Safety profile of Sodium Glucose Co-transporter-2 (SGLT-2) inhibitors in patients with Compensated Cirrhosis and Diabetes

Background and Aim: Diabetes in patients with cirrhosis is common occurrence. Available oral hypoglycaemic agents are hepatotoxic in patients with advanced liver disease. SGLT-2 inhibitors are newer class of oral hypoglycaemic drugs with pleiotropic effects. Its safety and efficacy has not been evaluated in patients with advanced cirrhosis and diabetes. We evaluated safety of SGLT-2 inhibitors in patients with cirrhosis and diabetes. Methods: Consecutive patients with cirrhosis and diabetes who were on SGLT-2 inhibitors were enrolled and followed every month for six months. Their clinical and biochemical parameters which includes liver and kidney function tests, urine test, glycosylated haemoglobin (HbA1c), Transient elastography (fibroscan), mean arterial pressure (MAP) and weight loss of >5 kg since treatment initiation were noted. Any relevant side effects (urinary and genital infection, hypotension) were noted. Results: Twenty patients (M:F-13:7), age (55±11year) with mean CTP score (6±1.3), etiology of cirrhosis (NASH related 17, HBV, n=1 and HCV, n=2) and MAP (92±5 mmHg) were enrolled. Five patients had hypertension and were on treatment with ACE inhibitors and 15 patients were also on carvidelol for primary prophylaxis of variceal bleed. Mean Fibroscan was (37±11kPa), large varices (n=3), small varices (n=16) and no varices were seen in one patient. Median duration of SGLT-2 inhibitors were 11 months (range 6-28 mo). Patients were on dapagliflogin (n=11, 55%), empagliflogin (n=6, 30%) and remogliflogin (n=3,15%). Twelve (60%) patients were taking metformin and 7(35%) were on DPP4 inhibitors also. There was no significant difference in mean bilirubin, ALT, HbA1c, MAP and fibroscan at baseline and at 6 months. Urinary tract infection occurred in n=3(15%), genital infection (n=2, 10%), frothy urine (n=4,20%) and weight loss of more than 5 kg from initiation of SGLT-2 inhibitors was seen in (n=8. 40%) of patients. Conclusion: SGLT-2 inhibitors can be used as oral hypogycemic agent in patients with compensated cirrhosis with diabetes.