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1.
Einstein (Sao Paulo) ; 18: eGS4442, 2020.
Artigo em Inglês, Português | MEDLINE | ID: mdl-31576910

RESUMO

OBJECTIVE: To analyze the legal demands of tiotropium bromide to treat chronic obstructive pulmonary disease. METHODS: We included secondary data from the pharmaceutical care management systems made available by the Paraná State Drug Center. RESULTS: Public interest civil action and ordinary procedures, among others, were the most common used by the patients to obtain the medicine. Two Health Centers in Paraná (Londrina and Umuarama) concentrated more than 50% of the actions. The most common specialty of physicians who prescribed (33.8%) was pulmonology. There is a small financial impact of tiotropium bromide on general costs with medicines of the Paraná State Drug Center. However, a significant individual financial impact was observed because one unit of the medicine represents 38% of the Brazilian minimum wage. CONCLUSION: Our study highlights the need of incorporating this medicine in the class of long-acting anticholinergic bronchodilator in the Brazilian public health system.


Assuntos
Broncodilatadores/economia , Medicamentos Essenciais/provisão & distribução , Necessidades e Demandas de Serviços de Saúde/legislação & jurisprudência , Função Jurisdicional , Doença Pulmonar Obstrutiva Crônica/economia , Brometo de Tiotrópio/economia , Brasil , Medicamentos Essenciais/economia , Acesso aos Serviços de Saúde/economia , Acesso aos Serviços de Saúde/legislação & jurisprudência , Acesso aos Serviços de Saúde/tendências , Necessidades e Demandas de Serviços de Saúde/economia , Necessidades e Demandas de Serviços de Saúde/tendências , Humanos , Programas Nacionais de Saúde , Doença Pulmonar Obstrutiva Crônica/tratamento farmacológico , Estudos Retrospectivos , Estatísticas não Paramétricas , Fatores de Tempo
2.
Artigo em Inglês | MEDLINE | ID: mdl-30863045

RESUMO

Purpose: Combinations of long-acting bronchodilators are recommended to reduce the rate of COPD exacerbations. Evidence from the DYNAGITO trial showed that the fixed-dose combination of tiotropium + olodaterol reduced the annual rate of total exacerbations (P<0.05) compared with tiotropium monotherapy. This study aimed to estimate the cost-effectiveness of the fixed-dose combination of tiotropium + olodaterol vs tiotropium monotherapy in COPD patients in the French setting. Patients and methods: A recently developed COPD patient-level simulation model was used to simulate the lifetime effects and costs for 15,000 patients receiving either tiotropium + olodaterol or tiotropium monotherapy by applying the reduction in annual exacerbation rate as observed in the DYNAGITO trial. The model was adapted to the French setting by including French unit costs for treatment medication, COPD maintenance treatment, COPD exacerbations (moderate or severe), and pneumonia. The main outcomes were the annual (severe) exacerbation rate, the number of quality-adjusted life-years (QALYs), and total lifetime costs. Results: The number of QALYs for treatment with tiotropium + olodaterol was 0.042 higher compared with tiotropium monotherapy. Using a societal perspective, tiotropium + olodaterol resulted in a cost increase of +€123 and an incremental cost-effectiveness ratio (ICER) of €2,900 per QALY compared with tiotropium monotherapy. From a French National Sickness Fund perspective, total lifetime costs were reduced by €272 with tiotropium + olodaterol, resulting in tiotropium + olodaterol being the dominant treatment option, that is, more effects with less costs. Sensitivity analyses showed that reducing the cost of exacerbations by 34% increased the ICER to €15,400, which could still be considered cost-effective in the French setting. Conclusion: Treatment with tiotropium + olodaterol resulted in a gain in QALYs and savings in costs compared with tiotropium monotherapy using a National Sickness Fund perspective in France. From the societal perspective, tiotropium + olodaterol was found to be cost-effective with a low cost per QALY.


