Long-term safety of pirfenidone: results of the prospective, observational PASSPORT study
Real-world studies include a broader patient population for a longer duration than randomised controlled trials (RCTs) and can provide relevant insights for clinical practice. PASSPORT was a multicentre, prospective, post-authorisation study of patients who were newly prescribed pirfenidone and foll...
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2018 |
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In: ERJ Open Research - European Respiratory Society, 2015, 4(2018), 4 |
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| Übergeordnetes Werk: |
volume:4 ; year:2018 ; number:4 |
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| DOI / URN: |
10.1183/23120541.00084-2018 |
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DOAJ045187681 |
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| 245 | 1 | 0 | |a Long-term safety of pirfenidone: results of the prospective, observational PASSPORT study |
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| 520 | |a Real-world studies include a broader patient population for a longer duration than randomised controlled trials (RCTs) and can provide relevant insights for clinical practice. PASSPORT was a multicentre, prospective, post-authorisation study of patients who were newly prescribed pirfenidone and followed for 2 years after initiating treatment. Physicians collected data on adverse drug reactions (ADRs), serious ADRs (SADRs) and ADRs of special interest (ADRSI) at baseline and then every 3 months. Post hoc stepwise logistic regression models were used to identify baseline characteristics associated with discontinuing treatment due to an ADR. Patients (n=1009, 99.7% with idiopathic pulmonary fibrosis) had a median pirfenidone exposure of 442.0 days. Overall, 741 (73.4%) patients experienced ADRs, most commonly nausea (20.6%) and fatigue (18.5%). ADRs led to treatment discontinuation in 290 (28.7%) patients after a median of 99.5 days. Overall, 55 (5.5%) patients experienced SADRs, with a fatal outcome in six patients. ADRSI were reported in 693 patients, most commonly gastrointestinal symptoms (38.3%) and photosensitivity reactions/skin rashes (29.0%). Older age and female sex were associated with early treatment discontinuation due to an ADR. Findings were consistent with the known safety profile of pirfenidone, based on RCT data and other post-marketing experience, with no new safety signals observed. | ||
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10.1183/23120541.00084-2018 doi (DE-627)DOAJ045187681 (DE-599)DOAJbc7d2efc99fe4cf088e6bcb6fe363782 DE-627 ger DE-627 rakwb eng Vincent Cottin verfasserin aut Long-term safety of pirfenidone: results of the prospective, observational PASSPORT study 2018 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Real-world studies include a broader patient population for a longer duration than randomised controlled trials (RCTs) and can provide relevant insights for clinical practice. PASSPORT was a multicentre, prospective, post-authorisation study of patients who were newly prescribed pirfenidone and followed for 2 years after initiating treatment. Physicians collected data on adverse drug reactions (ADRs), serious ADRs (SADRs) and ADRs of special interest (ADRSI) at baseline and then every 3 months. Post hoc stepwise logistic regression models were used to identify baseline characteristics associated with discontinuing treatment due to an ADR. Patients (n=1009, 99.7% with idiopathic pulmonary fibrosis) had a median pirfenidone exposure of 442.0 days. Overall, 741 (73.4%) patients experienced ADRs, most commonly nausea (20.6%) and fatigue (18.5%). ADRs led to treatment discontinuation in 290 (28.7%) patients after a median of 99.5 days. Overall, 55 (5.5%) patients experienced SADRs, with a fatal outcome in six patients. ADRSI were reported in 693 patients, most commonly gastrointestinal symptoms (38.3%) and photosensitivity reactions/skin rashes (29.0%). Older age and female sex were associated with early treatment discontinuation due to an ADR. Findings were consistent with the known safety profile of pirfenidone, based on RCT data and other post-marketing experience, with no new safety signals observed. Medicine R Dirk Koschel verfasserin aut Andreas Günther verfasserin aut Carlo Albera verfasserin aut Arata Azuma verfasserin aut C. Magnus Sköld verfasserin aut Sara Tomassetti verfasserin aut Philip Hormel verfasserin aut John L. Stauffer verfasserin aut Indiana Strombom verfasserin aut Klaus-Uwe Kirchgaessler verfasserin aut Toby M. Maher verfasserin aut PASSPORT study group verfasserin aut Peter Cerkl verfasserin aut Holger Flick verfasserin aut Christian Geltner verfasserin aut Judith Löffler-Ragg verfasserin aut Michael Studnicka verfasserin aut Elisabeth Bendstrup verfasserin aut Helle Dall Madsen verfasserin aut Saher B. Shaker verfasserin aut Maritta Kilpelainen verfasserin aut Marjukka Myllaerniemi verfasserin aut Minna Purokivi verfasserin aut Seppo Saarelainen verfasserin aut Emmanuel Bergot verfasserin aut Philippe Bonniaud verfasserin aut Raphael Borie verfasserin aut Pascal Chanez verfasserin aut Vincent Cottin verfasserin aut Francis Couturaud verfasserin aut Claire Dromer verfasserin aut Frederic Gagnadoux verfasserin aut Anne-Sophie Gamez verfasserin aut Anne Gondouin verfasserin aut Dominique Israel-Biet verfasserin aut Stephane Jouneau verfasserin aut Romain Kessler verfasserin aut Francois Lebargy verfasserin aut Sylvain Marchand-Adam verfasserin aut Borsi Melloni verfasserin aut Jean-Marc Naccache verfasserin aut Christophe Pison verfasserin aut Gregoire Prevot verfasserin aut Martine Reynaud-Gaubert verfasserin aut Abdellatif Tazi verfasserin aut Dominique Valeyre verfasserin aut Benoit Wallaert verfasserin aut Jost Achenbach verfasserin aut Stefan Andreas verfasserin aut Burkhard Bewig verfasserin aut