Usos del micofenolato de mofetilo en condiciones distintas de las autorizadas: nefritis lúpica / Off-lable uses of mycophenolate mofetil: lupus nephritis

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Desarrollo y validación de un modelo predictivo para la identificación de pacientes infectados por el VIH con problemas relacionados con los medicamentos. Estudio predictor / Development and validation of a prediction model to identify HIV+ patients with drug-related problems. A prediction study

Objetivo: Desarrollar y validar un modelo predictivo para la detección de problemas relacionados con los medicamentos (PRM) en pacientes con tratamiento antirretroviral (TAR), durante su seguimiento periódico en consultas de atención farmacéutica (AF) y previamente a la dispensación. Método Para encontrar factores pronósticos de PRM, se realizó un modelo de regresión logística binaria tras un análisis univariante, el cual identificó variables independientes relacionadas con PRM que fueron introducidas en el modelo multivariante para la selección final. La validez del modelo se determinó por el método Shrinkage y la capacidad discriminatoria por el estadístico C-Harrell. Estudio multicéntrico, abierto, prospectivo. Se incluyeron pacientes infectados por el VIH con y sin PRM. Para el diseño del modelo se incluyeron variables demográficas, clínicas y farmacoterapéuticas (relacionadas o no con el TAR).Resultados Se incluyeron 733 pacientes. Las variables «adherencia», «prescripción de fármacos con necesidad de ajuste posológico» y «número de medicamentos totales prescritos (al margen del TAR)» se relacionaban de manera independiente con la aparición de PRM. Las probabilidades predichas por el modelo, personalizando los coeficientes por el método shrinkage uniforme mostraron un valor R2=0,962 para la muestra de construcción y R2=0,872 para la de validación. La capacidad discriminatoria del modelo fue de 0,816 para la muestra de construcción y 0,779 para la de validación. Conclusiones El modelo predictivo desarrollado y validado permite la detección de pacientes con tratamiento antirretroviral y con mayor riesgo de sufrir un PRM. Las variables predictoras utilizadas se corresponden con las manejadas habitualmente en la historia farmacoterapéutica del paciente, permitiendo su empleo sistemático en la práctica asistencial (AU)

Objective: To develop and validate a prediction model for the detection of drug-related problems (DRP) in patients on antiretroviral treatment during their regular monitoring in Pharmaceutical Care Clinics before dispensing drugs. Method: Open multicentre prospective study. HIV patients with and without DRP were included. Demographic, clinical and pharmacotherapy variables (related and unrelated to antiretroviral treatment) were included in the model design. To find prognostic factors for DRP, a binary logistic regression model was created after performing a univariate analysis that identified independent variables related to DRP these variables were introduced in the multivariate model for the final selection. Model validity was determined by the shrinkage method and the discriminatory power by Harrell’s C-index. Results: 733 patients were included. The variables ‘‘adherence’’, ‘‘prescription of drugs needing dosage adjustment’’, and ‘‘total number of drugs prescribed (apart from the antiretroviral treatment)’’ were independently related to the appearance of DRP. Probabilities predicted by the model, customising the coefficients using the uniform shrinkage method, showed aR2= 0.962 for the construction sample and a R2= 0.872 for the validation sample. The discriminatory capacity of the model was 0.816 for the construction sample and 0.779 for the validationsample. Conclusions: The developed and validated model enables detection of patients on antiretroviral treatment who are at a higher risk for experiencing a DRP. The prediction variables employed are commonly used in patient’s pharmacotherapy record, allowing the model to be used in routine clinical practice (AU)

[Development and validation of a prediction model to identify HIV+ patients with drug-related problems. A prediction study]. / Desarrollo y validación de un modelo predictivo para la identificación de pacientes infectados por el VIH con problemas relacionados con los medicamentos. Estudio predictor.

