To Compare the Efficacy and Safety of Carvedilol With or Without Simvastatin in Patients With Portal Hypertension and Esophageal Varices.
Cirrhosis With Esophageal Varices
About this trial
This is an interventional treatment trial for Cirrhosis With Esophageal Varices
Eligibility Criteria
Inclusion Criteria:
- All patients of chronic liver disease with esophageal varices.
- Age more than and equal to 18 years.
Exclusion Criteria:
- Patients of chronic liver disease with history of upper Gastro Intestinal bleed.
- Patients of acute on chronic liver failure
- Thrombosis of splenoportal axis
- Hepatocellular carcinoma
- Patients who were on primary variceal ligation sessions as prophylaxis
- Patients who are beta blocker intolerant (Prior h/o hypotension, bradycardia).
- Patients who are contraindicated for beta blockers {H/O COPD (Coronary Obstructive Pulmonary Disease), heart block, refractory Ascites, SBP(Spontaneous Bacterial Peritonitis) , HRS(Hepato Renal Syndrome)}.
- Failure to give consent for inclusion in the study
Sites / Locations
- Institute of Liver and Biliary Sciences
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Carvedilol + Simvastatin
Carvedilol
Carvedilol will be administered orally at a start dose of 3.125 mg twice daily per day. After 1 week, this will increased to a dose of 6.25 mg twice daily per day. Target dose of 12.5 mg twice daily per day will be started after 2 weeks if systolic blood pressure does not fall below 90 mm Hg and HR 55-60/min. Simvastatin will be administered orally at a start dose of 20 mg for 15 days followed by 40 mg OD for the next 3 months. Along with Simvastatin, Carvedilol will be administered orally at a start dose of 3.125 mg twice daily per day. After 1 week, this will increased to a dose of 6.25 mg twice daily per day. Target dose of 12.5 mg twice daily per day will be started after 2 weeks if systolic blood pressure does not fall below 90 mm Hg and HR 55-60/min.
Carvedilol will be administered orally at a start dose of 3.125 mg twice daily per day. After 1 week, this will increased to a dose of 6.25 mg twice daily per day. Target dose of 12.5 mg twice daily per day will be started after 2 weeks if systolic blood pressure does not fall below 90 mm Hg and HR 55-60/min.