Valdecoxib Is Associated with Improved Dyspepsia-Related Health Compared with Nonspecific NSAIDs in Patients with Osteoarthritis or Rheumatoid Arthritis
Bibliographic record
Abstract
OBJECTIVES: Dyspepsia and related gastrointestinal (GI) symptoms are commonly reported by patients taking nonspecific nonsteroidal anti-inflammatory drugs (NSAIDs) and significantly impact treatment effectiveness, cost, and quality of life. This study sought to evaluate dyspepsia-related health in osteoarthritis (OA) and rheumatoid arthritis (RA) patients taking valdecoxib compared with patients taking nonspecific NSAIDs. METHODS: Analysis of two separate, double-blind, placebo-controlled studies: one in RA patients randomized to placebo, valdecoxib (10 and 20 mg once daily [o.d.]) and naproxen (500 mg twice daily [b.i.d.]); one in OA patients randomized to placebo, valdecoxib (10 and 20 mg o.d.), diclofenac (75 mg b.i.d.), or ibuprofen (800 mg three times daily [t.i.d.]). Study population comprised patients with RA in flare or clinically documented OA who required chronic symptomatic treatment with NSAIDs/analgesics. Dyspepsia-related health was evaluated at baseline and weeks 2, 6, and 12 (or early termination) using the validated Severity of Dyspepsia Assessment (SODA) questionnaire. This patient self-report tool consists of scales for evaluating dyspepsia pain intensity, nonpain symptoms, and satisfaction. Analysis was based on the intent-to-treat population with the last observation carried forward. RESULTS: Valdecoxib was significantly better at endpoint than standard doses of naproxen, diclofenac, and ibuprofen for pain intensity scores (p < 0.05), and provided significantly improved nonpain symptom and satisfaction scores compared with naproxen for patients with RA (p < 0.05). For RA patients, the difference between valdecoxib and naproxen pain intensity scores were clinically meaningful; at all the time points, significantly fewer patients receiving valdecoxib reported severe dyspepsia pain intensity increases (>/=10 points) than those receiving naproxen. At 12 wk, fewer patients receiving valdecoxib reported severe dyspepsia pain intensity increases versus those receiving ibuprofen and diclofenac. CONCLUSIONS: The GI tolerability of valdecoxib is superior to that of nonspecific NSAIDs, and therefore can potentially have a favorable impact on patient quality of life.
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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) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.002 | 0.001 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| 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".