title: [Study of Flexible Doses of Paliperidone ER in Pacients with Schizophrenia who Have Undergone Inefficient Treatment with other Antipsychotics].
abstract: BACKGROUND
  Extended-release (ER) paliperidone is an innovative atypical antipsychotic that allows minimal peak-to-through fluctuations with once-daily dosing.
  
  
  OBJECTIVE
  To evaluate effectiveness, safety and tolerability of flexible, once-daily doses of paliperidone ER (3-12 mg/day) in patients with schizophrenia from Argentina and Colombia who had previously failed treatment with other antipsychotic agents.
  
  
  METHODS
  The authors conducted a 6-month, open-label, prospective and multicentric study. Effectiveness was assessed with Positive and Negative Syndrome Scale (PANSS) and Personal and Social Performance scale (PSP). Other measures of effectiveness, safety and tolerability, were also conducted.
  
  
  RESULTS
  Paliperidone ER 3-12 mg/day improved Positive and Negative Syndrome Scale (PANSS) total scores (primary endpoint) from baseline to study end (p < 0,001). In the PANSS total score, the mean change from baseline (83, 9 units) to end point (53,7 units) was significant (p < 0,001). Flexible doses of paliperidone ER demonstrated a ≥20% reduction in the PANSS total score (p<0.001) in almost two-thirds of patients. PSP mean change from baseline (52 units) to end point (85 units) was significant (p < 0,001). Secondary effectiveness assessments, as well as safety and tolerability measures, demonstrated favourable results throughout the study.
  
  
  CONCLUSIONS
  Flexible doses of paliperidone ER over 6 months were effective, safe and well tolerated in patients with schizophrenia from Argentina and Colombia.
authors.affiliation: Centro de Investigaciones del Sistema Nervioso, Bogotá, Colombia. Electronic address: rodrinel@yahoo.com.
authors.forename: Rodrigo
authors.initials: R
authors.lastname: Córdoba
authors.affiliation: Centro de Investigaciones del Sistema Nervioso, Bogotá, Colombia.
authors.forename: Juan Fernando
authors.initials: JF
authors.lastname: Cano
authors.affiliation: Fundación Valle del Lili, Grupo de Investigación Biomédica Universidad Icesi, Cali, Colombia.
authors.forename: César Augusto
authors.initials: CA
authors.lastname: Arango-Dávila
authors.affiliation: Hospital Psiquiátrico del Valle, profesor de la Universidad del Valle, Cali, Colombia.
authors.forename: Carlos
authors.initials: C
authors.lastname: Miranda
authors.affiliation: Grupo Colciencias, Medellín, Colombia.
authors.forename: Jorge
authors.initials: J
authors.lastname: Holguín
authors.affiliation: Centro de Investigaciones, Universidad del Rosario, Bogotá, Colombia.
authors.forename: Darío
authors.initials: D
authors.lastname: Fernández
authors.affiliation: ADINEU, Buenos Aires, Argentina.
authors.forename: Miguel
authors.initials: M
authors.lastname: Márquez
authors.affiliation: Centro de Investigación y Asistencia en Psiquiatría (CIAP), Rosario, Argentina.
authors.forename: Christian
authors.initials: C
authors.lastname: Lupo
authors.affiliation: Clínica privada de Salud Mental Santa Teresa de Ávila, La Plata, Argentina.
authors.forename: Pedro
authors.initials: P
authors.lastname: Gargoloff
authors.affiliation: Instituto de Neurociencias Buenos Aires (INEBA), Buenos Aires, Argentina.
authors.forename: Gustavo
authors.initials: G
authors.lastname: Petracca
authors.affiliation: Plural Psi, Buenos Aires, Argentina.
authors.forename: César
authors.initials: C
authors.lastname: Lucchetti
keywords: Efectividad; Effectiveness; esquizofrenia; paliperidona ER; paliperidone ER; safety; schizophrenia; seguridad; tolerabilidad; tolerability