Assuntos
Benzoxazinas/economia , Benzoxazinas/uso terapêutico , Broncodilatadores/economia , Broncodilatadores/uso terapêutico , Custos de Medicamentos , Pulmão/efeitos dos fármacos , Doença Pulmonar Obstrutiva Crônica/tratamento farmacológico , Doença Pulmonar Obstrutiva Crônica/economia , Brometo de Tiotrópio/economia , Brometo de Tiotrópio/uso terapêutico , Idoso , Benzoxazinas/efeitos adversos , Broncodilatadores/efeitos adversos , Simulação por Computador , Redução de Custos , Análise Custo-Benefício , Progressão da Doença , Combinação de Medicamentos , Feminino , Volume Expiratório Forçado , França , Humanos , Pulmão/fisiopatologia , Masculino , Pessoa de Meia-Idade , Modelos Econômicos , Doença Pulmonar Obstrutiva Crônica/diagnóstico , Doença Pulmonar Obstrutiva Crônica/fisiopatologia , Qualidade de Vida , Anos de Vida Ajustados por Qualidade de Vida , Ensaios Clínicos Controlados Aleatórios como Assunto , Fatores de Tempo , Brometo de Tiotrópio/efeitos adversos , Resultado do Tratamento
3.
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
4.
Int J Chron Obstruct Pulmon Dis ; 12: 997-1008, 2017.
Artigo em Inglês | MEDLINE | ID: mdl-28392684

RESUMO

BACKGROUND: Bronchodilators such as long-acting muscarinic antagonists (LAMAs) and long-acting ß2-agonists (LABAs) are central to the pharmacological management of COPD. Dual bronchodilation with umeclidinium/vilanterol (UMEC/VI; 62.5/25 µg) is a novel LAMA/LABA combination approved for maintenance treatment for patients with COPD. OBJECTIVE: The objective of this study was to assess the cost-effectiveness of maintenance treatment with UMEC/VI compared with tiotropium (TIO) 18 µg, open dual LAMA + LABA treatment, or no long-acting bronchodilator treatment in patients with moderate to very severe COPD. METHODS: A Markov model was developed to estimate the costs and outcomes associated with UMEC/VI treatment in patients with moderate to very severe COPD (GSK study number: HO-13-13411). Clinical efficacy, costs, utilities, and mortality obtained from the published literature were used as the model inputs. Costs are presented in US dollars based on 2015 prices. The model outputs are total costs, drug costs, other medical costs, number of COPD exacerbations, and quality-adjusted life-years (QALYs). Costs and outcomes were discounted at a 3% annual rate. Incremental cost-effectiveness ratios were calculated. One-way and probabilistic sensitivity analyses were conducted to assess the effects of changing parameters on the uncertainty of the results. RESULTS: UMEC/VI treatment for moderate to very severe COPD was associated with lower lifetime medical costs ($82,344) compared with TIO ($88,822), open dual LAMA + LABA treatment ($114,442), and no long-acting bronchodilator ($86,751). Fewer exacerbations were predicted to occur with UMEC/VI treatment compared with no long-acting bronchodilator treatment. UMEC/VI provided an 0.11 and 0.25 increase in QALYs compared with TIO and no long-acting bronchodilator treatment, and as such, dominated these cost-effectiveness analyses. Sensitivity analyses confirmed that the results were robust. CONCLUSION: The results from this model suggest that UMEC/VI treatment would be dominant compared with TIO and no long-acting bronchodilator treatment, and less costly than open dual LAMA + LABA treatment in patients with moderate to very severe COPD.


