TASOSARTAN IN PATIENTS WITH ESSENTIAL-HYPERTENSION - A RANDOMIZED, DOUBLE-BLIND, DOSE TITRATION STUDY

This study evaluated the effect of titrating doses of tasosartan, a no vel angiotensin II receptor blocker, on blood pressure reduction in pa tients with essential hypertension. This randomized, double-blind, 9-w eek, placebo-controlled study included 142 patients (71 per group) bet ween 25 and 70 years of age. After baseline blood pressure and laborat ory assessments were made, patients received tasosartan 25 mg or place bo once daily. Tasosartan doses were titrated upward (25 to 50 to 100 mg) at 3-week intervals until effective blood pressure control was ach ieved without adverse events. Efficacy was assessed by observations of mean changes from baseline in sitting systolic and diastolic blood pr essure (SiSBP and SiDBP) and of the proportion of patients responding to treatment. Trough-to-peak ratios were derived from 24-hour ambulato ry blood pressure recordings. Safety evaluation was based on reported adverse events and laboratory and vital sign measurements. Significant (P<.05) blood pressure reductions were observed at 1 week in the taso sartan group. Respective final on-therapy reductions from baseline in SiSBP and SiDBP were 12.9 and 8.5 mm Hg in the tasosartan group and 1. 2 and 2.6 mm Hg in the placebo group. At the final on-therapy visit, s ignificantly more patients responded to tasosartan therapy (54%) than to placebo (21%); moreover, tasosartan demonstrated excellent trough-t o-peak ratios for SiSBP (0.80) and SiDBP (0.82). The tasosartan group mean SiDBP was less than 90 mm Hg for 23 (96%) of the 24 hourly evalua tions. Parameters of safety and tolerability were comparable between g roups. Tasosartan was effective and well tolerated, with evidence of e fficacy within 1 week, sustained blood pressure control over 24 hours, and tolerability comparable to that of placebo. Tasosartan has therap eutic value as a once-daily treatment for essential hypertension.