Efficacy and safety of metformin in over weight and obese patients with polycystic ovary syndrome

ABSTRACT

To evaluate the efficacy and safety of metformin in overweight and obese women with polycystic ovary syndrome. Forty-four overweight and obese female patients with diagnosed polycystic ovary syndrome were evaluated in an open label study. Patients were assigned metformin SOOmg thrice daily for six months. The primary outcomes were to assess change in the fasting serum insulin level, fasting plasma glucose, insulin sensitivity, weight, BMI, Waist to hip ratio and ultrasonographic features of overweight and obese women. The secondary outcomes were systolic and diastolic blood pressure, menstrual cyclicity and hirsutism. The safety of intervention was assessed by recording the self-reported adverse effects and performing renal and hepatic profiles. The patients were evaluated at monthly intervals. Forty subjects [90.9%] completed the study. At the end of six months, there was a significant effect of the drug on all the clinical parameters. Weight decreased from 85.71 +/- 1.04 to 84.38 +/- 1.02, BMI from 33.2 +/- 0.32 to 32.8 +/- 0.33[p <0.05] and Waist to hip ratio from 0.85 +/- 0.003 to 0.83 +/- 0.002.Ultrasonographic features, systolic and diastolic blood pressure also showed statistically significant improvement. Menstrual cyclicity, hirsutism, and metabolic parameters [serum fasting insulin level, fasting plasma glucose, HOMA index] also showed statistically significant improvement. The drug was well tolerated by the patients. No change was observed in blood urea, ALT and serum creatinine levels. Metformin is a safe and effective drug for the treatment of obese and over weight, women with PCOS