Tag: Asma

Selective Provision of Asthma Self-Management Tools to Families


Published online April 1, 2008
PEDIATRICS Vol. 121 No. 4 April 2008, pp. e900-e905 (doi:10.1542/peds.2007-1559)

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ARTICLE

Selective Provision of Asthma Self-Management Tools to Families

Michael D. Cabana, MD, MPHa,b,c, D. Curt Chaffin, MDd, Leah G. Jarlsberga, Shannon M. Thyne, MDa and Noreen M. Clark, PhDe

a Department of Pediatrics
b Department of Epidemiology and Biostatistics
c Institute for Health Policy Studies, University of California, San Francisco, California
d Division of Allergy, Department of Medicine, University of Michigan Health System, Ann Arbor, Michigan
e Center for Managing Chronic Disease, University of Michigan, Ann Arbor, Michigan

OBJECTIVE. Providing asthma education in a primary care setting can be challenging because of time and resource constraints. The purpose of this work was to determine factors associated with the provision of different asthma self-management tools.

METHODS. We conducted a cross-sectional survey with 896 parents of children with asthma (age 2–12 years). We collected information regarding demographics and asthma care, including parent receipt of an asthma action plan, a symptom diary, and asthma information materials; whether an asthma management plan was sent to the child’s school; and whether the physician reviewed written instructions on use of a metered-dose inhaler. We used multivariate logistic regression methods to determine factors associated with receipt of different asthma self-management tools controlling for demographic factors.

RESULTS. For families where parents only completed high school, there was greater likelihood of receipt of an asthma action plan and physician review of written instructions about how to use an inhaler. For families with a household income less than twice the poverty line, there was greater likelihood of receipt of an asthma action plan, the physician sending a letter to the child’s school regarding the child’s asthma, and receipt of an asthma symptom diary.

CONCLUSIONS. In our sample, primary care pediatricians do not routinely provide asthma education in accordance with National Heart, Lung, and Blood Institute asthma guidelines and “triage” which families receive additional asthma education. We believe that the use of targeted asthma education is a symptom of the limited time and competing demands during a typical visit. As a result, those involved in quality improvement need to help physicians become more efficient and effective at providing asthma education within such time constraints or develop alternative systems of providing asthma education.

Macrólidos para el asma crónica


En las reagudizaciones del asma, el aumento de las dosis previas de corticoides inhalados no produce beneficio


University of Michigan Department of Pediatrics Evidence-Based Pediatrics Web Site. Critically Appraised Topics (Temas Valorados Críticamente). Traducción autorizada.

Términos clave en inglés: glucocorticoids/therapeutic use; asthma/drug therapy; drug administration schedule
Términos clave en español: glucocorticoides: uso terapéutico;  asma:farmacoterapia;  esquema de medicación 

Fecha de recepción:  7 de noviembre de 2005
Fecha de aceptación: 12 de noviembre de 2005

Pregunta

En los niños con asma persistente que sufren una reagudización de su enfermedad, ¿se consigue reducir la gravedad de los síntomas incrementando sus dosis previas de corticoides inhalados?

Aspectos clínicos centrales en la valoración del problema:

  1. En asmáticos en situación basal de asma persistente que experimentan una reagudización, el aumento al doble de la dosis de corticoides inhalados con que estaban siendo tratados, durante un periodo de tres días, no produjo diferencias estadísticamente significativas al valorar las cifras obtenidas en el registro de determinaciones matinales y vespertinas con medidores del PFE (Pico del Flujo Espiratorio).
  2. Además, no se constataron diferencias significativas en ninguno de los apartados siguientes: cifras obtenidas en evaluaciones mediante escalas de puntuación clínicas para síntomas del asma, valores obtenidos en las mediciones espirométricas, valoración del grado de satisfacción de los padres o vigilancia para la aparición de efectos adversos.

Resumen de las claves encontradas revisando las evidencias disponibles:

  1. El estudio seleccionado es un ensayo clínico controlado, aleatorizado, con doble cegamiento y grupo placebo, en el que se estudiaron 28 niños, con edades comprendidas entre 6 y 14 años y diagnóstico de asma persistente, leve o moderado. En este estudio, estos niños recibían tratamiento utilizando, durante los tres primeros días de la exacerbación de la enfermedad, una de las dos siguientes variedades de actuación, con respecto al uso de corticoides inhalados:
    • Incremento de las dosis previas de corticoides inhalados al doble.
    • Mantenimiento de las dosis basales de corticoides inhalados, añadiendo un placebo mediante dispositivo inhalador adecuado1.
  2. Criterios de exclusión utilizados en el estudio: La utilización de corticoides orales, beta agonistas de acción prolongada, cromoglicato, historia de ingreso en UCI, ingreso reciente, cambios en las dosis de corticoides inhalados en los dos meses previos al inicio del estudio.
  3. Los niños fueron estratificados por edad y sexo y posteriormente se distribuyeron, de forma aleatoria, en grupos. A cada uno de los grupos se le aplicaba una de las siguientes dos distintas secuencias de actuación posibles en sucesivas exacerbaciones que experimentasen:
    • Placebo inicialmente y después corticoides.
    • Corticoides la primera vez y posteriormente placebo.
  4. Los parámetros de medición del resultado principal investigado en el estudio incluían: determinaciones del PFE, registrando las cifras matinales y vespertinas; evaluaciones mediante escalas de medición de la gravedad de la sintomatología del asma; valores de la espirometría; grado de satisfacción de los padres y registro de los efectos adversos.
  5. La metodología del estudio se consideró válida si los pacientes se asignaron de forma aleatoria, si fueron seguidos hasta el final, si hubo cegamiento de los investigadores y si los grupos del estudio se trataron de la misma manera.
  6. Al comparar el grupo basal con el grupo que recibió un aumento de corticoides no se encontraron diferencias estadísticamente significativas (p<0,05) en ninguno de los parámetros del estudio. En total se incluyeron 18 pares de exacerbaciones de asma.

