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Comparison of Ethinyl-Estradiol Plus Cyproterone Acetate Versus Metformin Effects on Classic Metabolic Cardiovascular Risk Factors in Women with the Polycystic Ovary Syndrome

Departments of Endocrinology (M.L.-R., F.A.-B., J.I.B.-C., E.M.-B., H.F.E.-M.) and Biochemistry-Research (M.A.L.), Hospital Universitario Ramón y Cajal and Universidad de Alcalá, E-28034 Madrid, Spain; and Centro de Investigación Biomédica en Red (CIBER) Fisiopatologia Obesidad y Nutrición (CB06/03) (M.A.L.), Instituto de Salud Carlos III, E-28029 Madrid, Spain

Address all correspondence and requests for reprints to: Héctor F. Escobar-Morreale, M.D., Ph.D., Department of Endocrinology, Hospital Universitario Ramón y Cajal and Universidad de Alcalá, Carretera de Colmenar Viejo Km 9,1. 28034 Madrid, Spain. E-mail: hescobarm.hrc{at}salud.madrid.org.

Context: Oral contraceptives may worsen the metabolic profile of patients with polycystic ovary syndrome (PCOS), favoring the use of insulin sensitizers in these patients.

Objective: The aim of the study was to compare the effects of a contraceptive pill on metabolic classic cardiovascular risk factors with those of the insulin sensitizer metformin.

Design: We conducted a randomized, parallel, open-label clinical trial.

Setting: The study was conducted at an academic hospital.

Patients: Thirty-four consecutive PCOS patients were studied.

Interventions: Patients were randomized to oral treatment with metformin (850 mg twice daily) or with the Diane³⁵ Diario pill (35 µg of ethinyl-estradiol plus 2 mg of cyproterone acetate) for 24 wk.

Main Outcome Measures: Hyperandrogenism, lipid profiles, and indexes of glucose tolerance and insulin sensitivity were measured at baseline and after 12 and 24 wk of treatment.

Results: Diane³⁵ Diario resulted in higher reductions in hirsutism score and serum androgen levels compared with metformin. Menstrual regularity was restored in all the patients treated with Diane³⁵ Diario compared with only 50% of those receiving metformin. Plasma apolipoprotein A-I and HDL-phospholipid levels increased with Diane³⁵ Diario, whereas metformin did not induce any change in the lipid profile. On the contrary, the insulin sensitivity index increased with metformin but did not change with Diane³⁵ Diario. No differences in the frequencies of abnormalities of glucose tolerance and dyslipidemia were found between both treatments.

Conclusions: Diane³⁵ Diario appears to be superior to metformin for the control of hyperandrogenism and for the restoration of menstrual regularity in PCOS patients, and it is not associated with any clinically relevant worsening in the classic metabolic cardiovascular risk profile of these women.

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