OBJECTIVE: To develop and validate a prediction model for the detection of drug-related problems (DRP) in patients on antiretroviral treatment during their regular monitoring in Pharmaceutical Care Clinics before dispensing drugs. MEHOD: Open multicentre prospective study. HIV patients with and without DRP were included. Demographic, clinical and pharmacotherapy variables (related and unrelated to antiretroviral treatment) were included in the model design. To find prognostic factors for DRP, a binary logistic regression model was created after performing a univariate analysis that identified independent variables related to DRP these variables were introduced in the multivariate model for the final selection. Model validity was determined by the shrinkage method and the discriminatory power by Harrell's C-index. RESULTS: 733 patients were included. The variables "adherence", "prescription of drugs needing dosage adjustment", and "total number of drugs prescribed (apart from the antiretroviral treatment)" were independently related to the appearance of DRP. Probabilities predicted by the model, customising the coefficients using the uniform shrinkage method, showed a R(2)=0.962 for the construction sample and a R(2)=0.872 for the validation sample. The discriminatory capacity of the model was 0.816 for the construction sample and 0.779 for the validation sample. CONCLUSIONS: The developed and validated model enables detection of patients on antiretroviral treatment who are at a higher risk for experiencing a DRP. The prediction variables employed are commonly used in patient's pharmacotherapy record, allowing the model to be used in routine clinical practice.

[Survey of the pharmaceutical care situation of the HIV patient in Spain]. / Encuesta de la situación de la atención farmacéutica en el paciente con VIH en España.

OBJECTIVE: To understand the Pharmaceutical Care (PC) given to HIV+ patients in Spain. METHOD: In the year 2004, a survey on PC provided to HIV+ patients was conducted among pharmacists. The survey, with 33 questions, aimed to determine the material and human resources used in this area, as well as specific aspects of PC, and finally the pharmacist's opinion. The survey was distributed through the SEFH (Spanish Society of Hospital Pharmacists) webpage and at HIV conferences. RESULTS: Data was collected from 68 hospitals, most of them public. The most important strengths included the availability of material resources, extensive consulting hours, and the intervention of the pharmacist at key moments (treatment initiation, changes in treatment and changes at the request of the patient). Verbal information was provided in most hospitals, accompanied by written information in 68% of cases. Although 81% of hospitals monitored compliance, less than half did it in a systematic manner, with the most widely used method being the dispensing records. Dispensing data was recorded, and to a lesser extent, the patients' drug treatment histories were available. Differences were seen among the hospitals depending on their size. The pharmacist considered that the PC was acceptable, but that there was room for improvement, and considered the measures available insufficient, highlighting the need for specific personnel and training. CONCLUSIONS: The PC situation of HIV patients is of a good standard, but there is still a lot to be done to achieve acceptable, quality PC.

Encuesta de la situación de la atención farmacéutica en el paciente con VIH en España / Survey of the pharmaceutical care situation of the VIH patient in Spain

Objetivo: Conocer la situación de la atención farmacéutica (AF) alpaciente con VIH en España.Método: En el año 2004 se realizó una encuesta sobre AF al pacientecon VIH dirigida a farmacéuticos. La encuesta, de 33 preguntas, intentabaconocer los recursos materiales y humanos destinados aesta área, así como aspectos concretos de la AF y, finalmente, la opinióndel farmacéutico. La encuesta se distribuyó a través de la páginaweb de la SEFH y las jornadas de VIH.Resultados: Se recogieron datos de 68 hospitales, mayoritariamentepúblicos. Como puntos fuertes destacan la disponibilidad de recursosmateriales, un horario de atención amplio y la intervencióndel farmacéutico en los momentos clave (inicios, cambios de tratamientoy a petición del paciente). En la mayoría de los hospitales sefacilitaba información oral, acompañada de información escrita en el68% de los casos. Aunque el 81% de los hospitales controlaban laadhesión, menos de la mitad lo hacían de forma sistemática; el métodomás empleado era el registro de dispensación. Se registrabandatos de dispensación y, en menor medida, se disponía de una historiafarmacoterapéutica del paciente. Se observaron diferencias entrelos hospitales según su tamaño. El farmacéutico opinaba que laAF era aceptable pero mejorable y consideraba insuficientes los mediosdisponibles, destacando la necesidad de personal y formaciónespecífica.Conclusiones: La situación de la AF en el paciente con VIH tiene unbuen nivel, pero queda mucho por hacer para alcanzar una AF aceptabley de calidad

