Obese patients with chronic obstructive pulmonary disease (COPD) stand to gain as much from pulmonary rehabilitation as their slimmer counterparts, even though as a group they have a lower exercise capacity, according to new research from the University Hospitals of Leicester in the UK.
"Like the healthy population, the prevalence of obesity is increasing in those with COPD," said Neil Greening, M.B.B.S, M.R.C.P., who led the study. "There is evidence that obesity may lower exercise capacity but at the same time appears to confer a survival advantage, which is known as the obesity paradox. Pulmonary rehabilitation is effective in improving exercise capacity and health status in COPD but it is unclear whether these benefits accrue in patients with extreme obesity. We wanted to compare the outcomes of a pulmonary rehabilitation program in patients with obesity of varying severity and normal weight subjects."
The results of their study were reported at the ATS 2010 International Conference in New Orleans.
To compare the effects of pulmonary rehabilitation between obese and non-obese patients, Dr. Greening and colleagues recruited patients with clinical and spirometric COPD and classified them according to their level of obesity, from normal weight (BMI 21-25kg/m2) to extreme obesity (BMI >40 kg/m2). The patients underwent pulmonary rehabilitation at a single center in the UK. The improvements in their exercise performance and endurance, as well as their health status (chronic respiratory questionnaire) and baseline characteristics were assessed.
"We found that obese people with COPD are more disabled in terms of exercise capacity, despite having less severe airflow obstruction (the measure used to quantify severity of COPD). However, they do just as well with rehab including those with extreme obesity," said Dr. Greening. "There is no difference between obesity subgroups in the proportion of patients achieving a clinically significant improvement in the incremental shuttle walk test."
This is the first study to look at PR in extreme obesity. While the researchers expected to find that some improvement would be seen after the pulmonary rehabilitation program, they were surprised to see no difference in training effects between normal weight and extremely obese patients.
"Patients with COPD, irrespective of body mass, improve following a pulmonary rehabilitation program. Therefore extremely obese patients with COPD should still be considered for enrolment," said Dr. Greening, adding that although there are no weight limits for pulmonary rehabilitation programs, there is likely some discrimination by medical staff who may emphasize weight loss over exercise.
There remain questions about the disparity in obese patients with COPD. Obese patients do not have the same improvements in health status following pulmonary rehabilitation. In particular, fatigue does not improve, possibly due to co-existing medical problems, such as obstructive sleep apnea or obesity hypoventilation, according to Dr, Greening. However, the most puzzling question remains the survival benefit conferred by obesity. "As medical professionals, we know that obesity is linked with medical complications such as diabetes and heart disease, so how it can lead to a survival advantage in other diseases such as COPD or chronic kidney disease is puzzling. The reasons for this are currently unknown and further research is needed."
A larger study is planned to examine some of these issues. "We are planning a study to look at the underlying mechanisms of skeletal muscle dysfunction and obesity in COPD," said Dr. Greening. "Rather than a larger multi-centre study looking at epidemiology, we are trying to understand why obesity affects patients with COPD in the way it does."
"The Effects of Pulmonary Rehabilitation on Extreme Obesity in COPD" (Session A27, Sunday, May 16, 8:15-10:45 a.m., CC-Room 293-294 (Second Level), Morial Convention Center; Abstract 1342)
Source:
Keely Savoie
American Thoracic Society
Wednesday, 19 May 2010
Tuesday, 4 May 2010
Clinical Data, Inc. Reports Results Of Phase I Studies Of Stedivaze™ Demonstrating Safety And Tolerability In Patients With Asthma And COPD
Clinical Data, Inc. (NASDAQ: CLDA), announced results from two Phase I studies of Stedivaze™ (apadenoson), which demonstrated that Stedivaze was safe and well tolerated in patients with asthma and chronic obstructive pulmonary disease (COPD). Stedivaze is a potent and highly selective agonist of the adenosine A2A receptor subtype in development as a pharmacologic stress agent for myocardial perfusion imaging (MPI). Currently available adenosine agonists must be used with caution or are contraindicated in patients with asthma and COPD. The high selectivity of Stedivaze offers a potential advantage for the safe use in this population, accounting for approximately 10 percent of the 7.6M MPI tests performed annually.1 The Company is also actively enrolling patients in ASPECT 1, a Phase III trial designed to demonstrate the safety and effectiveness of Stedivaze.
