Comparative study between nadolol and 5‐isosorbide mononitrate vs. endoscopic band ligation plus sclerotherapy in the prevention of variceal rebleeding in cirrhotic patients: a randomized controlled trial

• Published in: Alimentary pharmacology & therapeutics Vol. 24; no. 4; pp. 601 - 611
• Main Authors: ROMERO, G., KRAVETZ, D., ARGONZ, J., VULCANO, C., SUAREZ, A., FASSIO, E., DOMINGUEZ, N., BOSCO, A., MUÑOZ, A., SALGADO, P., TERG, R.
• Format: Journal Article
• Language: English
• Published: Oxford, UK Blackwell Publishing Ltd 15.08.2006; Blackwell
• Subjects: Biological and medical sciences; Blood and lymphatic vessels; Cardiology. Vascular system; Digestive system; Diseases of the peripheral vessels. Diseases of the vena cava. Miscellaneous; Endoscopy, Gastrointestinal; Esophageal and Gastric Varices - drug therapy; Female; Gastroenterology. Liver. Pancreas. Abdomen; Gastrointestinal Hemorrhage - prevention & control; Humans; Isosorbide Dinitrate - analogs & derivatives; Isosorbide Dinitrate - therapeutic use; Ligation - methods; Liver Cirrhosis - drug therapy; Liver. Biliary tract. Portal circulation. Exocrine pancreas; Male; Medical sciences; Middle Aged; Nadolol - therapeutic use; Other diseases. Semiology; Pharmacology. Drug treatments; Sclerotherapy - methods; Secondary Prevention; Antianginal agent; Human; Relapse; Coronary vasodilator agent; Isosorbide mononitrate; Cardiovascular disease; Hepatic disease; Nadolol; Antiarrhythmic agent; Sclerosis; β-Adrenergic receptor; Venous disease; Vascular disease; Prevention; Cirrhosis; Organic nitrate; Randomised controlled trial; Digestive diseases; Antihypertensive agent; Antagonist; Endoscopy; Comparative study; Beta blocking agent; Varix
• ISSN: 0269-2813; 1365-2036
• DOI: 10.1111/j.1365-2036.2006.03007.x

SUMMARY Background  After variceal bleeding, cirrhotic patients should receive secondary prophylaxis. Aim  To compare nadolol plus 5‐isosorbide mononitrate (5‐ISMN) with endoscopic band ligation. The end points were rebleeding, treatment failure and death. Methods  One hundred and nine cirrhotic patients with a recent variceal bleeding were randomized: nadolol plus 5‐ISMN in 57 patients and endoscopic band ligation in 52 patients. Results  The mean follow‐up was 17 and 19 months in nadolol plus 5‐ISMN and endoscopic band ligation groups, respectively. No differences were observed between groups in upper rebleeding (47% vs. 46%), variceal rebleeding (40% vs. 36%), failure (32% vs. 22%), major complications (7% vs. 13.5%) and death (19% vs. 20%), respectively. The actuarial probability of remaining free of rebleeding, failure and deaths were similar in both groups. Time to rebleeding shows that endoscopic band ligation patients had an early rebleed, with a median of 0.5 month (95% CI: 0.0–4.2) compared with patients from nadolol plus 5‐ISMN, 7.6 months (95% CI: 2.9–12.3, P < 0.013). Multivariate analysis indicated that outcome‐specific predictive factor(s) for rebleeding was Child A vs. B + C (P < 0.01); for failure was Child A vs. B + C (P < 0.02); and for death ascites (P < 0.01) and rebleeding (P < 0.02). Conclusion  This trial suggests no superiority of endoscopic band ligation over nadolol plus 5‐ISMN mononitrate for the prevention of rebleeding in cirrhotic patients.