title: The effects of high-dose amlodipine/benazepril combination therapies on blood pressure reduction in patients not adequately controlled with amlodipine monotherapy.
abstract: BACKGROUND
  This study compared the efficacy and safety of amlodipine/benazepril (10/40 mg/day and 10/20 mg/day) with amlodipine 10 mg/day in patients whose blood pressure (BP) was not adequately controlled with amlodipine monotherapy.
  
  
  METHODS
  After a lead-in period with amlodipine monotherapy, 812 non-responder patients (mean sitting diastolic BP > or =95 mmHg) were randomized to one of three treatment groups. Ambulatory BP monitoring was conducted in 276 patients.
  
  
  RESULTS
  Treatment with amlodipine/benazepril 10/40 mg/day and 10/20 mg/day resulted in a decrease of mean sitting systolic and mean sitting diastolic BP by 13.3/12.7 mmHg and 12.1/11.6 mmHg, respectively, compared with monotherapy (6.6/8.5 mmHg) (p < 0.0001). Both combinations resulted in more responders than monotherapy (74% and 65% vs. 54%; p < 0.0001 and p < 0.0085, respectively). Amlodipine/benazepril 10/40 mg/day and 10/20 mg/day decreased ambulatory systolic and diastolic BP by 9.9/6.7 mmHg and 7.4/5.2 mmHg compared with monotherapy (p < 0.0001). The incidence of pedal edema was lower in the amlodipine/benazepril combinations compared with monotherapy (4.5%, 5.5% vs. 9.2%, respectively, p=NS). No significant metabolic side-effects were noted among the combination groups.
  
  
  CONCLUSIONS
  Amlodipine/benazepril combinations were well tolerated and resulted in significant BP reductions and better BP responder rates than amlodipine monotherapy.
authors.affiliation: Oklahoma Cardiovascular and Hypertension Center and the University of Oklahoma School of Medicine, Oklahoma City 73132, USA. schrysant@yahoo.com
authors.forename: Steven G
authors.initials: SG
authors.lastname: Chrysant
authors.forename: Daniel H
authors.initials: DH
authors.lastname: Sugimoto
authors.forename: Marty
authors.initials: M
authors.lastname: Lefkowitz
authors.forename: Thomas
authors.initials: T
authors.lastname: Salko
authors.forename: Mahmudul
authors.initials: M
authors.lastname: Khan
authors.forename: Vipin
authors.initials: V
authors.lastname: Arora
authors.forename: Victor
authors.initials: V
authors.lastname: Shi
mesh_terms: D000328:Adult; D017311:Amlodipine / Q000008:administration & dosage* / Q000009:adverse effects / Q000494:pharmacology; D000806:Angiotensin-Converting Enzyme Inhibitors / Q000008:administration & dosage* / Q000009:adverse effects / Q000494:pharmacology; D001552:Benzazepines / Q000008:administration & dosage* / Q000009:adverse effects / Q000494:pharmacology; D001794:Blood Pressure / Q000187:drug effects*; D018660:Blood Pressure Monitoring, Ambulatory; D002121:Calcium Channel Blockers / Q000008:administration & dosage* / Q000009:adverse effects / Q000494:pharmacology; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D006973:Hypertension / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged
chemical_list: D000806:Angiotensin-Converting Enzyme Inhibitors; D001552:Benzazepines; D002121:Calcium Channel Blockers; D017311:Amlodipine; C044946:benazepril