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INTRODUCTION: The relationship between immediate symptom control, reliever medication use and exacerbation risk on treatment response and factors that modify it have not been assessed in an integrated manner. Here we apply simulation scenarios to evaluate the effect of individual baseline characteristics on treatment response in patients with moderate-severe asthma on regular maintenance dosing monotherapy with fluticasone propionate (FP) or combination therapy with fluticasone propionate/salmeterol (FP/SAL) or budesonide/formoterol (BUD/FOR). METHODS: Reduction in reliever medication use (puffs/24 h), change in symptom control scores (ACQ-5), and annualised exacerbation rate over 12 months were simulated in a cohort of patients with different baseline characteristics (e.g. time since diagnosis, asthma control questionnaire (ACQ-5) symptom score, smoking status, body mass index (BMI) and sex) using drug-disease models derived from large phase III/IV clinical studies. RESULTS: Simulation scenarios show that being a smoker, having higher baseline ACQ-5 and BMI, and long asthma history is associated with increased reliever medication use (p < 0.01). This increase correlates with a higher exacerbation risk and higher ACQ-5 scores over the course of treatment, irrespective of the underlying maintenance therapy. Switching non-responders to ICS monotherapy to combination therapy after 3 months resulted in immediate reduction in reliever medication use (i.e. 1.3 vs. 1.0 puffs/24 h for FP/SAL and BUD/FOR, respectively). In addition, switching patients with ACQ-5 > 1.5 at baseline to FP/SAL resulted in 34% less exacerbations than those receiving regular dosing BUD/FOR (p < 0.01). CONCLUSIONS: We have identified baseline characteristics of patients with moderate to severe asthma that are associated with greater reliever medication use, poor symptom control and higher exacerbation risk. Moreover, the effects of different inhaled corticosteroid (ICS)/long-acting beta agonist (LABA) combinations vary significantly when considering long-term treatment performance. These factors should be considered in clinical practice as a basis for personalised management of patients with moderate-severe asthma symptoms.
In this study we looked at how different factors affect the response to asthma treatment in people with moderate to severe asthma who are taking regular medication. Specifically, we wanted to quantify how much asthma duration, differences in the degree of symptom control and lung function, as well as smoking habit, body weight, and sex influence how well someone responds to regular maintenance therapy. Using computer simulations based on models obtained from data in a large patient population with moderatesevere asthma, we explored scenarios that reflect real-life management of patients undergoing treatment with inhaled corticosteroids alone or in combination with long-acting beta agonists over a 12-month period. We looked at how much reliever inhaler they use, how well they rate their asthma control, and how often they have asthma attacks. By considering these results together, we evaluated how well the treatments work on ongoing symptoms and/or reduce the risk of future asthma attacks. Our simulations showed that smokers, people with higher asthma symptom scores, who are obese, and have a longer history of asthma tend to use their reliever inhalers more often. This was linked to a higher risk of having asthma attacks and worse symptom control. Switching those patients who do not respond well to their initial treatment with corticosteroid to combination therapy reduced how much reliever inhaler they need. Also, the effects of fluticasone propionate/salmeterol combination therapy were greater than budesonide/formoterol. In conclusion, our study found that certain patient characteristics can predict how well someone responds to asthma treatment.
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Antiasmáticos , Asma , Humanos , Asma/tratamento farmacológico , Masculino , Feminino , Antiasmáticos/uso terapêutico , Adulto , Índice de Gravidade de Doença , Pessoa de Meia-Idade , Simulação por Computador , Combinação Fluticasona-Salmeterol/uso terapêutico , Broncodilatadores/uso terapêutico , Combinação Budesonida e Fumarato de Formoterol/uso terapêutico , Quimioterapia Combinada , Resultado do TratamentoRESUMO
RESUMEN Objetivo: Comparar el nivel de control del asma mediante el uso del Asthma Control Test (ACT) y manifestaciones clínicas en dos grupos de pacientes tratados con diferentes corticosteroides inhalados (GCI): fluticasona y beclometasona. Materiales y métodos. Se realizó un estudio observacional, comparativo y prospectivo en 521 niños del programa de asma del Hospital III Yanahuara. Durante el periodo de junio de 2020 a diciembre de 2021, se evaluó el nivel de control del asma mediante consultas remotas utilizando el ACT y la recopilación de hallazgos clínicos. Los pacientes se agruparon según el tipo de GCI que se encontraban utilizando. Se registraron los datos en dos momentos diferentes para cada paciente, con un intervalo de 4 meses entre cada control, durante la pandemia de COVID-19 y se comparó el nivel de control mediante la puntuación obtenida en el ACT y las manifestaciones clínicas entre ambos grupos de pacientes en ambos momentos del estudio. Resultados . Ambos grupos tuvieron un control óptimo al inicio como al final del estudio. En las manifestaciones clínicas no hubo diferencia estadística (P > 0.05) a favor de ningún medicamento en ninguno de los dos controles. Sin embargo, en el segundo control (egreso) se encontró una diferencia significativa de la fluticasona frente a la beclometasona (p = 0.030). Conclusiones . Se encontró que la Fluticasona tuvo una superioridad en el nivel de control del asma frente a la beclometasona. Sin embargo, el factor determinante para lograr un buen control es el uso continuo de cualquier GCI.
