Kardiologia polska 2016 Oct 07() doi 10.5603/KP.a2016.0135
BACKGROUND AND AIM
The aim of the study was to establish the efficacy and safety of Valsacor® (valsartan) and Valsacombi® (combination of valsartan and hydrochlorothiazide) in wide populations of patients with mild to moderate arterial hypertension.
We performed an international, multicentre, open labelled, prospective trial. After one week of washout in previously treated patients, the patients were treated for 16 weeks according to the schedule. Naïve patients enter the treatment immediately. During the active treatment, 4 visits were planned for each patient to obtain the data for the primary and secondary efficacy endpoints analysis. Principal methodologies were blood pressure (BP) measurement and additionally in the subgroup of patient’s assessment of erectile function. Initial dosage valsartan 80 mg/day was titrated up to 320 mg/day to achieve BP goal, with the addition of hydrochlorothiazide (HCTZ) in a fixed-dose combination (FDC) if needed.
Mean ± standard deviation changes from baseline at week 16 were -26.6 ± 10.4 mm Hg (systolic BP) and -14.8 ± 7.6 mm Hg (diastolic BP). A total of 91% patients treated with either valsartan or valsartan FDC achieved BP goal. Adverse reactions were experienced by 7.1% of patients, with the most common being headache (1.9%), palpitation (1.6%), dizziness (1.6%) and fatigue (1.6%), during the whole trial.
The results of the present Victory trial shows that valsartan and valsartan FDC effectively reduces the BP in patients with mild to moderate arterial hypertension and provide good tolerability profile.