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[PMID]:28278391
[Au] Autor:Roche N; Chapman KR; Vogelmeier CF; Herth FJF; Thach C; Fogel R; Olsson P; Patalano F; Banerji D; Wedzicha JA
[Ad] Endereço:1 Service de Pneumologie AP-HP, University Paris Descartes (EA2511), Paris, France.
[Ti] Título:Blood Eosinophils and Response to Maintenance Chronic Obstructive Pulmonary Disease Treatment. Data from the FLAME Trial.
[So] Source:Am J Respir Crit Care Med;195(9):1189-1197, 2017 May 01.
[Is] ISSN:1535-4970
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:RATIONALE: Post hoc analyses suggest that blood eosinophils have potential as a predictive biomarker of inhaled corticosteroid efficacy in the management of chronic obstructive pulmonary disease (COPD). OBJECTIVES: We prospectively investigated the value of blood eosinophils as a predictor of responsiveness to an inhaled corticosteroid/long-acting ß -agonist combination versus a long-acting ß -agonist/long-acting muscarinic antagonist combination for exacerbation prevention. METHODS: We conducted prespecified analyses of data from the FLAME (Effect of Indacaterol Glycopyronium vs Fluticasone Salmeterol on COPD Exacerbations) study, which compared once-daily long-acting ß -agonist/long-acting muscarinic antagonist indacaterol/glycopyrronium 110/50 µg with twice-daily long-acting ß -agonist/inhaled corticosteroid salmeterol/fluticasone combination 50/500 µg in patients with one or more exacerbations in the preceding year. Subsequent post hoc analyses were conducted to address further cutoffs and endpoints. MEASUREMENTS AND MAIN RESULTS: We compared treatment efficacy according to blood eosinophil percentage (<2% and ≥2%, <3% and ≥3%, and <5% and ≥5%) and absolute blood eosinophil count (<150 cells/µl, 150 to <300 cells/µl, and ≥300 cells/µl). Indacaterol/glycopyrronium was significantly superior to salmeterol/fluticasone for the prevention of exacerbations (all severities, or moderate or severe) in the <2%, ≥2%, <3%, <5%, and <150 cells/µl subgroups, and at no cutoff was salmeterol/fluticasone superior to indacaterol/glycopyrronium. Furthermore, the rate of moderate or severe exacerbations did not increase with increasing blood eosinophils. The incidence of pneumonia was higher in patients receiving salmeterol/fluticasone than indacaterol/glycopyrronium in both the <2% and ≥2% subgroups. CONCLUSIONS: Our prospective analyses indicate that indacaterol/glycopyrronium provides superior or similar benefits over salmeterol/fluticasone regardless of blood eosinophil levels in patients with COPD. Clinical trial registered with www.clinicaltrials.gov (NCT01782326).
[Mh] Termos MeSH primário: Eosinófilos
Doença Pulmonar Obstrutiva Crônica/sangue
[Mh] Termos MeSH secundário: Corticosteroides/administração & dosagem
Corticosteroides/uso terapêutico
Agonistas de Receptores Adrenérgicos beta 2/administração & dosagem
Agonistas de Receptores Adrenérgicos beta 2/uso terapêutico
Idoso
Biomarcadores/sangue
Método Duplo-Cego
Quimioterapia Combinada
Eosinófilos/efeitos dos fármacos
Feminino
Combinação Fluticasona-Salmeterol/uso terapêutico
Seres Humanos
Indanos/uso terapêutico
Contagem de Leucócitos
Masculino
Meia-Idade
Doença Pulmonar Obstrutiva Crônica/tratamento farmacológico
Quinolonas/uso terapêutico
Resultado do Tratamento
[Pt] Tipo de publicação:JOURNAL ARTICLE; MULTICENTER STUDY; RANDOMIZED CONTROLLED TRIAL
[Nm] Nome de substância:
0 (Adrenal Cortex Hormones); 0 (Adrenergic beta-2 Receptor Agonists); 0 (Biomarkers); 0 (Fluticasone-Salmeterol Drug Combination); 0 (Indans); 0 (Quinolones); 8OR09251MQ (indacaterol)
[Em] Mês de entrada:1707
[Cu] Atualização por classe:171116
[Lr] Data última revisão:
171116
[Sb] Subgrupo de revista:AIM; IM
[Da] Data de entrada para processamento:170310
[St] Status:MEDLINE
[do] DOI:10.1164/rccm.201701-0193OC


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[PMID]:28176893
[Au] Autor:Wedzicha JA; Zhong N; Ichinose M; Humphries M; Fogel R; Thach C; Patalano F; Banerji D
[Ad] Endereço:National Heart and Lung Institute, Imperial College London, London, UK.
[Ti] Título:Indacaterol/glycopyrronium versus salmeterol/fluticasone in Asian patients with COPD at a high risk of exacerbations: results from the FLAME study.
[So] Source:Int J Chron Obstruct Pulmon Dis;12:339-349, 2017.
