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1.
Artigo em Inglês | MEDLINE | ID: mdl-31190781

RESUMO

Purpose: Clinically important deterioration (CID) in chronic obstructive pulmonary disease (COPD) is a novel composite endpoint that assesses disease stability. The association between short-term CID and future economic and quality of life (QoL) outcomes has not been previously assessed. This analysis considers 3-year data from the TOwards a Revolution in COPD Health (TORCH) study, to examine this question. Patients and methods: This post hoc analysis of TORCH (NCT00268216) compared costs and utilities at 3 years among patients without CID (CID-) and with CID (CID+) at 24 weeks. A positive CID status was defined as either: a deterioration in forced expiratory volume in 1 second (FEV1) of ≥100 mL from baseline; or a ≥4-unit increase from baseline in St George's Respiratory Questionnaire (SGRQ) total score; or the incidence of a moderate/severe exacerbation. Patients from all treatment arms were included. Utility change was based on the EQ-5D utility index. Costs were based on healthcare resource utilization from 24 weeks to end of follow-up combined with unit costs for the UK (2016 GBP), and reported as per patient per year (PPPY). Adjusted estimates were generated controlling for baseline characteristics, treatment assignment, and number of CID criteria met. Results: Overall, 3,769 patients completed the study and were included in the analysis (stable CID- patients, n=1,832; unstable CID+ patients, n=1,937). At the end of follow-up, CID- patients had higher mean (95% confidence interval [CI]) utility scores than CID+ patients (0.752 [0.738, 0.765] vs 0.697 [0.685, 0.71]; difference +0.054; P<0.001), and lower costs PPPY (£538 vs £916; difference: £378 [95% CI: £244, £521]; P<0.001). The cost differential was primarily driven by the difference in general hospital ward days (P=0.003). Conclusion: This study demonstrated that achieving early stability in COPD by preventing short-term CID is associated with better preservation of future QoL alongside reduced healthcare service costs.


Assuntos
Broncodilatadores/economia , Broncodilatadores/uso terapêutico , Combinação Fluticasona-Salmeterol/economia , Combinação Fluticasona-Salmeterol/uso terapêutico , Glucocorticoides/economia , Glucocorticoides/uso terapêutico , Custos de Cuidados de Saúde , Pulmão/efeitos dos fármacos , Doença Pulmonar Obstrutiva Crônica/tratamento farmacológico , Doença Pulmonar Obstrutiva Crônica/mortalidade , Idoso , Redução de Custos , Análise Custo-Benefício , Progressão da Doença , Método Duplo-Cego , Feminino , Volume Expiratório Forçado , Humanos , Pulmão/fisiopatologia , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Doença Pulmonar Obstrutiva Crônica/diagnóstico , Doença Pulmonar Obstrutiva Crônica/fisiopatologia , Qualidade de Vida , Fatores de Tempo , Resultado do Tratamento
2.
Pulmonology ; 25(2): 90-96, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-30502972

RESUMO

Chronic Obstructive Pulmonary Disease (COPD) is currently the 4th leading cause of death worldwide but is projected to be the 3rd leading cause of death by 2020. In Portugal, the estimated prevalence of COPD in the Lisbon region is 14.2%, and a large proportion of underdiagnosed disease has been detected. In 2016, a Portuguese panel of experts proposed pharmacological treatment approaches to COPD based on the evidence available at the time. However, given that the GOLD 2017 report introduced considerable changes to the 2016 version, and that new evidence has emerged regarding treatment options, these proposals need to be updated. Also, and based on several studies, the concept of Pre-GOLD patients, which has diagnostic, prognostic and therapeutic implications, is introduced, along with a proposed algorithm for the identification and treatment of these patients.


Assuntos
Volume Expiratório Forçado/efeitos dos fármacos , Doença Pulmonar Obstrutiva Crônica/tratamento farmacológico , Doença Pulmonar Obstrutiva Crônica/mortalidade , Administração por Inalação , Algoritmos , Broncodilatadores/uso terapêutico , Progressão da Doença , Combinação Fluticasona-Salmeterol/administração & dosagem , Combinação Fluticasona-Salmeterol/uso terapêutico , Glicopirrolato/administração & dosagem , Glicopirrolato/uso terapêutico , Humanos , Indanos/administração & dosagem , Indanos/uso terapêutico , Portugal/epidemiologia , Prevalência , Prognóstico , Doença Pulmonar Obstrutiva Crônica/classificação , Doença Pulmonar Obstrutiva Crônica/fisiopatologia , Quinolonas/administração & dosagem , Quinolonas/uso terapêutico , Fatores de Risco , Índice de Gravidade de Doença
3.
Pediatr Allergy Immunol ; 30(2): 195-203, 2019 03.
Artigo em Inglês | MEDLINE | ID: mdl-30556939

