Long-term safety of a new formulation of epoprostenol in pulmonary arterial hypertension
Bibliographic record
Abstract
Purpose: This study investigates the long-term safety of epoprostenol with arginine and sucrose excipients (epo-AS; approved for pulmonary arterial hypertension [PAH] in the USA as Veletri®), an infused prostacyclin with improved stability. Methods: In EPITOME-2 PAH patients were transitioned from epoprostenol with glycine and mannitol excipients (epo-GM; Flolan®) to epo-AS and treated initially for 3 months and then in the ongoing extension until discontinuation or access to commercially available epo-AS. Long-term safety was evaluated based on adverse events (AE), serious AE (SAE) and reasons for premature discontinuation. This analysis includes data from all patients treated between 22 March 2011 and 28 January 2013. Results: 41 patients, median (range) duration of PAH 5.4 (1.6–37.1) years and epo-GM exposure 41 (12–173) months, were transitioned to epo-AS. The median (range) epo-AS exposure was 16.2 (9–22) months. 5 patients discontinued study drug; 4 underwent lung transplant and 1 experienced sudden death. 40 (98%) patients had ≥1 AE; the most frequent (>10%) were collective issues with the delivery system, headache, nasopharyngitis, extremity pain, dyspnoea, jaw pain, flushing, bronchitis, diarrhoea and fatigue. 18 patients had SAE associated with the delivery system, including 6 patients with catheter-related infections. Other SAE included right ventricular failure (n=3) and syncope (n=2). Conclusion: The safety and tolerability profile of epo-AS was typical of that of an infused prostacyclin, and no new safety signals were identified in patients treated with epo-AS up to 22 months.
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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 | 0.001 | 0.001 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.000 | 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 | 0.001 |
| 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".