Carvedilol for preventing recurrent variceal bleeding: Waiting for convincing evidence

Background: Carvedilol has been shown to be more effective than propranolol in decreasing portal pressure. Sufficient data from controlled trials remains limited. This trial compared the relative safety and efficacy between carvedilol and nadolol plus isosorbide mononitrate in preventing variceal rebleeding. Methods: After successful control of acute esophageal variceal bleeding, eligible patients were randomized to Carvedilol group, 61 patients, using carvedilol 6.25-12.5 mg daily or N + I group, 60 patients, using nadolol 40-80 mg plus isorsorbide-5-mononitrate 20mg daily. The end points were rebleeding from varices, adverse events or death. Results: After a median follow up of 30 months, recurrent upper gastrointestinal bleeding developed in 37 patients (61%) in the Carvedilol group and 37 patients (62%) in the N + I group (p = 0.90). Recurrent bleeding from esophageal varices occurred in 31 patients (51%) in the Carvedilol group and in 26 patients (43%) in the N + I group (p = 0.46). Recurrent bleeding from gastric varices occurred in 2 patients (3%) in the Carvedilol group and in 8 patients (13%) in the N + I group (p = 0.05). Severe adverse events occurred in 1 patient in Carvedilol group and 17 patients in N + I group (p<0.0001). Fifteen patients of the Carvedilol group and 17 patients in the N + I group died (p = 0.83). Two patients in the Carvedilol group and 3 patients in N + I group died of variceal bleeding. Conclusions: Carvedilol was as effective as nadolol plus isorsorbide-5 -mononitrate mononitrate in the prevention of gastroesophageal variceal rebleeding with fewer severe adverse events and similar survival.