AstraZeneca is developing a new drug to treat hyperkalemia (HPK), which happens when there is too much potassium in the blood. One class of drugs that may increase the chance that someone develops HPK are Renin-angiotensin-aldosterone system inhibition (RAASi) drugs, which are often used to treat high blood pressure and heart failure. Some doctors may choose to change RAASi treatment for patients following an episode of HPK, including switching drugs, increasing or decreasing the dose, or stopping the drug altogether. This study aims to understand what changes are typically made in patient’s RAASi use after a first event of HPK. A second goal of the study is to understand how frequently other health consequences occur following HPK, and whether those event rates differ based on changes in RAASi treatment.
The first objective of this study is to describe RAASi use patterns following incident HPK event. All patients with incident HPK between 2009 and 2013 will be identified and those with concomitant RAASi use at the time of HPK will be included in this study. Patients will be classified following HPK by their next prescription for RAASi treatment, which will include: 1. continue at the same dose, 2. dose increase (same drug), 3. dose decrease (same drug), 4. change RAASi, 5. discontinue RAASi, or 6. augment with additional treatment for hyperkalemia. The second primary objective is to quantify the rate of important clinical events following incident hyperkalemia, stratified by the six defined sub-groups.
This study will utilize the Clinical Practice Research Datalink (CPRD) database linked to the Hospital Episodes Statistics (HES) database. Cases of HPK with concomitant RAASi use at the time of HPK will be identified. 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 clinical outcomes of interest will be reported as both incidence risks and observation time-adjusted incidence rates.
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