Base de dados : MEDLINE
Pesquisa : D02.033.100.291.425.500 [Categoria DeCS]
Referências encontradas : 5 [refinar]
Mostrando: 1 .. 5   no formato [Detalhado]

página 1 de 1

  1 / 5 MEDLINE  
              next record last record
seleciona
para imprimir
Fotocópia
Registro de Ensaios Clínicos
Registro de Ensaios Clínicos
Texto completo
[PMID]:27130691
[Au] Autor:Wenzel S; Castro M; Corren J; Maspero J; Wang L; Zhang B; Pirozzi G; Sutherland ER; Evans RR; Joish VN; Eckert L; Graham NM; Stahl N; Yancopoulos GD; Louis-Tisserand M; Teper A
[Ad] Endereço:Division of Pulmonary Allergy and Critical Care Medicine, University of Pittsburgh, Pittsburgh, PA, USA. Electronic address: wenzelse@upmc.edu.
[Ti] Título:Dupilumab efficacy and safety in adults with uncontrolled persistent asthma despite use of medium-to-high-dose inhaled corticosteroids plus a long-acting ß2 agonist: a randomised double-blind placebo-controlled pivotal phase 2b dose-ranging trial.
[So] Source:Lancet;388(10039):31-44, 2016 Jul 02.
[Is] ISSN:1474-547X
[Cp] País de publicação:England
[La] Idioma:eng
[Ab] Resumo:BACKGROUND: Dupilumab, a fully human anti-interleukin-4 receptor α monoclonal antibody, inhibits interleukin-4 and interleukin-13 signalling, key drivers of type-2-mediated inflammation. Adults with uncontrolled persistent asthma who are receiving medium-to-high-dose inhaled corticosteroids plus a long-acting ß2 agonist require additional treatment options as add-on therapy. We aimed to assess the efficacy and safety of dupilumab as add-on therapy in patients with uncontrolled persistent asthma on medium-to-high-dose inhaled corticosteroids plus a long-acting ß2 agonist, irrespective of baseline eosinophil count. METHODS: We did this randomised, double-blind, placebo-controlled, parallel-group, pivotal phase 2b clinical trial at 174 study sites across 16 countries or regions. Adults (aged ≥18 years) with an asthma diagnosis for 12 months or more based on the Global Initiative for Asthma 2009 Guidelines receiving treatment with medium-to-high-dose inhaled corticosteroids plus a long-acting ß2 agonist were eligible for participation. Patients were randomly assigned (1:1:1:1:1) to receive subcutaneous dupilumab 200 mg or 300 mg every 2 weeks or every 4 weeks, or placebo, over a 24-week period. The primary endpoint was change from baseline at week 12 in forced expiratory volume in 1 s (FEV1 in L) in patients with baseline blood eosinophil counts of at least 300 eosinophils per µL assessed in the intention-to-treat population. Safety outcomes were assessed in all patients that received at least one dose or part of a dose of study drug. This trial is registered at ClinicalTrials.gov, number NCT01854047, and with the EU Clinical Trials Register, EudraCT number 2013-000856-16. FINDINGS: 769 patients (158 in the placebo group and 611 in the dupilumab groups) received at least one dose of study drug. In the subgroup with at least 300 eosinophils per µL, the greatest increases (200 mg every 2 weeks, p=0·0008; 300 mg every 2 weeks, p=0·0063) in FEV1 compared with placebo were observed at week 12 with doses every 2 weeks in the 300 mg group (mean change 0·39 L [SE 0·05]; mean difference 0·21 [95% CI 0·06-0·36; p=0·0063]) and in the 200 mg group (mean change 0·43 L [SE 0·05]; mean difference 0·26 [0·11-0·40; p=0·0008]) compared with placebo (0·18 L [SE 0·05]). Similar significant increases were observed in the overall population and in the fewer than 300 eosinophils per µL subgroup (overall population: 200 mg every 2 weeks, p<0·0001; 300 mg every 2 weeks, p<0·0001; <300 eosinophils per µL: 200 mg every 2 weeks, p=0·0034; 300 mg every 2 weeks, p=0·0086), and were maintained to week 24. Likewise, dupilumab every 2 weeks produced the greatest reductions in annualised rates of exacerbation in the overall population (70-70·5%), the subgroup with at least 300 eosinophils per µL (71·2-80·7%), and the subgroup with fewer than 300 eosinophils per µL (59·9-67·6%). The most common adverse events with dupilumab compared with placebo were upper respiratory tract infections (33-41% vs 35%) and injection-site reactions (13-26% vs 13%). INTERPRETATION: Dupilumab increased lung function and reduced severe exacerbations in patients with uncontrolled persistent asthma irrespective of baseline eosinophil count and had a favourable safety profile, and hence in addition to inhaled corticosteroids plus long-acting ß2-agonist therapy could improve the lives of patients with uncontrolled persistent asthma compared with standard therapy alone. FUNDING: Sanofi-Genzyme and Regeneron Pharmaceuticals.
[Mh] Termos MeSH primário: Antiasmáticos/administração & dosagem
Anticorpos Monoclonais/administração & dosagem
Asma/tratamento farmacológico
[Mh] Termos MeSH secundário: Administração por Inalação
Adulto
Antiasmáticos/uso terapêutico
Asma/fisiopatologia
Testes Respiratórios
Combinação Budesonida e Fumarato de Formoterol/uso terapêutico
Progressão da Doença
Método Duplo-Cego
Quimioterapia Combinada
Feminino
Combinação Fluticasona-Salmeterol/uso terapêutico
Volume Expiratório Forçado
Seres Humanos
Injeções Subcutâneas
Masculino
Meia-Idade
Combinação Furoato de Mometasona e Fumarato de Formoterol/uso terapêutico
Óxido Nítrico/análise
Resultado do Tratamento
[Pt] Tipo de publicação:CLINICAL TRIAL, PHASE II; JOURNAL ARTICLE; MULTICENTER STUDY; RANDOMIZED CONTROLLED TRIAL; RESEARCH SUPPORT, NON-U.S. GOV'T
[Nm] Nome de substância:
0 (Anti-Asthmatic Agents); 0 (Antibodies, Monoclonal); 0 (Budesonide, Formoterol Fumarate Drug Combination); 0 (Fluticasone-Salmeterol Drug Combination); 0 (Mometasone Furoate, Formoterol Fumarate Drug Combination); 0 (SAR231893); 31C4KY9ESH (Nitric Oxide)
[Em] Mês de entrada:1608
[Cu] Atualização por classe:171116
[Lr] Data última revisão:
171116
[Sb] Subgrupo de revista:AIM; IM
[Da] Data de entrada para processamento:160501
[Cl] Clinical Trial:ClinicalTrial
[St] Status:MEDLINE


