Cholesterol lowering medications and risk of fatty liver disease and liver cancer

Study type
Protocol
Date of Approval
Study reference ID
17_256
Lay Summary

Statins are cholesterol-lowering medications prescribed to prevent cardiovascular disease. In a previous CPRD study, our group found that statin use was associated with a reduced risk of developing primary liver cancer. Whether statins are also associated with a reduced risk of developing a precursor of liver cancer, fatty liver disease, has not been well studied. Also not well studied is whether other cholesterol lowering drugs (bile acid resins, cholesterol absorption inhibitors, fibrates, niacin, and omega 3 fatty acids) are associated with a lower risk of fatty liver disease or liver cancer. Therefore, the proposed study will examine the relationship between all cholesterol lowering medications and the development of fatty liver disease and liver cancer. If an association exists between any cholesterol lowering medications and fatty liver disease or liver cancer, there could be significant public health implications as one third of the adult population in developed countries is estimated to have fatty liver disease and liver cancer incidence rates are rising.

Technical Summary

In a previous CPRD study, our group found that use of statins (HMG-CoA reductase inhibitors) was associated with a significantly reduced risk of primary liver cancer. Whether statins are also associated with a reduced risk of developing a precursor of liver cancer, fatty liver disease, has not been well studied. Also not well studied is whether other cholesterol lowering drugs (bile acid resins, cholesterol absorption inhibitors, fibrates, niacin, and omega 3 fatty acids) are associated with a lower risk of fatty liver disease or liver cancer. Therefore, the proposed study will examine the effect of all classes of cholesterol lowering medications on risk of fatty liver disease and liver cancer. We propose to conduct a case-control study which will match controls to cases at a 4:1 ratio. Matching factors include age, sex, general practice and length of time in CPRD. We will examine ever/never use as well as duration of use, cumulative dose (summation of doses in each prescription), and length of use. We will use conditional logistic regression to assess crude and adjusted risk estimates (odds ratios and 95% confidence intervals).

Health Outcomes to be Measured

Liver Cancer; Fatty Liver Disease.

Collaborators

Katherine McGlynn - Chief Investigator - National Institutes of Health - USA
Katherine McGlynn - Corresponding Applicant - National Institutes of Health - USA
Barry I Graubard - Collaborator - National Cancer Institute ( NCI )
Jake Thistle - Collaborator - National Cancer Institute ( NCI )
Jessica Petrick - Collaborator - National Cancer Institute ( NCI )