Safety, side effects and patient acceptance of the antiandrogen Casodex in the treatment of benign prostatic hyperplasia.

Casodex, a new nonsteroidal antiandrogen, was investigated in this double-blind, randomized, placebo-controlled study comprising 28 evaluable patients with benign prostatic hyperplasia, who received Casodex at a dosage of 50 mg daily or a placebo for 24 weeks. The good safety profile of Casodex was confirmed. In common with other nonsteroidal antiandrogens, Casodex was associated with breast enlargement and/or tenderness, being reported by all patients upon direct questioning. A change in sexual function was assessed by two questionnaires, one of them revealing no statistically significant difference between the groups. However, using an alternative questionnaire, approximately half of the patients reported reduced erectile function (p = 0.002), mostly partial, and reduced sexual activity (p = 0.015), whereas libido was well maintained when compared to the placebo. Casodex was not associated with hot flushes. No other side effects of clinical significance were seen, and Casodex was well tolerated by the majority of the patients.