[The intercontinental schizophrenia outpatient health outcomes study (IC-SOHO): initial 6 month findings of the sample in Latin America]. / Estudio observacional intercontinental de los resultados de salud en pacientes ambulatorios con esquizofrenia (IC-SOHO): hallazgos iniciales de 6 meses de la muestra en Latinoamérica.

The IC-SOHO study was designed to supply information on antipsychotic treatments in the real clinical practice by assessment of a large and diverse sample population with schizophrenia. This document describes the findings of the first 6 months of IC-SOHO in Latin America. To date, this is the largest observational study of its type in this region. In this observational and prospective study, those out-patients with schizophrenia, who require a change or initiation of antipsychotic medication are hospitalized. Effectiveness was evaluated using the Clinical Global Impression-Seriousness (CGI-S) grading scale. Tolerability was assessed by questionnaires on adverse events and weight measurements. Herein, the comparisons between olanzapine (monotherapy), risperidone (monotherapy) and conventional antipsychotics (monotherapy and combined therapy) are presented. As a whole, 7,658 patients participated in the ICSOHO; n=2,671 from 11 countries of Latin America that were included in this report. At 6 months, the proportion of patients who responded to olanzapine was significantly greater than those who responded to risperidone or conventional antipsychotics (p<0.001). Patients from the olanzapine group had greater improvements in all the symptom domains, including general, positive, negative, depressive and cognitive symptoms in comparison with risperidone (p<0.05) or conventional antipsychotics (p < 0.001). Extrapyramidal symptoms (EPS) and tardive dyskinesia (TD) decreased from baseline in the groups treated with olanzapine and risperidone, but increased in the conventional group. The adverse events related with the sexual function were more prominent in the conventional group. Weight gain was observed in each treatment group, although the patients from the olanzapine group had greater weight grain followed by those of risperidone and then by those of conventional antipsychotics. Our findings in this population of the Latin American sample emulate the results of other studies in different samples, where it was found that olanzapine was more effective and better tolerated than risperidone or conventional antipsychotics.

Estudio observacional intercontinental de los resultados de salud en pacientes ambulatorios con esquizofrenia (IC-SOHO): hallazgos iniciales de 6 meses de la muestra en Latinoamérica / The intercontinental schizophrenia outpatient health outcomes study (IC-SOHO): initial 6 month findings of the sample in Latin America

El estudio IC-SOHO se diseñó para aportar información sobre los tratamientos antipsicóticos en la práctica clínica real mediante la evaluación de una población de muestra grande y diversa con esquizofrenia. Este documento describe los hallazgos de los primeros 6 meses del IC-SOHO en Latinoamérica. A la fecha éste es el estudio observacional más grande de su tipo en esta región. En este estudio observacional y prospectivo se ingresaron aquellos pacientes ambulatorios con esquizofrenia que requirieron un cambio o un inicio de medicación antipsicótica. La efectividad se evaluó utilizando la escala de Calificación de Impresión Clínica Global-Gravedad (CGI-S). La tolerabilidad se evaluó mediante cuestionarios de efectos adversos y mediciones de peso. Se presentan aquí las comparaciones entre olanzapina (monoterapia), risperidona (monoterapia) y antipsicóticos convencionales (monoterapia y terapia combinada). En conjunto, participaron 7.658 pacientes en el IC-SOHO; n=2.671 provenientes de 11 países de Latinoamérica se incluyeron en este informe. A los 6 meses la proporción de pacientes que respondieron a la olanzapina fue significativamente mayor que los que respondieron a la risperidona o los antipsicóticos convencionales (p < 0,001). Los pacientes del grupo de olanzapina tuvieron mejorías mayores en todos los dominios de síntomas, incluyendo los síntomas generales, positivos, negativos, depresivos y cognoscitivos, en comparación con la risperidona (p<0,05) o los antipsicóticos convencionales (p<0,001). Los síntomas extrapiramidales (SEP) y la discinesia tardía (DT) disminuyeron desde la línea basal en los grupos tratados con olanzapina y risperidona, pero aumentaron en el grupo convencional. Los efectos adversos relacionados con la función sexual fueron más prominentes en el grupo convencional. Se observó ganancia de peso en cada grupo de tratamiento, aunque los pacientes del grupo de olanzapina aumentaron más de peso, seguidos por los de risperidona y después por los de antipsicóticos convencionales. Nuestros hallazgos en esta población de muestra latinoamericana emulan los resultados de otros estudios en muestras diferentes, donde se encontró que la olanzapina fue más efectiva y mejor tolerada que la risperidona o los antipsicóticos convencionales

The IC-SOHO study was designed to supply information on antipsychotic treatments in the real clinical practice by assessment of a large and diverse sample population with schizophrenia. This document describes the findings of the first 6 months of IC-SOHO in Latin America. To date, this is the largest observational study of its type in this region. In this observational and prospective study, those out-patients with schizophrenia, who require a change or initiation of antipsychotic medication are hospitalized. Effectiveness was evaluated using the Clinical Global Impression- Seriousness (CGI-S) grading scale. Tolerability was assessed by questionnaires on adverse events and weight measurements. Herein, the comparisons between olanzapine (monotherapy), risperidone (monotherapy) and conventional antipsychotics (monotherapy and combined therapy) are presented. As a whole, 7,658 patients participated in the ICSOHO; n=2,671 from 11 countries of Latin America that were included in this report. At 6 months, the proportion of patients who responded to olanzapine was significantly greater than those who responded to risperidone or conventional antipsychotics (p<0.001). Patients from the olanzapine group had greater improvements in all the symptom domains, including general, positive, negative, depressive and cognitive symptoms in comparison with risperidone (p<0.05) or conventional antipsychotics (p < 0.001). Extrapyramidal symptoms (EPS) and tardive dyskinesia (TD) decreased from baseline in the groups treated with olanzapine and risperidone, but increased in the conventional group. The adverse events related with the sexual function were more prominent in the conventional group. Weight gain was observed in each treatment group, although the patients from the olanzapine group had greater weight grain followed by those of risperidone and then by those of conventional antipsychotics. Our findings in this population of the Latin American sample emulate the results of other studies in different samples, where it was found that olanzapine was more effective and better tolerated than risperidone or conventional antipsychotics