Exploratory study of cardiovascular risk in early type 2 diabetes

Study type
Protocol
Date of Approval
Study reference ID
17_233
Lay Summary

Type 2 diabetes is a serious lifelong disease where the blood glucose is too high. Moreover it is well-known that patients with type 2 diabetes have a high risk for also developing heart disease. However, previous studies have primarily focused on patients with severe diabetes, and little is known about risk of cardiovascular disease in patients with less severe diabetes. We propose to study risk of heart disease in these patients by using routinely collected health information from the Clinical Practice Research Datalink. We will study patients treated with diabetes medications and describe their risk of developing heart disease at the point in time of their diabetes progression where they start the second type of a drug for diabetes. We will examine single risk factors for developing cardiovascular disease as well as use risk factor combination scores to estimate overall risk, and also examine which patients do actually get a diagnosis of heart disease later in life, both overall and in selected subgroups. The study will provide knowledge of whether certain subpopulations of T2D patients could potentially benefit from additional treatment to prevent heart disease.

Technical Summary

This study aims to characterise the cardiovascular risk profile of patients with T2D treated with 1st line anti-diabetic (AD) therapy and about to initiate 2nd line anti-diabetic (AD) therapy. The study will use a CPRD data extract on T2D patients initiating 2nd line AD therapy in year 2001 or later as the basis for a cross-sectional study and a cohort study. In the cross-sectional study, the CVD risk profiling will be conducted by describing the distribution of established CVD risk factors in the year prior to initiating 2nd line AD therapy and by describing the overall CVD risk for this population using the Framingham risk score model and the UKPDS risk engines for estimation of risk of primary events of CVD, stroke and Coronary Heart Disease (CHD), respectively. In the cohort study, patients will be followed up for CVD events and Cox regression analyses will be used to determine the association of baseline CVD risk and the incidence of CVD. CV risk will be examined overall and in selected subgroups expected to have a particular high CV risk. The study will provide knowledge of whether certain subpopulations of T2D patients could potentially benefit from additional CV preventive treatment.

Health Outcomes to be Measured

Individual cardiovascular risk factors; 10-year cardiovascular risk estimated by the Framingham risk score model; Risk of coronary heart disease (CHD) and stroke estimated by UKPDS risk engines; Composite endpoint of CVD mortality, AMI or stroke; Composite endpoint of CVD mortality, AMI, Stroke, hospitalisation for unstable angina hospitalisation for heart failure, or coronary revascularisation; All-cause mortality.

Collaborators

Lise Lotte Nystrup Husemoen - Chief Investigator - Novo Nordisk A/S
Lise Lotte Nystrup Husemoen - Corresponding Applicant - Novo Nordisk A/S
Christin Loeth Hertz - Collaborator - Novo Nordisk A/S
Emina Mocevic - Collaborator - Novo Nordisk A/S
Johanne Spanggaard Piltoft - Collaborator - Novo Nordisk A/S
Kamlesh Khunti - Collaborator - University of Leicester
Mikhail Kosiborod - Collaborator - University of Missouri-Kansas City School of Medicine
Rikke Baastrup Nordsborg - Collaborator - Novo Nordisk A/S
Stephen Bain - Collaborator - Swansea University

Linkages

HES Admitted Patient Care;ONS Death Registration Data;Patient Level Index of Multiple Deprivation