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1. Switching to riociguat versus maintenance therapy with phosphodiesterase-5 inhibitors in patients with pulmonary arterial hypertension (REPLACE): a multicentre, open-label, randomised controlled trial

Author

Olschewski, H, Delcroix, M, Andrade-Lima, M, de Amorim Corrêac, R, Figueiredo Campos, F, Ota Arakaki, J, Meyer, G, De Souza, R, Langleben, D, Al-Hiti, H, Jansa, P, Mellemkjær, S, Bauer, F, Montani, D, Simonneau, G, Drömann, D, Ghofrani, H-A, Grünig, E, Halank, M, Held, M, Hoeper, MM, Klose, H, Kneidinger, N, Leuchte, H, Opitz, C, Rosenkranz, S, Wilkens, H, Wirtz, H, Karvounis, H, Pitsiou, G, Orfanos, S, D'Alto, M, Ghio, S, Vizza, CD, Vitulo, P, Nakayama, T, Maki, H, Tatebe, S, de los Rios Ibarra, M, Pulido, T, Van Dijk, A, Vonk-Noordegraaf, A, Roleder, T, Castro, G, Loureiro, MJ, Robalo-Martins, S, Barberá, JA, Lázaro, M, Perez-Penate, GM, Román, A, Cheng, C-C, Hsu, C-H, Hsu, H-H, Atahan, E, Mogulkoc Bishop, N, Okumus, NG, Onen, Z, Chang, H-J, Chang, S-A, Lee, J-S, Kim, H-K, Coghlan, JG, Corris, PA, Church, AC, Condliffe, R, Gibbs, JSR, Peacock, AJ, Wort, S, Allen, R, Allen, S, Awdish, R, Benza, RL, DeSouza, S, Feldman, J, Johri, S, Klinger, JR, Layish, D, McConnell, J, McLaughlin, VV, Migliore, C, Rahaghi, F, Rischard, F, Robbins, I, Satterwhite, L, Shah, T, Sulica, R, White, RJ, Hoeper, Marius M, Al-Hiti, Hikmet, Benza, Raymond L, Chang, Sung-A, Corris, Paul A, Gibbs, J Simon R, Grünig, Ekkehard, Jansa, Pavel, Klinger, James R, Langleben, David, McLaughlin, Vallerie V, Meyer, Gisela M B, Ota-Arakaki, Jaquelina, Peacock, Andrew J, Pulido, Tomás, Rosenkranz, Stephan, Vizza, Carmine Dario, Vonk-Noordegraaf, Anton, White, R James, Chang, Mikyung, Kleinjung, Frank, Meier, Christian, Paraschin, Karen, Ghofrani, Hossein Ardeschir, and Simonneau, Gérald

Published
2021
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2. Switching to riociguat versus maintenance therapy with phosphodiesterase-5 inhibitors in patients with pulmonary arterial hypertension (REPLACE): a multicentre, open-label, randomised controlled trial

