Pharmacokinetic and clinical data supporting the use of fondaparinux 1.5 mg once daily in the prevention of venous thromboembolism in renally impaired patients
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Bibliographic record
Abstract
The study aim was to determine the value of fondaparinux at the once-daily 1.5 mg dose in patients with moderate renal impairment (creatinine clearance between 20 and 50 ml/min). Pharmacokinetic simulations were performed using a population pharmacokinetic model based on data obtained in 756 patients undergoing major orthopedic surgery. The efficacy (venous thromboembolism) and safety (major bleeding) of 1.5 mg fondaparinux were determined by analyzing the available data obtained in all thromboprophylaxis trials using this dosage. The predicted steady-state exposure [area under the plasma concentration-time curve from 0 to 24 h (AUC0-24)] to fondaparinux between patients with moderate renal impairment receiving 1.5 mg and patients with normal renal function receiving 2.5 mg was similar. In four phase II trials (two trials versus placebo, one versus enoxaparin and one without comparator), 353 patients undergoing total hip or knee replacement (10.8% with moderate renal impairment) received fondaparinux 1.5 mg. The overall rate of venous thromboembolism and major bleeding was 10.4 and 0.3%. Fondaparinux 1.5 mg was significantly more effective than placebo (P < 0.01) and was as effective as, and tended to be safer (P = 0.05) than, twice-daily 30 mg enoxaparin. The effect was maintained in patients with moderate renal impairment. The once-daily administration of 1.5 mg fondaparinux in patients with moderate renal impairment resulted in a predicted exposure to the drug similar to that achieved with 2.5 mg in patients with normal renal function. This dosage regimen showed a favorable efficacy/safety clinical profile and should be appropriate in preventing venous thromboembolism in patients with moderate renal impairment.
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Full frame distilled prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.001 | 0.000 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.000 |
| 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) | 0.000 | 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 it