[Is] ISSN:1178-2005
[Cp] País de publicação:New Zealand
[La] Idioma:eng
[Ab] Resumo:BACKGROUND: The FLAME study demonstrated that indacaterol/glycopyrronium (IND/GLY), the fixed-dose combination of a long-acting ß -agonist (LABA, IND) and a long-acting muscarinic antagonist (LAMA, GLY), was superior to salmeterol/fluticasone combination (SFC) in preventing exacerbations in COPD patients with a high risk of exacerbations. In this study, we report a prespecified analysis of the efficacy and safety of IND/GLY versus SFC in Asian patients from the FLAME study. PATIENTS AND METHODS: Patients from Asian centers with moderate-to-very severe COPD and ≥1 exacerbation in the previous year from the 52-week, randomized FLAME study were included. IND/GLY was compared versus SFC for effects on exacerbations, lung function (forced expiratory volume in 1 second [FEV ] and forced vital capacity [FVC]), health status (St George's Respiratory Questionnaire [SGRQ]), rescue medication use, and safety. RESULTS: A total of 510 Asian patients (IND/GLY, n=250 or SFC, n=260) were included. Compared to the overall FLAME population, the Asian cohort had more males, a shorter duration of COPD, fewer patients using inhaled corticosteroid (ICS) at screening, fewer current smokers, and more patients with very severe COPD. IND/GLY significantly reduced the rate of moderate/severe exacerbations (rate ratio: 0.75; 95% confidence interval: 0.58-0.97; =0.027) and prolonged time to first moderate/severe exacerbation versus SFC (hazard ratio: 0.77; 95% confidence interval: 0.59-1.01; =0.055). Predose trough FEV and FVC significantly improved in Asian patients ( <0.001). IND/GLY improved SGRQ for COPD (SGRQ-C score; =0.006) and reduced rescue medication use ( =0.058) at week 52. Pneumonia incidence was 3.6% with IND/GLY and 7.7% with SFC ( =0.046). CONCLUSION: In exacerbating Asian COPD patients, IND/GLY was more effective than SFC.
[Mh] Termos MeSH primário: Agonistas de Receptores Adrenérgicos beta 2/administração & dosagem
Grupo com Ancestrais do Continente Asiático
Broncodilatadores/administração & dosagem
Combinação Fluticasona-Salmeterol/administração & dosagem
Glicopirrolato/administração & dosagem
Indanos/administração & dosagem
Pulmão/efeitos dos fármacos
Antagonistas Muscarínicos/administração & dosagem
Doença Pulmonar Obstrutiva Crônica/tratamento farmacológico
Quinolonas/administração & dosagem
[Mh] Termos MeSH secundário: Agonistas de Receptores Adrenérgicos beta 2/efeitos adversos
Idoso
Ásia/epidemiologia
Broncodilatadores/efeitos adversos
Progressão da Doença
Método Duplo-Cego
Feminino
Combinação Fluticasona-Salmeterol/efeitos adversos
Volume Expiratório Forçado
Glicopirrolato/efeitos adversos
Nível de Saúde
Seres Humanos
Indanos/efeitos adversos
Pulmão/fisiopatologia
Masculino
Meia-Idade
Antagonistas Muscarínicos/efeitos adversos
Doença Pulmonar Obstrutiva Crônica/diagnóstico
Doença Pulmonar Obstrutiva Crônica/etnologia
Doença Pulmonar Obstrutiva Crônica/fisiopatologia
Quinolonas/efeitos adversos
Recuperação de Função Fisiológica
Inquéritos e Questionários
Fatores de Tempo
Resultado do Tratamento
Capacidade Vital
[Pt] Tipo de publicação:COMPARATIVE STUDY; JOURNAL ARTICLE; MULTICENTER STUDY; RANDOMIZED CONTROLLED TRIAL
[Nm] Nome de substância:
0 (Adrenergic beta-2 Receptor Agonists); 0 (Bronchodilator Agents); 0 (Fluticasone-Salmeterol Drug Combination); 0 (Indans); 0 (Muscarinic Antagonists); 0 (Quinolones); 8OR09251MQ (indacaterol); V92SO9WP2I (Glycopyrrolate)
[Em] Mês de entrada:1710
[Cu] Atualização por classe:171116
[Lr] Data última revisão:
171116
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:170209
[St] Status:MEDLINE
[do] DOI:10.2147/COPD.S125058


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[PMID]:28115223
[Au] Autor:Chan R; Sousa AR; Hynds P; Homayoun-Valiani F; Edwards D; Tabberer M
[Ad] Endereço:GlaxoSmithKline, Stockley Park, Uxbridge, UK. Electronic address: robert.h.chan@gsk.com.
[Ti] Título:Assessment of the efficacy and safety of fluticasone propionate and salmeterol delivered as a combination dry powder via a capsule-based inhaler versus a multi-dose inhaler in patients with chronic obstructive pulmonary disease.
[So] Source:Pulm Pharmacol Ther;43:12-19, 2017 Apr.
