Table 1.
Study | Design | Inclusion criteria | Exclusion criteria | Aetiology of cirrhosis | Groups | N | Outcomes of interest | Outcomes | |
Statins users (n) | Non-users (n) |
||||||||
Mohanty et al 24 | Retrospective | HCV-positive patients defined by ICD-9 codes Compensated cirrhosis |
HIV or HBV coinfection Decompensation or HCC before or within 180 days after index date No laboratory results No follow-up Died within 180 days after index date Statin users with only one prescription fill or more than 365 days between first and second fill |
HCV | Statins Nonusers |
685 2062 |
Variceal haemorrhage | Variceal haemorrhage: 9 |
58 |
Abraldes et al 25 | RCT | Age between 18 and 75 years, positive diagnosis of cirrhosis and severe portal hypertension defined as HVPG of 12 mm Hg or greater | Pregnancy Cholestatic liver disease Severe liver failure, evaluated by the presence of a serum bilirubin level greater than 5 mg/dL, prothrombin rate less than 40% Hepatic encephalopathy grades II–IV Child-Pugh score of 12 or greater Serum creatinine level greater than 1.5 mg/dL Hepatocellular carcinoma Portal vein thrombosis |
Mixed | Statins Nonusers |
28 27 |
Reduction in portal hypertension | Reduction in portal hypertension: 9 | 3 |
Abraldes, et al 10 | RCT | Age between 18 and 80 years Previous diagnosis of liver cirrhosis Index variceal bleeding within the previous 5–10 days Plan to start standard treatment for the prevention of variceal rebleeding In woman documented absence of pregnancy and commitment to use adequate contraception if applicable |
Pregnancy or lactation multifocal hepatocellular carcinoma or a single nodule >5 cm in diameter. Creatinine >2 mg/dL Child–Pugh score >13 points Contraindication for statins Patients with HIV infection on protease inhibitors Pretreatment with portosystemic shunt (surgical or percutaneous) Index bleeding due to gastric varices Complete portal vein thrombosis or portal vein cavernomatosis Patients previously treated with the combination of endoscopic banding ligation and NSBB (before the index episode) Patients previously treated with statins within 1 month of randomization |
Mixed | Statins Nonusers |
69 78 |
Variceal haemorrhage | Variceal haemorrhage: 14 | 18 |
Alvarado-Tapias et al 26 | RCT | Cirrhosis, CSPH and high-risk oesophageal varices without previous bleeding | NR | Mixed | Statins Nonusers |
43 44 |
Reduction in portal hypertension | Reduction in portal hypertension: 16 | 8 |
Bishnu et al 27 | RCT | Age: 18–60 years Cirrhosis (diagnosed clinically, radiologically or histopathologically) Portal hypertension (history of variceal bleed, ascites, splenomegaly, oesophageal varices on upper GI endoscopy or history of having undergone EVL) |
Child–Pugh–Turcott (CPT) class C. Hepatic encephalopathy grades II–IV. Hepatocellular carcinoma Portal vein thrombosis or cavernomatosis. Hepatic venous outflow tract obstruction Previous portosystemic shunt surgery Obstructive airway diseases Cardiac conduction abnormalities Peripheral vascular disease Congestive cardiac failure NYHA class II–IV Renal insufficiency (serum creatinine >2 mg/dL) Previous episodes of rhabdomyolysis Hypersensitivity to HMG-CoA reductase inhibitors Previous treatment with HMG-CoA reductase inhibitor Participation in a concurring clinical trial Pregnancy or plan to conceive during study period |
Mixed | Statins Nonusers |
11 12 |
Reduction in portal hypertension Variceal haemorrhage |
Reduction in portal hypertension: 10 Variceal haemorrhage: 4 |
6 5 |
Flores et al 28 | RCT | Cirrhosis and portal hypertension detected using abdominal ultrasound with colour Doppler flowmetry or upper digestive endoscopy | NR | Mixed | Statins Nonusers |
11 11 |
Reduction in portal hypertension | Reduction in portal hypertension: 4 | 0 |
Pollo-Flores et al 29 | RCT | Age 18–75 years Diagnosis of cirrhosis with portal hypertension detected using an abdominal ultrasound with colour Doppler and an upper digestive endoscopy showing gastro-oesophageal varices Both procedures were performed within the previous 6 months |
Aminotransferases levels >3 times above the upper limit of normal (ULN) Recent (within the last 6 months) or current use of simvastatin Portal vein thrombosis, contrast medium allergy Hepatocellular carcinoma or any other malignancy reducing life expectancy Renal failure (creatinine level >1.5 mg/dL) Bleeding disorder (prothrombin activity test <30% or platelet count <35 × 10 9/L) or decompensated cirrhosis characterised by severe ascites or grade II or overt encephalopathy Patients with alcoholic cirrhosis were abstinent from alcohol consumption for at least 1 year |
Mixed | Statins Nonusers |
11 13 |
Reduction in portal hypertension | Reduction in portal hypertension: 6 | 0 |
Rajan et al 30 | RCT | Cirrhotics with varices who had never bled | NR | Mixed | Statins Nonusers |
44 46 |
Reduction in portal hypertension | Reduction in portal hypertension: 22 | 25 |
ALT, alanine aminotransferase; HBV, hepatitis B virus; HCV, hepatitis C virus; ICD-9, International Classification of Disease–9; NR, not reported; NSBB, non-selective beta- blockers; CSPH, clinically significant portal hypertension; EVL, endoscopic variceal ligation; HCC, hepatocellular carcinoma; GI, gastrointestinal; RCTs, randomised controlled trials.