Characterisation and cardiovascular risk profile of type 2 diabetes mellitus patients according to initiation of antidiabetic medications

Date of ISAC Approval: 
29/06/2016
Lay Summary: 
Recent clinical trials have found that new oral antidiabetic medications used in patients with type 2 diabetes might have a protective effect with respect to heart or blood vessel disease. This study will describe different subgroups of patients with type 2 diabetes who starts different classes of antidiabetic medications. Existing diseases, drug treatments and other characteristics will be described in these subgroups. Further, the rates of heart or blood vessel disease and mortality will be described. This information will help understand whether it is possible to conduct studies using routinely collected data to determine whether different types of antidiabetic medications have a protective effect on the risk of heart or blood vessel disease.
Technical Summary: 
The objective of this retrospective cohort study using the Clinical Practice Research Datalink (CPRD) database is to provide a characterisation of patients with type 2 diabetes mellitus (T2DM) according to initiation (index date) of antidiabetic medications including sodium glucose co-transporter-2 inhibitors (SGLT-2), dipeptidyl peptidase-4 inhibitors (DPP-4), sulphonylureas (SU), glucagon-like peptide-1 agonists (GLP-1) and other standard of care (SOC) treatments from November 1st, 2012 until last date of observation. The study will also describe the crude incidence rate of cardiovascular (CV) outcomes and mortality rate in the study cohorts. Outcomes will include hospitalisation for heart failure (HF), myocardial infarction , stroke, transient ischaemic attack (TIA), unstable angina and multi-vessel coronary artery disease; all-cause mortality and CV mortality. Propensity scores will be calculated to assess comparability between SGLT-2 users and groups of potential comparators. This is to assess the feasibility of conducting the next step; a potentially comparative study between SGLT-2 users and a suitable control group. The descriptive analyses will be performed overall, by antidiabetic medication, by matched comparator groups and a subset of patients with established CV disease. A descriptive comparison of CV outcomes/mortality between SGLT-2 users and propensity score matched comparator groups will be performed.
Health Outcomes to be Measured: 
Cardiovascular disease outcomes (fatal and non-fatal) Hospitalisation for specific CVD events Heart failure Myocardial infarction Stroke Transient ischaemic attack Unstable angina Multi-vessel coronary artery disease All-cause mortality Cardiovascular mortality
Collaborators: 

Karolina Anderson Sundell - Chief Investigator - Astra Zeneca R&D Molndal Sweden
Betina Blak - Corresponding Applicant - Astra Zeneca Ltd - UK Headquarters
Lucia Soriano - Researcher - University Complutense of Madrid
Dr Marcus Thuresson - Collaborator - Statisticon AB
Nikita Arya - Researcher - Clinical Solutions Group
Niklas Hammar - Researcher - Astra Zeneca Inc - USA
Peter Fenici - Researcher - Astra Zeneca Inc - USA

Linkages: 
HES Admitted;HES Admitted;ONS;ONS;Patient IMD;Patient Townsend;Patient Townsend