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Matrix study of irbesartan with hydrochlorothiazide in mild-to-moderate hypertension*

Matrix study of irbesartan with hydrochlorothiazide in mild-to-moderate hypertension* The purpose of this study was to assess the safety and antihypertensive dose-response effects of irbesartan and hydrochlorothiazide (HCTZ) in patients with mild-to-moderate hypertension. After a 4- to 5-week single-blind placebo lead-in period, 683 patients with seated diastolic blood pressure (SeDBP) between 95 and110 mm Hg were randomized to receive once-daily dosing with one of 16 different double-blind, fixed combinations of irbesartan (0, 37.5, 100, and 300 mg irbesartan) and HCTZ (0, 6.25, 12.5, and 25 mg HCTZ) for 8 weeks. The primary efficacy variable was the change from baseline in trough SeDBP after 8 weeks of therapy. Data were analyzed by response surface modeling. At Week 8, mean changes from baseline in trough SeDBP (mm Hg) ranged from −3.5 for placebo, −7.1 to −10.2 for the irbesartan monotherapy groups, −5.1 to −8.3 for the HCTZ monotherapy groups, and −8.1 to −15.0 for the combination groups. Irbesartan plus HCTZ produced additive reductions in both SeDBP and seated systolic BP, with at least one combination producing greater BP reduction than either drug alone (P < .001). All treatments were well tolerated; there were no treatment-related serious adverse events. Irbesartan tended to ameliorate the dose-related biochemical abnormalities associated with HCTZ alone. In conclusion, the combination of HCTZ in doses up to 25 mg with irbesartan, in doses up to 300 mg, is safe and produces dose-dependent reductions in BP. Am J Hypertens 1999;12:797–805 © 1999 American Journal of Hypertension, Ltd. http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png American Journal of Hypertension Oxford University Press

Matrix study of irbesartan with hydrochlorothiazide in mild-to-moderate hypertension*

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References (20)

Publisher
Oxford University Press
Copyright
© 1999 by the American Journal of Hypertension, Ltd.
ISSN
0895-7061
eISSN
1941-7225
DOI
10.1016/S0895-7061(99)00053-9
Publisher site
See Article on Publisher Site

Abstract

The purpose of this study was to assess the safety and antihypertensive dose-response effects of irbesartan and hydrochlorothiazide (HCTZ) in patients with mild-to-moderate hypertension. After a 4- to 5-week single-blind placebo lead-in period, 683 patients with seated diastolic blood pressure (SeDBP) between 95 and110 mm Hg were randomized to receive once-daily dosing with one of 16 different double-blind, fixed combinations of irbesartan (0, 37.5, 100, and 300 mg irbesartan) and HCTZ (0, 6.25, 12.5, and 25 mg HCTZ) for 8 weeks. The primary efficacy variable was the change from baseline in trough SeDBP after 8 weeks of therapy. Data were analyzed by response surface modeling. At Week 8, mean changes from baseline in trough SeDBP (mm Hg) ranged from −3.5 for placebo, −7.1 to −10.2 for the irbesartan monotherapy groups, −5.1 to −8.3 for the HCTZ monotherapy groups, and −8.1 to −15.0 for the combination groups. Irbesartan plus HCTZ produced additive reductions in both SeDBP and seated systolic BP, with at least one combination producing greater BP reduction than either drug alone (P < .001). All treatments were well tolerated; there were no treatment-related serious adverse events. Irbesartan tended to ameliorate the dose-related biochemical abnormalities associated with HCTZ alone. In conclusion, the combination of HCTZ in doses up to 25 mg with irbesartan, in doses up to 300 mg, is safe and produces dose-dependent reductions in BP. Am J Hypertens 1999;12:797–805 © 1999 American Journal of Hypertension, Ltd.

Journal

American Journal of Hypertension – Oxford University Press

Published: Aug 1, 1999

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