Sertraline hydrochloride for reducing impulsive behaviour in male, repeat-violent offenders (ReINVEST): protocol for a phase IV, double-blind, placebo-controlled, randomised clinical trial.

INTRODUCTION: Considerable evidence supports an association between poor impulse control (impulsivity) and violent crime. Furthermore, impulsivity and aggression has been associated with reduced levels of serotonergic activity in the brain. Selective serotonin reuptake inhibitors (SSRIs) are a class of anti-depressants that aim to regulate brain serotonin concentrations. Several small studies in psychiatric populations have administered SSRIs to impulsive--aggressive individuals, resulting in reduced impulsivity, anger, aggression and depression. However, no clinical trial has been undertaken in a criminal justice population. This protocol describes the design and implementation of the first systematic study of the potential benefits of SSRIs in impulsive---violent offenders who are at high risk of reoffending. METHODS AND ANALYSIS: A randomised, double-blinded, multicentre trial to test the clinical efficacy of an SSRI, sertraline hydrochloride, compared with placebo on recidivism and behavioural measures (including impulsivity, anger, aggression, depression and self-reported offending) over 12 months. 460 participants with histories of violence and screening positive for impulsivity are recruited at several local courts and correctional service offices in New South Wales, Australia. ETHICS AND DISSEMINATION: Results will be submitted for publication in a peer-reviewed journal. Possible implications of the effectiveness of this pharmacological intervention include economic benefits of reducing prison costs and societal benefits of improving safety. This study has received ethical approval from the University of New South Wales, Aboriginal Health & Medical Research Council, Corrective Services NSW and the NSW Justice Health and Forensic Mental Health Network. TRIAL REGISTRATION NUMBER: ACTRN12613000442707.

Residual symptoms of PTSD following Sertraline plus enhanced medication management, Sertraline plus PE, and PE plus placebo.

Although prolonged exposure (PE) and SSRI antidepressants are effective in treating posttraumatic stress disorder (PTSD), previous studies have shown that some symptoms tend to persist. The current study compared sertraline hydrochloride plus enhanced medication management (EMM), PE plus placebo, or PE plus sertraline hydrochloride in the likelihood of each individual PTSD symptom persisting in veterans with a PTSD diagnosis. We compared the likelihood of individual PTSD symptoms persisting in those with versus without a PTSD diagnosis at posttreatment. We found no significant differences across conditions in which symptoms were likely to persist posttreatment. Among those without a PTSD diagnosis at posttreatment, sleeping difficulties (63.0%), hypervigilance (47.3%), and nightmares (45.0%) were most likely to persist. Findings indicate no consistent differences in residual symptoms between PE and medications, and shared decision making with patients is encouraged in selecting treatments. Gold standard treatments (e.g., CBT-I) may be warranted for residual symptoms like insomnia.

A randomised controlled trial assessing the use of citalopram, sertraline, fluoxetine and mirtazapine in preventing relapse in primary care patients who are taking long-term maintenance antidepressants (ANTLER: ANTidepressants to prevent reLapse in dEpRession): study protocol for a randomised controlled trial.

BACKGROUND: Antidepressants are used both for treating acute episodes and for prophylaxis to prevent future episodes of depression, also called maintenance treatment. This article describes the protocol for a randomised controlled trial (ANTLER: ANTidepressants to prevent reLapse in dEpRession) to investigate the clinical effectiveness and cost-effectiveness in UK primary care of continuing on long-term maintenance antidepressants compared with a placebo in preventing relapse of depression in those who have taken antidepressants for more than 9 months and who are currently well enough to consider stopping maintenance treatment. METHODS/DESIGN: The ANTLER trial is an individually randomised, double-blind, placebo-controlled trial in which participants are randomised to remain on active medication or to take an identical placebo after a tapering period of 2 months. Eligible participants are those who: are between the ages of 18 and 74 years; have had at least two episodes of depression; and have been taking antidepressants for 9 months or more and are currently taking citalopram 20 mg, sertraline 100 mg, fluoxetine 20 mg or mirtazapine 30 mg but are well enough to consider stopping their medication. The participants will be followed up at 6, 12, 26, 39 and 52 weeks. The primary outcome will be the time in weeks to the beginning of the first episode of depression after randomisation. This will be measured using a retrospective version of the Clinical Interview Schedule-Revised administered at 12, 26, 39 and 52 weeks. Secondary outcomes will include depressive and anxiety symptoms, adverse effects, withdrawal symptoms, emotional processing tasks, quality of life and the resources and costs used. We will also perform a cost-effectiveness analysis based on results of the trial. DISCUSSION: The ANTLER trial findings will inform primary care prescribing practice by providing a valid and generalisable estimate of the clinical effectiveness and cost-effectiveness of long-term maintenance treatment with antidepressants in UK primary care. TRIAL REGISTRATION: Controlled Trials ISRCTN Registry, ISRCTN15969819. Registered on 21 September 2015.

Comparative effectiveness of generic and brand-name medication use: A database study of US health insurance claims.

BACKGROUND: To the extent that outcomes are mediated through negative perceptions of generics (the nocebo effect), observational studies comparing brand-name and generic drugs are susceptible to bias favoring the brand-name drugs. We used authorized generic (AG) products, which are identical in composition and appearance to brand-name products but are marketed as generics, as a control group to address this bias in an evaluation aiming to compare the effectiveness of generic versus brand medications. METHODS AND FINDINGS: For commercial health insurance enrollees from the US, administrative claims data were derived from 2 databases: (1) Optum Clinformatics Data Mart (years: 2004-2013) and (2) Truven MarketScan (years: 2003-2015). For a total of 8 drug products, the following groups were compared using a cohort study design: (1) patients switching from brand-name products to AGs versus generics, and patients initiating treatment with AGs versus generics, where AG use proxied brand-name use, addressing negative perception bias, and (2) patients initiating generic versus brand-name products (bias-prone direct comparison) and patients initiating AG versus brand-name products (negative control). Using Cox proportional hazards regression after 1:1 propensity-score matching, we compared a composite cardiovascular endpoint (for amlodipine, amlodipine-benazepril, and quinapril), non-vertebral fracture (for alendronate and calcitonin), psychiatric hospitalization rate (for sertraline and escitalopram), and insulin initiation (for glipizide) between the groups. Inverse variance meta-analytic methods were used to pool adjusted hazard ratios (HRs) for each comparison between the 2 databases. Across 8 products, 2,264,774 matched pairs of patients were included in the comparisons of AGs versus generics. A majority (12 out of 16) of the clinical endpoint estimates showed similar outcomes between AGs and generics. Among the other 4 estimates that did have significantly different outcomes, 3 suggested improved outcomes with generics and 1 favored AGs (patients switching from amlodipine brand-name: HR [95% CI] 0.92 [0.88-0.97]). The comparison between generic and brand-name initiators involved 1,313,161 matched pairs, and no differences in outcomes were noted for alendronate, calcitonin, glipizide, or quinapril. We observed a lower risk of the composite cardiovascular endpoint with generics versus brand-name products for amlodipine and amlodipine-benazepril (HR [95% CI]: 0.91 [0.84-0.99] and 0.84 [0.76-0.94], respectively). For escitalopram and sertraline, we observed higher rates of psychiatric hospitalizations with generics (HR [95% CI]: 1.05 [1.01-1.10] and 1.07 [1.01-1.14], respectively). The negative control comparisons also indicated potentially higher rates of similar magnitude with AG compared to brand-name initiation for escitalopram and sertraline (HR [95% CI]: 1.06 [0.98-1.13] and 1.11 [1.05-1.18], respectively), suggesting that the differences observed between brand and generic users in these outcomes are likely explained by either residual confounding or generic perception bias. Limitations of this study include potential residual confounding due to the unavailability of certain clinical parameters in administrative claims data and the inability to evaluate surrogate outcomes, such as immediate changes in blood pressure, upon switching from brand products to generics. CONCLUSIONS: In this study, we observed that use of generics was associated with comparable clinical outcomes to use of brand-name products. These results could help in promoting educational interventions aimed at increasing patient and provider confidence in the ability of generic medicines to manage chronic diseases.

