There was an error in this gadget
Powered by Blogger.

RSS Subscription

Subscribe via RSS reader:
Subscribe via Email Address:
 
Featured Post

Wednesday, 1 May 2013

Bronchiectasis Linked to Higher Mortality in COPD Patients


Smoking, pulmonary hypertension, and a decline in lung function are associated with an increased risk of death in people with chronic obstructive pulmonary disease (COPD). Now researchers in Spain have added another potential risk factor: the presence and severity of bronchiectasis.
Compared with unaffected patients with COPD, patients with bronchiectasis had more than double the risk of dying than those without, according to a prospective, observational study published online February 8 in the American Journal of Respiratory and Critical Care Medicine.
Miguel Angel Martínez-García, MD, from the Pneumology Service at the University and Polytechnic La Fe Hospital in Valencia, Spain, and colleagues assessed 201 participants with moderate to severe COPD from a consecutive series of outpatients diagnosed at 1 of 2 specialty clinics in Spain. The mean age of participants was 70 years, and 91% were men. A majority (77%) featured radiologic signs of emphysema. Patients were diagnosed between January 2004 and February 2007.
"Patients with bronchiectasis in our series were 2.5 times more likely to die than those without bronchiectasis, independently of other variables," the researchers write.
Of the participants, 115 (57%) presented with bronchiectasis, which is defined "as a permanent and progressive dilation of the airways." The researchers followed up the participants every 3 to 6 months for a median of 48 months. Mortality risk among these patients with bronchiectasis was higher compared with that for the 86 unaffected patients (unadjusted hazard ratio, 4.07; 95% confidence interval, 1.9 - 8.7; P = .0001).
Bronchiectasis remained an independent factor after adjustment for dyspnea (Medical Research Council Dyspnea Scale), partial pressure of oxygen, body mass index, presence of potentially pathogenic microorganisms in sputum, presence of daily sputum production, number of severe exacerbations and peripheral albumin, and ultrasensitive C-reactive protein concentrations (adjusted hazard ratio, 2.54; 95% confidence interval, 1.16 - 5.56; P = .02). Age, Charlson Index, and postbronchodilator forced expiratory volume in 1 second (%) were also significantly associated with mortality in the adjusted model.
"The results of this study confirm a high prevalence of bronchiectasis in moderate-to-severe COPD patients and suggest that bronchiectasis is independently associated with an increased risk of all-cause mortality in these patients," the authors write.
The 51 deaths during follow-up were attributed to respiratory causes (32 patients), cardiovascular disease (11), malignant disease (5), and other causes (3 patients). Other factors that can influence mortality in patients with COPD were not assessed (eg, inactivity or pulmonary hypertension), which is a limitation of the study.
Use of bronchiectasis as a new factor for prognosis would "have a major clinical impact," the authors note. Detection of bronchiectasis with high-resolution computed tomography scans is reliable, and, once identified, patients can be treated with effective therapy to combat the chronic bronchial inflammation and infection.
"The pathogenic vicious circle of infection-inflammation leading to the formation of bronchiectasis can probably be broken by the early identification of this subgroup of patients with COPD and bronchiectasis and the establishment of early treatment, probably focusing on bronchial colonization by [potentially pathogenic microorganisms]."
Therefore, high-resolution computed tomography chest imaging should be considered for patients with COPD who are at higher risk for bronchiectasis, according to the investigators. Severe disease, multiple or severe exacerbations of COPD, and chronic colonization by potentially pathogenic microorganisms can elevate the risk. Further studies are warranted to confirm the results and to clarify the association between bronchiectasis and COPD exacerbations, the authors note.
This study was supported by Praxis Pharmaceutical. The authors have disclosed no relevant financial relationships.

