Prospective Cohort Study on the Effects and Tolerability of Flutamide in Patients with Female Pattern Hair Loss

Roberto Paradisi, MD; Eleonora Porcu, MD; Raffaella Fabbri, BSc; Renato Seracchioli, MD; Cesare Battaglia, MD; Stefano Venturoli, MD

Disclosures

The Annals of Pharmacotherapy. 2011;45(4):469-475. 

In This Article

Results

Clinical Results

Figure 1 shows the mean (SD) changes in the alopecia Ludwig score from baseline to 4 years of treatment in both groups of patients studied. No significant difference was found during the treatment between the 2 groups, expressed as effect upon the constant term (intercept) of 2-way analysis of variance (Figure 1). Alopecia improved significantly in Ludwig scores just after 6 months of treatment (p < 0.001) and continued to improve to 2 years of treatment, when we had the best results, and remained stable from that point on. In percentage values, the mean improvement was about 15%, 20%, 26%, and 28% at 0.5, 1, 1.5 and 2 years.

Figure 1.

Mean (SD) changes in hyperandrogenic alopecia Ludwig score detected every 6 months in the first 3 years and once in the 4th year of treatment with flutamide and flutamide with oral contraceptive . Data are expressed as absolute values (for percentage values, see text). Numbers of patients are reported in parentheses. *p < 0.001 versus respective baseline score.

Patients' self-evaluations of the clinical outcomes of the treatment were also consistent with changes in the alopecia scores. Considering that, at baseline, almost all of the women were clearly dissatisfied with their current scalp hair condition, patients' self-evaluations indicated that more than 70% of the subjects were satisfied or highly satisfied after the first year of treatment and the percentage increased to 80% with continuing treatment in the following years (p ≤ 0.05) (Table 2).

Endocrine Results

Table 3 shows the mean (SD) steroid values at baseline and after 1, 2, 3, and 4 years of treatment in both groups studied. A total of 12 women (4 and 8 in the flutamide and flutamide plus oral contraceptive groups, respectively) had baseline testosterone above normal range. All of the androgens (testosterone, unbound testosterone, DHT, androstenedione, DHA, and DHA-S) showed a significant decrease induced by flutamide in both groups.

Tolerability, Adverse Effects, and Complications

A total of 14 (13.9%), 6 (5.9%), 10 (9.9%), and 32 (31.7%) women dropped out in the 1st, 2nd, 3rd, and 4th years of treatment, respectively (Figure 1). The percentage of patients who dropped out during the study was similar in both groups. Among the 62 (61.4%) patients who withdrew from the study, only 4 (4.0%) showed significant transaminase increases, all during the first year with flutamide 250 mg and none during the following years with flutamide 125 mg and 62.5 mg. However, no clear cases of hepatotoxicity were observed since all patients rapidly resumed normal transaminase values after treatment discontinuation. Among the slight and temporary adverse events most frequently reported, and for which treatment discontinuation was not requested, were headache (5.9%), respi- ratory tract disorders (4.0%), nausea and/or vomiting (5.0%), diarrhea (3.0%), dry skin (8.9%), and reduction of libido (5.0%). No cases of undesired pregnancy were observed in the flutamide group during the study. Some patients, for fear of recurrence of hair loss, continued, out of protocol, to undergo treatment up to 7 or 8 years or more.

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