The differential effects of ertugliflozin on glucosuria and natriuresis biomarkers: Prespecified analyses from <scp>VERTIS CV</scp>
Bibliographic record
Abstract
Abstract Aims This prespecified exploratory analyses from VERTIS CV (NCT01986881) aimed to assess the effects of the sodium‐glucose cotransporter‐2 (SGLT2) inhibitor ertugliflozin on glucosuria‐related (glycated haemoglobin [HbA1c], uric acid, body weight) and natriuresis‐related (blood pressure, haemoglobin, haematocrit, serum albumin) biomarkers according to kidney function risk category. Materials and methods Patients with type 2 diabetes and atherosclerotic cardiovascular disease were randomized to placebo, ertugliflozin 5 mg, or ertugliflozin 15 mg (1:1:1). Analyses compared placebo (n = 2747) versus ertugliflozin (pooled; n = 5499) on glucosuria‐ and natriuresis‐related biomarkers according to baseline estimated glomerular filtration rate (eGFR) subgroup and Kidney Disease: Improving Global Outcomes in Chronic Kidney Disease (KDIGO CKD) risk category. Results Patients were classified according to KDIGO CKD low‐ (49%), moderate‐ (32%) and high‐/very‐high‐risk categories (19%), and eGFR groups 1 (25%), 2 (53%) and 3 (19%). At Week 18, the high‐/very‐high‐risk category had a smaller placebo‐subtracted least squares mean (LSM) change from baseline (95% confidence interval) in HbA1c (−0.34 [−0.43, −0.25]) compared with the low‐ and moderate‐risk categories (−0.54 [−0.60, −0.49] and − 0.47 [−0.54, −0.40], respectively). This pattern was maintained throughout the study ( P interaction = 0.0001). Similar patterns based on baseline eGFR G stage were observed. Placebo‐subtracted LSM changes from baseline in uric acid were lowest in the high‐/very‐high‐risk category at Weeks 6 and 18, but the pattern was not maintained after Week 156 ( P interaction = 0.15). Effects of ertugliflozin on body weight and natriuresis‐related biomarkers did not differ across KDIGO CKD categories. Conclusions In VERTIS CV, ertugliflozin was associated with physiologically favourable changes in glucosuria‐ and natriuresis‐related biomarkers. Glycaemic efficacy of ertugliflozin was attenuated in patients with higher chronic kidney disease (CKD) risk. Effects on other biomarkers were consistent, regardless of CKD risk stage.
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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 | 0.006 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.002 | 0.004 |
| Bibliometrics | 0.000 | 0.001 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.001 | 0.000 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.001 | 0.001 |
| Insufficient payload (model declined to judge) | 0.009 | 0.001 |
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".