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Department of Digestive Diseases, Hospital Universitari i Politècnic La Fe, Valencia, Spain
David Le Bihan
Department of Echocardiography, Dante Pazzanese Institute of Cardiology, São Paulo, Brazil
Paula Ruiz Talero
Department of Internal Medicine, Hospital Universitario San Ignacio, Bogotá, Colombia
Universidad Central de Venezuela, Escuela de Medicina José María Vargas, Caracas, Venezuela
Juliana Neves da Costa
Department of Nursing, University of Campinas, Sao Paulo, Brazil.
Luana Cuadro Seregni
Department of Radiology, Asociación Española ASSE, Montevideo, Uruguay
Guilherme Duprat Ceniccola
Hospital de Base do D.F., Brasília-DF, Brazil
Department of Cardiology, Herzzentrum, Leipzig, Germany
Atsuko Nakagami Cetl
Department of Anesthesiology, Federal University of São Paulo, Brazil
Plastic Surgery Department, Hamad Medical Corporation, Doha, Qatar.
Flávia Souza Sobral
Brazilian Health Surveillance Agency, Anvisa, Brazil
Beatriz Teixeira Costa
Bahiana School of Medicine and Public Health, Salvador, Brazil
Pedro Lucena Leal
Bahiana School of Medicine and Public Health, Salvador, Brazil.
Roba-al-Safwa Pharmacy, Makkah, Saudi Arabia.
General Surgery Department, Hospital Policial, Montevideo, Uruguay.
Raquel Pei Chen chan
Faculty of Medicine, São Paulo University, Brazil.
Cristina Pires Camargo
Plastic Surgery Department, Faculty of Medicine, Universidade de São Paulo (FMUSP), Brazil.
Propranolol versus carvedilol for the primary prophylaxis of variceal bleeding: a proposed multicenter, randomized, double-blind trial
- 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
Vol 3 No 1 (2017): Principles and Practice of Clinical Research
Submitted: Mar 6, 2017
Published: Jun 28, 2017
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.