ABSTRACT Objective: To compare the level of asthma control using the Asthma Control Test (ACT) and clinical manifestations in two groups of patients treated with different inhaled corticosteroids (ICG): fluticasone and beclometasone. Materials and methods: An observational, comparative and prospective study was conducted in 521 children in the asthma program of Hospital III Yanahuara. During the period from June 2020 to December 2021, the level of asthma control was assessed by remote consultations using ACT and collection of clinical findings. Patients were grouped according to the type of ICG they were using. Data were recorded at two different time points for each patient, with a 4-month interval between each control, during the COVID-19 pandemic and the level of control was compared by ACT score and clinical manifestations between the two groups of patients at both time points of the study. Results: Both groups had optimal control at baseline and at the end of the study. In clinical manifestations there was no statistical difference (P > 0.05) in favor of either drug in either control. However, in the second control (discharge) a significant difference was found for fluticasone versus beclometasone (P = 0.030). Conclusions: Fluticasone was found to have superiority in the level of asthma control over beclomethasone. However, the determining factor in achieving good control is the continuous use of any IGC.
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OBJECTIVE: To assess the clinical effectiveness of fluticasone furoate nasal spray (FFNS) versus placebo on nasal symptoms and safety in children with perennial allergic rhinitis (AR). METHODS: A comprehensive review was conducted with data obtained from Medline and Embase databases up to April 2023. The population of interest was patients aged 2-12 years with perennial AR. The selection was limited to randomized controlled trials (RCTs), comparing FFNS with placebo. Outcomes of interest included the reflective total nasal symptoms scores (rTNSS) and safety. To assess the minimal clinically important difference for rTNSS, the Cohen's guideline was used. If the pooled standardized mean difference (SMD) and the lower limit of the 95 percent confidence interval (CI) exceeded the threshold of -0.20, effects were considered clinically significant. RESULTS: Three RCTs (959 pediatric patients) were selected. One study evaluated the short-term use of FFNS, another evaluated the long-term use of FFNS, and another evaluated both the short-term and long-term use of FFNS. FFNS produced a statistically significant reduction over placebo in rTNSS (SMD -0.18; 95 percent CI -0.35 to -0.01, p = 0.03) in long-term treatment studies, but not in short-term treatment studies. However, since the mean reduction did not reach the minimum clinically important difference (SMD -0.20), these results were considered clinically not relevant. Safety outcomes with FFNS were similar to placebo. CONCLUSIONS: The currently available evidence suggests that FFNS, 110 µg once daily, compared to placebo, does not produce a meaningful clinical effect on nasal symptom in children with perennial AR.
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Antialérgicos , Rinite Alérgica Perene , Humanos , Criança , Sprays Nasais , Rinite Alérgica Perene/tratamento farmacológico , Androstadienos/efeitos adversos , Resultado do Tratamento , Antialérgicos/uso terapêuticoRESUMO
BACKGROUND: In recent years, the combination of fluticasone furoate and vilanterol (FF/VI) has emerged as an alternative therapy, since it is administered every 24 h, in contrast to other ICS/LABAs such as fluticasone propionate plus salmeterol (FP/Salm), which requires administration every 12 h. Concerns have arisen over whether the benefit generated by FF/VI justifies the additional costs it involves over FP/Salm. This study aimed at assessing the health and economic consequences of FF/VI in patients with moderate-severe persistent asthma. METHODS: A probabilistic Markov model was created to estimate the cost and quality-adjusted life-years (QALYs) of patients with persistent asthma. Total costs and QALYs for FF/VI and FP/Salm were calculated over a lifetime horizon. Multiple sensitivity analyses were conducted. Cost-effectiveness was evaluated at a willingness-to-pay value of $19,000. RESULTS: We estimated a gain of 16.8 and 10.7 QALYs per patient per year on FF/VI and FP/Salm, respectively. At the same time, we observed a difference of US$216 in total discounted cost per person-year on FF/VI with respect to FP/Salm. The incremental cost-effectiveness ratio (ICER) of FF/VI was USD $70 per QALY with respect to FP/Salm. In the deterministic and probabilistic sensitivity analyses, our base-case results were robust to variations in all assumptions and parameters. CONCLUSION: FF/VI is more cost-effective than FP/Salm. The evidence supports using FF/VI therapy in Colombia, and the study should be replicated in other middle-income countries.
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Asma , Humanos , Asma/tratamento farmacológico , Análise Custo-Benefício , Combinação de Medicamentos , Resultado do Tratamento , Administração por Inalação , Androstadienos , Combinação Fluticasona-Salmeterol , Álcoois Benzílicos , Clorobenzenos , Fluticasona/uso terapêuticoRESUMO
Abstract This study investigatedthe efficacy and safety offluticasone propionate nasal spray in treatment of adenoidal hypertrophic snoring in children.Fifty-six children with adenoidal hypertrophic snoring were enrolled. According to adenoidal-nasopharyngeal ratio (ANR) in lateral nasal X-ray examination,the children were assigned in moderategroup (23 cases) and severegroup (33 cases).The fluticasone propionate nasal spray was used for all patientsfor 4 weeks.In 56 patients, after treatment, compared with before treatment, the snoring, sleep apneaand nasal obstruction scores in moderategroupand the nasal obstruction score in severegroupwere significantly decreased,respectively (P < 0.05).The decreases of snoring, sleep apnea, mouth breathing and nasal obstruction scores after treatment in moderate group were significantly higher than those in severe group, respectively (P <0.001).After treatment, in 18 patients with ateral nasal X-ray examination,the adenoid size was obviously reduced, and the nasopharynx airway was obviously enlarged. The meanANRdropped from 0.76±0.10 to 0.72±0.09(P <0.001).Duringtreatment, only 2 of 56 patients were reported with intranasal dryness and occasional epistaxis, which were self-healed without treatment.Fluticasone propionate nasal spray is effective and safe for treatment of children's snoring caused by adenoidal hypertrophy.