Escitalopram para trastornos psiquiátricos / Escitalopram for psychiatric disorders

En el Perú se estima que en el 2012 los trastornos mentales y de comportamiento en el Perú́ concentraron el 17% del total de años saludables perdidos por discapacidad y muerte prematura siendo responsables de la pérdida de 1 millón 10 mil 594 años saludables, representando la primera carga de años saludables perdidos en el país. La familia de los inhibidores selectivos de la recaptación de serotonina (ISRS) es una de las más usadas en psiquiatría. El mecanismo de acción principal de los ISRS generalmente se explica simplemente por su inhibición selectiva del transportador de serotonina. - Escitalopram es un fármaco de la familia de los ISRS. Se trata del enantiómero levógiro (S) puro del citalopram. Como todos los ISRS actúa inhibiendo selectivamente la recaptación de serotonina en la hendidura sináptica interneuronal, incrementa la concentración sináptica de serotonina y activa las vías serotonérgicas neurales. Se postula que el escitalopram podría ser una opción de tratamiento eficaz y asociada a menos eventos adversos comparado con sertalina y fluoxetina. - Se identificaron 3 RS. Además, se identificó tres GPC que mencionaban a la tecnología. No se encontraron ETS, ni EE de la región. - La evidencia con respecto a escitalopram en trastornos psiquiátricos es abundante. Para depresión y ansiedad generalizada en adultos, se evidencia una adecuada respuesta a tratamiento de escitalopram versus placebo. En comparaciones indirectas se evidencia un beneficio de escitalopram por sobre fluoxetina para depresión, pero no se evidencia diferencia con sertralina. Basado también en comparaciones indirectas, en el caso de ansiedad generalizada no hay diferencias entre la tecnología de interés y los comparadores. En el caso de efectividad en niños con diagnóstico de depresión, se identifica escitalopram y fluoxetina como los medicamentos con mayor evidencia y que mostraron beneficio, sin embargo, no se tiene disponibilidad de estudios comparativos de escitalopram vs fluoxetina o sertralina. - Las guías de práctica clínica recabadas, en general, recomiendan el uso de inhibidores de la recaptación de serotonina indistintamente como primera línea mencionando que la decisión entre estos medicamentos depende de las características del paciente, interacciones con drogas y criterio clínico.

Trends and Patterns of Antidepressant Use in French Children and Adolescents From 2009 to 2016: A Population-Based Study in the French Health Insurance Database.

PURPOSE/BACKGROUND: Over the last decade, the use of antidepressants (ATDs) in children and adolescents has markedly increased in several occidental countries, but recent data in French children are missing. This study aimed to assess trends of ATD use in French children (6-11 years) and adolescents (12-17 years) and to characterize changes in ATD prescribing patterns from 2009 to 2016. METHODS: Using data from the French Health Insurance Database, annual prevalence and incidence of ATD use and changes in ATD prescribing patterns were analyzed. RESULTS: Overall ATD prevalence of use rose slightly from 0.51% in 2009 to 0.53% in 2016 (+3.9%), with a decrease in children (0.18%-0.11%; -38.9%) and an increase in adolescents (0.86%-0.98%; +14.0%) and an overall female preponderance (56.7% in 2009; 58.7% in 2016). Serotonin reuptake inhibitor prevalence of use increased from 0.24% to 0.34%, whereas tricyclic ATD use decreased (from 0.20% to 0.16%). Similar trends were obtained with overall incidence of use, from 0.39% in 2009 to 0.36% in 2016 (-7.7%). Sertraline was the most frequently prescribed in adolescents (2009: 22.2% of all ATD prescriptions; 2016: 32.9%), whereas amitriptyline was the most prescribed in children (2009: 42.7% and 2016: 41.2%). Off-label use decreased in adolescents (from 48.4% to 34.8%) but increased in children (from 10.0% to 26.5%). IMPLICATIONS/CONCLUSIONS: Antidepressant level of use in French children and adolescents was stable in recent years and lower than that observed in other European countries and the United States.

Improvements in Quality-Adjusted Life Years and Cost-Utility After Pharmacotherapy for Premenstrual Dysphoric Disorder: A Retrospective Study.

BACKGROUND AND OBJECTIVE: To investigate the cost-effectiveness of pharmacotherapy for premenstrual dysphoric disorder (PMDD), a relatively new classification of depressive disorder that is characterized by recurrent depression during the premenstrual phase of the menstrual cycle. METHODS: We performed a retrospective analysis of data from 49 previously untreated PMDD patients who visited our psychiatric department between October 2013 and February 2016 and received pharmacotherapy for 3 or 6 subsequent menstrual cycles. Quality-adjusted life years (QALYs) were estimated across individual menstrual cycles using mean EuroQoL-5D values. Direct costs per patient were estimated in order to conduct a preliminary cost-effectiveness analysis. RESULTS: Pharmacotherapy produced a 0.190-point increase in mean EuroQoL-5D score per menstrual cycle after 6 menstrual cycles and an improvement of approximately 0.2 QALYs. Based on direct costs of 156,000 yen per patient, the cost-effectiveness of pharmacotherapy was calculated to be 823,000 yen per QALY. A cost-effectiveness acceptability curve analysis indicated that escitalopram tended to be superior to sertraline when willingness to pay per QALY was over 4,000,000 yen, whereas sertraline was superior when willingness to pay was below 2,000,000 yen. CONCLUSIONS: Pharmacotherapy is cost effective for the treatment of PMDD. Moreover, escitalopram is a more cost-effective option than sertraline when willingness to pay is sufficiently high.