Comentarios adicionales:

  • Existen tres estudios que evalúan la eficacia de los corticoides inhalados frente a placebo para el tratamiento de las crisis del asma en niños que previamente no estaban recibiendo corticoides inhalados. En general, la administración de dosis altas de corticoides inhalados no disminuye la necesidad de administración de corticoides por vía oral, ni tampoco la necesidad de hospitalización2.
  • En un estudio, de Connett y Lenney, se constató un descenso significativo de las sibilancias, pero no se encontraban diferencias en la tos, en el uso de broncodilatadores ni en la duración de los síntomas.
  • Wilson y Silverman encontraron que las puntuaciones en escalas clínicas del asma, fueron significativamente más bajas en el grupo de tratamiento con corticoides inhalados.
  • Svedmyr informó de cifras del PFE significativamente más altas (104% frente a un valor esperado del 96%), pero sin encontrar diferencias en la sintomatología.
  • Existen diversos estudios, tanto en niños como en adultos, que demuestran una eficacia similar en el uso de corticoides orales o inhalados. Sin embargo, en estos estudios se utilizaron dosis elevadas de corticoides inhalados, por lo que se plantea la posible explicación de que el efecto valorado pudiera en realidad ser el resultado de la actuación sistémica del medicamento tras su absorción2.
  • Los efectos secundarios de los corticoides inhalados son mínimos. En un estudio, realizado por el Childhood Asthma Management Program Group, se estudiaron estos efectos, causados por la administración de esteroides inhalados y observaron que tenía lugar un descenso en el crecimiento de 1,1 cm menos en la medición de la talla al final del estudio. Sin embargo, no se afectaba la talla final estimada, la edad ósea o los estadios de Tanner3.

Bibliografía:

  1. Garrett J, Williams S, Wong C, Holdaway D. Treatment of acute asthmatic exacerbations with an increased dose of inhaled steoid. Arch Dis Child. 1998; 79: 12-17.
  2. Hendeles L, Sherman J. Are inhaled corticosteroids effective for acute exacerbations of asthma in children. J Pediatr. 2003; 142: S26-S33.
  3. Childhood Asthma Management Program Research Group. Long-term effects of budesonide or nedocromil in children with asthma. N Engl J Med. 2000; 343: 1054-63.

Autor de este CAT: Jim Connelly, MD Evaluador de este CAT: John Frohna, MD Fecha de la evaluación: 25 de mayo de 2005 Última actualización: 25 de mayo de 2005 URL del original en ingles disponible en: http://www.med.umich.edu/pediatrics/ebm/cats/asthmainh.htm . Department of Pediatrics and Communicable Diseases © 1998-2002 University of Michigan Health System

Autor de la traducción: Domingo Barroso Espadero. CS de Don Benito (Badajoz). pediatria@eresmas.net  

Como citar este artículo

Barroso D. En las reagudizaciones del asma,  el aumento de las dosis previas de corticoides inhalados no produce beneficio. Evid Pediatr. 2005; 1: 11.Traducción autorizada de: Connelly J.Increased Doses of Inhaled Steroids During an Asthma Exacerbation Show No Benefit. University of Michigan. Department of Pediatrics. Evidence-Based Pediatrics Web Site [en línea] [fecha de actualización: 25-V-2005; fecha de consulta: 3-X-2005]. Disponible en: http://www.med.umich.edu/pediatrics/ebm/cats/asthmainh.htm

Budesonide – Formoterol


Title Efficacy and safety of budesonide/formoterol in the management of chronic obstructive pulmonary disease.
Comments Erratum in: Eur Respir J. 2003 May;21(5):912.
Authors Szafranski W, Cukier A, Ramirez A, Menga G, Sansores R, Nahabedian S, Peterson S, Olsson H
Source The European respiratory journal : official journal of the European Society for Clinical Respiratory Physiology
Date of publication 2003 Jan
Volume 21
Issue 1
Pages 74-81
Abstract The efficacy and safety of budesonide/formoterol in a single inhaler compared with placebo, budesonide and formoterol were evaluated in patients with moderate-to-severe chronic obstructive pulmonary disease (COPD). In a 12-month, randomised, double-blind, placebo-controlled, parallel-group study in 812 adults (mean age 64 yrs, mean forced expiratory volume in one second (FEV1) 36% predicted normal), patients received two inhalations twice daily of either budesonide/formoterol (Symbicort) 160/4.5 microg (delivered dose), budesonide 200 microg (metered dose), formoterol 4.5 microg or placebo. Severe exacerbations and FEV1 (primary variables), peak expiratory flow (PEF), COPD symptoms, health-related quality of life (HRQL), mild exacerbations, use of reliever beta2-agonist and safety variables were recorded. Budesonide/formoterol reduced the mean number of severe exacerbations per patient per year by 24% versus placebo and 23% versus formoterol. FEV1 increased by 15% versus placebo and 9% versus budesonide. Morning PEF improved significantly on day 1 versus placebo and budesonide; after 1 week, morning PEF was improved versus placebo, budesonide and formoterol. Improvements in morning and evening PEF versus comparators were maintained over 12 months. Budesonide/formoterol decreased all symptom scores and use of reliever beta2-agonists significantly versus placebo and budesonide, and improved HRQL versus placebo. All treatments were well tolerated. These results suggest a role for budesonide/formoterol in the long-term management of moderate-to-severe chronic obstructive pulmonary disease.
Medical Subject Headings (MeSH) Administration, Inhalation; Adrenal Cortex Hormones[administration & dosage][*therapeutic use]; Adrenergic beta-Agonists[administration & dosage][therapeutic use]; Budesonide[administration & dosage][*therapeutic use]; Double-Blind Method; Drug Combinations; Ethanolamines[administration & dosage][*therapeutic use]; Forced Expiratory Volume; Peak Expiratory Flow Rate; Pulmonary Disease, Chronic Obstructive[*drug therapy]; Time Factors
Mesh check words: Female; Humans; Male; Middle Aged
Correspondence address Dept Lung Diseases, Voivodeship Specialist Hospital, Radom, Poland.
Accession number PUBMED  12570112
Publication type Clinical Trial; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov’t
Cochrane code SR-AIRWAYS
ID CN-00435216
CLIB_SPECIFIC___________ EFFICACY AND SAFETY OF BUDESONIDEFORMOTEROL IN THE MANAGEMENT OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE

En las reagudizaciones del asma, el aumento de las dosis previas de corticoides inhalados no produce beneficio


University of Michigan Department of Pediatrics Evidence-Based Pediatrics Web Site. Critically Appraised Topics (Temas Valorados Críticamente). Traducción autorizada.

