Long-term effectiveness and safety of tolvaptan in autosomal dominant polycystic kidney disease.

BACKGROUND AND OBJECTIVES: Evidence on the long-term use of tolvaptan in autosomal dominant polycystic kidney disease (ADPKD) is limited. The aim was to evaluate the tolvaptan effectiveness and safety in real clinical setting. MATERIAL AND METHODS: A single-center observational study (2016-2022) involving ADPKD patients treated with tolvaptan was conducted. Annual change in serum creatinine (sCr) and estimated glomerular filtration rate (eGFR) before and after treatment initiation were evaluated. Change in total kidney volume (TKV), blood pressure (BP) and urinary albuminuria at 12, 24 and 36 months after initiation were also determined. Adverse events (AEs) according to the Common Terminology Criteria for Adverse Events (CTCAE) v5.0 were analyzed. RESULTS: A total of 22 patients were included. No significant differences pre- vs post tolvaptan treatment in annual rate of change in eGFR (-3.52ml/min/1.73m2 [-4.98%] vs -3.98ml/min/1.73m2 [-8.48%], p=0.121) and sCr (+0.06mg/dL [4.22%] vs +0.15mg/dL [7.77%], p=0.429) were observed. Tolvaptan improved urinary osmolality at 12 (p=0.019) and 24 months (p=0.008), but not at 36 months (p=0.11). There were no changes in TKV, BP control and urinary albuminuria at 12, 24 or 36 months. A worse response was shown in patients with rapid kidney function decline (p=0.042). A 36.4% of the patients developed grade III/IV AEs. A 22.7% discontinued treatment due to unacceptable toxicity. CONCLUSIONS: This study shows a modest benefit of tolvaptan in ADPKD patients, as well as safety concerns.

Acute Kidney Injury associated with "Triple whammy" combination: a protocol for a systematic review.

Background: "Triple whammy" (TW) refers to the simultaneous use of diuretics, renin-angiotensin-aldosterone system inhibitors and nonsteroidal anti-inflammatory drugs (NSAIDs). To date, the risk of developing acute kidney injury (AKI) associated to this combination has not been deeply investigated. The objectives are to analyze the incidence of AKI associated to the exposure to "triple whammy" including all NSAIDs versus non-exposure to this combination. Secondarily, the risk of hospitalization, severe adverse events, requirement of renal replacement therapy and mortality will be assessed. Also, the incidence of AKI associated to the exposure to "triple whammy" versus non-exposure will be analyzed, including only metamizole as NSAID.   Methods: A systematic literature search of intervention studies and analytical observational studies will be conducted in the Cochrane Library, Medline and EMBASE, among others. AKI 12 months after the last prescription of the triple combination will be the main outcome. Relative frequencies, risk of bias and certainty of evidence will be analyzed. Additionally, sensitivity and subgroup analyses will be performed.   Results: Once this systematic review has been completed, the results are expected to provide an estimate of the risk associated with this triple combination and the renal variables, in addition to new guidance on the renal treatment of patients potentially receiving triple therapy.  Conclusions: This is intended to be the first systematic review of observational studies to analyse TW combination and AKI's risk based on well-validated epidemiological databases exploring drug safety issues.

Efectividad de la analgesia controlada por el paciente en el dolor agudo y crónico después de cirugía cardiaca: estudio prospectivo / Effectiveness of patient-controlled analgesia in acute and chronic pain after cardiac surgery: a prospective study

INTRODUCCIÓN: La intensidad del dolor postoperatorio moderado-intenso después de una cirugía cardiaca (CC) varía, según los estudios, de un 45 a un 85 %. No existe evidencia sobre cuál es la pauta analgésica óptima en el postoperatorio de estos pacientes. El objetivo de este estudio es evaluar la efectividad de la aplicación de un protocolo analgésico multimodal, basado en la analgesia controlada por el paciente (PCA) con morfina, en pacientes sometidos a CC con circulación extracorpórea (CEC). PACIENTES Y MÉTODOS: Estudio prospectivo de todos los pacientes sometidos a CC con CEC, durante los primeros 3 días del postoperatorio (DPO). Se incluyeron 102 pacientes en dos periodos, noviembre de 2016, con analgesia convencional (AC) y enero-febrero de 2017 con PCA. RESULTADOS: El dolor en reposo se mantuvo controlado (mediana escala numérica < 3). Se registró un 27 % de pacientes con dolor moderado e intenso. No hubo diferencias en la intensidad del dolor entre los pacientes con AC y los de PCA. El grupo de PCA precisó menos analgesia de rescate (63 vs. 44 %, p = 0,0487). La incidencia de dolor crónico postquirúrgico fue de un 39 % a los tres meses y un 3 % al año. El dolor y la ansiedad preoperatorios se correlacionaron con la intensidad del dolor dinámico (r = 0,287, p = 0,03). CONCLUSIONES: La PCA con opioides a demanda y analgesia multimodal es una alternativa efectiva después de la CC. Se obtiene un buen control del dolor postoperatorio sin incrementar los efectos adversos y precisando menos analgesia de rescate administrada por enfermería

