A Trial of Nadolol Plus Isosorbide Mononitrate Versus Carvedilol for the Prevention of Variceal Rebleeding
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Variceal Rebleeding |
Drug: carvedilol Drug: nadolol + ISMN |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | A Controlled Trial of Nadolol Plus Isosorbide Mononitrate vs. Carvedilol for the Prevention of Variceal Rebleeding |
- variceal rebleeding [ Time Frame: 2 years ] [ Designated as safety issue: No ]hematemesis or melena,requiring blood transfusion of 2 units or more bleeding source was proven endoscopically to be from esophageal varices
- adverse events, mortality [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]hypotension, bradycardia, dizziness, impotence, shortness of breath survival
| Enrollment: | 121 |
| Study Start Date: | March 2005 |
| Estimated Study Completion Date: | January 2010 |
| Primary Completion Date: | January 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Carvedilol
carvedilol 6.25mg per day
|
Drug: carvedilol
6.25mg per day, increase to 6.25mg bid
|
|
Active Comparator: N+I
nadolol 40mg per day, ISMN 10 mg per day
|
Drug: nadolol + ISMN
nadolol 40-80mg ISMN 10-20mg
|
Detailed Description:
Bleeding from esophageal varices is a severe complication of portal hypertension. After initial control of acute variceal bleeding, patients have up to a 70% risk of rebleeding. Of those do rebleed, there is a 20%-35% mortality rate. Therefore, preventive procedures are required for patients surviving an episode of acute variceal bleeding. Both endoscopic injection sclerotherapy (EIS) and propranolol have been well documented to be effective for the prevention of variceal rebleeding. In recent years, endoscopic variceal ligation (EVL) has replaced EIS as the endoscopic treatment of choice in the management of bleeding esophageal varices. On the other hand, the addition of isosorbide-5-mononitrate (ISMN) has been shown to be even more effective than propranolol alone in the reduction of portal pressure and in the prevention of variceal rebleeding. A controlled trial showed that the combination of nadolol and ISMN was better than EIS in terms of prevention of variceal rebleeding and complications. The combination of nadolol and ISMN has been shown to be better than EVL in preventing variceal rebleeding. However, our study showed a contradictory result. On the other hand, 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 ISMN with carvedilol in the prevention of rebleeding from esophageal varices.
Eligibility| Ages Eligible for Study: | 20 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- acute or recent bleeding from esophageal varices (defined below),
- the etiology of portal hypertension was cirrhosis, and
- age was between 20 and 70 years old.
Exclusion Criteria:
- association with hepatocellular carcinoma or other malignancy,
- association with cerebral vascular accident, uremia, sepsis or other debilitating disease,
- had history of gastric variceal bleeding,
- received beta-blocker within 1 month prior to entry,
- 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),
- history of prior shunt operation, TIPS (transjugular intrahepatic portosystemic stent shunt),
- deep jaundice (serum bilirubin > 10 mg/dl),
- encephalopathy greater than stage II,
- failure in control of index variceal bleeding, or
- refused to participate in the trial.
Contacts and Locations More Information
Additional Information:
No publications provided
| Responsible Party: | Gin-Ho Lo, E-DA Hospital |
| ClinicalTrials.gov Identifier: | NCT01103154 History of Changes |
| Other Study ID Numbers: | Carvedilol vs. N+I, vghks96CT2-13 |
| Study First Received: | April 9, 2010 |
| Last Updated: | October 24, 2010 |
| Health Authority: | Taiwan: Public Health Administration |
Keywords provided by E-DA Hospital:
|
beta blocker variceal rebleeding efficacy and safety in reducing variceal rebleeding |
Additional relevant MeSH terms:
|
Isosorbide Isosorbide-5-mononitrate Carvedilol Isosorbide Dinitrate Nadolol Diuretics, Osmotic Diuretics Natriuretic Agents Physiological Effects of Drugs Pharmacologic Actions Cardiovascular Agents Therapeutic Uses Vasodilator Agents |
Nitric Oxide Donors Molecular Mechanisms of Pharmacological Action Adrenergic beta-Antagonists Adrenergic Antagonists Adrenergic Agents Neurotransmitter Agents Anti-Arrhythmia Agents Antihypertensive Agents Sympatholytics Autonomic Agents Peripheral Nervous System Agents Adrenergic alpha-1 Receptor Antagonists Adrenergic alpha-Antagonists |
ClinicalTrials.gov processed this record on May 22, 2013