ABSTRACT
Hypertension guidelines recommend a stepped-care approach that starts with titration of the initial agent followed by the addition of other agents, as necessary, to achieve goal blood pressure. This study assessed the effectiveness of an antihypertensive treatment algorithm with olmesartan medoxomil as the initial agent. This was a 24-week, open-label trial in patients (N=201) with mean seated diastolic blood pressure of 90-109 mm Hg. Following placebo run-in, all patients received olmesartan medoxomil 20 mg/d for 4 weeks. At subsequent 4-week intervals, the regimen was modified in patients with blood pressure >130/85 mm Hg: up-titration of olmesartan medoxomil to 40 mg/d; addition of hydrochlorothiazide 12.5 mg/d; up-titration of hydrochlorothiazide to 25 mg/d; addition of amlodipine besylate 5 mg/d; and up-titration of amlodipine besylate to 10 mg/d. Patients who achieved blood pressure < or =130/85 mm Hg at any point exited the study with no further follow-up. At Week 24, reductions in blood pressure from baseline were 33.7/18.2 mm Hg. Altogether, 87.7% of patients reached the goal blood pressure of < or =130/85 mm Hg and 93.3% achieved a blood pressure of < or =140/90 mm Hg. Thus, an antihypertensive algorithm with olmesartan medoxomil as the initial agent controlled blood pressure in the majority of patients, but with >60% of patients also requiring the use of a thiazide diuretic or a thiazide and a calcium channel blocker.
Subject(s)
Algorithms , Hypertension/drug therapy , Imidazoles/therapeutic use , Tetrazoles/therapeutic use , Drug Therapy, Combination , Female , Humans , Imidazoles/adverse effects , Male , Middle Aged , Olmesartan Medoxomil , Tetrazoles/adverse effects , Treatment OutcomeABSTRACT
Olmesartan medoxomil is a new angiotensin II receptor blocker. In this randomized, double-blind, placebo-controlled study, the efficacy and safety of olmesartan medoxomil was assessed in 334 patients with moderate to severe essential hypertension. Patients were randomized to receive placebo; 5, 20, or 80 mg olmesartan medoxomil q.d.; or 2.5, 10, or 40 mg olmesartan medoxomil b.i.d. Ambulatory and cuff blood pressure were measured prior to and after 8 weeks of treatment. Treatment with olmesartan medoxomil resulted in a significant placebo-adjusted reduction of mean 24-hour ambulatory diastolic blood pressure of 9.6 mm Hg, 12.2 mm Hg, and 10.6 mm Hg in the 5-, 20-, and 80-mg q.d. groups, respectively. Corresponding reductions in mean ambulatory systolic blood pressure were 14.5 mm Hg, 16.5 mm Hg, and 15.4 mm Hg. Similar reductions of diastolic and systolic blood pressure were seen with b.i.d. dosing. The diastolic trough-to-peak ratios of the q.d. doses of olmesartan medoxomil ranged from 57%-70%, indicating 24-hour effectiveness. The safety profile of olmesartan medoxomil was similar to that of placebo. Olmesartan medoxomil appears to be a safe and effective once-a-day treatment for hypertension.