Safety of the first dose of fingolimod for multiple sclerosis: results of an open-label clinical trial

Giuseppe Salemi; Giovanni L. Mancardi; Alice Laroni; Luciano Deotto; null Appendino; Davide Brogi; Bonaventura Ardito; null Cavallo; null Rosati; null Lenzi; null Bosco; null Batocchi; null Cottone; null Benedetti; null Bergamaschi; Luca Massacesi; null Dotta; Renato Turrini; Mario Guidotti; null Tinebra Asti; null Iudice; Debora Raimondi; null Vecchio; Giuseppe Salemi; null Centonze; null Danni; null Gallo; Patrizia Sola; null Francia; null Scarpini; null Scarpini; null Schoenhuber; null Sinisi; null Schoenhuber; null Bellantonio; Maria Buccafusca; null Bortolon; null Malentacchi; Alessandra Protti; null Serrati; Daniele Spitaleri; null Avolio; null Provera; null Lus; Leonardo Sinisi; null Ulivelli; Francesca De Robertis; null Tezzon; null Cavalla; Vincenzo B. Morra; Lorenzo Lorusso; null Maimone; null Zimatore; null Florio; null Giometto; null Schoenhuber; null Coniglio; Patrizia Perrone; null Galgani; null Salemi; null Totaro; Antonio Uccelli; Fabio Bandini; null Millefiorini; Alessandra Lugaresi; null Sarchielli; null Trojano; Leonello Guidi; null Ghezzi; null Rovaris; Gianfranco Costantino; Carlo Pozzilli; null Melato; null Di Battista; null Tola; null Montanari; Luigi M.E. Grimaldi; null Patti; null Mantegazza; null Giuliani; Giulio Rosati; Aldo Quattrone; Gioacchino Tedeschi; Maria Pia Amato; Giancarlo Comi; null Filippi; null Cargnelutti; Francesco Saccà; null Rasi

Safety of the first dose of fingolimod for multiple sclerosis: results of an open-label clinical trial

Giuseppe Salemi, Giovanni L. Mancardi, Alice Laroni, Luciano Deotto, Appendino, Davide Brogi, Bonaventura Ardito, Cavallo, Rosati, Lenzi, Bosco, Batocchi, Cottone, Benedetti, Bergamaschi, Luca Massacesi, Dotta, Renato Turrini, Mario Guidotti, Tinebra AstiIudice, Debora Raimondi, Vecchio, Giuseppe Salemi, Centonze, Danni, Gallo, Patrizia Sola, Francia, Scarpini, Scarpini, Schoenhuber, Sinisi, Schoenhuber, Bellantonio, Maria Buccafusca, Bortolon, Malentacchi, Alessandra Protti, Serrati, Daniele Spitaleri, Avolio, Provera, Lus, Leonardo Sinisi, Ulivelli, Francesca De Robertis, Tezzon, Cavalla, Vincenzo B. Morra, Lorenzo Lorusso, Maimone, Zimatore, Florio, Giometto, Schoenhuber, Coniglio, Patrizia Perrone, Galgani, Salemi, Totaro, Antonio Uccelli, Fabio Bandini, Millefiorini, Alessandra Lugaresi, Sarchielli, Trojano, Leonello Guidi, Ghezzi, Rovaris, Gianfranco Costantino, Carlo Pozzilli, Melato, Di Battista, Tola, Montanari, Luigi M.E. Grimaldi, Patti, Mantegazza, Giuliani, Giulio Rosati, Aldo Quattrone, Gioacchino Tedeschi, Maria Pia Amato, Giancarlo Comi, Filippi, Cargnelutti, Francesco Saccà, Rasi