Términos clave en inglés: glucocorticoids/therapeutic use; asthma/drug therapy; drug administration schedule
Términos clave en español: glucocorticoides: uso terapéutico;  asma:farmacoterapia;  esquema de medicación 

Fecha de recepción:  7 de noviembre de 2005
Fecha de aceptación: 12 de noviembre de 2005

Pregunta

En los niños con asma persistente que sufren una reagudización de su enfermedad, ¿se consigue reducir la gravedad de los síntomas incrementando sus dosis previas de corticoides inhalados?

Aspectos clínicos centrales en la valoración del problema:

  1. En asmáticos en situación basal de asma persistente que experimentan una reagudización, el aumento al doble de la dosis de corticoides inhalados con que estaban siendo tratados, durante un periodo de tres días, no produjo diferencias estadísticamente significativas al valorar las cifras obtenidas en el registro de determinaciones matinales y vespertinas con medidores del PFE (Pico del Flujo Espiratorio).
  2. Además, no se constataron diferencias significativas en ninguno de los apartados siguientes: cifras obtenidas en evaluaciones mediante escalas de puntuación clínicas para síntomas del asma, valores obtenidos en las mediciones espirométricas, valoración del grado de satisfacción de los padres o vigilancia para la aparición de efectos adversos.

Resumen de las claves encontradas revisando las evidencias disponibles:

  1. El estudio seleccionado es un ensayo clínico controlado, aleatorizado, con doble cegamiento y grupo placebo, en el que se estudiaron 28 niños, con edades comprendidas entre 6 y 14 años y diagnóstico de asma persistente, leve o moderado. En este estudio, estos niños recibían tratamiento utilizando, durante los tres primeros días de la exacerbación de la enfermedad, una de las dos siguientes variedades de actuación, con respecto al uso de corticoides inhalados:
    • Incremento de las dosis previas de corticoides inhalados al doble.
    • Mantenimiento de las dosis basales de corticoides inhalados, añadiendo un placebo mediante dispositivo inhalador adecuado1.
  2. Criterios de exclusión utilizados en el estudio: La utilización de corticoides orales, beta agonistas de acción prolongada, cromoglicato, historia de ingreso en UCI, ingreso reciente, cambios en las dosis de corticoides inhalados en los dos meses previos al inicio del estudio.
  3. Los niños fueron estratificados por edad y sexo y posteriormente se distribuyeron, de forma aleatoria, en grupos. A cada uno de los grupos se le aplicaba una de las siguientes dos distintas secuencias de actuación posibles en sucesivas exacerbaciones que experimentasen:
    • Placebo inicialmente y después corticoides.
    • Corticoides la primera vez y posteriormente placebo.
  4. Los parámetros de medición del resultado principal investigado en el estudio incluían: determinaciones del PFE, registrando las cifras matinales y vespertinas; evaluaciones mediante escalas de medición de la gravedad de la sintomatología del asma; valores de la espirometría; grado de satisfacción de los padres y registro de los efectos adversos.
  5. La metodología del estudio se consideró válida si los pacientes se asignaron de forma aleatoria, si fueron seguidos hasta el final, si hubo cegamiento de los investigadores y si los grupos del estudio se trataron de la misma manera.
  6. Al comparar el grupo basal con el grupo que recibió un aumento de corticoides no se encontraron diferencias estadísticamente significativas (p<0,05) en ninguno de los parámetros del estudio. En total se incluyeron 18 pares de exacerbaciones de asma.

Comentarios adicionales:

  • Existen tres estudios que evalúan la eficacia de los corticoides inhalados frente a placebo para el tratamiento de las crisis del asma en niños que previamente no estaban recibiendo corticoides inhalados. En general, la administración de dosis altas de corticoides inhalados no disminuye la necesidad de administración de corticoides por vía oral, ni tampoco la necesidad de hospitalización2.
  • En un estudio, de Connett y Lenney, se constató un descenso significativo de las sibilancias, pero no se encontraban diferencias en la tos, en el uso de broncodilatadores ni en la duración de los síntomas.
  • Wilson y Silverman encontraron que las puntuaciones en escalas clínicas del asma, fueron significativamente más bajas en el grupo de tratamiento con corticoides inhalados.
  • Svedmyr informó de cifras del PFE significativamente más altas (104% frente a un valor esperado del 96%), pero sin encontrar diferencias en la sintomatología.
  • Existen diversos estudios, tanto en niños como en adultos, que demuestran una eficacia similar en el uso de corticoides orales o inhalados. Sin embargo, en estos estudios se utilizaron dosis elevadas de corticoides inhalados, por lo que se plantea la posible explicación de que el efecto valorado pudiera en realidad ser el resultado de la actuación sistémica del medicamento tras su absorción2.
  • Los efectos secundarios de los corticoides inhalados son mínimos. En un estudio, realizado por el Childhood Asthma Management Program Group, se estudiaron estos efectos, causados por la administración de esteroides inhalados y observaron que tenía lugar un descenso en el crecimiento de 1,1 cm menos en la medición de la talla al final del estudio. Sin embargo, no se afectaba la talla final estimada, la edad ósea o los estadios de Tanner3.