  2 / 5 MEDLINE  
              first record previous record next record last record
seleciona
para imprimir
Fotocópia
Texto completo
[PMID]:27023685
[Au] Autor:Yip E; Karimi S; Pien LT
[Ad] Endereço:1 Primary Care Clinical Pharmacy Specialist, Kaiser Permanente Mid-Atlantic States, Upper Marlboro, Maryland.
[Ti] Título:Evaluation of a Therapeutic Interchange from Fluticasone/Salmeterol to Mometasone/Formoterol in Patients with Chronic Obstructive Pulmonary Disease.
[So] Source:J Manag Care Spec Pharm;22(4):316-23, 2016 Apr.
[Is] ISSN:2376-1032
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:BACKGROUND: Combination treatment with an inhaled corticosteroid and long-acting beta2-agonist is among the many treatment options for chronic obstructive pulmonary disease (COPD) that has been shown to improve clinical outcomes. While mometasone/formoterol does not currently have an FDA-approved indication for COPD, evidence from 2 phase 3 trials demonstrated that mometasone/formoterol can improve lung function and was well tolerated in patients with moderate-to-very severe COPD. Based on these data, a therapeutic interchange was implemented in the Kaiser Permanente Mid-Atlantic States region to convert patients with a COPD diagnosis from fluticasone/salmeterol to mometasone/formoterol. OBJECTIVE: To evaluate the impact of a therapeutic interchange from fluticasone/salmeterol to mometasone/formoterol on health outcomes in patients with COPD in a large ambulatory and managed care setting. METHODS: The investigators retrospectively reviewed the electronic medical records of patients with a COPD diagnosis who had a prescription for fluticasone/salmeterol converted to mometasone/formoterol between March 6, 2011, to March 6, 2013. Kaiser Permanente's Pharmacy and Therapeutics Committee provided recommended equivalent doses for conversion from fluticasone/salmeterol to mometasone/formoterol. Nonetheless, the final approval for the change in medication and selection of the dose was left to each physician's clinical judgment. Patients were excluded if they were (a) prescribed fluticasone/salmeterol 100/50 mcg, which has no equivalent mometasone/formoterol dose; (b) less than aged 18 years; or (c) prescribed fluticasone/salmeterol for a duration of less than 6 months preconversion to mometasone/formoterol. In addition, patients who left the Kaiser Permanente network or became deceased during the study period of interest were excluded. After the application of the inclusion and exclusion criteria, 521 patients were included in the data analysis. The primary endpoint was the determination of the difference in the occurrence of COPD exacerbations 6 months pre- and postconversion from fluticasone/salmeterol to mometasone/formoterol. COPD exacerbations were defined by the diagnosis or documentation of a COPD exacerbation during any hospitalizations, urgent care (UC)/emergency department (ED) visits, or clinic encounters. Secondary outcomes included the determination of the difference in the occurrence of intensive care unit admissions, hospitalizations, UC/ED visits, and clinic encounters for COPD exacerbations 6 months pre- and postconversion; number of patients who required modification in therapy; and any reasons for mometasone/for-moterol discontinuation postconversion. Patients served as their own controls to compare any differences in outcomes while taking mometasone/formoterol versus fluticasone/salmeterol. RESULTS: Within our patient population, 34.2% (n = 178) of patients experienced at least 1 COPD exacerbation while prescribed fluticasone/salmeterol compared with 28.6% (n = 149) of patients while prescribed mometasone/formoterol (P = 0.030). Mometasone/formoterol therapy did not demonstrate any statistically significant differences in the secondary outcomes (P < 0.050). A later subgroup analysis of the primary outcome revealed that factors associated with a statistically significant decrease in the occurrence of COPD exacerbations were male sex (P = 0.023), comorbid asthma (P = 0.026), and conversion from fluticasone/salmeterol to a more potent dose of mometasone/formoterol (P = 0.014). CONCLUSIONS: There was a statistically significant decrease in the proportion of patients who experienced COPD exacerbations postconversion from fluticasone/salmeterol to mometasone/formoterol. This study is an example of a real-world therapeutic interchange that provides additional data to support the use of mometasone/formoterol for its unlabeled COPD indication. DISCLOSURES: No outside funding supported this study. The authors report no financial or other conflicts of interest related to the subject of this article. All authors contributed to study design and manuscript revision. Yip collected and analyzed data and prepared the manuscript.
[Mh] Termos MeSH primário: Broncodilatadores/uso terapêutico
Combinação Fluticasona-Salmeterol/uso terapêutico
Combinação Furoato de Mometasona e Fumarato de Formoterol/uso terapêutico
Doença Pulmonar Obstrutiva Crônica/tratamento farmacológico
[Mh] Termos MeSH secundário: Idoso
Assistência Ambulatorial
Broncodilatadores/administração & dosagem
Estudos de Coortes
Substituição de Medicamentos
Feminino
Combinação Fluticasona-Salmeterol/administração & dosagem
Hospitalização/estatística & dados numéricos
Seres Humanos
Masculino
Programas de Assistência Gerenciada
Meia-Idade
Combinação Furoato de Mometasona e Fumarato de Formoterol/administração & dosagem
Estudos Retrospectivos
Resultado do Tratamento
[Pt] Tipo de publicação:COMPARATIVE STUDY; JOURNAL ARTICLE
[Nm] Nome de substância:
0 (Bronchodilator Agents); 0 (Fluticasone-Salmeterol Drug Combination); 0 (Mometasone Furoate, Formoterol Fumarate Drug Combination)
[Em] Mês de entrada:1701
[Cu] Atualização por classe:171116
[Lr] Data última revisão:
171116
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:160330
[St] Status:MEDLINE
[do] DOI:10.18553/jmcp.2016.22.4.316


