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Submitted on February 7, 2007
Accepted on March 30, 2007
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 & Universidad de Alcalá, Madrid, Spain and CIBER Fisiología Obesidad y Nutrición (CB06/03), Instituto de Salud Carlos III (M.A.L.)
* To whom correspondence should be addressed. 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. To compare the effects on metabolic classic cardiovascular risk factors of a contraceptive pill with those of the insulin sensitizer metformin.
Design. Randomized, parallel, open-label clinical trial.
Setting. Academic Hospital.
Patients. Thirty-four consecutive PCOS patients.
Interventions. Patients were randomized to oral treatment with metformin (850 mg twice daily) or with the Diane35 Diario (35µg of ethinyl-estradiol plus 2 mg of cyproterone acetate) pill for 24 weeks.
Main outcome measures. Hyperandrogenism, lipid profiles, and indexes of glucose tolerance and insulin sensitivity at baseline and after 12 and 24 weeks 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 Apo A-I and HDL-phospholipids 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 is not associated with any clinically relevant worsening in the classic metabolic cardiovascular risk profile of these women.
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