Introduction

Cirrhosis is a chronic condition with a high mortality. Cirrhotic patients with portal hypertension frequently present with large esophageal varices with bleeding or need for endoscopic intervention. The choice of treatment for variceal hemorrhage is endoscopic ligation and beta-blockers, which can be used as secondary prophylaxis. The pleiotropic effects of statins have been reported for the treatment of cardiovascular diseases, but at the liver level they favor the reduction of the hepatic venous pressure gradient (HVPG), with a decrease in the number of variceal hemorrhage events; however, their use had been restricted in cirrhotic patients due to their association with elevations in liver biochemistries.

Aims & Methods

To evaluate the safety statins in cirrhotic patients with an indication for high cardiovascular risk. And as a secondary aim, determine the presence of variceal hemorrhage during follow-up. This retrospective cohort study was carried out by the "Centro Médico Nacional 20 de Noviembre" between 2018 to 2022. Child Pugh A and B cirrhotic patients with a history of variceal hemorrhage or large varices with endoscopic ligation intervention without active hemorrhage were included and observed over a period of 4 years. To determine adverse events, compatible clinical data and biochemical examinations were searched in the electronic record, and pharmacovigilance committee records were reviewed.

Results

A total of 106 patients were included, of which 53 with statin use and 53 without statins. The characteristics were 41.5% men (n=44), 58.5% women (n=62). The average age was 62 ± 10 years. In order of frequency, the causes were: cryptogenic 25.5% (n=27), hepatitis C virus (HCV) 21.7% (n=23), primary biliary cholangitis (PBC) 14.2% (n=15), metabolic dysfunction-associated fatty liver disease (MAFLD) 13.2% (n=14), alcohol 12.3% (n=13), autoimmune hepatitis (AIH) 11.3% (n=12), hepatitis B virus (HBV) 1.9% (n= 2). With Child Pugh A 67% (n=71) Child Pugh B 35% (n=33). In the statin and non-statin group, the average values of the following variables were PT 12.7 ±1.9 vs 14 ±2.2, AST 39.6 ±24 vs 61 ±40, ALT 37.6 ±28 vs 51 ±38, albumin 3.8 ±0.6 vs 3.6 ±0.5, total cholesterol 157.6 ±35 vs 179.4 ±68, INR 1.06 ±0.17 vs 1.1 ±0.18 (p=< 0.05) (Table 1). In the group of patients with statin use in 18.4% (n=10) Variceal ligation was performed, and in the group without statins, 24.5% (n=13), with a RR of 1.075, 95% CI (0.8-1.3). In the group of patients with statin use, 9.5% (n=5) had a bleeding event, and in the group without statins, 7.5% (n=4) had a bleeding event, with an RR of 1.25, CI 95% (0.3-4.4). None of the participants had clinical adverse effects.

Table 1. Demographics, selected clinical characteristics, and outcomes of patients

Conclusion

The use of statins in cirrhosis compensated with portal hypertension was safe. In this study we could not demonstrate the pleiotropic effect of statins, probably due to the sample size. Therefore, it is necessary to generate subsequent studies including a larger number of patients.

Disclosure

The authors declare that they have no conflict of interest.