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Classic, novel treatments for androgen excess comparable
Ibáñez L. J Clin Endocrinol Metab. 2011;doi:10.1210/jc.2011-1671.
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Ethinyl estradiol/cyproterone acetate and low-dose pioglitazone, flutamide and metformin therapy appear to exert comparable effects on indices of androgen excess in adolescent girls after 6 months of treatment, researchers found.
However, the two treatments had “divergent effects” on markers of cardiovascular health, adiposity, inflammation and adipocyte biology, with the differences favoring treatment with low-dose pioglitazone, flutamide and metformin.
“The present study is the first to have explored the effects of low-dose pioglitazone-flutamide-metformin given continuously, concomitantly and in monotherapy,” Lourdes Ibáñez, MD, PhD, of the University of Barcelona, and colleagues wrote.
The randomized, open-label trial was designed to compare 6-month treatment in 34 adolescents with hyperinsulinemic androgen excess who were not at risk for pregnancy.
Results showed that ethinyl estradiol/cyproterone acetate and low-dose pioglitazone, flutamide and metformin attenuated androgen excess comparably. Divergent effects between the two were observed in insulin resistance, circulating cholesterol, triglycerides, C-reactive protein, high-molecular-weight adiponectin, leptin, follistatin, carotid intima-media thickness, lean mass, and abdominal, visceral and hepatic fat. “All divergences pointed to a healthier condition on low-dose pioglitazone-flutamide-metformin,” the researchers said. In addition, 77% of the girls assigned to low-dose pioglitazone, flutamide and metformin achieved spontaneously regular cycles within 6 months.
No participants dropped out of the study due to treatment-related effects. Two girls assigned to ethinyl estradiol/cyproterone acetate experienced transient alanine aminotransferase elevations after 6 weeks; this was not observed in any girls assigned to low-dose pioglitazone, flutamide and metformin.
The researchers said the pioglitazone (Actos, Takeda) dose used in this study was 7.5 mg/day, much lower than the common 30-mg or 45-mg doses used by patients with diabetes.
“The long-term safety of androgen-excess treatments should be kept in mind because these treatments are often continued for years,” Ibanez and colleagues concluded. “Further follow-up of our study subgroups will clarify whether the divergences between the effects of ethinyl estradiol-cyproterone acetate and pioglitazone-flutamide-metformin are transient or persist over time.”
Disclosure: The researchers report no relevant financial disclosures.
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