Reiner Bonnet verfasserin aut Stephan Budweiser verfasserin aut Ulrich Costabel verfasserin aut Martin Faehling verfasserin aut Joachim Ficker verfasserin aut Juergen Fisher verfasserin aut Sven Glaeser verfasserin aut Christian Grah verfasserin aut Christian Grohe verfasserin aut Andreas Günther verfasserin aut Martin Hetzel verfasserin aut Wolfgang Hohenforst-Schmidt verfasserin aut David Jungck verfasserin aut Peter Kardos verfasserin aut Claus Keller verfasserin aut Martin Kohlhaeufl verfasserin aut Dirk Koschel verfasserin aut Claus Kroegel verfasserin aut Rainer Kruegel verfasserin aut Berthold Michels verfasserin aut Joachim Mueller-Quernheim verfasserin aut Claus Neurohr verfasserin aut Heinz-Theodor Pelzer verfasserin aut Michael Pfeifer verfasserin aut Michael Prediger verfasserin aut Klaus F. Rabe verfasserin aut Winifried Randerath verfasserin aut Nicolas Scheonfeld verfasserin aut Robert Scheubel verfasserin aut Jens Schreiber verfasserin aut Hartwig Schutte verfasserin aut Bernd Schoenhofer verfasserin aut Barbara Wagener verfasserin aut Tobias Welte verfasserin aut Michael Westhoff verfasserin aut Heinrike Wilkens verfasserin aut Hubert Wirtz verfasserin aut Michael Henry verfasserin aut Michael Keane verfasserin aut Anthony O'Regan verfasserin aut Katherine O'Reilly verfasserin aut Carlo Albera verfasserin aut Fabrizio Luppi verfasserin aut Sandra Nutini verfasserin aut Alberto Pesci verfasserin aut Venerino Poletti verfasserin aut Elisabetta Rosi verfasserin aut Paola Rottoli verfasserin aut Thomas Eagan verfasserin aut Durdica Kulosman verfasserin aut Tone Blorg Sjaheim verfasserin aut Karl Axel Karlsson verfasserin aut Magnus Sköld verfasserin aut Sanjay Agrawal verfasserin aut Kesavan Suresh Babu verfasserin aut Stephen Bianchi verfasserin aut Nazia Chaudhuri verfasserin aut Sophie Fletcher verfasserin aut Michael Gibbons verfasserin aut Simon Hart verfasserin aut Gisli Jenkins verfasserin aut Toby Maher verfasserin aut Ann Millar verfasserin aut Joanna Porter verfasserin aut Nicky Simler verfasserin aut Lisa Spencer verfasserin aut Monica Spiteri verfasserin aut Melissa Wickremasinghe verfasserin aut In ERJ Open Research European Respiratory Society, 2015 4(2018), 4 (DE-627)830141227 (DE-600)2827830-6 23120541 nnns volume:4 year:2018 number:4 https://doi.org/10.1183/23120541.00084-2018 kostenfrei https://doaj.org/article/bc7d2efc99fe4cf088e6bcb6fe363782 kostenfrei http://openres.ersjournals.com/content/4/4/00084-2018.full kostenfrei https://doaj.org/toc/2312-0541 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ 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_2014 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 4 2018 4 |
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10.1183/23120541.00084-2018 doi (DE-627)DOAJ045187681 (DE-599)DOAJbc7d2efc99fe4cf088e6bcb6fe363782 DE-627 ger DE-627 rakwb eng Vincent Cottin verfasserin aut Long-term safety of pirfenidone: results of the prospective, observational PASSPORT study 2018 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Real-world studies include a broader patient population for a longer duration than randomised controlled trials (RCTs) and can provide relevant insights for clinical practice. PASSPORT was a multicentre, prospective, post-authorisation study of patients who were newly prescribed pirfenidone and followed for 2 years after initiating treatment. Physicians collected data on adverse drug reactions (ADRs), serious ADRs (SADRs) and ADRs of special interest (ADRSI) at baseline and then every 3 months. Post hoc stepwise logistic regression models were used to identify baseline characteristics associated with discontinuing treatment due to an ADR. Patients (n=1009, 99.7% with idiopathic pulmonary fibrosis) had a median pirfenidone exposure of 442.0 days. Overall, 741 (73.4%) patients experienced ADRs, most commonly nausea (20.6%) and fatigue (18.5%). ADRs led to treatment discontinuation in 290 (28.7%) patients after a median of 99.5 days. Overall, 55 (5.5%) patients experienced SADRs, with a fatal outcome in six patients. ADRSI were reported in 693 patients, most commonly gastrointestinal symptoms (38.3%) and photosensitivity reactions/skin rashes (29.0%). Older age and female sex were associated with early treatment discontinuation due to an ADR. Findings were consistent with the known safety profile of pirfenidone, based on RCT data and other post-marketing experience, with no new safety signals observed. Medicine R Dirk Koschel verfasserin aut Andreas Günther verfasserin aut Carlo Albera verfasserin aut Arata Azuma verfasserin aut C. Magnus Sköld verfasserin aut Sara Tomassetti verfasserin aut Philip Hormel verfasserin aut John L. Stauffer verfasserin aut Indiana Strombom verfasserin aut Klaus-Uwe Kirchgaessler verfasserin aut Toby M. Maher verfasserin aut PASSPORT study group verfasserin aut Peter Cerkl verfasserin aut Holger Flick verfasserin aut Christian Geltner verfasserin aut Judith Löffler-Ragg verfasserin aut Michael Studnicka verfasserin aut Elisabeth Bendstrup verfasserin aut Helle Dall Madsen verfasserin aut Saher B. Shaker verfasserin aut Maritta Kilpelainen verfasserin aut Marjukka Myllaerniemi verfasserin aut Minna Purokivi verfasserin aut Seppo Saarelainen verfasserin aut Emmanuel Bergot verfasserin aut Philippe Bonniaud verfasserin aut Raphael Borie verfasserin aut Pascal Chanez verfasserin aut Vincent Cottin verfasserin aut Francis Couturaud verfasserin aut Claire Dromer verfasserin aut Frederic Gagnadoux verfasserin aut Anne-Sophie Gamez verfasserin aut Anne Gondouin verfasserin aut Dominique Israel-Biet verfasserin aut Stephane Jouneau verfasserin aut Romain Kessler verfasserin aut Francois Lebargy verfasserin aut Sylvain Marchand-Adam verfasserin aut Borsi Melloni verfasserin aut Jean-Marc Naccache verfasserin aut Christophe Pison verfasserin aut Gregoire Prevot verfasserin aut Martine Reynaud-Gaubert verfasserin