Association of transdermal nitroglycerin to vasopressin infusion in the treatment of variceal hemorrhage: A placebo-controlled clinical trial

Authors

  • Jaime Bosch M.D.,

    Corresponding author
    1. Liver Unit, Hospital Clínic i Provincial, University of Barcelona, Barcelona, Spain
    2. Veterans Administration Medical Center, West Haven, Connecticut 06516
    3. Yale University School of Medicine, New Haven, Connecticut 06510
    • Liver Unit, Hospital Clínic i Provincial, University of Barcelona, Villaroel 170, 08036 Barcelona, Spain
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  • Roberto J. Groszmann,

    1. Liver Unit, Hospital Clínic i Provincial, University of Barcelona, Barcelona, Spain
    2. Veterans Administration Medical Center, West Haven, Connecticut 06516
    3. Yale University School of Medicine, New Haven, Connecticut 06510
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  • Joan C. García-Pagán,

    1. Liver Unit, Hospital Clínic i Provincial, University of Barcelona, Barcelona, Spain
    2. Veterans Administration Medical Center, West Haven, Connecticut 06516
    3. Yale University School of Medicine, New Haven, Connecticut 06510
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  • Josep Terés,

    1. Liver Unit, Hospital Clínic i Provincial, University of Barcelona, Barcelona, Spain
    2. Veterans Administration Medical Center, West Haven, Connecticut 06516
    3. Yale University School of Medicine, New Haven, Connecticut 06510
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  • Guadalupe García-Tsao,

    1. Liver Unit, Hospital Clínic i Provincial, University of Barcelona, Barcelona, Spain
    2. Veterans Administration Medical Center, West Haven, Connecticut 06516
    3. Yale University School of Medicine, New Haven, Connecticut 06510
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  • Miquel Navasa,

    1. Liver Unit, Hospital Clínic i Provincial, University of Barcelona, Barcelona, Spain
    2. Veterans Administration Medical Center, West Haven, Connecticut 06516
    3. Yale University School of Medicine, New Haven, Connecticut 06510
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  • Antoni Mas,

    1. Liver Unit, Hospital Clínic i Provincial, University of Barcelona, Barcelona, Spain
    2. Veterans Administration Medical Center, West Haven, Connecticut 06516
    3. Yale University School of Medicine, New Haven, Connecticut 06510
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  • Joan Rodés

    1. Liver Unit, Hospital Clínic i Provincial, University of Barcelona, Barcelona, Spain
    2. Veterans Administration Medical Center, West Haven, Connecticut 06516
    3. Yale University School of Medicine, New Haven, Connecticut 06510
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Abstract

The aim of this study was to evaluate, using a doubleblind technique, the efficacy of the association of transdermal nitroglycerin to vasopressin infusion for the treatment of variceal bleeding. Sixty-nine cirrhotic patients with active variceal bleeding were randomly allocated to receive vasopressin (0.4 to 0.8 unit per min until variceal bleeding has been controlled for 12 hr) associated with nitroglycerin administered transdermically in a slow-release preparation (10 mg in 24 hr) or placebo. An initial control of variceal hemorrhage was achieved in 83% of the patients receiving vasopressin-nitroglycerin and in 74% in the vasopressin-placebo group. Owing to a lower frequency of recurrent bleeding during therapy (18 vs. 42%, p = 0.11), vasopressin-nitroglycerin achieved a definitive control of bleeding in a higher proportion of patients than vasopressinplacebo (73 vs. 54%, p = 0.13). The group treated with the drug combination showed favorable results in relation to transfusion requirements (2.9 ± 0.4 vs. 4.2 ± 0.5 units, p = 0.05), total dose of vasopressin required (453 ± 47 vs. 587 ± 50 units, p < 0.05), need of balloon tamponade (6 vs. 15, p < 0.05) and requirement for emergency surgery (0 vs. 4, p = 0.07). There were no significant differences in the undesirable effects associated with treatment, observed in 37 and 49% of cases, respectively. Hospital mortality was similar (33 vs. 25%). This study demonstrates that transdermal nitroglycerin improves the effectiveness of vasopressin for controlling variceal hemorrhage.

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