Comparison of clinical efficacy and safety of original and generic forms of etoricoxib in patients with knee osteoarthritis
Bibliographic record
Abstract
Background. Nonsteroidal anti-inflammatory drugs (NSAIDs) are an important drug class for the treatment of osteoarthritis (OA). Despite existing studies on the bioequivalence of original and generic NSAIDs, comparative studies related to their clinical efficacy and safety are limited. The purpose of the study was to compare the clinical efficacy and safety of the original and generic forms of etoricoxib in patients with knee OA. Materials and methods. In an open, comparative, randomized, multicenter study, 150 patients with knee OA were examined: group I — 50 persons who received the original etoricoxib (60 mg/d for 10 days), groups II and III — 50 subjects each who received generic etoricoxib (60 mg/d for 10 days). The effectiveness of the treatment was evaluated using the four-component visual analog scale (VAS), the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), and the Lequesne index before the start of therapy and on the 10th day. Assessment of tolerability and safety was studied by controlling adverse events based on clinical and laboratory indicators. Results. The use of the original and generic forms of etoricoxib in patients with knee OA led to positive dynamics of pain syndrome and functional activity, while the dynamics of indices were the greatest in the case of using the original etoricoxib (VAS: group I — 50.0 [35.4–60.0] %, group II — 29.1 [16.7–55.0] % and III — 28.6 [14.3–33.3] %). The most pronounced positive dynamics of the pain syndrome against the background of taking the original etoricoxib compared to the generic forms was registered in the subgroup of patients with severe knee pain (VAS > 60 mm). The use of all forms of etoricoxib was safe and did not lead to serious clinical side effects or clinically significant changes in laboratory blood parameters. The highest rates of satisfaction with the treatment by patients and physicians were observed in the case of the original etoricoxib use. Conclusions. The use of the original etoricoxib in patients with knee OA, especially in the presence of severe pain syndrome (VAS > 60 mm) is the most justified and safe.
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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) | 0.001 | 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 | 0.000 | 0.000 |
| Insufficient payload (model declined to judge) | 0.001 | 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".