Tolerability, safety and survival in patients with severe pulmonary arterial hypertension treated with intravenous epoprostenol ($ Veletri^{®} $): a prospective, 6-months, open label, observational, non-interventional study
Background Epoprostenol AS ($ Veletri^{®} $), a thermostable epoprostenol formulation, provides better drug stability and improved clinical use compared to previous epoprostenol formulations. This study aims to expand clinical experience in the use of $ Veletri^{®} $, especially regarding tolerabili...
Ausführliche Beschreibung
Autor*in: |
Degering, Julia [verfasserIn] |
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E-Artikel |
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Englisch |
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2023 |
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Anmerkung: |
© The Author(s) 2023 |
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Übergeordnetes Werk: |
Enthalten in: Respiratory research - London : BioMed Central, 2001, 24(2023), 1 vom: 18. Jan. |
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Übergeordnetes Werk: |
volume:24 ; year:2023 ; number:1 ; day:18 ; month:01 |
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DOI / URN: |
10.1186/s12931-022-02296-z |
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SPR051360047 |
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245 | 1 | 0 | |a Tolerability, safety and survival in patients with severe pulmonary arterial hypertension treated with intravenous epoprostenol ($ Veletri^{®} $): a prospective, 6-months, open label, observational, non-interventional study |
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520 | |a Background Epoprostenol AS ($ Veletri^{®} $), a thermostable epoprostenol formulation, provides better drug stability and improved clinical use compared to previous epoprostenol formulations. This study aims to expand clinical experience in the use of $ Veletri^{®} $, especially regarding tolerability, safety and survival. Methods Pulmonary arterial hypertension (PAH) patients at high risk despite pretreatment with at least double oral combination therapy and with clinical indication for epoprostenol ($ Veletri^{®} $) treatment were consecutively included in this prospective, open label, observational, non-interventional study. Clinical data were assessed at baseline, after 3 and 6 months. Adverse events (AEs) and serious adverse events (SAEs) were documented. Survival from initiation of $ Veletri^{®} $ was assessed at last patient out. Results Fifteen patients (60 ± 13.7 years, WHO functional class III (n = 10) or IV (n = 5), severely impaired right ventricular function, mean pulmonary arterial pressure 54.8 ± 8.9 mmHg, mean pulmonary vascular resistance 4.4 ± 0.7 (median 3.8) Wood Units) were enrolled and treated with a mean dosage of 7.9 ± 3.9 (median 7.5) ng/kg/min. Eleven patients completed the study (treatment withdrawal n = 1, death n = 3). After a mean follow-up of 19.1 ± 13.5 (median 18.0) months, seven patients died and three were listed for lung transplantation. Seven AEs (nausea n = 3, diarrhea n = 1, flushing n = 2, headaches n = 1) and three SAEs (catheter infection n = 2, catheter occlusion n = 1) were related to $ Veletri^{®} $. The 1- and 2-year survival rates were 73.3% and 52.4%, respectively. Conclusions The study showed that safety and tolerability of epoprostenol AS ($ Veletri^{®} $) was comparable to previous prostacyclin formulations and was feasible for most patients. The maximum tolerable dosage was lower than dosages reported in the literature. In future applications/trials the up-titration process should be pushing for higher dosages of epoprostenol in the occurrence of side effects, as the achievement of a high and effective dosage is crucial for the clinical benefit of the patients. Survival was as expected in these prevalent severely impaired patients. Trial registration The study was registered in the EUPAS registry (EUPAS32492). | ||
650 | 4 | |a Epoprostenol |7 (dpeaa)DE-He213 | |
650 | 4 | |a Pulmonary hypertension |7 (dpeaa)DE-He213 | |
650 | 4 | |a Veletri |7 (dpeaa)DE-He213 | |
700 | 1 | |a Egenlauf, Benjamin |4 aut | |