Assuntos
Agonistas de Receptores Adrenérgicos beta 2/administração & dosagem , Agonistas de Receptores Adrenérgicos beta 2/economia , Álcoois Benzílicos/administração & dosagem , Álcoois Benzílicos/economia , Broncodilatadores/administração & dosagem , Broncodilatadores/economia , Clorobenzenos/administração & dosagem , Clorobenzenos/economia , Custos de Medicamentos , Modelos Econômicos , Antagonistas Muscarínicos/administração & dosagem , Antagonistas Muscarínicos/economia , Doença Pulmonar Obstrutiva Crônica/tratamento farmacológico , Doença Pulmonar Obstrutiva Crônica/economia , Quinuclidinas/administração & dosagem , Quinuclidinas/economia , Administração por Inalação , Agonistas de Receptores Adrenérgicos beta 2/efeitos adversos , Álcoois Benzílicos/efeitos adversos , Broncodilatadores/efeitos adversos , Clorobenzenos/efeitos adversos , Análise Custo-Benefício , Combinação de Medicamentos , Humanos , Cadeias de Markov , Antagonistas Muscarínicos/efeitos adversos , Doença Pulmonar Obstrutiva Crônica/diagnóstico , Doença Pulmonar Obstrutiva Crônica/fisiopatologia , Anos de Vida Ajustados por Qualidade de Vida , Quinuclidinas/efeitos adversos , Índice de Gravidade de Doença , Fatores de Tempo , Brometo de Tiotrópio/administração & dosagem , Brometo de Tiotrópio/economia , Resultado do Tratamento
5.
Value Health ; 20(3): 397-403, 2017 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-28292484

RESUMO

OBJECTIVES: To validate outcomes of presently available chronic obstructive pulmonary disease (COPD) cost-effectiveness models against results of two large COPD trials-the 3-year TOwards a Revolution in COPD Health (TORCH) trial and the 4-year Understanding Potential Long-term Impacts on Function with Tiotropium (UPLIFT) trial. METHODS: Participating COPD modeling groups simulated the outcomes for the placebo-treated groups of the TORCH and UPLIFT trials using baseline characteristics of the trial populations as input. Groups then simulated treatment effectiveness by using relative reductions in annual decline in lung function and exacerbation frequency observed in the most intensively treated group compared with placebo as input for the models. Main outcomes were (change in) total/severe exacerbations and mortality. Furthermore, the absolute differences in total exacerbations and quality-adjusted life-years (QALYs) were used to approximate the cost per exacerbation avoided and the cost per QALY gained. RESULT: Of the six participating models, three models reported higher total exacerbation rates than observed in the TORCH trial (1.13/patient-year) (models: 1.22-1.48). Four models reported higher rates than observed in the UPLIFT trial (0.85/patient-year) (models: 1.13-1.52). Two models reported higher mortality rates than in the TORCH trial (15.2%) (models: 20.0% and 30.6%) and the UPLIFT trial (16.3%) (models: 24.8% and 36.0%), whereas one model reported lower rates (9.8% and 12.1%, respectively). Simulation of treatment effectiveness showed that the absolute reduction in total exacerbations, the gain in QALYs, and the cost-effectiveness ratios did not differ from the trials, except for one model. CONCLUSIONS: Although most of the participating COPD cost-effectiveness models reported higher total exacerbation rates than observed in the trials, estimates of the absolute treatment effect and cost-effectiveness ratios do not seem different from the trials in most models.


Assuntos
Broncodilatadores/economia , Análise Custo-Benefício/métodos , Análise Custo-Benefício/normas , Fluticasona/economia , Doença Pulmonar Obstrutiva Crônica/economia , Xinafoato de Salmeterol/economia , Brometo de Tiotrópio/economia , Idoso , Idoso de 80 Anos ou mais , Broncodilatadores/uso terapêutico , Simulação por Computador , Tomada de Decisões , Economia Médica , Feminino , Fluticasona/uso terapêutico , Humanos , Masculino , Pessoa de Meia-Idade , Modelos Econométricos , Doença Pulmonar Obstrutiva Crônica/tratamento farmacológico , Doença Pulmonar Obstrutiva Crônica/mortalidade , Anos de Vida Ajustados por Qualidade de Vida , Ensaios Clínicos Controlados Aleatórios como Assunto , Xinafoato de Salmeterol/uso terapêutico , Brometo de Tiotrópio/uso terapêutico , Resultado do Tratamento
6.
Int J Chron Obstruct Pulmon Dis ; 11: 2191-2201, 2016.
Artigo em Inglês | MEDLINE | ID: mdl-27703341