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El incremento de la expectativa de vida con el advenimiento de la terapia antirretroviral de alta eficacia plantea desafíos en cuanto a la toxicidad e interacciones medicamentosas. El síndrome de Cushing exógeno por interacción entre ritonavir y fluticasona inhalada en niños con diagnóstico de infección por virus de la inmunodeficiencia humana y patología pulmonar crónica es infrecuente. Hasta el momento, hay 20 casos reportados. Se describen 3 casos pediátricos con diagnóstico de infección por virus de la inmunodeficiencia humana y patología pulmonar crónica que presentaron síndrome de Cushing exógeno con fluticasona inhalada en dosis habituales por la interacción medicamentosa entre esta y ritonavir. Los pacientes resolvieron el cuadro clínico luego de 2-4 meses de suspensión de la fluticasona y permanecieron asintomáticos en el seguimiento
The increase in life expectancy with the advent of highly effective antiretroviral therapy poses challenges in terms of toxicity and drug interactions. Exogenous Cushing syndrome by interaction between ritonavir and inhaled fluticasone in children diagnosed with human immunodeficiency virus infection and chronic pulmonary pathology is rare. So far, there are 20 cases reported. Three pediatric cases are reported, with a diagnosis of human immunodeficiency virus infection and chronic pulmonary pathology who presented exogenous Cushing syndrome with inhaled fluticasone at usual doses due to drug interaction between it and ritonavir. The patients resolved the clinical Síndrome de Cushing exógeno por interacción medicamentosa de ritonavir y fluticasona inhalada. Reporte de tres casos pediátricos Exogenous Cushing syndrome due to drug interaction of ritonavir and inhaled fluticasone. Report of three pediatric cases picture after 2-4 months of fluticasone suspension and remain asymptomatic in the follow-up.
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Humanos , Masculino , Criança , Adolescente , Síndrome de Cushing/diagnóstico , HIV , Ritonavir/uso terapêutico , Síndrome de Cushing/terapia , Fluticasona/efeitos adversos , Fluticasona/uso terapêutico , PneumopatiasRESUMO
The increase in life expectancy with the advent of highly effective antiretroviral therapy poses challenges in terms of toxicity and drug interactions. Exogenous Cushing syndrome by interaction between ritonavir and inhaled fluticasone in children diagnosed with human immunodeficiency virus infection and chronic pulmonary pathology is rare. So far, there are 20 cases reported. Three pediatric cases are reported, with a diagnosis of human immunodeficiency virus infection and chronic pulmonary pathology who presented exogenous Cushing syndrome with inhaled fluticasone at usual doses due to drug interaction between it and ritonavir. The patients resolved the clinical picture after 2-4 months of fluticasone suspension and remain asymptomatic in the follow-up.
El incremento de la expectativa de vida con el advenimiento de la terapia antirretroviral de alta eficacia plantea desafíos en cuanto a la toxicidad e interacciones medicamentosas. El síndrome de Cushing exógeno por interacción entre ritonavir y fluticasona inhalada en niños con diagnóstico de infección por virus de la inmunodeficiencia humana y patología pulmonar crónica es infrecuente. Hasta el momento, hay 20 casos reportados. Se describen 3 casos pediátricos con diagnóstico de infección por virus de la inmunodeficiencia humana y patología pulmonar crónica que presentaron síndrome de Cushing exógeno con fluticasona inhalada en dosis habituales por la interacción medicamentosa entre esta y ritonavir. Los pacientes resolvieron el cuadro clínico luego de 2-4 meses de suspensión de la fluticasona y permanecieron asintomáticos en el seguimiento.