Bibliografía:

  1. Garrett J, Williams S, Wong C, Holdaway D. Treatment of acute asthmatic exacerbations with an increased dose of inhaled steoid. Arch Dis Child. 1998; 79: 12-17.
  2. Hendeles L, Sherman J. Are inhaled corticosteroids effective for acute exacerbations of asthma in children. J Pediatr. 2003; 142: S26-S33.
  3. Childhood Asthma Management Program Research Group. Long-term effects of budesonide or nedocromil in children with asthma. N Engl J Med. 2000; 343: 1054-63.

Autor de este CAT: Jim Connelly, MD Evaluador de este CAT: John Frohna, MD Fecha de la evaluación: 25 de mayo de 2005 Última actualización: 25 de mayo de 2005 URL del original en ingles disponible en: http://www.med.umich.edu/pediatrics/ebm/cats/asthmainh.htm . Department of Pediatrics and Communicable Diseases © 1998-2002 University of Michigan Health System

Autor de la traducción: Domingo Barroso Espadero. CS de Don Benito (Badajoz). pediatria@eresmas.net  

Como citar este artículo

Barroso D. En las reagudizaciones del asma,  el aumento de las dosis previas de corticoides inhalados no produce beneficio. Evid Pediatr. 2005; 1: 11.Traducción autorizada de: Connelly J.Increased Doses of Inhaled Steroids During an Asthma Exacerbation Show No Benefit. University of Michigan. Department of Pediatrics. Evidence-Based Pediatrics Web Site [en línea] [fecha de actualización: 25-V-2005; fecha de consulta: 3-X-2005]. Disponible en: http://www.med.umich.edu/pediatrics/ebm/cats/asthmainh.htm

La lactancia materna no es protectora contra asma y alergia


Para evaluar si la lactancia materna exclusiva y prolongada disminuye el riesgo de asma y alergia en la niñez hasta la edad de 6.5 años, investigadores en Montreal y Belarus llevaron a cabo un estudio anidado randomizado en 31 hospitales maternos de Belarus y sus policlínicas afiliadas, involucrando a 17046 parejas madre-hijo, siguiendo a 81.5% hasta la edad de 6.5 años.

Ellos encontraron: “La intervención experimental condujo a un gran incremento en lactancia materna exclusiva a 3 meses (44.3% vs 6.4%) y una prevalencia significativamente mayor de lactancia materna en todas las edades hasta e incluyendo los 12 meses. El grupo experimental no tuvo disminución en riesgos de síntomas y diagnósticos alérgicos o en pruebas cutáneas positivas. De hecho alérgicos, luego de la exclusión de tres lugares (3 experimentales y 3 controles) con tasa sospechosamente altas de pruebas cutáneas positivas, los riesgos aumentaron significativamente en el grupo experimental para cuatro de los cinco antígenos.”

Los investigadores concluyeron: “Estos resultados no apoyan un efecto protector de lactancia materna exclusiva y prolongada sobre asma o alergia.”

¿Quizás es el tipo de leche?

BMJ 2007;335:815 (20 Octubre), doi:10.1136/bmj.39304.464016.AE © 2007 BMJ Publishing Group.

Efecto de lactancia materna prolongada y exclusiva sobre el riesgo de alergia y asma: ensayo anidado randomizado. Michael S Kramer, Lidia Matush, Irina Vanilovich, Robert Platt, Natalia Bogdanovich, Zinaida Sevkovskaya, Irina Dzikovich, Gyorgy Shishko, Bruce Mazer, para Promotion of Breastfeeding Intervention Trial (PROBIT) Study Group. Correspondencia a: M S Kramer michael.kramer@mcgill.ca

Anti-leukotriene agents compared to inhaled corticosteroids in the management of recurrent and/or chronic asthma in adults and children


EBM Reviews – Cochrane Database of Systematic Reviews Ducharme, FM. Di Salvio, F. Anti-leukotriene agents compared to inhaled corticosteroids in the management of recurrent and/or chronic asthma in adults and children. [Systematic Review] Cochrane Airways Group Cochrane Database of Systematic Reviews. 4, 2007.
AN: 00075320-100000000-01734

Background

Anti-leukotrienes agents are currently being studied as alternative first line agents to inhaled corticosteroids in mild to moderate chronic asthma.

Objectives

To compare the safety and efficacy of anti-leukotriene agents with inhaled glucocorticoids (ICS) and to determine the dose-equivalence of anti-leukotrienes to daily dose of ICS.

Search strategy

We searched MEDLINE (1966 to Aug 2003), EMBASE (1980 to Aug 2003), CINAHL (1982 to Aug 2003), the Cochrane Airways Group trials register, and the Cochrane Central Register of Controlled Trials (August 2003), abstract books, and reference lists of review articles and trials. We contacted colleagues and international headquarters of anti-leukotrienes producers.

Selection criteria

Randomised controlled trials that compared anti-leukotrienes with inhaled corticosteroids during a minimal 30-day intervention period in asthmatic patients aged 2 years and older.

Data collection and analysis

Two reviewers independently assessed the methodological quality or trials and extracted trial data. The primary outcome was the rate of exacerbations requiring systemic corticosteroids. Secondary outcomes included lung function, indices of chronic asthma control, adverse effects and withdrawal rates.

