Análisis de costo-efectividad de escitalopram comparado con paroxetina, fluoxetina, sertralina, fluvoxamina y clomipramina como terapia de mantenimiento para pacientes con trastorno obsesivo compulsivo en Colombia / Cost-effectiveness analysis of escitalopram compared to paroxetine, fluoxetine, sertraline, fluvoxamine and clomipramine as maintenance therapy for patients with obsessive-compulsive disorder in Colombia

Problema de investigación: Analizar los costos y la efectividad del escitalopram comparado con paroxetina, sertralina, fluoxetina, fluvoxamina y clomipramina como terapia de mantenimiento de primera línea en pacientes con trastorno obsesivo compulsivo en Colombia. Tipo de evaluación económica: Análisis de costo-efectividad. Población objetivo: Pacientes mayores de 18 años con diagnóstico de trastorno obsesivo compulsivo. Intervención y comparadores: Comparadores: paroxetina, sertralina, fluoxetina, fluvoxamina y clomipramina. Horizonte temporal: 32 semanas. Perspectiva: Sistema General de Seguridad Social en Salud (SGSSS). Tasa de descuento: No aplica. Estructura del modelo: Árbol de decisión. Fuentes de datos de efectividad y seguridad: Reporte de efectividad y seguridad, Ensayos clínicos aleatorios. Desenlaces y valoración: Años de vida ajustados por calidad (AVAC). Costos incluidos: Costo de los medicamentos, Costo de procedimientos, Costo de los eventos adversos. Fuentes de datos de costos: SISMED, Manual tarifario ISS 2001. Resultados del caso base: En el escenario del caso base, fluvoxamina, fluoxetina, paroxetina y clomipramina son dominados por sertralina y escitalopram. El costo por AVAC es $16.084.456 de escitalopram comparado con sertralina. Análisis de sensibilidad: Los análisis de sensibilidad y el diagrama de tornado mostraron que las variables con mayor impacto sobre las estimaciones de costo-efectividad del escitalopram son la probabilidad de respuesta y retiro por eventos adversos del medicamento sertralina. Conclusiones y discusión: Escitalopram parece ofrecer una mejor relación entre costos y efectividad respecto a sus comparadores. La principal limitación de este estudio se centra en la ausencia de ensayos clínicos de no inferioridad con un horizonte de largo plazo. La principal limitación de este estudio se centra en la ausencia de ensayos clínicos de no inferioridad con un horizonte de largo plazo.(AU)

Efectividad y seguridad del escitalopram comparado paroxetina fluvoxamina, clomipramina para pacientes mayores de 16 años con diagnóstico de Trastorno Obsesivo Compulsivo / Effectiveness and safety of escitalopram compared to paroxetine fluvoxamine, clomipramine for patients over 16 years of age with a diagnosis of Obsessive Compulsive Disorder

