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During the double-blind treatment period, 2,167 male subjects were exposed to Avodart, including 1,772 exposed for 1 year and 1,510 exposed for 2 years. If clinicians elect to use percent free PSA as an aid in the detection of prostate cancer in men receiving Avodart, no adjustment to its value appears necessary. Most of the 4,844 subjects randomly assigned to receive combination, Avodart, or tamsulosin completed 2 years of double-blind treatment (79%, 80%, and 78%, respectively). Avodart is a 5α-reductase inhibitor that prevents conversion of testosterone to dihydrotestosterone (DHT), a hormone necessary for normal development of male genitalia. No clinically significant adverse interactions could be attributed to the combination of Avodart and concurrent therapy when Avodart was coadministered with anti-hyperlipidemics, angiotensin-converting enzyme (ACE) inhibitors, beta-adrenergic blocking agents, calcium channel blockers, corticosteroids, diuretics, nonsteroidal anti-inflammatory drugs (NSAIDs), phosphodiesterase Type V inhibitors, and quinolone antibiotics. These reactions have been chosen for inclusion due to a combination of their seriousness, frequency of reporting, or potential causal connection to Avodart.

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