Safety of the first dose of fingolimod for multiple sclerosis: results of an open-label clinical trial
| Autor: | Laroni A., Brogi D., Morra V. B., Guidi L., Pozzilli C., Comi G., Lugaresi A., Turrini R., Raimondi D., Uccelli A., Mancardi G. L., Amato M. P., Appendino L., Ardito B., Avolio C., Bandini F., Batocchi A. P., Bellantonio P., Benedetti M. D., Bergamaschi R., Bortolon F., Bosco A., Buccafusca M., Cargnelutti D., Cavalla P., Cavallo R., Centonze D., Coniglio M. G., Costantino G., Cottone S., Danni M. C., De Robertis F., Deotto L., Dotta M., Di Battista G., Filippi M. M., Florio C., Francia A., Galgani S., Gallo P., Ghezzi A., Giometto B., Giuliani G., Grimaldi L. M. E., Guidotti M., Iudice A., Lenzi G. L., Lorusso L., Lus G., Maimone D., Malentacchi G. M., Mantegazza R. E., Massacesi L., Melato M., Millefiorini E., Montanari E., Patti F., Perrone P. S. M., Protti A., Provera P., Quattrone A., Rasi F., Rosati G., Rovaris M., Sacca F., Salemi G., Sarchielli P., Scarpini E. A., Schoenhuber R., Serrati C., Sinisi L., Sola P., Spitaleri D. L. A., Tedeschi G., Tezzon F., Tinebra Asti M. C., Tola M. R., Totaro R., Trojano M., Ulivelli M., Vecchio M. M., Zimatore G. B. |
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| Přispěvatelé: | Alice Laroni, Davide Brogi, Vincenzo Brescia Morra, Leonello Guidi, Carlo Pozzilli, Giancarlo Comi, Alessandra Lugaresi, Renato Turrini, Debora Raimondi, Antonio Uccelli, Giovanni Mancardi, EAP Investigators, Laroni, A, Brogi, D, BRESCIA MORRA, Vincenzo, Guidi, L, Pozzilli, C, Comi, G, Lugaresi, A, Turrini, R, Raimondi, D, Uccelli, A, Macardi, G., Laroni A, Brogi D, Morra VB, Guidi L, Pozzilli C, Comi G, Lugaresi A, Turrini R, Raimondi D, Uccelli A, Mancardi GL, Amato MP, Appendino L, Ardito B, Avolio C, Bandini F, Batocchi AP, Bellantonio P, Benedetti MD, Bergamaschi R, Bortolon F, Bosco A, Buccafusca M, Cargnelutti D, Cavalla P, Cavallo R, Centonze D, Coniglio MG, Costantino G, Cottone S, Danni MC, De Robertis F, Deotto L, Dotta M, Di Battista G, Filippi MM, Florio C, Francia A, Galgani S, Gallo P, Ghezzi A, Giometto B, Giuliani G Grimaldi LME, Guidotti M, Iudice A, Lenzi GL, Lorusso L, Lus G, Maimone D, Malentacchi GM, Mantegazza RE, Massacesi L, Melato M, Millefiorini E, Montanari E, Patti F, Perrone PSM, Protti A, Provera P, Quattrone A, Rasi F, Rosati G, Rovaris M, Saccà F, Salemi G, Sarchielli P, Scarpini EA, Schoenhuber R, Serrati C, Sinisi L, Sola P, Spitaleri DLA, Tedeschi G, Tezzon F, Tinebra Asti MC, Tola MR, Totaro R, Trojano M, Ulivelli M, Vecchio MM, Zimatore GB, Laroni, A., Brogi, D., Morra, V. B., Guidi, L., Pozzilli, C., Comi, G., Lugaresi, A., Turrini, R., Raimondi, D., Uccelli, A., Mancardi, G. L., Amato, M. P., Appendino, L., Ardito, B., Avolio, C., Bandini, F., Batocchi, A. P., Bellantonio, P., Benedetti, M. D., Bergamaschi, R., Bortolon, F., Bosco, A., Buccafusca, M., Cargnelutti, D., Cavalla, P., Cavallo, R., Centonze, D., Coniglio, M. G., Costantino, G., Cottone, S., Danni, M. C., De Robertis, F., Deotto, L., Dotta, M., Di Battista, G., Filippi, M. M., Florio, C., Francia, A., Galgani, S., Gallo, P., Ghezzi, A., Giometto, B., Giuliani, G., Grimaldi, L. M. E., Guidotti, M., Iudice, A., Lenzi, G. L., Lorusso, L., Lus, G., Maimone, D., Malentacchi, G. M., Mantegazza, R. E., Massacesi, L., Melato, M., Millefiorini, E., Montanari, E., Patti, F., Perrone, P. S. M., Protti, A., Provera, P., Quattrone, A., Rasi, F., Rosati, G., Rovaris, M., Sacca, F., Salemi, G., Sarchielli, P., Scarpini, E. A., Schoenhuber, R., Serrati, C., Sinisi, L., Sola, P., Spitaleri, D. L. A., Tedeschi, G., Tezzon, F., Tinebra Asti, M. C., Tola, M. R., Totaro, R., Trojano, M., Ulivelli, M., Vecchio, M. M., Zimatore, G. B., Mancardi, Gl, Brescia Morra, V, on behalf of the EAP, Investigator, Giometto, B |
| Jazyk: | angličtina |
| Rok vydání: | 2014 |
| Předmět: |
Oncology
Male Neurology fingolimod multiple sclerosis treatment first dose safety administration /&/ dosage/adverse effects/analogs /&/ derivatives/therapeutic use Immunosuppressive Agent Sphingosine Multiple Sclerosi Atrioventricular Block administration /&/ dosage/adverse effects/therapeutic use General Medicine Middle Aged Tolerability Propylene Glycol Fingolimod drug therapy Anesthesia Cohort Adolescent Adult Atrioventricular Block chemically induced/epidemiology Drug Therapy Combination Female Humans Immunosuppressive Agents administration /&/ dosage/adverse effects/therapeutic use Male Middle Aged Multiple Sclerosis drug therapy Propylene Glycols administration /&/ dosage/adverse effects/therapeutic use Sphingosine administration /&/ dosage/adverse effects/analogs /&/ derivatives/therapeutic use Young Adult Combination Drug Therapy Combination Settore MED/26 - Neurologia Female Atrioventricular block Bradycardia Multiple sclerosis Safety Adolescent Adult Fingolimod Hydrochloride Humans Immunosuppressive Agents Multiple Sclerosis Propylene Glycols Young Adult Neurology (clinical) Atrioventricular block Bradicardia Multiple sclerosis Fingolimod Safety Tolerability Research Article Human medicine.drug medicine.medical_specialty Clinical Neurology Internal medicine medicine Neurochemistry business.industry medicine.disease Clinical trial Atrioventricular block Bradycardia Multiple sclerosis Fingolimod Safety Tolerability chemically induced/epidemiology business |
| Zdroj: | BMC Neurology Publons |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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