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Córdoba R, Cano JF, Arango-Dávila CA, et al. Estudio de dosis flexibles de paliperidona ER en pacientes con esquizofrenia previamente tratados sin efectividad con otros antipsicóticos. [Study of Flexible Doses of Paliperidone ER in Pacients with Schizophrenia who Have Undergone Inefficient Treatment with other Antipsychotics]. Rev Colomb Psiquiatr. 2014;41(2):340-56doi: 10.1016/S0034-7450(14)60009-3.
Córdoba, R., Cano, J. F., Arango-Dávila, C. A., Miranda, C., Holguín, J., Fernández, D., Márquez, M., Lupo, C., Gargoloff, P., Petracca, G., & Lucchetti, C. (2012). Estudio de dosis flexibles de paliperidona ER en pacientes con esquizofrenia previamente tratados sin efectividad con otros antipsicóticos. [Study of Flexible Doses of Paliperidone ER in Pacients with Schizophrenia who Have Undergone Inefficient Treatment with other Antipsychotics]. Revista colombiana de psiquiatria, 41(2), 340-56. https://doi.org/10.1016/S0034-7450(14)60009-3
Córdoba, Rodrigo, et al. "Estudio de dosis flexibles de paliperidona ER en pacientes con esquizofrenia previamente tratados sin efectividad con otros antipsicóticos." [Study of Flexible Doses of Paliperidone ER in Pacients with Schizophrenia who Have Undergone Inefficient Treatment with other Antipsychotics]. Revista colombiana de psiquiatria vol. 41,2 (2012): 340-56. doi: https://doi.org/10.1016/S0034-7450(14)60009-3
Córdoba R, Cano JF, Arango-Dávila CA, Miranda C, Holguín J, Fernández D, Márquez M, Lupo C, Gargoloff P, Petracca G, Lucchetti C. Estudio de dosis flexibles de paliperidona ER en pacientes con esquizofrenia previamente tratados sin efectividad con otros antipsicóticos. [Study of Flexible Doses of Paliperidone ER in Pacients with Schizophrenia who Have Undergone Inefficient Treatment with other Antipsychotics]. Rev Colomb Psiquiatr. 2012 Jun;41(2):340-56. doi: 10.1016/S0034-7450(14)60009-3. Epub 2014 May 10. Spanish. PMID: 26573498.
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Rev Colomb Psiquiatr. 2012 Jun;41(2):340-56. doi: 10.1016/S0034-7450(14)60009-3. Epub 2014 May 10.

[Study of Flexible Doses of Paliperidone ER in Pacients with Schizophrenia who Have Undergone Inefficient Treatment with other Antipsychotics].

Revista colombiana de psiquiatria

[Article in Spanish]
Rodrigo Córdoba, Juan Fernando Cano, César Augusto Arango-Dávila, Carlos Miranda, Jorge Holguín, Darío Fernández, Miguel Márquez, Christian Lupo, Pedro Gargoloff, Gustavo Petracca, César Lucchetti

Affiliations

  1. Centro de Investigaciones del Sistema Nervioso, Bogotá, Colombia. Electronic address: [email protected].
  2. Centro de Investigaciones del Sistema Nervioso, Bogotá, Colombia.
  3. Fundación Valle del Lili, Grupo de Investigación Biomédica Universidad Icesi, Cali, Colombia.
  4. Hospital Psiquiátrico del Valle, profesor de la Universidad del Valle, Cali, Colombia.
  5. Grupo Colciencias, Medellín, Colombia.
  6. Centro de Investigaciones, Universidad del Rosario, Bogotá, Colombia.
  7. ADINEU, Buenos Aires, Argentina.
  8. Centro de Investigación y Asistencia en Psiquiatría (CIAP), Rosario, Argentina.
  9. Clínica privada de Salud Mental Santa Teresa de Ávila, La Plata, Argentina.
  10. Instituto de Neurociencias Buenos Aires (INEBA), Buenos Aires, Argentina.
  11. Plural Psi, Buenos Aires, Argentina.

PMID: 26573498 DOI: 10.1016/S0034-7450(14)60009-3

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.

Copyright © 2012 Asociación Colombiana de Psiquiatría. Publicado por Elsevier España. All rights reserved.

Keywords: Efectividad; Effectiveness; esquizofrenia; paliperidona ER; paliperidone ER; safety; schizophrenia; seguridad; tolerabilidad; tolerability

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