This study evaluated the efficacy and safety of adding Actos (pioglitazone) to metformin treatment in women with polycystic ovary syndrome (PCOS) who did not respond optimally to metformin alone. The study found that in women whose PCOS symptoms were not improved by metformin, the addition of Actos led to reductions in insulin levels, insulin resistance, and androgen levels, as well as improved menstrual regularity, without any safety issues.

1. Actos and Metformin in women with Polycystic Ovary Syndrome not optimally responsive to Metformin Glueck CJ, Goldenberg NM, Wang P, Sieve L

9. 13 non-Responders on Met for 12 months vs on Met+ Actos for 10 months P=.15 P=.34 P=.24 P=.0005 P=.47 P=.0046 P=.15 P=.0034 P=.033 P=.0007

11. Menstrual Status on Actos-metformin By paired comparison with metformin alone, 67% vs 46% of expected menses occurred at 3 months (p = .09), 77% vs 38% at 6 months (p = .004), 73% vs 27% at 9 months (p= .016)

12. Percent of menses occurring in women with PCOS P=.094 .0039 . 016 Responders better over 12 months p=0.0002 Non-responders improved over 9 months P=.016

13. SAFETY (Actos-Metformin): No change in liver function tests. No edema. No hypoglycemia