[Is] ISSN:1522-9629
[Cp] País de publicação:England
[La] Idioma:eng
[Ab] Resumo:BACKGROUND: This study tested the clinical non-inferiority of the fluticasone propionate/salmeterol combination 50/250 µg (FSC) Rotacaps /Rotahaler system, a single unit dose inhaler, with the multi-dose FSC Diskus inhaler in adults with chronic obstructive pulmonary disease (COPD). METHODS: This multi-centre, randomised, double-blind, double-dummy, two-way cross-over study compared 12 weeks' treatment of FSC administered twice daily using Rotacaps/Rotahaler or Diskus. The primary endpoint was change from baseline in trough morning forced expiratory volume in 1 s (FEV ) at Day 85, and the pre-defined non-inferiority criteria was: the lower limit of the confidence interval (CI) for the treatment difference (Rotacaps/Rotahaler-Diskus) in least squares (LS) mean change from baseline, being greater than -45 mL. Secondary endpoints included change in breathlessness (as measured by transition dyspnoea index (TDI)) and COPD-specific health status measures. RESULTS: The LS mean increase from baseline in trough FEV at Day 85 was 116 mL in the Rotacaps/Rotahaler group and 91 mL in the Diskus group (difference in model-adjusted LS mean change: 25 mL (95% CI 2 mL, 47 mL)), the lower limit of the CI for the treatment difference being greater than the protocol-defined criterion for non-inferiority i.e. -45 mL. Data for breathlessness, COPD-specific health status and safety parameters were similar following FSC treatment via either inhaler. CONCLUSIONS: This study demonstrated the clinical non-inferiority of FSC 50/250 µg when administered using Rotacaps/Rotahaler compared with Diskus in patients with COPD. The risk:benefit profile for the two inhalers was comparable.
[Mh] Termos MeSH primário: Broncodilatadores/administração & dosagem
Combinação Fluticasona-Salmeterol/administração & dosagem
Doença Pulmonar Obstrutiva Crônica/tratamento farmacológico
[Mh] Termos MeSH secundário: Adulto
Idoso
Idoso de 80 Anos ou mais
Estudos Cross-Over
Método Duplo-Cego
Feminino
Combinação Fluticasona-Salmeterol/efeitos adversos
Volume Expiratório Forçado
Seres Humanos
Masculino
Meia-Idade
Nebulizadores e Vaporizadores
Doença Pulmonar Obstrutiva Crônica/fisiopatologia
[Pt] Tipo de publicação:COMPARATIVE STUDY; JOURNAL ARTICLE; MULTICENTER STUDY; RANDOMIZED CONTROLLED TRIAL
[Nm] Nome de substância:
0 (Bronchodilator Agents); 0 (Fluticasone-Salmeterol Drug Combination)
[Em] Mês de entrada:1711
[Cu] Atualização por classe:171116
[Lr] Data última revisão:
171116
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:170125
[St] Status:MEDLINE


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[PMID]:27879191
[Au] Autor:Kobayashi Y; Asako M; Yamamoto T; Yasuba H; Tomoda K; Kanda A
[Ti] Título:Replacement of SFC-DPI with SFC-MDI exhaled through the nose improves eosinophilic chronic rhinosinusitis in patients with bronchial asthma.
[So] Source:Int J Clin Pharmacol Ther;55(1):89-94, 2017 Jan.
[Is] ISSN:0946-1965
[Cp] País de publicação:Germany
[La] Idioma:eng
[Ab] Resumo:OBJECTIVE: Eosinophilic chronic rhinosinusitis (ECRS), a subgroup of chronic rhinosinusitis with nasal polyps, is a refractory disease closely associated with bronchial asthma. We recently reported on the efficacy of ultra-fine particle inhaled corticosteroids (ICS) (hydrofluoroalkane-134a-beclomethasone dipropionate: HFA-BDP) exhalation through the nose (ETN) treatment for mild-to-moderate asthmatics with ECRS. However, the effect of HFA-BDP ETN was found to be transient in some cases with severe ECRS and asthma, requiring treatment with higher-dose ICS and long-acting ß2-agonists (LABA). Here, we present a case of refractory ECRS with severe asthma treated with a combination of high-dose ICS and LABA ETN, and we discuss the mechanisms for its effectiveness. METHODS: A 57-year-old man was treated with the combined regimen of HFA-BDP ETN and salmeterol/fluticasone combination (SFC) dry powder inhaler (DPI) for his refractory ECRS with severe asthma. For better control, we replaced SFC-DPI with SFC metered-dose inhaler (MDI) ETN and evaluated the clinical effect and corticosteroid sensitivity. We also examined the flow and deposition of fine particles released by SFC-MDI ETN. RESULTS: After switching to SFC-MDI ETN, the patient's conditions markedly resolved with the restoration of corticosteroid sensitivity and PP2A activity. The fine particles released by SFC-MDI ETN at least partially flowed out through the external nares and seemed to be deposited on the ethmoid sinus. CONCLUSION: Fine particle ICS/LABA ETN might be an additional therapeutic option for refractory ECRS with severe asthma and corticosteroid insensitivity.
.
