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2.
Respir Res ; 19(1): 224, 2018 Nov 20.
Article in English | MEDLINE | ID: mdl-30458866

ABSTRACT

BACKGROUND: A head-to-head study demonstrated the superiority of once-daily umeclidinium bromide/vilanterol (UMEC/VI) 62.5/25 mcg on trough forced expiratory volume in 1 s (FEV1) versus once-daily tiotropium/olodaterol (TIO/OLO) 5/5 mcg in symptomatic patients with chronic obstructive pulmonary disease (COPD). This analysis evaluated the cost effectiveness of UMEC/VI versus TIO/OLO from a Spanish National Healthcare System perspective, using data from this study and Spanish literature. METHODS: This analysis was conducted from the perspective of the Spanish National Healthcare System with a 3-year horizon as base case. A disease progression model using a linked risk equation approach was used to estimate disease progression and associated healthcare costs, and quality-adjusted life years (QALYs). The Evaluation of COPD Longitudinally to Identify Predictive Surrogate Endpoints (ECLIPSE) study was used to develop the statistical risk equations for clinical endpoints, and costs were calculated using a health state approach (by dyspnea severity). Utilities for QALY calculation were estimated using patient baseline characteristics within a regression fit to Spanish observational data. Treatment effect, expressed as change from baseline in FEV1 was obtained from the head-to-head study and used in the model (UMEC/VI minus TIO/OLO difference: + 52 mL [95% confidence interval: 28, 77]). Baseline patient characteristics were sourced from Spanish literature or the head-to-head study if unavailable. A scenario analysis using only the intent-to-treat (ITT) population from the head-to-head study, and sensitivity analyses (including probabilistic sensitivity analyses), were conducted. Direct healthcare costs (2017 Euro) were obtained from Spanish sources and costs and benefits were discounted at 3% per annum. RESULTS: UMEC/VI was associated with small improvements in QALYs (+ 0.029) over a 3-year time horizon, compared with TIO/OLO, alongside cost savings of €393/patient. The ITT scenario analysis and sensitivity analyses had similar results. All probabilistic simulations resulted in UMEC/VI being less costly and more effective than TIO/OLO. CONCLUSION: UMEC/VI dominated TIO/OLO (more effective and less expensive). These results may aid payers and decision-makers in Spain when making judgements on which long-acting muscarinic antagonist/long-acting ß2-agonist (LAMA/LABA) treatments can be considered cost effective in Spain.


Subject(s)
Benzoxazines/economics , Benzyl Alcohols/economics , Chlorobenzenes/economics , Cost-Benefit Analysis/methods , National Health Programs/economics , Pulmonary Disease, Chronic Obstructive/economics , Quinuclidines/economics , Tiotropium Bromide/economics , Aged , Benzoxazines/administration & dosage , Benzyl Alcohols/administration & dosage , Chlorobenzenes/administration & dosage , Cross-Over Studies , Drug Combinations , Female , Humans , Male , Middle Aged , Prospective Studies , Pulmonary Disease, Chronic Obstructive/drug therapy , Pulmonary Disease, Chronic Obstructive/epidemiology , Quinuclidines/administration & dosage , Single-Blind Method , Spain/epidemiology , Tiotropium Bromide/administration & dosage
3.
J Hum Nutr Diet ; 23(6): 601-8, 2010 Dec.
Article in English | MEDLINE | ID: mdl-20609036

ABSTRACT

BACKGROUND: The prevalence of the metabolic syndrome is increasing, especially in young individuals. Most of the previous studies that have investigated the association between dietary fibre intake and the metabolic syndrome are cross-sectional or of short duration, and their results are inconsistent. The present study investigated whether dietary fibre intake during adolescence has a protective effect on developing the metabolic syndrome as an adult. METHODS: Data on dietary intake and metabolic syndrome components were derived from a healthy sample of 174 men and 194 women who were followed-up from the age of 13 years onwards in the Amsterdam Growth and Health Longitudinal Study. Data were analysed with use of generalised estimating equations and linear regression analyses. RESULTS: The mean dietary fibre intake was 9.9 g/4.0 MJ (1000 kcal) during adolescence and 10.8 g/4.0 MJ (1000 kcal) at age 36 years. The prevalence of the metabolic syndrome at age 36 years was 10.1%. No differences were found in the time-course of dietary fibre intake between subjects with and those without the metabolic syndrome or its components. Dietary fibre intake during adolescence was not related to the components of the metabolic syndrome at age 36 years, except for an inverse relationship with waist circumference, where a gram/4.0 MJ (1000 kcal) higher fibre intake was associated with a 0.44 cm smaller waist circumference (P = 0.03, 95% CI -0.85 to -0.04). CONCLUSIONS: The present study found no association between dietary fibre intake and the metabolic syndrome in young adults. High fibre intake, however, was inversely associated with waist circumference.


Subject(s)
Dietary Fiber/administration & dosage , Metabolic Syndrome/epidemiology , Adolescent , Blood Pressure , Diet , Exercise , Female , Follow-Up Studies , Humans , Linear Models , Lipids/blood , Longitudinal Studies , Male , Metabolic Syndrome/diagnosis , Netherlands/epidemiology , Waist Circumference
4.
Eur J Clin Nutr ; 63(4): 536-42, 2009 Apr.
Article in English | MEDLINE | ID: mdl-18270523

ABSTRACT

BACKGROUND/OBJECTIVES: Coffee consumption has been postulated to decrease the risk of diabetes mellitus type II. The long-term effects of coffee consumption on the metabolic syndrome (MS) and its components are unknown. This study investigated the relationship of long-term coffee consumption between the age of 27 and 36 years with the prevalence of the MS at the age of 36 years. SUBJECT/METHODS: Data on coffee consumption and the MS components were derived from a healthy sample of 174 men and 194 women followed up from the age of 27 years onwards. Data analysis was performed with the use of generalized estimating equations and regression analysis. RESULTS: At the age of 36 years, the prevalence of the MS was 10.1%. The growth of coffee consumption did not differ significantly between subjects with or without the MS or its components. Regression analyses showed that one cup day(-1) higher coffee consumption was related to 0.11 mm Hg lower mean arterial blood pressure (P=0.03), 0.02 mg 100 ml(-1) higher triglyceride level (P=0.57), 0.04 mg 100 ml(-1) higher high-density lipoprotein cholesterol level (P=0.35), 0.09% higher HbA(1c) (P=0.12) and 0.02 cm larger waist circumference (P=0.57). After adjustment for physical activity, energy intake, smoking behaviour and alcohol consumption, none of the relationships between coffee consumption and the MS or its components was significant. CONCLUSIONS: Coffee consumption is not associated with the MS or its components in a healthy sample followed up for 9 years.


Subject(s)
Coffee , Metabolic Syndrome/epidemiology , Adult , Blood Pressure/drug effects , Cholesterol, HDL/blood , Coffee/adverse effects , Female , Glycated Hemoglobin/metabolism , Humans , Longitudinal Studies , Male , Metabolic Syndrome/chemically induced , Prevalence , Regression Analysis , Triglycerides/blood , Waist Circumference/drug effects
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