TOLERABILITY PROFILE OF TASOSARTAN, A LONG-ACTING ANGIOTENSIN-II AT(1) RECEPTOR BLOCKER, IN THE TREATMENT OF PATIENTS WITH ESSENTIAL-HYPERTENSION

This paper summarizes tolerability data for 1420 patients with essenti al hypertension mho were enrolled in eight double-masked, controlled c linical trials and who received tasosartan, a long-acting, nonpeptidic -angiotensin II AT, receptor blocker. A total of 2084 patients were in cluded in all treatment groups in these studies. Patients mere treated with tasosartan at doses ranging from 10 to 600 mg, over periods of 3 to 16 weeks, except for one study with a 6-day treatment period. Taso sartan was administered once daily (seven studies) or twice daily (one study). No adverse events occurred at a significantly greater frequen cy in tasosartan-treated patients than in patients who received placeb o. Headache, the most frequently reported adverse event, occurred sign ificantly less frequently among tasosartan-treated patients than among those taking placebo (19% and 28%, respectively). The following adver se events (tasosartan and placebo groups) were reported by at least 3% of tasosartan-treated patients: asthenia (7% in each group), pharyngi tis (7% in each group), dizziness (7% and 5%, respectively), infection (6% and 7%, respectively), rhinitis (4% and 6%, respectively), pain ( 4% in each group), diarrhea (4% in each group), nausea (3% in each gro up), and dyspepsia (3% and 2%, respectively). Cough occurred with a si milar frequency in the tasosartan group and in the placebo group (2%, and 3%, respectively). Peripheral edema occurred in 2.7% of tasosartan -treated patients and 3.4% of the patients who received placebo. Hyper glycemia occurred in <1% of patients in both groups. Potentially clini cally significant laboratory values occurred with comparable frequency in the tasosartan and placebo groups. Discontinuation rates because o f adverse events mere similar in the tasosartan and placebo groups (2. 8% and 2.6%, respectively). Discontinuations because of other medical events occurred less frequently in the tasosartan group than in the pl acebo group (2.5% vs 4.6%, respectively). Tasosartan had a smooth onse t of action without clinical evidence of first-dose hypotension. Blood pressure gradually returned to baseline after tasosartan withdrawal. No safety concerns were identified in these studies. The excellent tol erability profile of tasosartan administered once daily makes it an at tractive choice for the clinical management of essential hypertension.