Comparison of hemodynamic parameters in treatment-naive and pretreated patients with pulmonary arterial hypertension (PAH) in the Phase III PATENT-1 study
Bibliographic record
Abstract
Purpose: In PATENT-1, treatment with riociguat, a novel soluble guanylate cyclase stimulator, significantly improved 6-min walking distance (6MWD) and hemodynamic parameters in patients with PAH compared with placebo. Here we present the detailed hemodynamic findings from PATENT-1 in treatment-naïve and pretreated patients. Methods: In this Phase III, double-blind, placebo-controlled study, patients were randomized 2:4:1 to treatment with placebo, individually titrated riociguat (up to 2.5 mg tid), or a capped titration of riociguat (up to 1.5 mg tid; exploratory, analyzed descriptively) for 12 wks. The primary endpoint was change in 6MWD from baseline (BL) at 12 wks. Hemodynamic parameters were assessed by right heart catheterization at BL and Wk 12. Results: Of the 443 patients randomized and treated, 221 (50%) were treatment-naïve, 194 (44%) were pretreated with endothelin receptor antagonists (ERAs), and 31 (7%) with prostanoids. BL demographics were generally well balanced between these subgroups. At Wk 12, 6MWD improved by 32±74 m in treatment-naïve, 23±50 m in ERA pretreated, and 56±84 m in prostanoid pretreated patients in the riociguat individual titration arm, compared with −6±88 m, −0.4±82 m, and −40±78 m, respectively in the placebo arm. Changes in selected hemodynamic parameters from BL to Wk 12 in the riociguat individual titration and placebo arms are shown in Table 1. Table 1. Hemodynamic parameters Data shown are arithmetic mean ± standard deviation. CI, cardiac index; ERA, endothelin receptor antagonist; mPAP, mean pulmonary artery pressure; PCWP, pulmonary capillary wedge pressure; PVR, pulmonary vascular resistance; RAP, mean arterial pressure; SvO2, mixed venous oxygen saturation; SVR, systemic vascular resistance. Conclusions: Riociguat consistently improved exercise capacity and a range of hemodynamic parameters in both treatment-naïve patients and those pretreated with ERAs or prostanoids.
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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 | 0.003 | 0.001 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.002 | 0.001 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.000 |
| Research integrity | 0.001 | 0.002 |
| 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".