AstraZeneca is developing a new drug to treat hyperkalemia (HPK), which happens when there is too much potassium in the blood. This study will help to determine how many people in England have HPK and will provide information about how commonly HPK occurs in people who have other diseases, such as cardiovascular disease or diabetes. It will also help to determine what characteristics make a person more likely to develop hyperkalemia. Finally, this study will look at what other health events happen to people after experiencing hyperkalemia, including development of additional medical conditions or use of health care services.
The primary objective of this study is to describe the rate of clinical outcomes in patients with HPK. Rates of outcomes will be evaluated for: 1, the overall HPK population, 2, stratified by severity of HPK, and 3, within important clinical subgroups. Secondary objectives include: 1, to describe the annual incidence of HPK; 2, To describe healthcare resource utilization following an incident HPK event; 3, To describe the demographic and clinical characteristics associated with incident HPK.
This study will utilize the Clinical Practice Research Datalink (CPRD) database linked to the Hospital Episodes Statistics (HES) database. Cases of HPK will be identified and used to conduct both a cohort analysis as well as a case-control analysis (to specifically understand characteristics associated with incident HPK). For continuous variables, the number of observations, mean, standard deviation, median, interquartile range, and range will be presented; for categorical variables, the number and percentages of patients in each category will be presented. Event rates and 95% CIs for pre-specified clinical outcomes of interest will be reported as both incidence risks and observation time-adjusted incidence rates. Finally, we aim to identify predictors of clinical outcomes of interest, using Cox regression.
Primary objective: To describe the rate of clinical outcomes (i.e., a subsequent HPK event, heart failure, cardiac arrhythmia, cardiac arrest, declining kidney function, acute kidney injury (AKI), dialysis, all-cause mortality, or hospitalization) in patients with HPK. Rates of outcomes will be evaluated for: 1, the overall HPK population, 2, stratified by severity of HPK, and 3, within important clinical subgroups (i.e., with/without: T2DM, CKD, HF, HTN, RAASi use).. Secondary objectives: 1. To describe the annual incidence of HPK; 2. To describe healthcare resource utilization overall and within important clinical subgroups, following an incident HPK event; 3. To describe the demographic and clinical characteristics associated with incident HPK.
Robert LoCasale - Chief Investigator - Astra Zeneca Inc - USA
Laura Horne - Corresponding Applicant - Astra Zeneca Inc - USA
Akhtar Ashfaq - Collaborator - Astra Zeneca Inc - USA
Qin Lei - Collaborator - Astra Zeneca Inc - USA
Robin Mukherjee - Collaborator - Astra Zeneca Inc - USA
Sharon MacLachlan - Collaborator - Evidera, Inc
HES Admitted Patient Care;ONS Death Registration Data