ABSTRACT
Background and Aims: Cirrhotic patients who have bleeding from oesophageal varices are at high risk for rebleeding if no definite therapy to prevent rebleeding has been initiated. Angiotensin II type 1 receptor blockers [ARBs] have been proposed as new drugs for portal hypertension. This randomized prospective clinical trial aimed to assess the efficacy and safety of long-term valsartan [one of ARBs] treatment for prevention of variceal rebleeding in cirrhotic patients when added to endoscopic sclerotherapy [ES] comparing with ES alone and to assess the effect of valsartan on systemic and portal haemodynamics
Methods: Sixty hospitalized Cirrhotic patients [Child A and B with endoscopically proved first episode bleeding oesophageai varices were included into the study. After control of index variceal bleeding, patients were randomized into 2 groups: group I included 30 patients, treated by regular ES every 2 weeks plus valsartan 80 mg once daily orally, and group II included 80 patients, treated by regular ES alone every 2 weeks. All patients were subjected to thorough history taking and full clinical examination beside the following investigations at the start and after 8 weeks [end of the study]: complete blood picture, liver and kidney function tests, K+ and Na+ levels, and hepatic venous pressure gradient [HVPG]. Hepatitis B and C markers. I.H.A for schistosomal affection, abdominal ultrasonography were done only at the start of the study
Results: Initially, the 2 groups of patients were matched for age, sex, aetiology of liver disease, severity of liver disease [Child-Pugh score], biochemical, haematological and endoscopic data at randominzation. At the end of the study, group I had a higher variceal obliteration rate [66.6% vs. 6.7% in group II, P < 0.001] and lower variceal rebleeding [6.7% vs. 40% in group II, P = 0.005]. Portal haemodynamic results showed significant decrease of HVPG in group I [from 20 +/- 3 to 12 +/- 3 mmHg, P < 0.001] with insignificant increase in HVPG in group II. Insignificant correlation between MAP and HVPG was observed. No deterioration of kidney or liver functions were observed. No recorded hypotensive attacks or deaths in both groups
Conclusions: [1] Combination Of endoscopic sclerotherapy and valsartan is superior to sclerotherapy alone in inducing variceal obliteration and decreasing variceal rebleeding in class A and B cirrhotic patients with ruptured oesophageal varices. [2] Valsartan, in an oral dose of 80 mg orally, has a significant portal pressure lowering effect and well tolerated in child A and B cirrhotic patients