Sodium-glucose cotransporter-2 inhibitors in patients with type 2 diabetes in North India: A 12-month prospective study in real-world setting

Abstract

Objective: Sodium-glucose cotransporter-2 (SGLT2) inhibitors are increasingly being used in India. However, there is paucity of real-world clinical data of SGLT2 inhibitors. We aim to provide real-world experience regarding efficacy and safety of these drugs in Asian Indian patients with type 2 diabetes mellitus. Methodology: We enrolled patients with type 2 diabetes mellitus who were given SGLT2 inhibitors on top of other antidiabetes medication. After initial work up, patients were followed up to 12 months. Measurements included weight, body mass index, blood pressure, HbA1C, fasting and postprandial blood glucose, lipids, urinary microalbumin, etc. Results: Out of 1297 patients; 310 patients completed 12-month follow-up. Mean difference followed by percentage reduction of various parameters at 12 months was as follows; weight reduction (kg), −3.45 (95% CI, −2.9-−4.0), 4.5; body mass index, (kg/m2), −1.26 (95% CI, −1.0-−1.5), 4.4; HbA1c (%), −1.8 (95% CI, −0.2-−3.40), 19; fasting blood glucose (mg/dL), −35.7 (95% CI, −27.2-−44.1), 25.3; postprandial blood glucose (mg/dL), −54.7 (95% CI, −39.8-−69.7), 25.3; systolic blood pressure (mm Hg), −8.25 (95% CI, −5.8-−10.7), 5.2; diastolic blood pressure (mm Hg), −2.33 (95% CI, −1.0-−3.6), 1.1; and serum triglycerides (mg/dL), −25.77 (95% CI, −9.1-−42.5), 10.5. Of note, 41.9% and 10.6% of patients showed more than 5 and 10% decrease in body weight, respectively. Adverse drug reactions were seen in 22.8% patients and 41 (3.2%) patients stopped SGLT2 inhibitors because of various reasons. Importantly, five patients had severe urinary tract infection, one patient developed acute kidney injury because of rapid rise in creatinine, three developed slow rise in creatinine and one patient developed acute pyelonephritis. Ketosis was seen in 10 patients of whom one developed severe ketoacidosis. We did not record severe hypoglycaemia, lower extremity amputation, stroke, or bone fractures in this cohort.