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

Author

Ghofrani, H.-A. Gomez Sanchez, M.-A. Humbert, M. Pittrow, D. Simonneau, G. Gall, H. Grünig, E. Klose, H. Halank, M. Langleben, D. Snijder, R.J. Escribano Subias, P. Mielniczuk, L.M. Lange, T.J. Vachiéry, J.-L. Wirtz, H. Helmersen, D.S. Tsangaris, I. Barberá, J.A. Pepke-Zaba, J. Boonstra, A. Rosenkranz, S. Ulrich, S. Steringer-Mascherbauer, R. Delcroix, M. Jansa, P. Šimková, 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. Löffler-Ragg, J. Feistmantl, L.-T. Evrard, P. Louis, R. Guiot, J. Naldi, M. De Pauw, M. Mehta, S. Camacho, R.C. Tovar, P.P. Londoño, 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. Têtu, L. Noël-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. Airò, E. Ndreu, R. Pavlickova, I. Lunardi, C. Mulè, 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. Cárdenas, S.L. García, S.A. Rodríguez, P.V. Lopez, R. Garcia, A. Avilés, F.F. De La Pava, S. Yotti, R. Peñate, G.P. Marrero, F.L. Cifrián Martínez, J.M. Martinez-Meñaca, A. Alonso, L.P. Rozas, S.F. Fernandez, D.I. Cuesta, V.M. Söderberg, 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. NEW COLLABORATORS LIST

