Local adverse effects associated with the use of inhaled corticosteroids in patients with moderate or severe asthma / Eventos adversos locais associados ao uso de corticosteroides inalatorios em pacientes com asma moderada ou grave

OBJECTIVE: To describe and characterize local adverse effects (in the oral cavity, pharynx, and larynx) associated with the use of inhaled corticosteroids (ICSs) in patients with moderate or severe asthma. METHODS: This was a cross-sectional study involving a convenience sample of 200 asthma patients followed in the Department of Pharmaceutical Care of the Bahia State Asthma and Allergic Rhinitis Control Program Referral Center, located in the city of Salvador, Brazil. The patients were ≥ 18 years of age and had been using ICSs regularly for at least 6 months. Local adverse effects (irritation, pain, dry throat, throat clearing, hoarseness, reduced vocal intensity, loss of voice, sensation of thirst, cough during ICS use, altered sense of taste, and presence of oral candidiasis) were assessed using a 30-day recall questionnaire. RESULTS: Of the 200 patients studied, 159 (79.5%) were women. The mean age was 50.7 ± 14.4 years. In this sample, 55 patients (27.5%) were using high doses of ICS, with a median treatment duration of 38 months. Regarding the symptoms, 163 patients (81.5%) reported at least one adverse effect, and 131 (65.5%) had a daily perception of at least one symptom. Vocal and pharyngeal symptoms were identified in 57 (28.5%) and 154 (77.0%) of the patients, respectively. The most commonly reported adverse effects were dry throat, throat clearing, sensation of thirst, and hoarseness. CONCLUSIONS: Self-reported adverse effects ...

OBJETIVO: Descrever e caracterizar os eventos adversos locais na orofaringe e laringe associados ao uso de corticosteroide inalatório (CI) em pacientes com asma moderada ou grave. MÉTODOS: Estudo de corte transversal, com amostra de conveniência composta por 200 pacientes acompanhados no Serviço de Assistência Farmacêutica da Central de Referência do Programa para Controle da Asma na Bahia, em Salvador (BA). Os pacientes tinham ≥ 18 anos e estavam em uso regular de CI por período ≥ 6 meses. Os eventos adversos locais (irritação, dor, garganta seca, pigarro, rouquidão, redução da potência da voz, perda de voz; sensação de sede, tosse durante inalação, alteração do paladar e presença de monilíase oral) foram avaliados por meio de um questionário com período recordatório de 30 dias. RESULTADOS: Dos 200 pacientes estudados, 159 (79,5%) eram mulheres. A média de idade foi de 50,7 ± 14,4 anos. Nesta amostra, 55 pacientes (27,5%) utilizavam altas doses de CI, com mediana de duração de tratamento de 38 meses. Em relação aos sintomas, 163 pacientes (81,5%) reportaram ao menos um evento adverso, e 131 (65,5%) tinham a percepção diária de pelo menos um sintoma. Os sintomas de voz e de faringe foram identificados em 57 (28,5%) e 154 (77,0%) pacientes, respectivamente. Os eventos adversos mais frequentemente relatados foram garganta seca, ...

Efficacy and safety of inhaled steroids in children with asthma: a comparison of fluticasone propionate with beclomethasone