Biomedicina, Neuroscienze e Diagnostica avanzata

Risultato della ricerca: Article › peer review

40 Citazioni (Scopus)

Abstract

Background: In patients with relapsing-remitting MS (RRMS) fingolimod prevents disease relapses and delays disabilityprogression. First dose administration of fingolimod is associated with a transient, dose-dependent decrease in heart rate(HR) in the 6 hours after drug intake.The aim of the study is to to assess safety and tolerability of the first dose of fingolimod in a cohort of Italian patients withRRMS without alternative therapeutic options.Methods: Open-label, single arm, multicentre study. After the first dose of fingolimod, patients were observed for 6 hoursand had their vital signs monitored hourly. Extended on-site monitoring was provided when required.Results: Of the 906 patients enrolled in the study, most (95.2%) did not experience any adverse event (AE) followingfingolimod administration. Cardiovascular AEs occurred in 18 patients and included bradycardia (1.3%), first-andsecond-degree atrioventricular block (0.1% and 0.2%), palpitations (0.1%), sinus arrhythmia (0.1%) and ventricularpremature beats (0.1%). All events were self-limiting and did not require any intervention. Extended monitoringwas required in 34 patients.Conclusions: These results, in a population who better resembled real-world clinical practice in terms of concomitantdiseases and medications, are consistent with previous clinical trials and confirmed that the first dose administration offingolimod is generally safe and well tolerated.

Lingua originale	English
pagine (da-a)	65-74
Numero di pagine	10
Rivista	BMC Neurology
Volume	14
Stato di pubblicazione	Published - 2014

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Safety of the first dose of fingolimod for multiple sclerosis: results of an open-label clinical trial. / Salemi, Giuseppe; Mancardi, Giovanni L.; Laroni, Alice; Deotto, Luciano; Appendino; Brogi, Davide; Ardito, Bonaventura; Cavallo; Rosati; Lenzi; Bosco; Batocchi; Cottone; Benedetti; Bergamaschi; Massacesi, Luca; Dotta; Turrini, Renato; Guidotti, Mario; Tinebra Asti; Iudice; Raimondi, Debora; Vecchio; Salemi, Giuseppe; Centonze; Danni; Gallo; Sola, Patrizia; Francia; Scarpini; Scarpini; Schoenhuber; Sinisi; Schoenhuber; Bellantonio; Buccafusca, Maria; Bortolon; Malentacchi; Protti, Alessandra; Serrati; Spitaleri, Daniele; Avolio; Provera; Lus; Sinisi, Leonardo; Ulivelli; De Robertis, Francesca; Tezzon; Cavalla; Morra, Vincenzo B.; Lorusso, Lorenzo; Maimone; Zimatore; Florio; Giometto; Schoenhuber; Coniglio; Perrone, Patrizia; Galgani; Salemi; Totaro; Uccelli, Antonio; Bandini, Fabio; Millefiorini; Lugaresi, Alessandra; Sarchielli; Trojano; Guidi, Leonello; Ghezzi; Rovaris; Costantino, Gianfranco; Pozzilli, Carlo; Melato; Di Battista; Tola; Montanari; Grimaldi, Luigi M.E.; Patti; Mantegazza; Giuliani; Rosati, Giulio; Quattrone, Aldo; Tedeschi, Gioacchino; Amato, Maria Pia; Comi, Giancarlo; Filippi; Cargnelutti; Saccà, Francesco; Rasi.

In: BMC Neurology, Vol. 14, 2014, pag. 65-74.