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. © 2020 The Authors

Published
2021

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

Author

Ghofrani, H.A., Gomez Sanchez, M.-A. (Miguel-Angel), Humbert, M., Pittrow, D. (David), Simonneau, G. (Gérald), Gall, H. (Henning), Grünig, E. (Ekkehard), Klose, H. (Hans), Halank, M. (Michael), Langleben, D. (David), Snijder, R., Escribano Subías, P. (Pilar), Mielniczuk, L.M. (Lisa M.), Lange, T.J. (Tobias J.), Vachiéry, J.-L. (Jean-Luc), Wirtz, H. (Hubert), Helmersen, D.S. (Douglas S.), Tsangaris, I. (Iraklis), Barberá, J.A. (Joan A.), Pepke-Zaba, J. (Joanna), Boonstra, A. (Anco), Rosenkranz, S. (Stephan), Ulrich, S. (Silvia), Steringer-Mascherbauer, R. (Regina), Delcroix, M. (Marion), Jansa, P. (Pavel), Šimková, I. (Iveta), Giannakoulas, G. (George), Klotsche, J. (Jens), Williams, E. (Evgenia), Meier, C. (Christian), Hoeper, M.M. (Marius M.), Caneva, J. (Jorge), Tuhay, G. (Graciela), Diez, M. (Mirta), Talavera, M.L. (Maria Lujan), Acosta, A. (Adriana), Vulcano, N. (Norberto), Bosio, M. (Martin), Maldonado, L. (Lorena), Deleo, S. (Sabino), Melatini, L. (Luciano), Keogh, A. (Anne), Kotlyar, E. (Eugene), Feenstra, J. (John), Dwyer, N. (Nathan), Adams, H. (Heath), Stevens, W. (Wendy), Steele, P. (Peter), Proudman, S. (Susanna), Minson, R. (Robert), Reeves, G. (Glenn), Lavender, M. (Melanie), Ng, B. (Benjamin), Mackenzie, M. (Michele), Barry, L. (Lisa), Gruenberger, M. (Margarethe), Huber, C. (Charlotte), Lang, I. (Irene), Tilea, I. (Ioana), Sadushi-Kolici, R. (Roela), Löffler-Ragg, J. (Judith), Feistmantl, L.-T. (Lisa-Theresa), Evrard, P. (Patrick), Louis, R. (Renaud), Guiot, J. (Julien), Naldi, M. (Marco), De Pauw, M. (Michel), Mehta, S. (Sanjay), Camacho, R.C. (Rafael Conde), Tovar, P.P. (Patricia Parada), Londoño, A. (Alejandro), Campo, F. (Felipe), Garcia, P. (Paula), Lema, C. (Camila), Orozco-Levi, M. (Mauricio), Martinez, W. (William), Gomez, J.E. (Juan Esteban), Nielsen-Kudsk, J.E. (Jens Erik), Mellemkjaer, S. (Soren), Anton, L. (Ly), Altraja, A. (Alan), Vihinen, T. (Tapani), Vasankari, T. (Tuija), Sitbon, O. (Olivier), Cottin, V. (Vincent), Têtu, L. (Laurent), Noël-Savina, E. (Elise), Shearman, N. (Nicole), Tayler, S. (Susanne), Olzik, I. (Ilona), Kulka, C. (Christine), Grimminger, J. (Jan), Simon, M. (Marcel), Nolde, A. (Anna), Oqueka, T. (Tim), Harbaum, L. (Lars), Egenlauf, B. (Benjamin), Ewert, R. (Ralf), Schulz, C. (Christian), Regotta, S. (Sabine), Kramer, T. (Tilmann), Knoop-Busch, S. (Susanne), Gerhardt, F. (Felix), Konstantinides, S. (Stavros), Pitsiou, G. (Georgia), Stanopoulos, I. (Ioannis), Sourla, E. (Evdokia), Mouratoglou, S. (Sofia), Karvounis, H.I., Pappas, A. (Athanasios), Georgopoulos, D. (Dimitrios), Fanaridis, M. (Michail), Mitrouska, I. (Ioanna), Michalis, L.K. (Lampros), Pappas, K. (Konstantinos), Kotsia, A. (Anna), Gaine, S. (Sean), Vizza, C.D. (Carmine Dario), Manzi, G. (Giovanna), Poscia, R. (Roberto), Badagliacca, R. (Roberto), Agostoni, P. (Piergiuseppe), Bruno, N. (Noemi), Farina, S. (Stefania), D'Alto, M. (Michele), Argiento, P. (Paola), Correra, A. (Anna), Di Marco, G.M. (Giovanni Maria), Cresci, C. (Chiara), Vannucchi, V. (Vieri), Torricelli, E. (Elena), Garcea, A. (Alessio), Pesci, A. (Alberto), Sardella, L. (Luca), Paciocco, G. (Giuseppe), Pane, F. (Federico), D'Armini, A.M. (Andrea Maria), Pin, M. (Maurizio), Grazioli, V. (Valentina), Massola, G. (Giulia), Sciortino, A. (Antonio), Prediletto, R. (Renato), Bauleo, C. (Carolina), Airò, E. (Edoardo), Ndreu, R. (Rudina), Pavlickova, I. (Ivana), Lunardi, C. (Claudio), Mulè, M. (Massimiliano), Farruggio, S. (Silvia), Costa, S. (Serena), Galgano, G. (Giuseppe), Petruzzi, M. (Mario), De Luca, A. (Anna), Lombardi, F. (Francesco), Roncon, L. (Loris), Conte, L. (Luca), Picariello, C. (Claudio), Wirtz, G. (Gil), Alexandre, M. (Myriam), Vonk Noordegraaf, A. (Anton), Boogaard, H. (H.), Mager, J. (J.), Reesink, H.J. (Herre), Toorn, L.M. (Leon) van den, Boomars, K.A.T. (Karin), Andreassen, A.K. (Arne K.), Castro, G. (Graça), Tania, G. (Gonçalves), Baptista, R. (Rui), Marinho, A. (António), Shiang, T. (Teresa), Oliveira, A. (Ana), Coutinho, D. (Daniel), Sousa, J. (Joana), Loureiro, M.J. (Maria José), Repolho, D. (Débora), Martins Jesus, S.M. (Susana Maria), Capinha, M. (Marta), Agostinho, J. (João), Cardoso, T. (Tania), Rocha, A. (Andreia), Espinha, M. (Mafalda), Ivanov, K.I. (Kyundyul Ivanovich), Alexeeva, D.E. (Dalyana Eduardovna), Batalina, M.V. (Marina Vadimovna), Hegya, D.V. (Daria Viktorovna), Zvereva, T.N. (Tatyana Nikolaevna), Avdeev, S.N. (Sergey Nikolaevich), Tsareva, N.A. (Natalia Anatolievna), Galyavich, A.S. (Albert