Main results

27 trials (including 1 trial testing two protocols) met the inclusion criteria; 13 were of high methodological quality; 20 are published in full-text. All trials pertained to patients with mild to moderate persistent asthma. Only 3 trials focused on children and adolescents. Trial duration varied from 4 to 37 weeks. In most trials, daily dose of ICS was 400 mcg of beclomethasone or equivalent. Patients treated with anti-leukotrienes were 65% more likely to suffer an exacerbation requiring systemic steroids [Relative Risk 1.65; 95% Confidence Interval (CI) 1.36 to 2.00]. Twenty six (95% CI: 17 to 47) patients must be treated with anti-leukotrienes instead of inhaled corticosteroids to cause one extra exacerbation. Significant differences favouring ICS were noted in secondary outcomes where the improvement in FEV1 reached 130 mL [13 trials; 95% CI: 50, 140 mL]. Other significant benefits of ICS were seen for symptoms, nocturnal awakenings, rescue medication use, symptom-free days, and quality of life. Anti-leukotriene therapy was associated with 160% increased risk of withdrawals due to poor asthma control. Twenty nine (95% CI 20 to 48) patients must be treated with anti-leukotrienes instead of inhaled corticosteroids to cause one extra withdrawal due to poor control. Risk of side effects was not different between groups.

Authors’ conclusions

Inhaled steroids at a dose of 400 mcg/day of beclomethasone or equivalent are more effective than anti-leukotriene agents given in the usual licensed doses. The exact dose-equivalence of anti-leukotriene agents in mcg of ICS remains to be determined. Inhaled glucocorticoids should remain the first line monotherapy for persistent asthma

 

The Lancet: Articulos de interes


Safety of drug-eluting stents: demystifying network meta-analysis

Given concerns about the safety of drug-eluting stents, Christoph Stettler and colleagues (Sept 15, p 937) provide the most extensive meta-analysis to date comparing sirolimus-eluting stents, paclitaxel-eluting stents, and bare-metal stents: 38 trials in 18 023 patients.

Asthma guidelines on house dust mites are not evidence-basedIn your Sept 8 Editorial (p 802), you describe the new US guidelines for asthma control as being rigorous and evidence-based. This is not correct for the recommendations on house dust mites.

Lamotrigine and the risk of fulminant hepatic failureI refer to a letter by Debbie Shawcross and colleagues (July 28, p 314), written in response to the SANAD study, in which a case of fatal hepatic failure is attributed to lamotrigine. As the consultant neurologist involved in the care of this patient, I would like to add some relevant information that seems to have been either omitted or neglected: continuous exposure to valproate before the liver failed, and a concomitant acute cytomegalovirus infection.

AP al dia: Resumenes comentados


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El tratamiento combinado con tiotropio, fluticasona y salmeterol reduce los ingresos hospitalarios en la EPOC HTML PPT

La eficacia de la condroitina en el tratamiento de la artrosis es dudosa HTML PPT

Los corticoides inhalados para el tratamiento del asma durante el embarazo no aumentan el riesgo de malformaciones HTML PPT

En mujeres con cáncer de mama, la RMN aumenta la detección de tumores en la mama contralateral HTML PPT

El balance riesgo-beneficio de la mamografía de cribado ente los 40-49 años no está claro HTML PPT

La asociación de sumatriptan y naproxeno para el tratamiento de la migraña es más eficaz que cualquiera de ellos por separado HTML PPT

Un 1% de la población tiene neutropenia y es más frecuente en personas de raza negra HTML PPT

Sesgo de publicacion o sesgo de financiamiento? * Sign In to E-Mail or Save This * Print * Reprints * Share o Del.icio.us o Digg o Facebook o Newsvine o Permalink Article Tools Sponsored By By ERIC NAGOURNEY Published: November 13, 2007 Sesgo de publicacion o sesgo de financiamiento?


By ERIC NAGOURNEY

Published: November 13, 2007

Inhalers are an effective treatment for asthma and other respiratory diseases, but they can have adverse side effects. The conclusions of studies on these effects apparently depend in part on who pays for the study.

A review of more than 500 studies has found that independently backed studies of the inhalers, formally known as inhaled corticosteroids, are up to four times as likely to find adverse effects as studies paid for by drug companies. The paper appears in the Oct. 22 issue of The Archives of Internal Medicine.

Even randomized clinical trials — the “gold standard” for clinical research — were two and a half times as likely to find adverse effects if a drug company did not pay for the work. Moreover, when authors of studies with drug company financing did report adverse events, they were less likely than authors of independently backed studies to interpret them as clinically significant. But when the researchers did a statistical analysis that eliminated the effect of study design, the disparities were no longer apparent. This suggests that design features chosen before the study begins might lead to a certain kind of finding about adverse effects.

Reviews of drug-company backed studies of other drugs have found similar results.

Many medical journals now require authors to disclose their financial relationships. The senior author of the review, Dr. F. Javier Nieto, professor of population and health studies at the University of Wisconsin, recommended requiring “that the disclosure is made in the abstract, right up front.”

Resto del articulo en el NYT. Sin desperdicios.

Sesgo de publicacion o sesgo de financiamiento? * Sign In to E-Mail or Save This * Print * Reprints * Share o Del.icio.us o Digg o Facebook o Newsvine o Permalink Article Tools Sponsored By By ERIC NAGOURNEY Published: November 13, 2007 Sesgo de publicacion o sesgo de financiamiento?


By ERIC NAGOURNEY

Published: November 13, 2007

Inhalers are an effective treatment for asthma and other respiratory diseases, but they can have adverse side effects. The conclusions of studies on these effects apparently depend in part on who pays for the study.

A review of more than 500 studies has found that independently backed studies of the inhalers, formally known as inhaled corticosteroids, are up to four times as likely to find adverse effects as studies paid for by drug companies. The paper appears in the Oct. 22 issue of The Archives of Internal Medicine.

Even randomized clinical trials — the “gold standard” for clinical research — were two and a half times as likely to find adverse effects if a drug company did not pay for the work. Moreover, when authors of studies with drug company financing did report adverse events, they were less likely than authors of independently backed studies to interpret them as clinically significant. But when the researchers did a statistical analysis that eliminated the effect of study design, the disparities were no longer apparent. This suggests that design features chosen before the study begins might lead to a certain kind of finding about adverse effects.

Reviews of drug-company backed studies of other drugs have found similar results.