Author

Hoeper, Marius M, primary, Al-Hiti, Hikmet, additional, Benza, Raymond L, additional, Chang, Sung-A, additional, Corris, Paul A, additional, Gibbs, J Simon R, additional, Grünig, Ekkehard, additional, Jansa, Pavel, additional, Klinger, James R, additional, Langleben, David, additional, McLaughlin, Vallerie V, additional, Meyer, Gisela M B, additional, Ota-Arakaki, Jaquelina, additional, Peacock, Andrew J, additional, Pulido, Tomás, additional, Rosenkranz, Stephan, additional, Vizza, Carmine Dario, additional, Vonk-Noordegraaf, Anton, additional, White, R James, additional, Chang, Mikyung, additional, Kleinjung, Frank, additional, Meier, Christian, additional, Paraschin, Karen, additional, Ghofrani, Hossein Ardeschir, additional, Simonneau, Gérald, additional, Olschewski, H, additional, Delcroix, M, additional, Andrade-Lima, M, additional, de Amorim Corrêac, R, additional, Figueiredo Campos, F, additional, Ota Arakaki, J, additional, Meyer, G, additional, De Souza, R, additional, Langleben, D, additional, Al-Hiti, H, additional, Jansa, P, additional, Mellemkjær, S, additional, Bauer, F, additional, Montani, D, additional, Simonneau, G, additional, Drömann, D, additional, Ghofrani, H-A, additional, Grünig, E, additional, Halank, M, additional, Held, M, additional, Hoeper, MM, additional, Klose, H, additional, Kneidinger, N, additional, Leuchte, H, additional, Opitz, C, additional, Rosenkranz, S, additional, Wilkens, H, additional, Wirtz, H, additional, Karvounis, H, additional, Pitsiou, G, additional, Orfanos, S, additional, D'Alto, M, additional, Ghio, S, additional, Vizza, CD, additional, Vitulo, P, additional, Nakayama, T, additional, Maki, H, additional, Tatebe, S, additional, de los Rios Ibarra, M, additional, Pulido, T, additional, Van Dijk, A, additional, Vonk-Noordegraaf, A, additional, Roleder, T, additional, Castro, G, additional, Loureiro, MJ, additional, Robalo-Martins, S, additional, Barberá, JA, additional, Lázaro, M, additional, Perez-Penate, GM, additional, Román, A, additional, Cheng, C-C, additional, Hsu, C-H, additional, Hsu, H-H, additional, Atahan, E, additional, Mogulkoc Bishop, N, additional, Okumus, NG, additional, Onen, Z, additional, Chang, H-J, additional, Chang, S-A, additional, Lee, J-S, additional, Kim, H-K, additional, Coghlan, JG, additional, Corris, PA, additional, Church, AC, additional, Condliffe, R, additional, Gibbs, JSR, additional, Peacock, AJ, additional, Wort, S, additional, Allen, R, additional, Allen, S, additional, Awdish, R, additional, Benza, RL, additional, DeSouza, S, additional, Feldman, J, additional, Johri, S, additional, Klinger, JR, additional, Layish, D, additional, McConnell, J, additional, McLaughlin, VV, additional, Migliore, C, additional, Rahaghi, F, additional, Rischard, F, additional, Robbins, I, additional, Satterwhite, L, additional, Shah, T, additional, Sulica, R, additional, and White, RJ, additional

Published
2021
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3. 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, RJ, Escribano Subias, P, Mielniczuk, LM, Lange, TJ, Vachiéry, J-L, Wirtz, H, Helmersen, DS, Tsangaris, I, Barberá, JA, 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, MM, NEW COLLABORATORS LIST, Ghofrani, H-A, Gomez Sanchez, M-A, 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, J-L, Wirtz, H, Helmersen, DS, Tsangaris, I, Barberá, JA, 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, MM, and 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.

Published
2021

4. 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

7. Efficacy and safety of selexipag in pulmonary arterial hypertension (PAH) patients with and without significant cardiovascular (CV) comorbidities

Author

Rosenkranz, S, additional, Channick, R, additional, Chin, K, additional, Jenner, B, additional, Gaine, S, additional, Galie, N, additional, Ghofrani, HA, additional, Hoeper, MM, additional, McLaughlin, V, additional, Preiss, R, additional, Rubin, L, additional, Simonneau, G, additional, Sitbon, O, additional, Tapson, V, additional, and Lang, I, additional

Published
2020
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9. The impact of time from diagnosis at baseline on long-term outcome in the GRIPHON Study: Selexipag in pulmonary arterial hypertension (PAH)

Author

Gaine, S, additional, Sitbon, O, additional, Channick, R, additional, Chin, K, additional, Di Scala, L, additional, Galie, N, additional, Hoeper, MM, additional, McLaughlin, V, additional, Preiss, R, additional, Rubin, L, additional, Simonneau, G, additional, Tapson, V, additional, Ghofrani, HA, additional, and Lang, I, additional

Published
2020
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11. Right ventricular size and function under riociguat in pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension (the RIVER study)

Author

Egenlauf, B, additional, Marra, AM, additional, Harutyunova, S, additional, Halank, M, additional, Benjamin, N, additional, Bossone, E, additional, Cittadini, A, additional, Eichstaedt, C, additional, Fischer, C, additional, Gall, H, additional, Ghofrani, HA, additional, Hoeper, MM, additional, Lange, TJ, additional, Olsson, KM, additional, and Grünig, E, additional

Published
2019
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12. Pulmonary arterial hypertension-related morbidity is prognostic for survival: Insights from the SERAPHIN and GRIPHON studies