RESUMO

PURPOSE: The fixed-dose dual bronchodilator combination (FDC) of tiotropium and olodaterol showed increased effectiveness regarding lung function and health-related quality of life in patients with chronic obstructive pulmonary disease (COPD) compared with the use of its mono-components. Yet, while effectiveness and safety have been shown, the health economic implication of this treatment is still unknown. The aim of this study was to assess the cost-utility and budget impact of tiotropium-olodaterol FDC in patients with moderate to very severe COPD in the Netherlands. PATIENTS AND METHODS: A cost-utility study was performed, using an individual-level Markov model. To populate the model, individual patient-level data (age, height, sex, COPD duration, baseline forced expiratory volume in 1 second) were obtained from the tiotropium-olodaterol TOnado trial. In the model, forced expiratory volume in 1 second and patient-level data were extrapolated to utility and survival, and treatment with tiotropium-olodaterol FDC was compared with tiotropium. Cost-utility analysis was performed from the Dutch health care payer's perspective using a 15-year time horizon in the base-case analysis. The standard Dutch discount rates were applied (costs: 4.0%; effects: 1.5%). Both univariate and probabilistic sensitivity analyses were performed. Budget impact was annually assessed over a 5-year time horizon, taking into account different levels of medication adherence. RESULTS: As a result of cost increases, combined with quality-adjusted life-year (QALY) gains, results showed that tiotropium-olodaterol FDC had an incremental cost-effectiveness ratio of €7,004/QALY. Without discounting, the incremental cost-effectiveness ratio was €5,981/QALY. Results were robust in univariate and probabilistic sensitivity analyses. Budget impact was estimated at €4.3 million over 5 years assuming 100% medication adherence. Scenarios with 40%, 60%, and 80% adherence resulted in lower 5-year incremental cost increases of €1.7, €2.6, and €3.4 million, respectively. CONCLUSION: Tiotropium-olodaterol FDC can be considered a cost-effective treatment under current Dutch cost-effectiveness thresholds.


Assuntos
Agonistas de Receptores Adrenérgicos beta 2/economia , Agonistas de Receptores Adrenérgicos beta 2/uso terapêutico , Benzoxazinas/economia , Benzoxazinas/uso terapêutico , Broncodilatadores/economia , Broncodilatadores/uso terapêutico , Orçamentos , Antagonistas Colinérgicos/economia , Antagonistas Colinérgicos/uso terapêutico , Custos de Medicamentos , Pulmão/efeitos dos fármacos , Doença Pulmonar Obstrutiva Crônica/tratamento farmacológico , Doença Pulmonar Obstrutiva Crônica/economia , Brometo de Tiotrópio/economia , Brometo de Tiotrópio/uso terapêutico , Idoso , Análise Custo-Benefício , Progressão da Doença , Combinação de Medicamentos , Feminino , Volume Expiratório Forçado , Humanos , Pulmão/fisiopatologia , Masculino , Cadeias de Markov , Adesão à Medicação , Pessoa de Meia-Idade , Modelos Econômicos , Países Baixos , Doença Pulmonar Obstrutiva Crônica/mortalidade , Doença Pulmonar Obstrutiva Crônica/fisiopatologia , Anos de Vida Ajustados por Qualidade de Vida , Índice de Gravidade de Doença , Fatores de Tempo , Resultado do Tratamento
7.
Ther Adv Respir Dis ; 10(5): 391-401, 2016 10.
Artigo em Inglês | MEDLINE | ID: mdl-27405723

