Nadolol plus isosorbide mononitrate compared with sclerotherapy for the prevention of variceal rebleeding.
BACKGROUND
Patients who have bleeding from esophageal varices are at high risk for rebleeding and death. We compared the efficacy and safety of endoscopic sclerotherapy with the efficacy and safety of nadolol plus isosorbide mononitrate for the prevention of variceal rebleeding.


METHODS
Eighty-six hospitalized patients with cirrhosis and bleeding from esophageal varices diagnosed by endoscopy were randomly assigned to treatment with repeated sclerotherapy (43 patients) or nadolol plus isosorbide-5-mononitrate (43 patients). The primary outcomes were rebleeding, death, and complications. The hepatic venous pressure gradient was measured at base line and after three months.


RESULTS
Base-line data were similar in the two groups, and the median follow-up was 18 months in both. Eleven patients in the medication group and 23 in the sclerotherapy group had rebleeding. The actuarial probability of remaining free of rebleeding was higher in the medication group for all episodes related to portal hypertension (P = 0.001) and variceal rebleeding (P = 0.002). Four patients in the medication group and nine in the sclerotherapy group died (P = 0.07 for the difference in the actuarial probability of survival). Seven patients in the medication group and 16 in the sclerotherapy group had treatment-related complications (P = 0.03). Thirty-one patients in the medication group underwent two hemodynamic studies; 1 of the 13 patients with more than a 20 percent decrease in the hepatic venous pressure gradient had rebleeding, as compared with 8 of the 18 with smaller decreases in the pressure gradient (P = 0.04) for the actuarial probability of rebleeding at two years).


CONCLUSIONS
As compared with sclerotherapy, nadolol plus isosorbide mononitrate significantly decreased the risk of rebleeding from esophageal varices.
Villanueva
C
C
Department of Gastroenterology, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain.
Balanzó
J
J
Novella
M T
MT
Soriano
G
G
Sáinz
S
S
Torras
X
X
Cussó
X
X
Guarner
C
C
Vilardell
F
F
D000206:Actuarial Analysis; D000319:Adrenergic beta-Antagonists / Q000009:adverse effects / Q000627:therapeutic use*; D004359:Drug Therapy, Combination; D004932:Esophageal and Gastric Varices / Q000188:drug therapy / Q000401:mortality / Q000628:therapy*; D005260:Female; D006471:Gastrointestinal Hemorrhage / Q000517:prevention & control*; D006801:Humans; D007548:Isosorbide Dinitrate / Q000031:analogs & derivatives* / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D009248:Nadolol / Q000009:adverse effects / Q000627:therapeutic use*; D012008:Recurrence; D015911:Sclerotherapy / Q000009:adverse effects; D016019:Survival Analysis; D016896:Treatment Outcome; D014665:Vasodilator Agents / Q000627:therapeutic use*
D000319:Adrenergic beta-Antagonists; D014665:Vasodilator Agents; D009248:Nadolol; D007548:Isosorbide Dinitrate; C030397:isosorbide-5-mononitrate