The use of statins is associated with >40% lower risk of decompensation and death in HCV infected patients with compensated cirrhosis, according to a retrospective study.1,2
The role of statins in the management of hyperlipidemia and the prevention of associated cardiovascular events is well-established. Due to concerns of elevated transaminases, statins are contraindicated in patients with active liver disease as labelled in the package inserts.
“The use of statins is generally avoided in people with liver disease because of the possibility of hepatotoxicity”, said Dr. Arpan Mohanty, clinical fellow of the Section of Digestive Disease at the Yale University School of Medicine in the International Liver Congress 2015 in echoing the concerns of physicians. As such, patients with liver diseases are less likely to be prescribed statins. “However, statins are less dangerous than it is thought”, she continued with presenting the latest findings on the use of statins in cirrhotic patients with hepatitis C virus (HCV) infection.2
It was a large-scale observational study in patients with compensated HCV-cirrhosis (n=40,512) in a large cohort of US-veterans. Within this cohort, 685 statin users were propensity-score matched with 2,062 non-users (c-statistic: 0.92).1,2
Statin users were predominantly on simvastatin (85%). In a median follow-up of approximately 2 years, the use of statins was associated with a lower overall risk of decompensation (HR=0.55, 95%CI:0.39-0.77) and death (HR=0.56, 95%CI:0.45-0.69) compared to nonuse, including lower risks of variceal hemorrhage (HR=0.39, 95%CI:0.19-0.78) and ascites (HR=0.59, 95%CI:0.39-0.91), but not a lower risk for the development of spontaneous bacterial peritonitis. These findings remain significant after adjustment for antiviral therapy.
In addition, statin users were found having lower risks of development of hepatocellular carcinoma (HR=0.42, 95%CI:0.27-0.64) as well as liver transplantation (HR=0.37, 95%CI:0.15-0.96)
Although statins can be hepatotoxic (increasing the level of transaminases), this is usually mild and self-limited,3 and their safety has been shown previously in patients with chronic liver diseases.4-6 Previous studies have indicated that statins can prevent the progression of hepatic fibrosis in patients with hepatitis C virus (HCV) infection, improve virological response (VR) rates to antiviral therapy and decrease the incidence of hepatocellular carcinoma (HCC).7 The study by Mohanty et al. takes this even a step further by demonstrating that the use of statin in patients with HCV infection, who already have developed compensated cirrhosis, is associated with a significant lower risk of hepatic decompensation or death. This is of great clinical importance in a patient population with limited treatment options beyond liver transplantation and high mortality rates.
“We may have something right in front of us that is very effective”, commented by session moderator (of ILC 2015) Aleksander Krag, MD, from the University of Southern Denmark. However, “We should be cautious in interpreting a retrospective study, which reinforces the need to do a randomized trial to prove this”, he noted.
Agreeing with Dr. Krag, “Until randomized controlled trials are established to confirm these results, statins cannot be widely recommended in this setting; however, in patients who otherwise require statins, their use should not be avoided,” added Dr. Mohanty2, and emphasized in the recently published article in Gastroenterology.1