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

Background In patients with relapsing-remitting MS (RRMS) fingolimod prevents disease relapses and delays disability progression. 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...
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Autor*in:	Laroni, Alice [verfasserIn] Brogi, Davide Morra, Vincenzo Brescia Guidi, Leonello Pozzilli, Carlo Comi, Giancarlo Lugaresi, Alessandra Turrini, Renato Raimondi, Debora Uccelli, Antonio Mancardi, Giovanni Luigi

Format:	E-Artikel
Sprache:	Englisch

Erschienen:	2014

Schlagwörter:	Atrioventricular block Bradycardia Multiple sclerosis Fingolimod Safety Tolerability

Anmerkung:	© Laroni et al.; licensee BioMed Central Ltd. 2014. This article is published under license to BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (

Übergeordnetes Werk:	Enthalten in: BMC neurology - London : BioMed Central, 2001, 14(2014), 1 vom: 01. Apr.
Übergeordnetes Werk:	volume:14 ; year:2014 ; number:1 ; day:01 ; month:04

Links:	Volltext

DOI / URN:	10.1186/1471-2377-14-65

Katalog-ID:	SPR027543153

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520			\|a Background In patients with relapsing-remitting MS (RRMS) fingolimod prevents disease relapses and delays disability progression. 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 with RRMS without alternative therapeutic options. Methods Open-label, single arm, multicentre study. After the first dose of fingolimod, patients were observed for 6 hours and 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) following fingolimod administration. Cardiovascular AEs occurred in 18 patients and included bradycardia (1.3%), first-and second-degree atrioventricular block (0.1% and 0.2%), palpitations (0.1%), sinus arrhythmia (0.1%) and ventricular premature beats (0.1%). All events were self-limiting and did not require any intervention. Extended monitoring was required in 34 patients. Conclusions These results, in a population who better resembled real-world clinical practice in terms of concomitant diseases and medications, are consistent with previous clinical trials and confirmed that the first dose administration of fingolimod is generally safe and well tolerated. Trial registration EudraCT 2011-000770-60
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allfields	10.1186/1471-2377-14-65 doi (DE-627)SPR027543153 (SPR)1471-2377-14-65-e DE-627 ger DE-627 rakwb eng Laroni, Alice verfasserin aut Safety of the first dose of fingolimod for multiple sclerosis: results of an open-label clinical trial 2014 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © Laroni et al.; licensee BioMed Central Ltd. 2014. This article is published under license to BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License ( Background In patients with relapsing-remitting MS (RRMS) fingolimod prevents disease relapses and delays disability progression. 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 with RRMS without alternative therapeutic options. Methods Open-label, single arm, multicentre study. After the first dose of fingolimod, patients were observed for 6 hours and 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) following fingolimod administration. Cardiovascular AEs occurred in 18 patients and included bradycardia (1.3%), first-and second-degree atrioventricular block (0.1% and 0.2%), palpitations (0.1%), sinus arrhythmia (0.1%) and ventricular premature beats (0.1%). All events were self-limiting and did not require any intervention. Extended monitoring was required in 34 patients. Conclusions These results, in a population who better resembled real-world clinical practice in terms of concomitant diseases and medications, are consistent with previous clinical trials and confirmed that the first dose administration of fingolimod is generally safe and well tolerated. Trial registration EudraCT 2011-000770-60 Atrioventricular block (dpeaa)DE-He213 Bradycardia (dpeaa)DE-He213 Multiple sclerosis (dpeaa)DE-He213 Fingolimod (dpeaa)DE-He213 Safety (dpeaa)DE-He213 Tolerability (dpeaa)DE-He213 Brogi, Davide aut Morra, Vincenzo Brescia aut Guidi, Leonello aut Pozzilli, Carlo aut Comi, Giancarlo aut Lugaresi, Alessandra aut Turrini, Renato aut Raimondi, Debora aut Uccelli, Antonio aut Mancardi, Giovanni Luigi aut Enthalten in BMC neurology London : BioMed Central, 2001 14(2014), 1 vom: 01. Apr. (DE-627)326643664 (DE-600)2041347-6 1471-2377 nnns volume:14 year:2014 number:1 day:01 month:04 https://dx.doi.org/10.1186/1471-2377-14-65 kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 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_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 14 2014 1 01 04