Objective: To understand the Pharmaceutical Care (PC) given toHIV+ patients in Spain.Method: In the year 2004, a survey on PC provided to HIV+ patientswas conducted among pharmacists. The survey, with 33 questions,aimed to determine the material and human resources used in thisarea, as well as specific aspects of PC, and finally the pharmacist’sopinion. The survey was distributed through the SEFH (Spanish Societyof Hospital Pharmacists) webpage and at HIV conferences.Results: Data was collected from 68 hospitals, most of them public.The most important strengths included the availability of material resources,extensive consulting hours, and the intervention of the pharmacistat key moments (treatment initiation, changes in treatmentand changes at the request of the patient). Verbal information wasprovided in most hospitals, accompanied by written information in68% of cases. Although 81% of hospitals monitored compliance, lessthan half did it in a systematic manner, with the most widely usedmethod being the dispensing records. Dispensing data was recorded,and to a lesser extent, the patients’ drug treatment histories wereavailable. Differences were seen among the hospitals depending ontheir size. The pharmacist considered that the PC was acceptable, butthat there was room for improvement, and considered the measuresavailable insufficient, highlighting the need for specific personnel andtraining.Conclusions: The PC situation of HIV patients is of a good standard,but there is still a lot to be done to achieve acceptable, quality PC

Características psicométricas de la escala de satisfacción con el / tratamiento antirretroviral (ESTAR): estudio ARPAS (I) / No disponible

Objetivo: Evaluar las características psicométricas, la validez convergente y la fiabilidad de la escala de satisfacción con el tratamientoantirretroviral (ESTAR).Método: La satisfacción de los pacientes con el TAR se determinó mediante la ESTAR, desarrollada en castellano a partir de la versióninglesa HIV-Treatment-Satisfaction-Questionnaire (HIVTSQ).Para su evaluación, se midió la consistencia interna y la fiabilidad test-retest. Se efectuó el análisis de constructo estudiando la covarianzay la correlaciones de las cuestiones, y se valoró la validez convergente empleando como estándar el cuestionario MOS-HIV (MedicalOutcomes Study HIV Health Survey), y la validez de contenido mediante la correlación entre la ESTAR y las variables clínicas y terapéuticas.Resultados: La ESTAR se estructura en dos dimensiones (desatisfacción clínica y de satisfacción con el estilo de vida) con ligeras modificaciones sobre la versión original; la cuestión 4, desechada en la versión original, es reformulada en la versión española, y la cuestión 9 se extrajo por su baja comunalidad. Respecto a la fiabilidad test-retest, todos las cuestiones presentan coeficientes de correlación intraclase significativos (p < 0,001). La consistencia interna presenta valores más altos que la versión original en la dimensión estilo de vida (α = 0,81 frente a α = 0,74) y en la puntuación total (α = 0,84 frente a α = 0,82). Respecto a la validezconvergente, la ESTAR presenta correlaciones significativas con la totalidad y con diversas dimensiones del MOS-HIV, destacando la asociación con las dimensiones salud mental, problemas de salud y función cognitiva.Conclusiones: La ESTAR se muestra como un instrumentoadecuado y fiable para evaluar la satisfacción con el TAR de los pacientes infectados por el VIH

