#58 SGLT2 inhibitor kidney outcome trials: under-representation of the majority of people with chronic kidney disease in real-world clinical practice

Abstract

Abstract Background and Aims Observational studies suggest that sodium-glucose co-transporter-2 (SGLT2) inhibitor kidney outcome trials are not representative of people with chronic kidney disease (CKD). However, there are limited data on the generalisability to those without co-existing type 2 diabetes (T2D) and representativeness of the EMPA-KIDNEY trial. Method A cross-sectional analysis of adults with CKD in English primary care was conducted using the Oxford-Royal College of General Practitioners Clinical Information Digital Hub database. The proportions of people with CKD that met the eligibility criteria of SGLT2 inhibitor kidney outcome trials were determined, and their characteristics described. Logistic regression analyses were performed to identify factors associated with trial eligibility. Results Of 6 670 829 adults, 516 491 (7.7%) with CKD were identified, including 32.8% (n = 169 443) with co-existing T2D. In the total CKD cohort, 0.9%, 2.2%, and 8.0% met the CREDENCE, DAPA-CKD, and EMPA-KIDNEY eligibility criteria, respectively. All trials were more representative of people with co-existing T2D than those without T2D. Trial participants were 9-14 years younger than the trial eligible populations, and had more advanced CKD, including higher levels of albuminuria. A higher proportion of the CREDENCE (100%), DAPA-CKD (67.6%) and EMPA-KIDNEY (44.5%) trial participants had T2D compared to the total CKD population (32.8%). Renin-angiotensin-aldosterone system inhibitors were prescribed in almost all trial participants compared to less than half of the total CKD population. Females were underrepresented and less likely to be eligible for the trials. Conclusion SGLT2 inhibitor kidney outcome trials are not representative of most people with CKD in English Primary Care. These findings highlight the importance of complementing trials with real-world studies, exploring the effectiveness of SGLT2 inhibitors in the broader population of people with CKD treated in routine clinical practice.