aut Abdellatif Tazi verfasserin aut Dominique Valeyre verfasserin aut Benoit Wallaert verfasserin aut Jost Achenbach verfasserin aut Stefan Andreas verfasserin aut Burkhard Bewig verfasserin aut Reiner Bonnet verfasserin aut Stephan Budweiser verfasserin aut Ulrich Costabel verfasserin aut Martin Faehling verfasserin aut Joachim Ficker verfasserin aut Juergen Fisher verfasserin aut Sven Glaeser verfasserin aut Christian Grah verfasserin aut Christian Grohe verfasserin aut Andreas Günther verfasserin aut Martin Hetzel verfasserin aut Wolfgang Hohenforst-Schmidt verfasserin aut David Jungck verfasserin aut Peter Kardos verfasserin aut Claus Keller verfasserin aut Martin Kohlhaeufl verfasserin aut Dirk Koschel verfasserin aut Claus Kroegel verfasserin aut Rainer Kruegel verfasserin aut Berthold Michels verfasserin aut Joachim Mueller-Quernheim verfasserin aut Claus Neurohr verfasserin aut Heinz-Theodor Pelzer verfasserin aut Michael Pfeifer verfasserin aut Michael Prediger verfasserin aut Klaus F. Rabe verfasserin aut Winifried Randerath verfasserin aut Nicolas Scheonfeld verfasserin aut Robert Scheubel verfasserin aut Jens Schreiber verfasserin aut Hartwig Schutte verfasserin aut Bernd Schoenhofer verfasserin aut Barbara Wagener verfasserin aut Tobias Welte verfasserin aut Michael Westhoff verfasserin aut Heinrike Wilkens verfasserin aut Hubert Wirtz verfasserin aut Michael Henry verfasserin aut Michael Keane verfasserin aut Anthony O'Regan verfasserin aut Katherine O'Reilly verfasserin aut Carlo Albera verfasserin aut Fabrizio Luppi verfasserin aut Sandra Nutini verfasserin aut Alberto Pesci verfasserin aut Venerino Poletti verfasserin aut Elisabetta Rosi verfasserin aut Paola Rottoli verfasserin aut Thomas Eagan verfasserin aut Durdica Kulosman verfasserin aut Tone Blorg Sjaheim verfasserin aut Karl Axel Karlsson verfasserin aut Magnus Sköld verfasserin aut Sanjay Agrawal verfasserin aut Kesavan Suresh Babu verfasserin aut Stephen Bianchi verfasserin aut Nazia Chaudhuri verfasserin aut Sophie Fletcher verfasserin aut Michael Gibbons verfasserin aut Simon Hart verfasserin aut Gisli Jenkins verfasserin aut Toby Maher verfasserin aut Ann Millar verfasserin aut Joanna Porter verfasserin aut Nicky Simler verfasserin aut Lisa Spencer verfasserin aut Monica Spiteri verfasserin aut Melissa Wickremasinghe verfasserin aut In ERJ Open Research European Respiratory Society, 2015 4(2018), 4 (DE-627)830141227 (DE-600)2827830-6 23120541 nnns volume:4 year:2018 number:4 https://doi.org/10.1183/23120541.00084-2018 kostenfrei https://doaj.org/article/bc7d2efc99fe4cf088e6bcb6fe363782 kostenfrei http://openres.ersjournals.com/content/4/4/00084-2018.full kostenfrei https://doaj.org/toc/2312-0541 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ 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_2014 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 4 2018 4 |
| allfields_unstemmed |
10.1183/23120541.00084-2018 doi (DE-627)DOAJ045187681 (DE-599)DOAJbc7d2efc99fe4cf088e6bcb6fe363782 DE-627 ger DE-627 rakwb eng Vincent Cottin verfasserin aut Long-term safety of pirfenidone: results of the prospective, observational PASSPORT study 2018 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Real-world studies include a broader patient population for a longer duration than randomised controlled trials (RCTs) and can provide relevant insights for clinical practice. PASSPORT was a multicentre, prospective, post-authorisation study of patients who were newly prescribed pirfenidone and followed for 2 years after initiating treatment. Physicians collected data on adverse drug reactions (ADRs), serious ADRs (SADRs) and ADRs of special interest (ADRSI) at baseline and then every 3 months. Post hoc stepwise logistic regression models were used to identify baseline characteristics associated with discontinuing treatment due to an ADR. Patients (n=1009, 99.7% with idiopathic pulmonary fibrosis) had a median pirfenidone exposure of 442.0 days. Overall, 741 (73.4%) patients experienced ADRs, most commonly nausea (20.6%) and fatigue (18.5%). ADRs led to treatment discontinuation in 290 (28.7%) patients after a median of 99.5 days. Overall, 55 (5.5%) patients experienced SADRs, with a fatal outcome in six patients. ADRSI were reported in 693 patients, most commonly gastrointestinal symptoms (38.3%) and photosensitivity reactions/skin rashes (29.0%). Older age and female sex were associated with early treatment discontinuation due to an ADR. Findings were consistent with the known safety profile of pirfenidone, based on RCT data and other post-marketing experience, with no new safety signals observed. Medicine R Dirk Koschel verfasserin aut Andreas Günther verfasserin aut Carlo Albera verfasserin aut Arata Azuma verfasserin aut C. Magnus Sköld verfasserin aut Sara Tomassetti verfasserin aut Philip Hormel verfasserin aut John L. Stauffer verfasserin aut Indiana Strombom verfasserin aut Klaus-Uwe Kirchgaessler verfasserin aut Toby M. Maher verfasserin aut PASSPORT study group verfasserin aut Peter Cerkl verfasserin aut Holger Flick verfasserin aut Christian Geltner verfasserin aut Judith Löffler-Ragg verfasserin aut Michael Studnicka verfasserin aut Elisabeth Bendstrup verfasserin aut Helle Dall Madsen verfasserin aut Saher B. Shaker verfasserin aut Maritta Kilpelainen verfasserin aut Marjukka Myllaerniemi verfasserin aut Minna Purokivi verfasserin aut Seppo Saarelainen verfasserin aut Emmanuel Bergot verfasserin aut Philippe Bonniaud verfasserin aut Raphael Borie verfasserin aut Pascal Chanez verfasserin aut Vincent Cottin verfasserin aut Francis Couturaud verfasserin aut Claire Dromer verfasserin aut Frederic Gagnadoux verfasserin aut Anne-Sophie Gamez verfasserin aut Anne Gondouin verfasserin aut Dominique Israel-Biet verfasserin aut Stephane Jouneau verfasserin aut Romain Kessler verfasserin aut Francois Lebargy verfasserin aut Sylvain Marchand-Adam verfasserin aut