Blood pressure and adverse cardiovascular outcomes in older people with chronic kidney disease and type 2 diabetes

Study type
Protocol
Date of Approval
Study reference ID
23_002560
Lay Summary

People with diabetes often have high blood pressure and their coexistence promote the development of heart and kidney disease, which are leading causes of death. It is well known that appropriate blood pressure control prevents heart disease and early deaths in people with diabetes. Blood pressure control in older people (≥65 years) in general can be especially challenging because of the possibility of adverse effects when overtreated. However, it is more challenging in older people with diabetes. This is partly because most of the published studies have been based on younger adults, with older people only making up a small percentage of participants in some of these studies. Diabetes, high blood pressure and kidney disease are common conditions that co-exist. There is very little information on the impact of blood pressure on heart disease and death in older people with diabetes and kidney disease. The level of blood pressure which can prevent or delay heart disease and death in this group of people is also not well known. Using data collected by GPs all over the country, we will study the relationship between blood pressure and heart disease and death in older people with diabetes and kidney disease. The findings from this study could provide more knowledge on the effective treatment of blood pressure in older people with diabetes and kidney disease.

Technical Summary

The relationship between blood pressure and adverse cardiovascular outcomes in older people with type 2 diabetes (T2D) and chronic kidney disease (CKD) is uncertain. There is also limited data on optimal blood pressure levels for cardiovascular benefit in this population group. Using CPRD data linked to HES APC and ONS, the current study will investigate the longitudinal relationships between blood pressure and the risk of adverse cardiovascular outcomes in older people (≥65 years) with T2D and CKD. A retrospective cohort study design will be used for the analysis. Cox regression analysis will be used to model the associations of blood pressure (systolic blood pressure, SBP and diastolic blood pressure, DBP) with adverse cardiovascular outcomes, whilst adjusting for key confounders such as age, sex, duration of T2D, prescription of antidiabetic and cardiovascular drugs, smoking status, body mass index (BMI), previous diagnoses of cardiovascular disease (CVD) and frailty. We will also assess for evidence of effect modification by important characteristics such as age, body mass index, CKD stage, frailty and ethnicity, using interaction analyses.

Health Outcomes to be Measured

Primary (cardiovascular) outcomes: 3-point MACE (major adverse cardiovascular events) defined as nonfatal stroke, nonfatal myocardial infarction and cardiovascular death.
Secondary outcomes: Other cardiovascular endpoints and all-cause death.

Collaborators

Setor Kunutsor - Chief Investigator - University of Leicester
Setor Kunutsor - Corresponding Applicant - University of Leicester
Clare Gillies - Collaborator - University of Leicester
Francesco Zaccardi - Collaborator - University of Leicester
Kamlesh Khunti - Collaborator - University of Leicester
Sharmin Shabnam - Collaborator - University of Leicester

Linkages

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