RESUMO

BACKGROUND: The objective of this study was to compare the cost-effectiveness of the fixed-dose combination (FDC) of tiotropium + olodaterol Respimat(®) FDC with tiotropium alone for patients with chronic obstructive pulmonary disease (COPD) in the Italian health care setting using a newly developed patient-level Markov model that reflects the current understanding of the disease. METHODS: While previously published models have largely been based around a cohort approach using a Markov structure and GOLD stage stratification, an individual-level Markov approach was selected for the new model. Using patient-level data from the twin TOnado trials assessing Tiotropium + olodaterol Respimat(®) FDC versus tiotropium, outcomes were modelled based on the trough forced expiratory volume (tFEV1) of over 1000 patients in each treatment arm, tracked individually at trial visits through the 52-week trial period, and after the trial period it was assumed to decline at a constant rate based on disease stage. Exacerbation risk was estimated based on a random-effects logistic regression analysis of exacerbations in UPLIFT. Mortality by age and disease stage was estimated from an analysis of TIOSPIR trial data. Cost of bronchodilators and other medications, routine management, and costs of treatment for moderate and severe exacerbations for the Italian setting were included. A cost-effectiveness analysis was conducted over a 15-year time horizon from the perspective of the Italian National Health Service. RESULTS: Aggregating total costs and quality-adjusted life years (QALYs) for each treatment cohort over 15 years and comparing tiotropium + olodaterol Respimat(®) FDC with tiotropium alone, resulted in mean incremental costs per patient of €1167 and an incremental cost-effectiveness ratio (ICER) of €7518 per additional QALY with tiotropium + olodaterol Respimat(®) FDC. The lung function outcomes observed for tiotropium + olodaterol Respimat(®) FDC in TOnado drove the results in terms of slightly higher mean life-years (12.24 versus 12.07) exacerbation-free months (11.36 versus 11.32) per patient and slightly fewer moderate and severe exacerbations per patient-year (0.411 versus 0.415; 0.21 versus 0.24) versus tiotropium. Probabilistic sensitivity analyses showed tiotropium + olodaterol Respimat(®) FDC to be the more cost-effective treatment in 95.2% and 98.4% of 500 simulations at thresholds of €20,000 and €30,000 per QALY respectively. CONCLUSION: Tiotropium + olodaterol Respimat(®) FDC is a cost-effective bronchodilator in the maintenance treatment of COPD for the Italian health care system.


Assuntos
Benzoxazinas/uso terapêutico , Broncodilatadores/uso terapêutico , Modelos Econômicos , Doença Pulmonar Obstrutiva Crônica/tratamento farmacológico , Brometo de Tiotrópio/uso terapêutico , Idoso , Benzoxazinas/administração & dosagem , Benzoxazinas/economia , Broncodilatadores/administração & dosagem , Broncodilatadores/economia , Análise Custo-Benefício , Combinação de Medicamentos , Feminino , Volume Expiratório Forçado , Humanos , Itália , Masculino , Cadeias de Markov , Pessoa de Meia-Idade , Doença Pulmonar Obstrutiva Crônica/economia , Doença Pulmonar Obstrutiva Crônica/mortalidade , Anos de Vida Ajustados por Qualidade de Vida , Testes de Função Respiratória , Brometo de Tiotrópio/administração & dosagem , Brometo de Tiotrópio/economia , Resultado do Tratamento
8.
Artigo em Inglês | MEDLINE | ID: mdl-26848262