Author

Ghofrani, A, additional, Hoeper, MM, additional, McLaughlin, V, additional, Channick, R, additional, Chin, K, additional, Delcroix, M, additional, Gaine, S, additional, Jansa, P, additional, Lang, I, additional, Mehta, S, additional, Pulido, T, additional, Sastry, BKS, additional, Simonneau, G, additional, Sitbon, O, additional, De Souza, R, additional, Torbicki, A, additional, Tapson, V, additional, Perchenet, L, additional, Preiss, R, additional, Verweij, P, additional, Rubin, L, additional, and Galie, N, additional

Published
2018
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13. [Pulmonary hypertension due to chronic lung disease: Recommendations of the Cologne Consensus Conference 2016]

Author

Olschewski H, Behr J, Bremer H, Claussen M, Douschan P, Halank M, Held M, Hoeper MM, Holt S, Klose H, Krüger S, Lange TJ, Reichenberger F, Skowasch D, Ulrich S, Wilkens H, and Seeger W

Subjects
Germany, Hypertension, Pulmonary, Practice Guidelines as Topic, Cardiology, Pulmonary Medicine, Humans, Lung Injury
Abstract

The 2015 European Guidelines on Pulmonary Hypertension did not cover only pulmonary arterial hypertension (PAH) but also some aspects of pulmonary hypertension (PH) associated with chronic lung disease. The European Guidelines point out that the drugs currently used to treat patients with PAH (prostanoids, endothelin receptor antagonists, phosphodiesterase-5 inhibitors, sGC stimulators) have not been sufficiently investigated in other forms of PH. Therefore, the European Guidelines do not recommend the use of these drugs in patients with chronic lung disease and PH. This recommendation, however, is not always in agreement with medical ethics as physicians feel sometimes inclined to treat other form of PH which may affect quality of life and survival of these patients in a similar manner. To this end, it is crucial to consider the severity of both PH and the underlying lung disease. In June 2016, a Consensus Conference organized by the PH working groups of the German Society of Cardiology (DGK), the German Society of Respiratory Medicine (DGP) and the German Society of Pediatric Cardiology (DGPK) was held in Cologne, Germany, to discuss open and controversial issues surrounding the practical implementation of the European Guidelines. Several working groups were initiated, one of which was dedicated to the diagnosis and treatment of PH in patients with chronic lung disease. The recommendations of this working group are summarized in the present paper.

Published
2016

14. [Risk stratification and follow-up assessment of patients with pulmonary arterial hypertension: Recommendations of the Cologne Consensus Conference 2016]

Author

Leuchte HH, Ten Freyhaus H, Gall H, Halank M, Hoeper MM, Kaemmerer H, Kähler C, Riemekasten G, Ulrich S, Schwaiblmair M, and Ewert R

Subjects
Treatment Outcome, Germany, Hypertension, Pulmonary, Practice Guidelines as Topic, Cardiology, Pulmonary Medicine, Humans, Blood Pressure Determination, Prognosis, Risk Assessment
Abstract

The 2015 European Guidelines on Diagnosis and Treatment of Pulmonary Hypertension are also valid for Germany. The guidelines contain detailed information about the diagnosis of pulmonary hypertension, and furthermore provide novel recommendations for risk stratification and follow-up assessments. However, the practical implementation of the European Guidelines in Germany requires the consideration of several country-specific issues and already existing novel data. This requires a detailed commentary to the guidelines, and in some aspects an update already appears necessary. In June 2016, a Consensus Conference organized by the PH working groups of the German Society of Cardiology (DGK), the German Society of Respiratory Medicine (DGP) and the German Society of Pediatric Cardiology (DGPK) was held in Cologne, Germany. This conference aimed to solve practical and controversial issues surrounding the implementation of the European Guidelines in Germany. To this end, a number of working groups was initiated, one of which was specifically dedicated to risk stratification and follow-up assessment of patients with PAH. This manuscript summarizes the results and recommendations of this working group.

