title: [Fingolimod: effectiveness and safety in routine clinical practice. An observational, retrospective, multi-centre study in Galicia].
abstract: BACKGROUND
  The effectiveness and safety of fingolimod in patients with relapsing-remitting multiple sclerosis (RRMS) have been proven in clinical trials. Yet, due to their limitations, it is important to know how it behaves under everyday clinical practice conditions. Hence, the aim of this study is to evaluate the effectiveness and safety of fingolimod after 12 months' usage in clinical practice in Galicia.
  
  
  METHODS
  We conducted a retrospective, multi-centre study (n = 8) of patients with RRMS who were treated with one or more doses of fingolimod, 0.5 mg/day. Effectiveness was assessed -annualised relapse rate (ARR), changes in the score on the Expanded Disability Status Scale (EDSS), percentage of patients free from relapses, free from progression of disability and free from activity in resonance- for the total number of patients and according to previous treatment. Safety was assessed based on the percentage of patients who withdrew and presented adverse side effects.
  
  
  RESULTS
  After 12 months' use, fingolimod reduced the ARR by 87% (1.7 to 0.23; p < 0.0001) and, consequently, 81% of patients were free from relapses. The score was reduced by 9%. In all, 91% of patients were free from progression of disability and 72% were free from resonance activity. No signs of disease activity were found in 43% of the patients. Most of the benefits of fingolimod differed depending on previous treatment. About a third of the patients reported adverse side effects, but only 2% of them withdrew for this reason.
  
  
  CONCLUSIONS
  In clinical practice, most of the results on the effectiveness of the clinical trials conducted with fingolimod were observed during the first 12 months of treatment. A better safety profile was observed than that reported in the clinical trials.
authors.affiliation: Hospital Povisa, 36211 Vigo, Espana.
authors.forename: A
authors.initials: A
authors.lastname: Pato-Pato
authors.affiliation: Complejo Hospitalario Universitario de Vigo, 36200 Vigo, Espana.
authors.forename: L
authors.initials: L
authors.lastname: Midaglia
authors.affiliation: Complejo Hospitalario Universitario de Santiago de Compostela, 15706 Santiago de Compostela, Espana.
authors.forename: E
authors.initials: E
authors.lastname: Costa-Arpin
authors.affiliation: Complejo Hospitalario de Pontevedra, 36001 Pontevedra, Espana.
authors.forename: A
authors.initials: A
authors.lastname: Rodriguez-Regal
authors.affiliation: Complejo Hospitalario de Pontevedra, 36001 Pontevedra, Espana.
authors.forename: A
authors.initials: A
authors.lastname: Puy-Nunez
authors.affiliation: Hospital Universitario Lucus Augusti, Lugo, Espana.
authors.forename: M
authors.initials: M
authors.lastname: Rodriguez-Rodriguez
authors.affiliation: Complejo Hospitalario Universitario Juan Canalejo, 15006 A Coruna, Espana.
authors.forename: A
authors.initials: A
authors.lastname: Lopez-Real
authors.affiliation: Complejo Hospitalario Arquitecto Marcide - Profesor Novoa Santos, 15405 El Ferrol, Espana.
authors.forename: M A
authors.initials: MA
authors.lastname: Llaneza-Gonzalez
authors.affiliation: Hospital Comarcal de Monforte de Lemos, 27400 Monforte de Lemos, Espana.
authors.forename: D A
authors.initials: DA
authors.lastname: Garcia-Estevez
authors.affiliation: Complejo Hospitalario Universitario de Vigo, 36200 Vigo, Espana.
authors.forename: M J
authors.initials: MJ
authors.lastname: Moreno-Carretero
authors.affiliation: Complejo Hospitalario Universitario de Vigo, 36200 Vigo, Espana.
authors.forename: D
authors.initials: D
authors.lastname: Escriche-Jaime
authors.affiliation: Complejo Hospitalario Universitario de Vigo, Vigo, Espana.
authors.forename: M L
authors.initials: ML
authors.lastname: Aguado-Valcarcel
authors.affiliation: Complejo Hospitalario Universitario de Vigo, 36200 Vigo, Espana.
authors.forename: D
authors.initials: D
authors.lastname: Munoz
authors.affiliation: Complejo Hospitalario Universitario de Santiago de Compostela, 15706 Santiago de Compostela, Espana.
authors.forename: J M
authors.initials: JM
authors.lastname: Prieto
authors.affiliation: Hospital Povisa, 36211 Vigo, Espana.
authors.forename: J R
authors.initials: JR
authors.lastname: Lorenzo-Gonzalez
authors.affiliation: Complejo Hospitalario de Pontevedra, 36001 Pontevedra, Espana.
authors.forename: M C
authors.initials: MC
authors.lastname: Amigo-Jorrin