Polifarmacia antipsicótica y patrones prescriptivos de psicofármacos en internación psiquiátrica de larga estancia: comparación 1995-2009 / Antipsychotic polypharmacy and psychopharmacological prescription patterns in long stay psychiatry hospitalization: 1995-2009 comparison

RESUMEN Objetivos: Identificar cambios de patrones prescriptivos en pacientes con hospitalización psiquiátrica de larga estancia entre los años 1995-2009. Material y métodos: Estudio comparativo transversal de dos censos diarios (15/06/1995 y 14/12/2009) en el Hospital Neuropsiquiátrico Alejandro Korn, Argentina. Se examinaron listas de agentes psicotrópicos prescritos a todos los pacientes de salas de larga estancia. Resultados: Disminución de 33% de admitidos en el censo de 1995 (n=1048) comparado con el de 2009 (n=698), aumento de pacientes varones (44% a 57%) y de internación de mayores de 20 años de duración (29% a 40%). El diagnóstico más prevalente continuó siendo esquizofrenia seguido de retardo mental: 45% y 27%, respectivamente, en 1995, 44% y 33% en 2009. La dosis media de antipsicóticos para esquizofrenia fue similar, alrededor de un equivalente de 760 mg/d de clorpromazina. Pacientes con dosis de antipsicóticos mayores (equivalente a 1200 mg/d de clorpromazina) disminuyeron de 28% a 23,9%. En pacientes con problemas de aprendizaje/retardo mental, cerca del 80% recibían antipsicóticos en ambos censos. La polifarmacia antipsicótica aumentó un 6,7% en esquizofrenia (61%), disminuyó 12,6% en retraso mental (45%) y 6,5% en todos los pacientes (49%). Haloperidol y levomepromazina continuaron siendo los antipsicóticos más usados, en tanto que el uso de anticolinérgicos disminuyó en un 21%. En cuanto a drogas sedantes, creció el uso de benzodiazepinas y prometazina (15% y 19% respectivamente), y alrededor del 35% continuó recibiendo levomepromazina. Discusión: La introducción de antipsicóticos atípicos no dio lugar a grandes mejorías en el uso racional de psicofármacos, excepto por la prescripción de menos fármacos antipsicóticos en pacientes con retardo mental, y de anticolinérgicos en la población general. Conclusión: El aumento de polifarmacia antipsicótica en esquizofrenia y del uso de benzodiacepinas subraya la necesidad de una práctica mejor basada en evidencias provenientes de la investigación clínica.

SUMMARY Objective : To identify changes of prescription patterns in long term psychiatric inpatients in 1995 and 2009. Material and Methods: Cross sectional comparative study of two one-day-census, (06/15/1995 and 12/14/2009) at the Hospital Neuropsiquiátrico Alejandro Korn, Argentina. Records of prescribed psychotropic agents to all patients in long stay wards were examined. Results: The number of hospitalized patients decreased 33% from 1995 (n=1048) to 2009 (n=698), with increases in male gender (44% a 57%) and hospitalizations lasting more than 20 years (29% a 40%). Schizophrenia remained as the most prevalent diagnosis followed by learning disabilities/mental retardation (45% and 27% in 1995, respectively, 44% and 33% in 2009). The average antipsychotic dosis in schizophrenia was almost the same, the equivalent of around 760 mg of chlorpromazine. Patients on antipsychotic doses above an equivalent of 1200 mg decreased from 28% to 23,9%. Around 80% of those with learning disabilities were prescribed antipsychotics on both census. Antipsychotic polypharmacy increased 6,7% in schizophrenia (61%) and decreased 12,6% in learning disabilities (45%), and 6,5% in all inpatients (49%). Haloperidol and levomepromazine were still the more frequently prescribed antipsychotics while the use of anticholinergic agents diminished in a 21%. Regarding sedatives, the use of benzodiazepines and promethazine increased (15% and 19% respectively), while around 35% in both census was still receiving levomepromazine. Discussion: The introduction of atypical antipsychotic was not followed by great improvements in the rational use of psychotropics drugs, except for less antipsychotic polypharmacy in learning disabilities and of anticholinergics in the general population. Conclusion: The increase in antipsychotic polypharmacy in schizophrenia and the continuous use of benzodiazepines highlight the need to bring the usual practice closer to the evidence provided by clinical research.

[Argentine consensus on the diagnosis and therapeutics of treatment resistant schizophrenia]. / Consenso argentino sobre diagnóstico y tratamiento de la esquizofrenia resistente al tratamiento.

Approximately 30% of people with schizophrenia fail to respond to first-line antipsychotic treatment which impacts the burden of the disease. Treatment-resistant schizophrenia (TRS) denotes patients with failure to respond to at least two adequate trials of different antipsychotics. Clozapine is a unique drug approved for treating treatment-resistant schizophrenia, however 1/3 of patients fail to respond to clozapine. Even though different strategies have been proposed for treating clozapine-resistant schizophrenia, the evidence is very limited, unclear, and of poor quality. A formal literature search was conducted and then, panel members were asked to complete 35 questions addressing different aspects of TRS. A modified Delphi method was used to unify expert opinion and achieve consensus. The expert consensus in diagnostic and treatment of TRS is the result of experts from the main national scientific societies under the organization of the Argentine Association of Biological Psychiatric (AAPB). The consensus statement aims to guide on diagnosis and treatment.