Published
2016

15. [Chronic thromboembolic pulmonary hypertension: Recommendations of the Cologne Consensus Conference 2016]

Author

Wilkens H, Konstantinides S, Lang I, Bunck AC, Gerges M, Gerhardt F, Grgic A, Grohé C, Guth S, Held M, Hinrichs J, Hoeper MM, Klepetko W, Kramm T, Krüger U, Lankeit M, Meyer BC, Olsson KM, Schäfers HJ, Schmidt M, Seyfarth HJ, Ulrich S, Wiedenroth CB, and Mayer E

Subjects
Fibrinolytic Agents, Hypertension, Pulmonary, Practice Guidelines as Topic, Cardiology, Pulmonary Medicine, Humans, Drug Therapy, Combination, Molecular Targeted Therapy, Pulmonary Embolism, Antihypertensive Agents
Abstract

The 2015 European Guidelines on Pulmonary Hypertension did not cover only pulmonary arterial hypertension (PAH), but also other significant subgroups of pulmonary hypertension (PH). In June 2016, a Consensus Conference organized by the PH working groups of the German Society of Cardiology (DGK), the German Society of Respiratory Medicine (DGP) and the German Society of Pediatric Cardiology (DGPK) was held in Cologne, Germany to discuss open and controversial issues surrounding the practical implementation of the European Guidelines. Several working groups were initiated, one of which was dedicated to the diagnosis and treatment of chronic thromboembolic pulmonary hypertension (CTEPH). In every patient with PH of unknown cause CTEPH should be excluded. The primary treatment option is surgical pulmonary endarterectomy (PEA) in a specialized multidisciplinary CTEPH center. Inoperable patients or patients with persistent or recurrent CTEPH after PEA are candidates for targeted drug therapy. For balloon pulmonary angioplasty (BPA), there is currently only limited experience. This option - as PEA - is reserved to specialized centers with expertise for this treatment method. In addition, a brief overview is given on pulmonary artery sarcoma, since its surgical treatment is often analogous to PEA. The recommendations of this working group are summarized in the present paper.

Published
2016

16. Guidelines for the diagnosis and treatment of pulmonary hypertension: The Task Force for the Diagnosis and Treatment of Pulmonary Hypertension of the European Society of Cardiology (ESC) and the European Respiratory Society (ERS), endorsed by the International Society of Heart and Lung Transplantation (ISHLT)

Author

Authors/Task Force Members, Galiè N, Hoeper MM, Humbert M, Torbicki A, Vachiery JL, Barbera JA, Beghetti M, Corris P, Gaine S, Gibbs JS, Gomez Sanchez MA, Jondeau G, Klepetko W, Opitz C, Peacock A, Rubin L, Zellweger M, Simonneau G, ESC Committee for Practice Guidelines, Vahanian A, Auricchio A, Bax J, Ceconi C, Dean V, Filippatos G, Funck Brentano C, Hobbs R, Kearney P, McDonagh T, McGregor K, Popescu BA, Reiner Z, Sechtem U, Sirnes PA, Tendera M, Vardas P, Widimsky P, Document Reviewers, Al Attar N, Andreotti F, Aschermann M, Asteggiano R, Benza R, Berger R, Bonnet D, Delcroix M, Howard L, Kitsiou AN, Lang I, Maggioni A, Nielsen Kudsk JE, Park M, Price S, Domenech MT, Vonk Noordegraaf A, Zamorano J.L., PERRONE FILARDI, PASQUALE, Authors/Task Force, Member, Galiè, N, Hoeper, Mm, Humbert, M, Torbicki, A, Vachiery, Jl, Barbera, Ja, Beghetti, M, Corris, P, Gaine, S, Gibbs, J, Gomez Sanchez, Ma, Jondeau, G, Klepetko, W, Opitz, C, Peacock, A, Rubin, L, Zellweger, M, Simonneau, G, ESC Committee for Practice, Guideline, Vahanian, A, Auricchio, A, Bax, J, Ceconi, C, Dean, V, Filippatos, G, Funck Brentano, C, Hobbs, R, Kearney, P, Mcdonagh, T, Mcgregor, K, Popescu, Ba, Reiner, Z, Sechtem, U, Sirnes, Pa, Tendera, M, Vardas, P, Widimsky, P, Document, Reviewer, Al Attar, N, Andreotti, F, Aschermann, M, Asteggiano, R, Benza, R, Berger, R, Bonnet, D, Delcroix, M, Howard, L, Kitsiou, An, Lang, I, Maggioni, A, Nielsen Kudsk, Je, Park, M, PERRONE FILARDI, Pasquale, Price, S, Domenech, Mt, Vonk Noordegraaf, A, Zamorano, J. L., Cardiovascular Centre (CVC), Galie N, Hoeper MM, Humbert M, Torbicki A, Vachiery JL, Barbera JA, Beghetti M, Corris P, Gaine S, Gibbs JS, Gomez-Sanchez MA, Jondeau G, Klepetko W, Opitz C, Peacock A, Rubin L, Zellweger M, and Simonneau G.