Borsi Melloni verfasserin aut Jean-Marc Naccache verfasserin aut Christophe Pison verfasserin aut Gregoire Prevot verfasserin aut Martine Reynaud-Gaubert verfasserin aut Abdellatif Tazi verfasserin aut Dominique Valeyre verfasserin aut Benoit Wallaert verfasserin aut Jost Achenbach verfasserin aut Stefan Andreas verfasserin aut Burkhard Bewig verfasserin aut Reiner Bonnet verfasserin aut Stephan Budweiser verfasserin aut Ulrich Costabel verfasserin aut Martin Faehling verfasserin aut Joachim Ficker verfasserin aut Juergen Fisher verfasserin aut Sven Glaeser verfasserin aut Christian Grah verfasserin aut Christian Grohe verfasserin aut Andreas Günther verfasserin aut Martin Hetzel verfasserin aut Wolfgang Hohenforst-Schmidt verfasserin aut David Jungck verfasserin aut Peter Kardos verfasserin aut Claus Keller verfasserin aut Martin Kohlhaeufl verfasserin aut Dirk Koschel verfasserin aut Claus Kroegel verfasserin aut Rainer Kruegel verfasserin aut Berthold Michels verfasserin aut Joachim Mueller-Quernheim verfasserin aut Claus Neurohr verfasserin aut Heinz-Theodor Pelzer verfasserin aut Michael Pfeifer verfasserin aut Michael Prediger verfasserin aut Klaus F. Rabe verfasserin aut Winifried Randerath verfasserin aut Nicolas Scheonfeld verfasserin aut Robert Scheubel verfasserin aut Jens Schreiber verfasserin aut Hartwig Schutte verfasserin aut Bernd Schoenhofer verfasserin aut Barbara Wagener verfasserin aut Tobias Welte verfasserin aut Michael Westhoff verfasserin aut Heinrike Wilkens verfasserin aut Hubert Wirtz verfasserin aut Michael Henry verfasserin aut Michael Keane verfasserin aut Anthony O'Regan verfasserin aut Katherine O'Reilly verfasserin aut Carlo Albera verfasserin aut Fabrizio Luppi verfasserin aut Sandra Nutini verfasserin aut Alberto Pesci verfasserin aut Venerino Poletti verfasserin aut Elisabetta Rosi verfasserin aut Paola Rottoli verfasserin aut Thomas Eagan verfasserin aut Durdica Kulosman verfasserin aut Tone Blorg Sjaheim verfasserin aut Karl Axel Karlsson verfasserin aut Magnus Sköld verfasserin aut Sanjay Agrawal verfasserin aut Kesavan Suresh Babu verfasserin aut Stephen Bianchi verfasserin aut Nazia Chaudhuri verfasserin aut Sophie Fletcher verfasserin aut Michael Gibbons verfasserin aut Simon Hart verfasserin aut Gisli Jenkins verfasserin aut Toby Maher verfasserin aut Ann Millar verfasserin aut Joanna Porter verfasserin aut Nicky Simler verfasserin aut Lisa Spencer verfasserin aut Monica Spiteri verfasserin aut Melissa Wickremasinghe verfasserin aut In ERJ Open Research European Respiratory Society, 2015 4(2018), 4 (DE-627)830141227 (DE-600)2827830-6 23120541 nnns volume:4 year:2018 number:4 https://doi.org/10.1183/23120541.00084-2018 kostenfrei https://doaj.org/article/bc7d2efc99fe4cf088e6bcb6fe363782 kostenfrei http://openres.ersjournals.com/content/4/4/00084-2018.full kostenfrei https://doaj.org/toc/2312-0541 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ 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_2014 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 4 2018 4 |
| allfieldsGer |
10.1183/23120541.00084-2018 doi (DE-627)DOAJ045187681 (DE-599)DOAJbc7d2efc99fe4cf088e6bcb6fe363782 DE-627 ger DE-627 rakwb eng Vincent Cottin verfasserin aut Long-term safety of pirfenidone: results of the prospective, observational PASSPORT study 2018 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Real-world studies include a broader patient population for a longer duration than randomised controlled trials (RCTs) and can provide relevant insights for clinical practice. PASSPORT was a multicentre, prospective, post-authorisation study of patients who were newly prescribed pirfenidone and followed for 2 years after initiating treatment. Physicians collected data on adverse drug reactions (ADRs), serious ADRs (SADRs) and ADRs of special interest (ADRSI) at baseline and then every 3 months. Post hoc stepwise logistic regression models were used to identify baseline characteristics associated with discontinuing treatment due to an ADR. Patients (n=1009, 99.7% with idiopathic pulmonary fibrosis) had a median pirfenidone exposure of 442.0 days. Overall, 741 (73.4%) patients experienced ADRs, most commonly nausea (20.6%) and fatigue (18.5%). ADRs led to treatment discontinuation in 290 (28.7%) patients after a median of 99.5 days. Overall, 55 (5.5%) patients experienced SADRs, with a fatal outcome in six patients. ADRSI were reported in 693 patients, most commonly gastrointestinal symptoms (38.3%) and photosensitivity reactions/skin rashes (29.0%). Older age and female sex were associated with early treatment discontinuation due to an ADR. Findings were consistent with the known safety profile of pirfenidone, based on RCT data and other post-marketing experience, with no new safety signals observed. Medicine R Dirk Koschel verfasserin aut Andreas Günther verfasserin aut Carlo Albera verfasserin aut Arata Azuma verfasserin aut C. Magnus Sköld verfasserin aut Sara Tomassetti verfasserin aut Philip Hormel verfasserin aut John L. Stauffer verfasserin aut Indiana Strombom verfasserin aut Klaus-Uwe Kirchgaessler verfasserin aut Toby M. Maher verfasserin aut PASSPORT study group verfasserin aut Peter Cerkl verfasserin aut Holger Flick verfasserin aut Christian Geltner verfasserin aut Judith Löffler-Ragg verfasserin aut Michael Studnicka verfasserin aut Elisabeth Bendstrup verfasserin aut Helle Dall Madsen verfasserin aut Saher B. Shaker verfasserin aut Maritta Kilpelainen verfasserin aut Marjukka Myllaerniemi verfasserin aut Minna Purokivi verfasserin aut Seppo Saarelainen verfasserin aut Emmanuel Bergot verfasserin aut Philippe Bonniaud verfasserin aut Raphael Borie verfasserin aut Pascal Chanez verfasserin aut Vincent Cottin verfasserin aut Francis Couturaud verfasserin aut Claire Dromer verfasserin aut Frederic Gagnadoux verfasserin aut Anne-Sophie Gamez verfasserin aut Anne Gondouin verfasserin aut Dominique Israel-Biet