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Fármacos Anti-HIV/efeitos adversos , Asma/tratamento farmacológico , Broncodilatadores/efeitos adversos , Síndrome de Cushing/induzido quimicamente , Fluticasona/efeitos adversos , Doenças Pulmonares Intersticiais/tratamento farmacológico , Ritonavir/efeitos adversos , Administração por Inalação , Adolescente , Fármacos Anti-HIV/uso terapêutico , Asma/complicações , Broncodilatadores/uso terapêutico , Criança , Doença Crônica , Síndrome de Cushing/diagnóstico , Interações Medicamentosas , Fluticasona/uso terapêutico , Infecções por HIV/complicações , Infecções por HIV/tratamento farmacológico , Humanos , Doenças Pulmonares Intersticiais/etiologia , Masculino , Ritonavir/uso terapêuticoRESUMO
Abstract Objective: There is a scarcity of studies that assessed the association between adherence to combination therapy and asthma control in pediatric patients. The authors investigated the association between adherence to fluticasone propionate/salmeterol xinafoate combination-metered aerosol and the level of asthma control in children. Methods: This was a prospective observational study of 84 patients aged 5-16 years with moderate persistent asthma, who remained uncontrolled despite the use of 1000 µg/day of inhaled nonextrafine-hydrofluoric alkane-beclomethasone dipropionate in the three months prior to study enrollment. Participants were prescribed two daily doses of FP (125 µg)/salmeterol xinafoate (25 µg) combination by metered aerosol/spacer for six months. Adherence rates were assessed using the device's dose counter after the 2nd, 4th, and 6th months of follow up. Asthma control was assessed using a simplified Global Initiative for Asthma 2014 Report classification. Results: Mean adherence rates after the second, fourth, and sixth months were 87.8%, 74.9%, and 62.1% respectively, for controlled asthma, and 71.7%, 56.0%, and 47.6% respectively, for uncontrolled asthma (all p-values ≤ 0.03). The proportion of children achieving asthma control increased to 42.9%, 67.9% and 89.3% after the 2nd, 4th and 6th months of follow-up, respectively (p ≤ 0.001). Conclusion: Adherence rates between 87.8% in the 2nd month and 62.1% in the 6th month were strong determinants of asthma control.
Resumo Objetivo: São escassos os estudos que avaliaram a relação entre a taxa de adesão à combinação de proprionato de fluticasona/xinafoato de salmeterol e o nível de controle da asma na infância. O presente estudo teve como objetivo avaliar essa relação. Métodos: Estudo prospectivo observacional com 84 participantes, de 5 a 16 anos, todos eles com asma persistente moderada que permaneceram não controlados apesar do uso de 1.000 µg/dia de dipropionato de beclometasona em partículas não extrafinas nos três meses que antecederam a admissão no estudo. Os participantes receberam prescrição de 125 µg de propionato de fluticasona e 25 µg xinafoato de salmeterol através de inalador pressurizado, duas vezes ao dia, e foram avaliados após o 2°, 4° e 6° meses de tratamento. A taxa de adesão foi obtida por meio do contador analógico de doses incorporado ao inalador. A classificação do nível de controle da asma foi baseada numa simplificação das recomendações da Global Initiative for Asthma. Resultados: As taxas de adesão aos 2, 4 e 6 meses para a asma controlada foram 87,8%, 74,9% e 62,1% e para a asma não controlada de 71,7%, 56,0% e 47,6% (p ≤ 0,03), respectivamente. A proporção de pacientes com asma controlada elevou- se para 42,9%, 67,9% e 89,3% nas três avaliações subsequentes (p ≤ 0,001). Conclusões: Taxas de adesão entre 87,8% no 2° mês e de 62,1% no 6° mês foram determinantes para o nível de controle da asma.
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Humanos , Masculino , Feminino , Pré-Escolar , Criança , Adolescente , Asma/tratamento farmacológico , Broncodilatadores/administração & dosagem , Xinafoato de Salmeterol/administração & dosagem , Fluticasona/administração & dosagem , Cooperação e Adesão ao Tratamento , Estudos Prospectivos , Seguimentos , Resultado do Tratamento , Quimioterapia CombinadaRESUMO
OBJECTIVE: There is a scarcity of studies that assessed the association between adherence to combination therapy and asthma control in pediatric patients. The authors investigated the association between adherence to fluticasone propionate/salmeterol xinafoate combination-metered aerosol and the level of asthma control in children. METHODS: This was a prospective observational study of 84 patients aged 5-16 years with moderate persistent asthma, who remained uncontrolled despite the use of 1000µg/day of inhaled nonextrafine-hydrofluoric alkane-beclomethasone dipropionate in the three months prior to study enrollment. Participants were prescribed two daily doses of FP (125µg)/salmeterol xinafoate (25µg) combination by metered aerosol/spacer for six months. Adherence rates were assessed using the device's dose counter after the 2nd, 4th, and 6th months of follow up. Asthma control was assessed using a simplified Global Initiative for Asthma 2014 Report classification. RESULTS: Mean adherence rates after the second, fourth, and sixth months were 87.8%, 74.9%, and 62.1% respectively, for controlled asthma, and 71.7%, 56.0%, and 47.6% respectively, for uncontrolled asthma (all p-values≤0.03). The proportion of children achieving asthma control increased to 42.9%, 67.9% and 89.3% after the 2nd, 4th and 6th months of follow-up, respectively (p≤0.001). CONCLUSION: Adherence rates between 87.8% in the 2nd month and 62.1% in the 6th month were strong determinants of asthma control.