Many medical journals now require authors to disclose their financial relationships. The senior author of the review, Dr. F. Javier Nieto, professor of population and health studies at the University of Wisconsin, recommended requiring “that the disclosure is made in the abstract, right up front.”

Resto del articulo en el NYT. Sin desperdicios.

Estudio SMART: salmeterol y asma A Comparison of Usual Pharmacotherapy for Asthma or Usual Pharmacotherapy Plus Salmeterol Harold S. Nelson, MD; Scott T. Weiss, MD, MS; Eugene R. Bleecker, MD; Steven W. Yancey, MS; Paul M. Dorinsky, MD; the SMART Study Group * From the National Jewish Medical and Research Center (Dr. Nelson), Denver, CO; Brigham and Women’s Hospital and Harvard Medical School (Dr. Weiss), Boston, MA; Wake Forest University School of Medicine (Dr. Bleecker), Winston Salem, NC; and GlaxoSmithKline (Mr. Yancey and Dr. Dorinsky), Research Triangle Park, NC.More… Correspondence to: Paul M. Dorinsky, MD, GlaxoSmithKline, 5 Moore Dr, Research Triangle Park, NC 27709; e-mail: paul.m.dorinsky@gsk.com Abstract Study objective: To compare the safety of salmeterol xinafoate or placebo added to usual asthma care. Design: A 28-week, randomized, double-blind, placebo-controlled, observational study. Setting: Study subjects were seen once in the study physician’s office for screening and were provided all blinded study medication for the entire study period. Follow-up by telephone was scheduled every 4 weeks. Participants: Subjects (> 12 years old) with asthma as judged by the study physician were eligible. Individuals with a history of long-acting ß2-agonist use were excluded. Interventions: Salmeterol, 42 µg bid via metered-dose inhaler (MDI), and placebo bid via MDI. Measurements and results: Following an interim analysis in 26,355 subjects, the study was terminated due to findings in African Americans and difficulties in enrollment. The occurrence of the primary outcome, respiratory-related deaths, or life-threatening experiences was low and not significantly different for salmeterol vs placebo (50 vs 36; relative risk [RR] = 1.40; 95% confidence interval [CI], 0.91 to 2.14). There was a small, significant increase in respiratory-related deaths (24 vs 11; RR, 2.16; 95% CI, 1.06 to 4.41) and asthma-related deaths (13 vs 3; RR, 4.37; 95% CI, 1.25 to 15.34), and in combined asthma-related deaths or life-threatening experiences (37 vs 22; RR, 1.71; 95% CI, 1.01 to 2.89) in subjects receiving salmeterol vs placebo. The imbalance occurred largely in the African-American subpopulation: respiratory-related deaths or life-threatening experiences (20 vs 5; RR, 4.10; 95% CI, 1.54 to 10.90) and combined asthma-related deaths or life-threatening experiences (19 vs 4; RR, 4.92; 95% CI, 1.68 to 14.45) in subjects receiving salmeterol vs placebo. Conclusions: For the primary end point in the total population, there were no significant differences between treatments. There were small, but statistically significant increases in respiratory-related and asthma-related deaths and combined asthma-related deaths or life-threatening experiences in the total population receiving salmeterol. Subgroup analyses suggest the risk may be greater in African Americans compared with Caucasian subjects. Whether this risk is due to factors including but not limited to a physiologic treatment effect, genetic factors, or patient behaviors leading to poor outcomes remains unknown. Estudio SMART: The Salmeterol Multicenter Asthma Research Trial


The Salmeterol Multicenter Asthma Research Trial

A Comparison of Usual Pharmacotherapy for Asthma or Usual Pharmacotherapy Plus Salmeterol

Harold S. Nelson, MD; Scott T. Weiss, MD, MS; Eugene R. Bleecker, MD; Steven W. Yancey, MS; Paul M. Dorinsky, MD; the SMART Study Group

* From the National Jewish Medical and Research Center (Dr. Nelson), Denver, CO; Brigham and Women’s Hospital and Harvard Medical School (Dr. Weiss), Boston, MA; Wake Forest University School of Medicine (Dr. Bleecker), Winston Salem, NC; and GlaxoSmithKline (Mr. Yancey and Dr. Dorinsky), Research Triangle Park, NC. Continue reading Estudio SMART: salmeterol y asma

A Comparison of Usual Pharmacotherapy for Asthma or Usual Pharmacotherapy Plus Salmeterol

Harold S. Nelson, MD; Scott T. Weiss, MD, MS; Eugene R. Bleecker, MD; Steven W. Yancey, MS; Paul M. Dorinsky, MD; the SMART Study Group

* From the National Jewish Medical and Research Center (Dr. Nelson), Denver, CO; Brigham and Women’s Hospital and Harvard Medical School (Dr. Weiss), Boston, MA; Wake Forest University School of Medicine (Dr. Bleecker), Winston Salem, NC; and GlaxoSmithKline (Mr. Yancey and Dr. Dorinsky), Research Triangle Park, NC.More…

Correspondence to: Paul M. Dorinsky, MD, GlaxoSmithKline, 5 Moore Dr, Research Triangle Park, NC 27709; e-mail: paul.m.dorinsky@gsk.com

Abstract

Study objective: To compare the safety of salmeterol xinafoate or placebo added to usual asthma care.

Design: A 28-week, randomized, double-blind, placebo-controlled, observational study.

Setting: Study subjects were seen once in the study physician’s office for screening and were provided all blinded study medication for the entire study period. Follow-up by telephone was scheduled every 4 weeks.

Participants: Subjects (> 12 years old) with asthma as judged by the study physician were eligible. Individuals with a history of long-acting ß2-agonist use were excluded.

Interventions: Salmeterol, 42 µg bid via metered-dose inhaler (MDI), and placebo bid via MDI.

