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.

Chinese abstract

目的: 评估氟他胺治疗女性高雄激素血症长期的安全性、满意度和耐受性。

设计: 一项20年的监测研究。

方法: 地点: 某教学医院妇科。患者: 随访1995年2月到2015年4月以多毛为主诉的高雄激素血症妇女。干预: 妇女单独接受氟他胺125mg/天或250mg/天(n = 55) 或联合

口服避孕药(N = 65) 。主要观察指标: 在整个随访期间, 每6个月评估一次不良事件、安全性、耐受性、满意度和有效性。每个对照组还记录了实验室检测指标, 包括肝功能和血脂水平。

结果: 患者经过氟他胺治疗6个月以后, 多毛评分显著改善, 治疗12个月时效果最显著, 并维持整个治疗期。患者报告的对药物疗效的满意度看起来也很高。总共有54.2%的妇女在随访期间提出一个或多个不良反应；33.3%的妇女表示至少有一个可能与研究药物相关的不良反应；24.1%的妇女因为不良反应退出了研究。在随访过程中, 多达89.9%的患者终止了氟他胺治疗。原因包括: 与医疗问题相关的问题(50%) , 尝试怀孕(4%) , 症状明显改善(35.8%) 。

结论: 氟他胺治疗多毛非常有效；然而, 副反应很常见, 影响依从性。

Keywords:

• Adverse effects
• hyperandrogenism
• safety
• tolerability

Declaration of interest

The authors declare no conflict of interest.

This research did not receive any specific grant from any funding agency in the public, commercial or not-for-profit sector.

Authors’ contributions

C.C.B. designed the study and wrote the manuscript. L.A. and C.H. recorded the data and interviewed the subjects. J.B. critically reviewed the manuscript and took part in the discussion section.