6533b7d8fe1ef96bd126b71d
RESEARCH PRODUCT
Safety of the first dose of fingolimod for multiple sclerosis: results of an open-label clinical trial
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.subject
OncologyMaleNeurologyfingolimod multiple sclerosis treatment first dose safetyadministration /&/ dosage/adverse effects/analogs /&/ derivatives/therapeutic useImmunosuppressive AgentSphingosineMultiple SclerosiAtrioventricular Blockadministration /&/ dosage/adverse effects/therapeutic useGeneral MedicineMiddle AgedTolerabilityPropylene GlycolFingolimoddrug therapyTolerabilityAnesthesiaCohortAdolescent 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 AdultCombinationDrug Therapy CombinationSettore MED/26 - NeurologiaFemaleAtrioventricular block; Bradycardia; Fingolimod; Multiple sclerosis; Safety; Tolerability; Adolescent; Adult; Atrioventricular Block; Drug Therapy Combination; Female; Fingolimod Hydrochloride; Humans; Immunosuppressive Agents; Male; Middle Aged; Multiple Sclerosis; Propylene Glycols; Sphingosine; Young Adult; Neurology (clinical)SafetyAtrioventricular block Bradicardia Multiple sclerosis Fingolimod Safety TolerabilityImmunosuppressive AgentsResearch ArticleHumanmedicine.drugAdultmedicine.medical_specialtyMultiple SclerosisAdolescentClinical NeurologyYoung AdultFingolimod HydrochlorideInternal medicineBradycardiamedicineHumansNeurochemistryFingolimod Hydrochloridebusiness.industryMultiple sclerosisFingolimodmedicine.diseaseClinical trialPropylene GlycolsAtrioventricular block Bradycardia Multiple sclerosis Fingolimod Safety Tolerabilitychemically induced/epidemiologyNeurology (clinical)businessdescription
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.
| year | journal | country | edition | language |
|---|---|---|---|---|
| 2014-01-01 |