RESUMO

BACKGROUND: Fluticasone propionate 50 µg/salmeterol xinafoate 25 µg (FP/SAL) is widely used in adults and children with asthma, but there is sparse information on its use in very young children. METHODS: This was a randomized, double-blind, multicentre, controlled trial conducted in children aged 8 months to 4 years. During a 2-week run-in period, they all received FP twice daily. At randomization, they commenced FP/SAL or FP twice daily for 8 weeks. All were then given FP/SAL only, in a 16-week open-label study continuation. Medications were inhaled through an AeroChamber Plus with attached face mask. The primary end-point was mean change in total asthma symptom scores from baseline to the last 7 days of the double-blind period. Analyses were undertaken in all children randomized to treatment and who received at least one dose of study medication. RESULTS: Three hundred children were randomized 1:1 to receive FP/SAL or FP. Mean change from baseline in total asthma symptom scores was -3.97 for FP/SAL and -3.01 with FP. The between-group difference was not statistically significant (P = 0.21; 95% confidence interval: -2.47, 0.54). No new safety signals were seen with FP/SAL. CONCLUSION: This is the first randomized, double-blind study of this size to evaluate FP/SAL in very young children with asthma. FP/SAL did not show superior efficacy to FP; no clear add-on effect of SAL was demonstrated. No clinically significant differences in safety were noted with FP/SAL usage.


Assuntos
Asma/tratamento farmacológico , Broncodilatadores/uso terapêutico , Combinação Fluticasona-Salmeterol/uso terapêutico , Administração por Inalação , Broncodilatadores/efeitos adversos , Pré-Escolar , Método Duplo-Cego , Combinação Fluticasona-Salmeterol/efeitos adversos , Seguimentos , Humanos , Lactente , Japão , Índice de Gravidade de Doença , Resultado do Tratamento
4.
Int J Chron Obstruct Pulmon Dis ; 13: 3923-3936, 2018.
Artigo em Inglês | MEDLINE | ID: mdl-30584293

RESUMO

Background and purpose: Fixed-dose combinations of a long-acting beta agonist and an inhaled corticosteroid are more effective than the individual components in COPD. The primary study objective was to demonstrate that the combination indacaterol acetate/mometasone furoate (IND/MF [QMF149]) was non-inferior to the twice-daily combination salmeterol xinafoate/fluticasone propionate (Sal/Flu) in terms of trough FEV1 at week 12 (day 85). Secondary objectives were to compare the efficacy of IND/MF (QMF149) vs Sal/Flu with respect to other lung function parameters, COPD exacerbations, symptoms and dyspnea, health status/health-related quality of life, and rescue medication use. Materials and methods: This was a 12-week multicenter, randomized, double-blind, double-dummy, parallel-group, Phase II study in patients with moderate-to-very-severe COPD, who were randomized (1:1) to IND/MF (QMF149) (150/160 µg once daily; n=316) or Sal/Flu (50/500 µg twice daily; n=313). Results: Over 90% of patients completed the study: 94.6% in the IND/MF (QMF149) group and 92.0% in the Sal/Flu group. The primary objective of non-inferiority of IND/MF (QMF149) to Sal/Flu for trough FEV1 at week 12 (day 85) was met: the lower limit of the CI (95% CI: 27.7, 83.3 mL) was greater than -60 mL. The analysis for superiority of IND/MF (QMF149) to Sal/Flu demonstrated superiority of IND/MF (QMF149), with a difference of 56 mL (P<0.001). In addition, IND/MF (QMF149) treatment significantly improved COPD exacerbation-related parameters during the 12-week period. Other significant improvements with IND/MF (QMF 149) vs Sal/Flu were noted for dyspnea at week 12 and other COPD symptoms and COPD rescue medication use over the 12 weeks. The safety and tolerability profiles of both the treatments were similar. Conclusion: IND/MF (QMF149) (150/160 µg once daily) offered superior lung function and symptom efficacy and a favorable safety profile compared with Sal/Flu (50/500 µg twice daily) in patients with moderate-to-very severe COPD.


Assuntos
Corticosteroides/uso terapêutico , Agonistas de Receptores Adrenérgicos beta 2/uso terapêutico , Broncodilatadores/uso terapêutico , Combinação Fluticasona-Salmeterol/uso terapêutico , Indanos/uso terapêutico , Pulmão/efeitos dos fármacos , Furoato de Mometasona/uso terapêutico , Doença Pulmonar Obstrutiva Crônica/tratamento farmacológico , Quinolonas/uso terapêutico , Corticosteroides/efeitos adversos , Agonistas de Receptores Adrenérgicos beta 2/efeitos adversos , Adulto , Idoso , Broncodilatadores/efeitos adversos , Método Duplo-Cego , Combinação de Medicamentos , Feminino , Combinação Fluticasona-Salmeterol/efeitos adversos , Volume Expiratório Forçado , Nível de Saúde , Humanos , Indanos/efeitos adversos , Pulmão/fisiopatologia , Masculino , Pessoa de Meia-Idade , Furoato de Mometasona/efeitos adversos , Doença Pulmonar Obstrutiva Crônica/diagnóstico , Doença Pulmonar Obstrutiva Crônica/fisiopatologia , Qualidade de Vida , Quinolonas/efeitos adversos , Recuperação de Função Fisiológica , Índice de Gravidade de Doença , Fatores de Tempo , Resultado do Tratamento
5.
Expert Rev Respir Med ; 12(12): 997-1005, 2018 12.
Artigo em Inglês | MEDLINE | ID: mdl-30463451