Objective: To evaluate the psychometric characteristics, convergent validity and reliability of the antiretroviral treatment satisfactionscale (ESTAR, escala de satisfacción con el tratamientoantirretroviral ).Method: Patient satisfaction with ART was determined using the ESTAR questionnaire, developed in Spanish based on the English language version of the HIV-Treatment-Satisfaction Questionnaire(HIVTSQ). In order to evaluate this, internal consistency and test-retest reliability were measured. The construct analysis was performedby studying the covariance and correlation of the questions, and the convergent validity was assessed by using the MOS-HIV (Medical Outcomes Study HIV Health Survey) questionnaire as the standard, as was the content validity by the correlation between theESTAR and the clinical and therapeutic variables.Results: The ESTAR is structured in two dimensions (clinical satisfaction and satisfaction with lifestyle) with slight modifications to the original version; question 4, discarded in the original version,has been reworded in the Spanish version, and question 9was deleted because of low communality. As regards the testretest reliability, all the questions show significant intraclass correlation coefficients (p < 0.001). The internal consistency shows higher values than the original version in the lifestyle dimension (α = 0.81 vs. α =0.74) and in the total score (α = 0.84 vs. α = 0.82). With regard to convergent validity, the ESTAR presents significant correlations with the MOS-HIV as a whole and with different imensions of it, especially the association with mental health, health distress and cognitive functioning dimensions.Conclusions: The ESTAR turns out to be a suitable, reliable instrument for evaluating satisfaction with ART by HIV+ patients

Preferencias, satisfacción y adherencia con el tratamientoantirretroviral: estudio ARPAS (II) / No disponible

Objetivo: Describir el estudio ARPAS y analizar las características sociodemográficas, clínicas y las preferencias de los pacientes con el tratamiento antirretroviral (TAR), así como la relación entrela adherencia y la satisfacción con el TAR y la calidad de vida.Método: El estudio ARPAS ha evaluado a pacientes adultos,diagnosticados de infección por VIH y con TAR, mediante un protocolo que incluye variables sociodemográficas, clínicas, terapéuticas y de calidad de vida. La adherencia se estimó mediante el cuestionarioSMAQ, la satisfacción mediante el cuestionario ESTAR, la calidad de vida mediante el MOS-HIV y las preferencias con el tratamiento se determinaron mediante un cuestionario elaborado a partir del consenso de un equipo experto en el seguimiento terapéutico de estospacientes. Se realizó un análisis univariante estratificado en funciónde la adherencia y un análisis de regresión logística para estudiar la asociación de las variables independientes con la adherencia.Resultados: Se evaluaron 234 pacientes (73,7% varones;43,2 ± 7,8 años). El tiempo medio desde el diagnóstico y desde el inicio del TAR fue, respectivamente, de 10,1 ± 5,7 y 7,4 ± 4,4 años. El régimen terapéutico de dos tomas diarias (bid) se dio en el 71% de los pacientes, y el de una toma (qd) en el 21%. El 47,3% de los pacientes cumplieron criterios de adherencia según el SMAQ. El porcentaje de los pacientes con qd adherentes alTAR fue mayor que el resto de esquemas posológicos (55,3 vs. 45,1%), aunque no significativamente (p = 0,251). No se observaron diferencias en las variables sociodemográficas y clínicas en función de la adherencia. Se observó una preferencia electivasobre los regímenes terapéuticos más sencillos que contrasta con la valoración de las características de los TAR, donde se antepone la potencia sobre la durabilidad, tolerancia y, en último lugar, comodidad de tomar el TAR. El análisis univariante muestra unamayor puntuación en las escalas de satisfacción (50,4 ± 7,8 vs.46,5 ± 9,7, p = 0,001) y calidad de vida (81,6 ± 10,7 vs. 75,7 ± 11,8, p < 0,001) en los pacientes adherentes respecto de los no adherentes. Los modelos multivariante confirman la existencia de una asociación significativa entre adherencia y satisfacción, y adherencia y calidad de vida.Conclusiones: Los pacientes consideran prioritario tratarse con un TAR potente, duradero y bien tolerado y, dentro de las preferencias entre las diferentes pautas, destacan los regímenes de una toma diaria. El estudio ARPAS demuestra la relación directa entre adherencia y satisfacción con el TAR, y entre adherencia y calidad de vida, de forma que las estrategias de mejora de la adherencia deben incluir necesariamente aspectos que permitan mejorar la satisfacción del paciente con su tratamiento e incrementarla calidad de vida

