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

Dig Liver Dis. 2015 Nov;47(11):957-63. doi: 10.1016/j.dld.2015.07.156. Epub 2015 Aug 6.


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 6/11 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.

Keywords: Azygos blood flow; Cirrhotic portal hypertension; HVPG; Simvastatin.

Publication types

  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aged
  • Double-Blind Method
  • Endosonography
  • Esophageal and Gastric Varices / etiology
  • Female
  • Gastrointestinal Hemorrhage / etiology
  • Humans
  • Hydroxymethylglutaryl-CoA Reductase Inhibitors / therapeutic use*
  • Hypertension, Portal / drug therapy*
  • Hypertension, Portal / etiology
  • Liver Cirrhosis / complications
  • Male
  • Middle Aged
  • Portal Pressure*
  • Simvastatin / therapeutic use*
  • Treatment Outcome
  • Ultrasonography, Doppler, Color
  • Venous Pressure


  • Hydroxymethylglutaryl-CoA Reductase Inhibitors
  • Simvastatin