Inhaled corticosteroids are indicated in children who have mild persistent asthma. Fluticasone propionate is a newer corticosteroid agent with higher potency compared with previous generations. However, still few dose-ranging studies have been investigated for optimal dosing of inhaled corticosteroids particularly in children with regard to the tolerability and safety of the drug. The primary purpose of this study was to compare and evaluate the efficacy and safety of fluticasone with beclomethosone in the treatment of childhood asthma unresponsive to non-steroidal medications and also in persistent, moderate and severe asthma. Seventy children, aged 6 to 14 years were enrolled in an open randomized trial with a parallel group design. Fiftytwo children with moderate, severe or persistent asthma received fluticasone 100 micro g twice daily for 12 weeks compared with 18 asthmatic children on beclomethasone 200 micro g daily. The outcome was assessed by data on questionnaires, changes in clinical symptoms, and results of peak flowmetery [PEFR]. Moreover, safety was assessed by 24 hour urinary cortisol measurement at the beginning of the study and comparison of the data with urinary cortisol at the end of 12 weeks. A total of 70 children between 6 to 14 years [33 girls and 37 boys] were randomized to start treatment with fluticasone or beclomethasone. From 70 children 13[18.6%] had a history of contact with pets during their life. At the beginning in beclomethasone group: 88.9% had cough, 88.9% had post exercise cough, 66.7% had dyspnea and 72.2% had wheezing. In Fluticasone group: 75% had cough,76.9% had post exercise cough, 46.2% had dyspnea and 59.6% had wheezing. After 3 months of therapy in beclomethasone group: cough was seen in 16.7%, post exercise cough in 11.1%, dyspnea in 11.1%, wheezing in 16.7% and in fluticasone group: cough in 15.4%, post exercise cough in 11.1%, dyspnea in 1.9% and wheezing in 3.8%.Data showed a better improvement in clinical signs of patients with fluticasone [p < 0.05]. Pulmonary function tests revealed better lung function in fluticasone group [p < 0.05]. In addition, 24 hours urinary cortisol level was measured at the beginning and after 12 weeks of therapy and it was within the normal range for both drugs. Fluticasone produced significantly greater improvement in lung function and control of asthma symptoms compared to beclomethasone and is efficient in the treatment of persistent, moderate and severe asthma in children. In addition these improvements were achieved with no greater degree of cortisol suppression compared with beclomethasone

Inhaled corticosteroids and bone density in chemical warfare patients with pulmonary complications

The most effective treatment in chemical warfare victims [CWV] suffering from severe long-term obstructive pulmonary disease is inhaled corticosteroids [ICS] and long acting beta-2 agonists. Study results on adverse effects of ICS on bone were conflicting. In the present study, we evaluated the effect of ICS on bone mineral density [BMD] of CWV and possible effects of chemical warfare agents on BMD. Thirty-five CWVs entered this study. Demographic and spirometric data [including staging of severity of lung disease] and BMD results as shown by z-score and t- score measured in lumbar and femoral regions were evaluated in this group of patients. In comparison, 75 normal subjects as controls were included in this study and their BMD results were compared with those of the case group. The mean age in CWVs was 41.40 +/- 7.74 years, which showed no significant difference with that of the control group. According to spirometric data, CWVs had obstructive lung disease. BMD in lumbar and femoral regions in the case group was 1.14 +/- 0.14 and 0.93 +/- 0.13 g/cm[2] respectively, which showed no significant difference with that of the control group. Regression analysis showed that BMD in the femoral region was correlated with forced expiratory volume in 1 second [FEV1] and forced vital capacity [FVC] and t-score in lumbar region was correlated with FEV1. BMD in the femoral region decreased as the severity of bronchial obstruction increased [0.99 +/- 1.07 g/cm[2] in mild form to 0.75 +/- 0.27 in severe form; F=3.91, P=0.03] but in the lumbar region BMD had no significant correlation with severity of bronchial obstruction. BMD did not decrease during long-term therapy with ICS in CWVs. Severity of bronchial obstruction can be an important risk factor

Inhaled corticosteroids in the treatment of respiratory allergy: safety vs. efficacy

