Abstract 15: Long Term Outcomes of Intravenous Glyburide in Patients 70 Years of Age or Under: Subgroup Analysis From the Phase II GAMES-RP Study of Patients with Large Hemispheric Infarction
Bibliographic record
Abstract
Background: Prior evidence suggests that younger patients are at increased risk for the deleterious consequences associated with edema after large hemispheric infarction (LHI). GAMES-RP was a double-blind, randomized, placebo controlled phase 2 study. Patients presenting to 18 centers with baseline infarct volumes between 82 and 300 cm 3 on MRI were randomized 1:1 within 10 hours of symptom onset. Although the primary analysis, which included decompressive craniectomy as part of a composite endpoint, suggested no difference between groups, there was a trend toward decreased mortality for patients treated with IV glyburide. Objective: Exploratory analyses of the GAMES-RP trial suggested that overall trend of decreased mortality for patients treated with IV glyburide may be more pronounced with younger patients. We hypothesized that patients age 70 and under who were treated with IV glyburide would have improved long term outcomes compared to placebo. Methods: This exploratory analysis included the subset of patients aged < 70 who met the Per-Protocol definition: IV glyburide (n=35) and placebo (n=30). We analyzed 12-month mortality, functional outcome by analysis of the modified Rankin Scale (mRS), functional improvement on the Barthel Index (BI), and quality of life using the EQ-5D. Differences were analyzed using Fisher’s exact test except for shift analysis, which used a two sided Mann-Whitney test. Results: Subjects treated with IV glyburide had lower mortality at 12 months (14% vs 40%, p=0.025, OR 4.00). Shift analysis revealed a trend towards improved functional outcome in IV glyburide treated patients (OR 2.24; p=0.080), higher score on the BI (mean 60.1; SD 37.9 vs mean 39.5; SD 40.1, p=0.03), and higher score on the EQ-5D (mean 0.49; SD 0.31 vs mean 0.33; SD 0.32, p=0.04). Conclusion: This post-hoc analysis suggests that patients under 70, who may be at highest risk for poor outcomes secondary to edema after large hemispheric infarction, may have improved survival, better functional outcome and improved quality of life following treatment with IV glyburide. A prospective study is required in this population in order to definitively establish that IV glyburide can improve outcome. Registry: NCT01794182
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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 | 0.003 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.003 | 0.006 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.000 | 0.001 |
| Research integrity | 0.001 | 0.001 |
| 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".