Isosorbide mononitrate in the prevention of first variceal bleed in patients who cannot receive beta-blockers.

Abstract

BACKGROUND & AIMS:

Nonselective beta-blockers (beta-blockers) are very effective in preventing first variceal bleeding (FVB) in patients with cirrhosis. However, 15%-25% of patients have contraindications or develop severe side effects precluding its use. The present study evaluates whether isosorbide-5-mononitrate (Is-MN) effectively prevents variceal bleeding in patients with contraindications or who could not tolerate beta-blockers.

METHODS:

One hundred thirty-three consecutive cirrhotic patients with gastro-esophageal varices and contraindications or intolerance to beta-blockers were included in a multicenter, prospective, double-blind randomized controlled trial. Sixty-seven were randomized to receive Is-MN, and 66 to receive placebo.

RESULTS:

There were no significant differences in the 1- and 2-year actuarial probability of experiencing a FVB between the 2 treatment groups. Presence of variceal red signs at endoscopy was the only variable independently associated with an increased risk of variceal bleeding on follow-up (relative risk 3.4; P < 0.01). Survival and adverse events were similar in the 2 groups. There were no significant differences in the incidence of ascites or changes in renal function.

CONCLUSIONS:

Is-MN does not reduce the incidence of FVB in patients with cirrhosis and esophageal varices who cannot be treated with beta-blockers because contraindications or intolerance to these drugs, suggesting that Is-MN has no place in the primary prophylaxis of variceal bleeding.

• Authors: J C García-Pagán, C Villanueva, M C Vila, A Albillos, J Genescà, L Ruiz-Del-Arbol, R Planas, M Rodriguez, J L Calleja, A González, R Solà, J Balanzó, J Bosch, MOVE Group. Mononitrato Varices Esofágicas
• Journal: Gastroenterology (Gastroenterology) Vol. 121 Issue 4 Pg. 908-14 (Oct 2001) ISSN: 0016-5085 [Print] United States
• PMID: 11606504 (Publication Type: Clinical Trial, Comparative Study, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Adrenergic beta-Antagonists
• Isosorbide Dinitrate
• isosorbide-5-mononitrate

Topics

• Adrenergic beta-Antagonists
• Ascites (physiopathology)
• Contraindications
• Double-Blind Method
• Female
• Gastroesophageal Reflux (drug therapy)
• Hemodynamics (drug effects)
• Humans
• Isosorbide Dinitrate (analogs & derivatives, therapeutic use)
• Kidney Function Tests
• Liver Cirrhosis (classification, etiology)
• Male
• Middle Aged
• Odds Ratio
• Patient Selection
• Probability
• Prothrombin Time
• Survival Rate