Real-world patterns of pirfenidone use and safety in patients with idiopathic pulmonary fibrosis in Canada: Data from INSPIRATION PLUS
Bibliographic record
Abstract
RATIONALE: INSPIRATION PLUS (NCT02552849) was a prospective, observational registry of Canadian patients with idiopathic pulmonary fibrosis (IPF) treated with the oral antifibrotic agent pirfenidone. As an exploratory analysis of the registry, pirfenidone usage and safety were examined in patients with incident pirfenidone use.OBJECTIVE: To describe pirfenidone usage and tolerability in Canadian patients with IPF.METHODS: Patients with IPF who received pirfenidone were monitored prospectively beginning in April 2013. Planned outcomes included change in percent predicted forced vital capacity and the proportion of patients receiving a full pirfenidone dose (2403 mg/day). Data were collected during routine clinical visits. Pirfenidone usage and safety were analyzed in patients who initiated pirfenidone within 3 months of enrollment.RESULTS: A total of 297 patients enrolled; 125 patients with incident pirfenidone use; 98 patients with both baseline data and ≥ 1 follow-up visit comprised the analysis population. Median (range) duration of follow-up and number of follow-up visits were 10 (0.9–34.4) months and 3 (1–9) visits, respectively. Dose modifications occurred more frequently during the first 6 months of treatment than in the subsequent 6 months (23% vs 8% of patients). The incidence of adverse drug reactions was consistent with the known safety profile for pirfenidone; gastrointestinal-related events were most frequent. Increased age or a history of smoking was associated with an increased risk of discontinuing pirfenidone in the first 12 months of treatment.CONCLUSIONS: Canadian patients with IPF receiving pirfenidone had a similar safety profile compared with clinical trial data.
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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 | 0.004 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.001 |
| Bibliometrics | 0.001 | 0.004 |
| Science and technology studies | 0.002 | 0.001 |
| Scholarly communication | 0.001 | 0.000 |
| Open science | 0.001 | 0.001 |
| 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".