Sarvatovich), Nikolaevich, B.A. (Bykov Aleksander), Filippov, E.V. (Evgeny Vladimirovich), Yakovleva, O.E. (Olga Eduardovna), Pavlova, O.B. (Olga Borisovna), Skripkina, E.S. (Elena Sergeevna), Martynyuk, T.V. (Tamila Vitalievna), Bukatova, I.F. (Irina Fedorovna), Tregubova, A.V. (Anna Viktorovna), Platonov, D.Y. (Dmitry Yurievich), Kolomeytseva, T.M. (Tatyana Mikhaylovna), Al Dalaan, A. (Abdullah), Abdelsayed, A.A. (Abeer Abeer), Weheba, I. (Ihab), Saleemi, S. (Sarferaz), Sakkijha, H. (Hussam), Bohacekova, M. (Marcela), Valkovicova, T. (Tatiana), Farkasova, I. (Iveta), Quezada, C.A. (Carlos Andres), Piccari, L. (Lucilla), Blanco, I. (Isabel), Sebastian, L. (Laura), Roman, A. (Antonio), Lopez, M. (Manuel), Otero, R. (Remedios), Elias, T. (Teresa), Jara, L. (Luis), Asencio, I. (Isabel), Arjona, J.J. (Josefa Jiménez), Almagro, R.M. (Raúl Menor), Cárdenas, S.L. (Salvador López), García, S.A. (Salvador Alcaraz), Rodríguez, P.V. (Patricia Villanueva), Lopez, R. (Raquel), Garcia, A. (Alberto), Avilés, F.F. (Francisco Fernandez), De La Pava, S. (Sebastian), Yotti, R. (Raquel), Peñate, G.P. (Gregorio Pérez), Marrero, F.L. (Fernando León), Cifrián Martínez, J.M. (José Manuel), Martinez-Meñaca, A. (Amaya), Alonso, L.P. (Lecue Pilar), Rozas, S.F. (Sonia Fernandez), Fernandez, D.I. (David Iturbe), Cuesta, V.M. (Victor Mora), Söderberg, S. (Stefan), Bartfay, S.-E. (Sven-Erik), Rundqvist, B. (Bengt), Alfetlawi, M. (Monthir), Wodlin, P. (Peter), Schwarz, E.I. (Esther Irene), Speich, R. (Rudolf), Lador, F. (Frédéric), Rochat, T. (Thierry), Gasche-Soccal, P. (Paola), Hsu, C.-H. (Chih-Hsin), Lin, T.-H. (Tsung-Hsien), Su, H.-M. (Ho-Ming), Lai, W.-T. (Wen-Ter), Chu, C.Y. (Chun Yuan), Hsu, P.-C. (Po-Chao), Voon, W.-C. (Wen-Chol), Yen, H.-W. (Hsueh-Wei), Yih-Jer Wu, J. (Jacob), Wu, S.-H. (Shu-Hao), Huang, W.-P. (Wen-Pin), Fong, M.-C. (Man-Cai), Huang, C.-L. (Chien-Lung), Kuo, P.-H. (Ping-Hung), Lin, Y.-H. (Yen-Hung), Lin, J.-L. (Jiunn-Lee), Hung, C.-S. (Chi-Sheng), Wu, C.-K. (Cho-Kai), Sung, S.-H. (Shih-Hsien), Huang, W.-C. (Wei-Chun), Cheng, C.-C. (Chin-Chang), Kuo, S.-H. (Shu-Hung), Wang, W.-H. (Wen-Hwa), Ho, W.-J. (Wan-Jing), Hsu, T.-S. (Tsu-Shiu), Mutlu, B. (Bülent), Atas, H. (Halil), Ongen, G. (Gul), Un, Z. (Zeynep), Okumus, G. (Gulfer), Hanta, I. (Ismail), Corris, P. (Paul), Peacock, A. (Andrew), Church, C. (Colin), Toshner, M. (Mark), Newnham, M. (Michael), Ghofrani, H.A., Gomez Sanchez, M.-A. (Miguel-Angel), Humbert, M., Pittrow, D. (David), Simonneau, G. (Gérald), Gall, H. (Henning), Grünig, E. (Ekkehard), Klose, H. (Hans), Halank, M. (Michael), Langleben, D. (David), Snijder, R., Escribano Subías, P. (Pilar), Mielniczuk, L.M. (Lisa M.), Lange, T.J. (Tobias J.), Vachiéry, J.-L. (Jean-Luc), Wirtz, H. (Hubert), Helmersen, D.S. (Douglas S.), Tsangaris, I. (Iraklis), Barberá, J.A. (Joan A.), Pepke-Zaba, J. (Joanna), Boonstra, A. (Anco), Rosenkranz, S. (Stephan), Ulrich, S. (Silvia), Steringer-Mascherbauer, R. (Regina), Delcroix, M. (Marion), Jansa, P. (Pavel), Šimková, I. (Iveta), Giannakoulas, G. (George), Klotsche, J. (Jens), Williams, E. (Evgenia), Meier, C. (Christian), Hoeper, M.M. (Marius M.), Caneva, J. (Jorge), Tuhay, G. (Graciela), Diez, M. (Mirta), Talavera, M.L. (Maria Lujan), Acosta, A. (Adriana), Vulcano, N. (Norberto), Bosio, M. (Martin), Maldonado, L. (Lorena), Deleo, S. (Sabino), Melatini, L. (Luciano), Keogh, A. (Anne), Kotlyar, E. (Eugene), Feenstra, J. (John), Dwyer, N. (Nathan), Adams, H. (Heath), Stevens, W. (Wendy), Steele, P. (Peter), Proudman, S. (Susanna), Minson, R. (Robert), Reeves, G. (Glenn), Lavender, M. (Melanie), Ng, B. (Benjamin), Mackenzie, M. (Michele), Barry, L. (Lisa), Gruenberger, M. (Margarethe), Huber, C. (Charlotte), Lang, I. (Irene), Tilea, I. (Ioana), Sadushi-Kolici, R. (Roela), Löffler-Ragg, J. (Judith), Feistmantl, L.-T. (Lisa-Theresa), Evrard, P. (Patrick), Louis, R. (Renaud), Guiot, J. (Julien), Naldi, M. (Marco), De Pauw, M. (Michel), Mehta, S. (Sanjay), Camacho, R.C. (Rafael Conde), Tovar, P.P. (Patricia Parada), Londoño, A. (Alejandro), Campo, F. (Felipe), Garcia, P. (Paula), Lema, C. (Camila), Orozco-Levi, M. (Mauricio), Martinez, W. (William), Gomez, J.E. (Juan Esteban), Nielsen-Kudsk, J.E. (Jens