RESUMO

Introduction: Triple therapy with two bronchodilators (LABA plus LAMA) and an inhaled corticosteroid (ICS) is recommended for patients suffering from severe chronic obstructive pulmonary disease (COPD). Areas covered: All 12-52 week-long studies comparing triple therapy with umeclidinium (UM) added to either fluticasone furoate/vilanterol (FF/VI) or fluticasone propionate/salmeterol (FP/SAL) vs. other comparators in COPD patients of group B or D (2011 GOLD classification) were considered. When UM was added to ICS/LABA with separate devices or within a single device, triple combination was more effective than comparators (usually, ICS/LABA combinations) regarding improvements to pulmonary function, symptoms, quality of life and, in the longer studies, rate of moderate-severe exacerbations. The IMPACT study (a large trial comparing UM/FF/VI with both FF/VI and UM/VI combinations) showed that triple therapy had a greater effect compared to dual therapies in reducing the rate of moderate-severe exacerbations, improving trough FEV1 and improving quality of life. The safety profile was good, without excess cardiovascular effects or pneumonia, however, the presence of comorbidities was frequent. Expert commentary: UM/FF/VI combination represents a good option for severe COPD patients who remain symptomatic and/or with frequent exacerbations despite dual therapies. Once daily administration with a simple and effective device may increase adherence and efficacy of the treatment.


Assuntos
Androstadienos/uso terapêutico , Álcoois Benzílicos/uso terapêutico , Broncodilatadores/uso terapêutico , Clorobenzenos/uso terapêutico , Combinação Fluticasona-Salmeterol/uso terapêutico , Doença Pulmonar Obstrutiva Crônica/tratamento farmacológico , Quinuclidinas/uso terapêutico , Administração por Inalação , Corticosteroides/administração & dosagem , Quimioterapia Combinada , Humanos , Doença Pulmonar Obstrutiva Crônica/fisiopatologia , Qualidade de Vida
6.
PLoS One ; 13(8): e0197358, 2018.
Artigo em Inglês | MEDLINE | ID: mdl-30067737

RESUMO

BACKGROUND: Education on inhaler technique is critical for effective asthma treatment. However, traditionally used face-to-face education is time-consuming, costly, and often laborious. The current study evaluated the efficacy of a newly developed video-based inhaler technique education method. METHODS: A total of 184 subjects with well-controlled or partly-controlled asthma were enrolled from 12 hospitals in South Korea from 30 November 2015 to 01 June 2016. Subjects were randomly divided into two groups in a 1:1 ratio; a control group that received face-to-face education, and a study group that received video education. All subjects received fluticasone propionate plus salmeterol xinafoate (Fluterol® 250/50 inhalation capsules) for 12 weeks. The primary outcome measure was forced expiratory volume in the 1st second (FEV1) at 12 weeks. The secondary outcome measures were change in FEV1 at 4 weeks, change in asthma control test (ACT) score, and changes in various inhaler technique parameters. These measures were assessed with a non-inferiority margin of 10% between the control group and the study group. RESULTS: FEV1 was significantly improved at 12 weeks in the control group and the study group. After adjustment, FEV1 improvement was not significantly inferior in the study group compared to the control group. The secondary outcome measures, including change in FEV1 at 4 weeks, ACT score, and various parameters pertaining to inhaler technique and satisfaction at 4 and 12 weeks did not differ significantly in the two groups. In subgroup analysis of elderly subjects and subjects with well-controlled asthma, FEV1 was significantly improved at 12 weeks in the study group but not the control group. CONCLUSION: The newly developed video education technique investigated functioned as a suitable substitute for face-to-face education on inhaler technique (dry powder inhalation capsule) in patients with stable asthma, particularly in elderly patients and patients with well-controlled asthma.


Assuntos
Asma/tratamento farmacológico , Broncodilatadores/uso terapêutico , Educação de Pacientes como Assunto/métodos , Administração por Inalação , Idoso , Asma/patologia , Esquema de Medicação , Feminino , Combinação Fluticasona-Salmeterol/uso terapêutico , Volume Expiratório Forçado , Humanos , Masculino , Pessoa de Meia-Idade , República da Coreia , Testes de Função Respiratória , Resultado do Tratamento
8.
Acta Biomed ; 89(2): 186-192, 2018 06 07.
Artigo em Inglês | MEDLINE | ID: mdl-29957750

RESUMO

BACKGROUND: Asthma is the most chronic inflammatory disease of the airways worldwide. Combination therapy with inhaled fluticasone and salmeterol is a common practice for the long-term management of asthma. Seretide® and Fluticort plus® are two available generic and brand name products of salmeterol/fluticasone. This study aimed to compare the efficacy and safety of these two drugs. MATERIALS AND METHODS: In this randomized comparative, clinical trial, 80 asthmatic patients were allocated to Fluticort plus® (n=40) or Seretide® (n=40) for a period of 4 weeks. Patients with mild asthma were instructed to inhale one puff each 12 hours and those with moderate asthma two puffs every 12 hours. Respiratory volumes (assessed using spirometry), quality of life (assessed using St. George's Respiratory Questionnaire [SGRQ]) and control of asthmatic symptoms (assessed using asthma control test [ACT]) were evaluated at baseline and at the end of the study. RESULTS: ACT score improved only in the Fluticort plus® group (p=0.012) while it was not significantly changed in the Seretide® group (p=0.178). In both treatment groups, FEV1, FEV1/FVC, and total as well as subscale SGRQ scores were significantly improved by the end of the study (p<0.05). Seretide® more efficiently improved respiratory volumes and SGRQ score in comparison with Fluticort plus® (p<0.05). CONCLUSION: Our comparative trial indicated that generic fluticasone/salmeterol product could improve respiratory volumes, quality of life but its efficacy is lower than the brand-name product. However, Fluticort plus® improved asthma control more efficiently compared with Seretide®.


