BACKGROUND AND AIM: Statins can modulate portal microvascular dynamics in patients with cirrhosis. We present data from a proof-of-concept study aimed at comparing combination of propranolol and atorvastatin versus propranolol alone in reducing portal pressure in patients with cirrhosis. PATIENTS AND METHODS: In this open-label proof-of-concept study, 23 consecutive patients with cirrhosis were randomized into group A (incremental dose propranolol, n=12) or group B (atorvastatin 20 mg daily with propranolol in incremental dose, n=11). Hepatic venous pressure gradient (HVPG) was estimated at baseline, and after 30 days, clinical outcomes were evaluated after 1 year. RESULTS: The two groups were matched with respect to etiology of cirrhosis; clinical, biochemical, and endoscopic parameters; child status; and baseline HVPG. Decreases of wedged hepatic venous pressure, free hepatic venous pressure, and HVPG in group A and group B after 30 days were 4.67±2.57 versus 6.09±3.56 (P=0.290), 1.83±2.62 versus 1.27±1.67 (P=0.546), and 2.58±1.88 versus 4.81±2.82 mmHg (P=0.041), respectively. The proportion of HVPG responders in group A and group B were 50.00 and 90.91%, respectively. The two groups did not, however, differ significantly in terms of clinical outcomes (variceal bleed, endoscopic variceal ligation sessions, hepatic encephalopathy, requirement of therapeutic paracentesis, spontaneous bacterial peritonitis, and death). CONCLUSION:Decrease of HVPG in patients with cirrhosis treated withatorvastatin and propranolol is significantly more than those treated with only propranolol. Atorvastatin, with its pleiotropic effects, may be useful in portal hypertension in cirrhosis. Larger data sets are required for ratification.
RCT Entities:
BACKGROUND AND AIM: Statins can modulate portal microvascular dynamics in patients with cirrhosis. We present data from a proof-of-concept study aimed at comparing combination of propranolol and atorvastatin versus propranolol alone in reducing portal pressure in patients with cirrhosis. PATIENTS AND METHODS: In this open-label proof-of-concept study, 23 consecutive patients with cirrhosis were randomized into group A (incremental dose propranolol, n=12) or group B (atorvastatin 20 mg daily with propranolol in incremental dose, n=11). Hepatic venous pressure gradient (HVPG) was estimated at baseline, and after 30 days, clinical outcomes were evaluated after 1 year. RESULTS: The two groups were matched with respect to etiology of cirrhosis; clinical, biochemical, and endoscopic parameters; child status; and baseline HVPG. Decreases of wedged hepatic venous pressure, free hepatic venous pressure, and HVPG in group A and group B after 30 days were 4.67±2.57 versus 6.09±3.56 (P=0.290), 1.83±2.62 versus 1.27±1.67 (P=0.546), and 2.58±1.88 versus 4.81±2.82 mmHg (P=0.041), respectively. The proportion of HVPG responders in group A and group B were 50.00 and 90.91%, respectively. The two groups did not, however, differ significantly in terms of clinical outcomes (variceal bleed, endoscopic variceal ligation sessions, hepatic encephalopathy, requirement of therapeutic paracentesis, spontaneous bacterial peritonitis, and death). CONCLUSION: Decrease of HVPG in patients with cirrhosis treated with atorvastatin and propranolol is significantly more than those treated with only propranolol. Atorvastatin, with its pleiotropic effects, may be useful in portal hypertension in cirrhosis. Larger data sets are required for ratification.
Authors: Melissa Merkel; Christina Schneider; Robin Greinert; Alexander Zipprich; Cristina Ripoll; Frank Lammert; Matthias C Reichert Journal: Hepatol Commun Date: 2021-08-28