Dapagliflozin Plus Metformin Versus Metformin Alone in Overweight and Obese Patients with Polycystic Ovary Syndrome - An Open-Label, Parallel, Randomized Controlled Trial.

Abstract

Introduction: Insulin resistance plays the central role in the pathophysiology of polycystic ovary syndrome (PCOS). While metformin is widely used, its metabolic and androgen-lowering benefits are modest and often limited by tolerability, highlighting the need to evaluate newer therapeutic agents targeting insulin resistance in PCOS. Dapagliflozin complements metformin's effects through an insulin-independent mechanism of action and may be beneficial in improving metabolic outcomes in PCOS.

Methods: Women diagnosed with PCOS based on Rotterdam criteria were randomly allocated to receive either dapagliflozin (10 mg daily) plus metformin (2000 mg/day) or metformin (2000 mg/day) alone, over a 12-week period.

Results: At 12 weeks, there were no statistically significant differences between the dapagliflozin plus metformin group and the metformin alone group in improving insulin resistance or biochemical hyperandrogenism. While within-group changes were statistically significant, the differences between the two arms did not achieve statistical significance. Mild adverse effects, including urinary tract infections and vaginal irritation, were reported more in the dapagliflozin plus metformin group than the metformin alone group.

Conclusion: In overweight and obese women with PCOS, the addition of dapagliflozin to metformin did not result in significant improvement in insulin resistance or hyperandrogenaemia over metformin alone and was associated with a higher rate of adverse effects. Larger and longer-term trials are needed to fully clarify their role in routine clinical care.