Bibliographic record
Abstract
# Rofecoxib did not provide unequivocal benefit over traditional NSAIDs {#article-title-2} EDITOR—In their editorial Jüni et al say that celecoxib is no safer than diclofenac or ibuprofen and that the CLASS authors “spun” their analysis to suggest otherwise.1 They also state: “In contrast with the CLASS trial, the VIGOR trial, which was similar in design and outcomes, found an unequivocal benefit of another selective COX 2 inhibitor, rofecoxib, over traditional non-steroidal anti-inflammatory agents [NSAIDs].”2 I disagree. Although serious gastrointestinal adverse effects were less frequent in rofecoxib users than in patients with rheumatoid arthritis treated with naproxen (number needed to treat to prevent one serious upper gastrointestinal event 191; 95% confidence interval 114 to 586), rofecoxib was in fact less safe than naproxen. The published version of the VIGOR trial focused on the narrow outcome of serious gastrointestinal complications. The US Food and Drug Administration took the unprecedented step of presenting its review of both the CLASS trial and the VIGOR trial on its website.3 Review of the complete data presented there shows that when all serious adverse events are included—not just gastrointestinal events—patients treated with naproxen had fewer serious events. Among patients treated with rofecoxib, 9.3% experienced a serious adverse event compared with 7.8% of those treated with naproxen (relative risk 0.81; 0.62 to 0.97). When all serious adverse events are counted, the number needed to harm when rofecoxib is used compared with naproxen is 66 (36 to 332). The increased risk of serious adverse events was due to an increase of serious adverse cardiovascular events, including a 300% greater risk of myocardial infarction in those treated with rofecoxib. The VIGOR results, examined fully, show that at least one traditional non-steroidal anti-inflammatory drug—naproxen—is unequivocally safer than rofecoxib, albeit with an increased risk of adverse events limited to the gastrointestinal tract. ![Graphic][1] Three other responses on bmj.com (bmj.com/cgi/eletters/324/7349/1287) made similar … [1]: /embed/inline-graphic-1.gif
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 | 0.009 | 0.035 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.003 | 0.001 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.000 | 0.002 |
| Scholarly communication | 0.003 | 0.006 |
| Open science | 0.002 | 0.001 |
| Research integrity | 0.006 | 0.007 |
| Insufficient payload (model declined to judge) | 0.012 | 0.003 |
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".