title: The effects of 2 mg chlormadinone acetate/30 mcg ethinylestradiol, alone or combined with spironolactone, on cardiovascular risk markers in women with polycystic ovary syndrome.
abstract: BACKGROUND
  Polycystic ovary syndrome (PCOS) is an endocrine disorder associated with metabolic dysfunction and changes in cardiovascular risk markers, and using oral contraceptives (OCs) may exert a further negative effect on these alterations in patients with PCOS. Thus, the primary objective of this study was to assess the effects on arterial function and structure of an OC containing chlormadinone acetate (2 mg) and ethinylestradiol (30 mcg), alone or combined with spironolactone (OC+SPL), in patients with PCOS.
  
  
  METHODS
  This was a randomized, controlled clinical trial. Fifty women with PCOS between 18 and 35 years of age were randomized by a computer program to use OC or OC+SPL. Brachial artery flow-mediated vasodilation, carotid intima-media thickness and the carotid artery stiffness index were evaluated at baseline and after 6 and 12 months. Serum markers for cardiovascular disease were also analyzed. The intragroup data were analyzed using analysis of variance with Tukey's post hoc test. A multivariate linear regression model was used to analyze the intergroup data.
  
  
  RESULTS
  At 12 months, the increase in mean total cholesterol levels was greater in the OC+SPL group than in the OC group (27% vs. 13%, respectively; p=.02). The increase in mean sex hormone-binding globulin levels was greater in the OC group than in the OC+SPL group (424% vs. 364%, respectively; p=.01). No statistically significant differences between the groups were found for any of the other variables.
  
  
  CONCLUSIONS
  The addition of spironolactone to an OC containing chlormadinone acetate and ethinylestradiol conferred no cardiovascular risk-marker advantages in young women with PCOS.
authors.affiliation: Department of Gynecology and Obstetrics, Medical School of Ribeirão Preto, University of São Paulo, Brazil, Avenida Bandeirantes, 3900 - Campus Universitário, Monte Alegre, Ribeirão Preto, SP, CEP-14049-900, Brazil. carol.sales@uol.com.br
authors.forename: Carolina Sales
authors.initials: CS
authors.lastname: Vieira
authors.forename: Wellington P
authors.initials: WP
authors.lastname: Martins
authors.forename: Janaína Boldrini França
authors.initials: JB
authors.lastname: Fernandes
authors.forename: Gustavo Mafaldo
authors.initials: GM
authors.lastname: Soares
authors.forename: Rosana Maria
authors.initials: RM
authors.lastname: dos Reis
authors.forename: Marcos Felipe Silva
authors.initials: MF
authors.lastname: de Sá
authors.forename: Rui Alberto
authors.initials: RA
authors.lastname: Ferriani
mesh_terms: D000328:Adult; D001786:Blood Glucose; D015992:Body Mass Index; D002097:C-Reactive Protein / Q000032:analysis; D002318:Cardiovascular Diseases / Q000097:blood / Q000503:physiopathology*; D002339:Carotid Arteries / Q000000981:diagnostic imaging; D059168:Carotid Intima-Media Thickness; D002715:Chlormadinone Acetate / Q000031:analogs & derivatives* / Q000627:therapeutic use; D008076:Cholesterol, HDL / Q000097:blood; D008078:Cholesterol, LDL / Q000097:blood; D003277:Contraceptives, Oral, Combined / Q000627:therapeutic use*; D004359:Drug Therapy, Combination; D004997:Ethinyl Estradiol / Q000031:analogs & derivatives* / Q000627:therapeutic use; D005260:Female; D006801:Humans; D007328:Insulin / Q000097:blood; D000451:Mineralocorticoid Receptor Antagonists / Q000627:therapeutic use*; D011085:Polycystic Ovary Syndrome / Q000097:blood / Q000188:drug therapy* / Q000503:physiopathology; D012307:Risk Factors; D012738:Sex Hormone-Binding Globulin / Q000032:analysis; D013148:Spironolactone / Q000627:therapeutic use*; D013739:Testosterone / Q000097:blood; D014280:Triglycerides / Q000032:analysis; D014664:Vasodilation
chemical_list: D001786:Blood Glucose; D008076:Cholesterol, HDL; D008078:Cholesterol, LDL; D003277:Contraceptives, Oral, Combined; D007328:Insulin; D000451:Mineralocorticoid Receptor Antagonists; D012738:Sex Hormone-Binding Globulin; D014280:Triglycerides; C488302:ethinylestradiol-chlormadinone acetate; D002715:Chlormadinone Acetate; D013148:Spironolactone; D013739:Testosterone; D004997:Ethinyl Estradiol; D002097:C-Reactive Protein