Clinical studies are often conducted with selected sub-groups of patient populations, meaning that the results dont necessarily apply to everyone in the patient population. This is the case with studies that explored the effect of medications within a class of treatment for type 2 diabetes (T2D) called GLP-1 receptor agonists on the risk of heart attack or stroke. Although several of the studies showed that some medications within the class reduce the risk of heart attack or stroke, the studies differed greatly regarding the types of patients that were studied in terms of their underlying risk of heart attack or stroke. The aim of this study is to compare the risk profiles for heart attack and stroke of the participants in the studies mentioned with the risk profiles for heart attack and stroke of the T2D population in UK general practice. This will determine the extent to which the results of each of those studies can be applied to the UK T2D population.
The aim of the study is to determine the extent to which patients with T2D enrolled into the REWIND, LEADER and SUSTAIN-6 Cardiovascular Outcome Trials (CVOTs) are representative, from a CV profile perspective, of T2D patients in UK routine clinical practice. A cross-section of adult patients with a diagnostic code indicative of T2D or treatment history with at least 2 classes of glucose lowering medications will be selected in CPRD at a single point of time, and those eligible for linkage with HES Admitted Patient Care records will form the analytical cohort.
A combination of Read Codes, ICD and procedural codes, or laboratory test results will be applied in the linked HES-CPRD dataset to determine the CV criteria for each of the REWIND, LEADER and SUSTAIN-6 CVOTs. Counts and proportion of T2D patients included in the linked CPRD-HES database who match the CV profile of participants in REWIND, LEADER and SUSTAIN-6 will be estimated. This study will generate evidence about the representativeness of each CVOT for the UK population with T2D and therefore the extent of the generalisability of their results to the UK T2D population.
Primary outcome:
Counts and proportion of T2D patients in the UK primary care who meet the CV criteria for each of the following CVOTs:
o REWIND (n, %)
o LEADER (n, %)
o SUSTAIN-6 (n, %)
Secondary outcomes:
Counts and proportion of T2D patients in the UK primary care who meet the core criteria (CV profile, age, BMI, HbA1c and eGFR, medication history) for each of the following CVOTs:
o REWIND (n. %)
o LEADER (n, %)
o SUSTAIN-6 (n, %)
Descriptive statistics (n, %, mean, SD) of clinical and demographic characteristics of T2D patients in the UK primary care:
o Age (years) : mean, SD
o Gender (cat: male/female): n, %
o HbA1c (%): mean, SD
o eGFR (ml/min/1.73m2): mean, SD
o eGFR (ml/min/1.73m2)
? <60 (n, %)
? >=60 (n, %)
o Disease duration (years): mean, SD
Exploratory outcomes:
Counts and proportion of patients with T2D in UK primary care who meet the applicable established CV disease criteria for each of the following CVOTs:
o REWIND (n. %)
o LEADER (n, %)
o SUSTAIN-6 (n, %)
Counts and proportion of patients with T2D in UK primary care who meet the applicable CV risk factors criteria for each of the following CVOTs:
o REWIND (n. %)
o LEADER (n, %)
o SUSTAIN-6 (n, %)
Jonathan Rachman - Chief Investigator - Eli Lilly & Co - UK
Dionysios Spanopoulos - Corresponding Applicant - Eli Lilly & Co - UK
Antje Hottgenroth - Collaborator - Lilly Deutschland GmbH
Christina Diomatari - Collaborator - Adelphi Real World
Iskandar Idris - Collaborator - University of Nottingham
Joanne Webb - Collaborator - Eli Lilly & Co Ltd - US Headquarters
Julie Mount - Collaborator - Eli Lilly & Co - UK
Lill-Brith von Arx - Collaborator - Eli Lilly & Co - UK
Olivia Massey - Collaborator - Adelphi Real World
Robert Wood - Collaborator - Adelphi Real World
Theo Tritton - Collaborator - Adelphi Real World
HES Admitted Patient Care