P0696CHARACTERIZATION OF A DAPA-CKD-LIKE POPULATION USING A CONTEMPORARY US HEALTHCARE SYSTEM: COHORT CHARACTERISTICS AND CLINICAL OUTCOMES

Abstract

Abstract Background and Aims The Sodium Glucose Co-Transporter 2 inhibitor (SGLT-2i) class of drugs have demonstrated significant cardiorenal benefits in patients with type 2 diabetes (T2D), including reducing the composite renal outcome of significant eGFR decline, End Stage Kidney Disease (ESKD) or renal death in patients with T2D and preserved renal function and also in patients with overt Diabetic Kidney Disease. In addition, SGLT-2i have proven to have beneficial effects on cardiovascular (CV) outcomes in patients with heart failure with reduced ejection fraction (HFrEF) independent of glycaemic status. The DAPA-CKD Trial (A study to evaluate the effect of dapagliflozin on renal outcomes and CV mortality in patients with CKD) is the first SGLT-2i renal outcome trial to test the efficacy and safety of an SGLT-2i, dapagliflozin, in patients with diagnosed CKD with and without T2D. In order to appropriately evaluate the future results and aid clinical interpretation of the DAPA-CKD trial, the present study assessed the renal and CV outcomes of a “DAPA-CKD-like population” (eGFR 25-75ml/min/1.73m2 and UACR 200-5000mg/g) in a contemporary US real healthcare system. Method Administrative data from the Henry Ford Health System was used to identify persons with CKD stages 2 through 4 between 2006 and 2016 based on eGFR lab reading (n=38,376). Exclusions included no confirmatory eGFR > 90 days from index date, death within 30 days, history of renal transplant, and evidence of renal replacement therapy, or progression to CKD stage 5 during the baseline period (6 months pre or post index date). Within that cohort, 17,742 had eGFR (25-75ml/min/1.73m2) and 9,177 had a UACR (0-5000 mg/g) within 12 months of index date. Additional exclusions included type 1 diabetes (n=2,546), lupus nephritis (n=1) and polycystic kidney disease (n=20). Patients were followed through December 31st, 2018. Results Of the 6,557 patients that met the eligibility criteria and were included in the study cohort, the mean age was 62.9 years and 46.2% were male. The population was stratified by UACR (0-<30, 30–199, 200–5,000mg/g). Across all outcomes assessed, the clinical outcomes were highest in the DAPA-CKD-like cohort (UACR 200-5000mg/g) (HF 36.1%; MI 11.3%, Stroke 8.9%; ESKD 18.6%; Mortality 18.5%; see Figure 1). The greatest increase was observed for renal outcomes particularly ESKD, increasing from 0.9% (UACR 0-<30mg/g) to 3.4% (UACR 30-199mg/g) to 18.6% (UACR 200-5000mg/g). Conclusion In a contemporary US healthcare system, there remains significant adverse renal, CV and mortality outcomes among patients fitting the DAPA-CKD study inclusion criteria. These results highlight the unmet need existing for additional therapies to delay disease progression and improve patient outcomes and survival in this population.