Assuntos
Asma/tratamento farmacológico , Broncodilatadores/uso terapêutico , Medicamentos Genéricos , Combinação Fluticasona-Salmeterol/uso terapêutico , Asma/fisiopatologia , Feminino , Volume Expiratório Forçado/efeitos dos fármacos , Volume Expiratório Forçado/fisiologia , Humanos , Masculino , Pessoa de Meia-Idade , Projetos Piloto , Qualidade de Vida , Capacidade Vital/efeitos dos fármacos , Capacidade Vital/fisiologia
10.
Am J Respir Crit Care Med ; 198(3): 329-339, 2018 08 01.
Artigo em Inglês | MEDLINE | ID: mdl-29779416

RESUMO

RATIONALE: There are no studies on withdrawal of inhaled corticosteroids in patients on long-term triple therapy in the absence of frequent exacerbations. OBJECTIVES: To evaluate the efficacy and safety of direct de-escalation from long-term triple therapy to indacaterol/glycopyrronium in nonfrequently exacerbating patients with chronic obstructive pulmonary disease (COPD). METHODS: This 26-week, randomized, double-blind, triple-dummy study assessed the direct change from long-term triple therapy to indacaterol/glycopyrronium (110/50 µg once daily) or continuation of triple therapy (tiotropium [18 µg] once daily plus combination of salmeterol/fluticasone propionate [50/500 µg] twice daily) in nonfrequently exacerbating patients with moderate-to-severe COPD. Primary endpoint was noninferiority on change from baseline in trough FEV1. Moderate or severe exacerbations were predefined secondary endpoints. MEASUREMENTS AND MAIN RESULTS: A total of 527 patients were randomized to indacaterol/glycopyrronium and 526 to triple therapy. Inhaled corticosteroids withdrawal led to a reduction in trough FEV1 of -26 ml (95% confidence interval, -53 to 1 ml) with confidence limits exceeding the noninferiority margin of -50 ml. The annualized rate of moderate or severe COPD exacerbations did not differ between treatments (rate ratio, 1.08; 95% confidence interval, 0.83 to 1.40). Patients with ≥300 blood eosinophils/µl at baseline presented greater lung function loss and higher exacerbation risk. Adverse events were similar in the two groups. CONCLUSIONS: In patients with COPD without frequent exacerbations on long-term triple therapy, the direct de-escalation to indacaterol/glycopyrronium led to a small decrease in lung function, with no difference in exacerbations. The higher exacerbation risk in patients with ≥300 blood eosinophils/µl suggests that these patients are likely to benefit from triple therapy. Clinical trial registered with www.clinicaltrials.gov (NCT 02603393).


Assuntos
Glucocorticoides/uso terapêutico , Glicopirrolato/uso terapêutico , Indanos/uso terapêutico , Doença Pulmonar Obstrutiva Crônica/tratamento farmacológico , Quinolonas/uso terapêutico , Administração por Inalação , Corticosteroides/uso terapêutico , Idoso , Broncodilatadores/uso terapêutico , Método Duplo-Cego , Feminino , Combinação Fluticasona-Salmeterol/uso terapêutico , Humanos , Masculino , Antagonistas Muscarínicos/uso terapêutico , Brometo de Tiotrópio/uso terapêutico , Resultado do Tratamento
11.
Medicine (Baltimore) ; 97(21): e10681, 2018 May.
Artigo em Inglês | MEDLINE | ID: mdl-29794744

RESUMO

RATIONALE: This combination of fluticasone propionate (FP) and the long-acting ß2-agonist salmeterol (Salm) can control the symptoms of asthma and COPD better than FP or Salm on their own and better than the combination of inhaled corticosteroids plus montelukast. FP/Salm has been shown to control symptoms of asthma and COPD better than a double dose of inhaled steroids. The patient in our report had a history of COPD, and suffered relapse of RP when given only steroids. It is possible that COPD history helps explain this patient's more difficult treatment course. Therefore, this combination may be more effective than inhaled steroids for patients with a history of COPD. PATIENT CONCERS: This patient suffered adverse reactions triggered by methylprednisolone: weight gain, hyperglycaemia and sleep disturbance after more than two months of intravenous and oral prednisolone. These reactions disappeared when we switched the patients to FP/Salm maintenance therapy. DIAGNOSES: The patient underwent upper right lobectomy in September 2011. Immunohistochemistry indicated low squamous cell differentiation, and he was diagnosed with stage IIB disease (T2N1M0) according to the Union for International Cancer Control (UICC) (7th edition).One month after repeat radiotherapy, the patient experienced fever (37.6°C), cough, chest distress and shortness of breath. We performed serologic tests, laboratory tests for procalcitonin and C-reactive protein, as well as sputum and blood cultures to rule out bacterial infection. Chest CT showed consolidation with air bronchogram in the hilum of the right lung and ground-glass densities in the right lower lobe and left upper lobe. These radiographic signs are typical of RP. Since the patient required oxygen, he was diagnosed with grade III RP. INTERVENTIONS: After the patinet was diagnosed with grade III RP. The patient was immediately prescribed oxygen, anti-infectives for prophylaxis, treatments to facilitate expectoration and prevent asthma, and most importantly, intravenous methylprednisone at an initial dose of 60  per day. And we cut the steroid dose in half every one week when the patient's symptoms improved obviously, and the patchy shadow on the chest radiograph sharply reduced. Then we give him FP (500 mg)/Salm (50 mg) twice daily for two months. Then the dose was halved for an additional two months. OUTCOMES: The patient showed no signs of tumor or RP relapse by the last follow-up in March 2018. LESSONS: This maintenance therapy of FP/Salm for patient with grade III RP may help avoid relapse when steroid therapy is tapered, particularly for patients with a history of COPD. It may also reduce risk of steroid-associated adverse effects. Based on the results observed with our patient, we intend to design a prospective trial to assess the efficacy of FP/Salm when used as preventive treatment for patients at high risk of RP, and when used as maintenance treatment for patients with grade III RP.