Risultato della ricerca: Article › peer review

Salemi, G, Mancardi, GL, Laroni, A, Deotto, L, Appendino, Brogi, D, Ardito, B, Cavallo, Rosati, Lenzi, Bosco, Batocchi, Cottone, Benedetti, Bergamaschi, Massacesi, L, Dotta, Turrini, R, Guidotti, M, Tinebra Asti, Iudice, Raimondi, D, Vecchio, Salemi, G, Centonze, Danni, Gallo, Sola, P, Francia, Scarpini, Scarpini, Schoenhuber, Sinisi, Schoenhuber, Bellantonio, Buccafusca, M, Bortolon, Malentacchi, Protti, A, Serrati, Spitaleri, D, Avolio, Provera, Lus, Sinisi, L, Ulivelli, De Robertis, F, Tezzon, Cavalla, Morra, VB, Lorusso, L, Maimone, Zimatore, Florio, Giometto, Schoenhuber, Coniglio, Perrone, P, Galgani, Salemi, Totaro, Uccelli, A, Bandini, F, Millefiorini, Lugaresi, A, Sarchielli, Trojano, Guidi, L, Ghezzi, Rovaris, Costantino, G, Pozzilli, C, Melato, Di Battista, Tola, Montanari, Grimaldi, LME, Patti, Mantegazza, Giuliani, Rosati, G, Quattrone, A, Tedeschi, G, Amato, MP, Comi, G, Filippi, Cargnelutti, Saccà, F & Rasi 2014, 'Safety of the first dose of fingolimod for multiple sclerosis: results of an open-label clinical trial', BMC Neurology, vol. 14, pagg. 65-74.

Salemi, Giuseppe ; Mancardi, Giovanni L. ; Laroni, Alice ; Deotto, Luciano ; Appendino ; Brogi, Davide ; Ardito, Bonaventura ; Cavallo ; Rosati ; Lenzi ; Bosco ; Batocchi ; Cottone ; Benedetti ; Bergamaschi ; Massacesi, Luca ; Dotta ; Turrini, Renato ; Guidotti, Mario ; Tinebra Asti ; Iudice ; Raimondi, Debora ; Vecchio ; Salemi, Giuseppe ; Centonze ; Danni ; Gallo ; Sola, Patrizia ; Francia ; Scarpini ; Scarpini ; Schoenhuber ; Sinisi ; Schoenhuber ; Bellantonio ; Buccafusca, Maria ; Bortolon ; Malentacchi ; Protti, Alessandra ; Serrati ; Spitaleri, Daniele ; Avolio ; Provera ; Lus ; Sinisi, Leonardo ; Ulivelli ; De Robertis, Francesca ; Tezzon ; Cavalla ; Morra, Vincenzo B. ; Lorusso, Lorenzo ; Maimone ; Zimatore ; Florio ; Giometto ; Schoenhuber ; Coniglio ; Perrone, Patrizia ; Galgani ; Salemi ; Totaro ; Uccelli, Antonio ; Bandini, Fabio ; Millefiorini ; Lugaresi, Alessandra ; Sarchielli ; Trojano ; Guidi, Leonello ; Ghezzi ; Rovaris ; Costantino, Gianfranco ; Pozzilli, Carlo ; Melato ; Di Battista ; Tola ; Montanari ; Grimaldi, Luigi M.E. ; Patti ; Mantegazza ; Giuliani ; Rosati, Giulio ; Quattrone, Aldo ; Tedeschi, Gioacchino ; Amato, Maria Pia ; Comi, Giancarlo ; Filippi ; Cargnelutti ; Saccà, Francesco ; Rasi. / Safety of the first dose of fingolimod for multiple sclerosis: results of an open-label clinical trial. In: BMC Neurology. 2014 ; Vol. 14. pagg. 65-74.

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title = "Safety of the first dose of fingolimod for multiple sclerosis: results of an open-label clinical trial",

abstract = "Background: In patients with relapsing-remitting MS (RRMS) fingolimod prevents disease relapses and delays disabilityprogression. First dose administration of fingolimod is associated with a transient, dose-dependent decrease in heart rate(HR) in the 6 hours after drug intake.The aim of the study is to to assess safety and tolerability of the first dose of fingolimod in a cohort of Italian patients withRRMS without alternative therapeutic options.Methods: Open-label, single arm, multicentre study. After the first dose of fingolimod, patients were observed for 6 hoursand had their vital signs monitored hourly. Extended on-site monitoring was provided when required.Results: Of the 906 patients enrolled in the study, most (95.2%) did not experience any adverse event (AE) followingfingolimod administration. Cardiovascular AEs occurred in 18 patients and included bradycardia (1.3%), first-andsecond-degree atrioventricular block (0.1% and 0.2%), palpitations (0.1%), sinus arrhythmia (0.1%) and ventricularpremature beats (0.1%). All events were self-limiting and did not require any intervention. Extended monitoringwas required in 34 patients.Conclusions: These results, in a population who better resembled real-world clinical practice in terms of concomitantdiseases and medications, are consistent with previous clinical trials and confirmed that the first dose administration offingolimod is generally safe and well tolerated.",

