Three months of simvastatin therapy vs. placebo for severe portal hypertension in cirrhosis: A randomized controlled trial

Background: Pleiotropic effects of statins decrease intrahepatic resistance and portal hypertension. Aim: We evaluated the effects of simvastatin on hepatic venous pressure gradient (HVPG) and azygos vein blood flow in cirrhotic patients. Methods: A 3-month prospective, randomized, triple-blind trial with simvastatin (40 mg/day) vs. placebo was conducted in patients with cirrhotic portal hypertension. HVPG and azygos blood flow, measured by colour Doppler endoscopic ultrasound, were assessed before and after treatment. The primary endpoint was a decrease in the HVPG of at least 20% from baseline or to <= 12 mmHg after the treatment. Results: 34 patients were prospectively enrolled, and 24 completed the protocol. In the simvastatin group 6111 patients (55%) presented a clinically relevant decrease in the HVPG; no decrease was observed in the placebo group (p = 0.036). Patients with medium/large oesophageal varices and previous variceal bleeding had a higher response rate to simvastatin. HVPG and azygos blood flow values were not correlated. No significant adverse events occurred. Conclusion: Simvastatin lowers portal pressure and may even improve liver function. The haemodynamic effect appears to be more evident in patients with severe portal hypertension. (C) 2015 Editrice Gastroenterologica Italiana S.r.l. Published by Elsevier Ltd. All rights reserved.