Introducción: se estima que la prevalencia del Trastorno Obsesivo Compulsivo (TOC) en la población general es de 1.6% (1), siendo uno de los principales trastornos que afecta a niños y adolescentes. Estudios realizados en Colombia muestran mayor incidencia de este trastorno en las mujeres con respecto a los hombres, evidenciándose una fuerte relación con episodios psicóticos y otros tipos de trastornos como la esquizofrenia. Objetivo: esta evaluación de tecnología tiene como objetivo examinar los beneficios y riesgos del uso del Escitalopram en el Trastorno Obsesivo Compulsivo, como uno de los criterios para informar la toma de decisiones relacionada con la posible inclusión de tecnologías en el Plan Obligatorio de Salud, en el marco de su actualización integral para el año 2015. Metodología: a partir de la pregunta PICO se establecieron los criterios de elegibilidad para la realización de la búsqueda de la evidencia científica (ensayos clínicos, revisiones sistemáticas de estudios observacionales y estudios de cohortes analíticas). Se realizó la tamización y selección de la evidencia evaluando su calidad y posteriormente se realizó la extracción de datos y la síntesis de la evidencia. Resultados: Se identificaron dos experimentos clínicos con asignación aleatoria, controlados por placebo, para evaluar la efectividad y tolerabilidad del Escitalopram en el manejo del TOC, sin embargo, ambos estudios se encontraban fuera del rango de fechas establecidas para la búsqueda de la literatura, por lo que no fueron considerados para la elaboración del presente informe. Uno de los experimentos clínicos realizado con Escitalopram fue incorporado en una revisión sistemática y un meta-análisis más recientes. El propósito del meta-análisis fue evaluar la relación dosis-respuesta de los Inhibidores Selectivos de la Recaptación de la Serotonina con la tasa de mejoría de los pacientes medido como el cambio promedio en la escala Y-BOC. Los resultados sugieren que altas dosis de ISRS son más efectivas para el tratamiento de esta enfermedad (F = 10,8, df = 3, P <0,001). Asimismo, no hubo una tendencia significativa en términos de la proporción de abandonos relacionadas a la dosis del ISRS (X2 = 1,6, df = 1, p = 0,20). Ninguna de las diferentes categorías de dosis de ISRS difería de placebo, o entre sí, en términos de la proporción de causas abandonos de la terapia. Conclusiones: los pocos experimentos clínicos ejecutados a la fecha en el TOC, están focalizados en demostrar la efectividad de los Inhibidores Selectivos de la Recaptación de la Serotonina como un grupo, por lo que no se ha acumulado un cuerpo de evidencia suficiente para establecer le efectividad de cada uno de estos medicamentos de manera más específica. Varios estudios se han ejecutado para investigar algunos aspectos más generales de los ISRS, como por ejemplo la utilidad de emplear estos medicamentos a altas dosis para mejorar el índice de respuesta de los pacientes a estos tratamientos. En dos experimentos clínicos registrados hasta la fecha, el Escitalopram mostró ser más efectivo en comparación con el placebo en el tratamiento del TOC, además de ser bien tolerado por los sujetos durante terapias de largo término.(AU)

Psychodynamic psychotherapy and clomipramine in the treatment of major depression.

OBJECTIVE: The authors compared a combination of clomipramine and psychodynamic psychotherapy with clomipramine alone in a randomized controlled trial among patients with major depression. METHODS: Seventy-four patients between the ages of 20 and 65 years who were assigned to ten weeks of acute outpatient treatment for major depression were studied. Bipolar disorder, psychotic symptoms, severe substance dependence, organic disorder, past intolerance to clomipramine, and mental retardation were exclusion criteria. RESULTS: Marked improvement was noted in both treatment groups. Combined treatment was associated with less treatment failure and better work adjustment at ten weeks and with better global functioning and lower hospitalization rates at discharge. A cost savings of 2,311 dollars per patient in the combined treatment group, associated with lower rates of hospitalization and fewer lost work days, exceeded the expenditures related to providing psychotherapy. CONCLUSIONS: Provision of supplemental psychodynamic psychotherapy to patients with major depression who are receiving antidepressant medication is cost-effective.

Assessment of the serotonin and norepinephrine reuptake blocking properties of duloxetine in healthy subjects.

Duloxetine is a dual inhibitor of norepinephrine (NE) and serotonin (5-HT) uptake. Initial trials conducted in depressed patients using regimens of 20 mg/day or less did not convincingly demonstrate its efficacy as an antidepressant. The aim of this study was to assess the effects of duloxetine on the 5-HT and NE reuptake processes in healthy human volunteers. Twenty-seven healthy young males without a history of psychiatric disorder were randomly assigned to four groups, each group receiving one of the following daily drug regimens: placebo, clomipramine (a potent 5-HT/NE reuptake blocker) 100 mg/day, duloxetine 20 mg/day, or duloxetine 60 mg/day. In order to assess the NE reuptake process, the pressor response to intravenous tyramine (4 and 6 mg) was measured. Determination of the whole blood 5-HT content was used to evaluate the 5-HT reuptake blockade. These measurements were performed at baseline and repeated after 7 and 14 days of drug intake. Both duloxetine, at doses of 20 to 60 mg/day, and clomipramine significantly interfered with the 5-HT reuptake process, as demonstrated by marked decreases in blood 5-HT concentrations. However, the same doses of duloxetine, unlike clomipramine, failed to impede the usual increase in blood pressure that follows a tyramine intravenous infusion, indicating that clomipramine but not duloxetine blocked NE reuptake. At doses tested in a population of healthy volunteers, duloxetine acted as a selective 5-HT reuptake inhibitor, having no clear effect on the NE reuptake process. Nevertheless, given that the highest dose of duloxetine increased supine systolic blood pressure, it is possible that it represents the threshold regimen for NE reuptake inhibition.

