A comparison of the EMPA-REG OUTCOME clinical trial population with T2DM patients treated in the routine clinical practice: An exploratory study using the Clinical Practice Research Datalink (CPRD).

Date of Approval: 
2016-12-08 00:00:00
Lay Summary: 
The study 'Empagliflozin, Cardiovascular Outcomes, and Mortality in Type 2 Diabetes' provided evidence that patients with Type 2 Diabetes who were at high risk of heart disease and were treated with empagliflozin, were less likely to die from heart disease, lived longer and were less likely to be hospitalised with heart failure. Nevertheless, patients included in the study had to meet specific criteria which suggests, that study participants might differ from the general patient population with Type 2 Diabetes in the community. The purpose of this study is to assess the eligibility of Type 2 Diabetes patients treated in community to the aforementioned study and examine their characteristics. As a result, this study can contribute in raising awareness about the actual patient population that is more likely to benefit from treatment with empagliflozin. This is a descriptive study using CPRD data.
Technical Summary: 
The intention of the study is to determine how representative the participants of EMPAREG-OUTCOME RCT are to T2DM patients identified from primary care records. A T2DM patient cohort will be defined in CPRD on which the inclusion and exclusion criteria of the EMPA-REG OUTCOME RCT will be operationalised to define a patient cohort that would be eligible for inclusion in the RCT. This patient subpopulation will be further characterised in terms of clinical and demographic parameters to understand how 'real world' patients matching RCT's eligibility criteria, compare to patients that actually took part in the RCT. As a result, this study can contribute in raising awareness about the generalizability of RCT results and the representativeness of RCT patients. The treatment history of patients who participated in the EMPAREG-OUTCOME RCT has been reported in detail in the supplementary material section of the study report, including history of glucose lowering therapy, anti-hypertensive therapies, lipid lowering therapies and anticoagulants. The proposed study therefore will also describe the treatment history of patients treated in routine clinical practice who meet the main eligibility criteria of the clinical trial.
Health Outcomes to be Measured: 
The main outcome of the study is the percentage of patients who meet EMPA-REG OUTCOME clinical trial eligibility criteria from the initial T2DM patient cohort.
Application Number: 

Kamlesh Khunti - Chief Investigator - University of Leicester
Dionysios Spanopoulos - Corresponding Applicant - Eli Lilly & Co - UK
Alicia Gayle - Collaborator - Imperial College London
Andrew Pain - Collaborator - Boehringer-Ingelheim Pharmaceuticals, Inc
Chris D Poole - Collaborator - Digital Health Labs Limited
Emaddin Kidher - Collaborator - Eli Lilly & Co Ltd - US Headquarters
Emma Forsyth - Collaborator - Boehringer-Ingelheim - UK
Ilana Gibbons - Collaborator - Boehringer-Ingelheim Pharmaceuticals, Inc
William Henry Fitzgerald Spencer - Collaborator - Boehringer-Ingelheim Pharmaceuticals, Inc