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

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). 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 + 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.