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Kidney Week

Abstract: FR-OR69

Sodium Glucose Cotransporter-2 (SGLT2) Inhibitors Among Patients with and without Diabetes: Collaborative Meta-Analysis of Large Placebo-Controlled Trials

Session Information

  • High-Impact Clinical Trials
    November 04, 2022 | Location: W415 Valencia, Orange County Convention Center‚ West Building
    Abstract Time: 12:30 PM - 12:40 PM

Category: CKD (Non-Dialysis)

  • 2202 CKD (Non-Dialysis): Clinical‚ Outcomes‚ and Trials

Authors

  • Staplin, Natalie, Medical Research Council Population Health Research Unit at the University of Oxford, Oxford, United Kingdom
  • Mayne, Kaitlin J., Medical Research Council Population Health Research Unit at the University of Oxford, Oxford, United Kingdom
  • Haynes, Richard, Medical Research Council Population Health Research Unit at the University of Oxford, Oxford, United Kingdom
  • Herrington, William G., Medical Research Council Population Health Research Unit at the University of Oxford, Oxford, United Kingdom

Group or Team Name

  • On Behalf of the Renal Studies Group & SGLT2 Meta-Analysis cardio-Renal Trialists’ Consortium (SMART-C)
Background

The effects of SGLT2 inhibitors on kidney disease progression, cardiovascular (CV) disease and safety outcomes from all the reported large placebo-controlled trials have not been quantified in a combined fashion.

Methods

We performed a collaborative 2-stage trial-level meta-analysis of 13 large (>500 participants/arm) placebo-control SGLT2 inhibitor trials. The key outcome is kidney disease progression, standardized to a definition of a sustained ≥50% decline in eGFR from randomization, development of end-stage kidney disease, or renal death. Other outcomes include acute kidney injury, hospitalization for heart failure (HF) or CV death, non-CV death, ketoacidosis and amputations. Meta-analyses include unpublished data from 8 trials, including EMPA-KIDNEY which is presenting its main results at ASN Kidney Week 2022. Effects of SGLT2 inhibitors will be presented overall and by diabetes mellitus (DM) status. Kidney disease progression outcomes will also be presented by primary kidney diagnosis (CKD trials only).

Results

A total of 90,413 participants are included from the 13 trials: four type 2 DM high-atherosclerotic CV disease risk trials (n=42,568); five HF trials (n=21,947, including 10,962 with & 10,985 without DM), and four CKD trials (n=25,898, including 20,930 with & 4968 without DM). The SMART-C Steering Committee currently remain blind to results. Over 2000 participants had a kidney disease progression outcome. This includes about 1600 with DM and 450 without DM. From the CKD trials, kidney disease progression outcomes occurred in about 940 participants with diabetic kidney disease, 130 with hypertensive/ischemic disease, 230 with glomerular disease and 110 with other/unknown causes.

Conclusion

This collaborative meta-analysis of 13 large SGLT2 inhibitor trials is aggregating data across key outcomes studies with previously unpublished analyses on kidney disease progression, including data from EMPA-KIDNEY. Quantification of the relative and absolute benefits and harms of SGLT2 inhibitors in the broad range of patients with and without DM treated by nephrologists will be presented at Kidney Week 2022.

Funding

  • Commercial Support