[2022 Practice guidelines for the management of arterial hypertension of the Spanish Society of Hypertension]. / Guía práctica sobre el diagnóstico y tratamiento de la hipertensión arterial en España, 2022. Sociedad Española de Hipertensión - Liga Española para la Lucha contra la Hipertensión Arterial (SEH-LELHA).

Hypertension is the most important risk factor for global disease burden. Detection and management of hypertension are considered as key issues for individual and public health, as adequate control of blood pressure levels markedly reduces morbidity and mortality associated with hypertension. Aims of these practice guidelines for the management of arterial hypertension of the Spanish Society of Hypertension include offering simplified schemes for diagnosis and treatment for daily practice, and strategies for public health promotion. The Spanish Society of Hypertension assumes the 2018 European guidelines for management of arterial hypertension developed by the European Society of Cardiology and the European Society of Hypertension, although relevant aspects of the 2017 American College of Cardiology/American Heart Association guidelines and the 2020 International Society of Hypertension guidelines are also commented. Hypertension is defined as a persistent elevation in office systolic blood pressure ≥ 140 and/or diastolic blood pressure ≥ 90 mmHg, and assessment of out-of-office blood pressure and global cardiovascular risk are considered of key importance for evaluation and management of hypertensive patients. The target for treated blood pressure should be < 130/80 for most patients. The treatment of hypertension involves lifestyle interventions and drug therapy. Most people with hypertension need more than one antihypertensive drug for adequate control, so initial therapy with two drugs, and single pill combinations are recommended for a wide majority of hypertensive patients.

Documento de la Sociedad Española de Hipertensión-Liga Española para la Lucha contra la Hipertensión Arterial (SEH-LELHA) sobre las guías ACC/AHA 2017 de hipertensión arterial / Spanish Society of Hypertension position statement on the 2017 ACC/AHA hypertension guidelines

El American College of Cardiology (ACC) y la American Heart Association (AHA) han publicado recientemente la guía para la prevención, detección, evaluación y tratamiento de la hipertensión arterial (HTA) en adultos. El punto más controvertido es el umbral diagnóstico de 130/80 mmHg, lo cual conlleva diagnosticar HTA en un gran número de personas previamente consideradas no hipertensas. La presión arterial (PA) se clasifica como normal (sistólica < 120 y diastólica 80 mmHg), elevada (120-129 y < 80 mmHg), grado 1 (130-139 o 80-89 mmHg) y grado 2 (≥ 140 o ≥ 90 mmHg). Se recomienda la medida de PA fuera de la consulta para confirmar el diagnóstico de HTA o para aumentar el tratamiento. En la toma de decisiones sería determinante el riesgo cardiovascular (RCV), ya que precisarían tratamiento farmacológico personas con HTA grado 1 con riesgo a 10 años de enfermedad cardiovascular aterosclerótica ≥ 10% y aquellas con enfermedad cardiovascular establecida, enfermedad renal crónica y diabetes, siendo el resto susceptibles de medidas no farmacológicas hasta umbrales de 140/90 mmHg. Dichas recomendaciones permitirían a los sujetos con HTA grado 1 y alto RCV beneficiarse de terapias farmacológicas y podrían mejorar las intervenciones no farmacológicas en todos los sujetos. Sin embargo, habría que ser cauteloso ya que sin poder garantizar una toma correcta de PA, ni el cálculo sistemático del RCV, la aplicación de dichos criterios podría sobrestimar el diagnóstico de HTA y suponer un sobretratamiento innecesario. Las guías son recomendaciones, no imposiciones, y el abordaje y manejo de la PA debe ser individualizado, basado en decisiones clínicas, preferencias de los pacientes y en un balance adecuado del beneficio y riesgo al establecer los diferentes objetivos de PA

