Eficacia del alprazolam en comprimidos sublinguales para el tratamiento de los trastornos de pánico en la fase aguda.

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Title: Eficacia del alprazolam en comprimidos sublinguales para el tratamiento de los trastornos de pánico en la fase aguda.
Alternate Title: Efficacy of alprazolam sublingual tablets in the treatment of the acute phase of panic disorders.
Authors: Márquez, Miguel1 miguelmarquez@fibertel.com.ar, Arenoso, Hector2, Caruso, Norberto2
Source: Actas Espanolas de Psiquiatria. mar2011, Vol. 39 Issue 2, p88-94. 7p. 11 Charts.
Subjects: ALPRAZOLAM, ANTIDEPRESSANTS, TRANQUILIZING drugs, PANIC disorder treatment, PANIC attacks, AGORAPHOBIA, ACUTE diseases, THERAPEUTICS
Geographic Terms: ARGENTINA
Abstract (English): Background. Panic disorder affects 2-5% of the general population. In Argentina, one million people would be affected with a 91% rate of psychiatric comorbidity. Aim. To compare efficacy parameters between sublingual (ALP-SL) and conventional (ALP-CT) tablets of alprazolam in the treatment of acute phase of panic disorder with and without agoraphobia. Subjects and Methods. A comparative, multicenter (6 sites), double blind, randomized study was carried out. A total of 190 outpatients with (n=117) and without (n=73) agoraphobia were treated with ALP-SL or ALP-CT for 12 weeks. Outcome was assessed with the Clinical Global Impressions (CGI-S/CGI-I), Hamilton Rating Scale for Anxiety (HAM-A), Arizona Sexual Experiences Scale (ASEX), Patient Global Impression (PGI), Psychological General Well-Being Index (PGWBI), Panic Disorder Severity Scale (PDSS) also by the number of panic attacks and extension and intensity of panic attacks and anticipatory anxiety. Results. Both treatments resulted in statistically significant clinical improvement in all measures. ASEX presented no changes during the study. The average dose of alprazolam for 12 weeks was 1.36 ± 0.70 mg/day (1.39 ± 0.77 ALP-CT and 1.33 ± 0.64 ALP-SL). With ALP-SL, panic attacks were shorter (p < 0.05) with shorter extension (p=0.16) and intensity of anticipatory anxiety (p=0.14). The treatment was well tolerated, there being no differences between both groups. Conclusions. Alprazolam has been demonstrated to have efficacy, safety and good tolerability in the treatment of the acute phase of panic disorder, the sublingual tablets showing some comparative advantages. [ABSTRACT FROM AUTHOR]
Abstract (Spanish): Introducción. El trastorno de pánico afecta del 2 al 5% de la población general. En Argentina habría un millón de afectados con una tasa de comorbilidad psiquiátrica del 91%. Objetivo. Comparar parámetros de eficacia entre comprimidos convencionales (CC) y sublinguales (CS) de alprazolam en el tratamiento de la fase aguda de los trastornos de pánico con o sin agorafobia. Metodología. Estudio comparativo, multicéntrico (6 centros), doble ciego, aleatorizado. Se trataron 190 pacientes con (n=117) y sin (n=73) agorafobia, con CC o CS durante 12 semanas y se evaluaron con: Impresión Clínica Global (CGI), Escala de Ansiedad de Hamilton, Escala de Experiencia Sexual de Arizona (ASEX), Impresión General del Paciente (PGI), Índice de Bienestar Psicológico y General (PGWBI), Escala de Severidad del Trastorno de Pánico (PDSS) y por la cantidad de ataques de pánico, su duración, intensidad y ansiedad anticipatoria. Resultados. Ambos tratamientos lograron una mejoría clínica estadísticamente significativa en todas las mediciones. El ASEX no presentó cambios durante el estudio. La dosis promedio de alprazolam durante las 12 semanas fue de 1,36 ± 0,70 mg/día (1,39 ± 0,77 CC y 1,33 ± 0,64 CS). Con CS los ataques de pánico fueron más breves (p < 0,05) así como menor la duración (p=0,16) e intensidad de la ansiedad anticipatoria (p=0,14). El tratamiento fue bien tolerado sin diferencias entre los dos grupos. Conclusiones. el alprazolam demostró eficacia, seguridad y buena tolerabilidad en el tratamiento de la fase aguda de los trastornos de pánico. Los comprimidos sublinguales mostraron algunas ventajas comparativas. [ABSTRACT FROM AUTHOR]
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Database: MedicLatina
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Abstract:Background. Panic disorder affects 2-5% of the general population. In Argentina, one million people would be affected with a 91% rate of psychiatric comorbidity. Aim. To compare efficacy parameters between sublingual (ALP-SL) and conventional (ALP-CT) tablets of alprazolam in the treatment of acute phase of panic disorder with and without agoraphobia. Subjects and Methods. A comparative, multicenter (6 sites), double blind, randomized study was carried out. A total of 190 outpatients with (n=117) and without (n=73) agoraphobia were treated with ALP-SL or ALP-CT for 12 weeks. Outcome was assessed with the Clinical Global Impressions (CGI-S/CGI-I), Hamilton Rating Scale for Anxiety (HAM-A), Arizona Sexual Experiences Scale (ASEX), Patient Global Impression (PGI), Psychological General Well-Being Index (PGWBI), Panic Disorder Severity Scale (PDSS) also by the number of panic attacks and extension and intensity of panic attacks and anticipatory anxiety. Results. Both treatments resulted in statistically significant clinical improvement in all measures. ASEX presented no changes during the study. The average dose of alprazolam for 12 weeks was 1.36 ± 0.70 mg/day (1.39 ± 0.77 ALP-CT and 1.33 ± 0.64 ALP-SL). With ALP-SL, panic attacks were shorter (p < 0.05) with shorter extension (p=0.16) and intensity of anticipatory anxiety (p=0.14). The treatment was well tolerated, there being no differences between both groups. Conclusions. Alprazolam has been demonstrated to have efficacy, safety and good tolerability in the treatment of the acute phase of panic disorder, the sublingual tablets showing some comparative advantages. [ABSTRACT FROM AUTHOR]
ISSN:11399287