title: Efficacy of nebivolol-valsartan single-pill combination in obese and nonobese patients with hypertension.
abstract: Antihypertensive efficacy of single-pill combinations (SPCs) consisting of a β1-selective adrenergic blocker with vasodilatory properties via β3-agonism (nebivolol) and an angiotensin II receptor blocker (valsartan) was demonstrated in an 8-week phase 3 trial (NCT01508026). In this post hoc analysis, seated blood pressure, heart rate, 24-hour ambulatory blood pressure monitoring, plasma aldosterone, estimated glomerular filtration rate, and safety measures were assessed in obese (body mass index >32 kg/m2; n=1823) and nonobese (body mass index <27 kg/m2; n=847) adults with hypertension (stage I or II) treated with nebivolol-valsartan SPCs, nebivolol or valsartan monotherapy, or placebo. At week 8, reductions from baseline in blood pressure and ambulatory blood pressure monitoring were greater with SPCs and most nebivolol and valsartan monotherapy doses vs placebo regardless of obesity status. Aldosterone declined with all active treatments and estimated glomerular filtration rate remained steady. The nebivolol-valsartan 5/80 mg/d SPC was efficacious regardless of degree of obesity.
authors.affiliation: University of California, San Diego, CA, USA.
authors.forename: Christian W
authors.initials: CW
authors.lastname: Mende
authors.affiliation: Tulane University, New Orleans, LA, USA.
authors.forename: Thomas D
authors.initials: TD
authors.lastname: Giles
authors.affiliation: Allergan plc, Jersey City, NJ, USA.
authors.forename: David B
authors.initials: DB
authors.lastname: Bharucha
authors.affiliation: Allergan plc, Jersey City, NJ, USA.
authors.forename: William G
authors.initials: WG
authors.lastname: Ferguson
authors.affiliation: Allergan plc, Jersey City, NJ, USA.
authors.forename: Madhuja
authors.initials: M
authors.lastname: Mallick
authors.affiliation: Allergan plc, Jersey City, NJ, USA.
authors.forename: Mehul D
authors.initials: MD
authors.lastname: Patel
mesh_terms: D058665:Adrenergic beta-1 Receptor Agonists / Q000627:therapeutic use; D000328:Adult; D000450:Aldosterone / Q000097:blood; D047228:Angiotensin II Type 1 Receptor Blockers / Q000627:therapeutic use; D000959:Antihypertensive Agents / Q000627:therapeutic use; D054316:Biomarkers, Pharmacological / Q000097:blood; D001794:Blood Pressure / Q000187:drug effects; D018660:Blood Pressure Monitoring, Ambulatory; D015992:Body Mass Index; D004359:Drug Therapy, Combination / Q000379:methods*; D005260:Female; D005919:Glomerular Filtration Rate / Q000187:drug effects; D006339:Heart Rate / Q000187:drug effects; D006801:Humans; D006973:Hypertension / Q000188:drug therapy* / Q000208:ethnology / Q000503:physiopathology; D008297:Male; D008875:Middle Aged; D000068577:Nebivolol / Q000008:administration & dosage / Q000494:pharmacology*; D009765:Obesity / Q000150:complications* / Q000188:drug therapy / Q000208:ethnology; D012307:Risk Factors; D016896:Treatment Outcome; D000068756:Valsartan / Q000008:administration & dosage / Q000494:pharmacology*
chemical_list: D058665:Adrenergic beta-1 Receptor Agonists; D047228:Angiotensin II Type 1 Receptor Blockers; D000959:Antihypertensive Agents; D054316:Biomarkers, Pharmacological; D000068577:Nebivolol; D000450:Aldosterone; D000068756:Valsartan
keywords: hypertension; nebivolol; obesity; single-pill combination; valsartan