[Mh] Termos MeSH primário: Asma/tratamento farmacológico
Eosinofilia/tratamento farmacológico
Combinação Fluticasona-Salmeterol/administração & dosagem
Rinite/tratamento farmacológico
Sinusite/tratamento farmacológico
[Mh] Termos MeSH secundário: Asma/complicações
Asma/diagnóstico
Doença Crônica
Inaladores de Pó Seco
Eosinofilia/complicações
Combinação Fluticasona-Salmeterol/uso terapêutico
Seres Humanos
Masculino
Inaladores Dosimetrados
Meia-Idade
Tamanho da Partícula
Rinite/complicações
Índice de Gravidade de Doença
Sinusite/complicações
Resultado do Tratamento
[Pt] Tipo de publicação:CASE REPORTS; JOURNAL ARTICLE
[Nm] Nome de substância:
0 (Fluticasone-Salmeterol Drug Combination)
[Em] Mês de entrada:1711
[Cu] Atualização por classe:171116
[Lr] Data última revisão:
171116
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:161124
[St] Status:MEDLINE
[do] DOI:10.5414/CP202633


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[PMID]:27727445
[Au] Autor:Burmeister Getz E; Carroll KJ; Mielke J; Benet LZ; Jones B
[Ad] Endereço:Oriel Therapeutics, Inc, Berkeley, California, USA.
[Ti] Título:Between-Batch Pharmacokinetic Variability Inflates Type I Error Rate in Conventional Bioequivalence Trials: A Randomized Advair Diskus Clinical Trial.
[So] Source:Clin Pharmacol Ther;101(3):331-340, 2017 Mar.
[Is] ISSN:1532-6535
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:We previously demonstrated pharmacokinetic differences among manufacturing batches of a US Food and Drug Administration (FDA)-approved dry powder inhalation product (Advair Diskus 100/50) large enough to establish between-batch bio-inequivalence. Here, we provide independent confirmation of pharmacokinetic bio-inequivalence among Advair Diskus 100/50 batches, and quantify residual and between-batch variance component magnitudes. These variance estimates are used to consider the type I error rate of the FDA's current two-way crossover design recommendation. When between-batch pharmacokinetic variability is substantial, the conventional two-way crossover design cannot accomplish the objectives of FDA's statistical bioequivalence test (i.e., cannot accurately estimate the test/reference ratio and associated confidence interval). The two-way crossover, which ignores between-batch pharmacokinetic variability, yields an artificially narrow confidence interval on the product comparison. The unavoidable consequence is type I error rate inflation, to ∼25%, when between-batch pharmacokinetic variability is nonzero. This risk of a false bioequivalence conclusion is substantially higher than asserted by regulators as acceptable consumer risk (5%).
[Mh] Termos MeSH primário: Broncodilatadores/farmacocinética
Combinação Fluticasona-Salmeterol/farmacocinética
Projetos de Pesquisa/normas
United States Food and Drug Administration/legislação & jurisprudência
[Mh] Termos MeSH secundário: Adulto
Área Sob a Curva
Estudos Cross-Over
Feminino
Meia-Vida
Voluntários Saudáveis
Seres Humanos
Masculino
Taxa de Depuração Metabólica
Meia-Idade
Reprodutibilidade dos Testes
Equivalência Terapêutica
Estados Unidos
[Pt] Tipo de publicação:JOURNAL ARTICLE; RANDOMIZED CONTROLLED TRIAL
[Nm] Nome de substância:
0 (Bronchodilator Agents); 0 (Fluticasone-Salmeterol Drug Combination)
[Em] Mês de entrada:1705
[Cu] Atualização por classe:171116
[Lr] Data última revisão:
171116
[Sb] Subgrupo de revista:AIM; IM
[Da] Data de entrada para processamento:161012
[St] Status:MEDLINE
[do] DOI:10.1002/cpt.535


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[PMID]:28008244
[Au] Autor:Vogelmeier C; Zhong N; Humphries MJ; Mezzi K; Fogel R; Bader G; Patalano F; Banerji D
[Ad] Endereço:Department of Medicine, Pulmonary and Critical Care Medicine, University Medical Center Giessen and Marburg, Philipps-University Marburg, Member of the German Center for Lung Research (DZL), Marburg, Germany.
[Ti] Título:Indacaterol/glycopyrronium in symptomatic patients with COPD (GOLD B and GOLD D) versus salmeterol/fluticasone: ILLUMINATE/LANTERN pooled analysis.
[So] Source:Int J Chron Obstruct Pulmon Dis;11:3189-3197, 2016.
[Is] ISSN:1178-2005
[Cp] País de publicação:New Zealand
[La] Idioma:eng
[Ab] Resumo:BACKGROUND: Indacaterol/glycopyrronium (IND/GLY) is approved for maintenance treatment of adult patients with COPD. This post hoc analysis explored the efficacy and safety of IND/GLY versus salmeterol/fluticasone (SFC) in symptomatic (Global Initiative for Chronic Obstructive Lung Disease [GOLD] B and GOLD D) patients with moderate-to-severe COPD. PATIENTS AND METHODS: Data from LANTERN and ILLUMINATE studies were pooled and analyzed. In both studies, symptomatic COPD patients were randomized to once-daily IND/GLY 110 µg/50 µg or twice-daily SFC 50 µg/500 µg. End points were pre-dose trough forced expiratory volume in one second (FEV ), standardized area under the curve for FEV from 0 to 12 hours (FEV AUC hours), peak FEV , peak forced vital capacity (FVC), pre-dose trough FVC, Transition Dyspnea Index (TDI) total score, St George's Respiratory Questionnaire total score, rescue medication use and safety. RESULTS: A total of 1,263 patients were classified as either GOLD B (n=809) or GOLD D (n=454). At week 26, IND/GLY demonstrated statistically significant improvement in all lung function parameters versus SFC in patients in both the GOLD B and GOLD D subgroups. TDI total score and rescue medication use were significantly improved with IND/GLY versus SFC in the overall population and in the GOLD B (TDI total score only) and GOLD D (rescue medication only) subgroups. IND/GLY also reduced the rate of exacerbations in the pooled population. Overall safety profile was comparable with a higher incidence of pneumonia in the SFC-treated group. CONCLUSION: In this pooled analysis, IND/GLY demonstrated superior efficacy compared with SFC in patients in the GOLD B and GOLD D subgroups and supported its use in symptomatic COPD patients.