spelling	10.1186/1471-2377-14-65 doi (DE-627)SPR027543153 (SPR)1471-2377-14-65-e DE-627 ger DE-627 rakwb eng Laroni, Alice verfasserin aut Safety of the first dose of fingolimod for multiple sclerosis: results of an open-label clinical trial 2014 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © Laroni et al.; licensee BioMed Central Ltd. 2014. This article is published under license to BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License ( Background In patients with relapsing-remitting MS (RRMS) fingolimod prevents disease relapses and delays disability progression. 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 with RRMS without alternative therapeutic options. Methods Open-label, single arm, multicentre study. After the first dose of fingolimod, patients were observed for 6 hours and 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) following fingolimod administration. Cardiovascular AEs occurred in 18 patients and included bradycardia (1.3%), first-and second-degree atrioventricular block (0.1% and 0.2%), palpitations (0.1%), sinus arrhythmia (0.1%) and ventricular premature beats (0.1%). All events were self-limiting and did not require any intervention. Extended monitoring was required in 34 patients. Conclusions These results, in a population who better resembled real-world clinical practice in terms of concomitant diseases and medications, are consistent with previous clinical trials and confirmed that the first dose administration of fingolimod is generally safe and well tolerated. Trial registration EudraCT 2011-000770-60 Atrioventricular block (dpeaa)DE-He213 Bradycardia (dpeaa)DE-He213 Multiple sclerosis (dpeaa)DE-He213 Fingolimod (dpeaa)DE-He213 Safety (dpeaa)DE-He213 Tolerability (dpeaa)DE-He213 Brogi, Davide aut Morra, Vincenzo Brescia aut Guidi, Leonello aut Pozzilli, Carlo aut Comi, Giancarlo aut Lugaresi, Alessandra aut Turrini, Renato aut Raimondi, Debora aut Uccelli, Antonio aut Mancardi, Giovanni Luigi aut Enthalten in BMC neurology London : BioMed Central, 2001 14(2014), 1 vom: 01. Apr. (DE-627)326643664 (DE-600)2041347-6 1471-2377 nnns volume:14 year:2014 number:1 day:01 month:04 https://dx.doi.org/10.1186/1471-2377-14-65 kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 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_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 14 2014 1 01 04
allfields_unstemmed	10.1186/1471-2377-14-65 doi (DE-627)SPR027543153 (SPR)1471-2377-14-65-e DE-627 ger DE-627 rakwb eng Laroni, Alice verfasserin aut Safety of the first dose of fingolimod for multiple sclerosis: results of an open-label clinical trial 2014 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © Laroni et al.; licensee BioMed Central Ltd. 2014. This article is published under license to BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License ( Background In patients with relapsing-remitting MS (RRMS) fingolimod prevents disease relapses and delays disability progression. 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 with RRMS without alternative therapeutic options. Methods Open-label, single arm, multicentre study. After the first dose of fingolimod, patients were observed for 6 hours and 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) following fingolimod administration. Cardiovascular AEs occurred in 18 patients and included bradycardia (1.3%), first-and second-degree atrioventricular block (0.1% and 0.2%), palpitations (0.1%), sinus arrhythmia (0.1%) and ventricular premature beats (0.1%). All events were self-limiting and did not require any intervention. Extended monitoring was required in 34 patients. Conclusions These results, in a population who better resembled real-world clinical practice in terms of concomitant diseases and medications, are consistent with previous clinical trials and confirmed that the first dose administration of fingolimod is generally safe and well tolerated. Trial registration EudraCT 2011-000770-60 Atrioventricular block (dpeaa)DE-He213 