author = "Giuseppe Salemi and Mancardi, {Giovanni L.} and Alice Laroni and Luciano Deotto and Appendino and Davide Brogi and Bonaventura Ardito and Cavallo and Rosati and Lenzi and Bosco and Batocchi and Cottone and Benedetti and Bergamaschi and Luca Massacesi and Dotta and Renato Turrini and Mario Guidotti and {Tinebra Asti} and Iudice and Debora Raimondi and Vecchio and Giuseppe Salemi and Centonze and Danni and Gallo and Patrizia Sola and Francia and Scarpini and Scarpini and Schoenhuber and Sinisi and Schoenhuber and Bellantonio and Maria Buccafusca and Bortolon and Malentacchi and Alessandra Protti and Serrati and Daniele Spitaleri and Avolio and Provera and Lus and Leonardo Sinisi and Ulivelli and {De Robertis}, Francesca and Tezzon and Cavalla and Morra, {Vincenzo B.} and Lorenzo Lorusso and Maimone and Zimatore and Florio and Giometto and Schoenhuber and Coniglio and Patrizia Perrone and Galgani and Salemi and Totaro and Antonio Uccelli and Fabio Bandini and Millefiorini and Alessandra Lugaresi and Sarchielli and Trojano and Leonello Guidi and Ghezzi and Rovaris and Gianfranco Costantino and Carlo Pozzilli and Melato and {Di Battista} and Tola and Montanari and Grimaldi, {Luigi M.E.} and Patti and Mantegazza and Giuliani and Giulio Rosati and Aldo Quattrone and Gioacchino Tedeschi and Amato, {Maria Pia} and Giancarlo Comi and Filippi and Cargnelutti and Francesco Sacc{\`a} and Rasi",

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language = "English",

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pages = "65--74",

journal = "BMC Neurology",

issn = "1471-2377",

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TY - JOUR

T1 - Safety of the first dose of fingolimod for multiple sclerosis: results of an open-label clinical trial

AU - Salemi, Giuseppe

AU - Mancardi, Giovanni L.

AU - Laroni, Alice

AU - Deotto, Luciano

AU - Appendino, null

AU - Brogi, Davide

AU - Ardito, Bonaventura

AU - Cavallo, null

AU - Rosati, null

AU - Lenzi, null

AU - Bosco, null

AU - Batocchi, null

AU - Cottone, null

AU - Benedetti, null

AU - Bergamaschi, null

AU - Massacesi, Luca

AU - Dotta, null

AU - Turrini, Renato

AU - Guidotti, Mario

AU - Tinebra Asti, null

AU - Iudice, null

AU - Raimondi, Debora

AU - Vecchio, null

AU - Salemi, Giuseppe

AU - Centonze, null

AU - Danni, null

AU - Gallo, null

AU - Sola, Patrizia

AU - Francia, null

AU - Scarpini, null

AU - Schoenhuber, null

AU - Sinisi, null

AU - Schoenhuber, null

AU - Bellantonio, null

AU - Buccafusca, Maria

AU - Bortolon, null

AU - Malentacchi, null

AU - Protti, Alessandra

AU - Serrati, null

AU - Spitaleri, Daniele

AU - Avolio, null

AU - Provera, null

AU - Lus, null

AU - Sinisi, Leonardo

AU - Ulivelli, null

AU - De Robertis, Francesca

AU - Tezzon, null

AU - Cavalla, null

AU - Morra, Vincenzo B.

