Refereed journal article or data article (A1)

Riociguat treatment in patients with pulmonary arterial hypertension: Final safety data from the EXPERT registry




List of Authors: Hoeper Marius M, Gomez Sanchez Miguel-Angel, Humbert Marc, Pittrow David, Simonneau Gérald, Gall Henning, Grünig Ekkehard, Klose Hans, Halank Michael, Langleben David, Snijder Repke J, Escribano Subias Pilar, Mielniczuk LisaM, Lange Tobias J, Vachiéry Jean-Luc, Wirtz Hubert, Helmersen Douglas S, Tsangaris Iraklis, Barberà Joan A, Pepke-Zaba Joanna, Boonstra Anco, Rosenkranz Stephan, Ulrich Silvia, Steringer-Mascherbauer Regina, Delcroix Marion, Jansa Pavel, Šimková Iveta, Giannakoulas George, Klotsche Jens, Williams Evgenia, Meier Christian, Ghofrani Hossein-Ardeschir; EXPERT Collaborators list

Publication year: 2021

Journal: Respiratory Medicine

Journal name in source: Respiratory medicine

Journal acronym: Respir Med

Volume number: 177

ISSN: 0954-6111

eISSN: 1532-3064

DOI: http://dx.doi.org/10.1016/j.rmed.2020.106241

Self-archived copy’s web address: https://research.utu.fi/converis/portal/Publication/52185552


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.


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Last updated on 2022-30-09 at 12:10