None listed
Conditions
Brief summary
Empagliflozin is a sodium glucose transporter-2 (SGLT2) inhibitor drug, a class of diabetic medication. Interestingly, there is survival benefit in patients with heart failure. There are similarities between heart failure and the complications of severe liver disease, termed cirrhosis. As a result, it has been suggested that the SGLT2 inhibitors, may be of benefit in managing cirrhosis. While safe in liver disease in single dose studies, there is no long-term safety data in patients with cirrhosis. The aim of the study is to assess the safety of empagliflozin in three different groups (n=5) of increasing degrees of severity of cirrhosis and healthy controls (n=8). If this small pilot study demonstrates empagliflozin to be safe, then we will be able to do a larger study to assess the benefit of this medication in cirrhosis. This would be a significant advance in the treatment of cirrhosis.
Interventions
To determine the safety of empagliflozin in cirrhosis with and without diabetes, an oral dose of empagliflozin 10 mg oral tablet daily will be given for a four week period to three groups of participants:
1. Cirrhosis compensated (Childs-Pugh A) n=5
2. Cirrhosis decompensated (Childs-Pugh B n=5
3. Cirrhosis decompensated (Childs-Pugh C) n=5
Each participant will undergo: Clinical Assessment; Tablet return to assess medication compliance, Monitoring of safety, clinical, empagliflozin concentrati
To determine the safety of empagliflozin in cirrhosis with and without diabetes, an oral dose of empagliflozin 10 mg oral tablet daily will be given for a four week period to three groups of participants: 1. Cirrhosis compensated (Childs-Pugh A) n=5 2. Cirrhosis decompensated (Childs-Pugh B n=5 3. Cirrhosis decompensated (Childs-Pugh C) n=5 Each participant will undergo: Clinical Assessment; Tablet return to assess medication compliance, Monitoring of safety, clinical, empagliflozin concentrations, renal, diabetic, liver parameters, renin-angiotensin levels, microbiome parameters and QOL.
Sponsors
St Vincent's Hospital, Sydney
Study design
Allocation
Non-randomised trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
Inclusion Criteria for liver disease: • Age: 18 years or older, AND; • Provision of written, informed consent, AND; • Known or evident liver cirrhosis. Diagnosis of liver cirrhosis may be based on clinical, radiological, and or histological criteria, including 1 or more of the following: a) Previous histologic diagnosis on liver biopsy; or b) Clinical evidence of cirrhosis, defined as aspartate aminotransferase > alanine aminotransferase (i.e., AST > ALT), platelet count < 150,000, and nodular liver surface on computed tomography (CT) scan or magnetic resonance imaging (MRI); or c) Clinical evidence of significant portal hypertension, based on current or history of gastroesophageal varices on endoscopy, evidence of portosystemic collaterals (on contrast CT or MRI with contrast), and/or presence of ascites; or d) Transient elastography consistent with cirrhosis, i.e., result of > 13.0 kPa.
Exclusion criteria
• Patients with kidney disease (creatinine clearance < 30 ml/min) OR; • Women lactating, pregnant or of childbearing potential and unwilling to avoid becoming pregnant during the study, OR; • Patients with a history of a psychological illness or condition such as to interfere with the patient's ability to understand the requirements of the study, OR; • Significant cardiac failure with left ventricular ejection fraction <30%, OR; • Gastrointestinal surgery that would interfere with medication absorption.
Outcome results
None listed