Abstract: PO0746
Effects of Ertugliflozin on Kidney End Points in Patients with Non-Albuminuric Diabetic Kidney Disease in VERTIS CV
Session Information
- Diabetic Kidney Disease: Clinical
November 04, 2021 | Location: On-Demand, Virtual Only
Abstract Time: 10:00 AM - 12:00 PM
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 | ||||||
| Treatment | Number of participants | Number of participants with event (%) | Event rate/ 100 person-years | Hazard ratio (95% confidence interval) | ||
| Overall population | Placebo | 2747 | 85 (3.09) | 0.90 | 0.66 (0.50, 0.88) | P-value <0.01 |
| Ertugliflozin | 5499 | 113 (2.05) | 0.60 | |||
| N-DKD | Placebo | 1307 | 31 (2.37) | 0.68 | 0.44 (0.26, 0.74) | P-interaction = 0.26 |
| Ertugliflozin | 2609 | 27 (1.03) | 0.30 | |||
| A-DKD | Placebo | 1087 | 51 (4.69) | 1.41 | 0.73 (0.51, 1.04) | |
| Ertugliflozin | 2160 | 75 (3.47) | 1.03 | |||
| NA-DKD | Placebo | 290 | 3 (1.03) | 0.30 | 0.82 (0.20, 3.44) | |
| Ertugliflozin | 577 | 5 (0.87) | 0.25 | |||
Figure
Funding
- Commercial Support – The study and this analysis were funded by Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA, in collaboration with Pfizer Inc. Medical writing and/or editorial assistance was provided by Moamen Hammad, PhD, and Ian Norton, PhD, both of Scion, London, UK. This assistance was funded by Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA and Pfizer Inc., New York, NY, USA.