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.

• Authors: Camil Castelo-Branco, Claudio Hernández-Angeles, Lina Alvarez-Olivares, Juan Balasch
• Journal: Gynecological endocrinology : the official journal of the International Society of Gynecological Endocrinology (Gynecol Endocrinol) Vol. 32 Issue 9 Pg. 723-727 (Sep 2016) ISSN: 1473-0766 [Electronic] England
• PMID: 27176209 (Publication Type: Journal Article)

Chemical References

• Androgen Antagonists
• Contraceptives, Oral, Hormonal
• Flutamide

Topics

• Adult
• Androgen Antagonists (administration & dosage, adverse effects, pharmacology)
• Contraceptives, Oral, Hormonal (therapeutic use)
• Drug Therapy, Combination
• Female
• Flutamide (administration & dosage, adverse effects, pharmacology)
• Follow-Up Studies
• Hirsutism (drug therapy)
• Humans
• Hyperandrogenism (drug therapy)
• Medication Adherence
• Middle Aged
• Outcome Assessment, Health Care
• Patient Satisfaction
• Young Adult