INTRODUCTION: The intensity of postoperative moderate/intense pain after cardiac surgery (CC), varies according to the different studies, from 45 % to 85 %. There is no evidence about which is the optimal analgesic regimen in the postoperative period. The main objective of this study is to evaluate the effectiveness of the application of a multimodal analgesic protocol, based on patient-controlled analgesia (PCA) with morphine, in patients undergoing cardiac surgery with extracorporeal circulation (ECC). PATIENTS AND METHODS: Prospective observational study of all patients undergoing CS with ECC, during the first 3 days postoperatively. There were included 102 patients in two periods, first, in November 2016 with conventional analgesia and second, in January - February 2017 with PCA. RESULTS: The pain at rest was controlled (median numerical scale <3). An average of 27 % of moderate and intense pain was recorded. There was no difference in pain intensity between patients with CA and those with PCA. The PCA group required less rescue analgesia in the first postoperative days (63 % vs. 44 % p = 0.0487). The incidence of Post-surgical Chronic Pain was 39 % at three months, and 3 % at one year. There was a correlation between preoperative pain and anxiety with the intensity of the dynamic pain (r = 0.287, p = 0.03). CONCLUSIONS: PCA with on-demand opioids and multimodal analgesia is an effective alternative after cardiac surgery. Good control of postoperative pain is obtained without increasing adverse effects, and requiring less rescue analgesia administered by the nursing staff

Psicoestimulantes para el TDAH: análisis integral para una medicina basada en la prudencia / Psychostimulants for ADHD: a comprehensive analysis for a prudence-based medicine

Objetivo: Analizar en profundidad la evolución del diagnóstico y las alternativas actuales de tratamiento del TDAH, prestando atención a los argumentos del modelo neurobiológico, los datos estadísticos, distintos aspectos de eficacia y seguridad, las tendencias en población adulta y las alternativas de abordaje no farmacológico. Métodos: Búsqueda bibliográfica actualizada a diciembre de 2017 sobre TDAH y términos asociados en Medline y Cochrane Library, ampliada a guías clínicas (NICE, Guía Española), bases de datos de agencias reguladoras (AEMPS, EMA, FDA) y otras fuentes de información complementaria (boletines de fármacos, medios de comunicación, webs). Se solicitaron datos de prescripción al Departamento de Salud del Servicio Navarro de Salud-Osasunbidea (SNS-O) y de consumo farmacéutico nacional a la Dirección General de Cartera Básica de Servicios del Sistema Nacional de Salud. Resultados y conclusiones: El TDAH se presenta como un fenómeno con prevalencia variable y consumo de fármacos creciente. La evolución de su constructo ha experimentado cambios sustanciales, permaneciendo desconocida su etiología. Los argumentos a favor de una hipótesis biológica son poco consistentes y, a falta de marcadores biológicos fiables, las escalas de síntomas no se correlacionan bien con la funcionalidad de los individuos. La terapia no farmacológica merece ser mejor investigada, destacando la terapia conductual por su potencial utilidad. Los medicamentos podrían aportar cierta eficacia en síntomas a corto plazo, sin garantía de mejora en variables relevantes a largo plazo. Crecen los tratamientos en población adulta y se reemplaza progresivamente el metilfenidato por la lisdexanfetamina. Destacan los efectos adversos cardiovasculares, psiquiátricos y endocrinos. De acuerdo con la medicina basada en la prudencia, deberían considerarse un recurso de uso breve y excepcional

Objective:To carry out an in-depth analysis of the evolution and current management of ADHD, paying attention to the neurobiological model narrative, statistical data, information on drug efficacy and safety, trends in adult population and non-pharmacological alternatives. Methods: A bibliographical search was carried out (December 2017) on ADHD and associated trends through Medline and the Cochrane Library. Clinical practice guidelines (NICE, Spanish guideline), regulatory agencies databases (Spanish Medicines Agency, EMA, FDA) and other complementary sources of information (drug bulletins, news media, websites) were also explored. Moreover, data on drug prescription and national consumption were requested from the Health Department of Navarre and the Department of Basic Common Services Portfolio (Ministry of Health). Results/Conclusions:ADHD is a phenomenon of variable prevalence and increasing drug consumption. The evolution of the ADHD concept has constantly changed in a substantial way and its etiology remains unknown. Arguments in favour of a biologic hypothesis lack consistency and no reliable biological markers have been found. Symptom-based scales are poorly correlated with relevant dysfunction outcomes. More and better designed research studies are expected on non-pharmacological therapies, playing behavioural therapy a lead role because of its potential usefulness. Drug treatment might provide some efficacy in the short term, with no clear improvement in long-term relevant outcomes. While adults are increasingly diagnosed and treated for ADHD, methylphenidate seems to be gradually replaced by lisdexamfetamine. Cardiovascular psychiatric and endocrine adverse events should be closely monitored. According to a prudence-based medicine approach, drugs should always be considered as a short and exceptional help