Effectiveness of agomelatine on anhedonia in depressed patients: an outpatient, open-label, real-world study.

OBJECTIVE: The aim of this real-world study was to evaluate the effect of agomelatine on anhedonia as primary endpoint in outpatients under treatment of major depressive episodes. METHODS: The study was an open-label, multicenter, 8-week phase IV trial. Two hundred fifty-seven (257) patients were recruited, and 143 patients were included in the analysis. Agomelatine was administered orally as a 25-mg tablet. The dose could be increased to 50 mg after 2 weeks of treatment. RESULTS: An improvement in the severity of anhedonia (Snaith-Hamilton Pleasure Scale total score) was observed from 8.5 points at baseline to 4.1 at week 8, statistically significant (p < 0.05) from the first week. Significant decreases in scores on the severity of depression (Quick Inventory of Depressive Symptomatology 16-item Self-Report [QIDS-SR-16]), anxiety (Generalized Anxiety Disorder 7-item scale), and in overall clinical status (CGI) were also found over 8 weeks, independently from the presence of a first or recurrence episode. Response (QIDS-SR-16 score ≥ 50% of baseline) at week 8 was observed in 65.7% of the patients, while 49.6% of the patients achieved remission (QIDS-SR-16 score ≤ 5). CONCLUSION: Agomelatine was shown to be effective on anhedonia, depression, and anxiety in subjects with major depression. The pragmatic design of the study reflects real-world clinical practice providing interesting insights into routine care management.

[Study of Flexible Doses of Paliperidone ER in Pacients with Schizophrenia who Have Undergone Inefficient Treatment with other Antipsychotics]. / Estudio de dosis flexibles de paliperidona ER en pacientes con esquizofrenia previamente tratados sin efectividad con otros antipsicóticos.

BACKGROUND: Extended-release (ER) paliperidone is an innovative atypical antipsychotic that allows minimal peak-to-through fluctuations with once-daily dosing. OBJECTIVE: To evaluate effectiveness, safety and tolerability of flexible, once-daily doses of paliperidone ER (3-12 mg/day) in patients with schizophrenia from Argentina and Colombia who had previously failed treatment with other antipsychotic agents. METHODS: The authors conducted a 6-month, open-label, prospective and multicentric study. Effectiveness was assessed with Positive and Negative Syndrome Scale (PANSS) and Personal and Social Performance scale (PSP). Other measures of effectiveness, safety and tolerability, were also conducted. RESULTS: Paliperidone ER 3-12 mg/day improved Positive and Negative Syndrome Scale (PANSS) total scores (primary endpoint) from baseline to study end (p < 0,001). In the PANSS total score, the mean change from baseline (83, 9 units) to end point (53,7 units) was significant (p < 0,001). Flexible doses of paliperidone ER demonstrated a ≥20% reduction in the PANSS total score (p<0.001) in almost two-thirds of patients. PSP mean change from baseline (52 units) to end point (85 units) was significant (p < 0,001). Secondary effectiveness assessments, as well as safety and tolerability measures, demonstrated favourable results throughout the study. CONCLUSIONS: Flexible doses of paliperidone ER over 6 months were effective, safe and well tolerated in patients with schizophrenia from Argentina and Colombia.

Ventajas y desventajas de brindar a los pacientes información detallada sobre potenciales efectos adversos a los ISRS / Advantages and disdvantages of providing patients with detailed information on the potential adverse effects of SSRis

La introducción de los inhibidores selectivos de la recaptación de serotonina (ISRS) significó un gran avance en el tratamiento de los trastornos del humor y los trastornos de ansiedad. No es infrecuente escuchar entre los profesionales de la salud que brindar información detallada sobre potenciales efectos adversos puede generar un mayor reporte de estos. ¿Con qué evidencia científica contamos para decidir sobre brindar más o menos información sobre potenciales efectos adversos de los antidepresivos del grupo de los ISRS? ¿Cuál es el impacto de esta información en términos de reporte de efectos adversos y adherencia al tratamiento con estos fármacos? En este trabajo se revisaron los métodos para la evaluación de efectos adversos farmacológicos, el concepto de adherencia y las modalidades para su medición y los fundamentos de la jerarquía de la evidencia científica con que se clasifican los resultados de las investigaciones. Para ello se realizó una revisión exhaustiva de la literatura médica utilizando las bases de datos de MEDLINE (1966-2008), Cochrane (2008, número 4) y LILACS (1982-2008). No hemos encontrado estudios que hayan tenido como objetivo primario el reporte de efectos adversos de los ISRS al brindar información detallada, aunque sí existe alguna información no concluyente con otras clases de antidepresivos y psicofármacos. No hay trabajos específicos para los ISRS pero sí para los antidepresivos tricíclicos: los resultados de estos trabajos permiten señalar que la adherencia a los tratamientos presentan una mejoría significativa cuando se registran intervenciones consistentes en brindar a los pacientes información sobre los medicamentos que reciben. Sobre la base de los datos disponibles en la actualidad, puede sostenerse que, a mayor información se registra también una adherencia al tratamiento con antidepresivos; sin embargo, no se sabe a ciencia cierta si existe un mayor reporte de efectos adversos.

