Your browser doesn't support javascript.
loading
Safety outcomes of disease-modifying therapies for relapsing-remitting multiple sclerosis: A network meta-analysis.
Lucchetta, Rosa C; Leonart, Letícia P; Becker, Jefferson; Pontarolo, Roberto; Fernandez-Llimós, Fernando; Wiens, Astrid.
Afiliação
  • Lucchetta RC; Departament of Pharmacy, Federal University of Paraná, Brazil.
  • Leonart LP; Departament of Pharmacy, Federal University of Paraná, Brazil.
  • Becker J; Department of Neurology, School of Medicine, Pontifical Catholic University of Rio Grande do Sul, Brazil.
  • Pontarolo R; Departament of Pharmacy, Federal University of Paraná, Brazil.
  • Fernandez-Llimós F; Department of Social Pharmacy, Faculty of Pharmacy, Research Institute for Medicines (iMed.ULisboa), University of Lisbon, Portugal.
  • Wiens A; Departament of Pharmacy, Federal University of Paraná, Brazil. Electronic address: astrid@ufpr.br.
Mult Scler Relat Disord ; 35: 7-15, 2019 Oct.
Article em En | MEDLINE | ID: mdl-31276913
BACKGROUND: Randomised clinical trials (RCTs) and observational studies have reported adverse events that preclude the use of disease-modifying therapies (DMTs) in relapsing-remitting multiple sclerosis (RRMS) in the long term or in specific populations, however, little is known about the relationship between the use of DMTs and frequency of undesirable events. We aimed to conduct a systematic review and network meta-analyses (NMAs) of RCTs and observational studies to synthesise the evidence on the safety of all available DMTs for patients with RRMS. METHODS: PubMed, Scopus and a manual search were performed. Bayesian NMAs of safety outcomes reported in RCTs and observational studies assessing DMTs as monotherapies were conducted. RESULTS: Forty-seven studies were included in the systematic review. Considering all studies, 368 and 149 different safety outcomes were reported for at least one study and two studies, respectively. Considering clinical trials, 22 NMAs were conducted for 16 outcomes. Regarding geometry metrics, the median number of studies, DMTs, common comparator, strong edge, and patients were 5 (IQR 5-9), 5 (IQR 4-8), 44%, 33%, and 3998 (IQR 3380-6761). In summary, most comparisons showed similar risk of safety events for DMTs and placebo for all outcomes. Considering cohort studies, only three meta-analyses were conducted. CONCLUSION: Safety outcomes are poorly reported in primary studies of DMTs in RRMS, precluding the conduction of robust meta-analyses. Therefore, the current available data on safety of these drugs is not contributing to regulatory and clinical decision making, with adverse event reports underbalanced compared to efficacy outcomes.
Assuntos
Palavras-chave
Texto completo
Adicionar na Minha BVS
Imprimir
XML
PubMed Links
Buscar no Google

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Esclerose Múltipla Recidivante-Remitente / Segurança do Paciente / Metanálise em Rede / Fatores Imunológicos Tipo de estudo: Clinical_trials / Guideline / Health_technology_assessment / Observational_studies / Prognostic_studies / Risk_factors_studies / Systematic_reviews Limite: Humans Idioma: En Revista: Mult Scler Relat Disord Ano de publicação: 2019 Tipo de documento: Article País de afiliação: Brasil País de publicação: Holanda
Texto completo
Adicionar na Minha BVS
Imprimir
XML
PubMed Links
Buscar no Google

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Esclerose Múltipla Recidivante-Remitente / Segurança do Paciente / Metanálise em Rede / Fatores Imunológicos Tipo de estudo: Clinical_trials / Guideline / Health_technology_assessment / Observational_studies / Prognostic_studies / Risk_factors_studies / Systematic_reviews Limite: Humans Idioma: En Revista: Mult Scler Relat Disord Ano de publicação: 2019 Tipo de documento: Article País de afiliação: Brasil País de publicação: Holanda