OBJETIVO: Revisar os mecanismos moleculares de ação, eficácia e potenciais efeitos adversos relacionados aos corticosteróides inalados (CEI) em crianças com asma persistente. FONTES DOS DADOS: Artigos de língua inglesa da base de dados MEDLINE. Foram empregados os termos: corticosteroids, inhaled corticosteroids, asthma, children, beclomethasone, fluticasone, budesonide, ciclesonide, growth, adrenal insufficiency, bone mineral density, oral candidiasis. Foram selecionados guias de tratamento, artigos de revisão, estudos controlados, meta-análises e revisões sistemáticas que avaliaram a eficácia e os eventos adversos do tratamento com CEI. SíNTESE DOS DADOS: Estudos in vivo e in vitro mostram que os CEI disponíveis apresentam diferentes características farmacocinéticas e farmacodinâmicas que lhes conferem diferentes potenciais de ação. Os CEI também diferem quanto aos efeitos adversos sistêmicos e locais. Salienta-se a biodisponibilidade desses produtos como essencial para determinar a incidência de efeitos colaterais. Em linhas gerais, os CEI são capazes de controlar a asma, reduzindo o número de exacerbações, atendimentos médicos, hospitalizações e a necessidade de pulsos de corticosteróides orais. Também se observa melhora da função pulmonar, sobretudo nos pacientes com asma de início recente. O efeito adversos mais documentado é a desaceleração transitória do ritmo de crescimento. CONCLUSÕES: Os CEI são o principal agente antiinflamatório utilizado no tratamento da asma persistente. Quando administrados em doses baixas, mostram-se seguros e efetivos. O monitoramento dos pacientes permite a detecção precoce de eventuais efeitos adversos associados aos CEI.

OBJECTIVE: Review the molecular mechanisms of action, efficacy, and potential side effects associated with inhaled corticosteroids (ICS) in children with persistent asthma. SOURCES: Articles in English from MEDLINE. The following terms were used: corticosteroids, inhaled corticosteroids, asthma, children, beclomethasone, fluticasone, budesonide, ciclesonide, growth, adrenal insufficiency, bone mineral density, and oral candidiasis. Treatment guidelines, review articles, controlled trials, meta-analyses, and systematic reviews evaluating the efficacy and the adverse events of treatment with ICS were selected. SUMMARY OF THE FINDINGS: In vivo and in vitro studies show that the available ICS have different pharmacokinetic and pharmacodynamic properties that result in different action potentials. ICS also differ as to the systemic and local side effects. The bioavailability of these products is essential in order to determine the incidence of side effects. In general, ICS are capable of controlling asthma, reducing the number of exacerbations, medical consultations, hospitalizations, and the need of oral corticosteroid (applications) bursts. Improvement can also be seen in pulmonary function, especially in patients with recent onset asthma. The most documented adverse effect is transitory decrease of growth rate. CONCLUSIONS: ICS are the main anti-inflammatory agent used to treat persistent asthma. When administered in low doses, they seem to be safe and effective. Patient monitoring allows for early detection of possible side effects associated with ICS.

¿Varía la presión intraocular con el uso de dipropionato de beclometasona en pacientes con rinitis? Estudio comparativo / Does the use of beclometasone propionate produce variation of the intraocular pressure? A comparative trial

Propósito: El objetivo del estudio fue valorar si existía aumento de la presión intraocular en pacientes con el diagnóstico de rinitis que se encontraban bajo tratamiento con dipropionato de beclometasona aplicado a 400 mcg al día por vía nasal. Material y Métodos: Se seleccionaron 60 pacientes con el diagnóstico de rinitis sin importar la etiología, de entre 18 y 60 años de edad. Los pacientes se dividieron mediante un proceso aleatorio en dos grupos de 30 pacientes cada uno. El primer grupo recibió dipropionato de beclometasona. El segundo grupo recibió placebo. A todos los pacientes se les realizó tonometría por aplanamiento a las 3, 6 12, 26 y 52 semanas. Resultados: Se encontró que las variaciones de la presión intraocular en ambos grupos estuvieron dentro de limites de referencia. El promedio de la presión intraocular no mostró diferencias significativas en las mediciones realizadas de las 3 a las 52 semanas (p = 0.473). Conclusión: El dipropionato de beclometasona en aplicación tópica nasal no aumenta significativamente la presión intraocular, incluso después de un año de tratamiento

Corticoesteroides inhalados y catarata: aclaración de confusiones / Inhaled corticosteroids and cataract: Clarification of confusions