verfasserin aut Stephane Jouneau verfasserin aut Romain Kessler verfasserin aut Francois Lebargy verfasserin aut Sylvain Marchand-Adam verfasserin aut Borsi Melloni verfasserin aut Jean-Marc Naccache verfasserin aut Christophe Pison verfasserin aut Gregoire Prevot verfasserin aut Martine Reynaud-Gaubert verfasserin aut Abdellatif Tazi verfasserin aut Dominique Valeyre verfasserin aut Benoit Wallaert verfasserin aut Jost Achenbach verfasserin aut Stefan Andreas verfasserin aut Burkhard Bewig verfasserin aut Reiner Bonnet verfasserin aut Stephan Budweiser verfasserin aut Ulrich Costabel verfasserin aut Martin Faehling verfasserin aut Joachim Ficker verfasserin aut Juergen Fisher verfasserin aut Sven Glaeser verfasserin aut Christian Grah verfasserin aut Christian Grohe verfasserin aut Andreas Günther verfasserin aut Martin Hetzel verfasserin aut Wolfgang Hohenforst-Schmidt verfasserin aut David Jungck verfasserin aut Peter Kardos verfasserin aut Claus Keller verfasserin aut Martin Kohlhaeufl verfasserin aut Dirk Koschel verfasserin aut Claus Kroegel verfasserin aut Rainer Kruegel verfasserin aut Berthold Michels verfasserin aut Joachim Mueller-Quernheim verfasserin aut Claus Neurohr verfasserin aut Heinz-Theodor Pelzer verfasserin aut Michael Pfeifer verfasserin aut Michael Prediger verfasserin aut Klaus F. Rabe verfasserin aut Winifried Randerath verfasserin aut Nicolas Scheonfeld verfasserin aut Robert Scheubel verfasserin aut Jens Schreiber verfasserin aut Hartwig Schutte verfasserin aut Bernd Schoenhofer verfasserin aut Barbara Wagener verfasserin aut Tobias Welte verfasserin aut Michael Westhoff verfasserin aut Heinrike Wilkens verfasserin aut Hubert Wirtz verfasserin aut Michael Henry verfasserin aut Michael Keane verfasserin aut Anthony O'Regan verfasserin aut Katherine O'Reilly verfasserin aut Carlo Albera verfasserin aut Fabrizio Luppi verfasserin aut Sandra Nutini verfasserin aut Alberto Pesci verfasserin aut Venerino Poletti verfasserin aut Elisabetta Rosi verfasserin aut Paola Rottoli verfasserin aut Thomas Eagan verfasserin aut Durdica Kulosman verfasserin aut Tone Blorg Sjaheim verfasserin aut Karl Axel Karlsson verfasserin aut Magnus Sköld verfasserin aut Sanjay Agrawal verfasserin aut Kesavan Suresh Babu verfasserin aut Stephen Bianchi verfasserin aut Nazia Chaudhuri verfasserin aut Sophie Fletcher verfasserin aut Michael Gibbons verfasserin aut Simon Hart verfasserin aut Gisli Jenkins verfasserin aut Toby Maher verfasserin aut Ann Millar verfasserin aut Joanna Porter verfasserin aut Nicky Simler verfasserin aut Lisa Spencer verfasserin aut Monica Spiteri verfasserin aut Melissa Wickremasinghe verfasserin aut In ERJ Open Research European Respiratory Society, 2015 4(2018), 4 (DE-627)830141227 (DE-600)2827830-6 23120541 nnns volume:4 year:2018 number:4 https://doi.org/10.1183/23120541.00084-2018 kostenfrei https://doaj.org/article/bc7d2efc99fe4cf088e6bcb6fe363782 kostenfrei http://openres.ersjournals.com/content/4/4/00084-2018.full kostenfrei https://doaj.org/toc/2312-0541 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ 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_2014 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 4 2018 4 |
| allfieldsSound |
10.1183/23120541.00084-2018 doi (DE-627)DOAJ045187681 (DE-599)DOAJbc7d2efc99fe4cf088e6bcb6fe363782 DE-627 ger DE-627 rakwb eng Vincent Cottin verfasserin aut Long-term safety of pirfenidone: results of the prospective, observational PASSPORT study 2018 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Real-world studies include a broader patient population for a longer duration than randomised controlled trials (RCTs) and can provide relevant insights for clinical practice. PASSPORT was a multicentre, prospective, post-authorisation study of patients who were newly prescribed pirfenidone and followed for 2 years after initiating treatment. Physicians collected data on adverse drug reactions (ADRs), serious ADRs (SADRs) and ADRs of special interest (ADRSI) at baseline and then every 3 months. Post hoc stepwise logistic regression models were used to identify baseline characteristics associated with discontinuing treatment due to an ADR. Patients (n=1009, 99.7% with idiopathic pulmonary fibrosis) had a median pirfenidone exposure of 442.0 days. Overall, 741 (73.4%) patients experienced ADRs, most commonly nausea (20.6%) and fatigue (18.5%). ADRs led to treatment discontinuation in 290 (28.7%) patients after a median of 99.5 days. Overall, 55 (5.5%) patients experienced SADRs, with a fatal outcome in six patients. ADRSI were reported in 693 patients, most commonly gastrointestinal symptoms (38.3%) and photosensitivity reactions/skin rashes (29.0%). Older age and female sex were associated with early treatment discontinuation due to an ADR. Findings were consistent with the known safety profile of pirfenidone, based on RCT data and other post-marketing experience, with no new safety signals observed. Medicine R Dirk Koschel verfasserin aut Andreas Günther verfasserin aut Carlo Albera verfasserin aut Arata Azuma verfasserin aut C. Magnus Sköld verfasserin aut Sara Tomassetti verfasserin aut Philip Hormel verfasserin aut John L. Stauffer verfasserin aut Indiana Strombom verfasserin aut Klaus-Uwe Kirchgaessler verfasserin aut Toby M. Maher verfasserin aut PASSPORT study group verfasserin aut Peter Cerkl verfasserin aut Holger Flick verfasserin aut Christian Geltner verfasserin aut Judith Löffler-Ragg verfasserin aut Michael Studnicka verfasserin aut Elisabeth Bendstrup verfasserin aut Helle Dall Madsen verfasserin aut Saher B. Shaker verfasserin aut Maritta Kilpelainen verfasserin aut Marjukka Myllaerniemi verfasserin aut Minna Purokivi verfasserin aut Seppo Saarelainen verfasserin aut Emmanuel Bergot verfasserin aut Philippe Bonniaud verfasserin aut Raphael Borie verfasserin aut Pascal Chanez verfasserin aut Vincent Cottin verfasserin aut Francis Couturaud