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Heterogeneity in clinical characteristics and co-morbidities in dyspneic individuals with COPD GOLD D: Findings of the DICES trial

Publication date: August 2013 Source:Respiratory Medicine, Volume 107, Issue 8

Author(s): Maurice J.H. Sillen , Frits M.E. Franssen , Jeannet M.L. Delbressine , Nicole H.M.K. Uszko-Lencer , Lowie E.G.W. Vanfleteren , Erica P.A. Rutten , Emiel F.M. Wouters , Martijn A. Spruit

Introduction Chronic obstructive pulmonary disease (COPD) is a complex and heterogeneous respiratory disease with important extra-pulmonary features and comorbidities. The aim of this study was to assess clinical heterogeneity in a well-defined subgroup of individuals with COPD GOLD D, including possible gender differences. Methods Pulmonary function, arterial blood gases, exercise performance, quadriceps muscle function, problematic activities of daily life, dyspnea, health status and comorbidities have been assessed in 117 individuals with a MRC dyspnea grade 4/5 and COPD GOLD D entering pulmonary rehabilitation. Results A broad range of values were found for diffusion capacity, exercise capacity, quadriceps muscle function and health status. Indeed, the high coefficients of variation were found for these outcomes. Problematic activities of daily life as well as objectified comorbidities also varied to a great extent. Moreover, significant gender differences were found for exercise performance, lower-limb muscle function and various comorbidities. Conclusion The current findings emphasize that COPD is a heterogeneous disease whose clinical presentation varies significantly, even in individuals with very severe COPD with the same degree of dyspnea and all classified as GOLD D. Trial registration: NTR2322.





Safety and efficacy of pirfenidone in idiopathic pulmonary fibrosis in clinical practice

Publication date: Available online 9 July 2013 Source:Respiratory Medicine

Author(s): Ryo Okuda , Eri Hagiwara , Tomohisa Baba , Hideya Kitamura , Terufumi Kato , Takashi Ogura

Backgroud Previous pirfenidone trials have only involved patients with mild-to-moderate idiopathic pulmonary fibrosis (IPF). The aim of this study was to investigate the safety and efficacy of pirfenidone in patients with mild-to-severe IPF in clinical practice. Methods The clinical records of 76 patients who were diagnosed with IPF and received pirfenidone were reviewed. Results The most frequent adverse event was anorexia, although the grade of anorexia in most patients was mild. Dose reduction of pirfenidone improved anorexia in 84% affected patients, which resulted in a high medication compliance rate. The mean forced vital capacity (FVC) at the initiation of pirfenidone therapy in this study was approximately 10% lower than that in previous clinical trials. The mean change in FVC during the 6-month period prior to the therapy initiation was −188 mL, which improved to −19 mL during the 6-month period after therapy. Significant attenuation in percentage predicted diffusion capacity of the lung for carbon monoxide decline was also achieved after pirfenidone therapy initiation. The efficacy of pirfenidone in attenuating the degree of FVC decline was higher in the group with FVC decline of ≥150 mL during the 6-month period prior to therapy initiation. The levels of serum markers, such as KL-6 and SP-D, were also lowered by the therapy. Conclusions These results showed that pirfenidone was well-tolerated and had beneficial effects in patients with mild-to-severe and/or progressive IPF. The degree of disease progression prior to the initiation of pirfenidone therapy had an impact on the response to the therapy.





Cost effectiveness of adding budesonide/formoterol to tiotropium in COPD in four Nordic countries

Publication date: Available online 13 July 2013 Source:Respiratory Medicine

Author(s): Rune Nielsen , Hannu Kankaanranta , Leif Bjermer , Peter Lange , Sofie Arnetorp , Morten Hedegaard , Anna Stenling , Nicole Mittmann

