Hepatotoxicity with low- and ultralow-dose flutamide: a surveillance study on 203 hyperandrogenic young females
Fertility and Sterility, 07/16/2012
Bruni V et al. – Hepatotoxicity is a rare but possible event using low– and ultralow–dose regimens of flutamide. Authors need larger study populations in order to identify risk patterns for hepatotoxicity development.Methods
- A 10–year surveillance study.
- Two hundred three hyperandrogenic young females (mean age: 20.9 ± 4.9 years).
- Inclusion criterion was receiving low– or ultralow–dose of flutamide as antiandrogenic treatment. Patients were categorized into Groups A and B, according to the administered dose (Group A = 62.5 mg/daily, Group B = 125 mg/daily).
- The two groups were further subdivided into subgroups (A1, A2, B1, B2) depending on the coadministration of estroprogestagen oral contraceptives (OCs) (A2, B2).
- Mild–to–severe increase of circulating AST/ALT was detected in 19 (9.4%; 95% CI = 5.9%–14.4%) patients during the first year of treatment (mild = 16 [7.9%, 95% CI = 4.7%–12.7%], moderate = 2 [0.9%, 95% CI = 0.1%–3.9%], severe = 1 [0.5%, 95% CI = 0.0%–3.1%]).
- No statistical differences were observed in relation to flutamide dose regimens and coadministration of OC.
- The median time to hypertransaminasemia was 12 weeks (range: 2–48) with no difference between Group A and Group B. A significant correlation was observed between hepatotoxicity and pretreatment BMI, ALT basal level, and AST basal level.