Following treatment of an initial variceal bleed, is pharmacologic treatment as effective as endoscopic ligation?

The combination of the beta-blocker nadolol (Corgard) and 5-isosorbide mononitrate (Imdur) significantly prolongs the time to rebleeding as compared with endoscopic band ligation (EBL) in cirrhotic patients with a previous single episode of variceal bleeding. Other outcomes -- death, rebleeding rates, and the likelihood of a severe rebleed -- were similar. (LOE = 1b)

Romero G, Kravetz D, Argonz J, et al. Comparative study between nadolol and 5-isosorbide mononitrate vs. endoscopic band ligations plus sclerotherapy in the prevention of variceal rebleeding in cirrhotic patients: a randomized controlled trial. Aliment Pharmacol Ther 2006;24:601-611.  [PMID:16827811]

Randomized controlled trial (nonblinded)

Self-funded or unfunded

Concealed

Outpatient (specialty)

The authors consecutively enrolled 109 patients with cirrhosis and a history of a single episode of variceal bleeding within the previous 3 months. The patients were randomly assigned, using concealed allocation, to receive either (1) EBL or (2) treatment with nadolol, titrated to a 25% decrease in heart rate and 5-isosorbide mononitrate titrated to 40 mg twice daily. EBL was performed by banding of up to 10 varices, and was repeated after 2 weeks until all varices were treated. One or 2 sclerotherapy sessions were used to treat residual varices. Most (69%) of the EBL-treated patients required an average of 3.4 sessions, though recurrences were common, occurring in 42%. Analysis was by intention to treat. Over the 24 months of follow up, mortality was 19% in both groups. Rebleeding rates were similar in both groups, although the time to rebleeding was significantly shorter with EBL (0.5 months vs 7.6 months; P < .013). Treatment failure (defined as 2 or more episodes of severe variceal bleeding or a single episode of bleeding that required surgery) was similar in both groups. Bradycardia, hypotension, and headache were the most common side effects in the drug treatment group, and dysphagia, bleeding ulcer, and candidiasis were the most common side effects in the EBL group.