title: [Usefulness of electronic drug registers: Spanish register of patients treated with fingolimod (Gilenya ®)].
abstract: BACKGROUND
  This study outlines the design of an electronic register of patients with multiple sclerosis who began treatment with fingolimod in Spain. The system is intended to serve as a tool to monitor its utilisation in daily clinical practice and thus allow optimisation of the way it is used.
  
  
  OBJECTIVE
  To establish the profile of patients with multiple sclerosis undergoing treatment with fingolimod and to determine the effectiveness and safety of this treatment in daily clinical practice.
  
  
  METHODS
  An observation-based, retrospective and prospective, multi-centre registry is set up, which will be active for five years. Forty neurologists working in Spain will participate in the project. Patients treated with fingolimod who fulfil the selection criteria will be included in the study. The effectiveness variables that will be evaluated are: disability measured by means of the Expanded Disability Status Scale, the rate of attacks, T1 gadolinium-enhancing lesions and new lesions in T2, and the percentage of patients who were free of activity and those who require concomitant treatments. The tolerability variables that will be evaluated are: the rate of patients who present events and adverse reactions, respectively, with a separate analysis of those presenting after the first dose or that are related to the fingolimod risk management plan and the treatment dropout rate.
  
  
  CONCLUSIONS
  New pharmaceuticals that have only recently been commercialised require more information about their effectiveness and safety, beyond the controlled environment of a clinical trial. Initiatives involving electronic registries such as the Gilenya register are a solution that can respond to such needs by providing information in the shortest possible time about the most suitable management in order to be able to make the best and most efficient use of it.
authors.affiliation: Fundacion IMABIS, Hospital Universitario Carlos Haya, 29190 Malaga, Espana.
authors.forename: Óscar
authors.initials: Ó
authors.lastname: Fernández
authors.forename: Alfredo
authors.initials: A
authors.lastname: Rodríguez-Antigüedad
authors.forename: Celia
authors.initials: C
authors.lastname: Oreja-Guevara
authors.forename: Margarida
authors.initials: M
authors.lastname: Garcia-Garcia
authors.forename: Xavier
authors.initials: X
authors.lastname: Montalban
mesh_terms: D001921:Brain / Q000187:drug effects / Q000473:pathology; D003219:Confidentiality; D011307:Drug Prescriptions / Q000706:statistics & numerical data; D004363:Drug Utilization; D057286:Electronic Health Records; D000068876:Fingolimod Hydrochloride; D006801:Humans; D007166:Immunosuppressive Agents / Q000009:adverse effects / Q000627:therapeutic use*; D007258:Informed Consent; D008279:Magnetic Resonance Imaging; D009103:Multiple Sclerosis / Q000188:drug therapy* / Q000473:pathology; D010352:Patient Dropouts; D010818:Practice Patterns, Physicians'; D011358:Product Surveillance, Postmarketing / Q000379:methods* / Q000706:statistics & numerical data; D011409:Propylene Glycols / Q000009:adverse effects / Q000627:therapeutic use*; D011446:Prospective Studies; D012042:Registries; D012189:Retrospective Studies; D018570:Risk Assessment; D012720:Severity of Illness Index; D012959:Socioeconomic Factors; D013030:Spain; D013110:Sphingosine / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D016896:Treatment Outcome
chemical_list: D007166:Immunosuppressive Agents; D011409:Propylene Glycols; D000068876:Fingolimod Hydrochloride; D013110:Sphingosine