Long-term safety of nebivolol and valsartan combination therapy in patients with hypertension: an open-label, single-arm, multicenter study

Long term safety of a free tablet combination of nebivolol and valsartan was assessed in a Phase III, open label trial (NCT01415505). Adults with hypertension entered a 4 week placebo run in phase, followed by a 52 week treatment phase. Initial dosage (Neb/Val 5/160 mg/d) was titrated up to 20/320 mg/d to achieve blood pressure (BP) goal (JNC7 criteria), with the addition of hydrochlorothiazide (up to 25 mg/d) if needed. Safety and tolerability parameters included adverse events. Efficacy assessments included baseline-to-endpoint change in diastolic BP and systolic BP and the percentage of patients who achieved BP goal. All analyses were performed using descriptive statistics. Study completion rate was 60.4% (489/810). The most frequent reason for discontinuation was insufficient therapeutic response (8.4%). Adverse events were experienced by 59.2% of patients, with the most common being headache (5.7%), nasopharyngitis (5.0%), and upper respiratory tract infection (4.6%). Three (0.4%) deaths occurred during the study; none was considered related to study medication. Mean +/- standard deviation changes from baseline at week 52 (observed cases) were -25.5 +/- 15.9 mm Hg (systolic BP) and -19.0 +/- 8.7 mm Hg (diastolic BP). A total of 75.7% nebivolol/valsartan treated and 57.8% nebivolol/valsartan/hydrochlorothiazide treated completers achieved BP goal. Long-term treatment with nebivolol and valsartan in adults with hypertension was safe and well tolerated. (C) 2014 American Society of Hypertension. All rights reserved.