Análisis de impacto presupuestal de citalopram, clomipramina escitalopram, paroxetina, fluvoxamina, fluoxetina y sertralina para pacientes con Trastorno Obsesivo Compulsivo en Colombia / Budget impact analysis of citalopram, clomipramine escitalopram, paroxetine, fluvoxamine, fluoxetine and sertraline for patients with Obsessive Compulsive Disorder in Colombia

INTRODUCCIÓN: El análisis de impacto presupuestal (AIP) del citalopram, clomipramina, escitalopram, paroxetina, fluvoxamida, fluoxetina y sertralina para pacientes con trastorno obsesivo compulsivo (TOC) en Colombia, se desarrolló en el marco del mecanismo técnico-científico para la ampliación progresiva del Plan de Beneficios en Salud con cargo a la UPC (PBSUPC) y la definición de la lista de exclusiones, establecido en el artículo 15 de la Ley 1751 de 2015 (1). Estas tecnologías fueron seleccionadas por la Dirección de Beneficios, Costos y Tarifas del Aseguramiento en Salud del Ministerio de Salud y Protección Social (MinSalud), y remitidas al Instituto de Evaluación Tecnológica en Salud (IETS) para su evaluación. El TOC es un trastorno de ansiedad que se caracteriza por pensamientos intrusivos, recurrentes (obsesiones) y persistentes, que producen inquietud, temor o preocupación y comportamientos repetitivos (compulsiones) dirigidos a reducir la ansiedad asociada. Afectan el rendimiento laboral, académico y las relaciones interpersonales, generando un deterioro en la calidad de vida de los pacientes, así como el desarrollo de ideas o comportamientos suicidas. Se estima que la prevalencia del TOC en la población general a nivel mundial es de 1,6%, siendo uno de los principales trastornos que afecta a niños y adolescentes (3). La prevalencia de TOC en Colombia oscila entre el 0,9% y el 2,4% (4); se ha observado una mayor incidencia de este trastorno en las mujeres que en los hombres, en quienes se evidencia una fuerte relación de episodios psicóticos con otros tipos de trastornos como la esquizofrenia (5,6).Según los reportes del Sistema Integral de Información de la Protección Social (SISPRO), entre los años 2009 y 2013, se diagnosticaron en promedio 1194 casos nuevos de pacientes con TOC en Colombia. Adicionalmente, se ha encontrado que el 55 % de los casos reportados han sido en pacientes entre los 27 a 59 años de edad. El DSM-IV establece como criterio para el diagnóstico de TOC, que las obsesiones y compulsiones resulten excesivas o irracionales para el paciente, aunque aclara que este criterio no es aplicable a los menores, ya que es frecuente que estos síntomas sean ego sintónicos para los niños e incluso para algunos adolescentes (8). En la actualidad, el TOC es entendido como un único trastorno sea cual sea la edad en el que aparezca, aunque en el 80% de los casos el inicio del trastorno ocurre antes de los 18 años. Este documento describe la metodología desarrollada para realizar el análisis de impacto presupuestal de citalopram y clomipramina para pacientes con TOC que requieren manejo farmacológico en Colombia. Este informe, sigue los lineamientos propuestos en el Manual para la Elaboración de Análisis de Impacto Presupuestal y en el Manual de Participación y Deliberación publicados por IETS. TECNOLOGÍAS EVALUADAS: En el escenario actual se incluyeron las tecnologías que se encuentran cubiertas por el Plan de Beneficios en Salud con cargo a la UPC (PBSUPC) para el TOC. Así mismo, se definieron los tratamientos farmacológicos para primera y segunda línea del TOC a partir de consideraciones clínicas expuestas por los expertos temáticos. Los tratamientos farmacológicos con las tecnologías que se encuentran dentro del escenario actual son: Tratamiento de primera línea: sertralina y fluoxetina. Tratamiento de segunda línea: no se identificó ninguna tecnología. INSUMOS Y MÉTODOS: Esta sección presenta los supuestos, parámetros y métodos utilizados para el modelo de estimación del impacto presupuestal. Cada una de las fuentes de información, estructuración de casos tipo y supuestos de modelación que fueron discutidos con el grupo de expertos temáticos en espacios de participación promovidos por el IETS. DISTRIBUCIÓN DE LA POBLACIÓN EN EL ESCENARIO ACTUAL: De acuerdo a la Base de Datos Única de Afiliados del Sistema General en Salud (BDUA) para el año 2017 se registran 32.768.685 personas mayores de 18 años en Colombia; al aplicar la prevalencia de TOC identificada previamente, se estimaron 1.540.128,195 casos. Considerando que entre estos pacientes el 33% presentan comorbilidades, el número de casos que tendrían únicamente diagnóstico de TOC correspondería a 508.242 casos. Para establecer la probabilidad de requerir tratamiento farmacológico en los pacientes con diagnóstico de TOC, el consenso de expertos y el estudio publicado por Martin P, en el año 2003 establecen que aproximadamente el 68% de los pacientes con TAG requieren tratamiento farmacológico de primera línea (22); tomando esta probabilidad se estiman para Colombia 345.605 casos de TOC como población objetivo para el presente AIP. Para establecer la probabilidad de requerir tratamiento farmacológico de segunda línea en los pacientes con diagnóstico de TOC, se extrajeron las probabilidades de respuesta a los tratamientos de primera línea reportadas en el 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 (21). Considerando este estudio, se estableció que la probabilidad de respuesta a los tratamientos de primera línea es de 0,515, por lo tanto, por propiedades de probabilidades complementarias, se estimó que el 48% (1-p) de los pacientes requerirían tratamiento de segunda línea, dando como resultado una estimación de 165.890 casos. MÉTODOS DE COSTEO Y COSTOS: Se obtuvo como primera medida los registros sanitarios vigentes por parte del INVIMA para el primer semestre del 2017. Para la valoración de los medicamentos se utilizó SISMED para el año 2016 (enero-diciembre), tomando como base el canal institucional laboratorio. Para cada tratamiento se identificó la dosis promedio recomendada para cada tecnología sugerida en la fuente de información Micromedex ® 2017 (23), la periodicidad y la duración del tratamiento. El precio promedio, mínimo y máximo por tableta o unidad calculada corresponde al precio ponderado de las diferentes presentaciones del medicamento, el cual comprende tanto los genéricos como las moléculas originales. Con lo anterior se buscó determinar un precio ponderado del principio activo, y no de una molécula en particular. Adicionalmente se revisaron las circulares de regulación de precios del Ministerio de Salud, con el fin de identificar si a la fecha existe un precio máximo regulado de alguna de las alternativas de comparación. El procedimiento para calcular los precios de los medicamentos siguió las recomendaciones del manual metodológico para la elaboración de evaluaciones económicas del IETS. RESULTADOS: Los resultados que se presentan en el informe corresponde al impacto presupuestal total e incremental obtenidos en los escenarios 1 y 2 para los tratamientos de TOC de primera y segunda línea.

Pilot of a randomised controlled trial of the selective serotonin reuptake inhibitor sertraline versus cognitive behavioural therapy for anxiety symptoms in people with generalised anxiety disorder who have failed to respond to low-intensity psychological treatments as defined by the National Institute for Health and Care Excellence guidelines.

