The majority of real-world patients with CKD are not eligible for SGLT2 inhibitor trials

Kidney outcome trials of sodium-glucose transport protein 2 (SGLT2) inhibitors in participants with chronic kidney disease (CKD) might not be representative of real-world populations due to including patients at higher risk for kidney adverse outcomes. According to a real-world analysis, less than 10% of English primary care patients would have been eligible for inclusion in phase 3 SGLT2 inhibitor trials.

The recently published cross-sectional analysis from the Oxford-RCGP RSC network included adults with chronic kidney disease who were treated in primary care in England [1]. Using this database, Dr Anna Forbes (University of Oxford, United Kingdom) and her colleagues explored SGLT2 inhibitor trial eligibility criteria as well as clinical characteristics. In total, 516491 adults with CKD were identified in the database, 32.8% of whom (N=169443) had comorbid type 2 diabetes [2].

Of the total CKD cohort, 2.23% of patients would have been eligible for the Dapa-CKD trial (NCT03036150), 7.98% for the EMPA-KIDNEY trial (NCT03594110) and 0.92% for the CREDENCE trial (NCT02065791). In the analysed comorbid type 2 diabetes sub-cohort, 4.74%, 13.05% and 2.80% would have been eligible for Dapa-CKD, EMPA-KIDNEY, and CREDENCE respectively, while 1 %, 5.50% and 0% of the sub-cohort with CKD and no type 2 diabetes would have been eligible for the Dapa-CKD, EMPA-KIDNEY, and CREDENCE trials, respectively. The major reasons for trial ineligibility included not receiving a renin-angiotensin system (RAS) inhibitor, and not meeting the albuminuria criteria for inclusion (insufficiently high albuminuria or lack of assessment). Compared with the EMPA-KIDNEY trial, real-world patients with CKD tended to be older, with a higher mean eGFR value, lower urine albumin-creatinine ratio and less likely treated with a RAS inhibitor (45.1% vs almost all in EMPA-KIDNEY).

“SGLT2 inhibitor outcome trials represent only a subgroup of people with chronic kidney disease at high risk for adverse kidney events, alleviating the interpretability of the results”, concluded Dr Forbes.

1. Forbes A, et al. Nephrol Dial Transplant 2024; Mar 22. DOI: 10.1093/ndt/gfae071.
2. Forbes A, et al. SGLT2 inhibitor kidney outcome trials: Under-representation of the majority of people with chronic kidney disease in real-world clinical practice. Abstract #58, ERA 2024, 23–26 May, Stockholm, Sweden.

Medical writing support was provided by Mihai Surducan, PhD.

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Posted on 20 June 202416 July 2024