[Mh] Termos MeSH primário: Agonistas de Receptores Adrenérgicos beta 2/administração & dosagem
Broncodilatadores/administração & dosagem
Combinação Fluticasona-Salmeterol/administração & dosagem
Glicopirrolato/administração & dosagem
Indanos/administração & dosagem
Pulmão/efeitos dos fármacos
Antagonistas Muscarínicos/administração & dosagem
Doença Pulmonar Obstrutiva Crônica/tratamento farmacológico
Quinolonas/administração & dosagem
[Mh] Termos MeSH secundário: Agonistas de Receptores Adrenérgicos beta 2/efeitos adversos
Idoso
Broncodilatadores/efeitos adversos
Ensaios Clínicos Fase III como Assunto
Feminino
Combinação Fluticasona-Salmeterol/efeitos adversos
Volume Expiratório Forçado
Glicopirrolato/efeitos adversos
Seres Humanos
Indanos/efeitos adversos
Pulmão/fisiopatologia
Masculino
Meia-Idade
Antagonistas Muscarínicos/efeitos adversos
Doença Pulmonar Obstrutiva Crônica/complicações
Doença Pulmonar Obstrutiva Crônica/diagnóstico
Doença Pulmonar Obstrutiva Crônica/fisiopatologia
Quinolonas/efeitos adversos
Ensaios Clínicos Controlados Aleatórios como Assunto
Recuperação de Função Fisiológica
Índice de Gravidade de Doença
Espirometria
Inquéritos e Questionários
Fatores de Tempo
Resultado do Tratamento
Capacidade Vital
[Pt] Tipo de publicação:COMPARATIVE STUDY; JOURNAL ARTICLE
[Nm] Nome de substância:
0 (Adrenergic beta-2 Receptor Agonists); 0 (Bronchodilator Agents); 0 (Fluticasone-Salmeterol Drug Combination); 0 (Indans); 0 (Muscarinic Antagonists); 0 (Quinolones); 8OR09251MQ (indacaterol); V92SO9WP2I (Glycopyrrolate)
[Em] Mês de entrada:1708
[Cu] Atualização por classe:171116
[Lr] Data última revisão:
171116
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:161224
[St] Status:MEDLINE
[do] DOI:10.2147/COPD.S116786


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[PMID]:27877031
[Au] Autor:Wang CY; Lai CC; Yang WC; Lin CC; Chen L; Wang HC; Yu CJ
[Ad] Endereço:Department of Internal Medicine; Medical Research Center, Cardinal Tien Hospital, Fu Jen Catholic University College of Medicine, New Taipei City.
[Ti] Título:The association between inhaled corticosteroid and pneumonia in COPD patients: the improvement of patients' life quality with COPD in Taiwan (IMPACT) study.
[So] Source:Int J Chron Obstruct Pulmon Dis;11:2775-2783, 2016.
[Is] ISSN:1178-2005
[Cp] País de publicação:New Zealand
[La] Idioma:eng
[Ab] Resumo:To investigate the association between inhaled corticosteroid (ICS) exposure patterns and the risk of pneumonia in chronic obstructive pulmonary disease (COPD) patients, we performed a nested case-control study. Between 1998 and 2010, 51,739 patients, including 19,838 cases of pneumonia, were matched to 74,849 control subjects selected from a cohort of COPD patients using ICSs via risk-set sampling of the database constructed by the National Health Research Institutes of Taiwan. After adjusting for covariates, the current use of ICSs was associated with a 25% increase in the risk of pneumonia (odds ratio [OR] =1.25, 95% confidence interval [CI] =1.20-1.30), and there was an increase in the OR with increase in the average daily dosage. Additionally, users of fluticasone/salmeterol, fluticasone, and either fluticasone/salmeterol or fluticasone were more likely to be at a higher risk of pneumonia (OR =1.35, 95% CI =1.28-1.41; OR =1.22, 95% CI =1.10-1.35; and OR =1.33, 95% CI =1.27-1.39, respectively). In contrast, there were no statistically significant associations between the risk of pneumonia and the use of budesonide/formoterol, budesonide, or either budesonide/formoterol or budesonide. In conclusion, ICSs are significantly associated with an increased risk of pneumonia in COPD patients. The effect is prominent for fluticasone-containing ICSs but not for budesonide-containing ICSs.
