Abstract
8016 Background: Effective and nontoxic nonhormonal means of alleviating hot flashes are desirable for men with androgen-ablation related hot flashes. Based on positive pilot information suggesting that relatively low doses of paroxetine were able to alleviate hot flashes in women (with subsequent placebo-controlled data in women confirming the efficacy of this agent in women), we developed a phase II trial of paroxetine in men with bothersome hot flashes related to androgen ablation therapy. Methods: Participants kept a daily hot flash diary during a baseline week and then during four treatment weeks while they received paroxetine SR in the following manner: 12.5 mg/d for one week, then 25 mg/d for one week, then 37.5 mg/d for one week, and then either 25 mg/d or 37.5 mg/d for the last week (patient preference). A total of 26 patients were entered on this study between 8/6/2001 and 10/22/2003. Two patients canceled before receiving treatment, 2 patients did not returned any questionnaires, and 4 patients did not complete all 4 weeks of their diaries. Results: Hot flash information on the 18 evaluable study patients are provided in the table, illustrating mean hot flash score (daily frequency times average severity) data compared to the baseline week (where patients had a mean of 14.8 hot flashes per day). For comparison, similarly obtained data from a previous pilot trial, examining venlafaxine in men with hot flashes, is also illustrated. The paroxetine was tolerated well overall, with most patients reporting an improvement, during the weeks they were receiving paroxetine compared to the baseline week, in most of the potential side effects that we followed. Conclusions: These preliminary data support paroxetine as a potentially effective nonhormonal agent for managing hot flashes in men. Author Disclosure Employment or Leadership Consultant or Advisory Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Glaxo
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