Clinical-liver, pancreas, and biliary tractA placebo-controlled clinical trial of nadolol in the prophylaxis of growth of small esophageal varices in cirrhosis 1☆,
Section snippets
Patients and methods
The study was a multicenter randomized clinical trial coordinated by the Department of Clinical and Experimental Medicine of the University of Padua (Padua, Italy). Seven further departments of medicine of general hospitals in the northeastern part of Italy participated in the study.
Results
Randomization resulted in 83 patients in the nadolol group and 78 patients in the placebo group; these 2 groups were well matched for demographic and clinical characteristics (Table 1 and Figure 1).
During follow-up, 11 patients randomized to nadolol and 10 patients randomized to placebo were lost to follow-up (P = 0.91) after a mean of 8 ± 6 and 11 ± 8 months of follow-up, respectively (range, 3–24 and 3–30 months; P = 0.30).
Nine patients in the nadolol group had to be withdrawn from treatment
Discussion
In the present trial, we observed that the administration of nonselective beta-blockers in patients with cirrhosis and small esophageal varices at low risk of bleeding markedly decreased the risk of growth of esophageal varices to large varices at relevant risk of bleeding. When designing the study protocol, we had to face the problem of whether it would be better to use a double-blind trial design, which minimizes bias in assessment of outcome but implies evident difficulties in the management
References (27)
- et al.
Current management of portal hypertension
J Hepatol
(2003) - et al.
Natural history of cirrhotic patients with small esophageal varicesa prospective study
Am J Gastroenterol
(2000) - et al.
Incidence and natural history of small esophageal varices in cirrhotic patients
J Hepatol
(2003) - et al.
Early chronic administration of propranolol reduces the severity of portal hypertension and portal-systemic shunts in conscious portal vein stenosed rats
J Hepatol
(1991) - et al.
Prediction of variceal hemorrhage by esophageal endoscopy
Gastrointest Endosc
(1981) - et al.
Hepatic venous pressure gradientan old test as a new prognostic marker in cirrhosis?
Hepatology
(1997) - et al.
Prognostic usefulness of hepatic vein catheterization in patients with cirrhosis and esophageal varices
Gastroenterology
(1992) - et al.
Gastroesophageal endoscopic features in cirrhosis. Observer variability, interassociation, and relationship to hepatic dysfunction
Gastroenterology
(1990) - et al.
The portal pressure response to beta-blockade is greater in cirrhotic patients without varices than in those without varices
Gastroenterology
(1997) - et al.
Efficacy and efficiency of treatments in portal hypertension
Incidence of large oesophageal varices in patients with cirrhosisapplication to prophylaxis of first bleeding
Gut
Portal hypertension in cirrhosisnatural history
Pre-primary prophylaxiscan (and should) we prevent the formation and growth of varices?
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2021, Clinics in Liver DiseaseUpper gastrointestinal bleeding
2023, Acute Care Surgery and Trauma: Evidence-Based Practice: Third Edition
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Supported by grants from the Italian Ministry of Education, University and Research (Rome, Italy) (National Project “Portal hypertension in cirrhosis”) and from the Veneto Region (Venezia, Italy) (Regional Center for Epidemiology and Treatment of Liver Diseases).
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Members of the Gruppo Triveneto per l’Ipertensione Portale are as follows. Steering committee: A. Gatta and C. Merkel (University of Padua, Padua, Italy); V. Donadon (General Hospital of Pordenone, Pordenone, Italy); P. Spandri (General Hospital of Thiene, Thiene, Italy); F. Tremolada (General Hospital of Belluno, Belluno, Italy); and G. Marin (General Hospital of Dolo, Dolo, Italy). Clinical investigators: E. Bernardinello, L. Chemello, and F. Vescovi (University of Padua, Padua, Italy); G. Marin (General Hospital of Dolo, Dolo, Italy); P. Spandri (General Hospital of Thiene, Thiene, Italy); L. Zancanella (General Hospital of Bolzano, Bolzano, Italy); C. Costan (General Hospital of Chioggia, Chioggia, Italy); C. Mazzaro (General Hospital of Pordenone, Pordenone, Italy); P. Torboli (General Hospital of Trento, Trento, Italy); and F. Tremolada (General Hospital of Belluno, Belluno, Italy). Endoscopists: P. Angeli (University of Padua, Padua, Italy); R. Marin (General Hospital of Dolo, Dolo, Italy); P. Zanella (General Hospital of Thiene, Thiene, Italy); M. Felder (General Hospital of Bolzano, Bolzano, Italy); G. Cavallarin (General Hospital of Chioggia, Chioggia, Italy); C. Donada (General Hospital of Pordenone, Pordenone, Italy); I. Avancini (General Hospital of Trento, Trento, Italy); and G. Sebastianelli (General Hospital of Belluno, Belluno, Italy). Statistical analysts: M. Bolognesi, B. Bellini, and C. Merkel (University of Padua, Padua, Italy).