Objective: To describe the ARPAS study and analyse thesociodemographic and clinical characteristics and patient preferenceswith regards the antiretroviral treatment (ART), as well as the relationship between compliance and satisfaction with the ART and quality of life.Method: The ARPAS study has looked at adult patients diagnosed with HIV and on ART, using a protocol including sociodemographic, clinical, therapeutic and quality of life variables. Compliance was estimated using the SMAQ questionnaire; satisfactionwas measured using the ESTAR questionnaire, as was quality of life with the MOS-HIV Health Survey, and treatment preferences were determined using a questionnaire prepared based on the consensus of an expert team in the field of therapeutic monitoringof these patients. A stratified univariate analysis according to compliance and a logistic regression analysis were carried out to study the association of the independent variables with compliance.Results: A total of 234 patients were evaluated (73.7% male; 43.2 ± 7.8 years of age). The average time since diagnosis and from the initiation of ART was 10.1 ± 5.7 and 7.4 ± 4.4 years respectively.The therapeutic regime of twice-daily doses (bid) wasapplied to 71% of the patients, and once daily (qd) in 21%. A total of 43% of the patients fulfilled compliance criteria according to the SMAQ. The percentage of the patients with qd complying with theART was greater than the remaining dosing schedules (55.3 vs. 45.1%), although not significantly (p = 0.251). No differences were observed in the sociodemographic and clinical variables in terms ofcompliance. An elective preference was observed for the simplest of the therapeutic regimes which contrasts with the evaluation of the ART characteristics, where power is given preference over durability,tolerance and lastly, the convenience of taking the ART. The univariate analysis showed the highest score on the satisfaction scales (50.4 ± 7.8 vs. 46.5 ± 9.7, p = 0.001) and quality of life (81.6± 10.7 vs. 75.7 ± 11.8, p < 0.001) in compliant patients with respect to non-compliers. The multivariate models confirm the existence of a significant association between compliance and satisfaction, and between compliance and quality of life.Conclusions: Patients consider treatment with a powerful,long-lasting and well-tolerated ART a priority and among their preferences for different treatment regimes, once-daily dosing regimes are highlighted. The ARPAS study showed a direct relationship between compliance and satisfaction with ART, and between complianceand quality of life, in a manner that the strategies improving compliance must necessarily include aspects that allow them to improve patient satisfaction with treatment and quality of life

[Psychometric characteristics of the antiretroviral treatment satisfaction scale (ESTAR): ARPAS study (I)]. / Características psicométricas de la escala de satisfacción con el tratamiento antirretroviral (ESTAR): estudio ARPAS (I).

OBJECTIVE: To evaluate the psychometric characteristics, convergent validity and reliability of the antiretroviral treatment satisfaction scale (ESTAR, escala de satisfacción con el tratamiento antirretroviral). METHOD: Patient satisfaction with ART was determined using the ESTAR questionnaire, developed in Spanish based on the English language version of the HIV-Treatment-Satisfaction Questionnaire (HIVTSQ). In order to evaluate this, internal consistency and test-retest reliability were measured. The construct analysis was performed by studying the covariance and correlation of the questions, and the convergent validity was assessed by using the MOS-HIV (Medical Outcomes Study HIV Health Survey) questionnaire as the standard, as was the content validity by the correlation between the ESTAR and the clinical and therapeutic variables. RESULTS: The ESTAR is structured in two dimensions (clinical satisfaction and satisfaction with lifestyle) with slight modifications to the original version; question 4, discarded in the original version, has been reworded in the Spanish version, and question 9 was deleted because of low communality. As regards the test-retest reliability, all the questions show significant intraclass correlation coefficients (p<0.001). The internal consistency shows higher values than the original version in the lifestyle dimension (a=0.81 vs. a=0.74) and in the total score (a=0.84 vs. a=0.82). With regard to convergent validity, the ESTAR presents significant correlations with the MOS-HIV as a whole and with different dimensions of it, especially the association with mental health, health distress and cognitive functioning dimensions. CONCLUSIONS: The ESTAR turns out to be a suitable, reliable instrument for evaluating satisfaction with ART by HIV+ patients.

