title: Isosorbide mononitrate in the prevention of first variceal bleed in patients who cannot receive beta-blockers.
abstract: OBJECTIVE
  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.affiliation: Hepatic Hemodynamic Laboratory, Liver Unit, IMD, Hospital Clínic, IDIBAPS, University of Barcelona, Barcelona, Spain. jcgarcia@clinic.ub.es
authors.forename: J C
authors.initials: JC
authors.lastname: García-Pagán
authors.forename: C
authors.initials: C
authors.lastname: Villanueva
authors.forename: M C
authors.initials: MC
authors.lastname: Vila
authors.forename: A
authors.initials: A
authors.lastname: Albillos
authors.forename: J
authors.initials: J
authors.lastname: Genescà
authors.forename: L
authors.initials: L
authors.lastname: Ruiz-Del-Arbol
authors.forename: R
authors.initials: R
authors.lastname: Planas
authors.forename: M
authors.initials: M
authors.lastname: Rodriguez
authors.forename: J L
authors.initials: JL
authors.lastname: Calleja
authors.forename: A
authors.initials: A
authors.lastname: González
authors.forename: R
authors.initials: R
authors.lastname: Solà
authors.forename: J
authors.initials: J
authors.lastname: Balanzó
authors.forename: J
authors.initials: J
authors.lastname: Bosch
mesh_terms: D000319:Adrenergic beta-Antagonists; D001201:Ascites / Q000503:physiopathology; D000075202:Contraindications; D004311:Double-Blind Method; D005260:Female; D005764:Gastroesophageal Reflux / Q000188:drug therapy*; D006439:Hemodynamics / Q000187:drug effects; D006801:Humans; D007548:Isosorbide Dinitrate / Q000031:analogs & derivatives* / Q000627:therapeutic use*; D007677:Kidney Function Tests; D008103:Liver Cirrhosis / Q000145:classification / Q000209:etiology; D008297:Male; D008875:Middle Aged; D016017:Odds Ratio; D018579:Patient Selection; D011336:Probability; D011517:Prothrombin Time; D015996:Survival Rate
chemical_list: D000319:Adrenergic beta-Antagonists; D007548:Isosorbide Dinitrate; C030397:isosorbide-5-mononitrate