Titre du document / Document title

Efficacy and safety of combination therapy using high- or low-dose hydrochlorothiazide with valsartan or other angiotensin-receptor blockers

Auteur(s) / Author(s)

FUENFSTUECK R. ; HEMPEL R.-D. ; ANSARI A. ; WEIDINGER G. ; KLEBS S. ;

Résumé / Abstract

Only a minority of patients treated for hypertension achieve controlled blood pressure (BP) levels. Therapy with fixed-dose combinations of an angiotensin-receptor blocker (ARB) and low-dose hydrochlorothiazide (HCTZ) iscommonly prescribed but not always sufficient to achieve the target BP. The efficacy and safety of the fixed-dose combination of valsartan 160 mg and HCTZ 25 mg was evaluated in patients in whom BP had not been controlled with a fixed-dose combination of another ARB and low-dose HCTZ (12.5 mg) in a multicenter trial. After a wash-out period for antihypertensive drugs, patients with a mean sitting diastolic BP (DBP) at trough ≥100 mm Hg but <110 mm Hg were treated with candesartan cilexetil 16 mg plus HCTZ 12.5 mg or telmisartan 80 mg plus HCTZ 12.5 mg for 4 weeks (phase 1). Patients whose BP was still uncontrolled (DBP ≥90 mm Hg) after 4 weeks of therapy were then given valsartan 160 mg plus HCTZ 25 mg for an additional 4 weeks (phase 2). The primary efficacy parameter was the reduction in DBP between week 4 and week 8 in the intention-to-treat (ITT) population. BP reduction during phase 1 was -14.3′11.3/-7.5′3.9 mm Hg. DBP was controlled in 26% of the patients after phase 1. In patients treated with valsartan 160 mg plus HCTZ 25 mg during phase 2, DBP decreased by an additional 10.3′6.5 mm Hg and the mean sitting systolic BP (SBP) by an additional 11.0′11.7 mm Hg. The additional decrease was significant (P<.0001) for both parameters and independent of the fixed-dose combination used during phase 1. Among patients whose BP remained uncontrolled during phase 1, 74% achieved a controlled DBP after phase 2. The incidence of adverse events during both phases was comparably low and the results of laboratory tests were unremarkable. Treatment with valsartan 160 mg/HCTZ 25 mg offered a substantial benefit for patients with hypertension not controlled with the combination of candesartan cilexetil 16 mg or telmisartan 80 mg and low-dose HCTZ, while maintaining a comparable safety and tolerability profile.

Revue / Journal Title

Advances in therapy   ISSN 0741-238X 

Source / Source

2005, vol. 22, n^o3, pp. 263-277 [15 page(s) (article)]

Langue / Language

Anglais

Editeur / Publisher

Health Communications, Edison, NJ, ETATS-UNIS  (1984) (Revue)

Mots-clés d'auteur / Author Keywords

valsartan ; hydrochlorothiazide ; combination therapy ; dose-related effects ; hypertension ; candesartan ; telmisartan ;

Localisation / Location

INIST-CNRS, Cote INIST : 26960, 35400013270203.0080