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
Authors: ROMERO, G.; KRAVETZ, D.; ARGONZ, J.1; VULCANO, C.1; SUAREZ, A.1; FASSIO, E.2; DOMINGUEZ, N.2; BOSCO, A.2; MUÑOZ, A.1; SALGADO, P.1; TERG, R.1
Source: Alimentary Pharmacology & Therapeutics, Volume 24, Number 4, August 2006 , pp. 601-611(11)
Publisher: Blackwell Publishing
Abstract:
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.Document Type: Research article
DOI: 10.1111/j.1365-2036.2006.03007.x
Affiliations: 1: Liver Unit, Hospital de Gastroenterologia `Prof. Bonorino Udaondo' 2: Gastroenterology Division, Hospital Nacional ` Prof. A Posadas', Buenos Aires, Argentina

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