P1502Open-label ODYSSEY APPRISE study: interim data from the first 843 participants
Bibliographic record
Abstract
Background: PCSK9 inhibitors have been recommended as an option by the ESC/EAS Task Force in very high-risk subjects with atherosclerotic cardiovascular (CV) disease and those with HeFH with persistent high LDL-C levels despite maximally tolerated statin and ezetimibe therapies. Purpose: ODYSSEY APPRISE (NCT02476006) was the first European-Canadian collaborative study to provide subjects with severe hypercholesterolaemia at very high CV risk access to the PCSK9 inhibitor alirocumab (ALI) prior to commercial availability (study treatment: ≥12 weeks; ≤30 months) and to assess ALI safety and tolerability. Methods: APPRISE was an open-label, single-arm study, conducted in a real-life setting in 16 European countries and Canada. The study population included subjects with inadequately controlled lipid levels, despite maximally tolerated statins with or without additional lipid-lowering therapies, excluding PCSK9 inhibitors. Based on physician's judgement, participants received either ALI 75 or 150 mg every 2 weeks (Q2W). Study endpoints included efficacy at Week (W)12 and safety.
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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 | 0.006 | 0.004 |
| Meta-epidemiology (narrow) | 0.001 | 0.001 |
| Meta-epidemiology (broad) | 0.002 | 0.002 |
| Bibliometrics | 0.000 | 0.001 |
| Science and technology studies | 0.001 | 0.001 |
| Scholarly communication | 0.002 | 0.001 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.001 | 0.002 |
| Insufficient payload (model declined to judge) | 0.013 | 0.005 |
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".