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

Abstract

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.