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Asma/tratamento farmacológico , Broncodilatadores/administração & dosagem , Fluticasona/administração & dosagem , Xinafoato de Salmeterol/administração & dosagem , Cooperação e Adesão ao Tratamento , Administração por Inalação , Adolescente , Criança , Pré-Escolar , Quimioterapia Combinada , Feminino , Seguimentos , Humanos , Masculino , Estudos Prospectivos , Resultado do TratamentoRESUMO
Introducción. La Enfermedad Pulmonar Obstructiva Crónica (EPOC) es una patología no transmisible, caracterizada por una limitación de flujo de aire en las vías respiratorias debido a una respuesta inmunológica anormal frente a partículas. Objetivo. Conocer la eficacia que tiene la budesonida/formoterol comparado con la fluticasona/salmeterol en la mejoría de la capacidad pulmonar en personas mayores de 40 años con Enfermedad Pulmonar Obstructiva Crónica. Materiales y métodos. Se realizó una revisión sistemática de documentos producidos entre el año 2000 y 2018 en distintas bases de datos, donde se incluyeron ensayos clínicos. Se identificaron cuatro artículos para el análisis final. Resultados. Durante la evaluación comparativa de budesonida con formoterol, los artículos muestran un total de 709 personas evaluadas, con un promedio de edad de 53,5 años. El 65,4 % eran varones, el 21 % manifestaba no haber consumido tabaco, todos con diagnóstico de Enfermedad Pulmonar Obstructiva Crónica moderada-severa, según la escala GOLD (Global Initiative For Chronic Obstrutive Lung Disease). Los estudios determinaron que al administrar budesonida/formoterol de 400/12 mcg y 320/9 mcg, los pacientes tuvieron una leve mejoría en el Volumen Espiratorio Forzado del primer segundo (VEF1). Solo dos pacientes presentaron efectos adversos. No obstante, para los resultados mencionados anteriormente no se encontró diferencias significativas. Conclusiones. El uso de budesonida/formoterol es eficaz al mejorar la capacidad ventilatoria pulmonar, disminuye el número de exacerbaciones anuales y genera un adecuado control de los síntomas, sin embargo, es igual de efectivo a la fluticasona/salmeterol.
Introduction. Chronic Obstructive Pulmonary Disease (COPD) is a not transmissible disease, characterized by a limitation of airflow in the respiratory tract, due to an abnormal immune response to particles. Objective. This article aims to show that the application of budesonide / formoterol improves lung capacity in people over 40 years with Chronic Obstructive Pulmonary Disease. Materials and methods. A systematic review was conducted in the period between 2000 and 2018 in different databases where clinical trials were included. Four articles were identified for the final analysis. Results. During the comparative evaluation of budesonide with formoterol, a total of 709 people were evaluated, with an average age of 53.5 years, 65.4% were male, 21% reported not having used tobacco, all with a diagnosis of moderate-severe Chronic Obstructive Pulmonary Disease according to the GOLD scale (Global Initiative For Chronic Obstrutive Lung Disease). The studies determined that when budesonide / formoterol of 400/12 mcg and 320/9 mcg was administered, the patients had a slight improvement in the Forced Expiratory Volume of the first second (FEV1). Only two patients presented adverse effects. However, for the results mentioned above no significant differences were found. Conclusions. The use of budesonide / formoterol is effective in improving pulmonary ventilatory capacity, decreases the number of annual exacerbations and generates adequate control of symptoms, however, it is equally effective in fluticasone / salmeterol.
Introdução. A Doença Pulmonar Obstrutiva Crônica (DPOC) é uma patologia não transmissível, caraterizada por uma limitação do fluxo de ar nas vias aéreas devido a uma resposta imune anormal contra partículas. Objetivo. Conhecer a eficiência que apresenta a budesonida/formoterol comparado com fluticasona/salmeterol na melhora da capacidade pulmonar em pessoas com mais de 40 anos com Doença Pulmonar Obstrutiva Crônica. Materiais e métodos. Foi realizada uma revisão sistemática dos documentos produzidos entre 2000 e 2018 em diferentes bancos de dados, onde foram incluídos ensaios clínicos. Quatro artigos foram identificados para a análise final. Resultados. Durante a avaliação comparativa de budesonida com formoterol, os artículos mostram um total de 709 pessoas avaliadas, com uma idade média de 53,5 anos. O 65,4 % eram do sexo masculino, o 21 % disseram que não usavam tabaco, todos diagnosticados com Doença Pulmonar Obstrutiva Crônica moderada a grave, de acordo com a escala GOLD (Global Initiative For Chronic Obstrutive Lung Disease). Os estudos determinaram que administrar budesonida/formoterol de 400/12 mcg e 320/9 mcg, os pacientes apresentaram uma leve melhora no Volume Expiratório Forçado no primeiro segundo (VEF1). Apenas dois pacientes tiveram efeitos adversos. No entanto, não foram encontradas diferenças significativas para os resultados mencionados acima. Conclusões. O uso de budesonida/formoterol é eficaz na melhora da capacidade ventilatória pulmonar, diminui o numero de exacerbações anuais e gera controle adequado dos sintomas, no entanto, é igualmente eficaz para a fluticasona/salmeterol.
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Doença Pulmonar Obstrutiva Crônica , Enfisema Pulmonar , Eficácia , Budesonida , Bronquite Crônica , Xinafoato de Salmeterol , Fumarato de Formoterol , FluticasonaRESUMO
Introducción: La azelastina es un antihistamínico tópico nasal, exento de los molestos efectos sistémicos, la cual asociada con fluticasona, ha mostrado excelentes resultados en el control de la rinitis alérgica. Objetivo: Evaluar los resultados del tratamiento del spray nasal de azelastina y fluticasona. Diseño: Observacional descriptivo prospectivo. Materiales y métodos: Se evaluaron 76 pacientes de ambos sexos, con edades entre los 12 y 59 años, con diagnóstico de rinitis alérgica en el que se midieron los síntomas: obstrucción, prurito, estornudos y rinorrea. La severidad de los síntomas fue valorada por el propio paciente de 0 a 10 pretratamiento, a la semana, dos, tres y cuatro semanas de iniciado el tratamiento, el cual fue igual para todos los pacientes, con control ambiental y la atomización de 2 puff en cada fosa nasal del spray de azelastina y fluticasona. Se hizo seguimiento de los síntomas nasales y la aparición de efectos colaterales. Resultados: Se observó una diferencia estadísticamente significativa entre el puntaje obtenido previo al tratamiento y en la evaluación posterior desde la primera semana de uso y hasta el momento del seguimiento final a la cuarta semana (p<0,0001 Friedman F). Conclusiones: El spray nasal de azelastina y fluticasona, es muy útil en el control de los síntomas de rinitis alérgica, mostrando además un adecuado perfil de seguridad.
