Titre du document / Document title

Long-term efficacy, safety, and tolerability of valsartan and hydrochlorothiazide in patients with essential hypertension

Auteur(s) / Author(s)

CHRYSANT S. G. ⁽¹⁾ ; WOMBOLT D. G. ⁽²⁾ ; FELICIANO N. ⁽³⁾ ; HONGJIE ZHENG ⁽³⁾ ;

Affiliation(s) du ou des auteurs / Author(s) Affiliation(s)

⁽¹⁾ Oklahoma Cardiovascular and Hypertension Center, Oklahoma City, Oklahoma, ETATS-UNIS
⁽²⁾ Clinical Research Associates, Norfolk, Virginia, ETATS-UNIS
⁽³⁾ Novartis Pharmaceuticals Corporation, East Hanover, New Jersey, ETATS-UNIS

Résumé / Abstract

The long-term safety data on angiotensin II receptor blockers in combination with thiazide diuretics are limited. The present study reports on the long-term efficacy, safety, and tolerability data from a third-year extension trial in patients receiving valsartan 80 mg in combination with hydrochlorothiazide (HCTZ) 12.5 or 25 mg for at least 2 years. Seventy-three patients (age range, 30 to 77 years) with essential hypertension who had participated in a 6-week, double-masked core trial followed by a 2-year, open-label extension phase entered the 3-year, open-label extension trial. They received valsartan 80 mg/HCTZ 12.5 mg (n = 18), valsartan 80 mg/HCTZ 25 mg (n = 52), or valsartan 80 mg with HCTZ that varied between 12.5 mg and 25 mg (n = 3) during the third year. For all patients, mean reductions from baseline (core trial) in trough mean sitting diastolic blood pressure (DBP) and systolic blood pressure (SBP) during the third-year extension phase remained stable over time and comparable to mean reductions at the end of the second-year extension phase. Comparable mean reductions in both SBP and DBP were observed for patients treated with valsartan 80 mg/HCTZ 12.5 mg (SBP, 11.7 to 17.1 mm Hg; DBP, 12.3 to 13.8 mm Hg) and those treated with valsartan 80 mg/HCTZ 25 mg (SBP, 15.0 to 16.4 mm Hg; DBP, 11.9 to 12.6 mm Hg). When the third-year extension results for blood pressure were compared with results at the end of the original 6-week core trial, further mean reductions in blood pressure were observed at all time points. No relevant differences in antihypertensive effect were seen in younger (<65 years) or older (≥65 years) patients or in male or female patients. Both combinations were well tolerated, and none of the patients discontinued therapy because of treatment-related adverse events. Based on these results, we concluded that long-term use of valsartan 80 mg in combination with HCTZ 12.5 or 25 mg is effective, safe, and well tolerated. There was no evidence of long-term safety or tolerability issues.

Revue / Journal Title

Current therapeutic research   ISSN 0011-393X   CODEN CTCEA9 

Source / Source

1998, vol. 59, n^o11, pp. 762-772 (26 ref.)

Langue / Language

Anglais

Editeur / Publisher

Excerpta medica, Belle Mead, NJ, ETATS-UNIS  (1959) (Revue)

Mots-clés anglais / English Keywords

Valsartan ; Angiotensin antagonist ; Antihypertensive agent ; Angiotensin II ; Hydrochlorothiazide ; Diuretic ; Hypertension ; Human ; Chemotherapy ; Treatment ; Treatment efficiency ; Long term ; Secondary effect ; Toxicity ; Chronic ; Drug combination ; Interindividual comparison ; Age ; Peptides ; Thiazide ; Sex ; Cardiovascular disease ;

Mots-clés français / French Keywords

Valsartan ; Antagoniste angiotensine ; Antihypertenseur ; Angiotensine II ; Hydrochlorothiazide ; Diurétique ; Hypertension artérielle ; Homme ; Chimiothérapie ; Traitement ; Efficacité traitement ; Long terme ; Effet secondaire ; Toxicité ; Chronique ; Association médicamenteuse ; Comparaison interindividuelle ; Age ; Peptide ; Thiazide ; Sexe ; Récepteur angiotensine AT1 ; Appareil circulatoire pathologie ;

Mots-clés espagnols / Spanish Keywords

Valsartán ; Antagonista angiotensina ; Antihipertensivo ; Angiotensina II ; Hidroclorotiazida ; Diurético ; Hipertensión arterial ; Hombre ; Quimioterapia ; Tratamiento ; Eficacia tratamiento ; Largo plazo ; Efecto secundario ; Toxicidad ; Crónico ; Asociación medicamentosa ; Comparación interindividual ; Edad ; Péptido ; Tiazida ; Sexo ; Aparato circulatorio patología ;

Localisation / Location

INIST-CNRS, Cote INIST : 9560, 35400007184808.0020