Bronchiectasis Linked to Higher Mortality in COPD Patients


Smoking, pulmonary hypertension, and a decline in lung function are associated with an increased risk of death in people with chronic obstructive pulmonary disease (COPD). Now researchers in Spain have added another potential risk factor: the presence and severity of bronchiectasis.
Compared with unaffected patients with COPD, patients with bronchiectasis had more than double the risk of dying than those without, according to a prospective, observational study published online February 8 in the American Journal of Respiratory and Critical Care Medicine.
Miguel Angel Martínez-García, MD, from the Pneumology Service at the University and Polytechnic La Fe Hospital in Valencia, Spain, and colleagues assessed 201 participants with moderate to severe COPD from a consecutive series of outpatients diagnosed at 1 of 2 specialty clinics in Spain. The mean age of participants was 70 years, and 91% were men. A majority (77%) featured radiologic signs of emphysema. Patients were diagnosed between January 2004 and February 2007.
"Patients with bronchiectasis in our series were 2.5 times more likely to die than those without bronchiectasis, independently of other variables," the researchers write.
Of the participants, 115 (57%) presented with bronchiectasis, which is defined "as a permanent and progressive dilation of the airways." The researchers followed up the participants every 3 to 6 months for a median of 48 months. Mortality risk among these patients with bronchiectasis was higher compared with that for the 86 unaffected patients (unadjusted hazard ratio, 4.07; 95% confidence interval, 1.9 - 8.7; P = .0001).
Bronchiectasis remained an independent factor after adjustment for dyspnea (Medical Research Council Dyspnea Scale), partial pressure of oxygen, body mass index, presence of potentially pathogenic microorganisms in sputum, presence of daily sputum production, number of severe exacerbations and peripheral albumin, and ultrasensitive C-reactive protein concentrations (adjusted hazard ratio, 2.54; 95% confidence interval, 1.16 - 5.56; P = .02). Age, Charlson Index, and postbronchodilator forced expiratory volume in 1 second (%) were also significantly associated with mortality in the adjusted model.
"The results of this study confirm a high prevalence of bronchiectasis in moderate-to-severe COPD patients and suggest that bronchiectasis is independently associated with an increased risk of all-cause mortality in these patients," the authors write.
The 51 deaths during follow-up were attributed to respiratory causes (32 patients), cardiovascular disease (11), malignant disease (5), and other causes (3 patients). Other factors that can influence mortality in patients with COPD were not assessed (eg, inactivity or pulmonary hypertension), which is a limitation of the study.
Use of bronchiectasis as a new factor for prognosis would "have a major clinical impact," the authors note. Detection of bronchiectasis with high-resolution computed tomography scans is reliable, and, once identified, patients can be treated with effective therapy to combat the chronic bronchial inflammation and infection.
"The pathogenic vicious circle of infection-inflammation leading to the formation of bronchiectasis can probably be broken by the early identification of this subgroup of patients with COPD and bronchiectasis and the establishment of early treatment, probably focusing on bronchial colonization by [potentially pathogenic microorganisms]."
Therefore, high-resolution computed tomography chest imaging should be considered for patients with COPD who are at higher risk for bronchiectasis, according to the investigators. Severe disease, multiple or severe exacerbations of COPD, and chronic colonization by potentially pathogenic microorganisms can elevate the risk. Further studies are warranted to confirm the results and to clarify the association between bronchiectasis and COPD exacerbations, the authors note.
This study was supported by Praxis Pharmaceutical. The authors have disclosed no relevant financial relationships.

FDA Floats Draft Guidance for Alzheimer's Drug Development


The US Food and Drug Administration (FDA) today issued a proposal designed to assist companies focused on the development of new treatments for patients in the early stages of Alzheimer's disease (AD).
"The scientific community and the FDA believe that it is critical to identify and study patients with very early Alzheimer's disease before there is too much irreversible injury to the brain," Russell Katz, MD, director of the Division of Neurology Products in the FDA's Center for Drug Evaluation and Research, said in a statement announcing the draft proposal. "It is in this population that most researchers believe that new drugs have the best chance of providing meaningful benefit to patients," he added.
The guidance document outlines the FDA's current thinking about how best to identify and select patients with early AD, or those who are at risk of developing the disease, for enrollment in clinical trials, the FDA explains.
The proposal addresses the selection of endpoints for clinical trials in these populations, as well as the manner in which disease modification might be demonstrated.
"We recognize that the standard approaches to the selection of outcome measures historically used in the development of treatments for dementia of the Alzheimer's type have major limitations when applied to clinical trials enrolling patients in the early clinical stages of the disease, or before clinical impairment has emerged at all," the proposal states. "This guidance addresses some possible adaptations of the current approach to drug development for the treatment of the dementia stage of AD that appear more appropriate for clinical trials in the early stages of the illness."
A Tool for Discussion
"This draft guidance," Dr. Katz emphasized, "is intended to serve as a focus for continued discussions between the FDA and pharmaceutical sponsors, the academic community, advocacy groups, and the public. The FDA is committed to vigorously addressing Alzheimer's disease and will work with industry to help develop new treatments in this early population as expeditiously as possible."
The design of clinical trials specifically focused on the treatment of patients with established AD dementia (ie, dementia of the Alzheimer's type), or any of the autosomal dominant forms of Alzheimer's, is not explicitly discussed in the guidance, "although many of the principles in this guidance will be pertinent to this setting as well," the FDA notes.
The agency is seeking public comment on the draft guidance for 60 days. Instructions on how to submit comments are included in a related Federal Register notice issued today.
The FDA proposal is part of the US Department of Health and Human Services' (HHS's) efforts under the National Plan to Address Alzheimer's Disease, which calls for both the government and the private sector to intensify efforts to treat or prevent Alzheimer's and related dementias and to improve care and services.
The proposal responds to recommendations from a May 2012 HHS and National Institutes of Health Alzheimer's research summit to conduct clinical trials in at-risk individuals without symptoms and to develop and validate new measures so that Alzheimer's can be measured at the earliest possible time in the course of the disease.