Effects of empagliflozin on metabolic parameters in polycystic ovary syndrome: A randomized controlled study

Abstract

Summary Background Empagliflozin is a sodium‐glucose‐cotransporter‐2 inhibitor that improves cardiovascular risk and promotes weight loss in patients with type‐2 diabetes. Polycystic ovary syndrome (PCOS) is associated with obesity and increased cardiovascular risk; therefore, empagliflozin may be of benefit for these women. The aim of this study was to compare the effects of empagliflozin vs metformin on anthropometric and body composition, hormonal and metabolic parameters in women with PCOS. Materials and methods A randomized open‐label study was conducted in women with PCOS who were randomized to either empagliflozin 25 mg (n = 19) or metformin 1500 mg (n = 20) daily for 12 weeks. The main outcomes assessed were changes in anthropometric and body composition, hormonal and metabolic parameters. Results Univariate analysis showed significant differences in weight (empagliflozin: −1.4 ± 3.2% vs metformin: 1.2 ± 2.3%; P = 0.006), body mass index (empagliflozin: −1.4 ± 3.2% vs metformin: 1.1 ± 2.2%; P = 0.006), waist circumference (empagliflozin: −1.6 ± 2.8% vs metformin: 0.2 ± 2.1%; P = 0.029) and hip circumference (empagliflozin: −2.0 ± 3.0% vs metformin: 1.1 ± 1.9%; P = 0.001), basal metabolic rate (empagliflozin: −1.8 ± 2.9% vs metformin: 0.1 ± 1.9%, P = 0.024) and fat mass (empagliflozin: −0.7 ± 4.9% vs metformin, 3.2 ± 5.0%; P = 0.023) between the empagliflozin and the metformin groups. These differences were confirmed in linear regression analysis after adjustment for relevant covariates. There were no significant changes in hormonal or metabolic parameters between both groups. Conclusion There was a significant improvement in anthropometric parameters and body composition, in overweight and obese women with PCOS after 12 weeks of treatment with empagliflozin compared to metformin, although no changes were seen in hormonal or metabolic parameters.

The effects of empagliflozin vs metformin on endothelial microparticles in overweight/obese women with polycystic ovary syndrome

“…The baseline anthropometric characteristics, hormonal and metabolic profile of the participants in the empagliflozin (n = 19, age: 26.0 (8.0) years, BMI: 37.1 ± 6.2 kg/m 2 ) and the metformin (n = 20, age: 31.5 (9.0) years, BMI: 38.7 ± 7.8 kg/m 2 ) groups have been presented previously (29).…”

“…SGLT-2 inhibitors have been demonstrated to reduce weight, improve arterial stiffness and vascular resistance and decrease the relative risk for cardiovascular and all-cause mortality in patients with type 2 diabetes (27,28). In the first study comparing the effects of empagliflozin and metformin in overweight/obese women with PCOS, we demonstrated that empagliflozin treatment over 12 weeks resulted in significant improvements in anthropometric parameters and body composition, without overt changes in hormonal or metabolic parameters (29).…”

“…Blood samples were collected at these time points and analysed for EMPs. Additional biochemical analyses included measurement of reproductive hormones and cardio-metabolic parameters (fasting glucose, fasting insulin, HOMA-IR, total cholesterol, LDL-C, HDL-C, triglycerides (TG) and hs-CRP): these results have been presented in our previous work (29).…”

“…The aim of this analysis was to explore and compare the effects of empagliflozin and metformin on a panel of EMPs bearing proteins with established roles in endothelial injury (13) in overweight/obese women with PCOS. Given that empagliflozin and metformin have been shown to exert positive effects on cardiovascular risk factors (27,28,30,31,32), with these effects potentially mediated by amelioration in inflammation and endothelial injury (30,31,32,33,3,35,36), we hypothesised that both treatments would result in reductions in EMP levels Inclusion/exclusion criteria and study procedures have been explained in detail (29). In brief, all women aged between 18 and 45 years, had a BMI ≥25 kg/m 2 and were diagnosed with PCOS according to the Rotterdam criteria (37).…”

Das polyzystische Ovarsyndrom: Aktuelle Evidenz und praktische Empfehlungen

“…Der Effekt von Antidiabetika wie Liraglutid und Empagliflozin ist Gegenstand von Studien. Diese weisen vereinzelt positive Daten zur Reduktion von Gewicht, Hyperandrogenämie, Anovulation und zur Schwangerschaftsrate unter IVF auf [16][17][18][19][20]. Der Einsatz ist derzeit als experimentell zu betrachten und für die Patientinnen auch im Rahmen der Indikation der Lifestyle-Medikation oder eines Off-Label-Use kostenintensiv.…”