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A placebo-controlled clinical trial of nadolol in the prophylaxis of growth of small esophageal varices in cirrhosis.

Abstract：

BACKGROUND & AIMS:Beta-blockers are extensively used to prevent variceal bleeding in patients with large esophageal varices. It is not established if beta-blockers delay the growth of small varices. METHODS:A total of 161 patients with cirrhosis and small esophageal varices (F1 according to the classification of Beppu et al.) without previous bleeding were enrolled. A total of 83 patients were randomized to nadolol (dose adjusted to decrease resting heart rate by 25%; mean dose given, 62 +/- 25 mg/day) and 78 to placebo. The principal end point was occurrence of large esophageal varices (F2 or F3 according to the classification of Beppu et al.). Endoscopic examination was performed after 12, 24, 36, 48, and 60 months of follow-up. Mean follow-up was 36 months. RESULTS:The 2 groups were well matched for demographic and clinical characteristics. During the study period, 9 patients randomized to nadolol and 29 randomized to placebo had growth of esophageal varices. At the end of follow-up, the cumulative risk was 20% versus 51% (P < 0.001) (absolute risk difference, 31%; 95% confidence interval, 17%-45%). When possible confounding factors were taken into account, treatment was a significant factor predicting growth of varices (odds ratio, 4.0; 95% confidence interval, 1.95-8.4). The cumulative probability of variceal bleeding was also lower in patients randomized to nadolol (P = 0.02). Survival was not different (P = 0.33). Adverse effects resulting in withdrawal of drug occurred in 9 in the nadolol group and one in the placebo group (P = 0.01). CONCLUSIONS:This study suggests that beta-blocker prophylaxis of variceal bleeding in patients with compensated cirrhosis should be started when small esophageal varices are present.

journal_name

Gastroenterology

journal_title

Gastroenterology

authors

Merkel C,Marin R,Angeli P,Zanella P,Felder M,Bernardinello E,Cavallarin G,Bolognesi M,Donada C,Bellini B,Torboli P,Gatta A,Gruppo Triveneto per l'Ipertensione Portale.

doi

10.1053/j.gastro.2004.05.004

keywords:

subject

Has Abstract

pub_date

2004-08-01 00:00:00

pages

476-84

issue

eissn

0016-5085

issn

1528-0012

pii

S0016508504008406

journal_volume

127

pub_type

临床试验,杂志文章,多中心研究,随机对照试验

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A placebo-controlled clinical trial of nadolol in the prophylaxis of growth of small esophageal varices in cirrhosis.