Pilot evaluation of venlafaxine for the treatment of hot flashes in men undergoing androgen ablation therapy for prostate cancer

Purpose: Hot flashes may be a,significant clinical problem in men undergoin g androgen deprivation therapy with gonadotropin releasing hormone analogue s, oral antiandrogens and/or surgical bilateral orchiectomy. Anecdotal info rmation suggests: that a low dose of the relatively new antidepressant venl afaxine may abrogate this clinical problem. We developed the current pilot trial to investigate further whether venlafaxine alleviates hot flashes in. such men. Materials and Methods: The study included men in whom substantial hot flash es were associated with androgen deprivation therapy. Hot flash data were c ollected by daily diary questionnaires during a 1-week baseline period when no therapy was given for hot flashes, as well as for the next 4 weeks when study participants received 12.5 mg. venlafaxine orally twice daily. Quest ionnaires completed during the 4 weeks of venlafaxine therapy also document ed data on potential drug toxicity. Results: Of the 16 evaluable patients who completed the study 10 (63%) bad a greater than 50% decrease in hot flash score, as determined using the for mula, frequency x severity, by week 4 of treatment versus: the baseline wee k. Median weekly hot flash scores decreased 54% from baseline during week 4 of venlafaxine therapy. Average incidence of severe and very severe hot fl ashes was reduced from 2.3 daily at baseline to 0.6 daily at study end (p = 0.003). Therapy was generally well tolerated. Conclusions: Venlafaxine hydrochloride appears to represent an efficacious new method for alleviating hot flashes in men undergoing androgen ablation therapy. Further evaluation of this compound for alleviating hot flashes is indicated.