The American College of Cardiology (ACC) and the American Heart Association (AHA) have recently published their guidelines for the prevention, detection, evaluation, and management of hypertension in adults. The most controversial issue is the classification threshold at 130/80mmHg, which will allow a large number of patients to be diagnosed as hypertensive who were previously considered normotensive. Blood pressure (BP) is considered normal (<120mmHg systolic and <80mmHg diastolic), elevated (120-129 and <80mmHg), stage 1 (130-139 or 80-89mmHg), and stage 2 (≥140 or ≥90mmHg). Out-of-office BP measurements are recommended to confirm the diagnosis of hypertension and for titration of BP-lowering medication. In management, cardiovascular risk would be determinant since those with grade 1 hypertension and an estimated 10-year risk of atherosclerotic cardiovascular disease ≥10%, and those with cardiovascular disease, chronic kidney disease and/or diabetes will require pharmacological treatment, the rest being susceptible to non-pharmacological treatment up to the 140/90mmHg threshold. These recommendations would allow patients with level 1 hypertension and high atherosclerotic cardiovascular disease to benefit from pharmacological therapies and all patients could also benefit from improved non-pharmacological therapies. However, this approach should be cautious because inadequate BP measurement and/or lack of systematic atherosclerotic cardiovascular disease calculation could lead to overestimation in diagnosing hypertension and to overtreatment. Guidelines are recommendations, not impositions, and the management of hypertension should be individualized, based on clinical decisions, preferences of the patients, and an adequate balance between benefits and risks

[Spanish Society of Hypertension position statement on the 2017 ACC/AHA hypertension guidelines]. / Documento de la Sociedad Española de Hipertensión-Liga Española para la Lucha contra la Hipertensión Arterial (SEH-LELHA) sobre las guías ACC/AHA 2017 de hipertensión arterial.

The American College of Cardiology (ACC) and the American Heart Association (AHA) have recently published their guidelines for the prevention, detection, evaluation, and management of hypertension in adults. The most controversial issue is the classification threshold at 130/80mmHg, which will allow a large number of patients to be diagnosed as hypertensive who were previously considered normotensive. Blood pressure (BP) is considered normal (<120mmHg systolic and <80mmHg diastolic), elevated (120-129 and <80mmHg), stage 1 (130-139 or 80-89mmHg), and stage 2 (≥140 or ≥90mmHg). Out-of-office BP measurements are recommended to confirm the diagnosis of hypertension and for titration of BP-lowering medication. In management, cardiovascular risk would be determinant since those with grade 1 hypertension and an estimated 10-year risk of atherosclerotic cardiovascular disease ≥10%, and those with cardiovascular disease, chronic kidney disease and/or diabetes will require pharmacological treatment, the rest being susceptible to non-pharmacological treatment up to the 140/90mmHg threshold. These recommendations would allow patients with level 1 hypertension and high atherosclerotic cardiovascular disease to benefit from pharmacological therapies and all patients could also benefit from improved non-pharmacological therapies. However, this approach should be cautious because inadequate BP measurement and/or lack of systematic atherosclerotic cardiovascular disease calculation could lead to overestimation in diagnosing hypertension and to overtreatment. Guidelines are recommendations, not impositions, and the management of hypertension should be individualized, based on clinical decisions, preferences of the patients, and an adequate balance between benefits and risks.

Fluticasone in mild to moderate atopic dermatitis relapse: A randomized controlled trial.

BACKGROUND: The long-term efficacy of corticosteroids to prevent atopic dermatitis (AD) relapses has partially been addressed in children. This study compared an intermittent dosing regimen of fluticasone propionate (FP) cream 0.05% with its vehicle base in reducing the risk of relapse in children with stabilized AD. METHODS: A randomized controlled, multicentric, double-blind trial was conducted. Children (2-10 years) with mild/moderate AD (exclusion criteria: >30% affected body surface area and/or head) were enrolled into an Open-label Stabilization Phase (OSP) of up to 2 weeks on twice daily FP. Those who achieved treatment success entered the Double-blind Maintenance Phase (DMP). They were randomly allocated to receive FP or vehicle twice-weekly on consecutive days for 16 weeks. The primary study endpoint was relapse rate; time to relapse and severity of disease were also studied. Kaplan-Meier estimates were calculated. RESULTS: Fifty-four patients (29 girls) entered the OSP (23 mild AD) and 49 (26 girls) continued into the DMP. Mean age was 5.5 (SD: 2.8) and 5.1 (SD: 2.3) yrs for FP and vehicle groups, respectively. Four patients withdrew from the DMP (two in every group). Patients treated with FP twice weekly had a 2.7 fold lower risk of experiencing a relapse than patients treated with vehicle (relative risk 2.72, SD: 1.28; p=0.034). FP was also superior to vehicle for delaying time to relapse. Both treatment therapies were well tolerated. CONCLUSION: This long-term study shows that twice weekly FP provides an effective maintenance treatment to control the risk of relapse in children with AD.

