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These data suggest that Avodart arrests the disease process of BPH in men with an enlarged prostate. To interpret an isolated PSA value in a man treated with Avodart for 6 months or more, the PSA value should be doubled for comparison with normal values in untreated men. Compared with placebo, Avodart was associated with a statistically significantly lower incidence of AUR (1. Therefore, for interpretation of serial PSAs in a man taking Avodart, a new baseline PSA concentration should be established after 3 to 6 months of treatment, and this new value should be used to assess potentially cancer-related changes in PSA. Avodart is contraindicated for use in women of childbearing potential and during pregnancy. During the first 2 years, 1,623 subjects received monotherapy with Avodart; 1,611 subjects received monotherapy with tamsulosin; and 1,610 subjects received combination therapy.
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