Long-term safety and efficacy of amisulpride in subchronic or chronic schizophrenia

Amisulpride vs. Risperidone in Chronic Schizophrenia Results of a 6-month Double-blind Study

“…Based on the results of a previous short-term (8 weeks) comparison between risperidone and haloperidol , and taking into account the 45% dropout rate in an amisulpride long-term (12 months) open comparison versus haloperidol (Colonna et al 2000), the total sample size to be included for noninferiority testing in the study was 300. Analyses were performed using SAS software 6.09 (SAS Institute Inc., Cary, NC).…”

“…Amisulpride significantly reduces negative symptoms in patients with chronic schizophrenia presenting with enduring predominant negative symptoms (Boyer et al 1995;Loo et al 1997;Danion et al 1999) and in neuroleptic naive mainly negative schizophrenics at the onset of the disorder (Paillère-Martinot et al 1995). The efficacy of amisulpride was maintained in an open long-term study, with a clear advantage over haloperidol in terms of safety and efficacy (Colonna et al 2000). This advantage over a standard neuroleptic was also demonstrated when social adjustment and quality of life were taken into account (Colonna et al 2000;Carrière et al 2000).…”

“…The efficacy of amisulpride was maintained in an open long-term study, with a clear advantage over haloperidol in terms of safety and efficacy (Colonna et al 2000). This advantage over a standard neuroleptic was also demonstrated when social adjustment and quality of life were taken into account (Colonna et al 2000;Carrière et al 2000). In all these trials, amisulpride constantly demonstrated a good safety and tolerability profile, with fewer extrapyramidal symptoms than typical neuroleptics and a low incidence of weight gain and endocrine side-effects (Coulouvrat and DondeyNouvel 1999).…”

Diretrizes da Federação Mundial das Sociedades de Psiquiatria Biológica para o tratamento biológico da esquizofrenia. Parte 2: tratamento de longo prazo

“…Foram observados resultados similares, incluindo melhora superior nos sintomas negativos num ECR duplo-cego com duração 12 meses feito com amisulprida (200 a 800 mg/dia) versus haloperidol (5 a 20 mg/dia) (Colonna et al, 2000). No ECR que envolveu pacientes com sintomatologia predominantemente negativa, a amisulprida em baixas doses também foi superior em melhorar os sintomas negativos (Speller et al, 1997).…”

“…EFICÁCIA DOS ANTIPSICÓTICOS DE SEGUNDA GERAÇÃO Num estudo de manutenção, duplo-cego e randomizado, com duração de 1 ano e com doses flexíveis (Colonna et al, 2000), a amisulprida foi associada à melhora superior na sintomatologia negativa quando comparada ao haloperidol. Um estudo randomizado, duplocego e de longo prazo, que selecionou pacientes com sintomas predominantemente negativos e comparou seis níveis de dose da amisulprida com o haloperidol, verificou resultado superior (mas não estatisticamente significativo) sobre os sintomas negativos após 1 ano de tratamento em favor da amisulprida (Speller et al, 1997).…”