Subjects
medicine.medical_treatment, Diagnostic Techniques, Cardiovascular, Cardiovascular Agents/therapeutic use, Cardiovascular, Anoxia, Risk Factors, Biological Markers/blood, Hypoxia, Referral and Consultation, Heart Diseases/complications/diagnosis/therapy, media_common, Terminal Care, ddc:618, Exercise Tolerance, Pulmonary, Prognosis, Terminal Care/methods, Thromboembolism/complications/diagnosis/therapy, Hypertension, Cardiology, Cardiology and Cardiovascular Medicine, Algorithms, Lung Transplantation, medicine.medical_specialty, Hypertension, Pulmonary/*diagnosis/etiology/*therapy, Heart Diseases, media_common.quotation_subject, Hypertension, Pulmonary, MEDLINE, Pulmonary Veno-Occlusive Disease/complications/diagnosis/therapy, Internal medicine, Thromboembolism, Exercise Tolerance/physiology, medicine, Lung transplantation, Humans, Quality (business), Task force, business.industry, Conflict of interest, Cardiovascular Agents, Evidence-based medicine, Diagnostic Techniques, Clinical trial, Cardiovascular agent, Anoxia/complications/diagnosis/therapy, Pulmonary Veno-Occlusive Disease, business, Biomarkers
Abstract

Guidelines and Expert Consensus Documents summarize and evaluate all currently available evidence on a particular issue with the aim to assist physicians in selecting the best management strategies for a typical patient, suffering from a given condition, taking into account the impact on outcome, as well as the risk/benefit ratio of particular diagnostic or therapeutic means. Guidelines are no substitutes for textbooks. The legal implications of medical guidelines have been discussed previously. A great number of Guidelines and Expert Consensus Documents have been issued in recent years by the European Society of Cardiology (ESC) as well as by other societies and organizations. Because of the impact on clinical practice, quality criteria for development of guidelines have been established in order to make all decisions transparent to the user. The recommendations for formulating and issuing ESC Guidelines and Expert Consensus Documents can be found on the ESC website (http://www.escardio.org/knowledge/guidelines). In brief, experts in the field are selected and undertake a comprehensive review of the published evidence for management and/or prevention of a given condition. Unpublished clinical trial results are not taken into account. A critical evaluation of diagnostic and therapeutic procedures is performed including assessment of the risk/benefit ratio. Estimates of expected health outcomes for larger societies are included, where data exist. The level of evidence and the strength of recommendation of particular treatment options are weighed and graded according to predefined scales, as outlined in Tables 1 and 2 . View this table: Table 1 Classes of recommendations View this table: Table 2 Levels of evidence The experts of the writing panels have provided disclosure statements of all relationships they may have which might be perceived as real or potential sources of conflicts of interest. These disclosure forms are kept on file at the European Heart House, headquarters of the ESC. Any changes in conflict of interest that arise …

Published
2009

18. Guidelines for the diagnosis and treatment of pulmonary hypertension Orientações para o diagnóstico e tratamento da hipertensão pulmonar

Author

GALIE', NAZZARENO, Hoeper MM, Humbert M, Torbicki A, Vachiery JL, Barbera JA, Beghetti M, Corris P, Gaine S, Gibbs JS, Gomez Sanchez MA, Jondeau G, Klepetko W, Opitz C, Peacock A, Rubin L, Zellweger M, Simonneau G, Vahanian A, Auricchio A, Bax J, Ceconi C, Dean V, Filippatos G, Funck Brentano C, Hobbs R, Kearney P, McDonagh T, McGregor K, Popescu BA, Reiner Z, Sechtem U, Sirnes PA, Tendera M, Vardas P, Widimsky P., Galié N, Hoeper MM, Humbert M, Torbicki A, Vachiery JL, Barbera JA, Beghetti M, Corris P, Gaine S, Gibbs JS, Gomez-Sanchez MA, Jondeau G, Klepetko W, Opitz C, Peacock A, Rubin L, Zellweger M, Simonneau G, Vahanian A, Auricchio A, Bax J, Ceconi C, Dean V, Filippatos G, Funck-Brentano C, Hobbs R, Kearney P, McDonagh T, McGregor K, Popescu BA, Reiner Z, Sechtem U, Sirnes PA, Tendera M, Vardas P, and Widimsky P.

