1665-P: Fracture Risk in Patients Using Sodium-Glucose Cotransporter 2 Inhibitors: A Real-World Study
Bibliographic record
Abstract
There are concerns that sodium-glucose co-transporter 2 inhibitors (SGLT2Is) may increase the risk of fractures in patients with type 2 diabetes. To date, large cardiovascular outcome trials have generated conflicting findings, and few real-world studies have been conducted to assess this association. As fracture risk in this vulnerable population is associated with increased mortality, there is an urgent need to address this safety issue using real-world data. Thus, the objective of this population-based cohort study is to determine if use of SGLT2Is is associated with an increased fracture risk in patients with type 2 diabetes. Using the UK Clinical Practice Research Datalink, a large primary care database, we identified a cohort of patients newly treated with antihyperglycemic drugs between January 2013 and December 2017. Use of SGLT2Is was modeled as a time-varying exposure and compared with use of dipeptidyl peptidase-4 inhibitors (DPP-4Is). Time-dependent Cox proportional hazards models were used to estimate hazard ratios (HRs) and 95% CIs of incident fractures associated with use of SGLT2Is overall and according to specific SGLT2Is (dapagliflozin, empagliflozin, canagliflozin). We conducted several sensitivity analyses to address potential sources of bias. The cohort included 73,178 patients, which generated 153,179 person-years of observation. During follow-up, 1,973 patients were newly diagnosed with fractures (incidence rate: 12.9/1000 per year). Compared with DPP-4Is, SGLT2Is were not associated with an increased risk of fracture (HR: 0.97, 95% CI: 0.79-1.19). Similar findings were observed when stratifying on specific SGLT2Is, with HRs ranging between 0.67 and 1.42, with all CIs including the null value. The sensitivity analyses yielded highly consistent findings. The results of this large population-based study suggest that use of SGLT2Is is not associated with fracture incidence. This finding should provide reassurance on the safety of this class of drugs. Disclosure D. Abrahami: None. A. Douros: None. H. Yin: None. O. Yu: None. L. Azoulay: None. Funding Canadian Institutes of Health Research
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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 | 0.008 |
| Meta-epidemiology (narrow) | 0.000 | 0.001 |
| Meta-epidemiology (broad) | 0.001 | 0.002 |
| Bibliometrics | 0.001 | 0.002 |
| Science and technology studies | 0.001 | 0.000 |
| 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 | 0.001 |
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".