Hoeper, Marius M. and Gomez Sanchez, Miguel-Angel and Humbert, Marc and Pittrow, David and Simonneau, Gerald and Gall, Henning and Gruenig, Ekkehard and Klose, Hans and Halank, Michael and Langleben, David and Snijder, Repke J. and Subias, Pilar Escribano and Mielniczuk, Lisa M. and Lange, Tobias J. and Vachiery, Jean-Luc and Wirtz, Hubert and Helmersen, Douglas S. and Tsangaris, Iraklis and Barbera, Joan A. and Pepke-Zaba, Joanna and Boonstra, Anco and Rosenkranz, Stephan and Ulrich, Silvia and Steringer-Mascherbauer, Regina and Delcroix, Marion and Jansa, Pavel and Simkova, Iveta and Giannakoulas, George and Klotsche, Jens and Williams, Evgenia and Meier, Christian and Ghofrani, Hossein-Ardeschir (2021) Riociguat treatment in patients with pulmonary arterial hypertension: Final safety data from the EXPERT registry. RESPIRATORY MEDICINE, 177: 106241. ISSN 0954-6111, 1532-3064
Full text not available from this repository. (Request a copy)Abstract
Objective: The soluble guanylate cyclase stimulator riociguat is approved for the treatment of adult patients with pulmonary arterial hypertension (PAH) and inoperable or persistent/recurrent chronic thromboembolic pulmonary hypertension following Phase 3 randomized trials. The EXPosurE Registry RiociguaT in patients with pulmonary hypertension (EXPERT) study was designed to monitor the long-term safety of riociguat in clinical practice. Methods: EXPERT was an international, multicenter, prospective, uncontrolled, non-interventional cohort study of patients treated with riociguat. Patients were followed for at least 1 year and up to 4 years from enrollment or until 30 days after stopping riociguat treatment. Primary safety outcomes were adverse events (AEs) and serious adverse events (SAEs) coded using Medical Dictionary for Regulatory Activities preferred terms and System Organ Classes version 21.0, collected during routine clinic visits (usually every 3-6 months) and collated via case report forms. Results: In total, 326 patients with PAH were included in the analysis. The most common AEs in these patients were dizziness (11.7%), right ventricular (RV)/cardiac failure (10.7%), edema/peripheral edema (10.7%), diarrhea (8.6%), dyspnea (8.0%), and cough (7.7%). The most common SAEs were RV/cardiac failure (10.1%), pneumonia (6.1%), dyspnea (4.0%), and syncope (3.4%). The exposure-adjusted rate of hemoptysis/pulmonary hemorrhage was 2.5 events per 100 patient-years. Conclusion: Final data from EXPERT show that in patients with PAH, the safety of riociguat in clinical practice was consistent with clinical trials, with no new safety concerns identified and a lower exposure-adjusted rate of hemoptysis/pulmonary hemorrhage than in the long-term extension of the Phase 3 trial in PAH.
| Item Type: | Article |
|---|---|
| Uncontrolled Keywords: | LONG-TERM EXTENSION; OPEN-LABEL; OUTCOMES; PREDICTORS; SURVIVAL; Pulmonary arterial hypertension; Pulmonary hypertension; Riociguat; Registry; Clinical practice; Safety |
| Subjects: | 600 Technology > 610 Medical sciences Medicine |
| Divisions: | Medicine > Lehrstuhl für Innere Medizin II |
| Depositing User: | Dr. Gernot Deinzer |
| Date Deposited: | 04 Oct 2022 10:32 |
| Last Modified: | 04 Oct 2022 10:32 |
| URI: | https://pred.uni-regensburg.de/id/eprint/48237 |
Actions (login required)
 |
View Item |