Hipertensión al día en 6 preguntas. Curso precongreso SEH-LELHA Valencia 2016. Presentación / Up to date in hypertension in 6 topics. Proceedings of the pre-congress course at the 2016 meeting of the Spanish Society of Hypertension. Introduction

No disponible

Notificación de reacciones adversas a la vacuna frente al virus del papiloma humano en la Comunidad Valenciana (2007-2011) / Adverse reactions to human papillomavirus vaccine in the Valencian Community (2007-2011)

INTRODUCCIÓN: En 2009, 2 casos de convulsiones en adolescentes tras la administración de la vacuna tetravalente frente al virus del papiloma humano (VPH) generaron impacto mediático y afectaron negativamente la confianza del público en esta vacuna. Nuestros objetivos fueron describir las sospechas de reacciones adversas (SRA) notificadas al Centro Autonómico de Farmacovigilancia de la Comunidad Valenciana (CAFCV) tras la administración de la vacuna frente al VPH y comparar la tasa de notificación de síncope y convulsiones de esta vacuna con la de otras vacunas administradas en adolescentes. MATERIAL Y MÉTODOS: Estudio descriptivo de las notificaciones de SRA relacionadas con esta vacuna recibidas por el CAFCV entre 2007 y 2011. RESULTADOS: Las manifestaciones clínicas más comunicadas fueron mareos, cefalea y síncope. Las tasas de notificación de síncope o pérdida de conciencia y convulsiones con la vacuna frente al VPH fueron de 17 y 3,2 por 100.000 dosis administradas, respectivamente, y de 15 y 1,6 para síncope o pérdida de conciencia y convulsiones sincopales ocurridas el día de la vacunación. Las tasas de notificación de síncope o pérdida de conciencia y convulsiones fueron de 6,4 y 0,4 para otras vacunas. CONCLUSIONES: Las tasas de notificación de síncope o pérdida de conciencia y convulsiones fueron mayores para la vacuna frente al VPH que para otras vacunas administradas en adolescentes; esto es consistente con la atención mediática originada por la vacuna y con hallazgos de estudios previos. No obstante, la información obtenida sobre las SRA a la vacuna sugiere un buen perfil de seguridad

INTRODUCTION: In 2009, two cases of seizures in adolescents following quadrivalent human papillomavirus vaccine (qHPV) administration, generated important media attention, and adversely affected public trust in this vaccine. Our objectives were to describe suspected adverse reactions (SARs) reported to the Pharmacovigilance Centre in the Valencian Community (PCVC) after administration of HPV vaccine, and to compare reporting rates of syncope and seizures following this vaccine with those of other vaccines administered to girls aged 13-15 years. MATERIAL AND METHODS: Descriptive study of SARs reported following this vaccine to the PCVC between 2007 and 2011. RESULTS: The clinical symptoms most frequently reported were dizziness, headache, and syncope. Reporting rates of syncope or loss of consciousness and seizures with qHPV vaccine were 17 and 3.2 per 100,000 doses administered, respectively, and 15 and 1.6 for syncope or loss of consciousness and syncopal seizures occurred on the day of vaccination. The reporting rates of syncope or loss of consciousness and seizures were 6.4 and 0.4, for the other vaccines. CONCLUSIONS: Consistent with the media attention generated, and with results from other studies, the reporting rates of syncope or loss of consciousness and seizures were higher for the HPV vaccine than for other vaccines given in adolescence. Nevertheless, the overall information obtained on SARs following the qHPV vaccine suggests a good safety profile

[Adverse reactions to human papillomavirus vaccine in the Valencian Community (2007-2011)]. / Notificación de reacciones adversas a la vacuna frente al virus del papiloma humano en la Comunidad Valenciana (2007-2011).

INTRODUCTION: In 2009, two cases of seizures in adolescents following quadrivalent human papillomavirus vaccine (qHPV) administration, generated important media attention, and adversely affected public trust in this vaccine. Our objectives were to describe suspected adverse reactions (SARs) reported to the Pharmacovigilance Centre in the Valencian Community (PCVC) after administration of HPV vaccine, and to compare reporting rates of syncope and seizures following this vaccine with those of other vaccines administered to girls aged 13-15 years. MATERIAL AND METHODS: Descriptive study of SARs reported following this vaccine to the PCVC between 2007 and 2011. RESULTS: The clinical symptoms most frequently reported were dizziness, headache, and syncope. Reporting rates of syncope or loss of consciousness and seizures with qHPV vaccine were 17 and 3.2 per 100,000 doses administered, respectively, and 15 and 1.6 for syncope or loss of consciousness and syncopal seizures occurred on the day of vaccination. The reporting rates of syncope or loss of consciousness and seizures were 6.4 and 0.4, for the other vaccines. CONCLUSIONS: Consistent with the media attention generated, and with results from other studies, the reporting rates of syncope or loss of consciousness and seizures were higher for the HPV vaccine than for other vaccines given in adolescence. Nevertheless, the overall information obtained on SARs following the qHPV vaccine suggests a good safety profile.