Assuntos
Agonistas de Receptores Adrenérgicos beta 2/uso terapêutico , Anti-Inflamatórios/uso terapêutico , Combinação Fluticasona-Salmeterol/uso terapêutico , Neoplasias Pulmonares/terapia , Pneumonite por Radiação/tratamento farmacológico , Glucocorticoides/efeitos adversos , Glucocorticoides/uso terapêutico , Humanos , Pulmão/patologia , Pulmão/efeitos da radiação , Masculino , Metilprednisolona/efeitos adversos , Metilprednisolona/uso terapêutico , Pessoa de Meia-Idade , Pneumonectomia , Doença Pulmonar Obstrutiva Crônica/complicações , Doença Pulmonar Obstrutiva Crônica/tratamento farmacológico , Pneumonite por Radiação/diagnóstico , Tomografia Computadorizada por Raios X , Resultado do Tratamento
12.
J Med Econ ; 21(6): 629-638, 2018 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-29577787

RESUMO

AIMS: To examine the clinical and economic outcomes associated with the use of long-acting bronchodilators for initial maintenance treatment of chronic obstructive pulmonary disease (COPD) by analyzing health insurance claims data in the US. METHODS: A retrospective, observational, matched cohort study used health insurance claims data (January 2008 to June 2013) to assess COPD-related outcomes for subjects aged ≥40 years. Subjects were assigned to a study cohort according to the first observed prescription fill for a long-acting bronchodilator (fluticasone propionate 250 mcg/salmeterol 50 mcg [FSC] or tiotropium bromide 18 mcg [TIO]). The analysis period for each subject comprised a 1-year pre-index date and 1-year post-index date. Primary outcome measure was total COPD-related costs per-patient per-year (PPPY) during the follow-up period. Secondary outcome measures included COPD-related exacerbations and the components of COPD-related costs. RESULTS: Overall, 24,040 subjects were identified; the analysis sample consisted of 19,090 subjects (9,545 per cohort) with no significant differences between cohorts. Mean COPD-related total costs PPPY were numerically lower among the FSC cohort; however, the difference was not statistically significant ($2,224 [±4,108] vs $2,352 [±3,721], p = .057). There was no difference between cohorts for COPD-related medical costs (p = .894). COPD-related pharmacy costs were significantly, yet modestly, lower in the FSC cohort compared with the TIO cohort ($1,160 [±1,106] vs 1,275 [±1,110], p < .001). There were no statistically significant differences in the rate or number of exacerbations between the matched cohorts. LIMITATIONS: While propensity scoring achieved balance in baseline characteristics, some residual confounding unobserved in the database may be present. CONCLUSIONS: Few clinical and economic differences between subjects initiating maintenance therapy with FSC or TIO were observed.


Assuntos
Broncodilatadores/uso terapêutico , Combinação Fluticasona-Salmeterol/uso terapêutico , Gastos em Saúde/estatística & dados numéricos , Doença Pulmonar Obstrutiva Crônica/tratamento farmacológico , Brometo de Tiotrópio/uso terapêutico , Fatores Etários , Idoso , Idoso de 80 Anos ou mais , Broncodilatadores/economia , Combinação de Medicamentos , Feminino , Combinação Fluticasona-Salmeterol/economia , Humanos , Revisão da Utilização de Seguros , Masculino , Programas de Assistência Gerenciada/estatística & dados numéricos , Pessoa de Meia-Idade , Modelos Econométricos , Características de Residência , Estudos Retrospectivos , Índice de Gravidade de Doença , Fatores Sexuais , Brometo de Tiotrópio/economia
13.
J Asthma ; 55(9): 984-993, 2018 09.
Artigo em Inglês | MEDLINE | ID: mdl-28961020

