Long-term satisfaction and tolerability with low-dose flutamide: a 20-year surveillance study on 120 hyperandrogenic women.

OBJECTIVE: To evaluate the long-term safety, satisfaction and tolerability of flutamide therapy for female hyperandrogenism. DESIGN: A 20-year surveillance study. METHODS: Setting: Gynecology Department in a teaching hospital. PATIENTS: Hyperandrogenic women complaining for hirsutism treatment were followed between February 1995 and April 2015. INTERVENTIONS: Women received flutamide 125 or 250 mg/day alone (n = 55) or combined with oral contraceptives (n = 65). MAIN OUTCOME MEASURES: Adverse events, safety, tolerability satisfaction and efficacy were assessed every 6 months during all the follow-up. Lab tests including liver and lipid profiles were also recorded in each control. RESULTS: Patients under flutamide therapy showed significant improvements in hirsutism scores after 6 months of treatment with a maximum effect at 12 months that was maintained during all the therapy time. Satisfaction reported by patients with the efficacy of the drug in a visual scale was also high. A total of 54.2 % women presented one or more adverse effects during the follow-up; 33.3% showed at least one adverse effect possibly related with the study drug; and 24.1% withdrew from the study because of adverse effects. During the follow-up, as many as 89.9 % of patients abandoned flutamide. Reasons include: questions linked to medical problems (50%), attempt pregnancy (4%) and significant improvement in the symptomatology (35.8%). CONCLUSIONS: Flutamide is very effective for hirsutism treatment; however, adverse effects are very frequent and affect compliance.