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Un ensayo comparativo doble ciego distribuido al azar de amisulprida frente a olanzapina durante 2 meses en el tratamiento de sujetos con esquizofrenia y depresion comorbida

Published online by Cambridge University Press:  12 May 2020

J. M. Vanelle
Affiliation:
Servicio de Psiquiatría, Hospital Saint-Jacques 85, rué Saint-Jacques, 44200Nantes, Francia
S. Douki
Affiliation:
Hópital Razi, La Manouba, Túnez
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Resumen

Propόsito

Comparar la eficacia y la seguridad de la amisulprida y la olanzapina en sujetos con esquizofrenia y depresiόn comόrbida en un ensayo doble ciego distribuido al azar.

Pacientes

Se distribuyό al azar a amisulprida (200-600 mg/día) u olanzapina (5-15 mg/dia) durante 8 semanas a 85 pacientes adultos que cumplían los criterios del DSM-IV para esquizofrenia y presentaban un episodio depresivo. Las variables de eficacia primaria fueron el cambio en la puntuaciόn de la Escala de Depresiόn de Calgary (CDS) y la Impresiόn Clínica Global (CGI) de cambio. La seguridad se vigilό por los informes de acontecimientos adversos y la determinaciόn de la funciόn extrapiramidal y las variables metabόlicas.

Resultados

El cambio medio desde la línea de base de la puntuaciόn de la CDS fue -6,84 en el grupo de amisulprida y -7,36 en el grupo de olanzapina. Se consideraron “mucho” o “muchisimo” mejor, respectivamente, 65,9% y 61,5% de los sujetos. No se observaron diferencias intergrupo significativas en el tamaño del efecto. La frecuencia de acontecimientos adversos fue baja y no se vio apariciόn de síntomas extrapiramidales. Cuatro pacientes en el grupo de olanzapina desarrollaron concentraciones anormales de triglicéridos. El aumento medio de peso fue 1,45 y 0,5 kg, respectivamente, en los grupos de olanzapina y amisulprida.

Conclusion

La amisulprida y la olanzapina son efectivas en los pacientes con esquizofrenia y depresiόn comόrbida. La tolerancia de ambos fármacos fue aceptable, aunque el uso de olanzapina se asociaba con una tendencia a efectos secundarios metabόlicos mayores [19].

Type
Artículo original
Copyright
Copyright © European Psychiatric Association 2007

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