BACKGROUND: Generalised anxiety disorder (GAD) is common, causing unpleasant symptoms and impaired functioning. The National Institute for Health and Care Excellence (NICE) guidelines have established good evidence for low-intensity psychological interventions, but a significant number of patients will not respond and require more intensive step 3 interventions, recommended as either high-intensity cognitive behavioural therapy (CBT) or a pharmacological treatment such as sertraline. However, there are no head-to-head comparisons evaluating which is more clinically effective and cost-effective, and current guidelines suggest that treatment choice at step 3 is based mainly on patient preference. OBJECTIVES: To assess clinical effectiveness and cost-effectiveness at 12 months of treatment with the selective serotonin reuptake inhibitor (SSRI) sertraline compared with CBT for patients with persistent GAD not improved with NICE-defined low-intensity psychological interventions. DESIGN: Participant randomised trial comparing treatment with sertraline with high-intensity CBT for patients with GAD who had not responded to low-intensity psychological interventions. SETTING: Community-based recruitment from local Improving Access to Psychological Therapies (IAPT) services. Four pilot services located in urban, suburban and semirural settings. PARTICIPANTS: People considered likely to have GAD and not responding to low-intensity psychological interventions identified at review by IAPT psychological well-being practitioners (PWPs). Those scoring ≥ 10 on the Generalised Anxiety Disorder-7 (GAD-7) anxiety measure were asked to consider involvement in the trial. INCLUSION CRITERIA: Aged ≥ 18 years, a score of ≥ 10 on the GAD-7, a primary diagnosis of GAD diagnosed on the Mini International Neuropsychiatric Interview questionnaire and failure to respond to NICE-defined low-intensity interventions. EXCLUSION CRITERIA: Inability to participate because of insufficient English or cognitive impairment, current major depression, comorbid anxiety disorder(s) causing greater distress than GAD, significant dependence on alcohol or illicit drugs, comorbid psychotic disorder, received antidepressants in past 8 weeks or high-intensity psychological therapy in previous 6 months and any contraindications to treatment with sertraline. RANDOMISATION: Consenting eligible participants randomised via an independent, web-based, computerised system. INTERVENTIONS: (1) The SSRI sertraline prescribed in therapeutic doses by the patient's general practitioner for 12 months and (2) 14 (± 2) CBT sessions delivered by high-intensity IAPT psychological therapists in accordance with a standardised manual designed for GAD. MAIN OUTCOME MEASURES: The primary outcome was the Hospital Anxiety and Depression Scale - Anxiety component at 12 months. Secondary outcomes included measures of depression, social functioning, comorbid anxiety disorders, patient satisfaction and economic evaluation, collected by postal self-completion questionnaires. RESULTS: Only seven internal pilot participants were recruited against a target of 40 participants at 7 months. Far fewer potential participants were identified than anticipated from IAPT services, probably because PWPs rarely considered GAD the main treatment priority. Of those identified, three-quarters declined participation; the majority (30/45) were reluctant to consider the possibility of randomisation to medication. LIMITATIONS: Poor recruitment was the main limiting factor, and the trial closed prematurely. CONCLUSIONS: It is unclear how much of the recruitment difficulty was a result of conducting the trial within a psychological therapy service and how much was possibly a result of difficulty identifying participants with primary GAD. FUTURE WORK: It may be easier to answer this important question by recruiting people from primary care rather than from those already engaged in a psychological treatment service. TRIAL REGISTRATION: Current Controlled Trials ISCRTN14845583. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 21, No. 45. See the NIHR Journals Library website for further project information.

Recent advances in AIDS-related cryptococcal meningitis treatment with an emphasis on resource limited settings.

INTRODUCTION: Recent advances in the treatment and prevention of cryptococcal meningitis have the potential to decrease AIDS-related deaths. Areas covered: Targeted screening for asymptomatic cryptococcal antigenemia in persons with AIDS is a cost effective method for reducing early mortality in patients on antiretroviral therapy. For persons with symptomatic cryptococcal meningitis, optimal initial management with amphotericin and flucytosine improves survival compared to alternative therapies; however, amphotsericin is difficult to administer and flucytosine has not been available in middle or low income countries, where cryptococcal meningitis is most prevalent. Expert commentary: Improved care for cryptococcal meningitis patients in resource-limited settings is possible, and new treatment possibilities are emerging.

Antidepressant Medication Prescribing Practices for Treatment of Major Depressive Disorder.

OBJECTIVE: The purpose of this study was to describe the prescribing practices of clinicians for patients with major depressive disorder (MDD). METHODS: This population-based, descriptive study of insured patients (N=54,107) identified people who were 18 years or older, had a claim for MDD, had at least one prescription for an antidepressant medication in 2013, and had continuous insurance coverage during the study period. Prescription claims were evaluated to determine the most commonly prescribed antidepressant medication and most common dose. RESULTS: The three most commonly prescribed antidepressant medications were citalopram (N=11,995, 22.2%), sertraline (N=10,791, 19.9%), and trazodone (N=9,501, 17.6%). The most common daily doses were 20 mg citalopram (N=6,304, 52.6%), 50 mg sertraline (N=4,173, 38.7%), and 100 mg trazodone (N=3,220, 33.9%). CONCLUSIONS: This is the first report of its kind that provides drug- and dosage-level details to demonstrate that antidepressant prescribing in clinical practice is largely within recommended guidelines.

Análisis de costo-efectividad del escitalopram comparado con paroxetina, sertralina, fluoxetina, imipramina y fluvoxamina como terapia de mantenimiento para pacientes con trastorno de pánico en Colombia / Cost-effectiveness analysis of escitalopram compared to paroxetine, sertraline, fluoxetine, imipramine and fluvoxamine as maintenance therapy for patients with panic disorder in Colombia

Problema de investigación: Describir los costos y la efectividad de escitalopram comparado con paroxetina, sertralina, fluoxetina, imipramina y fluvoxamina como terapia de mantenimiento en adultos con diagnóstico de trastorno de pánico en Colombia. Tipo de evaluación económica: Análisis de costo-efectividad. Población objetivo: Adultos colombianos con diagnóstico de trastorno de pánico. Intervención y comparadores: Intervención: escitalopram, Comparadores: paroxetina, sertralina, fluoxetina, imipramina y fluvoxamina. Horizonte temporal: 32 semanas. Perspectiva: SGSSS de Colombia. Tasa de descuento: No aplica. Estructura del modelo: Se estructuró un árbol de decisión, teniendo en cuenta modelos publicados en la literatura. Fuentes de datos de efectividad y seguridad: Reporte de efectividad y seguridad elaborado en diciembre de 2014 en el IETS, Ensayo s clínicos a leatorizados. Desenlaces y valoración: Ausencia de crisis de pánico, Semanas libres de crisis de pánico. 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: Para el caso base, escitalopram, fluvoxamina y fluoxetina e imipramina fueron tecnologías dominadas por sertralina y paroxetina. El costo adicional por crisis de pánico evitada en tratamiento con paroxetina comparado con trasertralina se estimó en $4.814.953. Análisis de sensibilidad: Los análisis de sensibilidad y el diagrama de tornado muestran a la probabilidad de lograr ausencia de crisis de pánico y la probabilidad de recaída, como a las variables con mayor impacto sobre las estimaciones de la razón de costo-efectividad. Conclusiones y discusión: De acuerdo con los hallazgos aquí presentados, paroxetina, ofrece mayor razón de costo-efectividad, respecto a sus comparadores. No obstante, es \r\nnecesario tener en cuenta que cualquiera de las alternativas aquí estudiadas, puede ser costo-efectiva, debido a que las pequeñas variaciones en la probabilidad de ausencia de crisis de pánico pueden cambiar el resultado. La principal limitación de este estudio es la ausencia de información roveniente de estudios de investigación clínica, que muestre el desempeño comparativo entre las tecnologías, así como el seguimiento de los participantes en los estudios, en escenarios de más largo plazo que los existentes al momento de elaborar este documento.(AU)

Análisis de impacto presupuestal de escitalopram, paroxetina, sertralina, fluoxetina, fluvoxamina y clomipramina como terapia de mantenimiento para pacientes adultos con trastorno obsesivo compulsivo en Colombia / Budget impact analysis of escitalopram, paroxetine, sertraline, fluoxetine, fluvoxamine and clomipramine as maintenance therapy for adult patients with obsessive-compulsive disorder in Colombia