Introduction: Azelastine, is a topical nasal antihistamine free of systemic effects, the quality associated with fluticasone, has been excellent in the control of allergic rhinitis. Objective: To evaluate the results of the treatment of the nasal spray of azelastine and fluticasone. Design: Prospective and descriptive study. Methods: 76 patients of both sexes, aged between 12 and 59 years, with a diagnosis of allergic rhinitis in which the symptoms were measured: obstruction, pruritus, sneezing and rhinorrhea. The severity of each symptom was assessed by the patient from 0 to 10 before and after a week, two, three and four weeks, which was the same for all patients, with environmental control and the atomization of 2 puffs in each nostril of the azelastine and fluticasone spray. A follow-up of nasal symptoms and the appearance of side effects. Results: A statistically significant difference was observed between the score obtained before the treatment and in the subsequent evaluation from the first week until the time of the final follow-up at the fourth week (p <0.0001 Friedman F). Conclusion: The nasal spray of azelastine and fluticasone is very useful in the control of the symptoms of allergic rhinitis.
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Humanos , Rinite Alérgica Perene , Fluticasona , Glucocorticoides , Antagonistas dos Receptores HistamínicosRESUMO
OBJECTIVE: To evaluate the dose-response, efficacy, and safety of fluticasone furoate (FF; 25 µg, 50 µg, and 100 µg), administered once daily in the evening during a 12-week treatment period to children with inadequately controlled asthma. STUDY DESIGN: This was a Phase IIb, multicenter, stratified, randomized, double-blind, double-dummy, parallel-group, placebo- and active-controlled study in children aged 5-11 years with inadequately controlled asthma. The study comprised a 4-week run-in period, 12-week treatment period, and 1-week follow-up period. Children were randomized to receive either placebo once daily, fluticasone propionate (FP) 100 µg twice daily, FF 25 µg, FF 50 µg, or FF 100 µg each once daily in the evening. Primary endpoint was the mean change from baseline in daily morning peak expiratory flow (PEF) averaged over weeks 1-12. Adverse events (AEs) also were investigated. RESULTS: In total, 593 children were included in the intent-to-treat population. The difference vs placebo in change from baseline daily morning PEF averaged over weeks 1-12 was statistically significant for the FF 25, FF 50, FF 100, and FP 100 groups (18.6 L/min, 19.5 L/min, 12.5 L/min, and 14.0 L/min, respectively; P < .001 for all). The incidence of AEs was greater in the FF groups (32%-36%) than in the placebo group (29%); the most frequent AE was cough. CONCLUSION: FF and FP resulted in significant improvements in morning PEF compared with placebo, suggesting that they are effective treatments for children with inadequately controlled asthma. All treatments were well tolerated; no new safety concerns were identified. TRIAL REGISTRATION: ClinicalTrials.gov:NCT01563029.
Assuntos
Androstadienos/administração & dosagem , Asma/tratamento farmacológico , Broncodilatadores/administração & dosagem , Administração por Inalação , Androstadienos/efeitos adversos , Broncodilatadores/efeitos adversos , Criança , Pré-Escolar , Método Duplo-Cego , Feminino , Volume Expiratório Forçado/efeitos dos fármacos , Humanos , Masculino , Resultado do TratamentoRESUMO
We report a 41-year-old man with HIV and a chronic obstructive pulmonary disease, treated for seven months with Fluticasone/Salmeterol and antiretroviral therapy (Lamivudine, Tenofovir, Atazanavir and Ritonavir). While using these medications, the patients developed a Cushing syndrome in a period of five months. After performing laboratory and imaging tests, it was concluded that the most probable cause of the syndrome was the interaction of inhaled steroids with Ritonavir. After discontinuing these medications the syndrome reverted in a period of 8 months.