  3 / 5 MEDLINE  
              first record previous record next record last record
seleciona
para imprimir
Fotocópia
Registro de Ensaios Clínicos
Texto completo
[PMID]:22292600
[Au] Autor:Gross NJ
[Ad] Endereço:St. Francis Hospital, Hartford, CT, USA.
[Ti] Título:The COPD Pipeline XIV.
[So] Source:COPD;9(1):81-3, 2012 Feb.
[Is] ISSN:1541-2563
[Cp] País de publicação:England
[La] Idioma:eng
[Mh] Termos MeSH primário: Doença Pulmonar Obstrutiva Crônica/tratamento farmacológico
[Mh] Termos MeSH secundário: Ensaios Clínicos como Assunto
Combinação de Medicamentos
Etanolaminas/uso terapêutico
Circulação Extracorpórea/instrumentação
Inativação Gênica
Seres Humanos
Isoquinolinas/uso terapêutico
Combinação Furoato de Mometasona e Fumarato de Formoterol
Inibidores de Fosfodiesterase/uso terapêutico
Pregnadienodiois/uso terapêutico
Pirimidinonas/uso terapêutico
RNA Interferente Pequeno/uso terapêutico
Receptores CCR2/antagonistas & inibidores
Produtos para o Abandono do Uso de Tabaco
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Nm] Nome de substância:
0 (9,10-dimethoxy-2-(2,4,6-trimethylphenylimino)-3-(N-carbamoyl-2-aminoethyl)-3,4,6,7-tetrahydro-2H-pyrimidino(6,1-a)isoquinolin-4-one); 0 (Drug Combinations); 0 (Ethanolamines); 0 (Isoquinolines); 0 (Mometasone Furoate, Formoterol Fumarate Drug Combination); 0 (Phosphodiesterase Inhibitors); 0 (Pregnadienediols); 0 (Pyrimidinones); 0 (RNA, Small Interfering); 0 (Receptors, CCR2)
[Em] Mês de entrada:1206
[Cu] Atualização por classe:151119
[Lr] Data última revisão:
151119
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:120202
[Cl] Clinical Trial:ClinicalTrial
[St] Status:MEDLINE
[do] DOI:10.3109/15412555.2012.646587