Therapeutic effects and long-term efficacy of antidepressant medication for persons with developmental disabilities. Behavioral assessment in two cases of treatment-resistant aggression and self-injury.

Recent advances in pharmacological treatment of severe behavior disorders in persons with developmental disabilities suggest the use of antidepressant medication for therapeutic management. This research evaluated two antidepressant medications for treatment-resistant aggression and self-injury exhibited by two persons with developmental disabilities. Behavioral assessment data documented that sertraline (a serotonin selective reuptake inhibitor) was effective in reducing self-injurious behaviors in a 20-year-old man with severe mental retardation and clomipramine (a tricyclic antidepressant) was associated with the elimination of aggressive behavior in a 14-year-old boy with autism. Clinical effects from the medications were measured in relation to and shown to be a function of dosage level. Extended follow-up assessments revealed maintenance of treatment gains with continued medication administration.

Sertraline and obsessive compulsive disorder: new indication. Limited assessment.

(1) Sertraline, a selective serotonin reuptake inhibitor (SSRI), is now licensed in France for the treatment of obsessive-compulsive disorder in adults. (2) In this indication the clinical file is of acceptable methodological quality, but it is incomplete: sertraline has not been compared with the other two serotonin reuptake inhibitors approved in obsessive-compulsive disorder, namely fluoxetine and paroxetine. (3) Three placebo-controlled trials have demonstrated the efficacy of sertraline in obsessive-compulsive disorder. (4) In a trial versus clomipramine, sertraline was no more effective in patients able to tolerate the drug, but the rate of treatment withdrawals for adverse events was higher on clomipramine.

Comorbid anxious signs and symptoms in major depression: impact on functional work capacity and comparative treatment outcomes.

Psychological distress is a driver both of direct and indirect health care costs. Depression compromises functional well-being, such as work productivity. Comorbid anxious features often complicate the recognition of depression and may herald a poor prognosis. We report the results of a cross-sectional naturalistic study to determine the impact of three interventions (no antidepressant, fluoxetine, or tricyclic antidepressant therapy) on relative risk of work days lost in 454 French outpatients with either major or minor depression. Most depressed patients also manifested anxious features (76% with a Hamilton Rating Scale for Anxiety score > or = 12). The presence of anxiety was related to the severity of depression, work absenteeism, and current social instability. Depression severity (Hamilton Rating Scale for Depression score > or = 26, including the contributions of anxious symptoms), psychiatric comorbidity, and psychomotor retardation best predicted continued work absenteeism. Patients with major depression were more likely to receive an antidepressant if they had a past history of depressive episodes and/or previous work disability. Patients with minor depression were less likely to receive drug therapy than patients with major depression, despite their current work disability. Among patients who received fluoxetine or a tricyclic antidepressant for at least 8 weeks, fluoxetine was associated with statistically significantly lower mean anxiety and depression scores and fewer work days missed.

The Shapiro cards scale as a method of assessment of obsessional symptoms in clomipramine therapy.

One of the major problems encountered in research into the value of a new treatment for obsessional states is the small number of patients seen in any one centre. Another problem is the great diversity of symptoms which obsessional patients display. These two problems may be partly overcome by the use of the method of rating devised by Shapiro. The technique is described and its application to the treatment of obsessional disorders illustrated.