"The positive results from our preliminary studies in asthmatics and COPD patients are encouraging and represent a milestone toward our goal of developing a coronary vasodilator that is both safe and well tolerated in these populations," said Carol R. Reed, M.D., Executive Vice President and Chief Medical Officer of Clinical Data. "We intend to expand these findings by initiating further safety studies of Stedivaze in patients with asthma and COPD, while continuing to evaluate the efficacy and potential for superior tolerability of Stedivaze in our ongoing Phase III program."
In both of these placebo-controlled studies, Stedivaze was administered as a single IV bolus, at the same dose utilized in the ASPECT 1 trial. In 49 patients with mild to moderate asthma and 50 patients with moderate to severe COPD, Stedivaze had no effects on pulmonary function tests. Adverse events overall were similar in both incidence and severity to the adverse event profile seen in previous studies of Stedivaze in patients without lung disease, and continue to support its potential for improved tolerability. Most frequently observed adverse events, common to this class of agents, included palpitations, flushing, chest discomfort and shortness of breath. Results of both of these trials support the continued study of Stedivaze in patients with asthma and COPD.
In addition to completing these Phase I studies, the Company is continuing to enroll patients in its ASPECT 1 trial of Stedivaze, a Phase III randomized, double blind, active control study initiated in November 2009, which is designed to demonstrate both efficacy and the potential for improved tolerability for Stedivaze in patients undergoing SPECT MPI. ASPECT 2, a second Phase III trial similar in design to ASPECT 1, is expected to begin in the second half 2010.
About Stedivaze
Stedivaze (apadenoson) is a potent agonist of the adenosine A2A receptor subtype and offers improved selectivity for this receptor over other subtypes (A1 and A2B). Phase II studies suggest that Stedivaze produces ample coronary artery vasodilation required for SPECT MPI testing and has a pharmacokinetic profile that will allow it to be administered as a fixed dose bolus injection. Because of its superior selectivity for the A2A receptor subtype and its optimal pharmacokinetic profile, Stedivaze may offer improved tolerability over other adenosine receptor agonists currently marketed for use in pharmacologic stress MPI.
About Myocardial Perfusion Imaging
Myocardial perfusion imaging is used as a primary screen to identify the presence of coronary artery disease (CAD) as evidenced by detection of areas of poor blood flow in the heart that can be caused by the presence of plaques that can reduce or block the normal flow of blood to the heart. A pharmacologic stress agent is used to temporarily increase blood flow through normal coronary arteries in order to define areas of the heart that may be receiving reduced blood flow under rest and then stress conditions. The A2A adenosine receptor is the receptor subtype responsible for coronary vasodilation, or the widening of blood vessels that supply the heart muscle.2
The U.S. market for MPI testing is projected to be $800 million in 2011. Over 7.6 million MPI tests were performed in the U.S. in 2008 and approximately 3.5 million of these tests required the use of a pharmacological agent to generate maximum coronary blood flow in lieu of exercise.3 The market is expected to continue to grow due to an aging population, a rise in the number of patients unable to perform exercise during diagnostic procedures, and emerging imaging modalities that require the use of a vasodilator.
1. Eliana Reyes, MD, et al. Adenosine myocardial perfusion scintigraphy in obstructive airway disease. Journal of Nuclear Cardiology, November/December 2007
2. Shryock, J.C., Snowdy, S., Baraldi, P.G., et al. "A2A - adenosine Receptor Reserve for Coronary Vasodilation," Circulation, 1998, pp. 711-718.
3. AMR Monthly Monitor SNM: Advanced Molecular Imaging and Therapy, September 15, 2008.
Source
Clinical Data, Inc.
"The positive results from our preliminary studies in asthmatics and COPD patients are encouraging and represent a milestone toward our goal of developing a coronary vasodilator that is both safe and well tolerated in these populations," said Carol R. Reed, M.D., Executive Vice President and Chief Medical Officer of Clinical Data. "We intend to expand these findings by initiating further safety studies of Stedivaze in patients with asthma and COPD, while continuing to evaluate the efficacy and potential for superior tolerability of Stedivaze in our ongoing Phase III program."