verfasserin aut Claire Dromer verfasserin aut Frederic Gagnadoux verfasserin aut Anne-Sophie Gamez verfasserin aut Anne Gondouin verfasserin aut Dominique Israel-Biet verfasserin aut Stephane Jouneau verfasserin aut Romain Kessler verfasserin aut Francois Lebargy verfasserin aut Sylvain Marchand-Adam verfasserin aut Borsi Melloni verfasserin aut Jean-Marc Naccache verfasserin aut Christophe Pison verfasserin aut Gregoire Prevot verfasserin aut Martine Reynaud-Gaubert verfasserin aut Abdellatif Tazi verfasserin aut Dominique Valeyre verfasserin aut Benoit Wallaert verfasserin aut Jost Achenbach verfasserin aut Stefan Andreas verfasserin aut Burkhard Bewig verfasserin aut Reiner Bonnet verfasserin aut Stephan Budweiser verfasserin aut Ulrich Costabel verfasserin aut Martin Faehling verfasserin aut Joachim Ficker verfasserin aut Juergen Fisher verfasserin aut Sven Glaeser verfasserin aut Christian Grah verfasserin aut Christian Grohe verfasserin aut Andreas Günther verfasserin aut Martin Hetzel verfasserin aut Wolfgang Hohenforst-Schmidt verfasserin aut David Jungck verfasserin aut Peter Kardos verfasserin aut Claus Keller verfasserin aut Martin Kohlhaeufl verfasserin aut Dirk Koschel verfasserin aut Claus Kroegel verfasserin aut Rainer Kruegel verfasserin aut Berthold Michels verfasserin aut Joachim Mueller-Quernheim verfasserin aut Claus Neurohr verfasserin aut Heinz-Theodor Pelzer verfasserin aut Michael Pfeifer verfasserin aut Michael Prediger verfasserin aut Klaus F. Rabe verfasserin aut Winifried Randerath verfasserin aut Nicolas Scheonfeld verfasserin aut Robert Scheubel verfasserin aut Jens Schreiber verfasserin aut Hartwig Schutte verfasserin aut Bernd Schoenhofer verfasserin aut Barbara Wagener verfasserin aut Tobias Welte verfasserin aut Michael Westhoff verfasserin aut Heinrike Wilkens verfasserin aut Hubert Wirtz verfasserin aut Michael Henry verfasserin aut Michael Keane verfasserin aut Anthony O'Regan verfasserin aut Katherine O'Reilly verfasserin aut Carlo Albera verfasserin aut Fabrizio Luppi verfasserin aut Sandra Nutini verfasserin aut Alberto Pesci verfasserin aut Venerino Poletti verfasserin aut Elisabetta Rosi verfasserin aut Paola Rottoli verfasserin aut Thomas Eagan verfasserin aut Durdica Kulosman verfasserin aut Tone Blorg Sjaheim verfasserin aut Karl Axel Karlsson verfasserin aut Magnus Sköld verfasserin aut Sanjay Agrawal verfasserin aut Kesavan Suresh Babu verfasserin aut Stephen Bianchi verfasserin aut Nazia Chaudhuri verfasserin aut Sophie Fletcher verfasserin aut Michael Gibbons verfasserin aut Simon Hart verfasserin aut Gisli Jenkins verfasserin aut Toby Maher verfasserin aut Ann Millar verfasserin aut Joanna Porter verfasserin aut Nicky Simler verfasserin aut Lisa Spencer verfasserin aut Monica Spiteri verfasserin aut Melissa Wickremasinghe verfasserin aut In ERJ Open Research European Respiratory Society, 2015 4(2018), 4 (DE-627)830141227 (DE-600)2827830-6 23120541 nnns volume:4 year:2018 number:4 https://doi.org/10.1183/23120541.00084-2018 kostenfrei https://doaj.org/article/bc7d2efc99fe4cf088e6bcb6fe363782 kostenfrei http://openres.ersjournals.com/content/4/4/00084-2018.full kostenfrei https://doaj.org/toc/2312-0541 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ 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_2014 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 4 2018 4 |
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Vincent Cottin @@aut@@ Dirk Koschel @@aut@@ Andreas Günther @@aut@@ Carlo Albera @@aut@@ Arata Azuma @@aut@@ C. Magnus Sköld @@aut@@ Sara Tomassetti @@aut@@ Philip Hormel @@aut@@ John L. Stauffer @@aut@@ Indiana Strombom @@aut@@ Klaus-Uwe Kirchgaessler @@aut@@ Toby M. Maher @@aut@@ PASSPORT study group @@aut@@ Peter Cerkl @@aut@@ Holger Flick @@aut@@ Christian Geltner @@aut@@ Judith Löffler-Ragg @@aut@@ Michael Studnicka @@aut@@ Elisabeth Bendstrup @@aut@@ Helle Dall Madsen @@aut@@ Saher B. Shaker @@aut@@ Maritta Kilpelainen @@aut@@ Marjukka Myllaerniemi @@aut@@ Minna Purokivi @@aut@@ Seppo Saarelainen @@aut@@ Emmanuel Bergot @@aut@@ Philippe Bonniaud @@aut@@ Raphael Borie @@aut@@ Pascal Chanez @@aut@@ Francis Couturaud @@aut@@ Claire Dromer @@aut@@ Frederic Gagnadoux @@aut@@ Anne-Sophie Gamez @@aut@@ Anne Gondouin @@aut@@ Dominique Israel-Biet @@aut@@ Stephane Jouneau @@aut@@ Romain Kessler @@aut@@ Francois Lebargy @@aut@@ Sylvain Marchand-Adam @@aut@@ Borsi Melloni @@aut@@ Jean-Marc Naccache @@aut@@ Christophe Pison @@aut@@ Gregoire Prevot @@aut@@ Martine Reynaud-Gaubert @@aut@@ Abdellatif Tazi @@aut@@ Dominique Valeyre @@aut@@ Benoit Wallaert @@aut@@ Jost Achenbach @@aut@@ Stefan Andreas @@aut@@ Burkhard Bewig @@aut@@ Reiner Bonnet @@aut@@ Stephan Budweiser @@aut@@ Ulrich Costabel @@aut@@ Martin Faehling @@aut@@ Joachim Ficker @@aut@@ Juergen Fisher @@aut@@ Sven Glaeser @@aut@@ Christian Grah @@aut@@ Christian Grohe @@aut@@ Martin Hetzel @@aut@@ Wolfgang Hohenforst-Schmidt @@aut@@ David Jungck @@aut@@ Peter Kardos @@aut@@ Claus Keller @@aut@@ Martin Kohlhaeufl @@aut@@ Claus Kroegel @@aut@@ Rainer Kruegel @@aut@@ Berthold Michels @@aut@@ Joachim Mueller-Quernheim @@aut@@ Claus Neurohr @@aut@@ Heinz-Theodor Pelzer @@aut@@ Michael Pfeifer @@aut@@ Michael Prediger @@aut@@ Klaus F. Rabe @@aut@@ Winifried Randerath @@aut@@ Nicolas Scheonfeld @@aut@@ Robert Scheubel @@aut@@ Jens Schreiber @@aut@@ Hartwig Schutte @@aut@@ Bernd Schoenhofer @@aut@@ Barbara Wagener @@aut@@ Tobias Welte @@aut@@ Michael Westhoff @@aut@@ Heinrike Wilkens @@aut@@ Hubert Wirtz @@aut@@ Michael Henry @@aut@@ Michael Keane @@aut@@ Anthony O'Regan @@aut@@ Katherine O'Reilly @@aut@@ Fabrizio Luppi @@aut@@ Sandra Nutini @@aut@@ Alberto Pesci @@aut@@ Venerino Poletti @@aut@@ Elisabetta Rosi @@aut@@ Paola Rottoli @@aut@@ Thomas Eagan @@aut@@ Durdica Kulosman @@aut@@ Tone Blorg Sjaheim @@aut@@ Karl Axel Karlsson @@aut@@ Magnus Sköld @@aut@@ Sanjay Agrawal @@aut@@ Kesavan Suresh Babu @@aut@@ Stephen Bianchi @@aut@@ Nazia Chaudhuri @@aut@@ Sophie Fletcher @@aut@@ Michael Gibbons @@aut@@ Simon Hart @@aut@@ Gisli Jenkins @@aut@@ Toby Maher @@aut@@ Ann Millar @@aut@@ Joanna Porter @@aut@@ Nicky Simler @@aut@@ Lisa Spencer @@aut@@ Monica Spiteri @@aut@@ Melissa Wickremasinghe @@aut@@ |
