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Low-dose pioglitazone, flutamide, metformin plus an estro-progestagen for non-obese young women with polycystic ovary syndrome: increasing efficacy and persistent safety over 30 months.

Author(s): Ibanez L, Lopez-Bermejo A, Diaz M, Enriquez G, Del Rio L, De Zegher F

Affiliation(s): Endocrinology Unit, Hospital Sant Joan de Deu, University of Barcelona, Barcelona, Spain. libanez@hsjdbcn.org

Publication date & source: 2010-12, Gynecol Endocrinol., 26(12):869-73. Epub 2010 May 26.

Publication type: Randomized Controlled Trial; Research Support, Non-U.S. Gov't

CONTEXT: Therapy of androgen excess should not only confer cosmetic benefit, but also improve long-term markers of endocrine-metabolic and cardiovascular health. Here we report on our pilot experience with a low-dose polytherapy for 30 months. DESIGN, PATIENTS, INTERVENTION: Unblinded extension (24-30 months) of a double-placebo study exploring low-dose polytherapy over 24 months. Between 24 and 30 months, women with hyperinsulinemic androgen excess (N = 36; mean age: 19.4 year; BMI: 23.7 kg/m(2)) received metformin (850 mg/day), flutamide (62.5 mg/day), pioglitazone (7.5 mg/day), ethinylestradiol (20 mug/day) plus drospirenone (3 mg/day) for 24/28 days. MAIN OUTCOMES: Carotid IMT, body composition (by absorptiometry), abdominal fat (by magnetic resonance), hirsutism score, fasting glycaemia, insulin, androgens, HDL cholesterol, C-reactive protein and hepatic safety indices. RESULTS: Low-dose polytherapy for 30 months was not accompanied by a change in body weight or bone mineral density, but it was associated with a marked rise of insulin sensitivity (p < 0.00001), with a loss of visceral fat (mean: -27%; p < 0.00001) and with a lowering of IMT (-0.16 mm; p < 0.00001). Aspartate aminotransferase, gamma-glutamyl transferase and lactate dehydrogenase levels decreased slightly over 30 months. CONCLUSION: Low-dose polytherapy (24/28 day) with pioglitazone, flutamide, metformin and estro-progestagen was found to improve, without changing weight, a spectrum of long-term health markers in young women with hyperinsulinemic androgen excess.

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