Fiabilidad de los ensayos clínicos. El peligroso camino de la desregulación de los medicamentos / The reliability of clinical trials. The risky way towards drug deregulation

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Percepción de la población general de nuestra especialidad: ¿están de acuerdo los pacientes con las decisiones diagnósticas y terapéuticas adoptadas por el médico de familia? / No disponible

Objetivo. Conocer el grado de conformidad de los pacientes con las decisiones que toma el médico de familia y sus conocimientos sobre nuestra especialidad. Diseño. Estudio descriptivo transversal. Emplazamiento y Participantes. Realizado en dos centros de salud urbanos con una muestra de adultos mayores de 18 años. Se seleccionaron 660 pacientes mediante muestreo estraficado, utilizando como fuente de datos la Tarjeta Sanitaria. Mediciones Principales. Se recogieron variables sociodemográficas, indicadores de utilización, conocimientos sobre nuestra especialidad y actitudes ante potenciales conflictos en la consulta. Se creó un cuestionario específico y enviamos una carta a los pacientes seleccionados, previa a la encuesta telefónica. Resultados. Conocen que se realiza formación especializada postgrado para ser médico de familia el 43,6 % (IC 95 %: 38,2-49) de los encuestados. El 38 % (IC 95 %: 32,9-43,3) de los pacientes está de acuerdo siempre con los cambios de medicación propuestos por el médico de familia. El 51 % (IC 95 %: 45,6-56,4) comprende la negativa de derivación a Atención Hospitalaria. Admitiría la negativa a una prueba complementaría no indicada, a criterio del médico de familia, el 57 % (IC 95 %: 51,6-62,4) de los participantes. Aceptarían que no se les recete antibióticos el 82,7 % (IC 95 %: 78,6-86,8) de los pacientes, aunque ellos lo solicitasen. Conclusiones. La formación específica que realiza su médico de familia es aún desconocida por muchos de nuestros pacientes. Aceptan que no se les recete antibiótico, aunque lo soliciten, una mayor proporción de pacientes que los que admiten una negativa a una prueba complementaria o a una derivación a Atención Hospitalaria (AU)

Objective. To determine patients' degree of agreement with Family Doctor´s decisions and their knowledge about our speciality. Design. Cross-sectional descriptive study. Location and Participants. The study was carried out in two urban primary care health centres with a sample of adults older than 18 years. 660 patients were selected through stratified sampling, using the health card as data source. Main measures. Socio-demographic variables, health care service use indicators, knowledge about our speciality and attitudes towards potential conflicts were registered. A specific questionnaire was designed and a letter was sent to the selected patients before telephone survey. Results. 43.6 % (CI 95 %: 38.2-49) patients know that postgraduate specialised training is required to become family doctor. 38 % (CI 95 %: 32.9-43.3) always agree with changes in medication proposed by the Family Doctor. 51 % (CI 95 %: 45.6-56.4) would agree with their doctor's refusal of referral to hospital care. 57 % (CI 95 %: 51.6-62.4) would agree with a doctor's refusal to make a complementary test although the patient had requested it. 82.7 % (CI 95 %: 78.6- 86.8) would agree with not being prescribed antibiotics although the patient had requested it. Conclusions. Family doctor´s specialized training is still unknown for many of our patients. They agree with the doctor´s decision about their demands of inappropriate antibiotic prescription easier than with decisions about refusal to complementary tests or referral to Specialist Care (AU)

Plan de mejora de los indicadores de farmacia en un área sanitaria de atención primaria de Madrid: descripción y resultados / Plan for improving pharmacy indicators in a primary health area of Madrid. Description and results