Assuntos
Humanos , Masculino , Adulto , Broncodilatadores/efeitos adversos , Infecções por HIV/tratamento farmacológico , Inibidores da Protease de HIV/efeitos adversos , Síndrome de Cushing/induzido quimicamente , Xinafoato de Salmeterol/efeitos adversos , Fluticasona/efeitos adversos , Nebulizadores e Vaporizadores , Broncodilatadores/uso terapêutico , Inibidores da Protease de HIV/uso terapêutico , Síndrome de Cushing/diagnóstico , Interações Medicamentosas , Xinafoato de Salmeterol/uso terapêutico , Fluticasona/uso terapêuticoRESUMO
Eosinophilic esophagitis is a clinico pathologic entity that has been increasingly recognized over the past two decades. It affects all ages, preferably men, with a history of atopy and is characterized by eating disorders, dysphagia and heartburn. It has elements in common with gastroesophageal reflux disease and the distinction between them can be a challenge for the clinician. It has several typical endoscopic features, such as longitudinal grooves, rings, plaques and stenosis, but none of them is pathognomonic of the disease. The correlation of history, endoscopic and histology are essential for a correct diagnosis. Management includes a period of use of proton pump inhibitors to rule out concomitant reflux disease. Treatment with topical corticosteroids such as fluticasone and budesonide are successful in the short term, but recurrence is common. Some cases may require endoscopic dilatation. Data is still insufficient to establish optimal management at short and long-term, therefore therapeutic decisions should be evaluated on a case-by-case basis.
La esofagitis eosinofílica es una entidad clínico patológica que ha sido reconocida en forma cada vez más frecuente en las últimas dos décadas. Afecta a todas las edades, de preferencia a hombres con antecedentes de atopia y se caracteriza por presentar trastornos alimentarios, disfagia y pirosis. Presenta elementos comunes con la enfermedad por reflujo gastroesofágico y la distinción entre ellas puede ser un desafío para el médico. Tiene varias características endoscópicas típicas, como los surcos longitudinales, anillos, placas y estenosis, pero ninguna de ellas es patognomónica de la enfermedad. La correlación de la historia, imagen endoscópica e histología son imprescindibles para el diagnóstico correcto. El manejo incluye un período de uso de inhibidores de la bomba de protones para descartar una enfermedad por reflujo concomitante. El tratamiento con corticoides tópicos como la fluticasona y budesonida da buenos resultados a corto plazo, pero la recidiva es frecuente. Algunos casos pueden requerir dilatación endoscópica. Faltan datos para establecer un manejo óptimo a corto y largo plazo, por lo que las decisiones terapéuticas deben ser evaluadas caso a caso.
Assuntos
Humanos , Masculino , Feminino , Esofagite Eosinofílica/diagnóstico , Esofagite Eosinofílica/terapia , Androstadienos/administração & dosagem , Budesonida/administração & dosagem , Endoscopia do Sistema Digestório , Esofagite Eosinofílica/patologia , Sensibilidade e Especificidade , Valor Preditivo dos TestesRESUMO
Objetivo. Comparar la bioequivalencia de tres formulas farmacéuticas nasales de propionato de fluticasona administradoscon un rociador nasal. Materiales y métodos. Ensayo clínico aleatorizado, abierto, de dosis única, cruzado a tresbrazos en 60 voluntarios sanos de ambos sexos entre 18 y 55 años de edad. El tratamiento consistió en una dosis nasalúnica (800 mcg) de rociador nasal de propionato de fluticasona (RNF), Flonase®, y Flixonase® en cinco visitas: una visita de selección, tres visitas de administración del medicamento y una de evaluación final. Se obtuvo muestras desangre a intervalos apropiados para análisis farmacocinético. El parámetro primario para determinar la bioequivalencia de las fórmulas farmacéuticas estudiadas fue el área bajo la curva de concentración-tiempo (AUC0-t). Como parámetro secundario se consideró la concentración máxima de la droga (Cmax). RNF se comparó separadamente a Flonase® y Flixonase®. Resultados. Se demostró bioequivalencia entre RNF y Flonase® (n=55) utilizando la transformación logarítmica invertida de AUC0-t (relación RNF a Flonase® = 1,021; IC90 por ciento, 0,88 a 1,19), y Cmax (relación = 0,995; IC90 por ciento, 0,92 a 1,07). Ambas medidas se encuentran dentro del rango aceptable de bioequivalencia (0,80 a 1,25). También se demostró la bioequivalencia entre RNF y Flixonase® (n=54) para AUC0-t (relación = 0,949; IC 90 por ciento 0,81 a 1,10) y Cmax (relación = 0,939, IC90 por ciento, 0,87 a 1,02). Se encontró que los tres tratamientos presentaron relativamente pocos efectos adversos. Conclusiones. RNF a una dosis de 800 mcg es bioequivalente tanto a Flonase® como Flixonase® administradas a voluntarios sanos. El perfil de seguridad de RNF es consistente con los de Flonase® y Flixonase®.
Objective: Comparison of the bioequivalence of three pharmaceutical formulations of fluticasone propionate nasal administered with a nasal spray (FANS). Materials y Methods: A randomized, open-label, single-dose, three-way crossover study in 60 healthy volunteers of both sexes between 18 and 55 years old. Subjects received a single intranasal dose (800 mcg) of FANS, Flonase®, and Flixonase® in 5 visits: screening, 3 dosing visits, and end of study. Forty-eight hours to 7 days were allowed between dosing visits. Blood was drawn for pharmacokinetics analysis at appropriate intervals. The primary pharmacokinetic parameter for determination of bioequivalence of the formulations was the areaunder the plasma concentration-time curve (AUC0-t). Secondary parameters included the maximum plasma concentration (Cmax). FANS was compared to Flonase® and to Flixonase® separately. Results: Bioequivalence between FANS and Flonase® (n=55) was demonstrated by the inverse log transformed AUC0-t (ratio FANS to Flonase® = 1.021; 90 per cent CI, 0.88 to 1.19), and Cmax, (ratio = 0.995; 90 per cent CI, 0.92 to 1.07), which are within the acceptable range of 0.80 to 1.25. Bioequivalence between FANS and Flixonase® (n=54) was also demonstrated for AUC0-t (ratio = 0.949; 90 per cent CI 0.81 to 1.10) and Cmax (ratio = 0.939, 90 per cent CI, 0.87 to 1.02). Active treatments were well tolerated and there were relatively few adverse events. Conclusions: A single dose of FANS 800 mcg is pharmacokinetically bioequivalent to both Flonase® and Flixonase® when administered to healthy subjects. The safety profile of FANS was consistent with that noted for Flonase® and Flixonase®.
