Obesity increases the risk of heart disease, and new treatments for people with obesity and heart disease are developed in clinical trials. Physicians find it hard to use the treatments developed in clinical trials, because they are concerned about whether the trial participants differ from their own patients. If there are big differences, the new treatments may not work safely in their patients.
We will therefore study if a population with obesity and heart disease as defined in a clinical trial reflect patients in general practice in England. To do this, we will use data from the AURUM Clinical Practice Research Datalink (CPRD). In these data, we will define a population from a set of often used trial criteria, and describe age, gender, ethnicity, race, and body mass index in the population.
Hopefully, the study may guide physicians about whether treatments developed in clinical trials are relevant to their broad patient population.
Obesity is associated with a wide range of cardiovascular (CV) risk factors, and obesity increases the risk of CV morbidity and mortality. Several clinical trials have therefore evaluated the CV benefit of different interventions in people with obesity and CV disease (CVD). Currently, there is a strong need to apply interventions to people with obesity and CV disease, but physicians often find it challenging to apply the lessons from clinical trials to their patients. Strict eligibility criteria in clinical trials may exclude relevant participants, and the trial population may not include groups representing large fractions of those who the physician see as candidates for treatment.
We will therefore use a set of commonly used trial eligibility criteria to extract a population with obesity and atherosclerotic CVD (ASCVD) from a large population of patients seen in general practice in England. In this population, we will describe basic demographic characteristics.
The objective of the study is to describe a middle-aged population with obesity, ASCVD and no diabetes according to gender, age, ethnicity, race, and body mass index (BMI).
The study is an observational, cross-sectional study of patients aged at least 45 years with obesity (BMI ≥27 kg/m2), ASCVD (ischemic heart disease, cerebrovascular disease, peripheral arterial disease), and no type 1 or type 2 diabetes registered in the AURUM Clinical Practice Research Datalink (CPRD). These patients will be characterised according to ethnicity and race derived from registrations in the Hospital Episodes Statistics (HES) and according to gender, age and BMI registered in CPRD AURUM at index date.
Hopefully this study may guide clinicians about whether interventions developed in a strictly defined clinical trial setting are relevant to their broader patient populations.
The five outcomes for the basic demographic description are age; gender; body mass index; race; ethnicity.
Details on the outcome variables are listed in the Section “Exposures, Outcomes and Covariates”.
Marie Michelsen - Chief Investigator - Novo Nordisk A/S
Tina Landsvig Berentzen - Corresponding Applicant - Novo Nordisk A/S
Lise Lotte Nystrup Husemoen - Collaborator - Novo Nordisk A/S
Mads Jeppe Tarp-Johansen - Collaborator - Novo Nordisk A/S
HES Admitted Patient Care