Abstract
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. A randomized open-label study was conducted in women with PCOS who were randomized to either empagliflozin 25mg (n=19) or metformin 1500mg (n=20) daily for 12weeks. The main outcomes assessed were changes in anthropometric and body composition, hormonal and metabolic parameters. 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. There was a significant improvement in anthropometric parameters and body composition, in overweight and obese women with PCOS after 12weeks of treatment with empagliflozin compared to metformin, although no changes were seen in hormonal or metabolic parameters.
Highlights
Polycystic ovary syndrome (PCOS) is a heterogeneous endocrine disorder featured by hyperandrogenism, menstrual irregularities and polycystic ovaries that affects women of reproductive age.[1]
Its principal action involves inhibition of glucose reabsorption by the kidney and glucose excretion via urine. This action mechanism is insulin-independent; as such it does not increase the risk of hypoglycaemia, making it attractive for use in normoglycaemic individuals.[10], treatment with empagliflozin promotes weight loss,[12] exerts positive effects on arterial stiffness, vascular resistance and cardiovascular and all-cause mortality in patients with type 2 diabetes.[10], preclinical studies suggests that these cardio-protective effects may be due to the reduction in oxidative stress and suppressed markers of inflammation and fibrosis.[14], cardiovascular benefits may be mediated by reductions in HbA1c, insulin resistance, blood
Forty-two participants with PCOS were screened; two participants were excluded from participation because they did not meet inclusion criteria, as such 40 participants were randomised to the two treatment arms
Summary
Polycystic ovary syndrome (PCOS) is a heterogeneous endocrine disorder featured by hyperandrogenism, menstrual irregularities and polycystic ovaries that affects women of reproductive age.[1]. Its principal action involves inhibition of glucose reabsorption by the kidney and glucose excretion via urine This action mechanism is insulin-independent; as such it does not increase the risk of hypoglycaemia, making it attractive for use in normoglycaemic individuals.[10], treatment with empagliflozin promotes weight loss,[12] exerts positive effects on arterial stiffness, vascular resistance and cardiovascular and all-cause mortality in patients with type 2 diabetes.[10], preclinical studies suggests that these cardio-protective effects may be due to the reduction in oxidative stress and suppressed markers of inflammation and fibrosis.[14], cardiovascular benefits may be mediated by reductions in HbA1c, insulin resistance, blood
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