Tecnologías evaluadas: Nuevas: escitalopram, paroxetina, fluvoxamina y clomipramina\r\nActuales: sertralina y fluoxetina. Población: Pacientes mayores\tde\t18 años\tcon trastorno\tobsesivo\r\ncompulsivo en Colombia. Perspectiva: La perspectiva del presente AIP corresponde al tercer pagador,\r\nque en este caso es el Sistema General de Seguridad Social en Salud (SGSSS) en Colombia. Horizonte temporal: El horizonte temporal de este AIP en el caso base es de un año. Adicionalmente, se reportan las estimaciones del impacto presupuestal para los años 2 y 3, bajo el supuesto de la inclusión en el POS en el año 1. Costos incluídos: Costo por mg de los medicamentos. Fuente de costos: SISMED. Escenarios: En el escenario 1 se considera una igualación progresiva de las participaciones de mercado de todos los medicamentos analizados hasta llegar al año 3. En el escenario 2, además de una participación\tde\tmercado\tigual para\ttodos los medicamentos, se asume un precio común para las nuevas alternativas con base en la metodología de inclusión de grupos terapéuticos definida por el Ministerio de Salud y Protección\r\nSocia. Resultados: Para la inclusión en el POS de escitalopram, paroxetina, fluvoxamina y Clomipramina como terapia de mantenimiento para pacientes con diagnóstico de trastorno obsesivo ompulsivo en Colombia, se requeriría una inversión de $99.508.967.049 en el año 1 y de $136.213.036.626 en el año 3. En el caso que los medicamentos del escenario nuevo sean incluidos con un precio igual basado en las metodología de grupos terapéuticos del Ministerio de Salud y protección Social, el impacto presupuestal\r\nse reduciría a $13.170.025.624 en el año 1 y $19.887.249.147, en el año 3.(AU)

Análisis de costo-efectividad del escitalopram comparado con paroxetina, sertralina, fluoxetina, imipramina y fluvoxamina como terapia de mantenimiento para pacientes con trastorno de pánico en Colombia / nalysis cost-effectiveness of escitalopram compared to paroxetine, sertraline, fluoxetine, imipramine and fluvoxamine as maintenance therapy for patients with panic disorder in Colombia

PROBLEMA DE INVESTIGACIÓN: Describir los costos y la efectividad de escitalopram comparado con paroxetina, sertralina, fluoxetina, imipramina y fluvoxamina como terapia de mantenimiento en adultos con diagnóstico de trastorno de pánico en Colombia. TIPO DE EVALUACIÓN ECONÓMICA: Análisis de costo-efectividad. POBLACIÓN OBJETIVO: Adultos colombianos con diagnóstico de trastorno de pánico. INTERVENCIÓN Y COMPARADORES: Intervención: escitalopram; Comparadores: paroxetina, sertralina, fluoxetina, imipramina y fluvoxamina. HORIZONTE TEMPORAL: 32 semanas. PERSPECTIVA: SGSSS de Colombia. TASA DE DESCUENTO: No aplica. ESTRUCTURA DEL MODELO: Se estructuró un árbol de decisión, teniendo en cuenta modelos publicados en la literatura. FUENTES DE DATOS DE EFECTIVIDAD Y SEGURIDAD: Reporte de efectividad y seguridad elaborado en diciembre de 2014 en el IETS; Ensayos clínicos aleatorizados. DESENLACES Y VALORACIÓN: Ausencia de crisis de pánico; Semanas libres de crisis de pánico. 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: Para el caso base, escitalopram, fluvoxamina y fluoxetina e imipramina fueron tecnologías dominadas por sertralina y paroxetina. El costo adicional por crisis de pánico evitada en tratamiento con paroxetina comparado contra sertralina se estimó en $4.814.953. ANÁLISIS DE SENSIBILIDAD: Los análisis de sensibilidad y el diagrama de tornado muestran a la probabilidad de lograr ausencia de crisis de pánico y la probabilidad de recaída, como a las variables con mayor impacto sobre las estimaciones de la razón de costo-efectividad. CONCLUSIONES Y DISCUSIÓN: De acuerdo con los hallazgos aquí presentados, paroxetina, ofrece mayor razón de costo-efectividad, respecto a sus comparadores. No obstante, es necesario tener en cuenta que cualquiera de las alternativas aquí estudiadas, puede ser costo-efectiva, debido a que las pequeñas variaciones en la probabilidad de ausencia de crisis de pánico pueden cambiar el resultado. La principal limitación de este estudio es la ausencia de información proveniente de estudios de investigación clínica, que muestre el desempeño comparativo entre las tecnologías, así como el seguimiento de los participantes en los estudios, en escenarios de más largo plazo que los existentes al momento de elaborar este documento.(AU)

Establishing the cut-off score for remission and severity-ranges on the Psychotic Depression Assessment Scale (PDAS).

BACKGROUND: The Psychotic Depression Assessment Scale (PDAS) is a rating scale dedicated to the measurement of severity in psychotic depression (PD). The aim of this study was to establish the PDAS cut-off for remission of PD as well as PDAS score-ranges for mild, moderate, and severe PD. The secondary aim was to test how remission, as defined by the PDAS, would perform as outcome measure when applied to the data from a large randomized controlled trial (RCT) in PD. METHODS: The study was based on data from the Study of Pharmacotherapy in Psychotic Depression (STOP-PD). The cut-off for remission on the PDAS and the severity-ranges for mild, moderate, and severe PD were defined using the Clinical Global Impression - Severity scale (CGI-S) as reference by means of pair-wise receiver operating characteristic (ROC) analyses. Subsequently, it was tested whether remission on the PDAS could separate the effects of Olanzapine+Sertraline vs. Olanzapine+Placebo through an intention-to-treat, mixed-effects logistic regression of the data from STOP-PD. RESULTS: According to the ROC analyses, the ideal cut-off for remission of PD was a PDAS total score <8, while the severity-ranges for mild, moderate and severe PD were 8-15, 16-23, and >23 respectively. When applying the PDAS total score <8 (remission) as outcome on the STOP-PD data, treatment with Olanzapine+Sertraline performed significantly better than Olanzapine+Placebo (p<0.001). LIMITATIONS: The STOP-PD was not designed specifically to answer the research questions of the present study. CONCLUSIONS: According to this study, a total score <8 on the PDAS corresponds to remission of PD.

Assessment of non-BDNF neurotrophins and GDNF levels after depression treatment with sertraline and transcranial direct current stimulation in a factorial, randomized, sham-controlled trial (SELECT-TDCS): an exploratory analysis.

The neurotrophic hypothesis of depression states that the major depressive episode is associated with lower neurotrophic factors levels, which increase with amelioration of depressive symptoms. However, this hypothesis has not been extended to investigate neurotrophic factors other than the brain-derived neurotrophic factor (BDNF). We therefore explored whether plasma levels of neurotrophins 3 (NT-3) and 4 (NT-4), nerve growth factor (NGF) and glial cell line derived neurotrophic factor (GDNF) changed after antidepressant treatment and correlated with treatment response. Seventy-three patients with moderate-to-severe, antidepressant-free unipolar depression were assigned to a pharmacological (sertraline) and a non-pharmacological (transcranial direct current stimulation, tDCS) intervention in a randomized, 2 × 2, placebo-controlled design. The plasma levels of NT-3, NT-4, NGF and GDNF were determined by enzyme-linked immunosorbent assay before and after a 6-week treatment course and analyzed according to clinical response and allocation group. We found that tDCS and sertraline (separately and combined) produced significant improvement in depressive symptoms. Plasma levels of all neurotrophic factors were similar across groups at baseline and remained significantly unchanged regardless of the intervention and of clinical response. Also, baseline plasma levels were not associated with clinical response. To conclude, in this 6-week placebo-controlled trial, NT-3, NT-4, NGF and GDNF plasma levels did not significantly change with sertraline or tDCS. These data suggest that these neurotrophic factors are not surrogate biomarkers of treatment response or involved in the antidepressant mechanisms of tDCS.

