Does SGLT-2 inhibitors improve the prognosis for patients on dialysis?

The aim  is to analyze the effect of SGLT-2 inhibitors on cardiovascular outcomes for patients on dialysis.Patients on dialysis have a high risk of cardiovascular disease and death. Previous randomized controlled studies (RCT) on SGLT-2-inhibitors have shown decreased risk of cardiovascular outcomes.

The DAPA-CKD study included patients with eGFR 25 to 75 ml/min/1.73 m2 and microalbuminuria and showed 30 % decreased risk of death from cardiovascular causes or hospitalization for heart failure.

However, patients on dialysis have been excluded from all previous RCT.We plan to include patients on dialysis in Sweden (age > 50-years or 18-49-years and diabetes mellitus type 2 or a cardiovascular disease) and to randomize to SGLT-2 inhibitors or not.

The primary outcome will be a composite of major cardiovascular events (cardiovascular mortality, myocardial infarction, hospitalization for heart failure and stroke).The steering committee of the Swedish National Nephrology Research group and patient representatives will be involved early.

Through all members of the research group we will be able to reach out to almost all nephrology clinics.During the planning phase a litterature review, applications to CTIS, and feasibility surveys will be performed. A statistician will be involved in the detailed study plan. We aim to plan the study during 2025 and 2026 and then start inclusion.