In both of these placebo-controlled studies, Stedivaze was administered as a single IV bolus, at the same dose utilized in the ASPECT 1 trial. In 49 patients with mild to moderate asthma and 50 patients with moderate to severe COPD, Stedivaze had no effects on pulmonary function tests. Adverse events overall were similar in both incidence and severity to the adverse event profile seen in previous studies of Stedivaze in patients without lung disease, and continue to support its potential for improved tolerability. Most frequently observed adverse events, common to this class of agents, included palpitations, flushing, chest discomfort and shortness of breath. Results of both of these trials support the continued study of Stedivaze in patients with asthma and COPD.
In addition to completing these Phase I studies, the Company is continuing to enroll patients in its ASPECT 1 trial of Stedivaze, a Phase III randomized, double blind, active control study initiated in November 2009, which is designed to demonstrate both efficacy and the potential for improved tolerability for Stedivaze in patients undergoing SPECT MPI. ASPECT 2, a second Phase III trial similar in design to ASPECT 1, is expected to begin in the second half 2010.
About Stedivaze
Stedivaze (apadenoson) is a potent agonist of the adenosine A2A receptor subtype and offers improved selectivity for this receptor over other subtypes (A1 and A2B). Phase II studies suggest that Stedivaze produces ample coronary artery vasodilation required for SPECT MPI testing and has a pharmacokinetic profile that will allow it to be administered as a fixed dose bolus injection. Because of its superior selectivity for the A2A receptor subtype and its optimal pharmacokinetic profile, Stedivaze may offer improved tolerability over other adenosine receptor agonists currently marketed for use in pharmacologic stress MPI.
About Myocardial Perfusion Imaging
Myocardial perfusion imaging is used as a primary screen to identify the presence of coronary artery disease (CAD) as evidenced by detection of areas of poor blood flow in the heart that can be caused by the presence of plaques that can reduce or block the normal flow of blood to the heart. A pharmacologic stress agent is used to temporarily increase blood flow through normal coronary arteries in order to define areas of the heart that may be receiving reduced blood flow under rest and then stress conditions. The A2A adenosine receptor is the receptor subtype responsible for coronary vasodilation, or the widening of blood vessels that supply the heart muscle.2
The U.S. market for MPI testing is projected to be $800 million in 2011. Over 7.6 million MPI tests were performed in the U.S. in 2008 and approximately 3.5 million of these tests required the use of a pharmacological agent to generate maximum coronary blood flow in lieu of exercise.3 The market is expected to continue to grow due to an aging population, a rise in the number of patients unable to perform exercise during diagnostic procedures, and emerging imaging modalities that require the use of a vasodilator.
1. Eliana Reyes, MD, et al. Adenosine myocardial perfusion scintigraphy in obstructive airway disease. Journal of Nuclear Cardiology, November/December 2007
2. Shryock, J.C., Snowdy, S., Baraldi, P.G., et al. "A2A - adenosine Receptor Reserve for Coronary Vasodilation," Circulation, 1998, pp. 711-718.
3. AMR Monthly Monitor SNM: Advanced Molecular Imaging and Therapy, September 15, 2008.
Source
Clinical Data, Inc.
Monday, 3 May 2010
News From The April Issue Of Chest
Electronic nose sniffs out asthma
New evidence shows that an "electronic nose" containing an array of gas sensors may have the ability to identify asthma in patients. Researchers from Italy compared the diagnostic performance of the electronic nose with lung function tests and fraction of exhaled nitric oxide (FENO) in seven patients with asthma and seven healthy subjects. For each person, the electronic nose analysis was performed on total exhaled air and alveolar air. Results showed that the diagnostic performance for the electronic nose, FENO, and lung function testing was 87.5 percent, 79.2 percent, and 70.8 percent, respectively. Overall, the electronic nose analysis obtained the best results when performed on alveolar air and in combination with FENO. Researchers conclude that the electronic nose discriminates between patients with asthma and healthy patients, with increased diagnostic performance when combined with FENO. This article is published in the April issue of CHEST, the peer-reviewed journal of the American College of Chest Physicians: CHEST 2010; 137(4):790.