RESUMO

OBJECTIVE: We aimed to demonstrate non-inferiority of once-daily fluticasone furoate/vilanterol 100/25 µg (FF/VI) to twice-daily fluticasone propionate/salmeterol 250/50 µg (FP/SAL) in adults/adolescents with asthma well controlled on inhaled corticosteroid/long-acting ß2 agonist (ICS/LABA). METHODS: This was a randomized, double-blind, double-dummy, parallel-group, 24-week study (NCT02301975/GSK study 201378). Patients whose asthma met study-defined criteria for control were randomized 1:1:1 to receive FF/VI, FP/SAL or twice-daily FP 250 µg for 24 weeks. Primary endpoint was change from baseline in evening trough forced expiratory volume in 1 second (FEV1). Secondary endpoints included rescue-/symptom-free 24-hour periods. Safety was also assessed. RESULTS: The intent-to-treat (ITT) population included 1504 randomized and treated patients (504 FF/VI; 501 FP/SAL; 499 FP); mean age 43.5 years, 64% female. FF/VI demonstrated non-inferiority (using a margin of -100 mL) to FP/SAL for evening trough FEV1 at Week 24 (ITT: 19 mL [95% confidence interval (CI) -11 to 49]; per protocol population [N = 1336]: 6 mL [95% CI -27 to 40]). Improvement in evening trough FEV1 at Week 24 for both FF/VI (123 mL; p < 0.001) and FP/SAL (104 mL; p < 0.001) was greater than FP. FF/VI increased rescue-/symptom-free 24-hour periods by 1.2%/1.2% compared with FP/SAL. All treatments were well tolerated. On-treatment adverse event (AE) rates were 43% to 45% across arms; there were no drug-related serious AEs. CONCLUSIONS: FF/VI was non-inferior to FP/SAL for evening trough FEV1 at 24 weeks. These data suggest that patients well controlled on FP/SAL could step across to FF/VI without loss of control.


Assuntos
Androstadienos/uso terapêutico , Asma/tratamento farmacológico , Álcoois Benzílicos/uso terapêutico , Broncodilatadores/uso terapêutico , Clorobenzenos/uso terapêutico , Combinação Fluticasona-Salmeterol/uso terapêutico , Administração por Inalação , Adolescente , Corticosteroides/uso terapêutico , Agonistas de Receptores Adrenérgicos beta 2/uso terapêutico , Adulto , Androstadienos/administração & dosagem , Álcoois Benzílicos/administração & dosagem , Broncodilatadores/administração & dosagem , Criança , Clorobenzenos/administração & dosagem , Método Duplo-Cego , Esquema de Medicação , Combinação de Medicamentos , Estudos de Equivalência como Asunto , Feminino , Combinação Fluticasona-Salmeterol/administração & dosagem , Volume Expiratório Forçado , Humanos , Masculino , Pessoa de Meia-Idade , Adulto Jovem
14.
Drug Res (Stuttg) ; 68(1): 38-44, 2018 01.
Artigo em Inglês | MEDLINE | ID: mdl-28926855

RESUMO

BACKGROUND: Asthma in the elderly population has been focused because it affects quality of life and results in a higher hospitalization rate and mortality. Fluticasone furoate (FF)/vilanterole (VI) is a novel inhaled corticosteroids (ICS)/long-acting ß2 agonist (LABA) combination being developed for once-daily administration for asthma with greater anti-inflammatory activity and longer duration of bronchidilation. The ElliptaTM dry powder inhaler (DPI) has also been available as a new device with high levels of satisfaction and preference. METHODS: A 12-week, randomized, open-label cross-over, pilot study was conducted in 18 elderly patients with bronchial asthma to compare the effectiveness of once-daily FF/VI 200/25 µg via the ElliptaTM DPI vs. twice-daily fluticasone propionate (FP)/salmeterol (SAL) 500/50 µg via the DiskusTM DPI. The study period included a 4-week run-in, the first 4-week treatment, and the second 4-week treatment. Respiratory functions, fractional exhaled nitric oxide (FeNO) and asthma control test (ACT) scores were measured 0, 4, and 8 weeks after randomization. Preferences for their device were also assessed using a self-completed questionnaire. RESULTS: Spirometric paramters, FeNO levels and ACT scores were not significantly different during the run-in period, the FP/SAL treatment period, and the FF/VI treatment period. FF/VI treatment via the ElliptaTM DPI was preferred to the FP/SAL treatment via the DiskusTM DPI (p<0.01). CONCLUSIONS: These data indicate that FF/VI treatment via the ElliptaTM DPI is preferred in elderly patients with asthma based on its ease-of-use, suggesting the potential to improve patient adherence and, as a result, overall disease management.


Assuntos
Androstadienos/uso terapêutico , Asma/tratamento farmacológico , Álcoois Benzílicos/uso terapêutico , Broncodilatadores/uso terapêutico , Clorobenzenos/uso terapêutico , Combinação Fluticasona-Salmeterol/uso terapêutico , Glucocorticoides/uso terapêutico , Administração por Inalação , Fatores Etários , Idoso , Idoso de 80 Anos ou mais , Estudos Cross-Over , Combinação de Medicamentos , Inaladores de Pó Seco , Feminino , Humanos , Masculino , Preferência do Paciente/estatística & dados numéricos , Satisfação do Paciente/estatística & dados numéricos , Projetos Piloto , Resultado do Tratamento
15.
BMC Pulm Med ; 17(1): 179, 2017 Dec 08.
Artigo em Inglês | MEDLINE | ID: mdl-29216852

