Comparison of ethinyl-estradiol plus cyproterone acetate versus metformin effects on classic metabolic cardiovascular risk factors in women with the polycystic ovary syndrome.
BACKGROUND
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.


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


METHODS
The study was conducted at an academic hospital.


METHODS
Thirty-four consecutive PCOS patients were studied.


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


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


RESULTS
Diane(35) 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 Diane(35) Diario compared with only 50% of those receiving metformin. Plasma apolipoprotein A-I and HDL-phospholipid levels increased with Diane(35) 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 Diane(35) Diario. No differences in the frequencies of abnormalities of glucose tolerance and dyslipidemia were found between both treatments.


CONCLUSIONS
Diane(35) 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.
Luque-Ramírez
Manuel
M
Department of Endocrinology, Hospital Universitario Ramón y Cajal and Universidad de Alcalá, Carretera de Colmenar Viejo Km 9,1. 28034 Madrid, Spain.
Alvarez-Blasco
Francisco
F
Botella-Carretero
José I
JI
Martínez-Bermejo
Elena
E
Lasunción
Miguel A
MA
Escobar-Morreale
Héctor F
HF
D000284:Administration, Oral; D000328:Adult; D000726:Androgen Antagonists / Q000008:administration & dosage; D000728:Androgens / Q000097:blood; D001786:Blood Glucose / Q000378:metabolism; D002318:Cardiovascular Diseases / Q000097:blood / Q000453:epidemiology*; D017373:Cyproterone Acetate / Q000008:administration & dosage*; D004338:Drug Combinations; D050171:Dyslipidemias / Q000097:blood / Q000453:epidemiology; D004997:Ethinyl Estradiol / Q000008:administration & dosage*; D005260:Female; D006801:Humans; D007004:Hypoglycemic Agents / Q000008:administration & dosage*; D007333:Insulin Resistance; D008055:Lipids / Q000097:blood; D008687:Metformin / Q000008:administration & dosage*; D011085:Polycystic Ovary Syndrome / Q000097:blood / Q000188:drug therapy* / Q000453:epidemiology*; D012307:Risk Factors
D000726:Androgen Antagonists; D000728:Androgens; D001786:Blood Glucose; D004338:Drug Combinations; D007004:Hypoglycemic Agents; D008055:Lipids; D004997:Ethinyl Estradiol; D017373:Cyproterone Acetate; C032640:Cyproterone acetate, ethinyl estradiol drug combination; D008687:Metformin