SGLT2i kidney outcome trial participants vs a real-world population
Sodium–glucose cotransporter-2 (SGLT2) inhibition is an established treatment for glucose-lowering treatment in type 2 diabetes and for reducing cardiovascular events. Several kidney outcomes trials have shown that it also reduces the risk of disease progression in people with CKD, with and without coexisting type 2 diabetes. Observational studies have indicated, however, that participants in these trials do not represent the broader population of people with CKD, as they comprised individuals at higher risk of serious kidney and cardiovascular events.
The current study explored the generalisability of three SGLT2 inhibitor kidney outcome trials to adults with CKD in a real-world setting. Computerised medical records for patients registered across 783 English primary care practices were used to identify adults with CKD. Further analyses were conducted to identify which of these individuals met the eligibility criteria of the CREDENCE, DAPA-CKD and EMPA-KIDNEY trials.
Of 6,670,829 adults, 516,491 (7.7%) were identified as having CKD, including 32.8% (n=169,443) with coexisting type 2 diabetes (CKD-T2D). Of this real-world CKD cohort, 0.9%, 2.2% and 8.0% met the CREDENCE, DAPA-CKD and EMPA-KIDNEY eligibility criteria, respectively.
The three trials were each more representative of people with coexisting type 2 diabetes than of people without. CREDENCE eligibility criteria applied to 2.8% of the CKD-T2D population, but did not include the CKD without T2D population. DAPA-CKD criteria applied to 4.7% of the CKD-T2D population and 1.0% of the CKD without T2D population, while the EMPA-KIDNEY criteria applied to 13.1% of the CKD-T2D population and 5.5% of the CKD without T2D population.
Trial participants were 9–14 years younger than the real-world cohort and had more advanced CKD, including higher albuminuria. RAAS inhibitors were prescribed to almost all trial participants, compared to 45.1% and 63.3% of the real-world CKD and real-world CKD-T2D populations, respectively. Women were under-represented and less likely to be eligible for trials.
SGLT2 inhibitor kidney outcome trial participants represent a sub-group of the population with CKD in English primary care. The findings of this study highlight the importance of complementing such trials with real-world studies, to establish the effectiveness of SGLT2 inhibitors in the broader population with CKD.
The full article can be read here.