Bradycardia (dpeaa)DE-He213 Multiple sclerosis (dpeaa)DE-He213 Fingolimod (dpeaa)DE-He213 Safety (dpeaa)DE-He213 Tolerability (dpeaa)DE-He213 Brogi, Davide aut Morra, Vincenzo Brescia aut Guidi, Leonello aut Pozzilli, Carlo aut Comi, Giancarlo aut Lugaresi, Alessandra aut Turrini, Renato aut Raimondi, Debora aut Uccelli, Antonio aut Mancardi, Giovanni Luigi aut Enthalten in BMC neurology London : BioMed Central, 2001 14(2014), 1 vom: 01. Apr. (DE-627)326643664 (DE-600)2041347-6 1471-2377 nnns volume:14 year:2014 number:1 day:01 month:04 https://dx.doi.org/10.1186/1471-2377-14-65 kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 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_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 14 2014 1 01 04
allfieldsGer	10.1186/1471-2377-14-65 doi (DE-627)SPR027543153 (SPR)1471-2377-14-65-e DE-627 ger DE-627 rakwb eng Laroni, Alice verfasserin aut Safety of the first dose of fingolimod for multiple sclerosis: results of an open-label clinical trial 2014 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © Laroni et al.; licensee BioMed Central Ltd. 2014. This article is published under license to BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License ( Background In patients with relapsing-remitting MS (RRMS) fingolimod prevents disease relapses and delays disability progression. 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 with RRMS without alternative therapeutic options. Methods Open-label, single arm, multicentre study. After the first dose of fingolimod, patients were observed for 6 hours and 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) following fingolimod administration. Cardiovascular AEs occurred in 18 patients and included bradycardia (1.3%), first-and second-degree atrioventricular block (0.1% and 0.2%), palpitations (0.1%), sinus arrhythmia (0.1%) and ventricular premature beats (0.1%). All events were self-limiting and did not require any intervention. Extended monitoring was required in 34 patients. Conclusions These results, in a population who better resembled real-world clinical practice in terms of concomitant diseases and medications, are consistent with previous clinical trials and confirmed that the first dose administration of fingolimod is generally safe and well tolerated. Trial registration EudraCT 2011-000770-60 Atrioventricular block (dpeaa)DE-He213 Bradycardia (dpeaa)DE-He213 Multiple sclerosis (dpeaa)DE-He213 Fingolimod (dpeaa)DE-He213 Safety (dpeaa)DE-He213 Tolerability (dpeaa)DE-He213 Brogi, Davide aut Morra, Vincenzo Brescia aut Guidi, Leonello aut Pozzilli, Carlo aut Comi, Giancarlo aut Lugaresi, Alessandra aut Turrini, Renato aut Raimondi, Debora aut Uccelli, Antonio aut Mancardi, Giovanni Luigi aut Enthalten in BMC neurology London : BioMed Central, 2001 14(2014), 1 vom: 01. Apr. (DE-627)326643664 (DE-600)2041347-6 1471-2377 nnns volume:14 year:2014 number:1 day:01 month:04 https://dx.doi.org/10.1186/1471-2377-14-65 kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 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_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 14 2014 1 01 04
allfieldsSound	10.1186/1471-2377-14-65 doi (DE-627)SPR027543153 (SPR)1471-2377-14-65-e DE-627 ger DE-627 rakwb eng Laroni, Alice verfasserin aut Safety of the first dose of fingolimod for multiple sclerosis: results of an open-label clinical trial 2014 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © Laroni et al.; licensee BioMed Central Ltd. 2014. This article is published under license to BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License ( Background In patients with relapsing-remitting MS (RRMS) fingolimod prevents disease relapses and delays disability progression. 