[Mh] Termos MeSH primário: Corticosteroides/efeitos adversos
Broncodilatadores/efeitos adversos
Combinação Fluticasona-Salmeterol/efeitos adversos
Pulmão/efeitos dos fármacos
Pneumonia/induzido quimicamente
Doença Pulmonar Obstrutiva Crônica/tratamento farmacológico
Qualidade de Vida
[Mh] Termos MeSH secundário: Administração por Inalação
Corticosteroides/administração & dosagem
Idoso
Idoso de 80 Anos ou mais
Broncodilatadores/administração & dosagem
Combinação Budesonida e Fumarato de Formoterol/efeitos adversos
Estudos de Casos e Controles
Estudos Transversais
Bases de Dados Factuais
Feminino
Seres Humanos
Modelos Logísticos
Pulmão/fisiopatologia
Masculino
Meia-Idade
Razão de Chances
Pneumonia/diagnóstico
Pneumonia/fisiopatologia
Pneumonia/psicologia
Doença Pulmonar Obstrutiva Crônica/diagnóstico
Doença Pulmonar Obstrutiva Crônica/fisiopatologia
Doença Pulmonar Obstrutiva Crônica/psicologia
Medição de Risco
Fatores de Risco
Taiwan
Fatores de Tempo
Resultado do Tratamento
[Pt] Tipo de publicação:COMPARATIVE STUDY; JOURNAL ARTICLE
[Nm] Nome de substância:
0 (Adrenal Cortex Hormones); 0 (Bronchodilator Agents); 0 (Budesonide, Formoterol Fumarate Drug Combination); 0 (Fluticasone-Salmeterol Drug Combination)
[Em] Mês de entrada:1708
[Cu] Atualização por classe:171116
[Lr] Data última revisão:
171116
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:161124
[St] Status:MEDLINE


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[PMID]:27853362
[Au] Autor:Perrone V; Sangiorgi D; Buda S; Degli Esposti L
[Ad] Endereço:CliCon S.r.l. Health, Economics and Outcomes Research, Ravenna, Italy.
[Ti] Título:Comparative analysis of budesonide/formoterol and fluticasone/salmeterol combinations in COPD patients: findings from a real-world analysis in an Italian setting.
[So] Source:Int J Chron Obstruct Pulmon Dis;11:2749-2755, 2016.
[Is] ISSN:1178-2005
[Cp] País de publicação:New Zealand
[La] Idioma:eng
[Ab] Resumo:AIM: The objective of this study was to evaluate the different outcomes associated with the use of budesonide/formoterol compared to fluticasone/salmeterol in fixed combinations in patients with COPD in a "real-world" setting. The outcomes included exacerbation rates and health care costs. PATIENTS AND METHODS: An observational retrospective cohort analysis, based on administrative databases of three local health units, was conducted. Patients with at least one prescription of fixed-dose combination of inhaled corticosteroids and long-acting ß2-agonists (budesonide/formoterol or fluticasone/salmeterol), at dosages and formulations approved for COPD in Italy, between January 1, 2009 and December 31, 2011 (inclusion period), were included. Patients were followed until December 2012, death or end of treatment (follow-up period), whichever occurred first. Patients were included if they were aged ≥40 years and had at least 6 months of follow-up. Propensity score matching was performed to check for confounding effects. Number of hospitalizations for COPD and number of oral corticosteroid and antibiotic prescriptions during follow-up were analyzed using Poisson regression models. The cost analysis was conducted from the perspective of the National Health System. RESULTS: After matching, 4,680 patients were analyzed, of which 50% were males with a mean age of 64±13 years. In the Poisson regression models, the incidence rate ratio for budesonide/formoterol as compared to fluticasone/salmeterol was 0.84 (95% confidence interval [CI]: 0.74-0.96, =0.010) for number of hospitalizations, 0.89 (95% CI: 0.87-0.92, <0.001) for number of oral corticosteroid prescriptions and 0.88 (95% CI: 0.86-0.89, <0.001) for number of antibiotic prescriptions. The mean annual expenditure for COPD management was €2,436 for patients treated with budesonide/formoterol and €2,784 for patients treated with fluticasone/salmeterol. CONCLUSION: Among patients with COPD, treatment with a fixed combination of budesonide/formoterol was associated with fewer exacerbations and a lower, but not significant, cost of illness than the treatment with fluticasone/salmeterol. Real-world analyses are requested to ameliorate interventions to address unmet needs, optimizing treatment pathways to improve COPD-related burden and outcomes.
