Effects of Ertugliflozin by Uric Acid Quintile: Observations from VERTIS CV
Bibliographic record
Abstract
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). Conclusions: In VERTIS CV, ERTU reduced UA while attenuating eGFR decline and albuminuria progression, irrespective of baseline UA quintile. 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. Table. - Demographic and clinical characteristics by uric acid (UA) quintile (Q) Variable Q1, UA ≤4.3 mg/dl Q2, UA >4.3 to 5.1 mg/dl Q3, UA >5.1 to 5.8 mg/dl Q4, UA >5.8 to 6.9 mg/dl Q5, 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.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.002 | 0.005 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.002 | 0.001 |
| Bibliometrics | 0.000 | 0.001 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.001 | 0.000 |
| Open science | 0.000 | 0.001 |
| Research integrity | 0.001 | 0.001 |
| Insufficient payload (model declined to judge) | 0.003 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".