Journal
JOURNAL OF INTERNATIONAL MEDICAL RESEARCH
Volume 29, Issue 3, Pages 236-251Publisher
CAMBRIDGE MED PUBL
DOI: 10.1177/147323000102900312
Keywords
tamsulosin; alpha(1A)-adrenergic receptor antagonist; benign prostatic hyperplasia; orthostatic hypotension; orthostatic test
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Two phase III studies with tamsulosin, a selective alpha (1A)-adrenergic receptor antagonist, were conducted to evaluate the safety and efficacy of the standard treatment doses of 0.4 mg/day and 0.8 mg/day in patients with symptoms of benign prostatic hyperplasia (BPH). These large-scale clinical trials were the first to include extensive testing for possible drug-induced orthostatic hypotension (OH). The frequency of positive orthostatic tests and magnitude of vital sign changes were compared among tamsulosin and placebo-treated groups. The results indicate that tamsulosin up to 0.8 mg/day does not induce higher risk of OH than that of placebo. Data from post-marketing surveillance (PMS) studies of tamsulosin indicate that the incidence of hypotension and syncope is extremely low in community-dwelling elderly men treated for BPH. From the results of the phase III studies, PMS studies and an active-controlled clinical pharmacology study, we conclude that the orthostatic test is a useful and convenient method to evaluate the risk of OH and syncope during the investigational stage.
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