Determining health outcomes and resource utilisation associated with hyperkalemia in the UK.

Study type
Protocol
Date of Approval
Study reference ID
17_259
Lay Summary

Hyperkalemia refers to high levels of potassium in the blood, which can occur when the body produces too much potassium, or when it cannot get rid of potassium very effectively. Too much potassium in the body can disrupt the regular beating pattern of the heart. Instead of beating in a natural rhythm to pump blood around the body, the lower part of the heart flutters rapidly, severely impairing the delivery of blood to tissues and organs. In the most severe cases of hyperkalemia, the heart may stop beating, leading to rapid death. Patients suffering from heart failure or chronic kidney disease are likely to need medications to treat their high blood pressure. However, through taking these medications these patients also develop a high risk for hyperkalemia. An effective treatment for hyperkalemia would allow for these patients to continue receiving the needed treatment whilst controlling potassium levels in the body. In light of such a treatment, the purpose of this research is to estimate the level of care these patients require in hospital which will provide a better understanding of the patients most in need of an effective hyperkalemia treatment.

Technical Summary

Patients diagnosed with CKD and /or heart failure are at high risk of developing hyperkalemia due to the fact that the glomerular filtration rate of their kidneys is too low to sufficiently remove excess potassium. This risk is compounded by medications they may be prescribed to treat their conditions- Renin-Angiotensin-Aldosterone System inhibitors (RAASi). A major side effect of RAASI therapy is the inhibition of potassium excretion in the kidneys. Thus, patients with CKD and/or heart failure who are being treated with RAASi are at an enhanced risk of developing hyperkalemia. There is a need in this patient population for a treatment that lets these patients to continue on RAASi therapy without the risk of developing hyperkalemia through excess potassium retention.

The purpose of this study is to estimate health outcomes and resource utilisation of patients with CKD and/or heart failure who experience hyperkalemia. To this aim, we will quantify healthcare resource use (number of doctor visits, hospitalisations medical tests, procedures and prescriptions) throughout the observation period. Furthermore, we will compute the numbers and percentages of patients who experienced clinical outcomes of interest among those who were treated with RAASi prior to developing hyperkalemia. Together, these results will help inform which patient groups are most in need of an effective hyperkalemia treatment.

Collaborators

Mireia Raluy Callado - Chief Investigator - Evidera, Inc
Mireia Raluy Callado - Corresponding Applicant - Evidera, Inc
Alex Simpson - Collaborator - Bristol-Myers Squibb Pharmaceuticals Limited - UK ( BMS )
Annalisa Rubino - Collaborator - Evidera, Inc
Rikisha Gupta Shah - Collaborator - Evidera, Inc
Vrouchou Panagiota - Collaborator - Vifor Pharma

Linkages

HES Accident and Emergency;HES Admitted Patient Care;HES Diagnostic Imaging Dataset;HES Outpatient