A Trial of Nadolol Plus Isosorbide Mononitrate Versus Carvedilol for the Prevention of Variceal Rebleeding

• Status: Completed
• Trial end date: 2010-01-01
• Target enrollment: 0
• Participant gender: All

Summary

Carvedilol is shown to be superior to propranolol to reduce the portal pressure. This study was undertaken to compare the effectiveness and complication rates of nadolol and isosorbide mononitrate (ISMN) with carvedilol in the prevention of rebleeding from esophageal varices.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: E-DA Hospital
• Collaborator: National Science Council, Taiwan
• Treatments: Carvedilol; Isosorbide; Isosorbide Dinitrate; Isosorbide-5-mononitrate; Nadolol

Criteria

Inclusion Criteria:

1. acute or recent bleeding from esophageal varices (defined below),

2. the etiology of portal hypertension was cirrhosis, and

3. age was between 20 and 70 years old.

Exclusion Criteria:

1. association with hepatocellular carcinoma or other malignancy,

2. association with cerebral vascular accident, uremia, sepsis or other debilitating disease,

3. had history of gastric variceal bleeding,

4. received beta-blocker within 1 month prior to entry,

5. history of contraindication to the use of beta-blockers, such as asthma, heart failure, atrioventricular block, bradycardia (pulse rate <55/min) or arterial hypotension (systolic blood pressure < 90 mmHg),

6. history of prior shunt operation, TIPS (transjugular intrahepatic portosystemic stent shunt),

7. deep jaundice (serum bilirubin > 10 mg/dl),

8. encephalopathy greater than stage II,

9. failure in control of index variceal bleeding, or

10. refused to participate in the trial.