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1.
Clin Drug Investig ; 32(3): 189-202, 2012 Mar 01.
Artigo em Inglês | MEDLINE | ID: mdl-22292415

RESUMO

BACKGROUND: The lack of adequate glycaemic control for patients with type 2 diabetes mellitus (T2DM), especially with existing second-line therapies, represents an unmet medical need. Of the newer therapies, the incretin-based medicines, such as saxagliptin, look promising to consolidate second-line pharmacotherapy. OBJECTIVE: This study evaluates the long-term economic consequences of saxagliptin versus sulfonylurea (glipizide) as second-line therapy when used in combination with metformin after failure of monotherapy treatment with metformin, in patients with T2DM in Germany. METHODS: A published discrete event simulation model with a fixed-time increment was used to model the effects of different treatment scenarios over a 40-year (life-) time horizon. Disease progression was modelled using evidence from the United Kingdom Prospective Diabetes Study (UKPDS) 68. The treatment sequence matched that of published German guidelines, and efficacy and safety data were derived from published sources. The model assumes that quality-adjusted life-years (QALYs) are affected by complications, hypoglycaemic events and weight change over a lifetime. Costs were specific to the German setting, where sulfonylureas are generic. Costs and effects were discounted annually at 3%. The extended perspective of the national sick funds was adopted, and recommendations from the Institute for Quality and Efficiency in Health Care (IQWiG) were considered. RESULTS: In the base-case analysis, treatment with saxagliptin plus metformin was associated with a lower incidence of both symptomatic and severe hypoglycaemic events, resulting in an incremental benefit of 0.12 QALYs and an incremental cost-effectiveness ratio (ICER) of €13,931 per QALY gained compared with sulfonylurea plus metformin (year of costing 2009). Modest reductions in all macro- and microvascular complications were seen in those receiving saxagliptin plus metformin compared with sulfonylurea plus metformin. Sensitivity analysis showed that treatment-related weight changes, as a risk factor for complications, represent the most influential driver of cost effectiveness. CONCLUSION: The study demonstrated improved outcomes with saxagliptin at a cost that would likely be considered acceptable in the German setting. Furthermore, the findings of the sensitivity analysis suggest that the results are robust to various assumptions concerning input variables and modelling assumptions.


Assuntos
Adamantano/análogos & derivados , Diabetes Mellitus Tipo 2/tratamento farmacológico , Dipeptídeos/administração & dosagem , Inibidores da Dipeptidil Peptidase IV/administração & dosagem , Glipizida/administração & dosagem , Hipoglicemiantes/administração & dosagem , Metformina/administração & dosagem , Adamantano/administração & dosagem , Análise Custo-Benefício , Quimioterapia Combinada , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Anos de Vida Ajustados por Qualidade de Vida
2.
Chest ; 124(2): 526-35, 2003 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-12907538

RESUMO

STUDY OBJECTIVE: To evaluate costs, clinical consequences, and cost-effectiveness from a German and French health-care system perspective of sequential i.v./po moxifloxacin monotherapy compared to co-amoxiclav with or without clarithromycin (AMC +/- CLA) in patients with community-acquired pneumonia (CAP) who required parenteral treatment. METHODS: Costs and consequences over 21 days were evaluated based on clinical cure rates 5 to 7 days after treatment and health resource use reported for the TARGET multinational, prospective, randomized, open-label trial. This trial compared sequential i.v./po monotherapy with moxifloxacin (400 mg qd) to i.v./po co-amoxiclav (1.2 g i.v./625 mg po tid) with or without clarithromycin (500 mg bid) for 7 to 14 days in hospitalized patients with CAP. Since no country-by-treatment interaction was found in spite of some country differences for length of hospital stays, resource data (antimicrobial treatment, hospitalization, and out-of-hospital care) from all centers were pooled and valued using German and French unit prices to estimate CAP-related cost to the German Sickness Funds and French public health-care sector, respectively. RESULTS: Compared to AMC +/- CLA, treatment with moxifloxacin resulted in 5.3% more patients achieving clinical cure 5 to 7 days after therapy (95% confidence interval [CI], 1.2 to 11.8%), increased speed of response (1 day sooner for median time to first return to apyrexia, p = 0.008), and a reduction in hospital stay by 0.81 days (95% CI, - 0.01 to 1.63) within the 21-day time frame. Treatment with moxifloxacin resulted in savings of 266 euro and 381 euro for Germany and France respectively, primarily due to the shorter length of hospital stay. Cost-effectiveness acceptability curves show moxifloxacin has a > or = 95% chance of being cost saving from French and German health-care perspectives, and higher probability of being cost-effective at acceptability thresholds up to 2,000 euro per additional patient cured. CONCLUSION: i.v./po monotherapy with moxifloxacin shows clinical benefits including increased speed of response and is cost-effective compared to i.v./po AMC +/- CLA in the treatment of CAP.


Assuntos
Combinação Amoxicilina e Clavulanato de Potássio , Anti-Infecciosos , Compostos Aza , Fluoroquinolonas , Pneumonia Bacteriana/tratamento farmacológico , Quinolinas , Administração Oral , Combinação Amoxicilina e Clavulanato de Potássio/administração & dosagem , Combinação Amoxicilina e Clavulanato de Potássio/economia , Combinação Amoxicilina e Clavulanato de Potássio/uso terapêutico , Anti-Infecciosos/administração & dosagem , Anti-Infecciosos/economia , Anti-Infecciosos/uso terapêutico , Claritromicina , Infecções Comunitárias Adquiridas/tratamento farmacológico , Infecções Comunitárias Adquiridas/economia , Análise Custo-Benefício , Quimioterapia Combinada , Feminino , França , Alemanha , Hospitalização , Humanos , Injeções Intravenosas , Masculino , Pessoa de Meia-Idade , Moxifloxacina , Pneumonia Bacteriana/economia , Ensaios Clínicos Controlados Aleatórios como Assunto
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