title: Isosorbide-5-mononitrate versus propranolol in the prevention of first bleeding in cirrhosis.
abstract: BACKGROUND
  Hemodynamic studies have shown the efficacy of nitrates in reducing portal pressure in cirrhosis. We therefore studied the efficacy of isosorbide-5-mononitrate vs. propranolol in the prevention of first bleeding within a prospective controlled trial.
  
  
  METHODS
  One hundred eighteen cirrhotics with esophageal varices were blindly randomized to receive 20 mg of isosorbide-5-mononitrate three times a day (n = 57) or propranolol (n = 61) up to the maximum tolerated dose. Both groups also received ranitidine (150 mg/day).
  
  
  RESULTS
  The median follow-up was 29 months. Twenty-six patients dropped out (13 in the isosorbide group) because of poor compliance or complications unrelated to treatment. Eighteen patients died (9 in the isosorbide-treated group), 6 due to bleeding. The 1- and 2-year actuarial percentages of patients free of bleeding was 90.8% and 82.2% in the isosorbide-5-mononitrate--and 93.9% and 85.8% in the propranolol-treated groups, respectively (P = NS). These values are higher than those expected from the North Italian Endoscopic Club predicting scores. There were few major side effects in either group. The 2-year survival rate did not differ between the two groups (82.2% vs. 85.4%).
  
  
  CONCLUSIONS
  Isosorbide-5-mononitrate administered orally is a safe and effective alternative to propranolol in the prophylaxis of bleeding in cirrhosis.
authors: Department of Public Health, Tor Vergata University Medical School, Rome, Italy.
authors: M
authors: M
authors: Angelico
authors: L
authors: L
authors: Carli
authors: C
authors: C
authors: Piat
authors: S
authors: S
authors: Gentile
authors: V
authors: V
authors: Rinaldi
authors: E
authors: E
authors: Bologna
authors: L
authors: L
authors: Capocaccia
mesh_terms: D000368:Aged; D004064:Digestive System / Q000473:pathology; D004724:Endoscopy; D005260:Female; D006471:Gastrointestinal Hemorrhage / Q000209:etiology / Q000517:prevention & control*; D006801:Humans; D007548:Isosorbide Dinitrate / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D008103:Liver Cirrhosis / Q000150:complications / Q000188:drug therapy* / Q000401:mortality; D008297:Male; D008875:Middle Aged; D010352:Patient Dropouts; D010560:Personnel Selection; D011433:Propranolol / Q000009:adverse effects / Q000627:therapeutic use*; D011446:Prospective Studies
chemical_list: D011433:Propranolol; D007548:Isosorbide Dinitrate; C030397:isosorbide-5-mononitrate