[Mh] Termos MeSH primário: Agonistas de Receptores Adrenérgicos beta 2/uso terapêutico
Broncodilatadores/uso terapêutico
Combinação Budesonida e Fumarato de Formoterol/uso terapêutico
Combinação Fluticasona-Salmeterol/uso terapêutico
Glucocorticoides/uso terapêutico
Pulmão/efeitos dos fármacos
Doença Pulmonar Obstrutiva Crônica/tratamento farmacológico
[Mh] Termos MeSH secundário: Demandas Administrativas em Assistência à Saúde
Agonistas de Receptores Adrenérgicos beta 2/efeitos adversos
Agonistas de Receptores Adrenérgicos beta 2/economia
Idoso
Broncodilatadores/efeitos adversos
Broncodilatadores/economia
Combinação Budesonida e Fumarato de Formoterol/efeitos adversos
Combinação Budesonida e Fumarato de Formoterol/economia
Análise Custo-Benefício
Bases de Dados Factuais
Progressão da Doença
Custos de Medicamentos
Feminino
Combinação Fluticasona-Salmeterol/efeitos adversos
Combinação Fluticasona-Salmeterol/economia
Glucocorticoides/efeitos adversos
Glucocorticoides/economia
Seres Humanos
Itália
Pulmão/fisiopatologia
Masculino
Meia-Idade
Pontuação de Propensão
Doença Pulmonar Obstrutiva Crônica/diagnóstico
Doença Pulmonar Obstrutiva Crônica/economia
Doença Pulmonar Obstrutiva Crônica/fisiopatologia
Recuperação de Função Fisiológica
Estudos Retrospectivos
Fatores de Tempo
Resultado do Tratamento
[Pt] Tipo de publicação:COMPARATIVE STUDY; JOURNAL ARTICLE; OBSERVATIONAL STUDY
[Nm] Nome de substância:
0 (Adrenergic beta-2 Receptor Agonists); 0 (Bronchodilator Agents); 0 (Budesonide, Formoterol Fumarate Drug Combination); 0 (Fluticasone-Salmeterol Drug Combination); 0 (Glucocorticoids)
[Em] Mês de entrada:1708
[Cu] Atualização por classe:171116
[Lr] Data última revisão:
171116
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:161118
[St] Status:MEDLINE


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[PMID]:27759640
[Au] Autor:Wei P; Yang JW; Lu HW; Mao B; Yang WL; Xu JF
[Ad] Endereço:aDepartment of Respiratory and Critical Care Medicine bDepartment of Pulmonary function test, Shanghai Pulmonary Hospital, Tongji University School of Medicine, Shanghai, China.
[Ti] Título:Combined inhaled corticosteroid and long-acting ß2-adrenergic agonist therapy for noncystic fibrosis bronchiectasis with airflow limitation: An observational study.
[So] Source:Medicine (Baltimore);95(42):e5116, 2016 Oct.
[Is] ISSN:1536-5964
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:BACKGROUND AND OBJECTIVE: There is presently no clear evidence on the effect of combined treatment for non-cystic fibrosis (non-CF) bronchiectasis with inhaled corticosteroid (ICS) and long-acting ß2-adrenergic agonist (LABA). The objective of this study is to assess the efficacy and safety of salmeterol-fluticasone combined inhaled therapy for non-CF bronchiectasis with airflow limitation. METHODS: An observational study was performed in 120 non-CF bronchiectasis patients diagnosed by high-resolution computed tomography (HRCT) scanning of the chest. Patients received either routine therapy or salmeterol-fluticasone (100/500 µg daily) combined inhaled therapy on the basis of routine therapy. Clinical symptoms, health-related quality of life (HRQL), lung function, short-acting ß2-adrenergic agonist (SABA) use, and safety were monitored throughout the study. RESULTS: OF the 120 subjects, 60 received combined inhaled therapy and 60 received routine therapy. Compared to the control group, the combined inhaled therapy group showed significant improvement in their clinical symptom scores (-2.21 vs. -0.31, P = 0.002) and a reduction in number of weekly SABA usage (-4.2 vs. 0.1, P < 0.01). In addition, patients in the inhaled therapy group achieved a significant improvement in HRQL based on mMRC (-1.51 vs. -0.31, P < 0.005) and SGRQ (-7.83 vs. -2.16, P < 0.01) scoring accompanied with no severe adverse events. There were fewer exacerbation frequencies in the combined inhaled therapy group over the 12 months of treatment compared to the control group (1 [0-2] vs. 2 [1-4], P = 0.017). Furthermore, stratified analysis indicated that combined inhaled therapy partially improve lung function for patients for whom it is severely impaired and those with pseudomonas aeruginosa isolated. CONCLUSION: Our results show that salmeterol-fluticasone combined inhaled therapy should be effective and safe for non-CF bronchiectasis patients especially for those patients with poor lung function or pseudomonas aeruginosa isolated.
[Mh] Termos MeSH primário: Agonistas de Receptores Adrenérgicos beta 2/administração & dosagem
Obstrução das Vias Respiratórias/tratamento farmacológico
Bronquiectasia/tratamento farmacológico
Combinação Fluticasona-Salmeterol/administração & dosagem
Fibrose Pulmonar/tratamento farmacológico
[Mh] Termos MeSH secundário: Administração por Inalação
Obstrução das Vias Respiratórias/diagnóstico
Obstrução das Vias Respiratórias/etiologia
Bronquiectasia/complicações
Bronquiectasia/diagnóstico
Preparações de Ação Retardada/administração & dosagem
Quimioterapia Combinada
Feminino
Seguimentos
Volume Expiratório Forçado
Glucocorticoides/administração & dosagem
Seres Humanos
Masculino
Meia-Idade
Fibrose Pulmonar/complicações
Fibrose Pulmonar/diagnóstico
Estudos Retrospectivos
Resultado do Tratamento
[Pt] Tipo de publicação:JOURNAL ARTICLE; OBSERVATIONAL STUDY
[Nm] Nome de substância:
0 (Adrenergic beta-2 Receptor Agonists); 0 (Delayed-Action Preparations); 0 (Fluticasone-Salmeterol Drug Combination); 0 (Glucocorticoids)
[Em] Mês de entrada:1702
[Cu] Atualização por classe:171116
[Lr] Data última revisão:
171116
[Sb] Subgrupo de revista:AIM; IM
[Da] Data de entrada para processamento:161021
[St] Status:MEDLINE


  10 / 336 MEDLINE  
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[PMID]:27703344
[Au] Autor:Cheng SL; Lin CH
[Ad] Endereço:Department of Internal Medicine, Far Eastern Memorial Hospital, Taipei; Department of Chemical Engineering and Materials Science, Yuan Ze University, Zhongli, Taoyuan City.
