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

Gastroenterology. 2001 Oct;121(4):908-14.


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.

Publication types

  • Clinical Trial
  • Comparative Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

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


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