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Abstract: PO0746

Effects of Ertugliflozin on Kidney End Points in Patients with Non-Albuminuric Diabetic Kidney Disease in VERTIS CV

Session Information

Category: Diabetic Kidney Disease

  • 602 Diabetic Kidney Disease: Clinical

Authors

  • Cherney, David, University of Toronto, Toronto, Ontario, Canada
  • Dagogo-Jack, Samuel, The University of Tennessee Health Science Center, Memphis, Tennessee, United States
  • Cosentino, Francesco, Unit of Cardiology, Karolinska Institute & Karolinska University Hospital, Stockholm, Sweden
  • Mcguire, Darren K., The University of Texas Southwestern Medical Center, Dallas, Texas, United States
  • Pratley, Richard E., AdventHealth Translational Research Institute, Orlando, Florida, United States
  • Frederich, Robert, Pfizer Inc., Collegeville, Pennsylvania, United States
  • Maldonado, Mario, MSD Limited, London, United Kingdom
  • Liu, Chih-Chin, Merck & Co., Inc., Kenilworth, New Jersey, United States
  • Cannon, Christopher P., Cardiovascular Division, Brigham and Women’s Hospital, Harvard Medical School, Boston, Massachusetts, United States

Group or Team Name

  • VERTIS CV investigators
Background

Non-albuminuric diabetic kidney disease (NA-DKD) is an increasingly recognised condition. Data from VERTIS CV (NCT01986881) were analyzed to study the impact of ertugliflozin on kidney outcomes in patients with NA-DKD.

Methods

Patients with type 2 diabetes mellitus and atherosclerotic cardiovascular disease were randomized (1:1:1) to ertugliflozin 5 mg, 15 mg (both doses were pooled for analyses) and placebo. Subgroups were defined by baseline eGFR (mL/min/1.73 m2) and UACR (mg/g): No DKD (N-DKD), eGFR ≥60 + UACR <30 (n=3916); NA-DKD, eGFR <60 + UACR <30 (n=867); albuminuric-DKD (A-DKD), UACR ≥30 (n=3247). eGFR slopes (chronic from week [W]6 to W260 and total from W0 to W260) and Cox proportional hazards for the time to first event of a kidney composite were assessed.

Results

The NA-DKD subgroup had the slowest rate of total eGFR decline and the A-DKD subgroup the fastest rate of decline (Figure). The effect of ertugliflozin to slow the rate of eGFR decline vs placebo did not significantly differ across the subgroups. The hazard ratio for ertugliflozin showing reduction in the risk of the composite kidney outcome vs placebo was consistent across subgroups, Pinteraction = 0.26 (Table).

Conclusion

In VERTIS CV, participants with NA-DKD had the slowest rate of eGFR decline over time and lower kidney composite outcome event rates.

Table
Cox proportional hazards model for time to first kidney composite comprising sustained 40% decrease from baseline in eGFR, chronic kidney replacement therapy, or kidney death
 TreatmentNumber of participantsNumber of participants with event (%)Event rate/ 100 person-yearsHazard ratio (95% confidence interval) 
Overall populationPlacebo274785 (3.09)0.900.66 (0.50, 0.88)P-value <0.01
Ertugliflozin5499113 (2.05)0.60
N-DKDPlacebo130731 (2.37)0.680.44 (0.26, 0.74)P-interaction = 0.26
Ertugliflozin260927 (1.03)0.30
A-DKDPlacebo108751 (4.69)1.410.73 (0.51, 1.04)
Ertugliflozin216075 (3.47)1.03
NA-DKDPlacebo2903 (1.03)0.300.82 (0.20, 3.44)
Ertugliflozin5775 (0.87)0.25

Figure

Funding

  • Commercial Support