Subjects
GUIDELINES, PULMONARY HYPERTENSION
Abstract

not available

Published
2012

19. Liver toxicity of sitaxentan in pulmonary arterial hypertension

Author

GALIE', NAZZARENO, Hoeper MM, Simon J, Gibbs R, Simonneau G, Task Force for the Diagnosis, Treatment of Pulmonary Hypertension of the European Society of Cardiology, the European Respiratory Society, Galiè N, Hoeper MM, Simon J, Gibbs R, Simonneau G, and Task Force for the Diagnosis and Treatment of Pulmonary Hypertension of the European Society of Cardiology (ESC) and the European Respiratory Society (ERS).

Subjects
Endothelin Receptor Antagonists, HYPERTENSION, Hypertension, Pulmonary, Sitaxentan, Isoxazoles, Thiophenes, PULMONARY, LIVER TOXICITY, Safety-Based Drug Withdrawals, Early Termination of Clinical Trials, Humans, Familial Primary Pulmonary Hypertension, Chemical and Drug Induced Liver Injury, Antihypertensive Agents
Abstract

NOT AVAILABLE

Published
2011

20. Guidelines for the diagnosis and treatment of pulmonary hypertension

Author

Task Force for Diagnosis, Treatment of Pulmonary Hypertension of European Society of Cardiology, European Respiratory Society, International Society of Heart, Lung Transplantation, Galiè N, Hoeper MM, Humbert M, Torbicki A, Vachiery JL, Barbera JA, Beghetti M, Corris P, Gaine S, Gibbs JS, Gomez Sanchez MA, Jondeau G, Klepetko W, Opitz C, Peacock A, Rubin L, Zellweger M, Simonneau G, Vahanian A, Auricchio A, Bax J, Ceconi C, Dean V, Filippatos G, Funck Brentano C, Hobbs R, Kearney P, McDonagh T, McGregor KH, Popescu BA, Reiner Z, Sechtem U, Sirnes PA, Tendera M, Vardas P, Widimsky P, Al Attar N, Andreotti F, Aschermann M, Benza R, Berger R, Bonnet D, Delcroix M, Howard L, Kitsiou AN, Lang I, Nielsen Kudsk JE, Park M, Price S, Subirana MT, Vonk Noordegraaf A, Zamorano J.L., PERRONE FILARDI, PASQUALE, Task Force for, Diagnosi, Treatment of Pulmonary Hypertension of European Society of, Cardiology, European Respiratory, Society, International Society of, Heart, Lung, Transplantation, Galiè, N, Hoeper, Mm, Humbert, M, Torbicki, A, Vachiery, Jl, Barbera, Ja, Beghetti, M, Corris, P, Gaine, S, Gibbs, J, Gomez Sanchez, Ma, Jondeau, G, Klepetko, W, Opitz, C, Peacock, A, Rubin, L, Zellweger, M, Simonneau, G, Vahanian, A, Auricchio, A, Bax, J, Ceconi, C, Dean, V, Filippatos, G, Funck Brentano, C, Hobbs, R, Kearney, P, Mcdonagh, T, Mcgregor, Kh, Popescu, Ba, Reiner, Z, Sechtem, U, Sirnes, Pa, Tendera, M, Vardas, P, Widimsky, P, Al Attar, N, Andreotti, F, Aschermann, M, Benza, R, Berger, R, Bonnet, D, Delcroix, M, Howard, L, Kitsiou, An, Lang, I, Nielsen Kudsk, Je, Park, M, PERRONE FILARDI, Pasquale, Price, S, Subirana, Mt, Vonk Noordegraaf, A, and Zamorano, J. L.

