Comparative effects of empagliflozin and metformin on metabolic dysfunction in polycystic ovary syndrome, a double blinded randomized control feasibility trial.
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OBJECTIVES: To determine the safety and efficacy of empagliflozin compared with those of metformin in polycystic ovary syndrome (PCOS) patients with insulin resistance (IR). METHOD: A single-center, prospective, double-blind randomized (1:1 ratio) noninferiority trial was conducted at the primary healthcare organization in slums between December 2023 and June 2024. Women aged 18-45 years with PCOS were enrolled and randomly assigned to either 10 mg (n = 41) empagliflozin daily or metformin 500 mg twice a day (n = 39) for 24 weeks. The primary outcome was changes in metabolic parameters and weight after 24 weeks of treatment. STATA software version 17 was used for statistical analysis, independent t tests were used for continuous variables, and Welch's correction was applied when variances were unequal. Categorical variables were compared via Fischer exact tests or chi-square (X2) tests. To address the significant loss to follow-up among participants and minimize bias, a mixed-model repeated-measures analysis was conducted to compare the effects of Drug A and Drug B over the 24-week treatment period. RESULT: Comparing the outcomes before and after treatment on the basis of the mean differences (MDs) revealed significant changes in various outcomes for both Drug A (Metformin) and Drug B (Empagliflozin). For weight, the MDs were 0.9 ± 1.4 kg for Drug A and 6.7 ± 1.6 kg for Drug B. In terms of lipid profiles, total cholesterol decreased by 18.3 ± 4.7 mg/dL in the Drug A group and by 34.9 ± 3.7 mg/dL in the Drug B group. Additionally, HDL cholesterol levels increased by 17.0 ± 3.2 mg/dL for Drug A and 25.2 ± 2.0 mg/dL for Drug B. Similarly, LDL cholesterol reductions were 22.4 ± 5.6 mg/dL for Drug A and 31.1 ± 4.9 mg/dL for Drug B. Triglycerides also decreased, with reductions of 46.2 ± 11.4 mg/dL in the Drug A group and 72.8 ± 7.0 mg/dL in the Drug B group. For fasting blood sugar (FBS), the MD was 28 ± 4.0 mg/dL for Drug A and 26.4 ± 3.6 mg/dL for Drug B. Finally, the HbA1c level was 0.4 ± 0.07% for Drug A and 0.9 ± 0.2% for Drug B. CONCLUSION: This study suggested that empagliflozin may offer greater metabolic benefits than metformin in overweight women with PCOS and prediabetes, although the adjusted results were not significantly different. These findings support the potential of SGLT2 inhibitors as alternative or add-on therapies. TRIAL REGISTRATION: The clinical trial registration number was NCT06140108 in https://register. CLINICALTRIALS: gov/ registration date 11th of November 2023. Recruitment of the participants started at 15th of November 2023 and trial started in December 2023 and ended in June 2024.