The purpose of this study is to evaluate the effects of continuous simvastatin administration on the hepatic venous pressure gradient (HVPG), as a surrogate marker of prognosis, and its safety in patients with cirrhosis and portal hypertension.
Statins exert beneficial vascular effects independently of cholesterol reduction by improving endothelial dysfunction. In cirrhosis sinusoidal endothelial dysfunction further increases intrahepatic resistance and portal pressure. Previous studies have shown that statins improve hepatic endothelial dysfunction in cirrhosis, suggesting that statins could be an effective therapy for portal hypertension (PHT). This randomized controlled trial evaluated the effects of continuous simvastatin administration on the hepatic venous pressure gradient (HVPG), as a surrogate marker of prognosis, and its safety in patients with cirrhosis and PHT.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
59
20 mg/day p.o., increased to 40 mg/day at day 15 if no safety end-point was met
Placebo with the same characteristics of the drug and at the same dose
Hepatic Hemodynamic Laboratory. Liver Unit. Hospital Clinic.
Barcelona, Barcelona, Spain
Servicio de Gastroenterología, Hospital Ramón y Cajal
Madrid, Madrid, Spain
Servicio de Gastroenterología, Hospital Universitario General Gregorio Marañón
Madrid, Madrid, Spain
Changes in hepatic venous pressure gradient (HVPG)
Time frame: 4 weeks
Changes in systemic hemodynamics
Time frame: 4 weeks
Changes in liver function tests
Time frame: 4 weeks
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