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

Lookup NU author(s): Emeritus Professor Nick Europe-Finner

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Abstract

© 2020 The AuthorsObjective: 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 (CTEPH) 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 and collated via case report forms. Results: In total, 956 patients with CTEPH were included in the analysis. The most common AEs in these patients were peripheral edema/edema (11.7%), dizziness (7.5%), right ventricular (RV)/cardiac failure (7.7%), and pneumonia (5.0%). The most common SAEs were RV/cardiac failure (7.4%), pneumonia (4.1%), dyspnea (3.6%), and syncope (2.5%). Exposure-adjusted rates of hemoptysis/pulmonary hemorrhage and hypotension were low and comparable to those in the long-term extension study of riociguat (Chronic Thromboembolic Pulmonary Hypertension Soluble Guanylate Cyclase–Stimulator Trial [CHEST-2]). Conclusion: Data from EXPERT show that in patients with CTEPH, the safety of riociguat in routine practice was consistent with the known safety profile of the drug, and no new safety concerns were identified.


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Author(s): Ghofrani H-A, Gomez Sanchez M-A, Humbert M, Pittrow D, Simonneau G, Gall H, Grunig E, Klose H, Halank M, Langleben D, Snijder RJ, Escribano Subias P, Mielniczuk LM, Lange TJ, Vachiery J-L, Wirtz H, Helmersen DS, Tsangaris I, Barbera JA, Pepke-Zaba J, Boonstra A, Rosenkranz S, Ulrich S, Steringer-Mascherbauer R, Delcroix M, Jansa P, Simkova I, Giannakoulas G, Klotsche J, Williams E, Meier C, Hoeper MM, Caneva J, Tuhay G, Diez M, Talavera ML, Acosta A, Vulcano N, Bosio M, Maldonado L, Deleo S, Melatini L, Keogh A, Kotlyar E, Feenstra J, Dwyer N, Adams H, Stevens W, Steele P, Proudman S, Minson R, Reeves G, Lavender M, Ng B, Mackenzie M, Barry L, Gruenberger M, Huber C, Lang I, Tilea I, Sadushi-Kolici R, Loffler-Ragg J, Feistmantl L-T, Evrard P, Louis R, Guiot J, Naldi M, De Pauw M, Mehta S, Camacho RC, Tovar PP, Londono A, Campo F, Garcia P, Lema C, Orozco-Levi M, Martinez W, Gomez JE, Nielsen-Kudsk JE, Mellemkjaer S, Anton L, Altraja A, Vihinen T, Vasankari T, Sitbon O, Cottin V, Tetu L, Noel-Savina E, Shearman N, Tayler S, Olzik I, Kulka C, Grimminger J, Simon M, Nolde A, Oqueka T, Harbaum L, Egenlauf B, Ewert R, Schulz C, Regotta S, Kramer T, Knoop-Busch S, Gerhardt F, Konstantinides S, Pitsiou G, Stanopoulos I, Sourla E, Mouratoglou S, Karvounis H, Pappas A, Georgopoulos D, Fanaridis M, Mitrouska I, Michalis L, Pappas K, Kotsia A, Gaine S, Vizza CD, Manzi G, Poscia R, Badagliacca R, Agostoni P, Bruno N, Farina S, D'Alto M, Argiento P, Correra A, Di Marco GM, Cresci C, Vannucchi V, Torricelli E, Garcea A, Pesci A, Sardella L, Paciocco G, Pane F, D'Armini AM, Pin M, Grazioli V, Massola G, Sciortino A, Prediletto R, Bauleo C, Airo E, Ndreu R, Pavlickova I, Lunardi C, Mule M, Farruggio S, Costa S, Galgano G, Petruzzi M, De Luca A, Lombardi F, Roncon L, Conte L, Picariello C, Wirtz G, Alexandre M, Vonk-Noordegraaf A, Boogaard H, Mager J, Reesink H, van den Toorn LM, Boomars K, Andreassen AK, Castro G, Tania G, Baptista R, Marinho A, Shiang T, Oliveira A, Coutinho D, Sousa J, Loureiro MJ, Repolho D, Martins Jesus SM, Capinha M, Agostinho J, Cardoso T, Rocha A, Espinha M, Ivanov KI, Alexeeva DE, Batalina MV, Hegya DV, Zvereva TN, Avdeev SN, Tsareva NA, Galyavich AS, Nikolaevich BA, Filippov EV, Yakovleva OE, Pavlova OB, Skripkina ES, Martynyuk TV, Bukatova IF, Tregubova AV, Platonov DY, Kolomeytseva TM, Al Dalaan A, Abdelsayed AA, Weheba I, Saleemi S, Sakkijha H, Bohacekova M, Valkovicova T, Farkasova I, Quezada CA, Piccari L, Blanco I, Sebastian L, Roman A, Lopez M, Otero R, Elias T, Jara L, Asencio I, Arjona JJ, Almagro RM, Cardenas SL, Garcia SA, Rodriguez PV, Lopez R, Garcia A, Aviles FF, De La Pava S, Yotti R, Penate GP, Marrero FL, Cifrian Martinez JM, Martinez-Menaca A, Alonso LP, Rozas SF, Fernandez DI, Cuesta VM, Soderberg S, Bartfay S-E, Rundqvist B, Alfetlawi M, Wodlin P, Schwarz EI, Speich R, Lador F, Rochat T, Gasche-Soccal P, Hsu C-H, Lin T-H, Su H-M, Lai W-T, Chu CY, Hsu P-C, Voon W-C, Yen H-W, Yih-Jer Wu J, Wu S-H, Huang W-P, Fong M-C, Huang C-L, Kuo P-H, Lin Y-H, Lin J-L, Hung C-S, Wu C-K, Sung S-H, Huang W-C, Cheng C-C, Kuo S-H, Wang W-H, Ho W-J, Hsu T-S, Mutlu B, Atas H, Ongen G, Un Z, Okumus G, Hanta I, Corris P, Peacock A, Church C, Toshner M, Newnham M

Publication type: Article

Publication status: Published

Journal: Respiratory Medicine

Year: 2021

Volume: 178

Print publication date: 01/03/2021

Online publication date: 11/11/2020

Acceptance date: 06/11/2020

Date deposited: 01/04/2021

ISSN (print): 0954-6111

ISSN (electronic): 1532-3064

Publisher: W.B. Saunders Ltd

URL: https://doi.org/10.1016/j.rmed.2020.106220

DOI: 10.1016/j.rmed.2020.106220


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