Abstract
Objective: The primary objective of this phase IV, nonblind, multicentre study was to determine the antihypertensive effectiveness of irbesartan alone or combined with hydrochlorothiazide (HCTZ) in women with mild to moderate essential hypertension. A secondary objective was to examine the effects of irbesartan on blood lipid levels.
Methods: 188 female patients (94 premenopausal and 94 postmenopausal) with mild to moderate hypertension [seated diastolic blood pressure (SDBP) 95 to 110mm Hg] participated in the study. A 2-week placebo lead-in period was followed by a 24-week active treatment period. Patients initially received 150mg of oral irbesartan once a day, which was titrated to 300 mg/day after 4 weeks in nonresponders. HCTZ 12.5 mg/day was added to treatment after 8 weeks in patients not responding to irbesartan 300 mg/day. The dose of HCTZ could be increased to 25 mg/day after 12 weeks in nonresponders.
Results: 174 patients completed the study, of whom 172 (98.9%) responded to treatment (SDBP <90mm Hg or a reduction of at least 10mm Hg from baseline in SDBP). Mean seated systolic blood pressure and SDBP reductions at 24 weeks were 28.1 and 20.0mm Hg (p = 0.0001), respectively. 88 patients completed the study with irbesartan 150mg, 42 patients with irbesartan 300mg, 18 patients with irbesartan plus HCTZ 300/12.5mg and 26 patients with irbesartan plus HCTZ 300/25mg; response rates were 100, 97.6, 100 and 96.2%, respectively. Total, low density lipoprotein- and high density lipoprotein-cholesterol blood levels were significantly reduced (p < 0.05), but there were no significant changes in blood triglyceride levels or the results of other clinical laboratory tests. Antihypertensive treatment was well tolerated.
Conclusion: Irbesartan, either alone or combined with HCTZ, showed excellent antihypertensive efficacy with a low incidence of adverse events. Hence, irbesartan appears to be a suitable agent for the treatment of hypertension in women.
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This study was supported by Bristol-Myers Squibb, México.
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Meaney-Mendiolea, E., Morales-Villegas, E., Vélez-Tello de Meneses, M. et al. Clinical Effectiveness of Irbesartan and Irbersartan plus Hydrochlorothiazide in Women with Mild to Moderate Essential Hypertension. Clin. Drug Investig. 19, 431–439 (2000). https://doi.org/10.2165/00044011-200019060-00005
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DOI: https://doi.org/10.2165/00044011-200019060-00005