Erik), Mellemkjaer, S. (Soren), Anton, L. (Ly), Altraja, A. (Alan), Vihinen, T. (Tapani), Vasankari, T. (Tuija), Sitbon, O. (Olivier), Cottin, V. (Vincent), Têtu, L. (Laurent), Noël-Savina, E. (Elise), Shearman, N. (Nicole), Tayler, S. (Susanne), Olzik, I. (Ilona), Kulka, C. (Christine), Grimminger, J. (Jan), Simon, M. (Marcel), Nolde, A. (Anna), Oqueka, T. (Tim), Harbaum, L. (Lars), Egenlauf, B. (Benjamin), Ewert, R. (Ralf), Schulz, C. (Christian), Regotta, S. (Sabine), Kramer, T. (Tilmann), Knoop-Busch, S. (Susanne), Gerhardt, F. (Felix), Konstantinides, S. (Stavros), Pitsiou, G. (Georgia), Stanopoulos, I. (Ioannis), Sourla, E. (Evdokia), Mouratoglou, S. (Sofia), Karvounis, H.I., Pappas, A. (Athanasios), Georgopoulos, D. (Dimitrios), Fanaridis, M. (Michail), Mitrouska, I. (Ioanna), Michalis, L.K. (Lampros), Pappas, K. (Konstantinos), Kotsia, A. (Anna), Gaine, S. (Sean), Vizza, C.D. (Carmine Dario), Manzi, G. (Giovanna), Poscia, R. (Roberto), Badagliacca, R. (Roberto), Agostoni, P. (Piergiuseppe), Bruno, N. (Noemi), Farina, S. (Stefania), D'Alto, M. (Michele), Argiento, P. (Paola), Correra, A. (Anna), Di Marco, G.M. (Giovanni Maria), Cresci, C. (Chiara), Vannucchi, V. (Vieri), Torricelli, E. (Elena), Garcea, A. (Alessio), Pesci, A. (Alberto), Sardella, L. (Luca), Paciocco, G. (Giuseppe), Pane, F. (Federico), D'Armini, A.M. (Andrea Maria), Pin, M. (Maurizio), Grazioli, V. (Valentina), Massola, G. (Giulia), Sciortino, A. (Antonio), Prediletto, R. (Renato), Bauleo, C. (Carolina), Airò, E. (Edoardo), Ndreu, R. (Rudina), Pavlickova, I. (Ivana), Lunardi, C. (Claudio), Mulè, M. (Massimiliano), Farruggio, S. (Silvia), Costa, S. (Serena), Galgano, G. (Giuseppe), Petruzzi, M. (Mario), De Luca, A. (Anna), Lombardi, F. (Francesco), Roncon, L. (Loris), Conte, L. (Luca), Picariello, C. (Claudio), Wirtz, G. (Gil), Alexandre, M. (Myriam), Vonk Noordegraaf, A. (Anton), Boogaard, H. (H.), Mager, J. (J.), Reesink, H.J. (Herre), Toorn, L.M. (Leon) van den, Boomars, K.A.T. (Karin), Andreassen, A.K. (Arne K.), Castro, G. (Graça), Tania, G. (Gonçalves), Baptista, R. (Rui), Marinho, A. (António), Shiang, T. (Teresa), Oliveira, A. (Ana), Coutinho, D. (Daniel), Sousa, J. (Joana), Loureiro, M.J. (Maria José), Repolho, D. (Débora), Martins Jesus, S.M. (Susana Maria), Capinha, M. (Marta), Agostinho, J. (João), Cardoso, T. (Tania), Rocha, A. (Andreia), Espinha, M. (Mafalda), Ivanov, K.I. (Kyundyul Ivanovich), Alexeeva, D.E. (Dalyana Eduardovna), Batalina, M.V. (Marina Vadimovna), Hegya, D.V. (Daria Viktorovna), Zvereva, T.N. (Tatyana Nikolaevna), Avdeev, S.N. (Sergey Nikolaevich), Tsareva, N.A. (Natalia Anatolievna), Galyavich, A.S. (Albert Sarvatovich), Nikolaevich, B.A. (Bykov Aleksander), Filippov, E.V. (Evgeny Vladimirovich), Yakovleva, O.E. (Olga Eduardovna), Pavlova, O.B. (Olga Borisovna), Skripkina, E.S. (Elena Sergeevna), Martynyuk, T.V. (Tamila Vitalievna), Bukatova, I.F. (Irina Fedorovna), Tregubova, A.V. (Anna Viktorovna), Platonov, D.Y. (Dmitry Yurievich), Kolomeytseva, T.M. (Tatyana Mikhaylovna), Al Dalaan, A. (Abdullah), Abdelsayed, A.A. (Abeer Abeer), Weheba, I. (Ihab), Saleemi, S. (Sarferaz), Sakkijha, H. (Hussam), Bohacekova, M. (Marcela), Valkovicova, T. (Tatiana), Farkasova, I. (Iveta), Quezada, C.A. (Carlos Andres), Piccari, L. (Lucilla), Blanco, I. (Isabel), Sebastian, L. (Laura), Roman, A. (Antonio), Lopez, M. (Manuel), Otero, R. (Remedios), Elias, T. (Teresa), Jara, L. (Luis), Asencio, I. (Isabel), Arjona, J.J. (Josefa Jiménez), Almagro, R.M. (Raúl Menor), Cárdenas, S.L. (Salvador López), García, S.A. (Salvador Alcaraz), Rodríguez, P.V. (Patricia Villanueva), Lopez, R. (Raquel), Garcia, A. (Alberto), Avilés, F.F. (Francisco Fernandez), De La Pava, S. (Sebastian), Yotti, R. (Raquel), Peñate, G.P. (Gregorio Pérez), Marrero, F.L. (Fernando León), Cifrián Martínez, J.M. (José Manuel), Martinez-Meñaca, A. (Amaya), Alonso, L.P. (Lecue Pilar), Rozas, S.F. (Sonia Fernandez), Fernandez, D.I. (David Iturbe), Cuesta, V.M. (Victor Mora), Söderberg, S. (Stefan), Bartfay, S.-E. (Sven-Erik), Rundqvist, B. (Bengt), Alfetlawi, M. (Monthir), Wodlin, P. (Peter), Schwarz, E.I. (Esther Irene), Speich, R. (Rudolf), Lador, F. (Frédéric), Rochat, T. (Thierry), Gasche-Soccal, P. (Paola), Hsu, C.-H. (Chih-Hsin), Lin, T.-H. (Tsung-Hsien), Su, H.-M. (Ho-Ming), Lai, W.-T. (Wen-Ter), Chu, C.Y. (Chun Yuan), Hsu, P.-C. (Po-Chao), Voon, W.-C. (Wen-Chol), Yen, H.-W. (Hsueh-Wei), Yih-Jer Wu, J. (Jacob), Wu, S.-H. (Shu-Hao), Huang, W.-P. (Wen-Pin), Fong, M.-C. (Man-Cai), Huang, C.-L. (Chien-Lung), Kuo, P.-H. (Ping-Hung), Lin, Y.-H. (Yen-Hung), Lin, J.-L. (Jiunn-Lee), Hung, C.-S. (Chi-Sheng), Wu, C.-K. (Cho-Kai), Sung, S.-H. (Shih-Hsien), Huang, W.-C. (Wei-Chun), Cheng, C.-C. (Chin-Chang), Kuo, S.-H. (Shu-Hung), Wang, W.-H. (Wen-Hwa), Ho, W.-J. (Wan-Jing), Hsu, T.-S. (Tsu-Shiu), Mutlu, B. (Bülent), Atas, H. (Halil), Ongen, G. (Gul), Un, Z. (Zeynep), Okumus, G. (Gulfer), Hanta, I. (Ismail), Corris, P. (Paul), Peacock, A. (Andrew), Church, C. (Colin), Toshner, M. (Mark), and Newnham, M. (Michael)