Objective Assess the cost effectiveness of budesonide/formoterol (BUD/FORM) Turbuhaler®+tiotropium (TIO) HandiHaler® vs. placebo (PBO)+TIO in patients with chronic obstructive pulmonary disease (COPD) eligible for inhaled corticosteroids/long-acting β2-agonists (ICS/LABA). Methods The cost-effectiveness analysis was based on the 12-week, randomised, double-blind CLIMB trial. The study included 659 patients with pre-bronchodilator forced expiratory volume in 1 s ≤ 50% and ≥1 exacerbation requiring systemic glucocorticosteroids or antibiotics the preceding year. Patients received BUD/FORM 320/9 μg bid + TIO 18 μg qd or PBO bid + TIO 18 μg qd. Effectiveness was defined as the number of severe exacerbations (hospitalisation/emergency room visit/systemic glucocorticosteroids) avoided. A sub-analysis included antibiotics in the definition of an exacerbation. Resource use from CLIMB was combined with Danish (DKK), Finnish (€), Norwegian (NOK) and Swedish (SEK) unit costs (2010). The incremental cost-effectiveness ratios (ICERs) for BUD/FORM + TIO vs. PBO + TIO were estimated using descriptive statistics and uncertainty around estimates using bootstrapping. Analyses were conducted from the societal and healthcare perspectives in Denmark, Finland, Norway and Sweden. Results From a societal perspective, the ICER was estimated at €174/severe exacerbation avoided in Finland while BUD/FORM + TIO was dominant in the other countries. From the healthcare perspective, ICERs were DKK 1580 (€212), €307 and SEK 1573 (€165) per severe exacerbation avoided for Denmark, Finland and Sweden, respectively, while BUD/FORM + TIO was dominant in Norway. Including antibiotics decreased ICERs by 8–15%. Sensitivity analyses showed that results were overall robust. Conclusion BUD/FORM + TIO represents a clinical and economic benefit to health systems and society for the treatment of COPD in the Nordic countries. (ClinicalTrials.gov Identifier: NCT00496470).





Daily vs. intermittent inhaled corticosteroids for recurrent wheezing and mild persistent asthma: A systematic review with meta-analysis

Intermittent ICS treatment with SABA in response to symptoms, is an emerging strategy for control of mild-to-moderate asthma, and recurrent wheezing. This systematic revue compares the efficacy of daily vs. intermittent ICS among preschoolers, children and adults with persistent wheezing and mild to moderate stable persistent asthma.

Methods : Systematic review of randomized, placebo-controlled trials with a minimum of 8 weeks of daily (daily ICS with rescue SABA during exacerbations) vs. intermittent ICS (ICS plus SABA at the onset of symptoms), were retrieved through different databases. Primary outcome was asthma exacerbations; secondary outcomes were pulmonary function tests, symptoms, days without symptoms, SABA use, corticosteroids use, days without rescue medication use, expired nitric oxide and serious adverse events.

Results : Seven trials (1367 participants) met inclusion criteria there was no statistically significant difference in the rate of asthma exacerbations between those with daily vs. intermittent ICS (0.96; 95% CI: 0.86, 1.06, I2 = 0%). In the sub-group analysis, no differences were seen in duration of studies, step-up strategy or age. However, compared to intermittent ICS, the daily ICS group had a significant increase in asthma-free days and non-significant decreases in rescue SABA use and exhaled nitric oxide measurement.

Conclusions : No significant differences between daily and intermittent ICS in reducing the incidence of asthma exacerbations was found. However, the daily ICS strategy was superior in many secondary outcomes. Therefore, this study suggests to not change daily for intermittent ICS use among preschoolers, children with persistent wheezing and adults with mild-to-moderate stable persistent asthma.

International prospective register of systematic reviews http://www.crd.york.ac.uk/PROSPERO/ (CRD42012003228).

Airway and parenchymal manifestations of pulmonary aspergillosis

Pulmonary aspergillosis encompasses a heterogeneous group of mycoses that result from either colonisation or pathogenic damage of lung tissue by Aspergillus fungi. These clinical entities range from relatively benign saprophytic hypersensitivity associated with fungal inhabitation to life threatening invasive disease.

The diagnosis of pulmonary disorders related to Aspergillus is on the increase and it is more important than ever those both general and respiratory physicians have a good understanding of these disorders.

This paper reviews the contemporary understanding of the clinical, radiographic and histopathological aspects of pulmonary aspergillosis.

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