[Has the use of antipyretics been modified after the introduction of different concentrations of ibuprofen into the market?]. / ¿Se ha modificado el uso de antitérmicos tras la introducción de ibuprofeno a diferentes concentraciones?

INTRODUCTION: Due to the emergence of new pharmaceutical presentations of ibuprofen (40 mg/ml), an analysis was made on the use of antipyretics in pediatric outpatient in Spain. PATIENTS AND METHODS: A cross-sectional, observational, descriptive study was carried out on a sample of children under 14 years old with treated febrile syndrome, seen in the Emergency Room of the Hospital General Universitario de Valencia from November 2012 to January 2013. RESULTS: Of the 217 children included, 144 were treated with paracetamol or ibuprofen, 69 received both drugs, and one received paracetamol and metamizol. There were 58.7% of exposures to paracetamol and 40.9% to ibuprofen. The parents decided the use of antipyretics in 63.2% of cases. In 98 exposures the dose was different from that authorized in the labeling of the drug (off-label use). Ibuprofen was used off-label in 40.2% of cases, mostly by underdosing (35.9%). Paracetamol was used off-label in 29.8% of cases, predominantly overdose (26.8%), with the difference being statistically significant. No significant differences were observed in the off-label use in either monotherapy or combined use. There were also no differences when antipyretics prescribed by doctors or given directly by parents were evaluated separately. CONCLUSIONS: The majority of children with treated febrile syndrome seen in the Emergency Room were receiving antipyretic drugs after a parental decision. Paracetamol is the most commonly used drug and one in three children received it simultaneously with ibuprofen. The antipyretics were used off label in one-third of the cases. Off label use of ibuprofen is increasing, and is probably due to the existence of different pharmaceutical presentations.

Conceptos nuevos sobre el sistema renina angiotensina / New concepts on the renin-angiotensin system

En los últimos años se han descrito nuevos componentes del sistema renina angiotensina. Se han identificado 5 nuevos polipéptidos, sus vías de síntesis y las enzimas responsables de ella. Se han descrito también receptores para la angiotensina 1–7, la angiotensina IV y la renina. El conocimiento de los sistemas renina angiotensina locales se ha completado con el descubrimiento de los sistemas intracelulares. Se han descrito mutaciones y polimorfismos en los genes de los distintos componentes del sistema, que podrían relacionarse con el desarrollo de hipertensión y de enfermedad cardiovascular. Además, se ha introducido en terapéutica el aliskiren, primer representante del nuevo grupo de los inhibidores directos de la renina. También se han publicado los primeros resultados positivos obtenidos con una vacuna antihipertensiva que genera anticuerpos frente a la angiotensina II. Todos estos hallazgos han permitido postular nuevas hipótesis sobre la relación entre los componentes del sistema y la enfermedad cardiovascular (AU)

In recent years, new components of the renin-angiotensin system have been described. Five new polypeptides with their synthesis routes and the enzymes involved in their synthesis have been identified. Receptors for angiotensin 1–7, angiotensin IV and rennin have also been described. The knowledge of local renin-angiotensin systems has been extended with the discovery of the intracellular systems. Mutations and polymorphisms in the genes of the different components of the renin-angiotensin system have been described. These could be involved in the development of hypertension and cardiovascular disease. In addition, aliskiren, the first component of the new group of renin directinhibitors, has been introduced in the therapeutics. The first positive results of a clinical trial with an antihypertensive vaccine that generates antibodies against angiotensin II have been published. All these findings have made it possible to generate new hypotheses on the relationship between the components of the system and cardiovascular diseases (AU)

[Management of high blood pressure in children and adolescents: Recommendations of the European Society of hypertension]. / Manejo de la hipertensión arterial en niños y adolescentes: recomendaciones de la Sociedad Europea de Hipertensión.