[Preferences, satisfaction and compliance with antiretroviral treatment: ARPAS study (II)]. / Preferencias, satisfacción y adherencia con el tratamiento antirretroviral: estudio ARPAS (II).

OBJECTIVE: To describe the ARPAS study and analyse the sociodemographic and clinical characteristics and patient preferences with regards the antiretroviral treatment (ART), as well as the relationship between compliance and satisfaction with the ART and quality of life. METHOD: The ARPAS study has looked at adult patients diagnosed with HIV and on ART, using a protocol including sociodemographic, clinical, therapeutic and quality of life variables. Compliance was estimated using the SMAQ questionnaire; satisfaction was measured using the ESTAR questionnaire, as was quality of life with the MOS-HIV Health Survey, and treatment preferences were determined using a questionnaire prepared based on the consensus of an expert team in the field of therapeutic monitoring of these patients. A stratified univariate analysis according to compliance and a logistic regression analysis were carried out to study the association of the independent variables with compliance. RESULTS: A total of 234 patients were evaluated (73.7% male; 43.2+/-7.8 years of age). The average time since diagnosis and from the initiation of ART was 10.1+/-5.7 and 7.4+/-4.4 years respectively. The therapeutic regime of twice-daily doses (bid) was applied to 71% of the patients, and once daily (qd) in 21%. A total of 43% of the patients fulfilled compliance criteria according to the SMAQ. The percentage of the patients with qd complying with the ART was greater than the remaining dosing schedules (55.3 vs. 45.1%), although not significantly (p=0.251). No differences were observed in the sociodemographic and clinical variables in terms of compliance. An elective preference was observed for the simplest of the therapeutic regimes which contrasts with the evaluation of the ART characteristics, where power is given preference over durability, tolerance and lastly, the convenience of taking the ART. The univariate analysis showed the highest score on the satisfaction scales (50.4+/-7.8 vs. 46.5+/-9.7, p=0.001) and quality of life (81.6+/-10.7 vs. 75.7+/-11.8, p<0.001) in compliant patients with respect to non-compliers. The multivariate models confirm the existence of a significant association between compliance and satisfaction, and between compliance and quality of life. CONCLUSIONS: Patients consider treatment with a powerful, long-lasting and well-tolerated ART a priority and among their preferences for different treatment regimes, once-daily dosing regimes are highlighted. The ARPAS study showed a direct relationship between compliance and satisfaction with ART, and between compliance and quality of life, in a manner that the strategies improving compliance must necessarily include aspects that allow them to improve patient satisfaction with treatment and quality of life.

Dosage programming of phenobarbital in neonatal seizures.

Owing to the changes occurring in the organism as a result of biological maturation, disposition kinetics of phenobarbital in newborns is significantly different to that observed in the paediatric and adult populations. Moreover, the disposition parameters change constantly during the first days of life. The data on the serum levels of phenobarbital in 17 newborns were analysed to quantify the changes in the elimination half-life of phenobarbital during the first weeks of life. The half-life of the drug was estimated to be (mean +/- SD) 114.2 +/- 43.0 h, 73.19 +/- 24.17 h and 41.23 +/- 13.95 h in patients 1-10, 11-30 and 31-70 days old, respectively. According to these values and assuming phenobarbital serum levels of 20 mg/l to be safe and effective in neonatal seizures, the initial dosing recommended is 2.9, 4.8 and 6.0 mg/kg/day in newborns 1-10, 11-30 and 31-70 days old, respectively.