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

Abstract

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.