Korean Society of Cardiology (대한심장학회)
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Additive Beneficial Effects of Valsartan Combined with Rosuvastatin in the Treatment of Hypercholesterolemic Hypertensive Patients

  • Jang, Ji-Yong (Division of Cardiology and Cardiovascular Research Institute, Department of Internal Medicine, Severance Hospital, Yonsei University College of Medicine) ;
  • Lee, Sang-Hak (Division of Cardiology and Cardiovascular Research Institute, Department of Internal Medicine, Severance Hospital, Yonsei University College of Medicine) ;
  • Kim, Byung Soo (Division of Cardiology, Department of Internal Medicine, Daedong Hospital) ;
  • Seo, Hong Seog (Division of Cardiology, Cardiovascular Center, Korea University Guro Hospital, Korea University College of Medicine) ;
  • Kim, Woo-Shik (Division of Cardiology, Department of Internal Medicine, Kyung Hee University Medical Center) ;
  • Ahn, Youngkeun (Department of Cardiology, Heart Research Center of Chonnam National University Hospital) ;
  • Lee, Nae-Hee (Department of Cardiology, Soon Chun Hyang University Bucheon Hospital) ;
  • Koh, Kwang Kon (Department of Cardiology, Gachon University Gil Medical Center) ;
  • Kang, Tae-Soo (Division of Cardiology, Dankook University College of Medicine) ;
  • Jo, Sang-Ho (Division of Cardiology, Department of Internal Medicine, Hallym University Sacred Heart Hospital) ;
  • Hong, Bum-Kee (Division of Cardiology, Department of Internal Medicine, Gangnam Severance Hospital, Yonsei University College of Medicine) ;
  • Bae, Jang-Ho (Division of Cardiology, Department of Internal Medicine, Konyang University Hospital) ;
  • Yang, Hyoung-Mo (Department of Cardiology, Ajou University Medical Center) ;
  • Cha, Kwang Soo (Division of Cardiology, Pusan National University Hospital) ;
  • Kim, Bum Soo (Division of Cardiology, Department of Internal Medicine, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine) ;
  • Kwak, Choong Hwan (Division of Cardiology, Department of Internal Medicine, Gyeongsang National University Hospital and Gyeongsang National University School of Medicine) ;
  • Cho, Deok-Kyu (Department of Cardiology, Myongji Hospital Cardiovascular Center) ;
  • Kim, Ung (Division of Cardiology, Department of Internal Medicine, Yeungnam University Hospital) ;
  • Zo, Joo-Hee (Division of Cardiology, Department of Internal Medicine, SMG-SNU Boramae Medical Center, Seoul National University College of Medicine) ;
  • Kang, Duk-Hyun (Division of Cardiology, Asan Medical Center, University of Ulsan College of Medicine) ;
  • Pyun, Wook Bum (Division of Cardiology, Department of Internal Medicine, Ewha Womans University Mokdong Hospital) ;
  • Chun, Kook Jin (Department of Cardiology, Pusan National University Yangsan Hospital) ;
  • Namgung, June (Division of Cardiology, Department of Internal Medicine, Inje University Ilsan Paik Hospital) ;
  • Cha, Tae-Joon (Division of Cardiology, Department of Internal Medicine, Kosin University Gospel Hospital) ;
  • Juhn, Jae-Hyeon (Clinical Development Department, LG Life Sciences Ltd.) ;
  • Jung, YeiLi (Clinical Development Department, LG Life Sciences Ltd.) ;
  • Jang, Yangsoo (Division of Cardiology and Cardiovascular Research Institute, Department of Internal Medicine, Severance Hospital, Yonsei University College of Medicine)
  • Received : 2014.12.10
  • Accepted : 2015.03.09
  • Published : 2015.05.30
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Abstract

Background and Objectives: We compared the efficacy and safety of valsartan and rosuvastatin combination therapy with each treatment alone in hypercholesterolemic hypertensive patients. Subjects and 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. Conclusion: 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.

Keywords

References

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