Assuntos
Humanos , Masculino , Feminino , Adulto , Pessoa de Meia-Idade , Equivalência Terapêutica , Farmacocinética , Medicamentos Genéricos , Rinite Alérgica PereneRESUMO
Objetivo. Establecer la equivalencia clínica de un rociador nasal de propionato de fluticasona (RNF) genérico comparadocon dos formulas farmacéuticas comerciales del mismo producto (Flonase® y Flixonase®) durante la estación de polinización del cedro de montaña (Juniperus ashei) en Texas, EEUU. Materiales y métodos. Estudio multicéntrico, aleatorizado, doble ciego, controlado con placebo, en grupos paralelos diseñado para investigar la seguridad y eficacia de RNF (200 mcg una vez al día), Flonase® (200 mcg una vez al día) y Flixonase® (200 mcg una vez al día), comparados con placebo, administrados por 13 a 15 días. Los pacientes registraron diariamente, en la mañana y en la tarde, sus síntomas nasales totales (SNT). La variable de desenlace primaria fue la suma de SNT en la mañana y tarde + 1. Las variables de desenlace secundarias fueron los SNT AM + 1 y SNT PM + 1, y la evaluación de seguridad. Resultados. No se observó diferencia estadísticamente significativa en ningún día de estudio, ni en todo el periodo de tratamiento, ni al punto de final entre SNT promedio tanto de Flonase® como Flixonase® y RNF. La equivalencia clínica entre RNF yFlonase® (cociente= 0,98; intervalo de confianza [IC] al 90 por ciento, 0,91 a 1,06), y entre RNF y Flixonase® (cociente= 1,02; IC 90 por ciento, 0,94 a 1,10) fue demostrada tanto para la variable de desenlace primaria como para las otras variables de eficacia. Conclusiones. Estos resultados respaldan la equivalencia clínica entre RNF 200 mcg una vez al día tanto con Flonase®como Flixonase® en el tratamiento de rinitis alérgica estacional.
Objective. The primary objective of this study was to establish the clinic equivalence of a new Fluticasone Propionate Aqueous Nasal Spray (FANS) compared to two commercially available active treatments of fluticasone propionate nasal spray (Flonase® and Flixonase®) during the mountain cedar (Juniperus ashei) pollen season in Texas. Material and methods. This was a multicenter, randomized, double-blind, double-dummy, active-controlled and placebo-controlled, parallel group study designed to investigate the safety and efficacy of FANS (200 mcg QD), Flonase® and Flixonase® (200 mcg QD) compared to placebo administered for 13 to 15 days. Patients recorded the total nasal symptoms dcores (TNSS) in a diary in the morning and evening every day. The primary endpoint was the patient-rated am and pm TNSS +1. Other key efficacy endpoints were patient-rated AM TNSS+1, patient-rated PM TNSS+1, and safety. Results. Mean TNSS values for Flonase® and Flixonase® were not statistically significantly different from FANS during any study day, over the entire treatment period, or at endpoint. Bioequivalence between FANS and Flonase® (ratio= 0.98, 90 per cent CI 0.91 to 1.06) as well as FANS and Flixonase® (ratio=1.02, 90 per cent CI 0.94 to 1.10) was demonstrated for the primary endpoint [Patient-Rated am and pm TNSS +1] as well as for the other key efficacy endpoints. Conclusions. The findings from this study support that FANS 200 mcg QD is therapeutically bioequivalent to both Flonase® and Flixonase® in the control ofthe symptoms of seasonal allergic rhinitis.
Assuntos
Humanos , Equivalência Terapêutica , Medicamentos Genéricos , Rinite Alérgica Sazonal , Estudos Multicêntricos como AssuntoRESUMO
Allergic rhinitis (AR) is a prevalent disease with great morbidity and significant societal and economic burden. Intranasal corticosteroids are recommended as first-line therapy for patients with moderate-to-severe disease, especially when nasal congestion is a major component of symptoms. To compare the efficacy and safety profile of different available intranasal corticosteroids for the treatment of AR, it is important to understand their different structures and pharmacokinetic and pharmacodynamic properties. Knowledge of these drugs has increased tremendously over the last decade. Studies have elucidated mechanisms of action, pharmacologic properties, and the clinical impact of these drugs in allergic respiratory diseases. Although the existing intranasal corticosteroids are already highly efficient, the introduction of further improved formulations with a better efficacy/safety profile is always desired. Fluticasone furoate nasal spray is a new topical corticosteroid, with enhanced-affinity and a unique side-actuated delivery device. As it has high topical potency and low potential for systemic effects, it is a good candidate for rhinitis treatment.