#2505 characteristics of medication-initiator cohorts of patients with chronic kidney disease and type 2 diabetes in japan: a report from fountain platform

Abstract Background and Aims The clinical landscape for the treatment of patients with chronic kidney disease (CKD) and type 2 diabetes (T2D) is rapidly evolving with the introduction of new treatments such as sodium-glucose cotransporter-2 inhibitors (SGLT2i), glucagon-like peptide-1 receptor agonist (GLP-1 RA), and non-steroidal mineralocorticoid receptor antagonists (nsMRA). However, limited information is available regarding the utilization patterns of these new therapies in worldwide clinical practice. The FINEGUST study (EUPAS48148; NCT05526157) is a multinational observational cohort study and part of the FOUNTAIN multi-database research platform. It aims to describe drug utilization and temporal changes of different treatments in adults with CKD and T2D in two time periods (before and after finerenone approval) using secondary data from population-based data sources in Europe, Japan, China, the United Kingdom, and the United States. Method In this country-specific analysis, four separate medication-specific cohorts of adults with CKD and T2D, including new users of SGLT2i, GLP-1 RA, steroidal MRA (sMRA), or esaxerenone as a nsMRA available in the study period, were retrospectively identified from the Japan Chronic Kidney Disease Database Extension (J-CKD-DB-Ex) between January 1st 2014 and June 30th 2021 (pre-finerenone period). The presence of T2D and CKD was assessed based on ICD-10 diagnostic codes, and lab measurement values, i.e., serum creatinine to calculate estimated glomerular filtration rate (CKD-EPI) or urine albumin-creatinine ratio (UACR). The CKD stage was categorized based on the KDIGO definition. Patients with type 1 diabetes, kidney cancer or kidney failure at baseline were excluded. The index date was the date of initial prescription of each drug class. Patient characteristics and baseline medication patterns were summarized overall and by presence or absence of UACR results in the previous year. Results Of 251,659 patients recorded in J-CKD-DB-Ex in the study period, we identified 6,934, 2,991, 18,974, and 301 patients with recorded use of SGLT2i, GLP-1 RA, sMRA, and nsMRA, respectively. After applying inclusion and exclusion criteria, 1,157 SGLT-2i (16.7%), 329 GLP-1 RA (11.0%), 1,769 sMRA (9.3%), and 63 nsMRA (20.9%) new users were included in the analysis. The mean age ranged from 66 years in the GLP-1 RA cohort to 74 years in the sMRA cohort (Table 1). All medication classes were most prescribed in patients with CKD stage 3 followed by patients with CKD stage 2. Insulin was most frequently prescribed in the GLP-1 RA cohort (65.3%). Patients in the sMRA cohort were most comorbid based on the prevalence of congestive heart failure (40.2%), coronary heart disease (26.9%), and cerebrovascular disease (16.1%). Compared to patients without UACR measurements, those with a UACR measurement in year prior to the index date were more likely to receive other treatments of interest in combination during the 90 days prior to index (Figure 1). Among the drug classes summarized, angiotensin-converting enzyme inhibitors or angiotensin-receptor blockers were the most prescribed drug class in all cohorts (43.0% in SGLT2i cohort, 28.9% in GLP-1 RA cohort, 30.4% in sMRA cohort, and 50.8% in nsMRA cohort, respectively). Conclusion Treatment initiation with either SGLT2i, GLP-1RA, sMRA or nsMRA occurred most frequently in patients with CKD stage 2–3 with variations in characteristics for each medication class, including the patterns of anti-hyperglycemic therapies and cardiovascular complications. Differences by UACR test result availability 1-year prior to index may indicate a possible association between treatment choice and the availability of UACR test results. Subsequent analyses from the FOUNTAIN program, including longitudinal drug utilization patterns and geographic variations across regions, will provide further insights about the clinical use of different treatment options for patients with CKD and T2D.