Non-alcoholic fatty liver disease (NAFLD) is the medial term used to describe fat building up in the liver of people who do not drink excessive levels of alcohol. The advanced form of NAFLD is known as non-alcoholic steatohepatitis (NASH) and occurs when too much fat causes fibrosis (liver scarring) and cirrhosis (liver failure) which may eventually lead to hepatocellular carcinoma (HCC; liver cancer), liver transplantation and mortality (death). The number of people living with NAFLD/NASH is increasingly worldwide. However, it is not fully understood how the condition develops, progresses, is cared for and what are the costs associated with that care. As of April 2019, there are no medicines available to prevent or treat NAFLD/NASH and its health consequences.
The aim of this study is to assess the feasibility of using CPRD/HES linked primary and secondary care data to investigate the patient profiles and health outcomes of individuals with NAFLD/NASH.
Nonalcoholic steatohepatitis (NASH; the progressive form of nonalcoholic fatty liver disease (NAFLD)) is an area of unmet medical need with rising prevalence, patients at risk of liver cirrhosis, hepatocellular carcinoma, liver transplantation and mortality and as of April 2019 no pharmacological therapies approved for marketing authorisation.
This study aims to investigate the clinical course of advanced NAFLD/NASH patients in the United Kingdom (UK) over the study period 1-January-2008 to 31-December-2018, in terms of diagnosis (primary/secondary care), patient characteristics (demography/comorbidities), resource use (imaging/biopsies), and outcomes (HCC/liver transplant/mortality). Individuals aged 18 years and above, with 12 months minimum baseline data at a CPRD practice consenting to data linkage, and have a NAFLD/NASH record in primary (CPRD) or secondary care (HES) during the study period will be included. Patients with viral hepatitis or excessive alcohol use are excluded.
To assess the feasibility of using CPRD/HES to investigate the clinical course of NAFLD/NASH, the following information are requested:
- Number of patients with NAFLD/NASH in CPRD or HES in 2008-2018
- Number and percentage of NAFLD/NASH patients with the following characteristics at the time of diagnosis (baseline) or thereafter (over follow-up):
- compensated liver cirrhosis
- decompensated liver cirrhosis
- portal hypertension
- HCC
- liver transplant
- liver imaging
- liver biopsy
Preliminary code lists for defining cases and health outcomes are provided as separate text files.
If sufficient patients with advanced NAFLD/NASH (inferred from codes for NAFLD/NASH and liver cirrhosis) are identified in CPRD/HES, a full protocol will be developed to research unmet medical needs among these patients. The results will help understand which patients have poor clinical outcomes and could potentially benefit from future therapies designed to treat advanced NAFLD/NASH.
In the event any clinical codes/characteristics result in fewer than 5 events, this data will not be reported, in line with CPRD policy.
Liver cirrhosis; hepatocellular carcinoma; liver transplantation; liver imaging; liver biopsy.
Sreeram Ramagopalan - Chief Investigator - London School Of Economics & Political Science
Victoria Allan - Corresponding Applicant - Bristol-Myers Squibb Pharmaceuticals Limited - UK ( BMS )
Aniket Mohan - Collaborator - Mu SIgma
Dhaval Patil - Collaborator - Bristol-Myers Squibb - USA ( BMS )
Radu Vadanici - Collaborator - Bristol-Myers Squibb - USA ( BMS )
HES Admitted Patient Care