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Vincent Cottin misc Medicine misc R Long-term safety of pirfenidone: results of the prospective, observational PASSPORT study |
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Long-term safety of pirfenidone: results of the prospective, observational PASSPORT study |
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Long-term safety of pirfenidone: results of the prospective, observational PASSPORT study |
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Long-term safety of pirfenidone: results of the prospective, observational PASSPORT study |
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Vincent Cottin Dirk Koschel Andreas Günther Carlo Albera Arata Azuma C. Magnus Sköld Sara Tomassetti Philip Hormel John L. Stauffer Indiana Strombom Klaus-Uwe Kirchgaessler Toby M. Maher PASSPORT study group Peter Cerkl Holger Flick Christian Geltner Judith Löffler-Ragg Michael Studnicka Elisabeth Bendstrup Helle Dall Madsen Saher B. Shaker Maritta Kilpelainen Marjukka Myllaerniemi Minna Purokivi Seppo Saarelainen Emmanuel Bergot Philippe Bonniaud Raphael Borie Pascal Chanez Francis Couturaud Claire Dromer Frederic Gagnadoux Anne-Sophie Gamez Anne Gondouin Dominique Israel-Biet Stephane Jouneau Romain Kessler Francois Lebargy Sylvain Marchand-Adam Borsi Melloni Jean-Marc Naccache Christophe Pison Gregoire Prevot Martine Reynaud-Gaubert Abdellatif Tazi Dominique Valeyre Benoit Wallaert Jost Achenbach Stefan Andreas Burkhard Bewig Reiner Bonnet Stephan Budweiser Ulrich Costabel Martin Faehling Joachim Ficker Juergen Fisher Sven Glaeser Christian Grah Christian Grohe Martin Hetzel Wolfgang Hohenforst-Schmidt David Jungck Peter Kardos Claus Keller Martin Kohlhaeufl Claus Kroegel Rainer Kruegel Berthold Michels Joachim Mueller-Quernheim Claus Neurohr Heinz-Theodor Pelzer Michael Pfeifer Michael Prediger Klaus F. Rabe Winifried Randerath Nicolas Scheonfeld Robert Scheubel Jens Schreiber Hartwig Schutte Bernd Schoenhofer Barbara Wagener Tobias Welte Michael Westhoff Heinrike Wilkens Hubert Wirtz Michael Henry Michael Keane Anthony O'Regan Katherine O'Reilly Fabrizio Luppi Sandra Nutini Alberto Pesci Venerino Poletti Elisabetta Rosi Paola Rottoli Thomas Eagan Durdica Kulosman Tone Blorg Sjaheim Karl Axel Karlsson Magnus Sköld Sanjay Agrawal Kesavan Suresh Babu Stephen Bianchi Nazia Chaudhuri Sophie Fletcher Michael Gibbons Simon Hart Gisli Jenkins Toby Maher Ann Millar Joanna Porter Nicky Simler Lisa Spencer Monica Spiteri Melissa Wickremasinghe |
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long-term safety of pirfenidone: results of the prospective, observational passport study |
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Long-term safety of pirfenidone: results of the prospective, observational PASSPORT study |
| abstract |
Real-world studies include a broader patient population for a longer duration than randomised controlled trials (RCTs) and can provide relevant insights for clinical practice. PASSPORT was a multicentre, prospective, post-authorisation study of patients who were newly prescribed pirfenidone and followed for 2 years after initiating treatment. Physicians collected data on adverse drug reactions (ADRs), serious ADRs (SADRs) and ADRs of special interest (ADRSI) at baseline and then every 3 months. Post hoc stepwise logistic regression models were used to identify baseline characteristics associated with discontinuing treatment due to an ADR. Patients (n=1009, 99.7% with idiopathic pulmonary fibrosis) had a median pirfenidone exposure of 442.0 days. Overall, 741 (73.4%) patients experienced ADRs, most commonly nausea (20.6%) and fatigue (18.5%). ADRs led to treatment discontinuation in 290 (28.7%) patients after a median of 99.5 days. Overall, 55 (5.5%) patients experienced SADRs, with a fatal outcome in six patients. ADRSI were reported in 693 patients, most commonly gastrointestinal symptoms (38.3%) and photosensitivity reactions/skin rashes (29.0%). Older age and female sex were associated with early treatment discontinuation due to an ADR. Findings were consistent with the known safety profile of pirfenidone, based on RCT data and other post-marketing experience, with no new safety signals observed. |
| abstractGer |
Real-world studies include a broader patient population for a longer duration than randomised controlled trials (RCTs) and can provide relevant insights for clinical practice. PASSPORT was a multicentre, prospective, post-authorisation study of patients who were newly prescribed pirfenidone and followed for 2 years after initiating treatment. Physicians collected data on adverse drug reactions (ADRs), serious ADRs (SADRs) and ADRs of special interest (ADRSI) at baseline and then every 3 months. Post hoc stepwise logistic regression models were used to identify baseline characteristics associated with discontinuing treatment due to an ADR. Patients (n=1009, 99.7% with idiopathic pulmonary fibrosis) had a median pirfenidone exposure of 442.0 days. Overall, 741 (73.4%) patients experienced ADRs, most commonly nausea (20.6%) and fatigue (18.5%). ADRs led to treatment discontinuation in 290 (28.7%) patients after a median of 99.5 days. Overall, 55 (5.5%) patients experienced SADRs, with a fatal outcome in six patients. ADRSI were reported in 693 patients, most commonly gastrointestinal symptoms (38.3%) and photosensitivity reactions/skin rashes (29.0%). Older age and female sex were associated with early treatment discontinuation due to an ADR. Findings were consistent with the known safety profile of pirfenidone, based on RCT data and other post-marketing experience, with no new safety signals observed. |