700 | 1 | |a Harutyunova, Satenik |4 aut | |
700 | 1 | |a Benjamin, Nicola |4 aut | |
700 | 1 | |a Salkić, Amina |4 aut | |
700 | 1 | |a Xanthouli, Panagiota |4 aut | |
700 | 1 | |a Eichstaedt, Christina A. |4 aut | |
700 | 1 | |a Seeger, Rebekka |4 aut | |
700 | 1 | |a Sitbon, Olivier |4 aut | |
700 | 1 | |a Grünig, Ekkehard |4 aut | |
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10.1186/s12931-022-02296-z doi (DE-627)SPR051360047 (SPR)s12931-022-02296-z-e DE-627 ger DE-627 rakwb eng Degering, Julia verfasserin aut Tolerability, safety and survival in patients with severe pulmonary arterial hypertension treated with intravenous epoprostenol ($ Veletri^{®} $): a prospective, 6-months, open label, observational, non-interventional study 2023 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © The Author(s) 2023 Background Epoprostenol AS ($ Veletri^{®} $), a thermostable epoprostenol formulation, provides better drug stability and improved clinical use compared to previous epoprostenol formulations. This study aims to expand clinical experience in the use of $ Veletri^{®} $, especially regarding tolerability, safety and survival. Methods Pulmonary arterial hypertension (PAH) patients at high risk despite pretreatment with at least double oral combination therapy and with clinical indication for epoprostenol ($ Veletri^{®} $) treatment were consecutively included in this prospective, open label, observational, non-interventional study. Clinical data were assessed at baseline, after 3 and 6 months. Adverse events (AEs) and serious adverse events (SAEs) were documented. Survival from initiation of $ Veletri^{®} $ was assessed at last patient out. Results Fifteen patients (60 ± 13.7 years, WHO functional class III (n = 10) or IV (n = 5), severely impaired right ventricular function, mean pulmonary arterial pressure 54.8 ± 8.9 mmHg, mean pulmonary vascular resistance 4.4 ± 0.7 (median 3.8) Wood Units) were enrolled and treated with a mean dosage of 7.9 ± 3.9 (median 7.5) ng/kg/min. Eleven patients completed the study (treatment withdrawal n = 1, death n = 3). After a mean follow-up of 19.1 ± 13.5 (median 18.0) months, seven patients died and three were listed for lung transplantation. Seven AEs (nausea n = 3, diarrhea n = 1, flushing n = 2, headaches n = 1) and three SAEs (catheter infection n = 2, catheter occlusion n = 1) were related to $ Veletri^{®} $. The 1- and 2-year survival rates were 73.3% and 52.4%, respectively. Conclusions The study showed that safety and tolerability of epoprostenol AS ($ Veletri^{®} $) was comparable to previous prostacyclin formulations and was feasible for most patients. The maximum tolerable dosage was lower than dosages reported in the literature. In future applications/trials the up-titration process should be pushing for higher dosages of epoprostenol in the occurrence of side effects, as the achievement of a high and effective dosage is crucial for the clinical benefit of the patients. Survival was as expected in these prevalent severely impaired patients. Trial registration The study was registered in the EUPAS registry (EUPAS32492). Epoprostenol (dpeaa)DE-He213 Pulmonary hypertension (dpeaa)DE-He213 Veletri (dpeaa)DE-He213 Egenlauf, Benjamin aut Harutyunova, Satenik aut Benjamin, Nicola aut Salkić, Amina aut Xanthouli, Panagiota aut Eichstaedt, Christina A. aut Seeger, Rebekka aut Sitbon, Olivier aut Grünig, Ekkehard aut Enthalten in Respiratory research London : BioMed Central, 2001 24(2023), 1 vom: 18. Jan. (DE-627)326646485 (DE-600)2041675-1 1465-993X nnns volume:24 year:2023 number:1 day:18 month:01 https://dx.doi.org/10.1186/s12931-022-02296-z kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_702 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2008 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2031 GBV_ILN_2038 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2056 GBV_ILN_2057 GBV_ILN_2061 GBV_ILN_2111 GBV_ILN_2113 GBV_ILN_2153 GBV_ILN_2190 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 24 2023 1 18 01 |
spelling |
