title: 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.
authors.affiliation: Orange County Research Center, Tustin, CA, USA. Electronic address: jmneutel@aol.com.
authors.forename: Joel M
authors.initials: JM
authors.lastname: Neutel
authors.affiliation: Department of Medicine, Tulane University, New Orleans, LA, USA.
authors.forename: Thomas D
authors.initials: TD
authors.lastname: Giles
authors.affiliation: Trinity Hypertension and Metabolic Research Institute, Carrollton, TX, USA; UT Southwestern Medical Center, Carrollton, TX, USA.
authors.forename: Henry
authors.initials: H
authors.lastname: Punzi
authors.affiliation: Maine Research Associates, Auburn, ME, USA.
authors.forename: Robert J
authors.initials: RJ
authors.lastname: Weiss
authors.affiliation: Department of Biostatistics, Forest Research Institute, Jersey City, NJ, USA.
authors.forename: Huiling
authors.initials: H
authors.lastname: Li
authors.affiliation: Trial Operations, Forest Research Institute, Jersey City, NJ, USA.
authors.forename: Amy
authors.initials: A
authors.lastname: Finck
mesh_terms: D000959:Antihypertensive Agents / Q000627:therapeutic use*; D001578:Benzopyrans / Q000627:therapeutic use*; D004338:Drug Combinations; D004983:Ethanolamines / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D006852:Hydrochlorothiazide / Q000627:therapeutic use; D006973:Hypertension / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D000068577:Nebivolol; D013777:Tetrazoles / Q000627:therapeutic use*; D016896:Treatment Outcome; D014633:Valine / Q000031:analogs & derivatives* / Q000627:therapeutic use; D000068756:Valsartan
chemical_list: D000959:Antihypertensive Agents; D001578:Benzopyrans; D004338:Drug Combinations; D004983:Ethanolamines; D013777:Tetrazoles; D000068577:Nebivolol; D006852:Hydrochlorothiazide; D000068756:Valsartan; D014633:Valine
keywords: Angiotensin receptor blocker; beta-blocker; blood pressure; clinical trial