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The effectiveness of glatiramer acetate in clinical practice: an observational study

Ó. Fernández, L. García-Trujillo, M. Guerrero-Fernández, A. León, J.C. López-Madrona, A. Alonso, R. Bustamante, V.E. Fernández-Sánchez [REV NEUROL 2012;54:1-9] PMID: 22187206 DOI: https://doi.org/10.33588/rn.5401.2011567

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Volumen 54 | Number 01 | Nº of views of the article 6.975 | Nº of PDF downloads 949 | Article publication date 01/01/2012

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ABSTRACT

AIM To evaluate the clinical effectiveness and safety of glatiramer acetate for use in routine clinical practice.

PATIENTS AND 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%). CONCLUSION. This evaluation of glatiramer acetate use in clinical practice supports the effectiveness and the safety profile observed in previously published clinical trial studies. KeywordsEffectiveness Glatiramer acetate Multiple sclerosis Progression Relapse Safety Treatment CategoriesEsclerosis múltiple

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Original

The effectiveness of glatiramer acetate in clinical practice: an observational study