title: Effects of drospirenone-ethinylestradiol and/or metformin on CD4(+)CD28(null) T lymphocytes frequency in women with hyperinsulinemia having polycystic ovary syndrome: a randomized clinical trial.
abstract: OBJECTIVE
  To evaluate the long-term effects of drospirenone (DRSP)/ethinylestradiol (EE) alone, metformin alone, and DRSP/EE-metformin on CD4(+)CD28(null) T lymphocytes frequency, a cardiovascular risk marker, in patients with hyperinsulinemic polycystic ovary syndrome (PCOS).
  
  
  METHODS
  Randomized clinical trial.
  
  
  METHODS
  Ninety three patients with hyperinsulinemic PCOS were age matched and body mass index matched and randomized to receive a 6 months daily treatment with DRSP (3 mg)/EE (0.03 mg), or metformin (1500 mg), or DRSP/EE combined with metformin.
  
  
  METHODS
  CD4(+)CD28(null) T-cell frequencies.
  
  
  RESULTS
  The DRSP/EE and metformin groups did not show any significant change in the CD4(+)CD28(null) frequency compared to the baseline. Interestingly, a statistically significant decrease in CD4(+)CD28(null) frequency occurred after 6 months of DRSP/EE-metformin (median 3-1.5; P < .01). Of note, this statistically significant association was confirmed after adjusting for baseline values in DRSP/EE-metformin group by analysis of covariance (P < .05).
  
  
  CONCLUSIONS
  In women with hyperinsulinemic PCOS, combined therapy with DRSP/EE and metformin may reduce cardiovascular risk.
authors.affiliation: 1Institute of Obstetrics and Gynaecology, Università Cattolica del Sacro Cuore, Rome, Italy.
authors.forename: Francesca
authors.initials: F
authors.lastname: Moro
authors.forename: Andrea
authors.initials: A
authors.lastname: Morciano
authors.forename: Anna
authors.initials: A
authors.lastname: Tropea
authors.forename: Francesca
authors.initials: F
authors.lastname: Sagnella
authors.forename: Carola
authors.initials: C
authors.lastname: Palla
authors.forename: Elisa
authors.initials: E
authors.lastname: Scarinci
authors.forename: Andrea
authors.initials: A
authors.lastname: Ciardulli
authors.forename: Daniela
authors.initials: D
authors.lastname: Martinez
authors.forename: Alessandra
authors.initials: A
authors.lastname: Familiari
authors.forename: Giovanna
authors.initials: G
authors.lastname: Liuzzo
authors.forename: Alessandra
authors.initials: A
authors.lastname: Tritarelli
authors.forename: Nicola
authors.initials: N
authors.lastname: Cosentino
authors.forename: Giampaolo
authors.initials: G
authors.lastname: Niccoli
authors.forename: Filippo
authors.initials: F
authors.lastname: Crea
authors.forename: Antonio
authors.initials: A
authors.lastname: Lanzone
authors.forename: Rosanna
authors.initials: R
authors.lastname: Apa
mesh_terms: D000293:Adolescent; D000328:Adult; D000704:Analysis of Variance; D000736:Androstenes / Q000627:therapeutic use*; D018106:CD28 Antigens / Q000172:deficiency*; D018791:CD4 Lymphocyte Count; D015496:CD4-Positive T-Lymphocytes / Q000187:drug effects* / Q000276:immunology; D002318:Cardiovascular Diseases / Q000209:etiology / Q000517:prevention & control; D016009:Chi-Square Distribution; D004997:Ethinyl Estradiol / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D006946:Hyperinsulinism / Q000097:blood / Q000150:complications / Q000175:diagnosis / Q000188:drug therapy* / Q000276:immunology; D007004:Hypoglycemic Agents / Q000627:therapeutic use*; D008687:Metformin / Q000627:therapeutic use*; D011085:Polycystic Ovary Syndrome / Q000097:blood / Q000150:complications / Q000175:diagnosis / Q000188:drug therapy* / Q000276:immunology; D012102:Reproductive Control Agents / Q000627:therapeutic use*; D012307:Risk Factors; D012384:Rome; D013997:Time Factors; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000736:Androstenes; D018106:CD28 Antigens; D007004:Hypoglycemic Agents; D012102:Reproductive Control Agents; C534342:drospirenone and ethinyl estradiol combination; D004997:Ethinyl Estradiol; D008687:Metformin
keywords: CD4+CD28null T-lymphocytes; drospirenone; ethinylestradiol; metformin; polycystic ovary syndrome