Hypertension in children and adolescents has been gaining ground in cardiovascular medicine, mainly due to the advances made in several areas of pathophysiological and clinical research. These guidelines arose from the consensus reached by specialists in the detection and control of hypertension in children and adolescents. Furthermore, these guidelines are a compendium of scientific data and the extensive clinical experience it contains represents the most complete information that doctors, nurses and families should take into account when making decisions. These guidelines, which stress the importance of hypertension in children and adolescents, and its contribution to the current epidemic of cardiovascular disease, should act as a stimulus for governments to develop a global effort for the early detection and suitable treatment of high pressure in children and adolescents. J Hypertens 27:1719-1742 Q 2009 Wolters Kluwer Health | Lippincott Williams & Wilkins.

Manejo de la hipertensión arterial en niños y adolescentes: recomendaciones de la Sociedad Europea de Hipertensión / Management of high blood pressure in children and adolescents: Recommendations of the European Society of hypertension

La hipertensión en niños y adolescentes ha ido ganando terreno en la medicina cardiovascular, gracias a los avances producidos en distintas áreas de la investigación fisiopatológica y clínica. Estas guías nacen del consenso al que han llegado los especialistas en la detección y control de la hipertensión en niños y adolescentes. Por otra parte, dichas guías son un compendio de los datos científicos y la extensa experiencia clínica con la que se cuenta, y constituyen la información clínica más completa que los médicos, enfermeras y familiares deberían tener en cuenta a la hora de tomar decisiones. Estas guías, que hacen hincapié en la importancia de la hipertensión en niños y adolescentes, así como en el papel que desempeña en la actual epidemia de enfermedades cardiovasculares, deberían constituir un estímulo para que los gobiernos desarrollaran un esfuerzo global para una detección precoz y un tratamiento adecuado de la hipertensión arterial en niños y adolescentes. J Hypertens 27:1719-1742 Q 2009 Wolters Kluwer Health | Lippincott Williams & Wilkins(AU)

Hypertension in children and adolescents has been gaining ground in cardiovascular medicine, mainly due to the advances made in several areas of pathophysiological and clinical research. These guidelines arose from the consensus reached by specialists in the detection and control of hypertension in children and adolescents. Furthermore, these guidelines are a compendium of scientific data and the extensive clinical experience it contains represents the most complete information that doctors, nurses and families should take into account when making decisions. These guidelines, which stress the importance of hypertension in children and adolescents, and its contribution to the current epidemic of cardiovascular disease, should act as a stimulus for governments to develop a global effort for the early detection and suitable treatment of high pressure in children and adolescents. J Hypertens 27:1719-1742 Q 2009 Wolters Kluwer Health | Lippincott Williams & Wilkins(AU)

[Drugs used in paediatric outpatients: do we have enough information available?]. / Medicamentos utilizados en pediatría extrahospitalaria: disponemos de información suficiente?

OBJECTIVE: To analyse the drugs taken in paediatric outpatients and the information available on these drugs. PATIENTS AND METHODS: A cross-sectional, observational, descriptive study was carried out. The study involved a sample of children under 14 years seen in the Emergency Room of the HGUV from June 2005 to August 2006. The medicines they received were quantified and classified, and the information on these drugs available in the Vademecum International Medicom and in the Summary of Product Characteristics, were analysed. RESULTS: Of the 462 children (mean age 5.2 (95 % CI 4.9-5.6)) included, 336 received 667 medicines (152 different medicines) that contained 864 drugs (161 different drugs). In 34.3 % of the cases it was for self-medication. Children under 4 years received more drugs than the older group (80.2 % in the younger group and 67.4 % in the older). Patients received from 1 to 7 medicines (mean 2.0). Children receiving 2 or 3 medicines were younger than those who received one. Five therapeutic groups of the Anatomical-Therapeutical-Chemical Classification (ATC) include the 93.1 % of the drugs administered (R: 26.5 %; M: 23.8 %; N: 22.8 %; J: 10.6 % and A: 10.0 %). In the information sources consulted there was no information available on paediatric use for 40 of the 152 medicines used. CONCLUSIONS: Almost 75 % of patients seen in the Emergency Room were already receiving drugs before they arrived at the hospital, in many cases as a result of self-medication. The information available on the paediatric use of drugs is deficient. Clinical research is required to study the effects of pharmacological treatment on children and to improve the information on their use.

Medicamentos utilizados en pediatría extrahospitalaria: ¿disponemos de información suficiente? / Drugs used in paediatric outpatients: Do we have enough information available?

