Date of Approval:
Alcoholic hepatitis (AH) is a disease of the liver caused by excessive drinking. AH can occur suddenly and can last for a long time. People with the disease have poor appetite, vomiting, weight loss, tiredness, fever, jaundice etc. AH can lead to long lasting problems and even death. Death among patients with serious AH is up to 50% while in mild cases it could be responsible for the death of up to 10% of people affected. In order to propose interventions aimed at relieving the burden of AH, it is important to first of all establish the “incidence” (new cases of AH within the population in a given year) of the disease in various populations. Only few studies have tried to establish the annual incidence of AH overtime and none has been conducted using a large UK population. This study will aim to determine the “annual incidence” (new cases of AH within the population in a given year) from 2016 to 2019 using the CPRD. Furthermore, we will analyse the annual incidence by gender and age category from 2016 to 2019.
Alcoholic hepatitis is an acute manifestation of alcoholic liver disease with mortality as high as 40–50 % in severe cases. This disease results mostly from prolonged alcohol abuse with or without a known history of liver disease. Although there is significant variability in severity at presentation, patients with severe alcoholic hepatitis typically, present with anorexia, fatigue, fever, jaundice, and ascites. In recent times only a few studies have tried to evaluate the trends of AH in Europe, with no recent study aimed at evaluating this question in the UK. Understanding trends of AH can help redirect healthcare policies and interventions to subgroups most affected by the disease, allow comparison between countries to aid healthcare planning, predict future healthcare challenges, and provide a basis for improving management in the future. Thus the aim of this study will be to evaluate the annual incidence rates of AH by age and gender in the UK from 2016 to 2019. The rates for AH in each calendar year will be calculated as the sum of AH in that year divided by the total duration of follow-up, in the given calendar year. This will be expressed as the number of patients with AH per 1000 person-years. We will break down these rates by gender, age categories (<18y., 18-65y., >65y.) . All analyses will be carried out using SAS 9.4 (SAS Institute, Cary, NC).
Health Outcomes to be Measured:
Primary outcome: The primary outcome of the study will be AH using read code: J611, J617, J617000, or ICD-10 code: K70.1 from the clinical and referral files. Secondary outcome: The secondary outcomes will included narrow definition for AAH defined as patients with alcoholic hepatitis (Read code: J611, J617 or ICD-10 code: K70.1) and at least one of the codes for the following diagnosis present: ascites, gastrointestinal haemorrhage, hepatic encephalopathy, cirrhosis, alcoholic hepatic failure, malnutrition. hepatorenal syndrome /renal failure, pancreatitis, alcohol abuse, alcohol dependence or alcohol withdrawal (see table appendix) from the referral and clinical files Furthermore, we will aim to assess the incidence rate of AH using read code: J611, J617, J617000 or ICD-10 code: K70.1 or patients with hepatitis unspecified, without codes for Hepatitis C Virus (HBC)/Hepatitis B Virus (HBV)/Autoimmune hepatitis (AIH)/Primary biliary cholangitis(PBC)/Primary sclerosing cholangitis(PSC)/Hemochromatosis) and a code related to excessive alcohol consumption, alcohol abuse or alcoholism treatment referral and clinical files.
Sigrid Behr - Chief Investigator - Novartis Pharma AG
Olorunfemi Oshagbemi - Corresponding Applicant - NOVARTIS
Olessia Zorina - Collaborator - NOVARTIS