Additive beneficial effects of valsartan combined with rosuvastatin in the treatment of hypercholesterolemic hypertensive patients
Ji Yong Jang ; Sang Hak Lee ; Yangsoo Jang ; YeiLi Jung ; Jae Hyeon Juhn ; Tae Joon Cha ; June Namgung ; Kook Jin Chun ; Wook Bum Pyun ; Duk Hyun Kang ; Joo Hee Zo ; Ung Kim ; Deok Kyu Cho ; Choong Hwan Kwak ; Bum Soo Kim ; Kwang Soo Cha ; Hyoung Mo Yang ; Jang Ho Bae ; Bum Kee Hong ; Sang Ho Jo ; Tae Soo Kang ; Kwang Kon Koh ; Nae Hee Lee ; Youngkeun Ahn ; Woo Shik Kim ; Hong Seog Seo ; Byung Soo Kim
Korean Circulation Journal (순환기), Vol.45(3) : 225~233, 2015
Korean Circulation Journal (순환기)
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.