RESUMO

PURPOSE: Umeclidinium/vilanterol (UMEC/VI) is a novel fixed dose combination of a long-acting muscarinic receptor antagonist (LAMA) and a long-acting beta 2 receptor antagonist (LABA) agent. This analysis evaluated the incremental cost-effectiveness ratio (ICER) of UMEC/VI compared with tiotropium (TIO), from the Spanish National Health System (NHS) perspective. METHODS: A previously published linked equations cohort model based on the epidemiological longitudinal study ECLIPSE (Evaluation of COPD Longitudinally to Identify Predictive Surrogate End-points) was used. Patients included were COPD patients with a post-bronchodilator forced expiratory volume in 1 second (FEV1) ≤70% and the presence of respiratory symptoms measured with the modified Medical Research Council dyspnea scale (modified Medical Research Council ≥2). Treatment effect, expressed as change in FEV1 from baseline, was estimated from a 24-week head-to-head phase III clinical trial comparing once-daily UMEC/VI with once-daily TIO and was assumed to last 52 weeks following treatment initiation (maximum duration of UMEC/VI clinical trials). Spanish utility values were derived from a published local observational study. Unitary health care costs (€2015) were obtained from local sources. A 3-year time horizon was selected, and 3% discount was applied to effects and costs. Results were expressed as cost/quality-adjusted life years (QALYs). Univariate and probabilistic sensitivity analysis (PSA) was performed. RESULTS: UMEC/VI produced additional 0.03 QALY and €590 vs TIO, leading to an ICER of €21,475/QALY. According to PSA, the probability of UMEC/VI being cost-effective was 80.3% at a willingness-to-pay of €30,000/QALY. CONCLUSION: UMEC/VI could be considered as a cost-effective treatment alternative compared with TIO in symptomatic COPD patients from the Spanish NHS perspective.


Assuntos
Álcoois Benzílicos , Clorobenzenos , Doença Pulmonar Obstrutiva Crônica , Quinuclidinas , Brometo de Tiotrópio , Administração por Inalação , Idoso , Álcoois Benzílicos/economia , Álcoois Benzílicos/uso terapêutico , Broncodilatadores/uso terapêutico , Clorobenzenos/economia , Clorobenzenos/uso terapêutico , Análise Custo-Benefício , Combinação de Medicamentos , Feminino , Volume Expiratório Forçado/efeitos dos fármacos , Humanos , Estudos Longitudinais , Masculino , Doença Pulmonar Obstrutiva Crônica/diagnóstico , Doença Pulmonar Obstrutiva Crônica/tratamento farmacológico , Doença Pulmonar Obstrutiva Crônica/economia , Doença Pulmonar Obstrutiva Crônica/epidemiologia , Anos de Vida Ajustados por Qualidade de Vida , Quinuclidinas/economia , Quinuclidinas/uso terapêutico , Índice de Gravidade de Doença , Espanha/epidemiologia , Avaliação de Sintomas/métodos , Brometo de Tiotrópio/economia , Brometo de Tiotrópio/uso terapêutico , Resultado do Tratamento
9.
Artigo em Inglês | MEDLINE | ID: mdl-26586940

RESUMO

Chronic obstructive pulmonary disease (COPD), a respiratory disease characterized by a progressive decline in lung function, is considered to be a leading cause of morbidity and mortality. Long-acting inhaled bronchodilators, such as long-acting ß2 agonists (LABAs) or long-acting muscarinic antagonists (LAMAs), are the cornerstone of maintenance therapy for patients with moderate-to-very-severe COPD. For patients not sufficiently controlled on a single long-acting bronchodilator, a combination of different bronchodilators has shown a significant increase in lung function. Tiotropium, a once-daily dosing LAMA, demonstrated sustained improvements in lung function as well as improved health-related quality of life, reduced exacerbations, and increased survival without altering the rate of decline in the mean forced expiratory volume in 1 second (FEV1) with fairly tolerable side effects. Olodaterol is a once-daily dosing LABA that has proven to be effective in improving lung function, reducing rescue medication use, and improving dyspnea and health-related quality of life, as well as improving exercise endurance with an acceptable safety profile. The combination of olodaterol and tiotropium provided additional improvements in lung function greater than monotherapy with each drug alone. Several well-designed randomized trials confirmed that the synergistic effect of both drugs in combination was able to improve lung function and health-related quality of life without a significant increase in adverse effects. The objective of this paper is to review available evidence on the clinical efficacy and safety of tiotropium, olodaterol, and their combination in patients with COPD.


