Type 2 diabetes (T2DM) is a common chronic disease with 1 in 10 people over 40 years old in the UK living with the condition. Heart disease is a common complication which affects almost one third of people with T2DM and can lead to worsening health. Heart disease and T2DM have many shared risk factors such as being overweight or having higher blood pressure. Some research to date suggests that some drugs used to control T2DM could reduce the risk of heart disease but results are not clear and mainly apply to a US healthcare context.
In this study, we will use anonymous data from GP and hospital records in England to look at how often people with T2DM experience heart attacks and other type of heart disease depending on their diabetes treatment, comparing glucagon-like peptide-1 receptor antagonists, dipeptidyl peptidase-4 inhibitors, and basal insulin. We will then investigate whether people who have the different diabetes treatments have more or longer stays at the hospital, more cardiology outpatient visits or higher healthcare costs.
Exploring the healthcare use and risk of heart disease for different diabetes drugs will help to better understand how diabetic treatment can be improved especially for patients at high risk of heart disease.
Type 2 diabetes mellitus (T2DM) is a prevalent chronic condition. It is associated with cardiovascular disease (CVD). There are many overlapping risk factors, such as higher body mass index, elevated blood pressure and other lifestyle habits. Some glucose-lowering drugs such as glucagon-like peptide-1 receptor antagonists (GLP-1RA) may be beneficial for CVD risk in diabetics. However, observational research results are mixed and have mainly been conducted in a US-setting.
In this retrospective study, we will use primary and secondary care data from the Clinical Practice Research Datalink (CPRD) and Hospital Episode Statistics (HES) as well as death registrations from the Office for National Statistics to compare differences in cardiovascular outcomes and healthcare use for GLP-1RA, dipeptidyl peptidase-4 inhibitors (DPP4i), and basal insulin. The study population will include all CPRD registered patients aged 18 years and older who have T2DM treated with a drug of interest between January 2014 and December 2018, and established CVD or at highest risk of CVD (based on time since diabetes diagnosis or multimorbidity).
We will calculate the incidence of major cardiovascular events (MACE) in patients exposed to a treatment of interest (GLP-1RA, DPP4i and basal insulin) and compare the occurrence of MACE among those treated with a GLP-1RA and DPP4i or basal insulin using Cox proportional hazard regression. The number of CV-related hospitalisations, revascularisations, and cardiology outpatient visits, as well as length of CV-related hospitalisations will be described and compared, by treatment, using linear regression. The cost of CV-related healthcare use, including interactions, tests, and prescriptions, will be estimated and compared using linear regression models by treatment. For all models, crude, age- and sex-adjusted, and fully-adjusted, to account for confounding, estimates will be generated.
This study should improve understanding of the potential cardiovascular benefits, clinically and to the healthcare system, of different antidiabetic drugs.
Major adverse cardiovascular events (MACE) and its components non-fatal myocardial infarction, non-fatal stroke, CV-related death; CV-related hospitalisations; revascularisations; length of stay for CV-related hospitalisations; cardiology outpatient appointments; costs of CV-related healthcare use including admissions, outpatient attendances, primary care consultations, primary care prescriptions; laboratory tests
Jennifer Davidson - Chief Investigator - Health iQ Ltd ( UK ) t/a CorEvitas
Caitlin Winton - Corresponding Applicant - Health iQ Ltd ( UK ) t/a CorEvitas
Edward Collins - Collaborator - Novo Nordisk Ltd
Gulsah Akin Unal - Collaborator - Health iQ Ltd ( UK ) t/a CorEvitas
harriet larvin - Collaborator - Health iQ Ltd ( UK ) t/a CorEvitas
Hongye Ren - Collaborator - Novo Nordisk A/S
James Baird - Collaborator - Health iQ Ltd ( UK ) t/a CorEvitas
John Tazare - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Judith Ruzangi - Collaborator - Health iQ Ltd ( UK ) t/a CorEvitas
Mico Hamlyn - Collaborator - Health iQ Ltd ( UK ) t/a CorEvitas
Sara Carvalho - Collaborator - Health iQ Ltd ( UK ) t/a CorEvitas
Sasha Berry - Collaborator - Novo Nordisk Ltd
Simon Wan Yau Ming - Collaborator - Health iQ Ltd ( UK ) t/a CorEvitas
James Baird - Collaborator - Health iQ Ltd ( UK ) t/a CorEvitas
Sara Carvalho - Collaborator - Health iQ Ltd ( UK ) t/a CorEvitas
HES Accident and Emergency;HES Admitted Patient Care;HES Outpatient;ONS Death Registration Data;Patient Level Index of Multiple Deprivation