10.1186/s12931-022-02296-z doi (DE-627)SPR051360047 (SPR)s12931-022-02296-z-e DE-627 ger DE-627 rakwb eng Degering, Julia verfasserin aut Tolerability, safety and survival in patients with severe pulmonary arterial hypertension treated with intravenous epoprostenol ($ Veletri^{®} $): a prospective, 6-months, open label, observational, non-interventional study 2023 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © The Author(s) 2023 Background Epoprostenol AS ($ Veletri^{®} $), a thermostable epoprostenol formulation, provides better drug stability and improved clinical use compared to previous epoprostenol formulations. This study aims to expand clinical experience in the use of $ Veletri^{®} $, especially regarding tolerability, safety and survival. Methods Pulmonary arterial hypertension (PAH) patients at high risk despite pretreatment with at least double oral combination therapy and with clinical indication for epoprostenol ($ Veletri^{®} $) treatment were consecutively included in this prospective, open label, observational, non-interventional study. Clinical data were assessed at baseline, after 3 and 6 months. Adverse events (AEs) and serious adverse events (SAEs) were documented. Survival from initiation of $ Veletri^{®} $ was assessed at last patient out. Results Fifteen patients (60 ± 13.7 years, WHO functional class III (n = 10) or IV (n = 5), severely impaired right ventricular function, mean pulmonary arterial pressure 54.8 ± 8.9 mmHg, mean pulmonary vascular resistance 4.4 ± 0.7 (median 3.8) Wood Units) were enrolled and treated with a mean dosage of 7.9 ± 3.9 (median 7.5) ng/kg/min. Eleven patients completed the study (treatment withdrawal n = 1, death n = 3). After a mean follow-up of 19.1 ± 13.5 (median 18.0) months, seven patients died and three were listed for lung transplantation. Seven AEs (nausea n = 3, diarrhea n = 1, flushing n = 2, headaches n = 1) and three SAEs (catheter infection n = 2, catheter occlusion n = 1) were related to $ Veletri^{®} $. The 1- and 2-year survival rates were 73.3% and 52.4%, respectively. Conclusions The study showed that safety and tolerability of epoprostenol AS ($ Veletri^{®} $) was comparable to previous prostacyclin formulations and was feasible for most patients. The maximum tolerable dosage was lower than dosages reported in the literature. In future applications/trials the up-titration process should be pushing for higher dosages of epoprostenol in the occurrence of side effects, as the achievement of a high and effective dosage is crucial for the clinical benefit of the patients. Survival was as expected in these prevalent severely impaired patients. Trial registration The study was registered in the EUPAS registry (EUPAS32492). Epoprostenol (dpeaa)DE-He213 Pulmonary hypertension (dpeaa)DE-He213 Veletri (dpeaa)DE-He213 Egenlauf, Benjamin aut Harutyunova, Satenik aut Benjamin, Nicola aut Salkić, Amina aut Xanthouli, Panagiota aut Eichstaedt, Christina A. aut Seeger, Rebekka aut Sitbon, Olivier aut Grünig, Ekkehard aut Enthalten in Respiratory research London : BioMed Central, 2001 24(2023), 1 vom: 18. Jan. (DE-627)326646485 (DE-600)2041675-1 1465-993X nnns volume:24 year:2023 number:1 day:18 month:01 https://dx.doi.org/10.1186/s12931-022-02296-z kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_702 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2008 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2031 GBV_ILN_2038 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2056 GBV_ILN_2057 GBV_ILN_2061 GBV_ILN_2111 GBV_ILN_2113 GBV_ILN_2153 GBV_ILN_2190 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 24 2023 1 18 01 |
allfields_unstemmed |
10.1186/s12931-022-02296-z doi (DE-627)SPR051360047 (SPR)s12931-022-02296-z-e DE-627 ger DE-627 rakwb eng Degering, Julia verfasserin aut Tolerability, safety and survival in patients with severe pulmonary arterial hypertension treated with intravenous epoprostenol ($ Veletri^{®} $): a prospective, 6-months, open label, observational, non-interventional study 2023 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © The Author(s) 2023 Background Epoprostenol AS ($ Veletri^{®} $), a thermostable epoprostenol formulation, provides better drug stability and improved clinical use compared to previous epoprostenol formulations. This study aims to expand clinical experience in the use of $ Veletri^{®} $, especially regarding tolerability, safety and survival. Methods Pulmonary arterial hypertension (PAH) patients at high risk despite pretreatment with at least double oral combination therapy and with clinical indication for epoprostenol ($ Veletri^{®} $) treatment were consecutively included in this prospective, open label, observational, non-interventional study. Clinical data were assessed at baseline, after 3 and 6 months. Adverse events (AEs) and serious adverse events (SAEs) were documented. Survival from initiation of $ Veletri^{®} $ was assessed at last patient out. Results Fifteen patients (60 ± 13.7 years, WHO functional class III (n = 10) or IV (n = 5), severely impaired right ventricular function, mean pulmonary arterial pressure 54.8 ± 8.9 mmHg, mean pulmonary vascular resistance 4.4 ± 0.7 (median 3.8) Wood Units) were enrolled and treated with a mean dosage of 7.9 ± 3.9 (median 7.5) ng/kg/min. Eleven patients completed the study (treatment withdrawal n = 1, death n = 3). After a mean follow-up of 19.1 ± 13.5 (median 18.0) months, seven patients died and three were listed for lung transplantation. Seven AEs (nausea n = 3, diarrhea n = 1, flushing n = 2, headaches n = 1) and three SAEs (catheter infection n = 2, catheter occlusion n = 1) were related to $ Veletri^{®} $. The 1- and 2-year survival rates were 73.3% and 52.4%, respectively. Conclusions The study showed that safety and tolerability of epoprostenol AS ($ Veletri^{®} $) was comparable to previous prostacyclin formulations and was feasible for most patients. The maximum tolerable dosage was lower than dosages reported in the literature. In future applications/trials the up-titration process should be pushing for higher dosages of epoprostenol in the occurrence of side effects, as the achievement of a high and effective dosage is crucial for the clinical benefit of the patients. Survival was as expected in these prevalent severely impaired patients. Trial registration The study was registered in the EUPAS registry (EUPAS32492). Epoprostenol (dpeaa)DE-He213 Pulmonary hypertension (dpeaa)DE-He213 Veletri (dpeaa)DE-He213 Egenlauf, Benjamin aut Harutyunova, Satenik aut Benjamin, Nicola aut Salkić, Amina aut Xanthouli, Panagiota aut Eichstaedt, Christina A. aut Seeger, Rebekka aut Sitbon, Olivier aut Grünig, Ekkehard aut Enthalten in Respiratory research London : BioMed Central, 2001 24(2023), 1 vom: 18. Jan. (DE-627)326646485 (DE-600)2041675-1 1465-993X nnns volume:24 year:2023 number:1 day:18 month:01 https://dx.doi.org/10.1186/s12931-022-02296-z kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_702 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2008 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2031 GBV_ILN_2038 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2056 GBV_ILN_2057 GBV_ILN_2061 GBV_ILN_2111 GBV_ILN_2113 GBV_ILN_2153 GBV_ILN_2190 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 24 2023 1 18 01 |
allfieldsGer |
10.1186/s12931-022-02296-z doi (DE-627)SPR051360047 (SPR)s12931-022-02296-z-e DE-627 ger DE-627 rakwb eng Degering, Julia verfasserin aut Tolerability, safety and survival in patients with severe pulmonary arterial hypertension treated with intravenous epoprostenol ($ Veletri^{®} $): a prospective, 6-months, open label, observational, non-interventional study 2023 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © The Author(s) 2023 Background Epoprostenol AS ($ Veletri^{®} $), a thermostable epoprostenol formulation, provides better drug stability and improved clinical use compared to previous epoprostenol formulations. This study aims to expand clinical experience in the use of $ Veletri^{®} $, especially regarding tolerability, safety and survival. Methods Pulmonary arterial hypertension (PAH) patients at high risk despite pretreatment with at least double oral combination therapy and with clinical indication for epoprostenol ($ Veletri^{®} $) treatment were consecutively included in this prospective, open label, observational, non-interventional study. Clinical data were assessed at baseline, after 3 and 6 months. Adverse events (AEs) and serious adverse events (SAEs) were documented. Survival from initiation of $ Veletri^{®} $ was assessed at last patient out. Results Fifteen patients (60 ± 13.7 years, WHO functional class III (n = 10) or IV (n = 5), severely impaired right ventricular function, mean pulmonary arterial pressure 54.8 ± 8.9 mmHg, mean pulmonary vascular resistance 4.4 ± 0.7 (median 3.8) Wood Units) were enrolled and treated with a mean dosage of 7.9 ± 3.9 (median 7.5) ng/kg/min. Eleven patients completed the study (treatment withdrawal n = 1, death n = 3). After a mean follow-up of 19.1 ± 13.5 (median 18.0) months, seven patients died and three were listed for lung transplantation. Seven AEs (nausea n = 3, diarrhea n = 1, flushing n = 2, headaches n = 1) and three SAEs (catheter infection n = 2, catheter occlusion n = 1) were related to $ Veletri^{®} $. The 1- and 2-year survival rates were 73.3% and 52.4%, respectively. Conclusions The study showed that safety and tolerability of epoprostenol AS ($ Veletri^{®} $) was comparable to previous prostacyclin formulations and was feasible for most patients. The maximum tolerable dosage was lower than dosages reported in the literature. In future applications/trials the up-titration process should be pushing for higher dosages of epoprostenol in the occurrence of side effects, as the achievement of a high and effective dosage is crucial for the clinical benefit of the patients. Survival was as expected in these prevalent severely impaired patients. Trial registration The study was registered in the EUPAS registry (EUPAS32492). Epoprostenol (dpeaa)DE-He213 Pulmonary hypertension (dpeaa)DE-He213 Veletri (dpeaa)DE-He213 Egenlauf, Benjamin aut Harutyunova, Satenik aut Benjamin, Nicola aut Salkić, Amina aut Xanthouli, Panagiota aut Eichstaedt, Christina A. aut Seeger, Rebekka aut Sitbon, Olivier aut Grünig, Ekkehard aut Enthalten in Respiratory research London : BioMed Central, 2001 24(2023), 1 vom: 18. Jan. (DE-627)326646485 (DE-600)2041675-1 1465-993X nnns volume:24 year:2023 number:1 day:18 month:01 https://dx.doi.org/10.1186/s12931-022-02296-z kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_702 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2008 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2031 GBV_ILN_2038 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2056 GBV_ILN_2057 GBV_ILN_2061 GBV_ILN_2111 GBV_ILN_2113 GBV_ILN_2153 GBV_ILN_2190 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 24 2023 1 18 01 |
allfieldsSound |
10.1186/s12931-022-02296-z doi (DE-627)SPR051360047 (SPR)s12931-022-02296-z-e DE-627 ger DE-627 rakwb eng Degering, Julia verfasserin aut Tolerability, safety and survival in patients with severe pulmonary arterial hypertension treated with intravenous epoprostenol ($ Veletri^{®} $): a prospective, 6-months, open label, observational, non-interventional study 2023 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © The Author(s) 2023 Background Epoprostenol AS ($ Veletri^{®} $), a thermostable epoprostenol formulation, provides better drug stability and improved clinical use compared to previous epoprostenol formulations. This study aims to expand clinical experience in the use of $ Veletri^{®} $, especially regarding tolerability, safety and survival. Methods Pulmonary arterial hypertension (PAH) patients at high risk despite pretreatment with at least double oral combination therapy and with clinical indication for epoprostenol ($ Veletri^{®} $) treatment were consecutively included in this prospective, open label, observational, non-interventional study. Clinical data were assessed at baseline, after 3 and 6 months. Adverse events (AEs) and serious adverse events (SAEs) were documented. Survival from initiation of $ Veletri^{®} $ was assessed at last patient out. Results Fifteen patients (60 ± 13.7 years, WHO functional class III (n = 10) or IV (n = 5), severely impaired right ventricular function, mean pulmonary arterial pressure 54.8 ± 8.9 mmHg, mean pulmonary vascular resistance 4.4 ± 0.7 (median 3.8) Wood Units) were enrolled and treated with a mean dosage of 7.9 ± 3.9 (median 7.5) ng/kg/min. Eleven patients completed the study (treatment withdrawal n = 1, death n = 3). After a mean follow-up of 19.1 ± 13.5 (median 18.0) months, seven patients