Retrospective observational study on the effects and tolerability of flutamide in a large population of patients with various kinds of hirsutism over a 15-year period

Abstract

ObjectiveThe aim of the study was to evaluate the long-term effects and tolerability of flutamide (Flu) in hirsute women. To the best of our knowledge, this study represents the largest report, concerning the population studied and the duration of treatment, to evaluate Flu use in hirsutism treatment.Design, patients and methodsOver a 15-year period spanning from January 1991 to January 2006, a total of 414 premenopausal women with hirsutism of different aetiopathogeneses received yearly reducing doses (250, 125 and 62.5 mg/day) of Flu alone or in combination with oral contraceptives for a period varying from at least 3 to 8 years and more. Clinical and endocrine evaluations were assessed half-yearly and yearly respectively in the first 3 years of the study, and yearly in the following years. Liver function evaluations were assessed quarterly.ResultsBoth the groups of patients under Flu therapy showed a marked decrease in hirsutism scores after 12 months compared with basal values. The maximum drug effect was observed after 2 years, and it was maintained during the following years of treatment. Androgens were strongly suppressed during treatment. During the first year of treatment, 6.0% of patients abandoned the study due to hepatic disorders related to the drug. During the following years with the lowest treatment regimen, none of the patients abandoned the study due to hepatic discomfort.ConclusionsFlu is a satisfactory therapeutic regimen for any form of hirsutism in the long run. Moreover, the use of very low doses of Flu is associated with minimal side-effects and high compliance.