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

Published
2021
Full Text
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9. Riociguat treatment in patients with chronic thromboembolic pulmonary hypertension: Final safety data from the EXPERT registry

Author

Ghofrani, HA, Gomez Sanchez, MA, Humbert, M, Pittrow, D, Simonneau, G, Gall, H, Grünig, E, Klose, H, Halank, M, Langleben, D, Snijder, RJ, Escribano Subias, P, Mielniczuk, LM, Lange, TJ, Vachiéry, JL, Wirtz, H, Helmersen, DS, Tsangaris, I, Barberá, JA, Pepke-Zaba, J, Boonstra, Andre, Rosenkranz, S, Ulrich, S, Steringer-Mascherbauer, R, Delcroix, M, Jansa, P, Šimková, 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, Löffler-Ragg, J, Feistmantl, LT, Evrard, P, Louis, R, Guiot, J, Naldi, M, Pauw, M, Mehta, S, Camacho, RC, Tovar, PP, Londoño, 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, Têtu, L, Noël-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, Airò, E, Ndreu, R, Pavlickova, I, Lunardi, C, Mulè, M, Farruggio, S, Costa, S, Galgano, G, Petruzzi, M, Luca, A, Lombardi, F, Roncon, L, Conte, L, Picariello, C, Wirtz, G, Alexandre, M, Vonk-Noordegraaf, A, van den Boogaard, H, Mager, J, Reesink, H, van den Toorn, Leon, Boomars, Karin, 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, Cárdenas, SL, García, SA, Rodríguez, PV, Lopez, R, Garcia, A, Avilés, FF, De La Pava, S, Yotti, R, Peñate, GP, Marrero, FL, Cifrián Martínez, JM, Martinez-Meñaca, A, Alonso, LP, Rozas, SF, Fernandez, DI, Cuesta, VM, Söderberg, S, Bartfay, SE, Rundqvist, B, Alfetlawi, M, Wodlin, P, Schwarz, EI, Speich, R, Lador, F, Rochat, T, Gasche-Soccal, P, Hsu, CH, Lin, TH, Su, HM, Lai, WT, Chu, CY, Hsu, PC, Voon, WC, Yen, HW, Yih-Jer Wu, J, Wu, SH, Huang, WP, Fong, MC, Huang, CL, Kuo, PH, Lin, YH, Lin, JL, Hung, CS, Wu, CK, Sung, SH, Huang, WC, Cheng, CC, Kuo, SH, Wang, WH, Ho, WJ, Hsu, TS, Mutlu, B, Atas, H, Ongen, G, Un, Z, Okumus, G, Hanta, I, Corris, P, Peacock, A, Church, C, Toshner, M, Ghofrani, HA, Gomez Sanchez, MA, Humbert, M, Pittrow, D, Simonneau, G, Gall, H, Grünig, E, Klose, H, Halank, M, Langleben, D, Snijder, RJ, Escribano Subias, P, Mielniczuk, LM, Lange, TJ, Vachiéry, JL, Wirtz, H, Helmersen, DS, Tsangaris, I, Barberá, JA, Pepke-Zaba, J, Boonstra, Andre, Rosenkranz, S, Ulrich, S, Steringer-Mascherbauer, R, Delcroix, M, Jansa, P, Šimková, 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, Löffler-Ragg, J, Feistmantl, LT, Evrard, P, Louis, R, Guiot, J, Naldi, M, Pauw, M, Mehta, S, Camacho, RC, Tovar, PP, Londoño, 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, Têtu, L, Noël-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, Airò, E, Ndreu, R, Pavlickova, I, Lunardi, C, Mulè, M, Farruggio, S, Costa, S, Galgano, G, Petruzzi, M, Luca, A, Lombardi, F, Roncon, L, Conte, L, Picariello, C, Wirtz, G, Alexandre, M, Vonk-Noordegraaf, A, van den Boogaard, H, Mager, J, Reesink, H, van den Toorn, Leon, Boomars, Karin, 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, Cárdenas, SL, García, SA, Rodríguez, PV, Lopez, R, Garcia, A, Avilés, FF, De La Pava, S, Yotti, R, Peñate, GP, Marrero, FL, Cifrián Martínez, JM, Martinez-Meñaca, A, Alonso, LP, Rozas, SF, Fernandez, DI, Cuesta, VM, Söderberg, S, Bartfay, SE, Rundqvist, B, Alfetlawi, M, Wodlin, P, Schwarz, EI, Speich, R, Lador, F, Rochat, T, Gasche-Soccal, P, Hsu, CH, Lin, TH, Su, HM, Lai, WT, Chu, CY, Hsu, PC, Voon, WC, Yen, HW, Yih-Jer Wu, J, Wu, SH, Huang, WP, Fong, MC, Huang, CL, Kuo, PH, Lin, YH, Lin, JL, Hung, CS, Wu, CK, Sung, SH, Huang, WC, Cheng, CC, Kuo, SH, Wang, WH, Ho, WJ, Hsu, TS, Mutlu, B, Atas, H, Ongen, G, Un, Z, Okumus, G, Hanta, I, Corris, P, Peacock, A, Church, C, and Toshner, M

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.