Objetivo: Analizar los medicamentos que reciben los pacientes pediátricos en el ámbito extrahospitalario y la información disponible sobre los mismos. Pacientes y métodos: Estudio transversal, observacional y descriptivo realizado en una muestra de pacientes menores de 14 años atendidos en urgencias del Servicio de Pediatría del Consorcio Hospital General Universitario de Valencia entre junio 2005 y agosto 2006. Se cuantifican y clasifican los medicamentos utilizados antes de acudir a urgencias y se analiza la información sobre su uso que contiene el Vademécum Internacional Medicom y la ficha técnica. Resultados: Se recogió información sobre 462 niños con media de edad de 5,2 años (intervalo de confianza del 95 % [IC 95 %]: 4,9-5,6). De ellos, 336 reciben 667 medicamentos (152 distintos) que contienen 864 principios activos (161 diferentes). En el 34,3 % de los casos el uso es por automedicación. Los menores de 4 años reciben medicamentos en mayor proporción que los mayores (80,2 y 67,4 %, respectivamente). Los pacientes reciben entre 1 y 7 medicamentos (media 2,0). Los que toman 2 o 3 medicamentos son menores que los que toman uno. Cinco grupos terapéuticos de la Clasificación anatómico-terapéutico-química (ATC) incluyen el 93,1 % de los medicamentos (R [aparato respiratorio]: 26,5 %; M [aparato locomotor]: 23,8 %; N [sistema nervioso central]: 22,8 %; J [antiinfecciosos por vía general]: 10,6 % y A [aparato digestivo y metabolismo]: 10,0 %). Para 40 de los 152 medicamentos no hay información pediátrica en las fuentes consultadas. Conclusiones: Casi tres cuartas partes de los niños atendidos en urgencias toman medicamentos antes de acudir a este servicio, en muchos casos por automedicación. La información sobre uso pediátrico de medicamentos es incompleta y presenta incongruencias. Es necesario fomentar la investigación clínica sobre los efectos del tratamiento farmacológico en los niños para mejorar la información sobre su uso (AU)

Objective: To analyse the drugs taken in paediatric outpatients and the information available on these drugs. Patients and methods: A cross-sectional, observational, descriptive study was carried out. The study involved a sample of children under 14 years seen in the Emergency Room of the HGUV from June 2005 to August 2006. The medicines they received were quantified and classified, and the information on these drugs available in the Vademecum International Medicom and in the Summary of Product Characteristics, were analysed. Results: Of the 462 children (mean age 5.2 (95 % CI 4.9-5.6)) included, 336 received 667 medicines (152 different medicines) that contained 864 drugs (161 different drugs). In 34.3 % of the cases it was for self-medication. Children under 4 years received more drugs than the older group (80.2 % in the younger group and 67.4 % in the older). Patients received from 1 to 7 medicines (mean 2.0). Children receiving 2 or 3 medicines were younger than those who received one. Five therapeutic groups of the Anatomical-Therapeutical-Chemical Classification (ATC) include the 93.1 % of the drugs administered (R: 26.5 %; M: 23.8 %; N: 22.8 %; J: 10.6 % and A: 10.0 %). In the information sources consulted there was no information available on paediatric use for 40 of the 152 medicines used. Conclusions: Almost 75 % of patients seen in the Emergency Room were already receiving drugs before they arrived at the hospital, in many cases as a result of self-medication. The information available on the paediatric use of drugs is deficient. Clinical research is required to study the effects of pharmacological treatment on children and to improve the information on their use (AU)

[Are the Spanish hypertensive children therapeutic orphans?]. / Son los niños hipertensos españoles huérfanos terapéuticos?

INTRODUCTION: According to current guidelines, hypertension in children should be treated with the same drugs as those used in adults, with adjustment of the dose to their body size. The term therapeutic orphans refers to the lack of information on how to use drugs in children. The aim of this study was to investigate whether the information in the International Vademecum (I-V) is sufficient for the correct use of antihypertensive drugs in children. MATERIAL AND METHOD: We reviewed the data on pediatric dosages of antihypertensive drugs in the I-V (44th and 45th editions). When there were several drugs for the same molecule, the last one marked with the Spanish Ministry of Health and Consumption's logo was selected. When information on a particular drug was not available, the entries for other drugs with the same active principle were reviewed. The information was compared with that provided by the Fourth Report of the National High Blood Pressure Education Program Working Group (NHBPEP). RESULTS: A total of 111 entries for 41 antihypertensive drugs were reviewed. Information on use in children is available for only 3 diuretics and 2 angiotensin converting enzyme inhibitors. The remaining entries either contain no information or indicate that the effectiveness and safety in children has not been evaluated. Some drugs are contraindicated in children. The Fourth Report of the NHBPEP includes pediatric dosages for 28 antihypertensive drugs. The Food and Drug Administration has authorized 10 antihypertensive drugs for use in children. CONCLUSIONS: The information in the V-I can be used to determine the correct dosage of only 5 antihypertensive drugs in children, making this age group authentic therapeutic orphans.

