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Levetiracetam extended release and levetiracetam immediate release as adjunctive treatment for partial-onset seizures: an indirect comparison of treatment-emergent adverse events using meta-analytic techniques.
Richy, Florent F; Banerjee, Soutrik; Brabant, Yves; Helmers, Sandra.
Afiliação
  • Richy FF; G3P Epidemiology, UCB Pharma S.A., Brussels, Belgium. florent.richy@ucb.com
Epilepsy Behav ; 16(2): 240-5, 2009 Oct.
Article em En | MEDLINE | ID: mdl-19699156
ABSTRACT
The safety profiles of once-daily adjunctive levetiracetam (LEV) extended release (XR) (1000mg/day) and adjunctive LEV immediate release (IR) (500mg twice daily) were compared using data from three randomized, placebo (PBO)-controlled phase III clinical trials in patients with partial-onset seizures. MedDRA 9.0 treatment-emergent adverse events (TEAEs) were indirectly compared using meta-analytic techniques, including calculation of risk difference (RD) and mixed-effects analysis. Statistical significance was set at 10% alpha risk, the normative value for these analyses. Data from 555 patients older than 16 (204 LEV IR, 70 LEV XR, 281 PBO) were analyzed. Following adjustment for incidence of placebo TEAEs, LEV XR showed statistically significantly lower rates of TEAEs than LEV IR across nervous system disorders (RD=-18%, P=0.03), psychiatric disorders (RD=-11%, P=0.08), and metabolism and nutrition disorders (RD=-3%, P=0.08). Among nervous system disorders, the RD for headache favored LEV XR (RD=-11%, P=0.08). These results suggest that adjunctive LEV XR may be associated with a lower incidence of nervous system, psychiatric, and nutritional and metabolic TEAEs as compared with LEV IR. However, this difference was observed at a broad scale and not at a specific TEAE level except for headache.
Assuntos

Texto completo: 1 Eixos temáticos: Pesquisa_clinica Base de dados: MEDLINE Assunto principal: Piracetam / Epilepsias Parciais / Anticonvulsivantes Tipo de estudo: Clinical_trials / Systematic_reviews Limite: Adolescent / Adult / Aged / Female / Humans / Male / Middle aged Idioma: En Ano de publicação: 2009 Tipo de documento: Article

Texto completo: 1 Eixos temáticos: Pesquisa_clinica Base de dados: MEDLINE Assunto principal: Piracetam / Epilepsias Parciais / Anticonvulsivantes Tipo de estudo: Clinical_trials / Systematic_reviews Limite: Adolescent / Adult / Aged / Female / Humans / Male / Middle aged Idioma: En Ano de publicação: 2009 Tipo de documento: Article