Effect of macitentan on haemodynamics in SERAPHIN, a randomised controlled trial in pulmonary arterial hypertension (PAH)
Bibliographic record
Abstract
Macitentan's effect on haemodynamics in PAH patients was assessed at selected centres in the SERAPHIN study ( NCT00660179 ). 742 patients were randomised to placebo, macitentan 3 or 10mg q.d. Background phosphodiesterase-5 inhibitors and oral/inhaled prostanoids were allowed. 187 patients had right heart catheterisation at randomisation and Month 6. Placebo (n=68), macitentan 3mg (n=62) and 10mg (n=57) groups were well balanced for baseline haemodynamics with median pulmonary vascular resistance (PVR), 800, 785, 789 dyn·sec/cm 5 and cardiac index (CI) 2.49, 2.23, 2.47 L/min/m 2 . On average, all cardiopulmonary haemodynamics improved at Month 6 with macitentan and worsened with placebo. Subgroup analyses by background PAH therapy (naïve or treated) and baseline WHO FC I/II or III/IV showed that beneficial treatment effects with macitentan remained almost entirely significant for PVR and CI. Treatment effect on PVR (%)* and CI (L/min/m2) PVR CI Macitentan 3mg Macitentan 10mg Macitentan 3mg Macitentan 10mg All (n=187) -28.7 (-32.2,-19.2) -37.4 (-46.3,-26.6) 0.5 (0.3,0.8) 0.6 (0.4,0.9) Naïve (n=95) -19.9 (-34.2,0.8)** -40.3 (-52.0,-22.3) 0.4 (0.1,0.8) 0.6 (0.2,1.0) Treated (n=92) -34.4 (-45.6,-22.3) -33.3 (-45.6,-20.7) 0.6 (0.4,1.0) 0.6 (0.2,1.0) FC I/II (n=82) -35.2 (-49.2,-21.6) -46.0 (-57.2,-28.8) 0.5 (0.2,0.9) 0.7 (0.2,1.1) FC III/IV (n=105) -21.8 (-37.8,-9.2) -29.0 (-43.8,-16.6) 0.5 (0.3,0.9) 0.6 (0.3,1.0) Median (95% CL) placebo-corrected change from baseline. *Based on the log of Month 6/baseline values. All P<0.05 except** Macitentan improved cardiopulmonary haemodynamics in PAH patients with consistent improvements in PVR and CI irrespective of background PAH therapy and baseline WHO FC.
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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) | 0.001 | 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 | 0.001 |
| 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".