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 with RRMS without alternative therapeutic options. Methods Open-label, single arm, multicentre study. After the first dose of fingolimod, patients were observed for 6 hours and 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) following fingolimod administration. Cardiovascular AEs occurred in 18 patients and included bradycardia (1.3%), first-and second-degree atrioventricular block (0.1% and 0.2%), palpitations (0.1%), sinus arrhythmia (0.1%) and ventricular premature beats (0.1%). All events were self-limiting and did not require any intervention. Extended monitoring was required in 34 patients. Conclusions These results, in a population who better resembled real-world clinical practice in terms of concomitant diseases and medications, are consistent with previous clinical trials and confirmed that the first dose administration of fingolimod is generally safe and well tolerated. Trial registration EudraCT 2011-000770-60 Atrioventricular block (dpeaa)DE-He213 Bradycardia (dpeaa)DE-He213 Multiple sclerosis (dpeaa)DE-He213 Fingolimod (dpeaa)DE-He213 Safety (dpeaa)DE-He213 Tolerability (dpeaa)DE-He213 Brogi, Davide aut Morra, Vincenzo Brescia aut Guidi, Leonello aut Pozzilli, Carlo aut Comi, Giancarlo aut Lugaresi, Alessandra aut Turrini, Renato aut Raimondi, Debora aut Uccelli, Antonio aut Mancardi, Giovanni Luigi aut Enthalten in BMC neurology London : BioMed Central, 2001 14(2014), 1 vom: 01. Apr. (DE-627)326643664 (DE-600)2041347-6 1471-2377 nnns volume:14 year:2014 number:1 day:01 month:04 https://dx.doi.org/10.1186/1471-2377-14-65 kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 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_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 14 2014 1 01 04
language	English
source	Enthalten in BMC neurology 14(2014), 1 vom: 01. Apr. volume:14 year:2014 number:1 day:01 month:04
sourceStr	Enthalten in BMC neurology 14(2014), 1 vom: 01. Apr. volume:14 year:2014 number:1 day:01 month:04
format_phy_str_mv	Article
institution	findex.gbv.de
topic_facet	Atrioventricular block Bradycardia Multiple sclerosis Fingolimod Safety Tolerability
isfreeaccess_bool	true
container_title	BMC neurology
authorswithroles_txt_mv	Laroni, Alice @@aut@@ Brogi, Davide @@aut@@ Morra, Vincenzo Brescia @@aut@@ Guidi, Leonello @@aut@@ Pozzilli, Carlo @@aut@@ Comi, Giancarlo @@aut@@ Lugaresi, Alessandra @@aut@@ Turrini, Renato @@aut@@ Raimondi, Debora @@aut@@ Uccelli, Antonio @@aut@@ Mancardi, Giovanni Luigi @@aut@@
publishDateDaySort_date	2014-04-01T00:00:00Z
hierarchy_top_id	326643664
id	SPR027543153
language_de	englisch
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Results Of the 906 patients enrolled in the study, most (95.2%) did not experience any adverse event (AE) following fingolimod administration. Cardiovascular AEs occurred in 18 patients and included bradycardia (1.3%), first-and second-degree atrioventricular block (0.1% and 0.2%), palpitations (0.1%), sinus arrhythmia (0.1%) and ventricular premature beats (0.1%). All events were self-limiting and did not require any intervention. Extended monitoring was required in 34 patients. Conclusions These results, in a population who better resembled real-world clinical practice in terms of concomitant diseases and medications, are consistent with previous clinical trials and confirmed that the first dose administration of fingolimod is generally safe and well tolerated. 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author	Laroni, Alice
spellingShingle	Laroni, Alice misc Atrioventricular block misc Bradycardia misc Multiple sclerosis misc Fingolimod misc Safety misc Tolerability Safety of the first dose of fingolimod for multiple sclerosis: results of an open-label clinical trial
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topic_title	Safety of the first dose of fingolimod for multiple sclerosis: results of an open-label clinical trial Atrioventricular block (dpeaa)DE-He213 Bradycardia (dpeaa)DE-He213 Multiple sclerosis (dpeaa)DE-He213 Fingolimod (dpeaa)DE-He213 Safety (dpeaa)DE-He213 Tolerability (dpeaa)DE-He213
topic	misc Atrioventricular block misc Bradycardia misc Multiple sclerosis misc Fingolimod misc Safety misc Tolerability
topic_unstemmed	misc Atrioventricular block misc Bradycardia misc Multiple sclerosis misc Fingolimod misc Safety misc Tolerability
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title	Safety of the first dose of fingolimod for multiple sclerosis: results of an open-label clinical trial
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title_full	Safety of the first dose of fingolimod for multiple sclerosis: results of an open-label clinical trial
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author_browse	Laroni, Alice Brogi, Davide Morra, Vincenzo Brescia Guidi, Leonello Pozzilli, Carlo Comi, Giancarlo Lugaresi, Alessandra Turrini, Renato Raimondi, Debora Uccelli, Antonio Mancardi, Giovanni Luigi