The introduction of selective serotonin reuptake inhibitors (SSRIs) has meant a significant progress for the treatment of mood and anxiety disorders. It is not unusual for health care professionals to state that providing patients with detailed information on the potential adverse events of SSRIs may result in a higher amount of reports on such events. On what scientific evidence do we base our decision of providing more or less informations about the potential adverse effects of SSRIs antidepressants? What impact does this piece of information has in terms of the reporting of adverse events and adherence to treatment with these pharmacological drugs? This article offers a review of the methods for evaluating pharmacological adverse events, the concept of adherence and the modalities for assessing it, as well as the foundtions of the scientific evidence hierarchy by which the outcomes and the modalities for assessing it, as well as the pundations of the scientific evidence hierarchy by which the outcomes of investigations are classed into. For that purpose, an extensive review of medical literature was conducted using MEDLINE (1966-2008), Cochrane (2008, number 4) and LILACS (1982-2008) databases. We did not find any study whose primary goal was the report of SSRIs adverse effects when providing detailed informations, and there is non conclusive information as regards other types of antidepressants and psychopharmacological drugs. There are no specific studies on SSRIs, although there are for tricyclic antidepressants: the latter demonstrated a significant improvement in terms of adherence when information on the medications administered to the patients is offered. We may therefore conclude that, based upon current evidence, the more informations is offered, the higher the adherence to antidepressants, although it is not know for certain whether the number of reports on adverse events increases or not.

[Functional status and quality of life in Latin American outpatients with schizophrenia treated with atypical or typical antipsychotics: outcomes of the 12 months schizophrenia outpatient health outcomes (IC-SOHO) Study]. / Estado funcional y calidad de vida en pacientes latinoamericanos con esquizofrenia tratados con un antipsicótico atípico o típico: resultado de 12 meses del estudio Intercontinental Schizophrenia Outpatient Health Outcomes (IC-SOHO).

OBJECTIVE: Functional status and quality of life outcomes in Latin American outpatients with schizophrenia were compared after 12 months of monotherapy treatment with olanzapine, risperidone or typical antipsychotics. METHOD: Both outcomes were assessed as part of a prospective, large (N= 7658), international (27 countries), observational study. RESULTS: from the Latin American subpopulation (N= 2671; 11 countries) are presented. Compared to typical antipsychotics, olanzapine and risperidone were associated with significantly (p < 0.05) greater odds of employment and social activity, and significantly greater improvements in quality of life. Olanzapine was also associated with significantly greater odds of living independently, compared to typical antipsychotics. CONCLUSION: This study indicates that functional status and quality of life outcomes are likely to be more favorable when Latin American outpatients with schizophrenia are treated with olanzapine or risperidone monotherapy, rather than typical antipsychotics.

[Mixed episode: complex recognition and complicated treatment]. / Episodio mixto: complejo reconocimiento, complicado abordaje.

Mixed Episode is a complex syndrome with difficult in its recognition, the most prolonged duration of bipolar episodes, more frequent psychotic profile than Pure Manic Episode, with high suicidality and poor response to drugs. There are evidences of less efficacy with Lithium and Carbamazepine in Manic Episode than mixed states. Valproate improve both, manic and depressive symptoms, and it is proposed to be first choice. Olanzapine has been widely evaluated, showing robust response in acute Mania as well in depressive symptoms during Mixed episode. In the field of clinical practice, there are many patients receiving more than one drug, usually Valproate plus a second generation antipsychotic.

Diagnóstico de alteraciones mentales en atención primaria. Adaptación de un procedimiento de tamizaje / Screening of mental disorders in primary care: linguistic adaptation procedure of a diagnostic instrument

Muchos trabajos extranjeros comunican una elevada incidencia de alteraciones mentales detectadas en el consultorio de atención primaria, pero casi no existen publicaciones que traten esta situación en nuestro país. Para revertir esta situación, es indispensable contar con instrumentos válidos que puedan ser administrados en forma rápida y sencilla, y que garanticen la obtención de datos seguros y confiables. En el presente trabajo se describe el procedimiento de traducción y adaptación lingüística para la Argentina del sistema PRIME-MD, un instrumento para diagnóstico de alteraciones mentales diseñado en los EUA, y se examina la confiabilidad y validez de esta versión. Los resultados muestran que la versión argentina es psicométricamente consistente y apropiada para su uso local. Por otro lado, la aceptación y comprensión del sistema por parte de los profesionales y los individuos entrevistados fue satisfactoria. Nuestros hallazgos indican que la versión argentina del PRIME-MD puede ser una herramienta útil para estudios de tamizaje de alteraciones mentales en la atención primaria