AU - Lorusso, Lorenzo

AU - Maimone, null

AU - Zimatore, null

AU - Florio, null

AU - Giometto, null

AU - Schoenhuber, null

AU - Coniglio, null

AU - Perrone, Patrizia

AU - Galgani, null

AU - Salemi, null

AU - Totaro, null

AU - Uccelli, Antonio

AU - Bandini, Fabio

AU - Millefiorini, null

AU - Lugaresi, Alessandra

AU - Sarchielli, null

AU - Trojano, null

AU - Guidi, Leonello

AU - Ghezzi, null

AU - Rovaris, null

AU - Costantino, Gianfranco

AU - Pozzilli, Carlo

AU - Melato, null

AU - Di Battista, null

AU - Tola, null

AU - Montanari, null

AU - Grimaldi, Luigi M.E.

AU - Patti, null

AU - Mantegazza, null

AU - Giuliani, null

AU - Rosati, Giulio

AU - Quattrone, Aldo

AU - Tedeschi, Gioacchino

AU - Amato, Maria Pia

AU - Comi, Giancarlo

AU - Filippi, null

AU - Cargnelutti, null

AU - Saccà, Francesco

AU - Rasi, null

PY - 2014

Y1 - 2014

N2 - Background: In patients with relapsing-remitting MS (RRMS) fingolimod prevents disease relapses and delays disabilityprogression. First dose administration of fingolimod is associated with a transient, dose-dependent decrease in heart rate(HR) in the 6 hours after drug intake.The aim of the study is to to assess safety and tolerability of the first dose of fingolimod in a cohort of Italian patients withRRMS without alternative therapeutic options.Methods: Open-label, single arm, multicentre study. After the first dose of fingolimod, patients were observed for 6 hoursand had their vital signs monitored hourly. Extended on-site monitoring was provided when required.Results: Of the 906 patients enrolled in the study, most (95.2%) did not experience any adverse event (AE) followingfingolimod administration. Cardiovascular AEs occurred in 18 patients and included bradycardia (1.3%), first-andsecond-degree atrioventricular block (0.1% and 0.2%), palpitations (0.1%), sinus arrhythmia (0.1%) and ventricularpremature beats (0.1%). All events were self-limiting and did not require any intervention. Extended monitoringwas required in 34 patients.Conclusions: These results, in a population who better resembled real-world clinical practice in terms of concomitantdiseases and medications, are consistent with previous clinical trials and confirmed that the first dose administration offingolimod is generally safe and well tolerated.

AB - Background: In patients with relapsing-remitting MS (RRMS) fingolimod prevents disease relapses and delays disabilityprogression. First dose administration of fingolimod is associated with a transient, dose-dependent decrease in heart rate(HR) in the 6 hours after drug intake.The aim of the study is to to assess safety and tolerability of the first dose of fingolimod in a cohort of Italian patients withRRMS without alternative therapeutic options.Methods: Open-label, single arm, multicentre study. After the first dose of fingolimod, patients were observed for 6 hoursand had their vital signs monitored hourly. Extended on-site monitoring was provided when required.Results: Of the 906 patients enrolled in the study, most (95.2%) did not experience any adverse event (AE) followingfingolimod administration. Cardiovascular AEs occurred in 18 patients and included bradycardia (1.3%), first-andsecond-degree atrioventricular block (0.1% and 0.2%), palpitations (0.1%), sinus arrhythmia (0.1%) and ventricularpremature beats (0.1%). All events were self-limiting and did not require any intervention. Extended monitoringwas required in 34 patients.Conclusions: These results, in a population who better resembled real-world clinical practice in terms of concomitantdiseases and medications, are consistent with previous clinical trials and confirmed that the first dose administration offingolimod is generally safe and well tolerated.

UR - http://hdl.handle.net/10447/358406

M3 - Article

VL - 14

SP - 65

EP - 74

JO - BMC Neurology

JF - BMC Neurology

SN - 1471-2377

ER -

Safety of the first dose of fingolimod for multiple sclerosis: results of an open-label clinical trial

Abstract

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