Heart and Kidney Outcomes With Ertugliflozin in People with Non-albuminuric Diabetic Kidney Disease: A post hoc Analysis from the Randomized VERTIS CV Trial
Bibliographic record
Abstract
Introduction Using data from the VERTIS CV trial (NCT01986881), the impact of ertugliflozin in patients with nonalbuminuric diabetic kidney disease (DKD-non-Alb) was assessed. Methods Patients with type 2 diabetes mellitus (T2DM) and atherosclerotic cardiovascular disease (ASCVD) were randomized to ertugliflozin or placebo. Subgroups were defined by estimated glomerular filtration rate (eGFR) (ml/min per 1.73 m 2 ) and urinary albumin-to-creatinine ratios (UACRs) (mg/g): DKD-Non-Alb (eGFR < 60 + UACR < 30, n = 867); Alb DKD stage 3 (DKD stage 3 Alb, eGFR < 60 + UACR ≥ 30, n = 891); Alb DKD stages 1 + 2 (DKD stages 1–2 Alb, eGFR ≥ 60 + UACR ≥ 30, n = 2356); and no DKD (non-DKD, eGFR ≥ 60 + UACR < 30, n = 3916). eGFR slopes, eGFR and UACR over time, time to first event of a prespecified exploratory kidney composite outcome, albuminuria progression, and hospitalization for heart failure (HHF) were assessed. Results Total eGFR slopes (ml/min per 1.73 m 2 per year; weeks 0–260) with placebo were −0.23, −1.27, −2.29, and −1.19 for the DKD-Non-Alb, DKD stage 3 Alb, DKD stages 1 to 2 Alb, and non-DKD subgroups, respectively ( P < 0.0001). Similar trends were found with ertugliflozin but with reduced rates of decline. Ertugliflozin treatment resulted in a significant reduction in the risk for albuminuria progression across subgroups, with Alb subgroups having the largest relative risk reduction ( P interaction = 0.04). The hazard ratios (HRs) for ertugliflozin revealing reduction in the risk of the exploratory kidney composite outcome versus placebo was consistent across subgroups ( P interaction = 0.34). Alb and the DKD-non-Alb subgroups had a larger relative risk reduction in the HHF outcome compared with other subgroups ( P interaction = 0.046). Conclusion Among the subgroups, participants with DKD-non-Alb had the slowest rate of eGFR decline. Ertugliflozin treatment resulted in reductions in albuminuria and slower decline in eGFR across subgroups. The effect of ertugliflozin on the HHF outcome was larger in those with more advanced kidney disease.
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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 | 0.005 | 0.005 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.003 | 0.005 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.001 | 0.002 |
| Insufficient payload (model declined to judge) | 0.005 | 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".