Oral vaccine may reduce exacerbations in patients with COPD
A novel vaccine may help reduce the number and severity of exacerbations in patients with severe chronic obstructive pulmonary disease (COPD). Australian researchers developed a new oral immunotherapy (HI-164OV) using Haemophilus influenzae, the bacteria causing meningitis in children. In a randomized, multicenter, double blind, placebo-controlled trial, researchers tested the efficacy of the new vaccine and its effects on outcomes in 38 patients with severe COPD. Results showed significant reductions in the areas of moderate to severe exacerbations (63 percent reduction), mean duration of episode (37 percent reduction), prescribed antibiotics (56 percent reduction), and exacerbations requiring hospital admission (90 percent reduction). No specific adverse effect was detected. Researchers conclude that the vaccine shows potential in improving the health of patients with COPD. The article is published in the April issue of CHEST, the peer-reviewed journal of the American College of Chest Physicians: CHEST 2010; 137(4):805.
Link between acid reflux and sleep apnea challenged
New research suggests that a causal link between gastroesophageal reflux (GER) and obstructive sleep apnea (OSA) may not exist. Researchers from the Medical College of Wisconsin studied the sleep events of nine patients with GER without OSA, six patients with OSA without GER, 11 patients with OSA and GER, and 15 control subjects. Although GER is thought to be induced by decreasing intraesophageal pressure during OSA, study results showed that esophageal pressures progressively increased during OSA. The incidence of GER during sleep in patients with OSA and GER did not differ from the remaining three groups. Researchers speculate that OSA may not induce GER or other reflux events. This study is published in the April issue of CHEST, the peer-reviewed journal of the American College of Chest Physicians: CHEST 2010; 137(4):769.
Source:
Jennifer Stawarz
American College of Chest Physicians
New evidence shows that an "electronic nose" containing an array of gas sensors may have the ability to identify asthma in patients. Researchers from Italy compared the diagnostic performance of the electronic nose with lung function tests and fraction of exhaled nitric oxide (FENO) in seven patients with asthma and seven healthy subjects. For each person, the electronic nose analysis was performed on total exhaled air and alveolar air. Results showed that the diagnostic performance for the electronic nose, FENO, and lung function testing was 87.5 percent, 79.2 percent, and 70.8 percent, respectively. Overall, the electronic nose analysis obtained the best results when performed on alveolar air and in combination with FENO. Researchers conclude that the electronic nose discriminates between patients with asthma and healthy patients, with increased diagnostic performance when combined with FENO. This article is published in the April issue of CHEST, the peer-reviewed journal of the American College of Chest Physicians: CHEST 2010; 137(4):790.
Oral vaccine may reduce exacerbations in patients with COPD
A novel vaccine may help reduce the number and severity of exacerbations in patients with severe chronic obstructive pulmonary disease (COPD). Australian researchers developed a new oral immunotherapy (HI-164OV) using Haemophilus influenzae, the bacteria causing meningitis in children. In a randomized, multicenter, double blind, placebo-controlled trial, researchers tested the efficacy of the new vaccine and its effects on outcomes in 38 patients with severe COPD. Results showed significant reductions in the areas of moderate to severe exacerbations (63 percent reduction), mean duration of episode (37 percent reduction), prescribed antibiotics (56 percent reduction), and exacerbations requiring hospital admission (90 percent reduction). No specific adverse effect was detected. Researchers conclude that the vaccine shows potential in improving the health of patients with COPD. The article is published in the April issue of CHEST, the peer-reviewed journal of the American College of Chest Physicians: CHEST 2010; 137(4):805.
Link between acid reflux and sleep apnea challenged
New research suggests that a causal link between gastroesophageal reflux (GER) and obstructive sleep apnea (OSA) may not exist. Researchers from the Medical College of Wisconsin studied the sleep events of nine patients with GER without OSA, six patients with OSA without GER, 11 patients with OSA and GER, and 15 control subjects. Although GER is thought to be induced by decreasing intraesophageal pressure during OSA, study results showed that esophageal pressures progressively increased during OSA. The incidence of GER during sleep in patients with OSA and GER did not differ from the remaining three groups. Researchers speculate that OSA may not induce GER or other reflux events. This study is published in the April issue of CHEST, the peer-reviewed journal of the American College of Chest Physicians: CHEST 2010; 137(4):769.
Source:
Jennifer Stawarz
American College of Chest Physicians
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