A Home Blood Pressure Monitoring Study Comparing the Antihypertensive Efficacy of Two Angiotensin II Receptor Antagonist Fixed Combinations
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.
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HBPT may achieve more satisfactory hypertension control rates.
“and to achieve more satisfactory hypertension control rates [57,112–115]”
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- Authors
- BOBRIE, G., DELONCA, J., MOULIN, C., GIACOMINO, A., POSTELVINAY, N., & ASMAR, R.
- Affiliations
- Hôpital Européen Georges-Pompidou (FR)
- Bristol-Myers Squibb (France) (FR)
- Corresponding author
- ASMAR, R
- ORCID
- ASMAR, R
- Venue
- American Journal of Hypertension
- Publisher
- Oxford University Press (OUP)
- Published
- 2005-11
- Volume
- 18
- Issue
- 11
- Pages
- 1482-1488
- ISSN
- 0895-7061 (ISSN-L)
- OpenAlex
- W2116766667
- Cited by
- 42
- References
- 30
- Citations by year
- 2021: 1 · 2015: 3 · 2014: 4 · 2013: 4 · 2012: 3
- FWCI
- 3.43
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- American Journal of Hypertension (publishedVersion)
- PubMed (publishedVersion)
- Funders
- Bristol-Myers Squibb
- Sanofi
- Topics
- Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Blood Pressure and Hypertension Studies
- Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Renin-Angiotensin System Studies
- Health Sciences › Nursing › Nutrition and Dietetics › Sodium Intake and Health
- Keywords
- home blood pressure monitoring, valsartan, irbesartan, hydrochlorothiazide, fixed-dose combination antihypertensive therapy, angiotensin receptor blockers, antihypertensive efficacy, uncontrolled hypertension, trough blood pressure, office blood pressure, blood pressure normalization, drug safety, primary care patients
- MeSH terms
- Valsartan, Irbesartan, Aged, Antihypertensive Agents, Biphenyl Compounds, Blood Pressure, Double-Blind Method, Drug Therapy, Combination, Female, Gastrointestinal Diseases, Humans, Hydrochlorothiazide, Hypertension, Male, Middle Aged, Musculoskeletal Diseases, Prospective Studies, Tetrazoles, Valine, Treatment Outcome, Blood Pressure Monitoring, Ambulatory, Angiotensin II Type 1 Receptor Blockers
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