title: Efficacy and safety of nebivolol in Hispanics with stage I-II hypertension: a randomized placebo-controlled trial.
abstract: OBJECTIVE
  Hispanics have lower rates of hypertension control compared with black and white patients. Nebivolol is a vasodilatory β1-selective blocker, with neutral metabolic effects. This phase IV trial evaluated the efficacy and safety of nebivolol in Hispanics with stage I-II hypertension.
  
  
  METHODS
  Self-identified Hispanics with stage I-II hypertension were randomized to receive a double-blind treatment: placebo (n = 136) or nebivolol (n = 141, starting dose 5 mg/day) for 8 weeks. Nebivolol dosage could be uptitrated at 2-week intervals to 10, 20, or 40 mg/day, as needed to achieve diastolic blood pressure (DBP) control (JNC7 criteria). Efficacy outcome measures were the mean changes from baseline to the end of week 8 in trough-seated DBP (primary) and systolic blood pressure (SBP) (secondary). Safety and tolerability were also assessed.
  
  
  RESULTS
  Baseline SBP/DBP (mmHg) was similar in both treatment groups (nebivolol: 156/100; placebo: 157/101). A total of 135 (96%) and 121 (89%) nebivolol- and placebo-treated participants completed the double-blind phase, respectively. Compared with the placebo, nebivolol treatment was associated with significant mean reductions in both trough-seated DBP and SBP (DBP: -11.1 mmHg vs. -7.3 mmHg, p < 0.0001; SBP: -14.1 mmHg vs. -9.3 mmHg; p = 0.001). Treatment-emergent adverse event (TEAE) rates were 17% (nebivolol) and 22% (placebo); the most frequent TEAEs were headache (4% vs. 6%, respectively), upper respiratory tract infection (2% vs. 2%), and dizziness (1% vs. 3%).
  
  
  CONCLUSIONS
  In Hispanics with stage I-II hypertension, 8-week nebivolol monotherapy resulted in significant reductions in blood pressure. The safety and tolerability profile of nebivolol was similar to that of placebo.
authors.affiliation: Trinity Hypertension & Metabolic Research Institute, 1932 Walnut Plaza, Carrollton, TX 75006, USA. punzimedcenter@aol.com
authors.forename: Henry
authors.initials: H
authors.lastname: Punzi
authors.forename: Andrew
authors.initials: A
authors.lastname: Lewin
authors.forename: Tatjana
authors.initials: T
authors.lastname: Lukić
authors.forename: Thomas
authors.initials: T
authors.lastname: Goodin
authors.lastname: Wei Chen
mesh_terms: D000328:Adult; D000959:Antihypertensive Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D001578:Benzopyrans / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D001794:Blood Pressure / Q000187:drug effects*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004983:Ethanolamines / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D006630:Hispanic or Latino; D006801:Humans; D006973:Hypertension / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D000068577:Nebivolol; D011446:Prospective Studies; D016037:Single-Blind Method; D016896:Treatment Outcome
chemical_list: D000959:Antihypertensive Agents; D001578:Benzopyrans; D004983:Ethanolamines; D000068577:Nebivolol