BACKGROUND: The clinical landscape for the treatment of patients with chronic kidney disease (CKD) and type 2 diabetes (T2D) is rapidly evolving. As part of the FOUNTAIN platform (NCT05526157; EUPAS48148), we characterized patients initiating a sodium-glucose cotransporter 2 inhibitor (SGLT2i) with prevalent CKD and T2D in 5 data sources in Europe, Japan, and the United States.
OBJECTIVES: The objectives of this drug utilization study were to describe baseline characteristics, comorbidities, and comedication, and to describe treatment changes over time.
METHODS: New users of the index SGLT2i had a prescription during the study period (1 January 2012 - 30 June 2021) and no prescription for any SGLT2i during the previous 12 months. Included patients were ≥18 years old on the index date with CKD and T2D recorded on or ever before the index date. Patients were excluded for diagnoses of T1D, kidney cancer, or kidney failure. Continuous treatment episodes after initiation were identified; a treatment interruption was defined as a gap in continuous use lasting 90 days or more. Patients’ treatment states throughout follow-up were described. Research partners at each data source (Danish National Health Registers (DNHR), PHARMO Data Network in the Netherlands, Valencia Health System Integrated Database (VID) in Spain, Japan Chronic Kidney Disease Database Extension (J-CKD-DB-Ex), and the OPTUM Clinformatics® DataMart in the US) conducted analyses using a common protocol.
RESULTS: We identified 111,281 patients initiating an SGLT2i across all data sources: 21,739 in DNHR, 381 in PHARMO, 31,785 in VID, 1,157 in J CKD DB Ex, and 56,219 in Optum. Across all data sources the mean age ranged from 66.5 years to 70.7 years and the percentage of males from 54.4% to 64.5%. Most had used renin-angiotensin system inhibitors before SGLT2i initiation. Over 70% of patients had hypertension at baseline and from 26.9% to 59.5% had coronary heart disease. Between 26.3% and 49.2% of patients had CKD stage 3. The median total follow-up duration ranged from 15.8 months to 26.5 months and the median duration of the initial SGLT2i exposure episode ranged from 2.8 months to 11.6 months. From 6.6% to 42.7% of SGLT2i initiators had a treatment interruption. The largest decreases in use occurred between 90 and 180 days after drug initiation. At the one-year timepoint, 50% or more of patients in all data sources were currently receiving SGLT2i treatment.
CONCLUSIONS: SGLT2i use was dynamic in patients with CKD and T2D in all data sources with patients frequently interrupting, restarting, or discontinuing SGLT2i treatment. Most patients had cardiovascular risk factors and less than half of patients were CKD stage 3 and the majority received guideline-recommended treatment.
