Diabetic retinopathy (DR) is a complication of diabetes that can result in vision loss and blindness in adults. It has increased the burden on the healthcare system and economy. However, there are few symptoms of DR reveled until develops into an advanced stage and vision loss occurs, indicating that the best treatment period has been missed. Sight-threatening diabetic retinopathy (STDR) is the advanced stage of DR, which affects 3% of people with type 2 diabetes. In the UK, most people with diabetes are type 2 diabetes and many of them have cholesterol disorders. Previous studies reported the fenofibrate could help people with DR by delaying the onset of DR, slowing the development of DR, and reducing the need for treatment for DR. However, little convincing data supported these associations. In our study, we will explore whether there are potential benefits of fenofibrate on STDR in people with type 2 diabetes, analysing medical records from the CPRD primary care database.
The aim of this study is to explore whether fenofibrate has additional benefits on DR in people with type 2 diabetes. This is due to previous studies that fenofibrate treatment may be related to reducing the risk of DR, however, there is no robust evidence to support this association. Therefore, this study is to design a retrospective cohort study with a new prevalent user design to investigate the effects of fenofibrate on DR in participants with type 2 diabetes, using the CPRD primary database selected by Read codes (CPRD GOLD) and SNOMED-CT codes (CPRD Aurum). People who received fenofibrate treatment will be included in the exposed group, which will be compared to individuals in the unexposed group who only received statins treatment. Given most people using fenofibrate have previously been treated with statins, we will apply propensity score matching tool to eliminate prescription by indication bias. Participants with balanced baseline characteristics in the exposed and unexposed groups will be identified through matching relevant covariates in the data extraction and analysis.
For the primary data analysis, the outcome of interest is the incidence of STDR in the exposed group compared to the unexposed group. The Cox proportional hazard models will be applied to calculate crude hazard ratios (HR) and adjusted hazard ratios (aHR) with 95% confidence intervals (CIs) of STDR comparing effects of fenofibrate with statins.
The implications of this study are to provide suggestions for clinicians in prescribing lipid-lowering medications to people with type 2 diabetes who are at the risk of DR.
The incidence of sight-threatening diabetic retinopathy (STDR)
Jingya Wang - Chief Investigator - University of Birmingham
Luyuan Tan - Corresponding Applicant - University of Birmingham
Krishnarajah Nirantharakumar - Collaborator - University of Birmingham
Practice Level Townsend Index