Tasosartan at dosages of 10 to 300 mg once daily produced significant, dose-related reductions in clinic and ambulatory blood pressure compared to placebo (P<0.05).
RCT (n=278)
Double-blind
randomly assigned
Yes
Does tasosartan reduce clinic and ambulatory blood pressure in patients with essential hypertension?
Tasosartan at doses of 10 to 300 mg once daily produces a significant, dose-related reduction in clinic and ambulatory blood pressure in patients with essential hypertension and is well tolerated.
p-value: p=< .05
Tasosartan, a new, long-acting, nonpeptide angiotensin II receptor antagonist was evaluated in a randomized, double-blind, placebo-controlled, multicenter trial at 21 sites in the United States and Canada. After a 2-week, placebo washout qualification period, 278 patients (187 men/91 women) with a mean age of 53.4+/-9.5 years (range, 30 to 70 years) and a baseline sitting diastolic blood pressure (DBP) of 95 to 114 mm Hg were randomly assigned to receive placebo (n = 56), or 10 mg (n = 57), 30 mg (n = 55), 100 mg (n = 55), or 300 mg (n = 55) tasosartan for 4 weeks. The treatment period was followed by a 2-week washout period. Ambulatory blood pressure (BP) monitoring was performed at the end of the placebo washout period and after at least 4 weeks of double-blind treatment. Clinically significant placebo-adjusted differences in baseline sitting systolic blood pressure (SBP)/DBP were observed in the 10 mg (5/3 mm Hg), 30 mg (5/4 mm Hg), 100 mg (10/7 mm Hg) and 300 mg (10/7 mm Hg) dose groups (P < .05). A dose-response relationship (P < .001) was observed within 1 to 2 weeks of treatment initiation and was maintained throughout the double-blind period. Discontinuation of tasosartan therapy was not associated with rebound hypertension. Moreover, significant (P < .05) placebo-adjusted differences in ambulatory SBP/DBP and a significant dose-response relationship (P < .001) were observed with all tasosartan dosages during the 24-h, daytime, and nighttime periods. Placebo-adjusted trough-to-peak ratios ranged from 87% to 100% for ambulatory SBP and 64% to 81% for DBP. In general, no significant differences were observed between the tasosartan treatment groups and the placebo group in the incidence of adverse events. Headache incidence was significantly lower in the 300 mg dose group than the placebo group. In conclusion, tasosartan at dosages of 10, 30, 100, or 300 mg given once daily produced a significant and dose-related reduction in both clinic and ambulatory BP that was maintained over the 24-h period. Tasosartan was generally well tolerated.
Yves Lacourcière (Wed,) conducted a rct in Essential Hypertension (n=278). Tasosartan vs. Placebo was evaluated on Placebo-adjusted differences in baseline sitting systolic blood pressure (SBP)/DBP (p=< .05). Tasosartan at dosages of 10 to 300 mg once daily produced significant, dose-related reductions in clinic and ambulatory blood pressure compared to placebo (P<0.05).