Article Text

other Versions

PDF
Nadolol plus isosorbide mononitrate alone or associated with band ligation in the prevention of recurrent bleeding: A multicenter randomized controlled trial
  1. Juan-Carlos Garcia-Pagan (jcgarcia{at}medicina.ub.es)
  1. Hepatic Hemodynamic Laboratory. Liver Unit, Spain
    1. Càndid Villanueva (cvillanueva{at}hsp.santpau.es)
    1. HOPITAL DE LA SANTA CREU I SANT PAU, Spain
      1. Agustin Albillos (aalbillosm{at}meditex.es)
      1. Hospital Ramón y Cajal. Universidad de Alcalá, Spain
        1. Rafael Bañares (rbanares{at}telefonica.net)
        1. Hospital General Universitario Gregorio Maranon, Spain
          1. Rosa Morillas (rmorillas.germanstrias{at}gencat.net)
          1. Department of Gastroenterology. Hospital Universitari Germans Trias y Pujol, Spain
            1. Juan G Abraldes (jgon{at}clinic.ub.es)
            1. Hospital Clinic, Spain
              1. Jaime Bosch (jbosch{at}clinic.ub.es)
              1. LIVER UNIT, Hospital Clinic, University of Barcelona, Spain

                Abstract

                Background & aims: Previous clinical trials suggest that adding non-selective beta-blockers improves the efficacy of endoscopic band ligation (EBL) in the prevention of recurrent bleeding, but no study has evaluated whether EBL improves the efficacy of beta-blockers +Isosorbide-5-mononitrate. The present study was aimed at evaluating this issue in a multicenter RCT and to correlate changes in hepatic venous pressure gradient (HVPG) during treatment with clinical outcomes

                Methods: 158 cirrhotic patients admitted because of variceal bleeding were randomized to receive Nadolol+Isosorbide-5-mononitrate alone (Drug: n=78) or combined with EBL (Drug+EBL; n=80). HVPG measurements were performed at randomization and after 4-6 weeks on medical therapy.

                Results: Median follow-up was 15 months. One-year probability of recurrent bleeding was similar in both groups (33% vs. 26%: p=0.3). There were no significant differences in survival or need of rescue shunts. Overall adverse events or those requiring hospital admission were significantly more frequent in the Drug+EBL group. Recurrent bleeding was significantly more frequent in HVPG non-responders than in responders (HVPG reduction >20% or <12mmHg). Among non-responders recurrent bleeding was similar in patients treated with Drugs or Drugs+EBL.

                Conclusions: Adding EBL to pharmacological treatment did not reduce recurrent bleeding, need of rescue therapy or mortality, and was associated with more adverse events. Furthermore, associating EBL to drug therapy did not reduce the high rebleeding risk of HVPG non-responders.

                Statistics from Altmetric.com

                Request permissions

                If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.

                Linked Articles