Purpose: This study aims to describe treatment patterns, associated outcomes, and the use and costs of healthcare resources in patients with chronic kidney disease (CKD) and diabetic kidney disease (DKD). Patients will be grouped by whether or not they have heart failure.
Background: Current treatments for CKD/DKD focus on slowing disease progression but do not address the underlying inflammation and cause of kidney disease. A new treatment approach, known as mineralocorticoid receptor antagonists (MRAs), is being developed by pharmaceutical companies and is believed to have a beneficial effect on CKD. This new treatment, however, may have severe side effects such as abnormally elevated levels of potassium in the blood.
Methods: A group of patients with CKD/DKD will be selected from CPRD GOLD and HES databases. Three years of data from each patient will be analysed. The primary outcome is to evaluate treatment pathways and describe the characteristics of patients who use the new MRA treatment. Secondary outcomes include assessing clinical outcomes and healthcare resource utilisation and costs.
Importance of findings: This study will identify real-world treatment patterns for CKD/DKD, including the use of MRAs. Outcomes associated with various treatments options may identify unmet medical needs in the treatment of CKD/DKD.
Objectives: The primary objective is to delineate treatment patterns in patients with CKD or DKD, with or without heart failure (HF), by conducting a longitudinal and retrospective analysis of CPRD data. Secondary objectives include describing cohort characteristics, evaluating clinical outcomes, and evaluating resource utilisation and costs.
Methods: Data for this retrospective and observational study will be obtained from the CPRD GOLD dataset linked with Hospital Episode Statistics (HES) and the Office of National Statistics (ONS) for mortality. The index period will run from 1 January 2008 to 31 March 2012, with a 12-month baseline period and 2-year follow-up period. The index date will be defined as the first prescription for a CKD/DKD-related medication.
Data analysis: Within each cohort, demographic and clinical characteristics will be described using summary statistics. Treatment pathways will be analysed including maps for consecutive lines of therapies during the follow-up period, duration of each line of therapy, reasons for initiation and discontinuation, and treatment adherence (measured with the medication possession ratio [MPR]). Therapy distributions between the cohorts will be compared using chi-square tests. Time to therapy change will be assessed by Kaplan-Meier estimates. Annualised resource utilisation and patient outcomes will also be analysed.
Guilhem Pietri - Chief Investigator - PAREXEL International Corporation
Canter Martin - Corresponding Applicant - PAREXEL International Corporation
Chi Thi Le Truong - Collaborator - PAREXEL International Corporation
Hilary Phelps - Collaborator - PAREXEL International Corporation
HES Admitted Patient Care;HES Outpatient;ONS Death Registration Data