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

Francesca Moro, Andrea Morciano, Anna Tropea, Francesca Sagnella, Carola Palla, Elisa Scarinci, Andrea Ciardulli, Daniela Martinez, Alessandra Familiari, Giovanna Liuzzo, Alessandra Tritarelli, Nicola Cosentino, Giampaolo Niccoli, Filippo Crea, Antonio Lanzone, Rosanna Apa

Research output: Contribution to journalArticle

Abstract

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 CD 4+CD28null 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.

Original languageEnglish
Pages (from-to)1508-1517
Number of pages10
JournalReproductive Sciences
Volume20
Issue number12
DOIs
Publication statusPublished - Dec 2013

Keywords

  • CD4CD28 T-lymphocytes
  • drospirenone
  • ethinylestradiol
  • metformin
  • polycystic ovary syndrome

ASJC Scopus subject areas

  • Obstetrics and Gynaecology

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    Moro, F., Morciano, A., Tropea, A., Sagnella, F., Palla, C., Scarinci, E., Ciardulli, A., Martinez, D., Familiari, A., Liuzzo, G., Tritarelli, A., Cosentino, N., Niccoli, G., Crea, F., Lanzone, A., & Apa, R. (2013). 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. Reproductive Sciences, 20(12), 1508-1517. https://doi.org/10.1177/1933719113488444