Propranolol versus carvedilol for the primary prophylaxis of variceal bleeding: a proposed multicenter, randomized, double-blind trial

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Diego Alvarez-Sotomayor
David Le Bihan
Paula Ruiz Talero
Wikien Hung
Juliana Neves da Costa
Luana Cuadro Seregni
Guilherme Duprat Ceniccola
Razvan Lapusca
Atsuko Nakagami Cetl
Mohammed Muneer
Flávia Souza Sobral
Beatriz Teixeira Costa
Pedro Lucena Leal
Muhammad Muzmil
Mauricio Gervasoni
Raquel Pei Chen chan
Cristina Pires Camargo

Abstract

Background: Bleeding from esophageal varices is one of the most frequent and deadly complications of liver cirrhosis, with six-week mortality rates as high as 30%. The estimation of portal pressure by means of hepatic venous pressure gradient (HVPG) measurement remains the single most accurate predictor of bleeding in individual patients. An increasing number of studies have reported a greater reduction of HVPG using carvedilol compared to the current standard of care, propranolol; however, there are still no clinical trials comparing carvedilol to propranolol head-to-head for the prophylaxis of variceal bleeding.

Aims:  To compare carvedilol versus propranolol for the prevention of a first variceal bleed (primary prophylaxis) in patients with cirrhosis and esophageal varices.

Methods: This is a proposed design and protocol for a multicenter, randomized, active-controlled, double-blind, parallel group, phase III superiority trial, including a total of 452 patients with cirrhosis and esophageal varices that are at high risk of bleeding.

Potential impact of the study: In view of the encouraging results obtained with carvedilol in prior studies, we believe a trial comparing propranolol to carvedilol in terms of clinical outcomes is necessary to clearly establish whether carvedilol should become the treatment of choice for the primary prohylaxis of variceal bleeding. If this trial is successfully conducted, results can be expected to have a substantial impact on clinical practice and future research directions. 

Article Details

How to Cite
Alvarez-Sotomayor, D., Le Bihan, D., Ruiz Talero, P., Hung, W., Neves da Costa, J., Cuadro Seregni, L., Duprat Ceniccola, G., Lapusca, R., Nakagami Cetl, A., Muneer, M., Souza Sobral, F., Teixeira Costa, B., Lucena Leal, P., Muzmil, M., Gervasoni, M., Pei Chen chan, R., & Pires Camargo, C. (2017). Propranolol versus carvedilol for the primary prophylaxis of variceal bleeding: a proposed multicenter, randomized, double-blind trial. Principles and Practice of Clinical Research, 3(1). Retrieved from https://journal.ppcr.org/index.php/ppcrjournal/article/view/52
Section
Study Design

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