Measuring treatment response in psychotic depression: the Psychotic Depression Assessment Scale (PDAS) takes both depressive and psychotic symptoms into account.

BACKGROUND: There is no established psychometric instrument dedicated to the measurement of severity in psychotic depression (PD). The aim of this study was to investigate whether a new composite rating scale, the Psychotic Depression Assessment Scale (PDAS), covering both the psychotic and the depressive domains of PD, could detect differences in effect between two psychopharmacological treatment regimens. METHODS: We reanalyzed the data from the Study of Pharmacotherapy of Psychotic Depression (STOP-PD), which compared the effect of Olanzapine+Sertraline (n=129) versus Olanzapine+Placebo (n=130). The response to the two regimens was compared using both a mixed effects model and effect size statistics on the total scores of three rating scales: the 17-item Hamilton Depression Rating Scale (HAM-D17), its 6-item melancholia subscale (HAM-D6), and the 11-item PDAS consisting of the HAM-D6 plus five items from the Brief Psychiatric Rating Scale covering psychotic symptoms. RESULTS: According to both statistical approaches, the PDAS, the HAM-D17 and the HAM-D6 were all able to detect significant differences in treatment effect between Olanzapine+Sertraline and Olanzapine+Placebo (Olanzapine+Sertraline being superior). Notably, 45% of the trial participants were at least "probable psychotic" at their last assessment in the trial. LIMITATIONS: The STOP-PD was not designed specifically to answer the research questions of the present study. CONCLUSIONS: The Psychotic Depression Assessment Scale (PDAS) is a sensitive measure of treatment response in PD. The fact that 45% of the patients still experienced psychotic symptoms at their last trial assessment emphasizes the need to include items pertaining to psychotic symptoms in rating scales for PD.

Is sertraline treatment or depression remission in depressed Alzheimer patients associated with improved caregiver well being? Depression in Alzheimer's Disease Study 2.

OBJECTIVE: We wanted to assess if sertraline treatment (versus placebo) or remission of depression at 12 weeks (versus nonremission) in Alzheimer patients is associated with improved caregiver well being. METHODS: We conducted a randomized, double-blind, placebo-controlled clinical trial of the efficacy and safety of sertraline for the treatment of depression in individuals with Alzheimer disease in five clinical research sites across the United States. Participants were caregivers of patients enrolled in the Depression in Alzheimer's Disease Study 2 (N = 131). All caregivers received standardized psychosocial support throughout the study. Caregiver outcome measures included depression (Beck Depression Inventory), distress (Neuropsychiatric Inventory), burden (Zarit Burden Interview), and quality of life (Medical Outcomes Study Short Form Health Survey). RESULTS: Fifty-nine percent of caregivers were spouses, 63.4% were women, and 64.1% were white. Caregivers of patients in both treatment groups had significant reductions in distress scores over the 24-week study period, but there was not a greater benefit for caregivers of patients taking sertraline. However, caregivers of patients whose depression was in remission at week 12 had greater declines in distress scores over the 24 weeks than caregivers of patients whose depression did not remit by week 12. CONCLUSION: Patient treatment with sertraline was not associated with significantly greater reductions in caregiver distress than placebo treatment. Distress but not level of depression or burden lessened for all caregivers regardless of remission status and even more so for those who cared for patients whose depression remitted. Results imply an interrelationship between caregiver distress and patient psychiatric outcomes.

Transtornos de Ansiedade I: eficácia e segurança de sertralina, citalopram e venlafaxina no tratamento de estresse pós-traumático e fobia social / Anxiety Disorders I: efficacy and safety of sertraline, citalopram and venlafixine in the treatment of posttraumatic stress disorder and social phobia / Trastornos de Ansiedad I: eficacia y seguridad de la sertralina, citalopram y venlafaxina en el tratamiento del trastorno por estrés postraumático y fobia social

TECNOLOGIAS: Venlafaxina, citalopram e sertralina. INDICAÇÃO: Tratamento de transtorno de estresse pós-traumático (TEPT) e transtorno de ansiedade social (fobia social) (TAS). CARACTERIZAÇÃO DA TECNOLOGIA: As tecnologias citalopram e sertralina pertencem à classe dos Inibidores Seletivos da Recaptação da Serotonina (ISRS) e a venlafaxina pertence à classe dos Inibidores da Recaptação de Serotonina e Norepinefrina (IRSN). PERGUNTA: Venlafaxina, citalopram e sertralina são mais eficazes e seguras no tratamento de pacientes com TEPT e TAS do que as tecnologias disponíveis no SUS (clomipramina, diazepam, clonazepam, clobazam e fluoxetina? BUSCA E ANÁLISE DE EVIDÊNCIAS CIENTÍFICAS: Foram pesquisadas as bases The Cochrane Library (via Bireme), Medline (via Pubmed), Lilacs, APA PsycNET (via PsychINFO) e Centre for Reviews and Dissemination (CRD). Buscaram-se revisões sistemáti cas (RS) de ensaios clínicos que comparassem os medicamentos entre si e com outras opções terapêuticas disponíveis no Sistema Único de Saúde para o tratamento de transtornos de ansiedade. Foram selecionadas também avaliações de tecnologias em saúde (ATS) em websites de agências internacionais e da Rede Brasileira de Avaliação de Tecnologia em saúde. Foram selecionados estudos publicados em inglês, português ou espanhol. RESUMO DOS RESULTADOS DOS ESTUDOS SELECIONADOS: Foram incluídas três RS sobre TEPT, e três RS sobre TAS. Em nenhuma das revisões foram encontrados estudos científicos que comparassem estes medicamentos diretamente entre si ou entre as alternativas incorporadas no Sistema Único de Saúde (SUS) sendo que, de maneira geral, nas comparações versus placebo os medicamentos demonstraram eficácia estatisticamente significante. Foram consideradas ainda Avaliações de Tecnologias em Saúde (ATS) de organismos internacionais acerca do tema. Em nenhuma dessas avaliações houve indicação de terapia farmacológica como primeira opção sendo que esses estudos preconizavam intervenções psicológicas. Estas avaliações indicaram antidepressivos como segunda linha para o tratamento demonstraram sua eficácia. Os estudos não recomendaram a terapia com benzodiazepínicos (BZD) e an psicóticos. RECOMENDAÇÕES: Nas atuais indicações terapêuticas listadas no Formulário Terapêutico Nacional ou nos Protocolos Clínicos e Diretrizes Terapêuticas, não há opção de tratamento farmacológico para os pacientes com TEPT e TAS no Sistema Único de Saúde. A fluoxetina apresentou eficácia e segurança comparáveis às alternativas avaliadas nesse PTC. Considerando indicações aprovadas em bula e os resultados das RS incluídas, bem como os custos estimados, recomenda-se o uso de sertralina para TEPT e TAS.(AU)

