Hyperkalaemia is caused by elevated potassium levels in the blood and can cause irregular heart rhythms that can affect the normal functioning of the heart and can be life-threatening. Hyperkalaemia is traditionally treated with reducing dietary potassium, withdrawing or reducing exacerbating medications like renin-angiotensin-aldosterone system inhibitor (RAASi) therapy which helps to regulate blood pressure and fluid balance in the body, or by administering potassium binder medications. Although RAASi treatment is a cornerstone of chronic kidney disease and heart failure treatment, it can also cause hyperkalaemia. The current clinical guidelines emphasise the importance of managing hyperkalaemia to facilitate RAASi therapy and recommend potassium binders (oral anti-hyperkalaemia treatment) for this purpose. The choice of conventional potassium binders to use is limited by their adverse effects, palatability, and questionable chronic efficacy, which limits their long-term use. Newer treatment options such as patiromer and sodium zirconium cyclosilicate (SZC), are non-systemic, non-absorbed potassium binders which increase potassium excretion through the intestine and are indicated for hyperkalaemia. It is important to understand how hyperkalaemia is managed nowadays, and how novel potassium binders, like SZC, can keep RAASi stable after a hyperkalaemia episode in routine clinical practice, to improve adherence to treatment guidelines and to optimise patient care. Therefore, this study will use administrative healthcare records to describe patient characteristics and treatment patterns with potassium binders and RAASi therapy in patients with heart and kidney diseases who are experiencing hyperkalaemia, and to describe healthcare resource use in these patients.
Using a cohort of patients with diagnostic clinical assessment for hyperkalaemia (HK), we aim to describe patient characteristics and treatment patterns with potassium binders and RAASi therapy in patients with cardiorenal disease (i.e. chronic kidney disease and/or heart failure) who experience an HK episode. We will describe the healthcare resource use associated with reduced RAASi treatment following an HK episode in cardiorenal patients. This study will utilise both CPRD Aurum and Gold database with linkage to Hospital Episode Statistics (HES) admitted patient records and the study period will begin on 1 January 2018 until the last GP’s collection day. Patient characteristics and health care resource use will be described for the study population and the results will be summarised using descriptive statistics.
In addition, propensity score matching or weighting will be applied to balance the cohort who reduced RAASi treatment to the cohort who maintained their RAASi treatment. In these PS-matched or weighted cohorts, patient characteristics and treatment patterns with potassium binders and RAASi therapy will be described using descriptive statistics, and cardiorenal health care resource use will be described using incidence rates and all-events rates per 100 person-years, and cumulative incidence via the Kaplan-Meier method. The association between reduced RAASi treatment and cardiorenal health care resource use will be assessed using Cox proportional hazards regression models. Such evidence will be used to highlight any unmet treatment needs and inform the evidence gap in this area.
• Patient characteristics and treatment patterns
• Cardiorenal healthcare resource use associated with reduced RAASi treatment
Pending feasibility
• Characteristics and treatment patterns in SZC initiators
• Odds of maintained RAASi in SZC relative to No potassium binder cohorts
• Odds of emergency department visits or hospitalisations with HK in SZC relative to No potassium binder cohorts
Eva Lesen - Chief Investigator - AstraZeneca AB (Sweden)
Jil Billy Mamza - Corresponding Applicant - AstraZeneca Ltd - UK Headquarters
Christen Gray - Collaborator - AstraZeneca Ltd - UK Headquarters
Clement Erhard - Collaborator - AstraZeneca Ltd - UK Headquarters
He Gao - Collaborator - AstraZeneca Ltd - UK Headquarters
Meg Parbrook - Collaborator - AstraZeneca Ltd - UK Headquarters
HES Admitted Patient Care;ONS Death Registration Data;Patient Level Index of Multiple Deprivation;Practice Level Index of Multiple Deprivation