Published
2021

10. Proceedings of the 14th annual conference of INEBRIA

Author

Holloway, A.S., Ferguson, J., Landale, S., Cariola, L., Newbury-Birch, D., Flynn, A., Knight, J.R., Sherritt, L., Harris, S.K., O’Donnell, A.J., Kaner, E., Hanratty, B., Loree, A.M., Yonkers, K.A., Ondersma, S.J., Gilstead-Hayden, K., Martino, S., Adam, A., Schwartz, R.P., Wu, L.-T., Subramaniam, G., Sharma, G., McNeely, J., Berman, A.H., Kolaas, K., Petersén, E., Bendtsen, P., Hedman, E., Linderoth, C., Müssener, U., Sinadinovic, K., Spak, F., Gremyr, I., Thurang, A., Mitchell, A.M., Finnell, D., Savage, C.L., Mahmoud, K.F., Riordan, B.C., Conner, T.S., Flett, J.A.M., Scarf, D., McRee, B., Vendetti, J., Gallucci, K.S., Robaina, K., Clark, B.J., Jones, J., Reed, K.D., Hodapp, R.M., Douglas, I., Burnham, E.L., Aagaard, L., Cook, P.F, Harris, B.R., Yu, J., Wolff, M., Rogers, M., Barbosa, C., Wedehase, B.J., Dunlap, L.J., Mitchell, S.G., Dusek, K.A., Gryczynski, J., Kirk, A.S., Oros, M.T., Hosler, C., O’Grady, K.E., Brown, B.S., Angus, C., Sherborne, S., Gillespie, D., Meier, P., Brennan, A., de Vargas, D., Soares, J., Castelblanco, D., Doran, K.M., Wittman, I., Shelley, D., Rotrosen, J., Gelberg, L., Edelman, E.J., Maisto, S.A., Hansen, N.B., Cutter, C.J., Deng, Y., Dziura, J., Fiellin, L.E., O’Connor, P.G., Bedimo, R., Gibert, C., Marconi, V.C., Rimland, D., Rodriguez-Barradas, M.C., Simberkoff, M.S., Justice, A.C., Bryant, K.J., Fiellin, D.A., Giles, E.L., Coulton, S., Deluca, P., Drummond, C., Howel, D., McColl, E., McGovern, R., Scott, S., Stamp, E., Sumnall, H., Vale, L., Alabani, V., Atkinson, A., Boniface, S., Frankham, J., Gilvarry, E., Hendrie, N., Howe, N., McGeechan, G.J., Ramsey, A., Stanley, G., Clephane, J., Gardiner, D., Holmes, J., Martin, N., Shevills, C., Soutar, M., Chi, F.W., Weisner, C., Ross, T.B., Mertens, J., Sterling, S.A., Shorter, G.W., Heather, N., Bray, J., Cohen, H.A., McPherson, T.L., Adam, C., López-Pelayo, H., Gual, A., Segura-Garcia, L., Colom, J., Ornelas, I.J., Doyle, S., Donovan, D., Duran, B., Torres, V., Gaume, J., Grazioli, V., Fortini, C., Paroz, S., Bertholet, N., Daeppen, J.-B., Satterfield, J.M., Gregorich, S., Alvarado, N.J., Muñoz, R., Kulieva, G., Vijayaraghavan, M., Cunningham, J.A., Díaz, E., Palacio-Vieira, J., Godinho, A., Kushir, V., O’Brien, K.H.M., Aguinaldo, L.D., Sellers, C.M., Spirito, A., Chang, G., Blake-Lamb, T., LaFave, L.R.A., Thies, K.M., Pepin, A.L., Sprangers, K.E., Bradley, M., Jorgensen, S., Catano, N.A., Murray, A.R., Schachter, D., Andersen, R.M., Rey, G.N., Vahidi, M., Rico, M.W., Baumeister, S.E., Johansson, M., Sinadinovic, C., Hermansson, U., Andreasson, S., O’Grady, M.A., Kapoor, S., Akkari, C., Bernal, C., Pappacena, K., Morley, J., Auerbach, M., Neighbors, C.J., Kwon, N., Conigliaro, J., Morgenstern, J., Magill, M., Apodaca, T.R., Borsari, B., Hoadley, A., Scott Tonigan, J., Moyers, T., Fitzgerald, N.M., Schölin, L., Barticevic, N., Zuzulich, S., Poblete, F., Norambuena, P., Sacco, P., Ting, L., Beaulieu, M., Wallace, P.G., Andrews, M., Daley, K., Shenker, D., Gallagher, L., Watson, R., Weaver, T., Bruguera, P., Oliveras, C., Gavotti, C., Barrio, P., Braddick, F., Miquel, L., Suárez, M., Bruguera, C., Brown, R.L., Capell, J.W., Paul Moberg, D., Maslowsky, J., Saunders, L.A., McCormack, R.P., Scheidell, J., Gonzalez, M., Bauroth, S., Liu, W., Lindsay, D.L., Lincoln, P., Hagle, H., Wallhed Finn, S., Hammarberg, A., Andréasson, S., King, S.E., Vargo, R., Kameg, B.N., Acquavita, S.P., Van Loon, R.A., Smith, R., Brehm, B.J., Diers, T., Kim, K., Barker, A., Jones, A.L., Skinner, A.C., Hinman, A., Svikis, D.S., Thacker, C.L., Resnicow, K., Beatty, J.R., Janisse, J., Puder, K., Bakshi, A.-S., Milward, J.M., Kimergard, A., Garnett, C.V., Crane, D., Brown, J., West, R., Michie, S., Rosendahl, I., Andersson, C., Gajecki, M., Blankers, M., Donoghue, K., Lynch, E., Maconochie, I., Phillips, C., Pockett, R., Phillips, T., Patton, R., Russell, I., Strang, J., Stewart, M.T., Quinn, A.E., Brolin, M., Evans, B., Horgan, C.M., Liu, J., McCree, F., Kanovsky, D., Oberlander, T., Zhang, H., Hamlin, B., Saunders, R., Barton, M.B., Scholle, S.H., Santora, P., Bhatt, C., Ahmed, K., Hodgkin, D., Gao, W., Merrick, E.L., Drebing, C.E., Larson, M.J., Sharma, M., Petry, N.M., Saitz, R., Weisner, C.M., Young-Wolff, K.C., Lu, W.Y., Blosnich, J.R., Lehavot, K., Glass, J.E., Williams, E.C., Bensley, K.M., Chan, G., Dombrowski, J., Fortney, J., Rubinsky, A.D., Lapham, G.T., Forray, A., Olmstead, T.A., Gilstad-Hayden, K., Kershaw, T., Dillon, P., Weaver, M.F., Grekin, E.R., Ellis, J.D., and McGoron, L.

