Additive Beneficial Effects of Valsartan Combined with Rosuvastatin in the Treatment of Hypercholesterolemic Hypertensive Patients.
10.4070/kcj.2015.45.3.225
- Author:
Ji Yong JANG
1
;
Sang Hak LEE
;
Byung Soo KIM
;
Hong Seog SEO
;
Woo Shik KIM
;
Youngkeun AHN
;
Nae Hee LEE
;
Kwang Kon KOH
;
Tae Soo KANG
;
Sang Ho JO
;
Bum Kee HONG
;
Jang Ho BAE
;
Hyoung Mo YANG
;
Kwang Soo CHA
;
Bum Soo KIM
;
Choong Hwan KWAK
;
Deok Kyu CHO
;
Ung KIM
;
Joo Hee ZO
;
Duk Hyun KANG
;
Wook Bum PYUN
;
Kook Jin CHUN
;
June NAMGUNG
;
Tae Joon CHA
;
Jae Hyeon JUHN
;
Yeili JUNG
;
Yangsoo JANG
Author Information
1. Division of Cardiology and Cardiovascular Research Institute, Department of Internal Medicine, Severance Hospital, Yonsei University College of Medicine, Seoul, Korea. jangys1212@yuhs.ac
- Publication Type:Randomized Controlled Trial ; Original Article
- Keywords:
Valsartan;
Rosuvastatin;
Drug therapy, combination;
Controlled clinical trials, randomized;
Blood pressure
- MeSH:
Blood Pressure;
Drug Therapy, Combination;
Humans;
Least-Squares Analysis;
Rosuvastatin Calcium;
Valsartan
- From:Korean Circulation Journal
2015;45(3):225-233
- CountryRepublic of Korea
- Language:English
-
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.