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Efficacy of roflumilast in the chronic obstructive pulmonary disease frequent exacerbator phenotype.

Chest. 2012 Nov 1;

Authors: Wedzicha1 JA, Rabe2 KF, Martinez3 FJ, Bredenbröker4 D, Brose5 M, Goehring4 UM, Calverley6 PM

Abstract
ABSTRACT BACKGROUND: COPD exacerbations are associated with increased morbidity and mortality and can accelerate disease progression. The best predictor of future exacerbations is a history of previous exacerbations, which helps identify a frequent exacerbator phenotype. This post-hoc analysis evaluated the effect of roflumilast, a drug known to reduce COPD exacerbation rate, on exacerbation status. METHODS: Pooled data from two 1-year, placebo-controlled, roflumilast (500μg once daily) studies in symptomatic COPD patients with severe airflow obstruction were evaluated (studies M2-124 and M2-125, ClinicalTrials.gov identifiers NCT00297102 and NCT00297115). A total of 3,091 patients were included in this analysis (62.5% with GOLD 3 COPD, 29.2% with GOLD 4). Based on their exacerbation frequency status in the previous year, patients were classified as frequent (≥ 2 events) or infrequent exacerbators (<2 events). Exacerbation frequency was analyzed at baseline and year 1. RESULTS: Among frequent exacerbators treated with roflumilast, 32.0% still had frequent exacerbations at year 1 versus 40.8% of placebo-treated patients (Risk ratio 0.799, p=0.0148). Among infrequent exacerbators, 17.5% of roflumilast-treated patients became frequent exacerbators at year 1, versus 22.9% of those taking placebo (Risk ratio 0.768, p=0.0018). The reduction in severe exacerbations leading to hospitalization/death was similar between subgroups, and occurred independently of concomitant long-acting β2-agonists or previous inhaled corticosteroid treatment. When analyzed by severity of airflow limitation, 26.4% of roflumilast-treated frequent exacerbators with GOLD 3 remained frequent exacerbators at year 1 versus 38.9% of those taking placebo (p=0.0042). CONCLUSIONS: Treatment with roflumilast shifts patients from the frequent to the more stable infrequent exacerbator state.

PMID: 23117188 [PubMed - as supplied by publisher]

The COPD control panel: towards personalised medicine in COPD.

Thorax. 2012 Nov 1;

Authors: Agusti A, Macnee W

Abstract
BACKGROUND: Chronic obstructive pulmonary disease (COPD) is a heterogeneous disease whose assessment and management have traditionally been based on the severity of airflow limitation (forced expiratory volume in 1 s (FEV(1))). Yet, it is now clear that FEV(1) alone cannot describe the complexity of the disease. In fact, the recently released Global Initiative for Chronic Obstructive Lung Disease (GOLD), 2011 revision has proposed a new combined assessment method using three variables (symptoms, airflow limitation and exacerbations). METHODS: Here, we go one step further and propose that in the near future physicians will need a 'control panel' for the assessment and optimal management of individual patients with complex diseases, including COPD, that provides a path towards personalised medicine. RESULTS: We propose that such a 'COPD control panel' should include at least three different domains of the disease: severity, activity and impact. Each of these domains presents information on different 'elements' of the disease with potential prognostic value and/or with specific therapeutic requirements. All this information can be easily incorporated into an 'app' for daily use in clinical practice. CONCLUSION: We recognise that this preliminary proposal needs debate, validation and evolution (eg, including 'omics' and molecular imaging information in the future), but we hope that it may stimulate debate and research in the field.

PMID: 23117977 [PubMed - as supplied by publisher]

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Profile of glycopyrronium for once-daily treatment of moderate-to-severe COPD.

Int J Chron Obstruct Pulmon Dis. 2012;7:729-41

Authors: Buhl R, Banerji D

Abstract
Bronchodilators are central in the symptomatic management of chronic obstructive pulmonary disease (COPD). Long-acting muscarinic antagonists (LAMAs) and long-acting β(2)-agonists (LABAs) are the main classes of long-acting bronchodilators. To date, tiotropium is the only once-daily LAMA available for the treatment of COPD. Glycopyrronium is a novel LAMA, currently in development for COPD. Phase II studies have shown that glycopyrronium 50 μg once daily provides clinically significant 24-hour bronchodilation with a rapid onset of action, which is faster than that of tiotropium, and a favorable safety and tolerability profile. The Phase III GLycopyrronium bromide in COPD airWays (GLOW) program has now confirmed the long-term efficacy and tolerability of glycopyrronium 50 μg once daily. The three studies included in this program have further shown that the effect of glycopyrronium versus placebo is similar to that of tiotropium in reducing dyspnea and the risk of exacerbations, as well as improving lung function, exercise tolerance, and health status in patients with COPD. The safety profile of glycopyrronium is also similar to that of tiotropium in terms of overall incidence of adverse events and muscarinic side effects. Glycopyrronium could be an alternative choice to tiotropium, and like tiotropium, has the potential to be used as a monotherapy or combination therapy. Phase II studies have shown that a fixed-dose combination of glycopyrronium and the 24-hour LABA indacaterol, produces rapid and sustained bronchodilation compared with indacaterol monotherapy in patients with COPD. Phase III studies are currently ongoing to assess the long-term efficacy and safety of this combination.

PMID: 23118536 [PubMed - in process]

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Diagnosis and treatment of latent infection with Mycobacterium tuberculosis.

Respirology. 2012 Oct 29;

Authors: Chee CB, Sester M, Zhang W, Lange C

Abstract
In clinical practice latent infection with Mycobacterium tuberculosis is defined by the presence of a M. tuberculosis specific immune response in the absence of active tuberculosis. Targeted testing of individuals from risk groups with the tuberculin-skin-test or an interferon-γ release assay is currently the best method to identify those with the highest risk for progression to tuberculosis. Positive predictive values of the immunodiagnostic tests are substantially influenced by the type of test, the age of the person who is tested, the prevalence of tuberculosis in the society and the risk group to which the person belongs. As a general rule, testing should only be offered when preventive chemotherapy will be accepted in the case of a positive test result. Preventive chemotherapy can effectively protect individuals at risk from the development of tuberculosis, although at least 3 months of combination therapy or up to 9 months of monotherapy are required, and overall acceptance rate is low. Improvements of the current generation of immunodiagnostic tests could substantially lower the number of individuals that need to be treated to prevent a case of tuberculosis. If shorter treatment regimens were equally effective than those currently recommended, acceptance of preventive chemotherapy could be much improved. © 2012 The Authors. Respirology © 2012 Asian Pacific Society of Respirology.

PMID: 23107218 [PubMed - as supplied by publisher]