Abstract
SGLT-2 inhibitors are shown to be nephroprotective, slowing progression of nonalcoholic steatohepatitis (NASH) in addition to improving glycemic control in patients with type 2 diabetes (T2D). To date, no real-life clinical data is available on the effect of SGLT-2 inhibitors on urine albumin-creatinine ratio (ACR) and liver enzymes in a Middle Eastern population. Therefore, we evaluated the effect of dapagliflozin (DAPA) on urine ACR, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) when added to standard therapy for T2D. This is an observational study of 40 patients with T2D in whom DAPA was added to their existing anti-diabetic regimen to improve glycemic control. The primary outcomes were changes in serum transaminase level and urine albumin-to-creatinine ratio (ACR). Secondary outcomes include changes in glycosylated hemoglobin (HbA1C), body mass index (BMI), oral hypoglycemic agents and insulin dose. Whole group analysis showed a reduction in ALT (p<0.0001), (AST) (p=0.009), ACR (p=0.009) and BMI (p<0.0001) following DAPA treatment. Further sub-group analysis showed that patients on insulin and DAPA combination had a reduction in ACR (p=0.0090), ALT (p=0.0312), BMI (p=0.0007) and HbA1c (p<0.0001) compared to the sulfonylurea and DAPA combination group. In the sulfonylurea and DAPA combination group, there was a reduction in the sulfonylurea requirement following DAPA therapy (p=0.0116), with reductions in ALT (p=0.0122), AST (p=0.0362), BMI (p=0.0026) and HbA1c (p<0.0001) but with no change in ACR (p=0.814). In routine clinical practice, the addition of DAPA to standard medical therapy is well tolerated and beneficial for T2D patients and is associated with a reduction of ALT and ACR.
Highlights
Sodium-glucose co-transporter 2 (SGLT-2) inhibitors are shown to be nephroprotective, slowing progression of nonalcoholic steatohepatitis (NASH) in addition to improving glycemic control in patients with type 2 diabetes (T2D)
In the United Kingdom Prospective Diabetes Study (UKPDS), poor glycemic control in patients with T2D was associated with an increased risk of diabetes complications and, with each percentage drop in HbA1c, there was a 14% risk reduction in myocardial infarction [2]
Diabetes is the leading cause for end stage renal disease (ESRD) and microalbuminuria is recognized as an independent risk factor for cardiovascular disease in patients with T2D [3]
Summary
SGLT-2 inhibitors are shown to be nephroprotective, slowing progression of nonalcoholic steatohepatitis (NASH) in addition to improving glycemic control in patients with type 2 diabetes (T2D). The relationship between diabetes and heart disease is well recognized and, as reported in the Framingham heart study, there is a ~2-3 fold increased risk of arteriosclerosis in patients with type 2 diabetes (T2D) [1]. Diabetes is the leading cause for end stage renal disease (ESRD) and microalbuminuria is recognized as an independent risk factor for cardiovascular disease in patients with T2D [3]. As diabetic nephropathy progresses from the normoalbuminuric stage to ESRD, the annual death rate due to cardiovascular disease increases [4]. The prevalence of NAFLD in T2D is 2-fold higher than in non-diabetic patients; the risk of developing T2D increases by 5-fold in patients with NAFLD [5, 6]. Various molecular and metabolic changes which occur in a genetically predisposed individual contribute to the pathogenesis of NAFLD; based on euglycemic clamp studies, the pathogenesis of NAFLD, and its association with insulin resistance and hyperinsulinemia, indicates that it is a feature of metabolic syndrome [8]
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