Subjects
lcsh:R5-920, lcsh:Social pathology. Social and public welfare. Criminology, lcsh:Medicine (General), Meeting Abstracts, lcsh:HV1-9960
Published
2017
Full Text
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12. Implementing a case management intervention for frequent users of the emergency department (I-CaM): An effectiveness-implementation hybrid trial study protocol

Author

Grazioli, V., Moullin, Joanna, Kasztura, M., Canepa-Allen, M., Hugli, O., Griffin, J., Vu, F., Hudon, C., Jackson, Y., Wolff, H., Burnand, B., Daeppen, J., Bodenmann, P., Grazioli, V., Moullin, Joanna, Kasztura, M., Canepa-Allen, M., Hugli, O., Griffin, J., Vu, F., Hudon, C., Jackson, Y., Wolff, H., Burnand, B., Daeppen, J., and Bodenmann, P.

Abstract

Background: ED overcrowding represents a significant public health problem in developed countries. Frequent users of the emergency departments (FUEDs; reporting 5 or more ED visits in the past year) are often affected by medical, psychological, social, and substance use problems and account for a disproportionately high number of ED visits. Past research indicates that case management (CM) interventions are a promising way to reduce ED overcrowding and improve FUEDs' quality of life. There is, however, very limited knowledge about how to disseminate and implement this intervention on a large scale to diverse clinical settings, including community hospitals and non-academic centers. This paper describes the protocol of a research project aiming to implement a CM intervention tailored to FUEDs in the public hospitals with ED in the French-speaking region of Switzerland and evaluate both the implementation process and effectiveness of the CM intervention. Methods: This research project uses a hybrid study design assessing both implementation and clinical outcomes. The implementation part of the study uses mixed methods a) to describe quantitatively and qualitatively factors that influence the implementation process, and b) to examine implementation effectiveness. The clinical part of the study uses a within-subject design (pre-post intervention) to evaluate participants' trajectories on clinical variables (e.g., quality of life, ED use) after receiving the CM intervention. We designed the study based on two implementation science frameworks. The Generic Implementation Framework guided the overall research protocol design, whereas the RE-AIM (reach, efficacy, adoption, implementation and maintenance) framework guided the implementation and effectiveness evaluations. Discussion: This research project will contribute to implementation science by providing key insights into the processes of implementing CM into broader practice. This research project is also likely to have

Published
2019

13. L'anfiteatro: i dati di scavo

Author

Grazioli, V.

Subjects
Settore L-ANT/03 - Storia Romana, Settore L-ANT/07 - Archeologia Classica
Published
2018

19. ALCOHOL HARM-REDUCTION APPROACHES ACROSS DIFFERENT POPULATIONS

Author

GRAZIOLI, V. S.

Abstract

Context. Certain populations, such as socially marginalized individuals and late adolescents (i.e., aged 17-19), are more prone than others to experience severe alcohol- related harm. However, these populations are often not interested in attaining alcohol abstinence or reducing alcohol consumption to moderate levels. Thus, their needs are not met within traditional primarily abstinence-based service options. In response, harm- reduction approaches have begun to be applied with these populations. The overall aim of this thesis was to contribute to the research on alcohol-related harm reduction in these populations by conducting 5 distinct studies. The two first studies were conducted with chronically homeless individuals with alcohol problems in the US: Study 1 examined their perceptions of twelve-step mutual-help groups (TMGs) and their association with treatment attendance, motivation and alcohol outcomes, whereas study 2 examined this population's use of safer-drinking strategies. Study 3 evaluated substance-use and related problems following exposure to a harm-reduction drop-in center that allows alcohol consumption onsite among socially marginalized alcohol and other drug (AOD) users in Switzerland. Studies 4 and 5 were conducted among US and Swedish high school seniors and prospectively tested a) the moderating effect of drinking intentions on the association between use of protective behavioral strategies (PBS) and alcohol outcomes, and b) the moderating effect of PBS use on the link between alcohol expectancies and alcohol outcomes. Findings. Study 1 found that most chronically homeless individuals with alcohol problems endorsed negative perceptions of TMGs, which were in turn associated with less treatment attendance. Study 2 found that chronically homeless individuals with alcohol dependence were interested in drinking safer and were able to commit to using safer-drinking strategies. Study 3 showed that exposure to a harm-reduction drop-in center that allows alcohol consumption onsite was followed by significant decrease in alcohol use and related problems among socially marginalized AOD users in Switzerland, with greater attendance being related to additional improvement in mental health-related quality of life (QoL) and decrease in drug-related problem severity. Finally, studies 4 and 5 showed that use of PBS was related to future decreases in alcohol use and related consequences among US and Swedish high school seniors. Findings also showed significant interactions between drinking intentions and PBS use (study 4), and between alcohol expectancies and PBS use (study 5). Conclusion. Taken together, findings confirmed that socially marginalized individuals and high school seniors show low interest in traditional approaches aiming abstinence or use reduction. Findings documented, however, that these distinct populations embrace alcohol harm-reduction approaches and that these approaches appear to be related to decreases in alcohol-related harm. Taken together, these findings suggest that alcohol harm-reduction approaches are promising ways to decrease alcohol- related harm across different populations and different cultures (i.e., US, Sweden, Switzerland). -- Contexte. Malgré leurs besoins importants en matière de traitement alcoologique, les personnes socialement marginalisées sont souvent sous-traitées par les traitements visant l'abstinence ou la consommation modérée. Similairement, les approches préventives promouvant l'abstinence ne suscitent généralement que peu d'intérêts et d'effets positifs au sein des jeunes (gymnasiens par exemple), qui sont pourtant connus pour leur usage d'alcool à risque. En réponse, les interventions ciblant ces populations intègrent de plus en plus des principes de réduction des risques et des méfaits. L'objectif général de ce travail de thèse était de contribuer à la recherche dans ce domaine en réalisant 5 études distinctes. Les deux premières études ont été conduites au sein de personnes sans-abris chroniques présentant un problème d'alcool aux États-Unis: L'étude 1 a examiné leurs perceptions des groupes d'entraide mutuelle en douze étapes (GEMs), et l'association entre ces perceptions et la fréquentation des traitements, la motivation et l'usage d'alcool. L'étude 2 a examiné l'usage des stratégies de consommation plus sûre au sein de cette population. L'étude 3 a évalué l'évolution de l'usage de substances et des problèmes associés après l'exposition à un espace d'accueil de jour tolérant la consommation d'alcool au sein de personnes socialement marginalisées en Suisse. Enfin, les études 4 et 5 ont été conduites parmi des gymnasiens aux États-Unis et en Suède et ont testé prospectivement a) l'effet modérateur des intentions de consommer sur le lien entre l'utilisation de stratégies de protection comportementales (SPCs) et l'usage d'alcool, et b) l'effet modérateur de l'usage de SPCs sur le lien entre les attentes liées à l'usage d'alcool et la consommation d'alcool. Résultats. L'étude 1 a montré que la plupart des participants avaient des perceptions négatives des GEMs et que ces perceptions étaient associées négativement à la fréquentation des traitements. L'étude 2 a montré que les participants étaient intéressés à réduire les risques liés à leur usage d'alcool et qu'ils pouvaient s'engager à utiliser des stratégies de consommation plus sûre. L'étude 3 a montré que les participants ont diminué leur usage d'alcool et les problèmes associés au cours de l'évaluation et que chaque mois supplémentaire passé au sein de l'espace d'accueil était associé à une diminution supplémentaire de la sévérité des problèmes liés aux drogues et à une amélioration de la qualité de vie liée à la santé mentale. Les études 4 et 5 ont indiqué que l'usage de SPCs était prospectivement associé à une diminution de la consommation d'alcool et des conséquences associées. Les résultats ont également montré des interactions significatives entre l'usage des SPCs et a) les intentions de consommer (étude 4), et b) les attentes liées à l'alcool (étude 5). Conclusion. Globalement, les études comprises dans ce travail de thèse confirment que les approches visant l'abstinence et la consommation modérée ne suscitent que peu d'intérêt au sein des personnes socialement marginalisées et des gymnasiens. Notre travail indique toutefois que ces populations acceptent les approches visant la réduction des risques et des méfaits et que celles-ci semblent être associées à une diminution des méfaits liés à l'usage d'alcool. De manière générale, ces résultats suggèrent que ces approches sont prometteuses au sein de différentes populations issues de cultures diverses (États-Unis, Suède, Suisse).