¿Son los niños hipertensos españoles huérfanos terapéuticos? / Are the Spanish hypertensive children therapeutic orphans?

Introducción: Según las guías, la hipertensión en los niños debe tratarse con los mismos fármacos usados en adultos ajustando las dosis al tamaño corporal. El término huérfano terapéutico se refiere a la falta de información sobre el uso de medicamentos en niños. El objetivo es investigar si el Vademécum Internacional (V-I) contiene información para el uso correcto de antihipertensivos en niños. Material y método: Revisión en el V-I de la posología pediátrica de antihipertensivos. Si existen varias especialidades para un fármaco se selecciona el del logotipo del Ministerio de Sanidad y Consumo más reciente. Si en una monografía no hay información, se revisan las de otras especialidades del mismo principio activo. La información se compara con la del 4.º informe del National High Blood Pressure Education Program Working Group (NHBPEP). Resultados: Se revisan 111 monografías de 41 fármacos con indicación de antihipertensivo. Sólo para 3 diuréticos y 2 inhibidores de la enzima conversora de angiotensina (IECA) hay información pediátrica. Las otras advierten de que no se ha establecido la eficacia y seguridad o no hacen referencia a niños. En algunos casos se contraindican. El 4.º informe del NHBPEP incluye dosificación pediátrica de 28 antihipertensivos. La Food and Drug Administration (FDA) tiene autorizados 10 antihipertensivos para uso en niños. Conclusiones: Con la información del V-I sólo es posible dosificar correctamente 5 antihipertensivos en niños, lo que los convierte en auténticos huérfanos terapéuticos

Introduction: According to current guidelines, hypertension in children should be treated with the same drugs as those used in adults, with adjustment of the dose to their body size. The term therapeutic orphans refers to the lack of information on how to use drugs in children. The aim of this study was to investigate whether the information in the International Vademecum (I-V) is sufficient for the correct use of antihypertensive drugs in children. Material and method: We reviewed the data on pediatric dosages of antihypertensive drugs in the I-V (44th and 45th editions). When there were several drugs for the same molecule, the last one marked with the Spanish Ministry of Health and Consumption's logo was selected. When information on a particular drug was not available, the entries for other drugs with the same active principle were reviewed. The information was compared with that provided by the Fourth Report of the National High Blood Pressure Education Program Working Group (NHBPEP). Results: A total of 111 entries for 41 antihypertensive drugs were reviewed. Information on use in children is available for only 3 diuretics and 2 angiotensin converting enzyme inhibitors. The remaining entries either contain no information or indicate that the effectiveness and safety in children has not been evaluated. Some drugs are contraindicated in children. The Fourth Report of the NHBPEP includes pediatric dosages for 28 antihypertensive drugs. The Food and Drug Administration has authorized 10 antihypertensive drugs for use in children. Conclusions: The information in the V-I can be used to determine the correct dosage of only 5 antihypertensive drugs in children, making this age group authentic therapeutic orphans

Clinical trials in children.

Randomized controlled clinical trials are felt by the medical community to provide the best evidence. Participation in trials involves the possibility of obtaining benefits but also of suffering some risks. Those risks are often considered unacceptable for children but if clinical trials are not conducted in children, clinicians are forced to extrapolate study data from adults. In 1968 H. Shirkey termed children "therapeutic orphans" because of the lack of adequately tested and labeled drugs available in appropriate formulations. Research involving children entails specific difficulties as the need to study children of different ages, the small number of children affected by certain diseases or ethical issues. This paper considers aspects of pediatric clinical pharmacology and children's responses to drugs. It also reviews some of the current situations in pediatric clinical trials, covering aspects such as: the benefits and risks of trial participation; the specificity of pediatric trial design; the ethical issues such as consent; the use of placebo or the participation of healthy children; and the current legal situation in Europe and in the USA.