Published
2009

21. Current and future management of chronic thromboembolic pulmonary hypertension:from diagnosis to treatment responses

Author

Rubin LJ, Hoeper MM, Klepetko W, Lang IM, Simonneau, GALIE', NAZZARENO, Rubin LJ, Hoeper MM, Klepetko W, Galie N, Lang IM, and Simonneau

Abstract

Although pulmonary endarterectomy (PEA) has been proven a very effective treatment for chronic thromboembolic pulmonary hypertension, it cannot be performed in a substantial proportion of patients. Here, we outline a proposed treatment algorithm, outlining therapeutic alternatives: (1) PEA should be considered as the first treatment option, where possible; (2) medical intervention is a possible option in inoperable patients and those with significant arteriopathy, although only chronic anticoagulation has been widely used to date (advanced medical treatment options could include prostanoids, endothelin receptor antagonists, or phosphodiesterase-5 inhibitors, but randomized clinical trials are required); (3) pulmonary hypertension is likely to persist after PEA in patients with significant small-vessel arteriopathy, resulting in poor clinical outcome and increased perioperative mortality (medical therapy could also be applied here); (4) anticoagulation therapy and, possibly, advanced medical treatment with careful monitoring may provide benefits in patients with mild or asymptomatic disease; (5) if medical therapy begins to fail, PEA should be offered without delay to avoid progression to severe, secondary arteriopathy; (6) in the absence of severe comorbidity, lung transplantation may be undertaken where PEA has failed, in nonresponders to medical therapy, and in patients with progressive arteriopathy; (7) in patients not eligible for PEA due to collateral and/or surgically inaccessible lesions, balloon angioplasty may be a possible alternative at some centers, but is experimental and requires further assessment. Continued research and clinical trials investigating possible applications of new medical treatments are required.

Published
2006

22. S109 Targeting the prostacyclin pathway in the treatment of connective tissue disease associated pulmonary arterial hypertension (pah): insights from the randomised controlled griphon trial with selexipag

Author

Coghlan, G, primary, Gaine, S, additional, Channick, R, additional, Scala, L Di, additional, Galiè, N, additional, Ghofrani, HA, additional, Hoeper, MM, additional, Lang, I, additional, McLaughlin, V, additional, Preiss, R, additional, Rubin, LJ, additional, Simonneau, G, additional, Sitbon, O, additional, Tapson, VF, additional, and Chin, K, additional

Published
2016
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23. Effekt von Selexipag auf den primären kombinierten Morbiditäts- und Mortalitätsendpunkt in Abhängigkeit von vorbestehenden PAH-Therapien, Ätiologie, Alter und geographischer Region: Ergebnisse der GRIPHON Studie

Author

Ewert, R, primary, Sitbon, O, additional, Channick, R, additional, Chin, K, additional, Frey, A, additional, Galiè, N, additional, Ghofrani, A, additional, Hoeper, MM, additional, Lang, I, additional, Le Brun, FO, additional, McLaughlin, V, additional, Preiss, R, additional, Rubin, LJ, additional, Simonneau, G, additional, Tapson, V, additional, and Gaine, S, additional

Published
2016
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25. Riociguat zur Behandlung der chronisch thromboembolischen pulmonalen Hypertonie (CTEPH): 2-Jahres-Ergebnisse aus der Folgestudie zur Langzeitbeobachtung CHEST-2

Author

Ghofrani, A, primary, Simonneau, G, additional, D'Armini, AM, additional, Grimminger, F, additional, Hoeper, MM, additional, Jansa, P, additional, Kim, NH, additional, Wang, C, additional, Wilkins, M, additional, Fritsch, A, additional, Davie, N, additional, Colorado, P, additional, and Mayer, E, additional

Published
2015
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26. Klinischer Verlauf von Patienten mit Idiopathischer Lungenfibrose in der klinischen Praxis: INSIGHTS-IPF Register

Author

Behr, J, primary, Kreuter, M, additional, Pittrow, D, additional, Hoeper, MM, additional, Klotsche, J, additional, Koschel, D, additional, Andreas, S, additional, Neurohr, C, additional, Grohé, C, additional, Claussen, M, additional, Wilkens, H, additional, Randerath, WJ, additional, Skowasch, D, additional, Kirschner, J, additional, Koch, A, additional, Meyer, FJ, additional, Ewert, R, additional, Welte, T, additional, Held, M, additional, Schwaiblmair, M, additional, Gamarra, F, additional, Herth, FJF, additional, Huber, RM, additional, and Wirtz, H, additional