  4 / 5 MEDLINE  
              first record previous record next record last record
seleciona
para imprimir
Fotocópia
Texto completo
[PMID]:21726121
[Au] Autor:LaForce C; Weinstein C; Nathan RA; Weinstein SF; Staudinger H; Meltzer EO
[Ad] Endereço:Department of Pediatrics, University of North Carolina School of Medicine, North Carolina Clinical Research, Raleigh, NC, USA. claforce@nccr.com
[Ti] Título:Patient satisfaction with a pressurized metered-dose inhaler with an integrated dose counter containing a fixed-dose mometasone furoate/formoterol combination.
[So] Source:J Asthma;48(6):625-31, 2011 Aug.
[Is] ISSN:1532-4303
[Cp] País de publicação:England
[La] Idioma:eng
[Ab] Resumo:INTRODUCTION: Inhaled delivery devices that are easy to use and facilitate dose tracking may lead to improved patient satisfaction and adherence. Patient satisfaction with a metered-dose inhaler (MDI) with an integrated dose counter containing a fixed-dose mometasone furoate/formoterol combination (MF/F MDI dose counter) was evaluated in subjects with persistent asthma or chronic obstructive pulmonary disease. METHODS: In this multicenter study (N = 272, age range: 12-92 years), subject experience and satisfaction with MDI devices was evaluated using baseline and poststudy surveys. Subjects responded to the baseline survey based on their previous MDI experience, then received MF/F MDI 100/10 µg with the integrated dose counter for 4 weeks before completing the poststudy survey. This evaluation was part of a broader study objective to assess performance of the MF/F MDI dose counter. RESULTS: At baseline, 52% of subjects reported being extremely satisfied with their previous MDI. After using the MF/F MDI dose counter, a relative increase of 43% in overall satisfaction was observed. Approximately 90% of subjects agreed the MF/F dose counter helped them track doses and was easy to use; >80% agreed the inhaler was of good quality and well designed. Subjects agreed the dose counter relieved anxiety about running out of medication (68%) or taking a subtherapeutic dose (65%). Nearly 80% of subjects had no reservations about the MF/F MDI dose counter, and most subjects stated they would request it from their physician (66%) and recommend it to a friend (75%). CONCLUSIONS: The MF/F MDI dose counter was found to be easy to use and have overall high patient satisfaction.
[Mh] Termos MeSH primário: Asma/tratamento farmacológico
Etanolaminas/administração & dosagem
Inaladores Dosimetrados
Satisfação do Paciente/estatística & dados numéricos
Pregnadienodiois/administração & dosagem
Doença Pulmonar Obstrutiva Crônica/tratamento farmacológico
[Mh] Termos MeSH secundário: Adolescente
Adulto
Idoso
Idoso de 80 Anos ou mais
Criança
Compreensão
Combinação de Medicamentos
Quimioterapia Combinada
Ergonomia/estatística & dados numéricos
Etanolaminas/uso terapêutico
Feminino
Fumarato de Formoterol
Seres Humanos
Masculino
Meia-Idade
Furoato de Mometasona
Combinação Furoato de Mometasona e Fumarato de Formoterol
Pregnadienodiois/uso terapêutico
Inquéritos e Questionários
Adulto Jovem
[Pt] Tipo de publicação:CLINICAL TRIAL, PHASE III; JOURNAL ARTICLE; MULTICENTER STUDY; RESEARCH SUPPORT, NON-U.S. GOV'T
[Nm] Nome de substância:
0 (Drug Combinations); 0 (Ethanolamines); 0 (Mometasone Furoate, Formoterol Fumarate Drug Combination); 0 (Pregnadienediols); 04201GDN4R (Mometasone Furoate); W34SHF8J2K (Formoterol Fumarate)
[Em] Mês de entrada:1109
[Cu] Atualização por classe:171116
[Lr] Data última revisão:
171116
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:110706
[St] Status:MEDLINE
[do] DOI:10.3109/02770903.2011.587579