Según los nuevos lineamientos para el manejo del asma persistente, los medicamentos claves para el tratamiento de mantenimiento son los corticoesteroides inhalados, utilizados en dosis bajas, medias o altas según la gravedad del padecimiento. Desafortunadamente aún muchos médicos tienen miedo al uso prolongado de este tipo de medicamentos y una reciente publicación de un estudio epidemiológico realizado en Australia causó aún más confusión en esta área. Los autores concluyeron sin fundamento que todos los corticoesteroides inhalados pueden causar catarata. En este artículo se revisan varios estudios realizados acerca de corticoesteroides y catarata y se analiza el estudio australiano. En conclusión, los corticoesteroides sistémicos se asocian con un aumento en la frecuencia de catarata posterior subcapsular y se ha encontrado una relación entre el (promedio 65 años), que -sin embargo- no alcanzó significancia estadística. Otros corticoesteroides inhalados con menores efectos sistémicos, probablemente también llevarán un menor riesgo para el desarrollo de catarata

Asma corticodependiente / Corticosteroid dependent asthma

Los corticoides son las drogas antiinflamatorias más potentes disponibles. En los últimos años, el énfasis puesto en el componente inflamatorio de la enfermedad y la introducción de nuevos compuestos por vía inhalatoria, ha llevado a usarlos en etapas de la enfermedad cada vez más tempranas. El concepto de corticodependencia fue introducido para categorizar a aquellos pacientes con cuadros más severos, que no podían controlarse con todo el resto del arsenal terapeútico. En este estudio se evaluó, mediante una encuesta, el concepto de corticodependencia en un grupo de especialistas argentinos; se halló gran diversidad de opiniones. El 9 por ciento consideró asmático corticodependiente al paciente que requiere 400 µg/dia de beclometasona. El paciente asmático severo, que requiere 800 µg/dia de beclometasona para su control, fue categorizado como corticodependiente (CD) con el 14 por ciento de los entrevistados, mientras el 18 por ciento no pudo clasificarlo con seguridad (no sabe-no contesta). El paciente asmático severo que requeria 1600 µg/dia de beclometasona para su control y tres cursos cortos de esteroides por año era CD para el 73 por ciento de los entrevistados. El paciente severo que requiere 10 mg/dia de prednisona fue considerado CD por el 95 por ciento de los entrevistados y no CD por el 5 por ciento restante. En mi opinión, debieron considerarse asmáticos CD a los que tienen un riesgo importante de efectos secundarios por los esteroides, clasificados en el grado 4 (asma severa) del Consenso Internacional para el Tratamiento del Asma, y que requieran corticoides por vía sistémica en cualquier dosis en forma prolongada o permanente. Los pacientes que requieren dosis elevadas de esteroides inhalados pertenecen a un grupo borderline y queda por definir la dosis a partir de lo cual pasan a ser asmáticos

Crecimiento de lactantes asmáticos tratados con beclometasona en aerosol / Growth of asthmatic infants treated with inhaled beclometasone

Los corticoides en aerosol son eficaces en el control del asma bronquial. En pediatría hay preocupación por su potencial efecto adverso sobre el crecimiento. Son pocos los trabajos publicados, dirigidos a evaluar su efecto en el crecimiento en esta edad. Por estos motivos decidimos efectuar el presente trabajo. Se estudió el crecimiento de la longitud corporal de 32 lactantes asmáticos (LA) tratados con 400 ug/día de beclometasona por un año y se comparó con un grupo control de lactantes sanos (LC). Ambos grupos fueron comparables en sus valores antropométricos al nacer y al inicio del estudio. Al finalizar el período de un año, la talla fue similar en ambos grupos: LA=84.2 cmñ3.4 vs LC=84.1 cmñ3.3 (xñDS,p=ns). La velocidad del crecimiento fue tambien similar: LA=0.39ñ0.81 cm/año versus LC=0.42ñ0.71 cm/año. Se concluye que la talla no se comprometió en lactantes asmáticos tratados con 400 ug diarios de dipropionato de beclometasona en aerosol durante un año