Investigating the cost effectiveness of alternative oral antiplatelet regimens in patients with type 2 diabetes in England.

Study type
Protocol
Date of Approval
Study reference ID
16_188
Lay Summary

In people with type 2 diabetes, complications like stroke and heart attack, are more common than in the general population. Once one of these complications has occurred, people are at increased risk of a second complication, so to prevent this, medications that are used as 'blood thinners' (aspirin, clopidogrel) are commonly prescribed. Those medications tend to be less effective at preventing these secondary events in people with diabetes than in the general population. Some newer medications have been introduced which may be more effective in the general population and in people with diabetes (ticagrelor, prasugrel). This study will search for the effects of each of these medications used as blood thinners on diabetes-related complications and death. The costs of treating complications will also be calculated by using information about treatments patients receive from the Clinical Practice Research Datalink and hospital-based medical records. Based on the findings about how each medication affects patient outcomes and NHS costs, we will make projections about how the choice of medication affects NHS costs and patient outcomes in the long term. We will estimate what would have happened to NHS costs and patient outcomes if people with type 2 diabetes received the newer blood thinners compared with the older medications.

Technical Summary

Acute coronary syndromes (ACS) represent a subgroup of ischaemic heart diseases ranging from unstable angina to transmural myocardial infarction. Type 2 diabetes populations (T2DM) are of particular interest as a subgroup of ACS sufferers, because ACS can occur if T2DM is not managed correctly, and ACS is one of the most costly complications of T2DM. Antiplatelet therapy is recommended for the secondary prevention of ACS, with aspirin and clopidogrel being the most commonly prescribed agents. In this study, we aim to identify and investigate the economic impact of different antiplatelet regimens in patients with T2DM post-ACS. Starting from descriptive analyses of the patient population, the variation of outcomes and resource use will be explored and long term costs and health effects of different antiplatelet treatments will be investigated. This will be achieved with the use of time-to-event analysis, cost analysis based on information from Clinical Practice Research Datalink (CPRD) and Hospital Episode Statistics (HES), and the use of a decision analytic model which will estimate the mean per patient cost per quality-adjusted-life year gained from the NHS perspective over lifetime.

Health Outcomes to be Measured

Adherence to antiplatelet medicines: Prescription information as recorded from CPRD will be used to estimate patients' adherence to antiplatelet regimens. All-cause mortality: Information about all-cause mortality will be extracted from the CPRD database, ONS and inpatient HES linked datasets. Cardiovascular disease (CVD) related death: Death event related to cardiovascular disease will be separated from the all-cause mortality information. Non-Fatal stroke: Information about stroke events of any type (ischaemic, haemorrhagic, transient ischaemic attack) that are not fatal will be extracted, with information sourced from ICD-10 codes from HES inpatient data. Major adverse cardiovascular events (MACE): MACE will be the composite outcome of interest in the analysis. Bleeding: Hospitalisation events due to internal bleeding will be obtained from the records of HES inpatient admission data. Regimen switch: The event date when patients are switching treatment groups will be obtained from the therapy files of CPRD. Health care costs and resource use: Information about prescriptions, diagnostic tests and primary care contacts will be obtained from CPRD therapy, clinical, additional, and consultation files respectively, whereas outpatient visits in secondary care, visits to A&E, and hospitalisations will be obtained from HES inpatient and outpatient linked datasets. Resource use in primary care will include information about general practice consultations that will be obtained from the consultation files and the clinical files of CPRD respectively.

Collaborators

Tony Avery - Chief Investigator - University of Nottingham
Georgios Gkountouras - Corresponding Applicant - University of Manchester
Li-Chia Chen - Collaborator - University of Manchester
Lukasz Tanajewski - Collaborator - University of Nottingham
Rachel Elliott - Collaborator - University of Manchester
Tony Avery - Collaborator - University of Nottingham

Linkages

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