Published
2015
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29. Pulmonary hypertension: future therapies

Author

Delcroix, M., Dorfmuller, P., Maclean, Mr, Berbera, Ja, Hoeper, Mm, Ghofrani, H., Adnot, S., Eddahibi, S., Janssens, S., Peacock, Aj, Pepkezaba, J., and Vizza, Carmine Dario

Published
2003

45. Extracorporeal membrane oxygenation in awake patients as bridge to lung transplantation.

Author

Fuehner T, Kuehn C, Hadem J, Wiesner O, Gottlieb J, Tudorache I, Olsson KM, Greer M, Sommer W, Welte T, Haverich A, Hoeper MM, and Warnecke G

Abstract

Rationale: The use of extracorporeal membrane oxygenation (ECMO) in patients who are awake and spontaneously breathing may represent a novel bridging strategy toward lung transplantation (LuTx). Objectives: To evaluate the outcomes of patients treated with the 'awake ECMO' concept as bridge to transplantation. Methods: We performed a retrospective, single-center, intention-to-treat analysis of consecutive LuTx candidates with terminal respiratory or cardiopulmonary failure receiving awake ECMO support. The outcomes were compared with a historical control group of patients treated with conventional mechanical ventilation (MV group) as bridge to transplant. Measurements and Main Results: Twenty-six patients (58% female; median age, 44 yr; range, 23-62) were included in the awake ECMO group and 34 patients (59% female; median age, 36 yr; range, 18-59) in the MV group. The duration of ECMO support or MV, respectively, was comparable in both groups (awake ECMO: median, 9 d; range, 1-45. MV: median, 15 d; range, 1-71; P = 0.25). Six (23%) of 26 patients in the awake ECMO group and 10 (29%) of 34 patients in the MV group died before a donor organ was available (P = 0.20). Survival at 6 months after LuTx was 80% in the awake ECMO group versus 50% in the MV group (P = 0.02). Patients in the awake ECMO group required shorter postoperative MV (P = 0.04) and showed a trend toward a shorter postoperative hospital stay (P = 0.06). Conclusions: ECMO support in patients who are awake and nonintubated represents a promising bridging strategy, which should be further evaluated to determine its role in patients with end-stage lung disease awaiting LuTx. [ABSTRACT FROM AUTHOR]

Published
2012
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48. Absence of Kaposi's sarcoma-associated herpesvirus in patients with pulmonary arterial hypertension.

Author

Henke-Gendo C, Mengel M, Hoeper MM, Alkharsah K, and Schulz TF

Abstract

Rationale: In addition to Kaposi's sarcoma, Kaposi's sarcoma-associated herpesvirus (KSHV or HHV-8) has been associated with two other diseases: primary effusion lymphoma and the plasma cell variant of multicentric Castleman's disease. Recently, evidence of KSHV infection was reported in plexiform lesions of idiopathic pulmonary arterial hypertension (IPAH) as well as in adjacent parenchyma and bronchial epithelial cells.Objectives: To further investigate a possible association of KSHV and pulmonary arterial hypertension.Methods and Measurements: Twenty-six lungs explanted from German patients suffering from IPAH were tested for the presence of KSHV antigen and genomes by immunohistochemistry (IHC) and polymerase chain reaction (PCR).Main Results: When stained with a commercial monoclonal antibody directed against the latency-associated nuclear antigen of KSHV, LANA-1, a positive signal reminiscent of the 'speckled' nuclear pattern typical of latently KSHV-infected cells was found in 16 (61.5%) cases. Alveolar and bronchial epithelial cells in areas of unremarkable lung tissue, but not cells within the plexiform lesions, were the predominantly stained cell types. Different KSHV-PCR assays (based on orf26, orfK6, and orf72) performed on samples that had tested positively in IHC, however, could not confirm KSHV infection, indicating that the IHC signal was not due to KSHV infection. One IHC-negative patient tested positive by PCR. A PCR based on consensus degenerate hybrid oligonucleotide primers (CODEHOP) to detect yet unknown gamma-herpesviruses did not reveal any specific sequences. [ABSTRACT FROM AUTHOR]

Published
2005
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