Rodrigo Córdoba1, Juan Fernando Cano2, César Augusto Arango-Dávila3, Carlos Miranda4, Jorge Holguín5, Darío Fernández6, Miguel Márquez7, Christian Lupo8, Pedro Gargoloff9, Gustavo Petracca10, César Lucchetti11. 1. Centro de Investigaciones del Sistema Nervioso, Bogotá, Colombia. Electronic address: rodrinel@yahoo.com. 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.
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.
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.