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. 2015 May;45(3):225-33.
doi: 10.4070/kcj.2015.45.3.225. Epub 2015 May 27.

Additive beneficial effects of valsartan combined with rosuvastatin in the treatment of hypercholesterolemic hypertensive patients

Ji-Yong Jang  1 , Sang-Hak Lee  1 , Byung Soo Kim  2 , Hong Seog Seo  3 , Woo-Shik Kim  4 , Youngkeun Ahn  5 , Nae-Hee Lee  6 , Kwang Kon Koh  7 , Tae-Soo Kang  8 , Sang-Ho Jo  9 , Bum-Kee Hong  10 , Jang-Ho Bae  11 , Hyoung-Mo Yang  12 , Kwang Soo Cha  13 , Bum Soo Kim  14 , Choong Hwan Kwak  15 , Deok-Kyu Cho  16 , Ung Kim  17 , Joo-Hee Zo  18 , Duk-Hyun Kang  19 , Wook Bum Pyun  20 , Kook Jin Chun  21 , June Namgung  22 , Tae-Joon Cha  23 , Jae-Hyeon Juhn  24 , YeiLi Jung  24 , Yangsoo Jang  1
Affiliations

Additive beneficial effects of valsartan combined with rosuvastatin in the treatment of hypercholesterolemic hypertensive patients

Ji-Yong Jang et al. Korean Circ J. 2015 May.

Erratum in

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: Blood pressure; Controlled clinical trials, randomized; Drug therapy, combination; Rosuvastatin; Valsartan.

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Figures

Fig. 1
Fig. 1. Subject disposition from enrollment to the end of the study.
Fig. 2
Fig. 2. BP change in the combination and valsartan groups at week 8 (A). Percentage LDL-C change in the combination and rosuvastatin groups at week 8 (B). Error bars represent standard error. BP: blood pressure, sitDBP: sitting diastolic blood pressure, sitSBP: sitting systolic blood pressure, LDLC: low-density lipoprotein-cholesterol.
Fig. 3
Fig. 3. Percentage of subjects achieving treatment goal. Percentage achieving ESH-ESC guideline (2003) BP target (A). Percentage achieving LDL-C NCEP-ATP III guideline (2004) target (B). ESH-ESC: European Society of Hypertension and European Society of Cardiology, BP: blood pressure, LDC-C: low-density lipoprotein-cholesterol, NCEP-ATP: National Cholesterol Education Program-Adult Treatment Panel.
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