Assuntos
Agonistas de Receptores Adrenérgicos beta 2/administração & dosagem , Benzoxazinas/administração & dosagem , Broncodilatadores/administração & dosagem , Antagonistas Colinérgicos/administração & dosagem , Pulmão/efeitos dos fármacos , Doença Pulmonar Obstrutiva Crônica/tratamento farmacológico , Brometo de Tiotrópio/administração & dosagem , Administração por Inalação , Agonistas de Receptores Adrenérgicos beta 2/efeitos adversos , Agonistas de Receptores Adrenérgicos beta 2/economia , Agonistas de Receptores Adrenérgicos beta 2/farmacocinética , Benzoxazinas/efeitos adversos , Benzoxazinas/economia , Benzoxazinas/farmacocinética , Broncodilatadores/efeitos adversos , Broncodilatadores/economia , Broncodilatadores/farmacocinética , Antagonistas Colinérgicos/efeitos adversos , Antagonistas Colinérgicos/economia , Antagonistas Colinérgicos/farmacocinética , Análise Custo-Benefício , Esquema de Medicação , Combinação de Medicamentos , Custos de Medicamentos , Sinergismo Farmacológico , Volume Expiratório Forçado , Humanos , Pulmão/fisiopatologia , Doença Pulmonar Obstrutiva Crônica/diagnóstico , Doença Pulmonar Obstrutiva Crônica/economia , Doença Pulmonar Obstrutiva Crônica/fisiopatologia , Qualidade de Vida , Recuperação de Função Fisiológica , Brometo de Tiotrópio/efeitos adversos , Brometo de Tiotrópio/economia , Brometo de Tiotrópio/farmacocinética , Resultado do Tratamento
10.
Appl Health Econ Health Policy ; 13(6): 637-45, 2015 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-26324401

RESUMO

OBJECTIVES: The objective of this study was to compare the cost effectiveness of once-daily Seebri Breezhaler(®) (glycopyrronium bromide) 50 µg with Spiriva(®) (tiotropium bromide) 18 µg in the maintenance treatment of chronic obstructive pulmonary disease (COPD) in the Swedish setting. METHODS: A previously published COPD Markov model accounting for disease progression and treatment discontinuation was used. Disease progression included the annual decline in forced expiratory volume in the first second (FEV1) and occurrence of any exacerbations. Efficacy in the model consisted of FEV1 improvement between baseline and 12 weeks and the annual risk ratio of having an exacerbation compared to placebo. These clinical efficacy inputs were derived from a 1-year head-to-head trial comparing glycopyrronium 50 µg to tiotropium 18 µg. Utility values and cost estimates were obtained from the literature. The base-case analysis was performed for a 3-year time horizon. Cost and effects were discounted with 3% in accordance to Swedish guidelines. Uncertainty was assessed by one-way and probabilistic sensitivity analyses. RESULTS: Glycopyrronium was found to be less costly and more effective than tiotropium in moderate to severe COPD patients with cost savings of 5197 Swedish kronor (€570, US$725) per patient over a 3-year time horizon. The probabilistic sensitivity analysis indicated that over 99% of the iterations produced dominant results for glycopyrronium. CONCLUSION: Glycopyrronium bromide 50 µg once daily can be considered a cost effective alternative to tiotropium bromide 18 µg once daily in the maintenance treatment of COPD patients in Sweden.


Assuntos
Broncodilatadores/economia , Broncodilatadores/uso terapêutico , Análise Custo-Benefício , Glicopirrolato/economia , Glicopirrolato/uso terapêutico , Antagonistas Muscarínicos/economia , Antagonistas Muscarínicos/uso terapêutico , Doença Pulmonar Obstrutiva Crônica/tratamento farmacológico , Brometo de Tiotrópio/economia , Brometo de Tiotrópio/uso terapêutico , Feminino , Volume Expiratório Forçado , Humanos , Masculino , Pessoa de Meia-Idade , Suécia
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