Isosorbide-5-mononitrate versus propranolol in the prevention of first bleeding in cirrhosis.
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.
Angelico
M
M
Department of Public Health, Tor Vergata University Medical School, Rome, Italy.
Carli
L
L
Piat
C
C
Gentile
S
S
Rinaldi
V
V
Bologna
E
E
Capocaccia
L
L
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
D011433:Propranolol; D007548:Isosorbide Dinitrate; C030397:isosorbide-5-mononitrate