title: Drospirenone/ethinyl estradiol versus rosiglitazone treatment in overweight adolescents with polycystic ovary syndrome: comparison of metabolic, hormonal, and cardiovascular risk factors.
abstract: BACKGROUND
  Adolescents with polycystic ovary syndrome (PCOS) have insulin resistance and higher rates of the metabolic syndrome.
  
  
  OBJECTIVE
  Our objective was to compare the effects of 6 months treatment with drospirenone/ethinyl estradiol (EE) (3 mg/30 μg) vs. rosiglitazone (4 mg) daily on the hormonal and cardiometabolic profiles of overweight/obese adolescents with PCOS.
  
  
  METHODS
  We conducted a randomized, double-blinded, parallel clinical trial in an academic hospital, with n = 46 patients.
  
  
  METHODS
  The primary outcome measure was insulin sensitivity, hepatic with [6,6-(2)H(2)]glucose and peripheral with a 3-h hyperinsulinemic-euglycemic clamp. Other outcome measures included plasma androgen profile and response to ACTH stimulation, glucose and insulin response to oral glucose tolerance test, insulin secretion with a 2-h hyperglycemic clamp, fasting lipid profile, inflammatory markers, intima media thickness, aortic pulse wave velocity, body composition by dual-energy x-ray absorptiometry, and abdominal adiposity by computed tomography scan.
  
  
  RESULTS
  Drospirenone/EE resulted in greater reductions in androgenemia. Neither treatment led to change in weight or body mass index, but rosiglitazone led to a significant decrease in visceral adiposity. Compared with drospirenone/EE, treatment with rosiglitazone improved hepatic and peripheral insulin sensitivity and lowered fasting and stimulated insulin levels during the oral glucose tolerance test. Treatment with drospirenone/EE was associated with elevations in total cholesterol, high-sensitivity C-reactive protein and leptin concentrations, whereas treatment with rosiglitazone led to lower triglycerides and higher adiponectin concentrations. Neither treatment affected intima media thickness or pulse wave velocity.
  
  
  CONCLUSIONS
  In overweight/obese adolescents with PCOS, 6 months treatment with rosiglitazone was superior to drospirenone/EE in improving the cardiometabolic risk profile, and effective but inferior in attenuating hyperandrogenemia. Additional studies are needed to test insulin sensitizers in the treatment of the reproductive and cardiometabolic aspects of PCOS.
authors.affiliation: Division of Weight Management and Wellness, Children's Hospital of Pittsburgh, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania 15224, USA.
authors.forename: Hala
authors.initials: H
authors.lastname: Tfayli
authors.forename: Julia Warren
authors.initials: JW
authors.lastname: Ulnach
authors.forename: SoJung
authors.initials: S
authors.lastname: Lee
authors.forename: Kim
authors.initials: K
authors.lastname: Sutton-Tyrrell
authors.forename: Silva
authors.initials: S
authors.lastname: Arslanian
mesh_terms: D000293:Adolescent; D000324:Adrenocorticotropic Hormone; D000736:Androstenes / Q000627:therapeutic use*; D001823:Body Composition / Q000187:drug effects; D002318:Cardiovascular Diseases / Q000453:epidemiology / Q000517:prevention & control*; D004311:Double-Blind Method; D004997:Ethinyl Estradiol / Q000627:therapeutic use*; D005260:Female; D015309:Glucose Clamp Technique; D005951:Glucose Tolerance Test; D006439:Hemodynamics / Q000502:physiology; D006728:Hormones / Q000097:blood; D006801:Humans; D017588:Hyperandrogenism / Q000097:blood / Q000188:drug therapy; D007004:Hypoglycemic Agents / Q000627:therapeutic use*; D007333:Insulin Resistance / Q000502:physiology; D008597:Menstrual Cycle / Q000187:drug effects; D000451:Mineralocorticoid Receptor Antagonists / Q000627:therapeutic use*; D050177:Overweight / Q000150:complications / Q000188:drug therapy*; D011085:Polycystic Ovary Syndrome / Q000150:complications / Q000188:drug therapy* / Q000378:metabolism; D012307:Risk Factors; D000077154:Rosiglitazone; D013268:Stimulation, Chemical; D045162:Thiazolidinediones / Q000627:therapeutic use*
chemical_list: D000736:Androstenes; D006728:Hormones; D007004:Hypoglycemic Agents; D000451:Mineralocorticoid Receptor Antagonists; D045162:Thiazolidinediones; D000077154:Rosiglitazone; D004997:Ethinyl Estradiol; D000324:Adrenocorticotropic Hormone; C035144:drospirenone