RESPITE: Riociguat in pulmonary arterial hypertension patients with an inadequate response to phosphodiesterase type 5 inhibitors
Bibliographic record
Abstract
Background: PDE5i treatment is widely used in PAH, but some patients fail to reach/maintain treatment goals. Aim: RESPITE investigates the safety and efficacy of replacing PDE5i by riociguat. Methods: RESPITE is a prospective, multicenter, uncontrolled, open-label, single-arm, Phase IIIb trial. PAH patients in WHO FC III with 6MWD 165–440 m and cardiac index <3.0 L/min/m2 despite receiving PDE5i, alone or with an ERA, were enrolled. After PDE5i wash-out, riociguat was individually adjusted to a maximum of 2.5 mg tid. Exploratory endpoints, including exercise capacity, hemodynamics and FC, were assessed at Week 24. We present planned interim analysis data. Results: Of 30 eligible patients (mean±SD age 57±12 years; 73% female), 70% and 30% were pretreated with sildenafil or tadalafil, respectively; 73% were receiving an ERA. All efficacy endpoints had improved at Week 24 with riociguat (Table). Four patients (13%) experienced clinical worsening, including 3 deaths (none drug related; 1 during the extension). The most common drug-related AEs were headache (17%), dyspepsia (13%) and epistaxis (13%); 1 patient discontinued due to drug-related AEs (both right ventricular failure and dyspnea reported). Conclusions: In the interim analysis of RESPITE, riociguat improved a range of clinical and hemodynamic endpoints in PAH patients transitioned from PDE5i. No new safety signals were observed.
Fetched live from OpenAlex and de-inverted. Abstracts are not stored in this database: the inverted indexes are 8.6 GB of the frame’s 9.3 GB of text, and the host has 13 GB free.
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 | 0.001 | 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".