title: Efficacy and safety of a fixed combination of irbesartan/hydrochlorothiazide in Chinese patients with moderate to severe hypertension.
abstract: OBJECTIVE
  In a multi-center, single-arm, prospective study, we investigated the efficacy and safety of the fixed irbesartan/hydrochlorothiazide combination in Chinese patients with moderate to severe hypertension.
  
  
  METHODS
  Eligible patients were aged 18-75 years, with a blood pressure of 160-199 mmHg systolic or 100-119 mmHg diastolic during a 1-week wash-out phase off antihypertensive medication. The enrolled patients started antihypertensive treatment with irbesartan/hydrochlorothiazide 150 mg/12.5 mg once daily, with the possible addition of irbesartan 150 mg once daily and up-titration to irbesartan/hydrochlorothiazide 300 mg/25 mg once daily at 4 and 8 weeks of follow-up, respectively. The primary efficacy variable was the goal blood pressure-attaining rate at 12 weeks of follow-up (<140/90 mmHg, or <130/80 mmHg in patients with diabetes mellitus).
  
  
  RESULTS
  In the intention-to-treat analysis (n = 501) at 12 weeks of follow-up, the goal blood pressure-attaining rate was 57.3%, and the mean change in blood pressure from baseline was 27.8 mmHg [95% confidence interval (CI) 26.4-29.1 mmHg; p < 0.001] systolic and 13.5 mmHg (95% CI 12.6-14.4 mmHg; p < 0.001) diastolic. Similar findings were observed in the per-protocol analysis (n = 449). The prevalence of microalbuminuria and left ventricular hypertrophy significantly (p ≤ 0.01) decreased from 33.4% (150/449) and 50.4% (215/427) at baseline to 23.4% (105/447) and 41.3% (176/427) at the end of follow-up, respectively. Four patients (2.0%) reported a serious adverse event.
  
  
  CONCLUSIONS
  The fixed irbesartan/hydrochlorothiazide combination may control blood pressure to the target level in about 60% of Chinese patients with moderate to severe hypertension, with an acceptable safety profile.
authors.affiliation: The Centre for Epidemiological Studies and Clinical Trials, The Shanghai Institute of Hypertension, Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Ruijin 2nd Road 197, Shanghai 200025, China.
authors.forename: Qi-Fang
authors.initials: QF
authors.lastname: Huang
authors.forename: Chang-Sheng
authors.initials: CS
authors.lastname: Sheng
authors.forename: Yan
authors.initials: Y
authors.lastname: Li
authors.forename: Gen-Shan
authors.initials: GS
authors.lastname: Ma
authors.forename: Qiu-Yan
authors.initials: QY
authors.lastname: Dai
authors.forename: Ji-Guang
authors.initials: JG
authors.lastname: Wang
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000419:Albuminuria / Q000188:drug therapy / Q000453:epidemiology; D000959:Antihypertensive Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D044466:Asian People; D001713:Biphenyl Compounds / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D001794:Blood Pressure / Q000187:drug effects; D004338:Drug Combinations; D005260:Female; D006801:Humans; D006852:Hydrochlorothiazide / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D006973:Hypertension / Q000175:diagnosis / Q000188:drug therapy*; D017379:Hypertrophy, Left Ventricular / Q000188:drug therapy; D000077405:Irbesartan; D008297:Male; D008875:Middle Aged; D013777:Tetrazoles / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*
chemical_list: D000959:Antihypertensive Agents; D001713:Biphenyl Compounds; D004338:Drug Combinations; D013777:Tetrazoles; D006852:Hydrochlorothiazide; D000077405:Irbesartan