R. Feldman et al., TASOSARTAN IN PATIENTS WITH ESSENTIAL-HYPERTENSION - A RANDOMIZED, DOUBLE-BLIND, DOSE TITRATION STUDY, Advances in therapy, 14(5), 1997, pp. 290-303
Citations number
21
Categorie Soggetti
Medicine, Research & Experimental","Pharmacology & Pharmacy
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.