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title_sort	safety of the first dose of fingolimod for multiple sclerosis: results of an open-label clinical trial
title_auth	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 disability progression. 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 with RRMS without alternative therapeutic options. Methods Open-label, single arm, multicentre study. After the first dose of fingolimod, patients were observed for 6 hours and 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) following fingolimod administration. Cardiovascular AEs occurred in 18 patients and included bradycardia (1.3%), first-and second-degree atrioventricular block (0.1% and 0.2%), palpitations (0.1%), sinus arrhythmia (0.1%) and ventricular premature beats (0.1%). All events were self-limiting and did not require any intervention. Extended monitoring was required in 34 patients. Conclusions These results, in a population who better resembled real-world clinical practice in terms of concomitant diseases and medications, are consistent with previous clinical trials and confirmed that the first dose administration of fingolimod is generally safe and well tolerated. Trial registration EudraCT 2011-000770-60 © Laroni et al.; licensee BioMed Central Ltd. 2014. This article is published under license to BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (
abstractGer	Background In patients with relapsing-remitting MS (RRMS) fingolimod prevents disease relapses and delays disability progression. 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 with RRMS without alternative therapeutic options. Methods Open-label, single arm, multicentre study. After the first dose of fingolimod, patients were observed for 6 hours and 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) following fingolimod administration. Cardiovascular AEs occurred in 18 patients and included bradycardia (1.3%), first-and second-degree atrioventricular block (0.1% and 0.2%), palpitations (0.1%), sinus arrhythmia (0.1%) and ventricular premature beats (0.1%). All events were self-limiting and did not require any intervention. Extended monitoring was required in 34 patients. Conclusions These results, in a population who better resembled real-world clinical practice in terms of concomitant diseases and medications, are consistent with previous clinical trials and confirmed that the first dose administration of fingolimod is generally safe and well tolerated. Trial registration EudraCT 2011-000770-60 © Laroni et al.; licensee BioMed Central Ltd. 2014. This article is published under license to BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (
abstract_unstemmed	Background In patients with relapsing-remitting MS (RRMS) fingolimod prevents disease relapses and delays disability progression. 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 with RRMS without alternative therapeutic options. Methods Open-label, single arm, multicentre study. After the first dose of fingolimod, patients were observed for 6 hours and 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) following fingolimod administration. Cardiovascular AEs occurred in 18 patients and included bradycardia (1.3%), first-and second-degree atrioventricular block (0.1% and 0.2%), palpitations (0.1%), sinus arrhythmia (0.1%) and ventricular premature beats (0.1%). All events were self-limiting and did not require any intervention. Extended monitoring was required in 34 patients. Conclusions These results, in a population who better resembled real-world clinical practice in terms of concomitant diseases and medications, are consistent with previous clinical trials and confirmed that the first dose administration of fingolimod is generally safe and well tolerated. Trial registration EudraCT 2011-000770-60 © Laroni et al.; licensee BioMed Central Ltd. 2014. This article is published under license to BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (
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title_short	Safety of the first dose of fingolimod for multiple sclerosis: results of an open-label clinical trial
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Safety of the first dose of fingolimod for multiple sclerosis: results of an open-label clinical trial

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