title: [Fixed irbesartan/amlodipine combination: efficacy and safety of the use of four dosing regimens in patients with arterial hypertension].
abstract: OBJECTIVE
  to assess efficacy, safety, and tolerability of 4 fixed irbesartan/amlodipine combinations in hypertensive patients resistant to monotherapy with 150 mg irbesartan or 5 mg amlodipine in a 16 week prospective open uncontrolled randomized multicenter study.
  
  
  METHODS
  We included in this study 158 patients with essential arterial hypertension (AH) (mean age 57.6 ± 10.1 years, 119 women) receiving monotherapy with 150 mg irbesartan (n=78; 49.4%) or 5 mg amlodipine (n=80; 50.6%). Patients not achieving target arterial pressure (AP) <140/90 mm (n=149) Hg were given fixed irbesartan/amlodipine combination 150/5 mg. If target AP was not achieved patients were randomized to 150/10 or 300/5 mg combinations. If necessary after 4 more weeks these doses were increased to maximal (300/10 mg). Thus 4 fixed irbesartan/amlodipine combinations were used: 150/5, 150/10, 300/5, 300/10 mg. Primary criterion of efficacy was portion of patients with target AP at last visit. Safety was assessed by presence of unfavorable events, clinical and laboratory parameters.
  
  
  RESULTS
  After 16 weeks 43, 23.5, 23.5 and 8.7% of patients received 150/5, 150/10, 300/5 and 300/10 mg combinations, respectively. At final visit 93.3% of patients had AP <140/90 mm Hg. Mean AP lowering in the total group was -21.7 ± 9.1/-10.9 ± 10.8mm Hg (<0.0001). There were 2 cases of ankle edema (5.7%) but no withdrawals due to unfavorable events. There were no differences between 4 dosing regimens in laboratory and clinical parameters of safety and tolerability.
  
  
  CONCLUSIONS
  In patients with AH not achieving target AP on monotherapy with irbesartan 150 or amlodipine 5 mg administration of irbesartan/amlodipine combination with possibility of dose titration using 4 fixed combinations was effective in 93.3% of patients, resulted in significant systolic and diastolic AP lowering in all therapeutic groups, was well tolerated and safe.
authors.forename: Zh D
authors.initials: ZhD
authors.lastname: Kobalava
mesh_terms: D000368:Aged; D017311:Amlodipine / Q000008:administration & dosage / Q000009:adverse effects; D000959:Antihypertensive Agents / Q000008:administration & dosage / Q000009:adverse effects; D001713:Biphenyl Compounds / Q000008:administration & dosage / Q000009:adverse effects; D001794:Blood Pressure / Q000187:drug effects*; D004305:Dose-Response Relationship, Drug; D004338:Drug Combinations; D016903:Drug Monitoring; D004357:Drug Synergism; D000075222:Essential Hypertension; D005260:Female; D006801:Humans; D006973:Hypertension / Q000175:diagnosis / Q000188:drug therapy* / Q000503:physiopathology; D000077405:Irbesartan; D008297:Male; D008875:Middle Aged; D013777:Tetrazoles / Q000008:administration & dosage / Q000009:adverse effects; D016896:Treatment Outcome
chemical_list: D000959:Antihypertensive Agents; D001713:Biphenyl Compounds; D004338:Drug Combinations; D013777:Tetrazoles; D017311:Amlodipine; D000077405:Irbesartan