RESUMO

BACKGROUND: Equitable access to affordable medicines and diagnostic tests is an integral component of optimal clinical care of patients with asthma and chronic obstructive pulmonary disease (COPD). In Uganda, we lack contemporary data about the availability, cost and affordability of medicines and diagnostic tests essential in asthma and COPD management. METHODS: Data on the availability, cost and affordability of 17 medicines and 2 diagnostic tests essential in asthma and COPD management were collected from 22 public hospitals, 23 private and 85 private pharmacies. The percentage of the available medicines and diagnostic tests, the median retail price of the lowest priced generic brand and affordability in terms of the number of days' wages it would cost the least paid public servant were analysed. RESULTS: The availability of inhaled short acting beta agonists (SABA), oral leukotriene receptor antagonists (LTRA), inhaled LABA-ICS combinations and inhaled corticosteroids (ICS) in all the study sites was 75%, 60.8%, 46.9% and 45.4% respectively. None of the study sites had inhaled long acting anti muscarinic agents (LAMA) and inhaled long acting beta agonist (LABA)-LAMA combinations. Spirometry and peak flow-metry as diagnostic tests were available in 24.4% and 6.7% of the study sites respectively. Affordability ranged from 2.2 days' wages for inhaled salbutamol to 17.1 days' wages for formoterol/budesonide inhalers and 27.8 days' wages for spirometry. CONCLUSION: Medicines and diagnostic tests essential in asthma and COPD care are not widely available in Uganda and remain largely unaffordable. Strategies to improve access to affordable asthma and COPD medicines and diagnostic tests should be implemented in Uganda.


Assuntos
Corticosteroides/provisão & distribução , Agonistas Adrenérgicos beta/provisão & distribução , Asma/tratamento farmacológico , Técnicas de Diagnóstico do Sistema Respiratório/estatística & dados numéricos , Acesso aos Serviços de Saúde , Antagonistas de Leucotrienos/provisão & distribução , Antagonistas Muscarínicos/provisão & distribução , Doença Pulmonar Obstrutiva Crônica/tratamento farmacológico , Administração por Inalação , Corticosteroides/economia , Corticosteroides/uso terapêutico , Agonistas Adrenérgicos beta/economia , Agonistas Adrenérgicos beta/uso terapêutico , Albuterol/economia , Albuterol/provisão & distribução , Albuterol/uso terapêutico , Antiasmáticos/provisão & distribução , Antiasmáticos/uso terapêutico , Asma/diagnóstico , Combinação Budesonida e Fumarato de Formoterol/economia , Combinação Budesonida e Fumarato de Formoterol/provisão & distribução , Combinação Budesonida e Fumarato de Formoterol/uso terapêutico , Combinação de Medicamentos , Custos de Medicamentos , Combinação Fluticasona-Salmeterol/economia , Combinação Fluticasona-Salmeterol/provisão & distribução , Combinação Fluticasona-Salmeterol/uso terapêutico , Humanos , Antagonistas de Leucotrienos/economia , Antagonistas de Leucotrienos/uso terapêutico , Antagonistas Muscarínicos/economia , Antagonistas Muscarínicos/uso terapêutico , Doença Pulmonar Obstrutiva Crônica/diagnóstico , Testes de Função Respiratória , Espirometria , Uganda
16.
Respir Med ; 129: 199-206, 2017 08.
Artigo em Inglês | MEDLINE | ID: mdl-28732831

RESUMO

OBJECTIVE: Asthma has a substantial impact on quality of life and health care resources. The identification of a more cost-effective, yet equally efficacious, treatment could positively influence the economic burden of this disease. Fluticasone propionate/Formoterol (FP/FOR) may be as effective as Fluticasone Salmeterol (FP/SAL). We evaluated non-inferiority of asthma control in terms of the proportion of patients free from exacerbations, and conducted a cost impact analysis. METHODS: This historical, matched cohort database study evaluated two treatment groups in the Optimum Patient Care Research Database in the UK: 1) an FP/FOR cohort of patients initiating treatment with FP/FOR or changing from FP/SAL to FP/FOR and; 2) an FP/SAL cohort comprising patients initiating, or remaining on FP/SAL pMDI combination therapy. The main outcome evaluated non-inferiority of effectiveness (defined as prevention of severe exacerbations, lower limit of the 95% confidence interval (CI) of the mean difference between groups in patient proportions with no exacerbations is -3.5% or higher) in patients treated with FP/FOR versus FP/SAL. RESULTS: After matching 1:3, we studied a total of 2472 patients: 618 in the FP/FOR cohort (174 patients initiated on FP/FOR and 444 patients changed to FP/FOR) and 1854 in the FP/SAL cohort (522 patients initiated FP/SAL and 1332 continued FP/SAL). The percentage of patients prescribed FP/FOR met non-inferiority as the adjusted mean difference in proportion of no severe exacerbations (95%CI) was 0.008 (-0.032, 0.047) between the two cohorts. No other significant differences were observed except acute respiratory event rates, which were lower for patients prescribed FP/FOR (rate ratio [RR] 0.82, 95% CI 0.71, 0.94). CONCLUSIONS: Changing to, or initiating FP/FOR combination therapy, is associated with a non-inferior proportion of patients who are severe exacerbation-free at a lower average annual cost compared with continuing or initiating treatment with FP/SAL.


