Effects of isosorbide-5-mononitrate compared with propranolol on first bleeding and long-term survival in cirrhosis.
OBJECTIVE
Isosorbide-5-mononitrate (Is-5-Mn) exerts beneficial hemodynamic effects in portal hypertension, yet the long-term clinical value is uncertain. The aim of this study was to determine the long-term effects of Is-5-Mn vs. propranolol (Pro) on first bleeding, complications, and death in cirrhosis.


METHODS
One hundred eighteen patients included in a previously published randomized trial comparing Is-5-Mn (20 mg three times daily) with Pro were followed up for up to 7 years (range, 2-91 months). Fifty-seven patients received Is-5-Mn and 61 received Pro.


RESULTS
Thirty episodes of first upper bleeding occurred; 16 were in the Is-5-Mn group. Actuarial probability of bleeding did not differ between the two groups. Endoscopic variceal red signs were the only independent predictors of early bleeding. Of the 52 patients who died, 28 were in the Is-5-Mn group. The likelihood of death was greater among patients assigned to Is-5-Mn than to Pro, but only in patients older than 50 years (72% vs. 48% at 6 years; P = 0.006). Child-Pugh score, bleeding, age, and assignment to Is-5-Mn were independent predictors of death. The likelihood of death without bleeding was also higher (P = 0.05) in the Is-5-Mn group.


CONCLUSIONS
Is-5-Mn is as effective as Pro in preventing early bleeding but is associated with higher long-term mortality.
Angelico
M
M
Cattedra di Gastroenterologia, Università di Roma Tor Vergata, Rome, Italy. angelico@utovrm.it
Carli
L
L
Piat
C
C
Gentile
S
S
Capocaccia
L
L
D000319:Adrenergic beta-Antagonists / Q000627:therapeutic use*; D000328:Adult; D000368:Aged; D005260:Female; D005500:Follow-Up Studies; D006471:Gastrointestinal Hemorrhage / Q000517:prevention & control*; D006801:Humans; D007548:Isosorbide Dinitrate / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D008103:Liver Cirrhosis / Q000401:mortality*; D008297:Male; D008875:Middle Aged; D011433:Propranolol / Q000009:adverse effects / Q000627:therapeutic use*; D016037:Single-Blind Method; D014665:Vasodilator Agents / Q000627:therapeutic use*
D000319:Adrenergic beta-Antagonists; D014665:Vasodilator Agents; D011433:Propranolol; D007548:Isosorbide Dinitrate; C030397:isosorbide-5-mononitrate