Published
2016

30. Gender and age-dependent etiology of community-acquired urinary tract infections

Author

Magliano, E, Grazioli, V, Deflorio, L, Leuci, A, Mattina, R, Romano, P, Cocuzza, C, COCUZZA, CLEMENTINA ELVEZIA, Magliano, E, Grazioli, V, Deflorio, L, Leuci, A, Mattina, R, Romano, P, Cocuzza, C, and COCUZZA, CLEMENTINA ELVEZIA

Abstract

Urinary tract infections (UTIs) are among the most frequent community-acquired infections worldwide. Escherichia coli is the most common UTI pathogen although underlying host factors such as patients' age and gender may influence prevalence of causative agents. In this study, 61 273 consecutive urine samples received over a 22-month period from outpatients clinics of an urban area of north Italy underwent microbiological culture with subsequent bacterial identification and antimicrobial susceptibility testing of positive samples. A total of 13 820 uropathogens were isolated and their prevalence analyzed according to patient's gender and age group. Overall Escherichia coli accounted for 67.6% of all isolates, followed by Klebsiella pneumoniae (8.8%), Enterococcus faecalis (6.3%), Proteus mirabilis (5.2%), and Pseudomonas aeruginosa (2.5%). Data stratification according to both age and gender showed E. coli isolation rates to be lower in both males aged ≥60 years (52.2%), E. faecalis and P. aeruginosa being more prevalent in this group (11.6% and 7.8%, resp.), as well as in those aged ≤14 years (51.3%) in whom P. mirabilis prevalence was found to be as high as 21.2%. Streptococcus agalactiae overall prevalence was found to be 2.3% although it was shown to occur most frequently in women aged between 15 and 59 years (4.1%). Susceptibility of E. coli to oral antimicrobial agents was demonstrated to be as follows: fosfomycin (72.9%), trimethoprim/sulfamethoxazole (72.9%), ciprofloxacin (76.8%), ampicillin (48.0%), and amoxicillin/clavulanate (77.5%). In conclusion, both patients' age and gender are significant factors in determining UTIs etiology; they can increase accuracy in defining the causative uropathogen as well as providing useful guidance to empiric treatment.

Published
2012

33. P.1.291: MYCOBACTERIUM AVIUM SUBSPECIES PARATUBERCULOSIS IN NORTHERN ITALY: WIDESPREAD COMMENSAL OR EMERGING PATHOGEN INVOLVED IN THE ETIOLOGY OF CROHN'S DISEASE?

Author

Pistone, D., primary, Marone, P., additional, Pajoro, M., additional, Fabbi, M., additional, Vicari, N., additional, Daffara, S., additional, Valle, C. Dalla, additional, Gabba, S., additional, Sassera, D., additional, Verri, A., additional, Epis, S., additional, Grazioli, V., additional, Arrigoni, N., additional, Monti, C., additional, Giacosa, A., additional, and Bandi, C., additional

Published
2011
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45. ANMCO position paper: Recommendations for the follow-up of patients with pulmonary thromboembolism,Position paper ANMCO: Raccomandazioni per il follow-up del paziente con tromboembolia polmonare

Author

D Agostino, C., Zonzin, P., Enea, I., Gulizia, M. M., Ageno, W., Agostoni, P., Azzarito, M., Becattini, C., Bongarzoni, A., Bux, F., Casazza, F., Nicoletta Corrieri, D Alto, M., D Amato, N., Maria D Armini, A., Natale, M. G., Di Minno, G., Favretto, G., Filippi, L., Grazioli, V., Palareti, G., Pesavento, R., Roncon, L., Scelsi, L., and Tufano, A.

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