Preliminary data from a 4-year mirror-image and multicentre study of patients initiating paliperidone palmitate 6-monthly long-acting injectable antipsychotic: the Paliperidone 2 per Year study.

Background: Paliperidone palmitate 6-monthly (PP6M) is the first long-acting antipsychotic injectable (LAI) to allow for only two medication administrations per year, though there is presently limited insight into its effectiveness and potential added value in real clinical practice conditions. Objectives: To present our ongoing study and draw its preliminary data on patient characteristics initiating PP6M and adherence during the first year of treatment. Methods: The paliperidone 2 per year (P2Y) study is a 4-year, multicentre, prospective mirror-image pragmatic study taking place at over 20 different sites in Europe. The mirror period covers 2 years either side of the PP6M LAI initiation. Retrospective data for the previous 2 years are collected for each patient from the electronic health records. Prospective data are recorded at baseline, 6, 12, 18 and 24 months of drug administration and also cover information on concomitant psychiatric medication, relapses, hospital admissions, side effects, discontinuation and its reasons. Meanwhile, here we present preliminary data from the P2Y study at basal and 6-month period (first and second PP6M administration). Results: At the point of PP6M initiation, the most frequent diagnosis was schizophrenia (69%), the clinical global impression scale mean score was 3.5 (moderately markedly ill) and the rate of previous hospital admissions per patient and year was 0.21. PP6M was initiated after a median of 3-4 years on previous treatment: 146 (73%) from paliperidone palmitate 3-monthly, 37 (19%) from paliperidone palmitate 1-monthly and 17 (9%) from other antipsychotics. The mean dose of the first PP6M was 1098.9 mg. The retention rate at 6 months and 1 year of treatment on PP6M in our cohort was 94%. Conclusion: Patient and clinician preference for LAIs with longer dosing intervals was the main reason for PP6M initiation/switching resulting in high treatment persistence. Future data are needed to evaluate the full impact of PP6M in clinical practice.

Hepatitis agudas, crónicas y fulminantes por virus de la hepatitis E: 7 años de experiencia (2004-2011) / Acute, chronic and fulminant hepatitis E: Seven years of experience (2004-2011)

OBJETIVO: Estudiar las características clínicas y epidemiológicas de 43 casos de hepatitis aguda, 5 casos de hepatitis fulminante y uno de hepatitis crónica causados por el virus de la hepatitis E (VHE), detectados en un periodo de 7 ańos. Pacientes Cuarenta y nueve (35 varones y 14 mujeres) pacientes atendidos entre 2004 y 2011 en el Hospital Ramón y Cajal, en la Comunidad de Madrid. El diagnóstico se realizó por detección de anticuerpos IgG e IgM anti-VHE y ARN VHE en suero. Se consideró el diagnóstico de hepatitis E aguda cuando el paciente presentaba un cuadro clínico compatible con hepatitis aguda y se detectó IgM anti-VHE y/o ARN VHE en suero; la hepatitis E crónica se definió por la presencia de ARN del VHE en suero por un periodo de tiempo mayor de 6 meses, y el fallo hepático fulminante E cuando se observó un deterioro severo de la función hepática asociado encefalopatía en presencia de IgM anti-VHE y/o ARN VHE en suero. RESULTADOS: La edad media fue de 46,67 y 49,6 ańos en los enfermos con hepatitis aguda y fulminante, respectivamente. Entre los antecedentes epidemiológicos, 13 referían viaje a zonas endémicas, 4 tenían contacto con animales, 4 tenían esteatosis hepática relacionada con consumo de alcohol, 3 consumían regularmente productos de herbolario y 2 bebían agua de arroyos. DISCUSIÓN: El VHE origina hepatitis aguda autolimitada, aunque el 36,73% requirieron hospitalización. Sin embargo, el 10,2% comenzaron con hepatitis fulminante, necesitando trasplante hepático. La hepatitis E crónica es excepcional en inmunocompetentes. El aumento de incidencia es debido a la mayor facilidad de diagnóstico en estos últimos ańos

OBJECTIVE: To study the clinical and epidemiological profiles of in 43cases of acute hepatitis, 5 cases of fulminant hepatitis, and one of chronic hepatitis due to hepatitis E virus (HEV), detected over a 7-year period. PATIENTS: Forty-nine individuals (33male and 10female) treated between 2004 and 2011 in the Hospital Ramón y Cajal (Comunidad de Madrid, Spain). The diagnosis was made by the detection of IgG and IgM anti-HEV and RNA HEV in serum samples. Acute hepatitis E was defined by the presence of IgM anti-HEV and/or RNA HEV in serum, and chronic hepatitis E if the ARN was detectable more than 6months. Fulminant hepatitis E was diagnosed if encephalopathy was observed in addition to IgM anti-HEV and/or RNA HEV in serum. RESULTS: The median age was 46.67 and 49.6years in acute hepatitis E and fulminant hepatitis E, respectively. The risk factors recorded were travel to endemic areas in 13 patients, 4 were in contact with animals, 4suffered from hepatic steatosis due to alcohol consumption, 3consumed uncontrolled foods, and 2drank water from streams. DISCUSSION: HEV is the cause of acute self-limited hepatitis, although 36.73% of the studied cases had to be hospitalised. However a small number of patients, 10.2%, had fulminant hepatitis requiring liver transplant. Chronic hepatitis E is very infrequent in immunocompetent individuals. The increase in incidence of hepatitis E is due to the introduction of better diagnostic tests in recent year

[Acute, chronic and fulminant hepatitisE: seven years of experience (2004-2011)]. / Hepatitis agudas, crónicas y fulminantes por virus de la hepatitisE: 7años de experiencia (2004-2011).

OBJECTIVE: To study the clinical and epidemiological profiles of in 43cases of acute hepatitis, 5cases of fulminant hepatitis, and one of chronic hepatitis due to hepatitis E virus (HEV), detected over a 7-year period. PATIENTS: Forty-nine individuals (33male and 10female) treated between 2004 and 2011 in the Hospital Ramón y Cajal (Comunidad de Madrid, Spain). The diagnosis was made by the detection of IgG and IgM anti-HEV and RNA HEV in serum samples. Acute hepatitisE was defined by the presence of IgM anti-HEV and/or RNA HEV in serum, and chronic hepatitisE if the ARN was detectable more than 6months. Fulminant hepatitisE was diagnosed if encephalopathy was observed in addition to IgM anti-HEV and/or RNA HEV in serum. RESULTS: The median age was 46.67 and 49.6years in acute hepatitisE and fulminant hepatitisE, respectively. The risk factors recorded were travel to endemic areas in 13patients, 4were in contact with animals, 4suffered from hepatic steatosis due to alcohol consumption, 3consumed uncontrolled foods, and 2drank water from streams. DISCUSSION: HEV is the cause of acute self-limited hepatitis, although 36.73% of the studied cases had to be hospitalised. However a small number of patients, 10.2%, had fulminant hepatitis requiring liver transplant. Chronic hepatitisE is very infrequent in immunocompetent individuals. The increase in incidence of hepatitisE is due to the introduction of better diagnostic tests in recent years.