TECHNOLOGIES: venlafaxine, citalopram and sertraline. INDICATION: Treatment of post-trauma c stress disorder and social anxiety disorder (social phobia). TECHNOLOGY CHARACTERIZATION: Technologies citalopram and sertraline belong to the class of Selec ve Serotonin Reuptake Inhibitors (SSRIs) and venlafaxine belongs to the class of Serotonin Reuptake Inhibitors and norepinephrine (SNRI). QUESTION: venlafaxine, citalopram and sertraline are safer and more effective in treating patients suffering from post-trauma c stress disorder and social anxiety than the technologies available in SUS (clomipramine, diazepam, clonazepam, clobazam and fluoxe ne? SEARCH AND ANALYSIS OF SCIENTIFIC EVIDENCE: the foundations The Cochrane Library (via BIREME), Medline (via Pubmed), Lilacs, APA PsycNET (via PsychINFO) and Centre for Reviews and Dissemination (CRD) were surveyed. We searched for systematic reviews (SR) of clinical trials that compared the drugs with each other and with other therapeutic options available in the Health System for the treatment of anxiety disorders. Reviews of health technologies (ATS) in international agencies and the Brazilian Network for Health Technology Assessment websites were also selected. Studies published in English, Portuguese or Spanish were selected. SUMMARY OF RESULTS OF SELECTED STUDIES: We included three RS on PTSD, and three RS on TAS. In none of the revisions scien fic studies comparing these drugs directly between themselves or between alterna ve incorporated into the Unified Health System (SUS) and, in general, the comparisons versus placebo medica ons demonstrated sta s cally significant efficacy were found. S ll Health Technology Assessments (HTA) were considered of interna onal organiza ons on the subject. In none of these ra ngs was no indica on of drug therapy as first choice and these studies advocated psychological interven ons. These evalua ons indicated as second -line an depressants for the treatment and demonstrated its effec veness. The studies did not recommend therapy with benzodiazepines (BZD) and an psycho cs. SUMMARY OF RESULTS OF SELECTED STUDIES: We included three RS on PTSD, and three RS on TAS. In none of the revisions scientific studies comparing these drugs directly between themselves or between alternative incorporated into the Unified Health System (SUS) and, in general, the comparisons versus placebo medications demonstrated statiscally significant efficacy were found. S ll Health Technology Assessments (HTA) were considered of international organizations on the subject. In none of these ratings was no indication of drug therapy as first choice and these studies advocated psychological interventions. These evaluations indicated as second -line an depressants for the treatment and demonstrated its effec veness. The studies did not recommend therapy with benzodiazepines (BZD) and an psycho cs. RECOMMENDATIONS: In the current therapeutic indications listed in the National Formulary or the Therapeutic Guidelines and Clinical Protocols, there is no pharmacological treatment option for patients with PTSD and SAD in the Unified Health System. Fluoxe ne showed efficacy and safety comparable to the alternatives evaluated in this PTC. Considering approved indications in bull and results of RS included, as well as es mated costs, it is recommended the use of sertraline for PTSD and SAD.(AU)

TECNOLOGÍAS: Venlafaxina, citalopram y la sertralina, INDICACIÓN: Tratamiento del trastorno de estrés postraumático y trastorno de ansiedad social (fobia social). TECNOLOGÍA CARACTERIZACIÓN : Tecnologías de citalopram y la sertralina pertenecen a la clase de inhibidores de la recaptación selectiva de serotonina (ISRS) y venlafaxina pertenece a la clase de inhibidores de la recaptación de serotonina y norepinefrina (IRSN). PREGUNTA: Venlafaxina, citalopram y la sertralina son más seguros y más eficaces en el tratamiento de pacientes que sufren de trastorno de estrés postraumático y la ansiedad social de las tecnologías disponibles en el SUS (clomipramina, diazepam, clonazepam, clobazam y fluoxe na? BÚSQUEDA Y ANÁLISIS DE LA EVIDENCIA CIENTIFICA: Las fundaciones La Biblioteca Cochrane (a través de BIREME), MEDLINE (vía PubMed), Lilas, APA PsycNET (vía PsychINFO) y Centro de Revisiones y Difusión (CRD) fueron encuestados. Se realizaron búsquedas de revisiones sistemáticas (RS) de los ensayos clínicos que compararon los fármacos entre sí y con otras opciones terapéuticas disponibles en el Sistema de Salud para el tratamiento de los trastornos de ansiedad. También se seleccionaron Avaliaciones de Tecnologías Sanitarias (ATS) en los organismos internacionales y la Red Brasileña por si os web Evaluación de Tecnologías Sanitarias. Se seleccionaron los estudios publicados en Inglés, Español o Portugués. RESUMEN DE LOS RESULTADOS DE LOS ESTUDIOS SELECCIONADOS: Tres RS fueron incluidas sobre trastorno de estrés postraumático, y tres RS en TAS. En ninguna de las revisiones de estudios cientificos que comparan estos fármacos directamente entre sí o entre alternativas incorporado en el Sistema Único de Salud (SUS) y, en general, se encontro que las comparaciones frente a los medicamentos de placebo demostró una eficacia estadíscamente significa va. Aún Evaluación de Tecnologías Sanitarias (HTA) se consideró de organizaciones internacionales en la materia. En ninguna de estas clasificaciones hubo indicación de la terapia con medicamentos como primera opción y estos estudios abogó intervenciones psicológicas. Estas evaluaciones indican que los an depresivos de segunda línea para el tratamiento y demostraron su eficacia. Los estudios no recomiendan el tratamiento con benzodiazepinas (BZD) y an psicóticos. RECOMENDACIONES: En las indicaciones terapéuticas actuales que figuran en el Formulario Nacional o las directrices terapéuticas terapéuticas y protocolos clínicos, no hay ninguna opción de tratamiento farmacológico para los pacientes con trastorno de estrés postraumático y SAD en el Sistema de Salud. Fluoxetina mostró una eficacia y una seguridad comparables a las alternativas evaluadas en este PTC. Teniendo en cuenta las indicaciones aprobadas por la Agencia Nacional de Vigilancia Sanitaria y los resultados de RS incluidos, así como los costos es mados, se recomienda el uso de sertralina para el trastorno de estrés postraumático y TAS.(AU)

Transtornos de Ansiedade III: eficácia e segurança de sertralina, citalopram e venlafaxina no tratamento de Transtorno Obsessivo-Compulsivo e Síndrome do Pânico / Anxiety Disorders III: efficacy and safety of sertraline, citalopram and venlafaxine in the treatment of Obsessive-Compulsive Disorder and Panic Disorder / Trastornos de Ansiedad III: eficacia y seguridad de la sertralina, citalopram y venlafaxina en el tratamiento del Trastorno Obsesivo-Compulsivo y Trastorno de Pánico