Assuntos
Androstadienos/uso terapêutico , Antiasmáticos/economia , Asma/tratamento farmacológico , Asma/economia , Estudos de Coortes , Análise Custo-Benefício/economia , Quimioterapia Combinada/métodos , Etanolaminas/uso terapêutico , Combinação Fluticasona-Salmeterol/uso terapêutico , Adulto , Idoso , Androstadienos/administração & dosagem , Androstadienos/economia , Antiasmáticos/uso terapêutico , Combinação de Medicamentos , Etanolaminas/administração & dosagem , Etanolaminas/economia , Feminino , Fluticasona , Combinação Fluticasona-Salmeterol/administração & dosagem , Combinação Fluticasona-Salmeterol/economia , Fumarato de Formoterol , Humanos , Masculino , Pessoa de Meia-Idade , Aceitação pelo Paciente de Cuidados de Saúde/estatística & dados numéricos , Qualidade de Vida , Resultado do Tratamento , Reino Unido/epidemiologia
17.
COPD ; 14(4): 375-381, 2017 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-28594587

RESUMO

In this pooled analysis, we compared the effect of indacaterol/glycopyrronium (IND/GLY) by sex versus other commonly used chronic obstructive pulmonary disease (COPD) treatments and placebo. Male and female patients with moderate-to-very-severe COPD who had participated in six randomized controlled trials were included in the analysis. Baseline demographics and disease characteristics were analyzed by sex, and any differences noted. The effects of IND/GLY versus salmeterol/fluticasone (SFC), glycopyrronium, tiotropium and placebo, on lung function and the patient-reported outcomes (health status, dyspnea, rescue medication use and symptoms) were assessed by sex after 26 weeks treatment. The analysis population comprised 4719 men and 1389 women. Most baseline parameters differed significantly between men and women. Nonetheless, despite these differences in baseline characteristics, IND/GLY significantly improved lung function versus placebo (p < 0.0001) and all active comparators (p < 0.01) in men and women. Overall, IND/GLY showed better improvement in dyspnea and health status compared with all other treatments in both sex. Greater reduction of rescue medication use was observed with IND/GLY versus placebo and other treatments (all p < 0.01 expect IND/GLY versus SFC). Although some variability was observed, improvements in health status, dyspnea, rescue medication use and symptoms were generally larger in women than in men. Irrespective of sex, IND/GLY provided superior efficacy to monotherapy or SFC in both men and women. Small differences in efficacy response by sex were observed, which should be evaluated further in prospective clinical studies. Nevertheless, the benefits observed with IND/GLY confirm dual bronchodilator as the preferred therapy in patients with moderate-to-very-severe COPD regardless of sex.


Assuntos
Combinação Fluticasona-Salmeterol/uso terapêutico , Glicopirrolato/uso terapêutico , Indanos/uso terapêutico , Doença Pulmonar Obstrutiva Crônica/tratamento farmacológico , Doença Pulmonar Obstrutiva Crônica/fisiopatologia , Quinolonas/uso terapêutico , Brometo de Tiotrópio/uso terapêutico , Idoso , Broncodilatadores/uso terapêutico , Combinação de Medicamentos , Dispneia/tratamento farmacológico , Dispneia/etiologia , Feminino , Volume Expiratório Forçado , Glucocorticoides/uso terapêutico , Nível de Saúde , Humanos , Masculino , Pessoa de Meia-Idade , Antagonistas Muscarínicos/uso terapêutico , Doença Pulmonar Obstrutiva Crônica/complicações , Índice de Gravidade de Doença , Fatores Sexuais , Capacidade Vital
18.
Br J Clin Pharmacol ; 83(11): 2377-2385, 2017 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-28626983

RESUMO

AIM: The aim of this study was to test the systemic pharmacodynamic effects of the salmeterol component of two pressurized metered dose inhalers that delivered a combination of salmeterol and fluticasone propionate (SM/FP). METHODS: This was a six-way crossover study in 43 adult subjects, using a single blind design (subject blinded to product and clinical assessor blinded for all measurements). Each subject received single doses of two, six, and twelve inhalations from test and reference products that delivered SM/FP as 25/125 mcg per inhalation. Heart rate, QTcB, and plasma potassium and glucose were monitored over 6 h. RESULTS: Safety equivalence was shown by relative potency analysis for primary endpoints of maximum heart rate and maximum QTcB, since the 90% confidence intervals for both endpoints were within the acceptance limit of (0.67, 1.50). There were six secondary analyses for relative potency and equivalence was met for five of these endpoints. There were also 18 pairwise comparisons performed at each dose level. No statistical differences (95% confidence intervals included zero) among these pairwise comparisons were seen at the two-inhalation dose (therapeutic dose) or the six-inhalation dose. At the supratherapeutic dose of twelve inhalations, the test product was either comparable to or statistically less than that of the reference product for all comparisons. Overall, the results demonstrated comparable systemic safety. No differences were seen between the products in reported adverse events. CONCLUSION: The safety equivalence of the systemic pharmacodynamic effects of the SM component of the test and reference SM/FP products was demonstrated.


Assuntos
Asma/tratamento farmacológico , Broncodilatadores/farmacologia , Combinação Fluticasona-Salmeterol/farmacologia , Administração por Inalação , Adolescente , Adulto , Área Sob a Curva , Broncodilatadores/uso terapêutico , Estudos Cross-Over , Eletrocardiografia , Feminino , Combinação Fluticasona-Salmeterol/uso terapêutico , Voluntários Saudáveis , Frequência Cardíaca/efeitos dos fármacos , Humanos , Masculino , Inaladores Dosimetrados , Pessoa de Meia-Idade , Método Simples-Cego , Adulto Jovem
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