Reduction in the Rate of eGFR Decline with Semaglutide vs. Placebo: A Post Hoc Pooled Analysis of SUSTAIN 6 and PIONEER 6
Bibliographic record
Abstract
Background: The SUSTAIN 6 cardiovascular outcomes trial (CVOT) indicated that once-weekly (OW) subcutaneous (s.c.) semaglutide may have beneficial effects on kidney function in subjects with type 2 diabetes (T2D) at high CV risk. SUSTAIN 6 and the PIONEER 6 CVOT (once-daily [OD] oral semaglutide) had similar designs and populations, and both evaluated the effects of semaglutide vs placebo (PBO) on macro-and microvascular outcomes. This post hoc analysis of pooled data from the two trials evaluated the effects of semaglutide vs PBO on kidney function decline. Methods: Data for 6,480 subjects with T2D from SUSTAIN 6 (OW s.c. semaglutide 0.5 and 1.0 mg or PBO, N=3,297; median follow-up 2.1 years) and PIONEER 6 (OD oral semaglutide 14 mg or PBO, N=3,183; median follow-up 1.3 years) were pooled into two groups: semaglutide and PBO. Annual change in estimated glomerular filtration rate (eGFR) was compared (semaglutide vs PBO) in the overall population and subgroups by baseline (BL) eGFR (≥30-<60 or ≥60 mL/min/1.73 m2). Changes in eGFR from BL during trial were analyzed using a linear random regression model with individual intercept and time slope. The estimated treatment difference (ETD) at 1 year between annual rates of eGFR slope from BL was calculated; an interaction p-value <0.05 indicated difference between subgroups. Results: In the overall population, the annual rate of eGFR change was 0.60 mL/min/1.73 m2 (p<0.0001) lower with semaglutide vs PBO. In the eGFR ≥30-<60 mL/min/1.73 m2 and ≥60 subgroups, the ETDs for semaglutide vs PBO were, respectively, 1.07 and 0.48 mL/min/1.73 m2/year, with a non-significant interaction p-value (Figure).Figure:: Estimated treatment difference in annual eGFR change between semaglutide and placebo in the pooled SUSTAIN 6 and PIONEER 6 trialsConclusions: Semaglutide was associated with a significantly smaller decline in kidney function than PBO in subjects with T2D at high CV risk across tested BL eGFR categories; the data suggest the main benefit might be observed in those with kidney disease. Funding: Commercial Support - Novo Nordisk
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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 | 0.010 | 0.009 |
| Meta-epidemiology (narrow) | 0.002 | 0.001 |
| Meta-epidemiology (broad) | 0.010 | 0.016 |
| Bibliometrics | 0.001 | 0.001 |
| 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) | 0.003 | 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".