ObjetivoEvaluar los resultados de un plan de mejora de los indicadores de farmacia de un Área Sanitaria de Atención Primaria (AP).DiseñoEstudio cuasiexperimental con grupo control. Se valoró la diferencia entre el periodo postintervención (ene–dic 2008) y preintervención (ene–dic 2007).Emplazamiento y participantesGrupo de intervención: médicos del Área 7 de AP de la Comunidad de Madrid (n=397). Grupo control: resto de médicos de AP de la Comunidad de Madrid (n=4.428).IntervenciónPlan de mejora multifocal cuyas principales acciones fueron: sesiones en los centros de salud con peores resultados, implicación de los responsables de Uso Racional del Medicamento, entrevistas con los médicos con indicadores más mejorables, reconocimiento de aquellos con buenos indicadores, elaboración notas breves sobre medicamentos.Mediciones principalesIndicadores de prescripción y de notificaciones relacionadas con la seguridad de los medicamentos.ResultadosEn relación a Madrid, las mejoras absolutas del Área 7 en los indicadores acumulados %EFG, %Estatinas elección, %ARAII y %Omeprazol fueron 0,29; 1,17; 0,61 y 0,37 puntos porcentuales, respectivamente. DHD Osteoporosis igualó la mejora de Madrid. En el Área 7, el incremento en las notificaciones de sospechas de RAM graves fue 180% y en el número de notificadores de RAM 233%, mejorando los datos de Madrid (48 y 21%). La notificación de errores de medicación presentó incrementos similares en ambos grupos (AP7 1.567% vs Madrid AP 1.633%).ConclusionesImplementar un plan de mejora multifocal con acciones factibles y concretas, puede ser una herramienta útil para la mejora de los indicadores de farmacia(AU)

ObjectiveTo evaluate the results of a plan for improving pharmacy indicators in a Primary Care (PC) Health Area.DesignQuasi-experimental study with a control group. The differences between the pre-intervention (Jan-Dec 2007) and post-intervention (Jan-Dec 2008) periods were evaluated.Setting and participantsIntervention group: Primary Care doctors from PC Area 7 of the Community of Madrid (n=397). Control group: the rest of PC doctors of the Community of Madrid (n=4428).MethodA multi-focus plan in which the main activities were: sessions in the health centres with the worst results, involvement of those responsible for the Rational Use of Drugs, interviews with the doctors with the most improvable indicators, recognition of those with good indicators, and preparing short notes on drugs.Main measurementsPrescription and notification indicators associated with the safety of drugs.ResultsIn relation to Madrid, the absolute improvements of Area 7 in the accumulated indicators, %Generic drugs, %Statins, %ARAII y %Omeprazole were 0.29; 1.17; 0.61 and 0.37 percentage points, respectively. DHD Osteoporosis equalled the improvement of Madrid. In Area 7, the increase in notifications of suspected serious ADRs was 180% and number of ADR notifications of ADRs was 233%, better than the Madrid data (48% and 21%). The notification of medication errors showed similar increases in both groups (PC Area 7 1567% vs. Madrid PC 1633%).ConclusionsImplementing a multi-focus improvement plan with feasible and specific actions can be a useful tool for improving pharmacy indicators(AU)

[Plan for improving pharmacy indicators in a primary health area of Madrid. Description and results]. / Plan de mejora de los indicadores de farmacia en un área sanitaria de atención primaria de Madrid: descripción y resultados.

OBJECTIVE: To evaluate the results of a plan for improving pharmacy indicators in a Primary Care (PC) Health Area. DESIGN: Quasi-experimental study with a control group. The differences between the pre-intervention (Jan-Dec 2007) and post-intervention (Jan-Dec 2008) periods were evaluated. SETTING AND PARTICIPANTS: Intervention group: Primary Care doctors from PC Area 7 of the Community of Madrid (n=397). CONTROL GROUP: the rest of PC doctors of the Community of Madrid (n=4428). METHOD: A multi-focus plan in which the main activities were: sessions in the health centres with the worst results, involvement of those responsible for the Rational Use of Drugs, interviews with the doctors with the most improvable indicators, recognition of those with good indicators, and preparing short notes on drugs. MAIN MEASUREMENTS: Prescription and notification indicators associated with the safety of drugs. RESULTS: In relation to Madrid, the absolute improvements of Area 7 in the accumulated indicators, %Generic drugs, %Statins, %ARAII y %Omeprazole were 0.29; 1.17; 0.61 and 0.37 percentage points, respectively. DHD Osteoporosis equalled the improvement of Madrid. In Area 7, the increase in notifications of suspected serious ADRs was 180% and number of ADR notifications of ADRs was 233%, better than the Madrid data (48% and 21%). The notification of medication errors showed similar increases in both groups (PC Area 7 1567% vs. Madrid PC 1633%). CONCLUSIONS: Implementing a multi-focus improvement plan with feasible and specific actions can be a useful tool for improving pharmacy indicators.