title: The effectiveness of glatiramer acetate in clinical practice: an observational study.
abstract: OBJECTIVE
  To evaluate the clinical effectiveness and safety of glatiramer acetate for use in routine clinical practice.
  
  
  METHODS
  A retrospective, observational study was conducted on patients with multiple sclerosis who were treated with glatiramer acetate in clinical practice. The primary outcome was the clinical effectiveness of glatiramer acetate treatment.
  
  
  RESULTS
  The study included a total of 104 patients (women, 59.6%; age at onset of glatiramer acetate treatment, 39.9 ± 10.9 years; prior treatment for multiple sclerosis, 30.8%). The patients had received glatiramer acetate treatment for an average of 3.6 ± 1.9 years. During the first year of glatiramer acetate treatment, the relapse rate decreased by 60%. At this time, the number of relapses had decreased for 47 patients (45.1%), 67 patients (68.4%) had not suffered a relapse and 78 patients (75.0%) showed no signs of progression. During the second year of glatiramer acetate treatment, the relapse rate decreased by 70%. At this time, the number of relapses had decreased for 43 patients (41.3%), 63 patients (75.9%) had not suffered a relapse and 59 patients (56.7%) showed no signs of progression. There were no reported relapses or progression in 56 patients (53.8%) and 41 patients (39.4%) during the first and second years of treatment, respectively. Discontinuation of glatiramer acetate was necessary in only three patients. The most common adverse effects included fatigue (28.9%) and spasticity (7.7%).
  
  
  CONCLUSIONS
  This evaluation of glatiramer acetate use in clinical practice supports the effectiveness and the safety profile observed in previously published clinical trial studies.
authors.affiliation: Institute of Clinical Neurosciences, Hospital Regional Universitario Carlos Haya, Malaga, España. oscar.fernandez.sspa@juntadeandalucia.es
authors.forename: Óscar
authors.initials: Ó
authors.lastname: Fernández-Fernández
authors.forename: Lucía
authors.initials: L
authors.lastname: Garcia-Trujillo
authors.forename: Miguel
authors.initials: M
authors.lastname: Guerrero-Fernández
authors.forename: Antonio
authors.initials: A
authors.lastname: León
authors.forename: José C
authors.initials: JC
authors.lastname: López-Madrona
authors.forename: Ana
authors.initials: A
authors.lastname: Alonso
authors.forename: Rafael
authors.initials: R
authors.lastname: Bustamante
authors.forename: Victoria E
authors.initials: VE
authors.lastname: Fernández-Sánchez
mesh_terms: D000276:Adjuvants, Immunologic / Q000009:adverse effects / Q000627:therapeutic use*; D000328:Adult; D000369:Aged, 80 and over; D002986:Clinical Trials as Topic; D018450:Disease Progression; D005260:Female; D000068717:Glatiramer Acetate; D006801:Humans; D007166:Immunosuppressive Agents / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D009103:Multiple Sclerosis / Q000188:drug therapy* / Q000503:physiopathology / Q000517:prevention & control; D010455:Peptides / Q000009:adverse effects / Q000627:therapeutic use*; D012008:Recurrence; D012189:Retrospective Studies; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000276:Adjuvants, Immunologic; D007166:Immunosuppressive Agents; D010455:Peptides; D000068717:Glatiramer Acetate