died and three were listed for lung transplantation. Seven AEs (nausea n = 3, diarrhea n = 1, flushing n = 2, headaches n = 1) and three SAEs (catheter infection n = 2, catheter occlusion n = 1) were related to $ Veletri^{®} $. The 1- and 2-year survival rates were 73.3% and 52.4%, respectively. Conclusions The study showed that safety and tolerability of epoprostenol AS ($ Veletri^{®} $) was comparable to previous prostacyclin formulations and was feasible for most patients. The maximum tolerable dosage was lower than dosages reported in the literature. In future applications/trials the up-titration process should be pushing for higher dosages of epoprostenol in the occurrence of side effects, as the achievement of a high and effective dosage is crucial for the clinical benefit of the patients. Survival was as expected in these prevalent severely impaired patients. Trial registration The study was registered in the EUPAS registry (EUPAS32492). Epoprostenol (dpeaa)DE-He213 Pulmonary hypertension (dpeaa)DE-He213 Veletri (dpeaa)DE-He213 Egenlauf, Benjamin aut Harutyunova, Satenik aut Benjamin, Nicola aut Salkić, Amina aut Xanthouli, Panagiota aut Eichstaedt, Christina A. aut Seeger, Rebekka aut Sitbon, Olivier aut Grünig, Ekkehard aut Enthalten in Respiratory research London : BioMed Central, 2001 24(2023), 1 vom: 18. Jan. (DE-627)326646485 (DE-600)2041675-1 1465-993X nnns volume:24 year:2023 number:1 day:18 month:01 https://dx.doi.org/10.1186/s12931-022-02296-z kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_702 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2008 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2031 GBV_ILN_2038 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2056 GBV_ILN_2057 GBV_ILN_2061 GBV_ILN_2111 GBV_ILN_2113 GBV_ILN_2153 GBV_ILN_2190 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 24 2023 1 18 01 |
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Degering, Julia @@aut@@ Egenlauf, Benjamin @@aut@@ Harutyunova, Satenik @@aut@@ Benjamin, Nicola @@aut@@ Salkić, Amina @@aut@@ Xanthouli, Panagiota @@aut@@ Eichstaedt, Christina A. @@aut@@ Seeger, Rebekka @@aut@@ Sitbon, Olivier @@aut@@ Grünig, Ekkehard @@aut@@ |
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This study aims to expand clinical experience in the use of $ Veletri^{®} $, especially regarding tolerability, safety and survival. Methods Pulmonary arterial hypertension (PAH) patients at high risk despite pretreatment with at least double oral combination therapy and with clinical indication for epoprostenol ($ Veletri^{®} $) treatment were consecutively included in this prospective, open label, observational, non-interventional study. Clinical data were assessed at baseline, after 3 and 6 months. Adverse events (AEs) and serious adverse events (SAEs) were documented. Survival from initiation of $ Veletri^{®} $ was assessed at last patient out. Results Fifteen patients (60 ± 13.7 years, WHO functional class III (n = 10) or IV (n = 5), severely impaired right ventricular function, mean pulmonary arterial pressure 54.8 ± 8.9 mmHg, mean pulmonary vascular resistance 4.4 ± 0.7 (median 3.8) Wood Units) were enrolled and treated with a mean dosage of 7.9 ± 3.9 (median 7.5) ng/kg/min. 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Degering, Julia misc Epoprostenol misc Pulmonary hypertension misc Veletri Tolerability, safety and survival in patients with severe pulmonary arterial hypertension treated with intravenous epoprostenol ($ Veletri^{®} $): a prospective, 6-months, open label, observational, non-interventional study |
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Tolerability, safety and survival in patients with severe pulmonary arterial hypertension treated with intravenous epoprostenol ($ Veletri^{®} $): a prospective, 6-months, open label, observational, non-interventional study Epoprostenol (dpeaa)DE-He213 Pulmonary hypertension (dpeaa)DE-He213 Veletri (dpeaa)DE-He213 |
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Tolerability, safety and survival in patients with severe pulmonary arterial hypertension treated with intravenous epoprostenol ($ Veletri^{®} $): a prospective, 6-months, open label, observational, non-interventional study |
