Prevalence of established cardiovascular disease in patients with type 2 diabetes mellitus in the UK

Study type
Protocol
Date of Approval
Study reference ID
19_137
Lay Summary

Acknowledging the results of recent cardiovascular outcomes trials in diabetes patients with superiority of the tested intervention in patients with established cardiovascular disease, we aim to identify the percentage of type 2 diabetes mellitus patients who have established cardiovascular disease in the UK.
Our objective is to describe the prevalence of established cardiovascular disease including stroke and TIA (cerebrovascular disease), myocardial infarction, peripheral artery disease, coronary artery disease and heart failure within the cohort of patients with type 2 diabetes in the United Kingdom.

Technical Summary

Acknowledging the results of recent cardiovascular outcomes trials in diabetes patients with superiority of the tested intervention in patients with established cardiovascular disease, we aim to identify the percentage of type 2 diabetes mellitus patients who have established cardiovascular disease in the UK.
Our objective is to describe the prevalence of established cardiovascular disease including stroke and TIA (cerebrovascular disease), myocardial infarction, peripheral artery disease, coronary artery disease and heart failure within the cohort of patients with type 2 diabetes in the United Kingdom.
This is a retrospective database study from the CPRD database.
We will analyse data from adults (>/=18 years of age) patients with type 2 diabetes in the UK.
There is a one year index period to identify eligible patients and a minimum of one year look back period. All available medical records prior to and including the index date will be examined.

Health Outcomes to be Measured

We aim to identify the proportion of patients who have either individual condition:

Prevalence of the following diseases within type 2 diabetes %
Post myocardial infarction
Post ischemic stroke/TIA
Peripheral artery disease
Heart failure
Angina pectoris
Coronary artery disease
Any of the above conditions ("established cardiovascular disease")

We will further determine if there are differences in the group of patients with established cardiovascular disease over those without with regards to:
Age (years of age, in years)
Gender (% of male gender; assessed: male, female)
Kidney function (estimated glomerular filtration rate in ml/min/1.73 m2 body surfaced as found in the records. Displayed as % of patients in the respective classes of international KDIGO classification – CKD1, 2, 3a, 3b, 4, 5 – and as a median with IQR).
Most recent LDL-cholesterol values (mmol/L, mean and 95% CI)
Most recent systolic and diastolic blood pressure values (mmHg, median and IQR)
Most recent HbA1C (%A1C, mean and 95%CI, as well as patients with A1C in the fixed categories <7%, <8%, <9%, >=9%)
Smoking status (patients who had ever smoked in their life, %).

Collaborators

Dominik Lautsch - Chief Investigator - Merck & Co., Inc.
Dominik Lautsch - Corresponding Applicant - Merck & Co., Inc.
Lingfeng Yang - Collaborator - Merck & Co., Inc.
Tongtong Wang - Collaborator - Merck & Co., Inc.