TECNOLOGIAS: Venlafaxina, citalopram e sertralina. INDICAÇÃO: Tratamento de Síndrome do Pânico e Transtorno Obsessivo-Compulsivo. CARACTERIZAÇÃO DA TECNOLOGIA: As tecnologias citalopram e sertralina pertencem à classe dos Inibidores Seletivos da Recaptação da Serotonina (ISRS) e a venlafaxina pertence à classe dos Inibidores da Recaptação de Serotonina e Norepinefrina (IRSN). PERGUNTA: Venlafaxina, citaloprame sertralina são mais eficazes e seguras no tratamento de pacientes com Síndrome do Pânico e Transtorno Obsessivo-Compulsivo do que as tecnologias disponíveis no SUS (clomipramina, diazepam, clonazepam, clobazam e fluoxetina)? BUSCA E ANÁLISE DE EVIDÊNCIAS CIENTÍFICAS: Foram pesquisadas as bases The Cochrane Library (via Bireme), Medline (via Pubmed), Lilacs, APA PsycNET (via PsychINFO) e Centre for Reviews and Dissemination (CRD). Buscaram-se revisões sistemáticas (RS) de ensaios clínicos que comparassem os medicamentos entre si e com outras opções terapêuticas disponíveis no Sistema Único de Saúde para o tratamento de transtornos de ansiedade. Foram selecionadas também avaliações de tecnologias em saúde (ATS) em websites de agências internacionais e da Rede Brasileira de Avaliação de Tecnologia em Saúde . Foram selecionados estudos publicados em inglês, português ou espanhol. RESUMO DOS RESULTADOS DOS ESTUDOS SELECIONADOS: Foram incluídas seis revisões sistemáticas: uma acerca da Síndrome do Pânico (SP) e cinco de Transtorno Obsessivo-Compulsivo (TOC). Em nenhuma das revisões foram encontrados estudos científicos que comparassem estes medicamentos diretamente entre si ou entre as alternativas incorporadas no Sistema Único de Saúde (SUS) sendo que, de maneira geral, nas comparações versus placebo, os medicamentos demonstraram eficácia estatisticamente significante. Foram consideradas ainda seis Avaliações de Tecnologias em Saúde (ATS) de organismos internacionais acerca do tema. Em nenhuma dessas avaliações houve indicação de terapia farmacológica como primeira opção sendo que esses estudos preconizavam intervenções psicológicas. Estas avaliações indicaram antidepressivos como segunda linha para o tratamento. Os estudos não recomendaram a terapia com benzodiazepínicos e antipsicóticos. RECOMENDAÇÕES: Os medicamentos venlafaxina, citalopram e sertralina apresentaram perfil de eficácia e segurança semelhantes aos dos medicamentos clomipramina e fluoxetina, disponíveis no SUS. Dessa forma, recomenda-se o uso de clomipramina para síndrome do pânico e de fluoxe na ou clomipramina para TOC.(AU)

TECHNOLOGIES: Venlafaxine, Citalopram and Sertraline. INDICATION: Treatment of panic disorder and obsessive-compulsive disorder. CHARACTERIZATION OF TECHNOLOGY: Citalopram and Sertraline belong to the class of Selective Serotonin Reuptake Inhibitors (SSRIs) and Velafaxine belong the class of Serotonin and Norepinephrine Reuptake Inhibitors (SNRIs). Question: Venlafaxine, Citalopram and Sertraline are safer and more effective in trea ng pa ents with panic disorder and obsessive-compulsive disorder than the technologies incorporated into the Brazilian Public Health System (SUS)? Search And Analysis Of Scien Fic Evidence: The databases The Cochrane Library (via Bireme), Medline (via Pubmed), Lilacs, APA PsycNET (via PsychINFO) and Centre for Reviews and Dissemination (CRD) were inves gated. We searched for systematic reviews (SR) of clinical trials that compared the drugs within each other and with other therapeutic options incorporated in SUS for the treatment of anxiety disorders. Health Technology Assessments (HTA) in international agencies sites and in Brazilian Network for Health Technology Assessment (REBRATS) were also selected. Studies published in English, Portuguese or Spanish were selected. SUMMARY OF RESULTS OF THE SELECTED STUDIES: Six systema c reviews, one about panic disorder and 5 about obsessive-compulsive, were included. None of the reviews of scien fic studies compared these drugs directly between themselves or between the alterna ves incorporated into SUS and, in general, was found statistically significant efficacy in studies comparing drugs versus placebo. SixHTA´s of international organizations on the subject were considered. These HTA´sfound no indication of drug therapy as first choice and these studies advocated psychological interventions. These evaluations have demonstrated the effectiveness of an depressants as second choice for the treatment of anxiety disorders. The studies did not recommend therapy with benzodiazepines (BZD) and an"psycho cs. RECOMMENDATIONS: Venlafaxine, citalopram and sertraline presented similar efficacy and safety profiles when compared to clomipramine and fluoxetine, available in SUS. Thus, we recommend the use of clomipramine for panic disorder and fluoxetine or clomipramine for OCD.(AU)

TECNOLOGÍAS: La venlafaxina, citalopram y sertralina. INDICACIÓN: Tratamiento de Trastorno Obsesivo Compulsivo y trastorno de pánico. CARACTERIZACIÓN DE LA TECNOLOGÍA: Las tecnologías de citalopram y sertralina pertenecen a la clase de los inhibidores selec vos de la recaptación de serotonina (ISRS) y Venlafaxina pertenece a la clase de los inhibidores de la recaptación de serotonina y norepinefrina (IRSN). PREGUNTA: ¿La venlafaxina, citalopram y sertralina son más seguros y más eficaces en el tratamiento de pacientes con Trastorno Obsesivo Compulsivo y trastorno de pánico que las tecnologías incorporadas en el SNS? BÚSQUEDA Y ANÁLISIS DE LA EVIDENCIA CIENTÍFICA: las fundaciones The Cochrane Library (vía Bireme), MEDLINE (vía PubMed), Lilacs, APA PsycNET (vía PsychINFO) y Centro de Revisiones y Difusión (CRD) fueron inves gados. Hemos tratado de revisiones sistemá cas (RS) de los ensayos clínicos que compararon los fármacos entre sí y con otras opciones terapéu cas incorporadas en el sistema nacional de salud para el tratamiento de los trastornos de ansiedad. También fueron seleccionados comentarios de tecnologías sanitarias (ATS) en las agencias de un si o y la Red Brasileña de Evaluación de Tecnologías Sanitarias. Los estudios publicados en inglés, se seleccionaron portugués o español. RESUMEN DE LOS RESULTADOS DE LOS ESTUDIOS SELECCIONADOS: Fueran incluidas seis revisiones sistemá cas, una acerca de lo trastorno de pánico e cinco acerca de lo trastorno obsesivo compulsivo. En ninguna de las revisiones de estudios cien ficos que comparan estos fármacos directamente entre sí o entre las alterna vas incluidas en el Sistema Único de Salud (SUS) y, en general, las comparaciones frente a los medicamentos de placebo demostraron estadís camente se encontraron una eficacia significa va. Seis estudios de Tecnologías en Salud (ATS) de las organizaciones internacionales en la materia fueron considerados. En ninguno de estos exámenes hubo indicación de la terapia con medicamentos como primera opción y estos estudios abogó intervenciones psicológicas. Estas evaluaciones han demostrado la eficacia de los an depresivos en general, como segunda opción para el tratamiento de trastornos de ansiedad. Los estudios no recomiendan el tratamiento con benzodiacepinas (BZD) y an psicó cos. RECOMENDACIONES: La venlafaxina, el citalopram y la sertralinapresentaron eficacia y seguridad semejante a de laclomipramina y la fluoxe na,disponibles enSUS. Por lo tanto, se recomienda el uso de clomipramina para el trastorno de pánico y la fluoxe na o clomipramina para el TOC.(AU)