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Tolerability, safety and survival in patients with severe pulmonary arterial hypertension treated with intravenous epoprostenol ($ Veletri^{®} $): a prospective, 6-months, open label, observational, non-interventional study |
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Degering, Julia Egenlauf, Benjamin Harutyunova, Satenik Benjamin, Nicola Salkić, Amina Xanthouli, Panagiota Eichstaedt, Christina A. Seeger, Rebekka Sitbon, Olivier Grünig, Ekkehard |
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tolerability, safety and survival in patients with severe pulmonary arterial hypertension treated with intravenous epoprostenol ($ veletri^{®} $): a prospective, 6-months, open label, observational, non-interventional study |
title_auth |
Tolerability, safety and survival in patients with severe pulmonary arterial hypertension treated with intravenous epoprostenol ($ Veletri^{®} $): a prospective, 6-months, open label, observational, non-interventional study |
abstract |
Background Epoprostenol AS ($ Veletri^{®} $), a thermostable epoprostenol formulation, provides better drug stability and improved clinical use compared to previous epoprostenol formulations. This study aims to expand clinical experience in the use of $ Veletri^{®} $, especially regarding tolerability, safety and survival. Methods Pulmonary arterial hypertension (PAH) patients at high risk despite pretreatment with at least double oral combination therapy and with clinical indication for epoprostenol ($ Veletri^{®} $) treatment were consecutively included in this prospective, open label, observational, non-interventional study. Clinical data were assessed at baseline, after 3 and 6 months. Adverse events (AEs) and serious adverse events (SAEs) were documented. Survival from initiation of $ Veletri^{®} $ was assessed at last patient out. Results Fifteen patients (60 ± 13.7 years, WHO functional class III (n = 10) or IV (n = 5), severely impaired right ventricular function, mean pulmonary arterial pressure 54.8 ± 8.9 mmHg, mean pulmonary vascular resistance 4.4 ± 0.7 (median 3.8) Wood Units) were enrolled and treated with a mean dosage of 7.9 ± 3.9 (median 7.5) ng/kg/min. Eleven patients completed the study (treatment withdrawal n = 1, death n = 3). After a mean follow-up of 19.1 ± 13.5 (median 18.0) months, seven patients died and three were listed for lung transplantation. Seven AEs (nausea n = 3, diarrhea n = 1, flushing n = 2, headaches n = 1) and three SAEs (catheter infection n = 2, catheter occlusion n = 1) were related to $ Veletri^{®} $. The 1- and 2-year survival rates were 73.3% and 52.4%, respectively. Conclusions The study showed that safety and tolerability of epoprostenol AS ($ Veletri^{®} $) was comparable to previous prostacyclin formulations and was feasible for most patients. The maximum tolerable dosage was lower than dosages reported in the literature. In future applications/trials the up-titration process should be pushing for higher dosages of epoprostenol in the occurrence of side effects, as the achievement of a high and effective dosage is crucial for the clinical benefit of the patients. Survival was as expected in these prevalent severely impaired patients. Trial registration The study was registered in the EUPAS registry (EUPAS32492). © The Author(s) 2023 |
abstractGer |
Background Epoprostenol AS ($ Veletri^{®} $), a thermostable epoprostenol formulation, provides better drug stability and improved clinical use compared to previous epoprostenol formulations. This study aims to expand clinical experience in the use of $ Veletri^{®} $, especially regarding tolerability, safety and survival. Methods Pulmonary arterial hypertension (PAH) patients at high risk despite pretreatment with at least double oral combination therapy and with clinical indication for epoprostenol ($ Veletri^{®} $) treatment were consecutively included in this prospective, open label, observational, non-interventional study. Clinical data were assessed at baseline, after 3 and 6 months. Adverse events (AEs) and serious adverse events (SAEs) were documented. Survival from initiation of $ Veletri^{®} $ was assessed at last patient out. Results Fifteen patients (60 ± 13.7 years, WHO functional class III (n = 10) or IV (n = 5), severely impaired right ventricular function, mean pulmonary arterial pressure 54.8 ± 8.9 mmHg, mean pulmonary vascular resistance 4.4 ± 0.7 (median 3.8) Wood Units) were enrolled and treated with a mean dosage of 7.9 ± 3.9 (median 7.5) ng/kg/min. Eleven patients completed the study (treatment withdrawal n = 1, death n = 3). After a mean follow-up of 19.1 ± 13.5 (median 18.0) months, seven patients died and three were listed for lung transplantation. Seven AEs (nausea n = 3, diarrhea n = 1, flushing n = 2, headaches n = 1) and three SAEs (catheter infection n = 2, catheter occlusion n = 1) were related to $ Veletri^{®} $. The 1- and 2-year survival rates were 73.3% and 52.4%, respectively. Conclusions The study showed that safety and tolerability of epoprostenol AS ($ Veletri^{®} $) was comparable to previous prostacyclin formulations and was feasible for most patients. The maximum tolerable dosage was lower than dosages reported in the literature. In future applications/trials the up-titration process should be pushing for higher dosages of epoprostenol in the occurrence of side effects, as the achievement of a high and effective dosage is crucial for the clinical benefit of the patients. Survival was as expected in these prevalent severely impaired patients. Trial registration The study was registered in the EUPAS registry (EUPAS32492). © The Author(s) 2023 |
abstract_unstemmed |
Background Epoprostenol AS ($ Veletri^{®} $), a thermostable epoprostenol formulation, provides better drug stability and improved clinical use compared to previous epoprostenol formulations. This study aims to expand clinical experience in the use of $ Veletri^{®} $, especially regarding tolerability, safety and survival. Methods Pulmonary arterial hypertension (PAH) patients at high risk despite pretreatment with at least double oral combination therapy and with clinical indication for epoprostenol ($ Veletri^{®} $) treatment were consecutively included in this prospective, open label, observational, non-interventional study. Clinical data were assessed at baseline, after 3 and 6 months. Adverse events (AEs) and serious adverse events (SAEs) were documented. Survival from initiation of $ Veletri^{®} $ was assessed at last patient out. Results Fifteen patients (60 ± 13.7 years, WHO functional class III (n = 10) or IV (n = 5), severely impaired right ventricular function, mean pulmonary arterial pressure 54.8 ± 8.9 mmHg, mean pulmonary vascular resistance 4.4 ± 0.7 (median 3.8) Wood Units) were enrolled and treated with a mean dosage of 7.9 ± 3.9 (median 7.5) ng/kg/min. Eleven patients completed the study (treatment withdrawal n = 1, death n = 3). After a mean follow-up of 19.1 ± 13.5 (median 18.0) months, seven patients died and three were listed for lung transplantation. Seven AEs (nausea n = 3, diarrhea n = 1, flushing n = 2, headaches n = 1) and three SAEs (catheter infection n = 2, catheter occlusion n = 1) were related to $ Veletri^{®} $. The 1- and 2-year survival rates were 73.3% and 52.4%, respectively. Conclusions The study showed that safety and tolerability of epoprostenol AS ($ Veletri^{®} $) was comparable to previous prostacyclin formulations and was feasible for most patients. The maximum tolerable dosage was lower than dosages reported in the literature. In future applications/trials the up-titration process should be pushing for higher dosages of epoprostenol in the occurrence of side effects, as the achievement of a high and effective dosage is crucial for the clinical benefit of the patients. Survival was as expected in these prevalent severely impaired patients. Trial registration The study was registered in the EUPAS registry (EUPAS32492). © The Author(s) 2023 |
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Tolerability, safety and survival in patients with severe pulmonary arterial hypertension treated with intravenous epoprostenol ($ Veletri^{®} $): a prospective, 6-months, open label, observational, non-interventional study |
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score |
7.3998413 |