Effects of empagliflozin on uric acid levels and gout: observations from the EMPA-REG OUTCOME trial
Bibliographic record
Abstract
Background Higher serum uric acid (UA) levels are associated with gout and other adverse outcomes in patients with type 2 diabetes (T2D). Sodium glucose co-transporter 2 inhibitors lower UA and may reduce gout flares. We studied on-treatment effects of empagliflozin on serum UA levels, prescription of anti-gout/UA-lowering medication, and gout flares in 7020 patients (pooled empagliflozin n=4687; placebo n=2333) with T2D and high CV risk treated in EMPA-REG OUTCOME. Methods We assessed effects of empagliflozin versus placebo on UA levels using MMRM analyses; time-to-first occurrence of either an adverse event attributed to gout flare or anti-gout/UA-lowering medication initiation was assessed using Cox proportional hazards models. Results From Week 12 onwards, mean UA was reduced with pooled empagliflozin versus placebo; by Week 52, the adjusted mean treatment difference (95% CI) was -0.37 (-0.42, -0.31) mg/dl. Week 52 treatment difference was more pronounced in participants with baseline UA levels ≥ 6 mg/dl (-0.46 [-0.55, -0.38] mg/dl). Among 6,607 participants not taking UA-lowering medication at baseline, 5.2% of placebo participants experienced gout flare or initiated anti-gout/UA-lowering treatment versus 3.6% of pooled empagliflozin participants (incidence rates: 21.6 versus 14.1 events per 1,000 patient-years, respectively; hazard ratio [95% CI]: 0.67 [0.53, 0.85], P=0.001). Risk reduction was similar for both individual empagliflozin doses, and across participants with baseline UA levels below/above 6.0 mg/dl, and across participants with versus without history of gout at baseline (treatment-by-subgroup interaction P=0.53 and P=0.48, respectively). Conclusions Empagliflozin versus placebo reduced mean UA, occurrence of gout flares or initiation of UA-lowering medication. Publication History Article published online: 26 May 2022 © 2022. Thieme. All rights reserved. Georg Thieme Verlag KG Rüdigerstraße 14, 70469 Stuttgart, Germany
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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 | 0.004 | 0.003 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.002 | 0.002 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.000 | 0.001 |
| Research integrity | 0.001 | 0.002 |
| Insufficient payload (model declined to judge) | 0.002 | 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".