Measurements and results: Following an interim analysis in 26,355 subjects, the study was terminated due to findings in African Americans and difficulties in enrollment. The occurrence of the primary outcome, respiratory-related deaths, or life-threatening experiences was low and not significantly different for salmeterol vs placebo (50 vs 36; relative risk [RR] = 1.40; 95% confidence interval [CI], 0.91 to 2.14). There was a small, significant increase in respiratory-related deaths (24 vs 11; RR, 2.16; 95% CI, 1.06 to 4.41) and asthma-related deaths (13 vs 3; RR, 4.37; 95% CI, 1.25 to 15.34), and in combined asthma-related deaths or life-threatening experiences (37 vs 22; RR, 1.71; 95% CI, 1.01 to 2.89) in subjects receiving salmeterol vs placebo. The imbalance occurred largely in the African-American subpopulation: respiratory-related deaths or life-threatening experiences (20 vs 5; RR, 4.10; 95% CI, 1.54 to 10.90) and combined asthma-related deaths or life-threatening experiences (19 vs 4; RR, 4.92; 95% CI, 1.68 to 14.45) in subjects receiving salmeterol vs placebo.

Conclusions: For the primary end point in the total population, there were no significant differences between treatments. There were small, but statistically significant increases in respiratory-related and asthma-related deaths and combined asthma-related deaths or life-threatening experiences in the total population receiving salmeterol. Subgroup analyses suggest the risk may be greater in African Americans compared with Caucasian subjects. Whether this risk is due to factors including but not limited to a physiologic treatment effect, genetic factors, or patient behaviors leading to poor outcomes remains unknown.
Estudio SMART: The Salmeterol Multicenter Asthma Research Trial

Estudio SMART: salmeterol y asma A Comparison of Usual Pharmacotherapy for Asthma or Usual Pharmacotherapy Plus Salmeterol Harold S. Nelson, MD; Scott T. Weiss, MD, MS; Eugene R. Bleecker, MD; Steven W. Yancey, MS; Paul M. Dorinsky, MD; the SMART Study Group * From the National Jewish Medical and Research Center (Dr. Nelson), Denver, CO; Brigham and Women’s Hospital and Harvard Medical School (Dr. Weiss), Boston, MA; Wake Forest University School of Medicine (Dr. Bleecker), Winston Salem, NC; and GlaxoSmithKline (Mr. Yancey and Dr. Dorinsky), Research Triangle Park, NC.More… Correspondence to: Paul M. Dorinsky, MD, GlaxoSmithKline, 5 Moore Dr, Research Triangle Park, NC 27709; e-mail: paul.m.dorinsky@gsk.com Abstract Study objective: To compare the safety of salmeterol xinafoate or placebo added to usual asthma care. Design: A 28-week, randomized, double-blind, placebo-controlled, observational study. Setting: Study subjects were seen once in the study physician’s office for screening and were provided all blinded study medication for the entire study period. Follow-up by telephone was scheduled every 4 weeks. Participants: Subjects (> 12 years old) with asthma as judged by the study physician were eligible. Individuals with a history of long-acting ß2-agonist use were excluded. Interventions: Salmeterol, 42 µg bid via metered-dose inhaler (MDI), and placebo bid via MDI. Measurements and results: Following an interim analysis in 26,355 subjects, the study was terminated due to findings in African Americans and difficulties in enrollment. The occurrence of the primary outcome, respiratory-related deaths, or life-threatening experiences was low and not significantly different for salmeterol vs placebo (50 vs 36; relative risk [RR] = 1.40; 95% confidence interval [CI], 0.91 to 2.14). There was a small, significant increase in respiratory-related deaths (24 vs 11; RR, 2.16; 95% CI, 1.06 to 4.41) and asthma-related deaths (13 vs 3; RR, 4.37; 95% CI, 1.25 to 15.34), and in combined asthma-related deaths or life-threatening experiences (37 vs 22; RR, 1.71; 95% CI, 1.01 to 2.89) in subjects receiving salmeterol vs placebo. The imbalance occurred largely in the African-American subpopulation: respiratory-related deaths or life-threatening experiences (20 vs 5; RR, 4.10; 95% CI, 1.54 to 10.90) and combined asthma-related deaths or life-threatening experiences (19 vs 4; RR, 4.92; 95% CI, 1.68 to 14.45) in subjects receiving salmeterol vs placebo. Conclusions: For the primary end point in the total population, there were no significant differences between treatments. There were small, but statistically significant increases in respiratory-related and asthma-related deaths and combined asthma-related deaths or life-threatening experiences in the total population receiving salmeterol. Subgroup analyses suggest the risk may be greater in African Americans compared with Caucasian subjects. Whether this risk is due to factors including but not limited to a physiologic treatment effect, genetic factors, or patient behaviors leading to poor outcomes remains unknown. Estudio SMART: The Salmeterol Multicenter Asthma Research Trial


The Salmeterol Multicenter Asthma Research Trial

A Comparison of Usual Pharmacotherapy for Asthma or Usual Pharmacotherapy Plus Salmeterol

Harold S. Nelson, MD; Scott T. Weiss, MD, MS; Eugene R. Bleecker, MD; Steven W. Yancey, MS; Paul M. Dorinsky, MD; the SMART Study Group

* From the National Jewish Medical and Research Center (Dr. Nelson), Denver, CO; Brigham and Women’s Hospital and Harvard Medical School (Dr. Weiss), Boston, MA; Wake Forest University School of Medicine (Dr. Bleecker), Winston Salem, NC; and GlaxoSmithKline (Mr. Yancey and Dr. Dorinsky), Research Triangle Park, NC. Continue reading Estudio SMART: salmeterol y asma

A Comparison of Usual Pharmacotherapy for Asthma or Usual Pharmacotherapy Plus Salmeterol

Harold S. Nelson, MD; Scott T. Weiss, MD, MS; Eugene R. Bleecker, MD; Steven W. Yancey, MS; Paul M. Dorinsky, MD; the SMART Study Group

* From the National Jewish Medical and Research Center (Dr. Nelson), Denver, CO; Brigham and Women’s Hospital and Harvard Medical School (Dr. Weiss), Boston, MA; Wake Forest University School of Medicine (Dr. Bleecker), Winston Salem, NC; and GlaxoSmithKline (Mr. Yancey and Dr. Dorinsky), Research Triangle Park, NC.More…

Correspondence to: Paul M. Dorinsky, MD, GlaxoSmithKline, 5 Moore Dr, Research Triangle Park, NC 27709; e-mail: paul.m.dorinsky@gsk.com

Abstract

Study objective: To compare the safety of salmeterol xinafoate or placebo added to usual asthma care.

