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IRIS
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 (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.
Riociguat treatment in patients with chronic thromboembolic pulmonary hypertension: Final safety data from the EXPERT registry
Ghofrani H. -A.;Gomez Sanchez M. -A.;Humbert M.;Pittrow D.;Simonneau G.;Gall H.;Grunig E.;Klose H.;Halank M.;Langleben D.;Snijder R. J.;Escribano Subias P.;Mielniczuk L. M.;Lange T. J.;Vachiery J. -L.;Wirtz H.;Helmersen D. S.;Tsangaris I.;Barbera J. A.;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 M. M.;Caneva J.;Tuhay G.;Diez M.;Talavera M. L.;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 R. C.;Tovar P. P.;Londono A.;Campo F.;Garcia P.;Lema C.;Orozco-Levi M.;Martinez W.;Gomez J. E.;Nielsen-Kudsk J. E.;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 C. D.;Manzi G.;Poscia R.;Badagliacca R.;Agostoni P.;Bruno N.;Farina S.;D'Alto M.;Argiento P.;Correra A.;Di Marco G. M.;Cresci C.;Vannucchi V.;Torricelli E.;Garcea A.;Pesci A.;Sardella L.;Paciocco G.;Pane F.;D'Armini A. M.;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 L. M.;Boomars K.;Andreassen A. K.;Castro G.;Tania G.;Baptista R.;Marinho A.;Shiang T.;Oliveira A.;Coutinho D.;Sousa J.;Loureiro M. J.;Repolho D.;Martins Jesus S. M.;Capinha M.;Agostinho J.;Cardoso T.;Rocha A.;Espinha M.;Ivanov K. I.;Alexeeva D. E.;Batalina M. V.;Hegya D. V.;Zvereva T. N.;Avdeev S. N.;Tsareva N. A.;Galyavich A. S.;Nikolaevich B. A.;Filippov E. V.;Yakovleva O. E.;Pavlova O. B.;Skripkina E. S.;Martynyuk T. V.;Bukatova I. F.;Tregubova A. V.;Platonov D. Y.;Kolomeytseva T. M.;Al Dalaan A.;Abdelsayed A. A.;Weheba I.;Saleemi S.;Sakkijha H.;Bohacekova M.;Valkovicova T.;Farkasova I.;Quezada C. A.;Piccari L.;Blanco I.;Sebastian L.;Roman A.;Lopez M.;Otero R.;Elias T.;Jara L.;Asencio I.;Arjona J. J.;Almagro R. M.;Cardenas S. L.;Garcia S. A.;Rodriguez P. V.;Lopez R.;Garcia A.;Aviles F. F.;De La Pava S.;Yotti R.;Penate G. P.;Marrero F. L.;Cifrian Martinez J. M.;Martinez-Menaca A.;Alonso L. P.;Rozas S. F.;Fernandez D. I.;Cuesta V. M.;Soderberg S.;Bartfay S. -E.;Rundqvist B.;Alfetlawi M.;Wodlin P.;Schwarz E. I.;Speich R.;Lador F.;Rochat T.;Gasche-Soccal P.;Hsu C. -H.;Lin T. -H.;Su H. -M.;Lai W. -T.;Chu C. Y.;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.
2021-01-01
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 (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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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/11571/1511718
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simulazione ASN
Il report seguente simula gli indicatori relativi alla propria produzione scientifica in relazione alle soglie ASN 2023-2025 del proprio SC/SSD. Si ricorda che il superamento dei valori soglia (almeno 2 su 3) è requisito necessario ma non sufficiente al conseguimento dell'abilitazione. La simulazione si basa sui dati IRIS e sugli indicatori bibliometrici alla data indicata e non tiene conto di eventuali periodi di congedo obbligatorio, che in sede di domanda ASN danno diritto a incrementi percentuali dei valori. La simulazione può differire dall'esito di un’eventuale domanda ASN sia per errori di catalogazione e/o dati mancanti in IRIS, sia per la variabilità dei dati bibliometrici nel tempo. Si consideri che Anvur calcola i valori degli indicatori all'ultima data utile per la presentazione delle domande.
La presente simulazione è stata realizzata sulla base delle specifiche raccolte sul tavolo ER del Focus Group IRIS coordinato dall’Università di Modena e Reggio Emilia e delle regole riportate nel DM 589/2018 e allegata Tabella A. Cineca, l’Università di Modena e Reggio Emilia e il Focus Group IRIS non si assumono alcuna responsabilità in merito all’uso che il diretto interessato o terzi faranno della simulazione. Si specifica inoltre che la simulazione contiene calcoli effettuati con dati e algoritmi di pubblico dominio e deve quindi essere considerata come un mero ausilio al calcolo svolgibile manualmente o con strumenti equivalenti.