  5 / 5 MEDLINE  
              first record previous record
seleciona
para imprimir
Fotocópia
[PMID]:21045758
[Ti] Título:Mometasone/Formoterol (dulera) for asthma.
[So] Source:Med Lett Drugs Ther;52(1349):83-4, 2010 Oct 18.
[Is] ISSN:1523-2859
[Cp] País de publicação:United States
[La] Idioma:eng
[Mh] Termos MeSH primário: Corticosteroides/uso terapêutico
Agonistas de Receptores Adrenérgicos beta 2/uso terapêutico
Antiasmáticos/uso terapêutico
Asma/tratamento farmacológico
Etanolaminas/uso terapêutico
Pregnadienodiois/uso terapêutico
[Mh] Termos MeSH secundário: Administração por Inalação
Adolescente
Corticosteroides/administração & dosagem
Corticosteroides/efeitos adversos
Corticosteroides/economia
Agonistas de Receptores Adrenérgicos beta 2/administração & dosagem
Agonistas de Receptores Adrenérgicos beta 2/efeitos adversos
Agonistas de Receptores Adrenérgicos beta 2/economia
Adulto
Antiasmáticos/administração & dosagem
Antiasmáticos/efeitos adversos
Antiasmáticos/economia
Criança
Pré-Escolar
Combinação de Medicamentos
Custos de Medicamentos
Interações Medicamentosas
Etanolaminas/administração & dosagem
Etanolaminas/efeitos adversos
Etanolaminas/economia
Fumarato de Formoterol
Seres Humanos
Inaladores Dosimetrados
Furoato de Mometasona
Combinação Furoato de Mometasona e Fumarato de Formoterol
Pregnadienodiois/administração & dosagem
Pregnadienodiois/efeitos adversos
Pregnadienodiois/economia
Resultado do Tratamento
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Nm] Nome de substância:
0 (Adrenal Cortex Hormones); 0 (Adrenergic beta-2 Receptor Agonists); 0 (Anti-Asthmatic Agents); 0 (Drug Combinations); 0 (Ethanolamines); 0 (Mometasone Furoate, Formoterol Fumarate Drug Combination); 0 (Pregnadienediols); 04201GDN4R (Mometasone Furoate); W34SHF8J2K (Formoterol Fumarate)
[Em] Mês de entrada:1012
[Cu] Atualização por classe:151119
[Lr] Data última revisão:
151119
[Sb] Subgrupo de revista:AIM; IM
[Da] Data de entrada para processamento:101104
[St] Status:MEDLINE



página 1 de 1
   


Refinar a pesquisa
  Base de dados : MEDLINE Formulário avançado   

    Pesquisar no campo  
1  
2
3
 
           



Search engine: iAH v2.6 powered by WWWISIS

BIREME/OPAS/OMS - Centro Latino-Americano e do Caribe de Informação em Ciências da Saúde