OBJECTIVES: The primary objective of this study was to characterize clinical characteristics, treatment patterns and outcomes of chronic kidney disease (CKD) in patients with diabetes, using a Japanese claims database with a focus on the use of Mineralocorticoid Receptor Antagonists (MRA) in this population in the real world setting.

METHODS: This retrospective cohort study utilized the MDV database, a large, electronic health records-based claims database in Japan. The observation period was a maximum of 8 years (from 1st Oct 2008 to 31st Aug 2016). The inclusion criteria were a claim with a diagnosis of diabetes (ICD-10: E10-E14), eGFR less than 60 ml/min/1.73m² at index, and use of any antiglycemic medications within 6 month’s pre-index or index month. Among them, patients who had a claim for MRA drug after the index date were identified as the MRA subcohort. The study exploratory investigated burden of disease in CKD in diabetes including their demographics, treatments, safety and time-to-event analysis for cardiovascular-related endpoints.

RESULTS: A total of 19,582 patients were included into the analysis and 2,295 MRA patients were included in the subcohort. The percentages of users of renin-angiotensin-aldosterone system inhibitors at baseline were 52.3% in the overall cohort and 58.8% in the MRA subcohort. Cumulative incidences of hyperkalemia were 5.19% in the overall cohort and 7.63% in the MRA subcohort. Cox models showed 30-44 mL/min/1.73m² eGFR group had significantly higher hazards of composite cardiovascular outcomes compared to the 45-59 mL/min/1.73m² (HR, 1.22; 95% CI, 1.09–1.36).

CONCLUSIONS: There are residual risks for hyperkalemia and CV events in CKD in patients with diabetes in a real world setting in Japan, even after treatment initiation by steroidal MRA drugs. The unmet needs and burden of disease should be considered in future treatment for CKD in diabetes.