Design: A 28-week, randomized, double-blind, placebo-controlled, observational study.

Setting: Study subjects were seen once in the study physician’s office for screening and were provided all blinded study medication for the entire study period. Follow-up by telephone was scheduled every 4 weeks.

Participants: Subjects (> 12 years old) with asthma as judged by the study physician were eligible. Individuals with a history of long-acting ß2-agonist use were excluded.

Interventions: Salmeterol, 42 µg bid via metered-dose inhaler (MDI), and placebo bid via MDI.

Measurements and results: Following an interim analysis in 26,355 subjects, the study was terminated due to findings in African Americans and difficulties in enrollment. The occurrence of the primary outcome, respiratory-related deaths, or life-threatening experiences was low and not significantly different for salmeterol vs placebo (50 vs 36; relative risk [RR] = 1.40; 95% confidence interval [CI], 0.91 to 2.14). There was a small, significant increase in respiratory-related deaths (24 vs 11; RR, 2.16; 95% CI, 1.06 to 4.41) and asthma-related deaths (13 vs 3; RR, 4.37; 95% CI, 1.25 to 15.34), and in combined asthma-related deaths or life-threatening experiences (37 vs 22; RR, 1.71; 95% CI, 1.01 to 2.89) in subjects receiving salmeterol vs placebo. The imbalance occurred largely in the African-American subpopulation: respiratory-related deaths or life-threatening experiences (20 vs 5; RR, 4.10; 95% CI, 1.54 to 10.90) and combined asthma-related deaths or life-threatening experiences (19 vs 4; RR, 4.92; 95% CI, 1.68 to 14.45) in subjects receiving salmeterol vs placebo.

Conclusions: For the primary end point in the total population, there were no significant differences between treatments. There were small, but statistically significant increases in respiratory-related and asthma-related deaths and combined asthma-related deaths or life-threatening experiences in the total population receiving salmeterol. Subgroup analyses suggest the risk may be greater in African Americans compared with Caucasian subjects. Whether this risk is due to factors including but not limited to a physiologic treatment effect, genetic factors, or patient behaviors leading to poor outcomes remains unknown.
Estudio SMART: The Salmeterol Multicenter Asthma Research Trial

AP al dia: resúmenes comentados


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National Asthma Guidelines Updated


National Asthma Guidelines Updated
BETHESDA, MD — September 5, 2007 — The National Asthma Education and Prevention Program (NAEPP) issued the first comprehensive update in a decade of clinical guidelines for the diagnosis and management of asthma. The guidelines emphasize the importance of asthma control and introduce new approaches for monitoring asthma. Updated recommendations …Full Stor

Tratamientos del asma Basados en la Evidencia


“No existe ningún problema, por complicado que sea, que cuando se analiza adecuadamente, no se complique más aún”.
A. Koestler

Tratamientos del asma Basados en la Evidencia

Dr. D. Pere Casan Clará.
Departamento de Pneumología. Hospital de la Santa Creu i de Sant Pau. Departament de Medicina.
Facultat de Medicina. U. A. B. Barcelona.

Cualquiera que se enfrente a las cuestiones que plantea el actual modelo de la “Medicina Basada en la Evidencia”, tiene la impresión de que está analizando el mismo problema de siempre, con nuevas herramientas, y no necesariamente con las que, de manera definitiva, le permitirán hallar la mejor solución y con el menor coste. Ocurre que el planteamiento es muy racional y pedagógico, pero las soluciones no siempre están fácilmente al alcance de la mano. La actual sociedad del bienestar busca constantemente cómo adaptarse a su modelo de vida, pero va dejando marginados al lado del camino. Marginados en temas materiales y en cuestiones intelectuales, que no son capaces de seguir la enorme velocidad con que se producen los cambios. Cada nuevo modelo precisa de nuevos lenguajes y, en términos de comprensión y diálogo, abundan los analfabetos. Pero dudar es avanzar y mientras dudemos podremos experimentar nuevas maneras de diagnosticar y tratar a nuestros enfermos. Y ya saben, mientras existan enfermos, habrá necesidad de que alguien los atienda. Sin embargo, conviene no perder de vista las palabras de Arthur Koestler, por si en algún momento hubiésemos creído que se trata de la piedra filosofal.

 

Guías, consensos, reconocimientos y normativas

Con el estado actual de los conocimientos y con la gran facilidad con que la información se difunde, podemos afirmar con un mínimo error a equivocarnos, que un paciente asmático puede ser tratado actualmente de forma muy parecida en cualquier parte del mundo. La única salvedad la constituyen la capacidades económicas, que impiden que la información (también mercancía de coste y consumo) llegue a los rincones donde el dinero no puede costearla.

Las grandes sociedades médicas mundiales han realizado un esfuerzo considerable para consensuar y aceptar procedimientos comunes, para tratar el asma de una forma muy parecida y asequible a todos los pacientes. En honor a la verdad hay que decir que el esfuerzo se aprecia, especialmente en la forma como los pacientes asmáticos vienen de su enfermedad, aunque no siempre este hecho vaya acompañado de un descenso en la prevalencia o en la gravedad de la enfermedad, variables que parece circulan por otros caminos.

Fruto de este impulso son la publicación de guías, recomendaciones y Continue reading Tratamientos del asma Basados en la Evidencia