| abstract_unstemmed |
Real-world studies include a broader patient population for a longer duration than randomised controlled trials (RCTs) and can provide relevant insights for clinical practice. PASSPORT was a multicentre, prospective, post-authorisation study of patients who were newly prescribed pirfenidone and followed for 2 years after initiating treatment. Physicians collected data on adverse drug reactions (ADRs), serious ADRs (SADRs) and ADRs of special interest (ADRSI) at baseline and then every 3 months. Post hoc stepwise logistic regression models were used to identify baseline characteristics associated with discontinuing treatment due to an ADR. Patients (n=1009, 99.7% with idiopathic pulmonary fibrosis) had a median pirfenidone exposure of 442.0 days. Overall, 741 (73.4%) patients experienced ADRs, most commonly nausea (20.6%) and fatigue (18.5%). ADRs led to treatment discontinuation in 290 (28.7%) patients after a median of 99.5 days. Overall, 55 (5.5%) patients experienced SADRs, with a fatal outcome in six patients. ADRSI were reported in 693 patients, most commonly gastrointestinal symptoms (38.3%) and photosensitivity reactions/skin rashes (29.0%). Older age and female sex were associated with early treatment discontinuation due to an ADR. Findings were consistent with the known safety profile of pirfenidone, based on RCT data and other post-marketing experience, with no new safety signals observed. |
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Long-term safety of pirfenidone: results of the prospective, observational PASSPORT study |
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https://doi.org/10.1183/23120541.00084-2018 https://doaj.org/article/bc7d2efc99fe4cf088e6bcb6fe363782 http://openres.ersjournals.com/content/4/4/00084-2018.full https://doaj.org/toc/2312-0541 |
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Dirk Koschel Andreas Günther Carlo Albera Arata Azuma C. Magnus Sköld Sara Tomassetti Philip Hormel John L. Stauffer Indiana Strombom Klaus-Uwe Kirchgaessler Toby M. Maher PASSPORT study group Peter Cerkl Holger Flick Christian Geltner Judith Löffler-Ragg Michael Studnicka Elisabeth Bendstrup Helle Dall Madsen Saher B. Shaker Maritta Kilpelainen Marjukka Myllaerniemi Minna Purokivi Seppo Saarelainen Emmanuel Bergot Philippe Bonniaud Raphael Borie Pascal Chanez Vincent Cottin Francis Couturaud Claire Dromer Frederic Gagnadoux Anne-Sophie Gamez Anne Gondouin Dominique Israel-Biet Stephane Jouneau Romain Kessler Francois Lebargy Sylvain Marchand-Adam Borsi Melloni Jean-Marc Naccache Christophe Pison Gregoire Prevot Martine Reynaud-Gaubert Abdellatif Tazi Dominique Valeyre Benoit Wallaert Jost Achenbach Stefan Andreas Burkhard Bewig Reiner Bonnet Stephan Budweiser Ulrich Costabel Martin Faehling Joachim Ficker Juergen Fisher Sven Glaeser Christian Grah Christian Grohe Martin Hetzel Wolfgang Hohenforst-Schmidt David Jungck Peter Kardos Claus Keller Martin Kohlhaeufl Claus Kroegel Rainer Kruegel Berthold Michels Joachim Mueller-Quernheim Claus Neurohr Heinz-Theodor Pelzer Michael Pfeifer Michael Prediger Klaus F. Rabe Winifried Randerath Nicolas Scheonfeld Robert Scheubel Jens Schreiber Hartwig Schutte Bernd Schoenhofer Barbara Wagener Tobias Welte Michael Westhoff Heinrike Wilkens Hubert Wirtz Michael Henry Michael Keane Anthony O'Regan Katherine O'Reilly Fabrizio Luppi Sandra Nutini Alberto Pesci Venerino Poletti Elisabetta Rosi Paola Rottoli Thomas Eagan Durdica Kulosman Tone Blorg Sjaheim Karl Axel Karlsson Magnus Sköld Sanjay Agrawal Kesavan Suresh Babu Stephen Bianchi Nazia Chaudhuri Sophie Fletcher Michael Gibbons Simon Hart Gisli Jenkins Toby Maher Ann Millar Joanna Porter Nicky Simler Lisa Spencer Monica Spiteri Melissa Wickremasinghe |
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Dirk Koschel Andreas Günther Carlo Albera Arata Azuma C. Magnus Sköld Sara Tomassetti Philip Hormel John L. Stauffer Indiana Strombom Klaus-Uwe Kirchgaessler Toby M. Maher PASSPORT study group Peter Cerkl Holger Flick Christian Geltner Judith Löffler-Ragg Michael Studnicka Elisabeth Bendstrup Helle Dall Madsen Saher B. Shaker Maritta Kilpelainen Marjukka Myllaerniemi Minna Purokivi Seppo Saarelainen Emmanuel Bergot Philippe Bonniaud Raphael Borie Pascal Chanez Vincent Cottin Francis Couturaud Claire Dromer Frederic Gagnadoux Anne-Sophie Gamez Anne Gondouin Dominique Israel-Biet Stephane Jouneau Romain Kessler Francois Lebargy Sylvain Marchand-Adam Borsi Melloni Jean-Marc Naccache Christophe Pison Gregoire Prevot Martine Reynaud-Gaubert Abdellatif Tazi Dominique Valeyre Benoit Wallaert Jost Achenbach Stefan Andreas Burkhard Bewig Reiner Bonnet Stephan Budweiser Ulrich Costabel Martin Faehling Joachim Ficker Juergen Fisher Sven Glaeser Christian Grah Christian Grohe Martin Hetzel Wolfgang Hohenforst-Schmidt David Jungck Peter Kardos Claus Keller Martin Kohlhaeufl Claus Kroegel Rainer Kruegel Berthold Michels Joachim Mueller-Quernheim Claus Neurohr Heinz-Theodor Pelzer Michael Pfeifer Michael Prediger Klaus F. Rabe Winifried Randerath Nicolas Scheonfeld Robert Scheubel Jens Schreiber Hartwig Schutte Bernd Schoenhofer Barbara Wagener Tobias Welte Michael Westhoff Heinrike Wilkens Hubert Wirtz Michael Henry Michael Keane Anthony O'Regan Katherine O'Reilly Fabrizio Luppi Sandra Nutini Alberto Pesci Venerino Poletti Elisabetta Rosi Paola Rottoli Thomas Eagan Durdica Kulosman Tone Blorg Sjaheim Karl Axel Karlsson Magnus Sköld Sanjay Agrawal Kesavan Suresh Babu Stephen Bianchi Nazia Chaudhuri Sophie Fletcher Michael Gibbons Simon Hart Gisli Jenkins Toby Maher Ann Millar Joanna Porter Nicky Simler Lisa Spencer Monica Spiteri Melissa Wickremasinghe |
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10.1183/23120541.00084-2018 |
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2024-07-03T13:30:29.583Z |
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