This is a prospective, double blind controlled trial in which patients with esophagic variceal bleeding treated with standard therapy (endoscopic variceal ligation(EVL) + B-blockers), will be randomized to receive statins or placebo. They will be followed up during 12 months to determinate whether statins are effective in prevention of variceal bleeding recurrence and evaluate patient survival. Randomization will be stratified according to the degree of hepatic insufficiency, assessed by the Child-Pugh classifications (A,B or C).
A mayor cause of cirrhosis-related morbility and mortality is the development of variceal hemorrhage, a direct consequence of portal hypertension. In addition, survivors of an episode of active bleeding have a 70 % risk of recurrent hemorrhage within two years of the bleeding episode and the highest risk it is situated in the first six weeks after the hemorrhage episode. The recommended treatment in AASLD guidelines is the combination of non selective Betablockers with endoscopic treatment with EVL, with high recurrence (30% in 2 years). The hypothesis of this study is that statins are candidates for improving portal hypertension treatment in patients with cirrhosis, improving vascular function as well as preventing venous thrombotic events. Patients with liver cirrhosis and variceal bleeding with standard treatment will be stratified and after randomized to undergo either statins (20 mg for 15 days, and after 40 mg/day) or placebo. They will be followed up for 12 months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
150
Simvastatin 20 mg for 15 days, then 40 mg until the end of the study.
Simvastatin placebo
Hospital Universitario de Alicante
Alicante, Alicante, Spain
Hospital Clinic
Barcelona, Barcelona, Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, Barcelona, Spain
Hospital German Trias i Pujol
Barcelona, Barcelona, Spain
Hospital de la Vall d'Hebron
Barcelona, Barcelona, Spain
Hospital Universitario del Mar
Barcelona, Barcelona, Spain
Hospital Universitari Bellvitge
L´Hospitalet Del LLobregat, Barcelona, Spain
Corporació Sanitària Parc Tauli
Sabadell, Barcelona, Spain
Hospital Arnau de Vilanova
Lleida, Catalonia, Spain
Complejo Hospitalario Pontevedra
Pontevedra, Galicia, Spain
...and 5 more locations
Recurrence of variceal bleeding and patient survival
Time frame: 12 months
Bleeding severity in both arms.
Time frame: 12 months
Appearance or progression of Portal Hypertension complications
Time frame: 12 months
Appearance or progression of Portal Vein Thrombosis
Time frame: 12 months
Need for alternative treatments (transjugular intrahepatic portosystemic shunt [TIPS], surgery)
Time frame: 12 months
Incidence of adverse events of statin treatment
Time frame: 12 months
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