Flutamide is Used Effectively in Women with PCOS Part 1

http://jcem.endojournals.org/cgi/content/full/88/6/2600
http://jcem.endojournals.org/cgi/content/full/89/4/1592
http://jcem.endojournals.org/cgi/content/full/89/9/4716
http://jcem.endojournals.org/cgi/con...ull/88/10/4720
http://jcem.endojournals.org/cgi/content/full/87/6/2870
http://www.blackwell-synergy.com/doi...5.2004.01973.x
http://jcem.endojournals.org/cgi/rap...005-2250v1.pdf
http://jcem.endojournals.org/cgi/con...ull/85/11/4047
http://humrep.oxfordjournals.org/cgi...hort/20/7/1833
http://www.medscape.com/viewarticle/467352


Absence of hepatotoxicity after long-term, low-dose flutamide in hyperandrogenic girls and young women. Hum Reprod. 2005; 20(7):1833-6 (ISSN: 0268-1161) Ibáñez L; Jaramillo A; Ferrer A; de Zegher F
Endocrinology Unit, Hospital Sant Joan de Déu, University of Barcelona, Barcelona, Spain. libanez@hsjdbcn.org
BACKGROUND: Flutamide is a pure non-steroidal anti-androgen that may be hepatotoxic, when given in high-dose (750 mg/d). Low- to ultralow-doses (250-62.5 mg/day) have been recently explored in patients with Polycystic Ovary Syndrome (PCOS), and these lower doses were found to confer benefit on multiple PCOS markers. There is a need for evidence on the potential hepatotoxicity of low- and ultralow-dose flutamide therapy. METHODS: We assessed circulating levels of alanine aminotransferase (ALT) and aspartate aminotransferase (AST) as markers of hepatotoxicity in a total of 190 hyperandrogenic girls and young women receiving low- or ultralow-dose flutamide because of established (n = 150) or incipient (n = 40) PCOS without obesity. Assessments were performed before start of flutamide, after 3 months, and subsequently at least twice yearly. RESULTS: AST and ALT results were normal at baseline, and they remained so on flutamide treatment, including between 3 months and last assessment, which was after a mean time of 19 months on low- or ultralow-dose flutamide (range 3-54 months). None of the AST or ALT levels at any time during flutamide treatment was > or = 45 U/L. CONCLUSION: We found no evidence for hepatotoxicity in 190 hyperandrogenic girls or young women receiving low- or ultralow-dose flutamide for up to 54 months. These results may represent a first step in a long process whereby the status of low- and ultralow-dose flutamide may gradually evolve from 'absence of evidence on toxicity' towards 'evidence of absence of hepatic toxicity'. Ultralow-dose flutamide may become a key component within future therapies for hyperandrogenic states in girls and young women.

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MEDLINE Results

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