Guidance adherent dabigatran etexilate treatment versus warfarin in the RE-LY population: an analysis on the basis of the European label recommendations for dabigatran etexilate
Bibliographic record
Abstract
Purpose: In the RE-LY trial, patients were randomized to treatment arms independent of baseline characteristics; dabigatran 150 mg twice daily (BID; D150) was associated with significantly fewer strokes and dabigatran 110 mg BID (D110) with significantly fewer major bleeding events, compared to well controlled warfarin. The European (EU) label recommends D150 in patients <80 years without an increased risk for bleeding or concomitant verapamil and D110 in other patients. In this analysis of the RE-LY dataset, we simulated how dabigatran, when used according to the EU label, would compare to well controlled warfarin. Methods: In this post hoc, non-randomized analysis, we simulated the outcomes of patients receiving dabigatran with a dose selected according to the EU label and compared them to the warfarin-treated patients. Results: "EU label simulated dabigatran treatment" was associated with significant reductions in stroke and systemic embolism, haemorrhagic stroke, death and vascular death compared to warfarin; also with significant reductions in major and life-threatening bleeding and intracranial haemorrhage, but not gastrointestinal major bleeding, compared to warfarin (table). EU label simulated dabigatran outcomes were not significantly different from those of patients receiving D150 in RE-LY. Conclusion: This post hoc, non-randomized analysis of the RE-LY trial suggests that "EU label adherent dabigatran treatment" may be associated with superior efficacy and safety compared to warfarin.
Fetched live from OpenAlex and de-inverted. Abstracts are not stored in this database: the inverted indexes are 8.6 GB of the frame’s 9.3 GB of text, and the host has 13 GB free.
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 | 0.023 | 0.033 |
| Meta-epidemiology (narrow) | 0.001 | 0.001 |
| Meta-epidemiology (broad) | 0.003 | 0.009 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.002 | 0.001 |
| Research integrity | 0.003 | 0.003 |
| 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".