[Ti] Título:Effectiveness using higher inhaled corticosteroid dosage in patients with COPD by different blood eosinophilic counts.
[So] Source:Int J Chron Obstruct Pulmon Dis;11:2341-2348, 2016.
[Is] ISSN:1178-2005
[Cp] País de publicação:New Zealand
[La] Idioma:eng
[Ab] Resumo:BACKGROUND: Blood eosinophil counts have been documented as a good biomarker for patients with chronic obstructive pulmonary disease (COPD) using inhaled corticosteroid (ICS) therapy. However, the effectiveness and safety of prescribing high or medium dose of ICS for patients with different eosinophil counts are unknown. METHODS: A post hoc analysis of a previous prospective randomized study was performed for COPD patients using higher dose (HD: Fluticasone 1,000 µg/day) or medium dose (MD: Fluticasone 500 µg/day) of ICS combined with Salmeterol (100 µg/day). Patients were classified into two groups: those with high eosinophil counts (HE ≥3%) and those with low eosinophil counts (LE <3%). Lung function was evaluated with forced expiratory volume in 1 second, forced vital capacity, and COPD assessment test. Frequencies of acute exacerbation and pneumonia were also measured. RESULTS: Two hundred and forty-eight patients were studied and classified into higher eosinophil (HE) (n=85, 34.3%) and lower eosinophil (LE) groups (n=163, 65.7%). The levels of forced expiratory volume in 1 second were significantly increased in patients of HE group treated with HD therapy, compared with the other groups (HE/HD: 125.9±27.2 mL vs HE/MD: 94.3±23.7 mL, vs LE/HD: 70.4±20.5 mL, vs LE/MD: 49.8±16.7 mL; <0.05) at the end of the study. Quality of life (COPD assessment test) markedly improved in HE/HD group than in MD/LE group (HE/HD: 9±5 vs LE/MD: 16±7, =0.02). The frequency of acute exacerbation was more decreased in HE/HD group patients, compared with that in LE/MD group (HE/HD: 13.5% vs LE/MD: 28.7%, <0.01). Pneumonia incidence was similar in the treatment groups (HE/HD: 3.2%, HE/MD: 2.6%, LE/HD: 3.5%, LE/MD 2.8%; =0.38). CONCLUSION: The study results support using blood eosinophil counts as a biomarker of ICS response and show the benefits of greater improvement of lung function, quality of life, and decreased exacerbation frequency in COPD patients with blood eosinophil counts higher than 3%, especially treated with higher dose of ICS.
[Mh] Termos MeSH primário: Corticosteroides/administração & dosagem
Anti-Inflamatórios/administração & dosagem
Broncodilatadores/administração & dosagem
Monitoramento de Medicamentos/métodos
Eosinófilos/efeitos dos fármacos
Combinação Fluticasona-Salmeterol/administração & dosagem
Fluticasona/administração & dosagem
Contagem de Leucócitos
Pulmão/efeitos dos fármacos
Doença Pulmonar Obstrutiva Crônica/tratamento farmacológico
[Mh] Termos MeSH secundário: Administração por Inalação
Corticosteroides/efeitos adversos
Idoso
Idoso de 80 Anos ou mais
Anti-Inflamatórios/efeitos adversos
Broncodilatadores/efeitos adversos
Progressão da Doença
Feminino
Fluticasona/efeitos adversos
Combinação Fluticasona-Salmeterol/efeitos adversos
Volume Expiratório Forçado
Seres Humanos
Pulmão/fisiopatologia
Masculino
Meia-Idade
Valor Preditivo dos Testes
Doença Pulmonar Obstrutiva Crônica/sangue
Doença Pulmonar Obstrutiva Crônica/diagnóstico
Doença Pulmonar Obstrutiva Crônica/fisiopatologia
Qualidade de Vida
Recuperação de Função Fisiológica
Fatores de Tempo
Resultado do Tratamento
Capacidade Vital
[Pt] Tipo de publicação:COMPARATIVE STUDY; JOURNAL ARTICLE; RANDOMIZED CONTROLLED TRIAL
[Nm] Nome de substância:
0 (Adrenal Cortex Hormones); 0 (Anti-Inflammatory Agents); 0 (Bronchodilator Agents); 0 (Fluticasone-Salmeterol Drug Combination); CUT2W21N7U (Fluticasone)
[Em] Mês de entrada:1708
[Cu] Atualização por classe:171116
[Lr] Data última revisão:
171116
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:161006
[St] Status:MEDLINE



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