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Clinical trial: a randomized controlled study on prevention of variceal rebleeding comparing nadolol + ligation vs. hepatic venous pressure gradient‐guided pharmacological therapy
Author(s) -
VILLANUEVA C.,
ARACIL C.,
COLOMO A.,
LOPEZBALAGUER J. M.,
PIQUERAS M.,
GONZALEZ B.,
TORRAS X.,
GUARNER C.,
BALANZO J.
Publication year - 2009
Publication title -
alimentary pharmacology and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 3.308
H-Index - 177
eISSN - 1365-2036
pISSN - 0269-2813
DOI - 10.1111/j.1365-2036.2008.03880.x
Subject(s) - nadolol , medicine , ligation , portal venous pressure , hemodynamics , randomized controlled trial , prazosin , portal hypertension , anesthesia , cardiology , gastroenterology , cirrhosis , antagonist , receptor , propranolol
Summary Background Hepatic venous pressure gradient (HVPG) monitoring of therapy to prevent variceal rebleeding provides strong prognostic information. Treatment of nonresponders to β‐blockers ± nitrates has not been clarified. Aim To assess the value of HVPG‐guided therapy using nadolol + prazosin in nonresponders to nadolol + isosorbide‐5‐mononitrate (ISMN) compared with a control group treated with nadolol + ligation. Methods Cirrhotic patients with variceal bleeding were randomized to HVPG‐guided therapy ( n = 30) or nadolol + ligation ( n = 29). A Baseline haemodynamic study was performed and repeated within 1 month. In the guided‐therapy group, nonresponders to nadolol + ISMN received nadolol and carefully titrated prazosin and had a third haemodynamic study. Results Nadolol + prazosin decreased HVPG in nonresponders to nadolol + ISMN ( P < 0.001). Finally, 74% of patients were responders in the guided‐therapy group vs. 32% in the nadolol + ligation group ( P < 0.01). The probability of rebleeding was lower in responders than in nonresponders in the guided therapy group ( P < 0.01), but not in the nadolol + ligation group ( P = 0.41). In all, 57% of nonresponders rebled in the guided‐therapy group and 20% in the nadolol + ligation group ( P = 0.05). The incidence of complications was similar. Conclusions In patients treated to prevent variceal rebleeding, the association of nadolol and prazosin effectively rescued nonresponders to nadolol and ISMN, improving the haemodynamic response observed in controls receiving nadolol and endoscopic variceal ligation. Our results also suggest that ligation may rescue nonresponders.