Effects of Drospirenone–Ethinylestradiol and/or Metformin on CD4+CD28null T Lymphocytes Frequency in Women With Hyperinsulinemia Having Polycystic Ovary Syndrome: A Randomized Clinical Trial

Objective:To evaluate the long-term effects of drospirenone (DRSP)/ethinylestradiol (EE) alone, metformin alone, and DRSP/EE-metformin on CD4+CD28null T lymphocytes frequency, a cardiovascular risk marker, in patients with hyperinsulinemic polycystic ovary syndrome (PCOS).Design:Randomized clinical trial.Interventions: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.Main Outcome Measures:CD4+CD28null T-cell frequencies.Results:The DRSP/EE and metformin groups did not show any significant change in the CD4+CD28null frequency compared to the baseline. Interestingly, a statistically significant decrease in CD4+CD28null 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...