A home blood pressure monitoring study comparing the antihypertensive efficacy of two angiotensin II receptor antagonist fixed combinations

Am J Hypertens. 2005 Nov;18(11):1482-8. doi: 10.1016/j.amjhyper.2005.06.009.

Abstract

Background: The objective of this prospective, randomized, open-label, blinded-endpoint study was to compare the antihypertensive efficacy of valsartan 80 mg v irbesartan 150 mg when combined with hydrochlorothiazide (HCTZ) 12.5 mg.

Methods: Untreated or uncontrolled hypertensive adults (n = 800) were enrolled by primary care physicians. After a 5-week open-label lead-in phase in which all patients received 12.5 mg HCTZ once daily, subjects whose blood pressure (BP) remained uncontrolled were randomized (n = 464) to valsartan/HCTZ (80/12.5 mg) or irbesartan/HCTZ (150/12.5 mg) for 8 weeks. Home BP monitoring (HBPM) was performed in the morning and in the evening for 5 days, at baseline, and after 8 weeks. Office BP measurements were obtained at baseline and after 8 weeks.

Results: Irbesartan/HCTZ produced greater reductions in average systolic BP (SBP) and diastolic BP (DBP) measured by HBPM than valsartan/HCTZ (SBP: -13.0 v -10.6 mm Hg, P = .0094; DBP: -9.5 v -7.4 mm Hg, P = .0007). These differences were more pronounced in the morning (trough) than in the evening. Office BP measurements also showed greater reductions in trough seated SBP and DBP with irbesartan/HCTZ compared with valsartan/HCTZ. Normalization rates observed with HBPM (SBP <135 mm Hg and DBP <85 mm Hg) were significantly greater with irbesartan/HCTZ than with valsartan/HCTZ (50.2 v 33.2%; P = .0003). The overall safety was similar in the two groups.

Conclusions: The superior BP-lowering potency of the fixed combination irbesartan/HCTZ (150/12.5 mg) over valsartan/HCTZ (80/12.5 mg), evidenced independently from the investigators by HBPM, supports the use of this technique in trials with prospective, randomized, open-label, blinded-endpoint designs.

Publication types

  • Comparative Study
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aged
  • Angiotensin II Type 1 Receptor Blockers / adverse effects
  • Angiotensin II Type 1 Receptor Blockers / therapeutic use*
  • Antihypertensive Agents / adverse effects
  • Antihypertensive Agents / therapeutic use*
  • Biphenyl Compounds / adverse effects
  • Biphenyl Compounds / therapeutic use
  • Blood Pressure / drug effects*
  • Blood Pressure Monitoring, Ambulatory
  • Double-Blind Method
  • Drug Therapy, Combination
  • Female
  • Gastrointestinal Diseases / chemically induced
  • Humans
  • Hydrochlorothiazide / adverse effects
  • Hydrochlorothiazide / therapeutic use
  • Hypertension / drug therapy*
  • Hypertension / physiopathology
  • Irbesartan
  • Male
  • Middle Aged
  • Musculoskeletal Diseases / chemically induced
  • Prospective Studies
  • Tetrazoles / adverse effects
  • Tetrazoles / therapeutic use
  • Treatment Outcome
  • Valine / adverse effects
  • Valine / analogs & derivatives
  • Valine / therapeutic use
  • Valsartan

Substances

  • Angiotensin II Type 1 Receptor Blockers
  • Antihypertensive Agents
  • Biphenyl Compounds
  • Tetrazoles
  • Hydrochlorothiazide
  • Valsartan
  • Valine
  • Irbesartan