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Abstract: SA-PO473

Effects of Ertugliflozin by Uric Acid Quintile: Observations from VERTIS CV

Session Information

Category: Diabetic Kidney Disease

  • 702 Diabetic Kidney Disease: Clinical

Authors

  • Sridhar, Vikas, Department of Medicine, Division of Nephrology, University Health Network and University of Toronto, Toronto, Ontario, Canada
  • Cosentino, Francesco, Unit of Cardiology, Karolinska Institute & Karolinska University Hospital, Stockholm, Sweden
  • Dagogo-Jack, Samuel, University of Tennessee Health Science Center, Memphis, Tennessee, United States
  • Pratley, Richard E., AdventHealth Translational Research Institute, Orlando, Florida, United States
  • Cater, Nilo B., Pfizer Inc., New York, New York, United States
  • Noyes Essex, Margaret, Pfizer Inc., New York, New York, United States
  • Maldonado, Mario, MSD (UK) Limited, London, United Kingdom
  • Zhao, Yujie, Merck & Co., Inc., Rahway, New Jersey, United States
  • Cherney, David, Department of Medicine, Division of Nephrology, University Health Network and University of Toronto, Toronto, Ontario, Canada

Group or Team Name

  • VERTIS CV Investigators.
Background

The sodium–glucose cotransporter 2 inhibitor ertugliflozin (ERTU) lowers serum uric acid (UA) levels. Using data from the VERTIS CV trial (NCT01986881), the impact of ERTU on eGFR and albuminuria was investigated in patients by baseline serum UA levels.

Methods

Patients with type 2 diabetes and atherosclerotic cardiovascular disease were randomized (1:1:1) to ERTU 5 mg, 15 mg (doses pooled for analyses), and placebo (PBO). Patients were categorized by baseline UA quintile (Table). UA over time, eGFR slopes (chronic from Weeks 6 to 260), and the time to first event of progression of albuminuria were analyzed for ERTU versus PBO.

Results

At baseline, there were notable differences by UA subgroup, such as sex, UACR, eGFR and diuretic use (Table). ERTU was associated with reductions in UA over time in all baseline UA subgroups (Fig. A). Treatment with ERTU resulted in a significantly slower rate of yearly eGFR decline in all UA subgroups compared with PBO (P<0.001; Fig. B). ERTU was associated with a reduced risk of albuminuria progression in all UA subgroups compared with PBO (Fig. C; Pinteraction=0.34).

Conclusion

In VERTIS CV, ERTU reduced UA while attenuating eGFR decline and albuminuria progression, irrespective of baseline UA quintile.

 Table. Demographic and clinical characteristics by uric acid (UA) quintile (Q)
VariableQ1, UA ≤4.3 mg/dlQ2, UA >4.3 to 5.1 mg/dlQ3, UA >5.1 to 5.8 mg/dlQ4, UA >5.8 to 6.9 mg/dlQ5, UA >6.9 mg/dl
N (%)1,685 (20.5)1,721 (21.0)1,540 (18.8)1,716 (20.9)1,551 (18.9)
Female, n (%)646 (38.3)565 (32.8)441 (28.6)460 (26.8)356 (23.0)
Mean age, years (SD)63.4 (7.8)64.1 (8.1)64.6 (8.2)64.7 (8.1)65.1 (8.0)
Mean body mass index, kg/m2 (SD)30.6 (4.9)31.3 (5.2)31.9 (5.2)32.2 (5.2)33.5 (6.0)
Mean glycated hemoglobin, % (SD)8.5 (1.0)8.3 (1.0)8.2 (0.9)8.1 (1.0)8.1 (0.9)
Median UACR, mg/g (range)16.0 (1.0-7,239.0)16.0 (1.0-5,357.0)17.0 (1.0-6,884.0)21.0 (1.0-8,584.0)28.5 (1.0-9,548.0)
Mean eGFR, ml/min/1.73 m2 (SD)86.2 (15.7)82.1 (16.6)78.3 (17.5)73.9 (18.2)64.9 (18.9)
Antihypertensive use, n (%)1,567 (93.0)1,619 (94.1)1,465 (95.1)1,655 (96.4)1,516 (97.7)
Diuretic use, n (%)498 (29.6)609 (35.4)634 (41.2)811 (47.3)982 (63.3)
eGFR, estimated glomerular filtration rate; Q, quintile; SD, standard deviation; UA, uric acid; UACR, urinary albumin-to-creatinine ratio.

Funding

  • Commercial Support – The study and this analysis were funded by Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA, in collaboration with Pfizer Inc., New York, NY, USA. Medical writing and/or editorial assistance was provided by Moamen Hammad, PhD, and Melissa Ward, BA, both of Scion, London, UK. This assistance was funded by Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA and Pfizer Inc., New York, NY, USA.