Protocol registration: NCT 01103154; The study was supported by a grant from Kaohsiung Veterans General Hospital. No conflict of interest exists.
Randomized, controlled trial of carvedilol versus nadolol plus isosorbide mononitrate for the prevention of variceal rebleeding
Article first published online: 29 OCT 2012
© 2012 Journal of Gastroenterology and Hepatology Foundation and Wiley Publishing Asia Pty Ltd
Journal of Gastroenterology and Hepatology
Volume 27, Issue 11, pages 1681–1687, November 2012
How to Cite
Lo, G.-H., Chen, W.-C., Wang, H.-M. and Yu, H.-C. (2012), Randomized, controlled trial of carvedilol versus nadolol plus isosorbide mononitrate for the prevention of variceal rebleeding. Journal of Gastroenterology and Hepatology, 27: 1681–1687. doi: 10.1111/j.1440-1746.2012.07244.x
Study concept and design, drafting of manuscript: Gin-Ho Lo; Acquisition of data: Huay-Min Wang, Hsien-Chung Yu; Analysis of data and statistical analysis: Wen- Chi Chen.
Part of this work has been presented at 2010 AASLD annual meeting, Boston.
- Issue published online: 29 OCT 2012
- Article first published online: 29 OCT 2012
- Accepted manuscript online: 31 JUL 2012 07:39AM EST
- Manuscript Accepted: 27 JUN 2012
- Kaohsiung Veterans General Hospital
- variceal rebleeding
Background and Aim
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.
After successful control of acute esophageal variceal bleeding, eligible patients were randomized to the carvedilol group, 61 patients, using carvedilol 6.25–12.5 mg daily or the N + I group, 60 patients, using nadolol 40–80 mg plus isorsorbide-5-mononitrate 20 mg daily. The end points were rebleeding from varices, adverse events or death.
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 two patients (3%) in the carvedilol group and in eight patients (13%) in the N + I group (P = 0.05). Severe adverse events occurred in one patient in the carvedilol group and 17 patients in the 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 three patients in the N + I group died of variceal bleeding.
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.