Efficacy of Atorvastatin Plus Aspirin in Comparison with Atorvastatin Alone on Liver Function and Degree of Fibrosis in Patients with Cryptogenic Cirrhosis: A Randomized Double-Blind Clinical Trial

Abstract

Objectives: This study was conducted to evaluate the efficacy of a combination therapy using aspirin (also known as acetylsalicylic acid (ASA)) and atorvastatin in comparison with atorvastatin alone to improve liver fibrosis and function in patients with cryptogenic cirrhosis. Methods:In this randomized double-blinded clinical trail, 40 patients with cryptogenic cirrhosis were randomly allocated to the intervention group (atorvastatin + ASA) and the control group (atorvastatin) treated for six months. Then liver function and stiffness (based on transient electrography) were compared. A checklist was used for data collection and the results were analyzed by SPSS 24 using chi-square test and paired t-test at the 0.05 significance level. Results:A total of 33 cases, including16 patients in group A (atorvastatin + ASA) and 17 in group B (atorvastatin + placebo) with a mean age of 50.3 ± 11.2 and 47.9 ± 10.6 years and BMI of 30.7 ± 4.2 and 30.8± 3.1 in groups A and B, were studied, respectively.Twelve patients (75%) in group A and 14 cases (82%) in group B were male. Both groups were homogenized in terms of demographic information at baseline. A significant improvement in Child score (P = 0.001 and P = 0.002 for groups A and B, respectively) and liver stiffness (P < 0.0001 and P = 0.007 for groups A and B, respectively) were observed in both groups after the intervention, however there was no significant improvement in child score (P = 0.982) and liver stiffness (P = 0.611) in comparing both groups. Conclusions:Although atorvastatin is effective in improvement of liver fibrosis and function in cryptogenic cirrhosis, adding ASA cannot improve its effects.

A systematic review on pharmacokinetics, cardiovascular outcomes and safety profiles of statins in cirrhosis

“…Indeed, none of the studies reporting clinical outcomes or safety of statins in cirrhosis provided pharmacokinetic information. These RCTs focused on liver-specific efficacy outcomes including hepatic venous pressure gradient (HVPG] [ 42 , 48 – 50 ], mortality and survival [ 33 , 42 , 51 ], survival in hepatocellular carcinoma [ 31 , 52 ], variceal bleeding [ 33 , 42 , 51 ], and liver stiffness [ 53 ].…”

“…However, this was not seen in the two RCTs included. [ 42 , 53 ] It is important to note that both studies were assessed to be at high risk of bias and low quality (Additional file 1 : Table S3). In conclusion, with the reported risk of rhabdomyolysis and muscle injury, alternatives to simvastatin 40 mg should be considered for studies in decompensated cirrhosis.…”

Vitamin D role in hepatitis B: focus on immune system and genetics mechanism

“…The HBV virus is a noncytopathic virus; liver damages are due to the host immune reaction against its own infected cells [ 120 , 121 ]. Although it has been a long time since the discovery of HBV, the immune-pathogenicity is still unknown.…”