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Dual bronchodilator combination shines in patients with high-risk COPD
SAN FRANCISCO – It may be time to revise guidelines when it comes to initial treatment of chronic obstructive pulmonary disease (COPD) complicated by exacerbations, based on data from a phase III trial reported at an international conference of the American Thoracic Society.
The trial, known as FLAME, undertook a head-to-head comparison of two inhaled drug combinations among more than 3,300 patients from 43 countries. Patients were randomized to once-daily indacaterol (a long-acting beta-agonist, or LABA, bronchodilator) and glycopyrronium (a long-acting muscarinic antagonist, or LAMA, bronchodilator), or to twice-daily salmeterol, also a LABA bronchodilator, and the inhaled glucocorticoid fluticasone.
After a year, the annual rate of exacerbations was 11% lower with indacaterol-glycopyrronium than with salmeterol-fluticasone, according to results reported in a press conference and simultaneously published (N Engl J Med. 2016 May 15. doi: 10.1056/NEJMoa1516385). The difference not only met the trial’s primary endpoint of noninferiority, but also established superiority.
The dual bronchodilator combination was also superior to salmeterol-fluticasone when it came to other outcomes, such as respiratory-related health status and rescue medication use, and it had a good safety profile.
“I think we can say that... a dual bronchodilator is the first-choice combination that can be used in patients with COPD,” commented lead author Dr. Jadwiga A. Wedzicha, a professor of respiratory medicine at the National Heart and Lung Institute, Imperial College London.
“This has a lot of implications. We are going to have to rewrite the guidelines and change our algorithms,” she said, noting that they currently recommend a LABA with an inhaled corticosteroid (the latter of which has adverse effects, especially in an aging population) or single-agent LAMA. “I’m pretty convinced by the data. We’ve got basically four LABA-LAMAs out there; we need to see other studies and look at different patient populations. But I think the data is pretty persuasive, so that we can now change our algorithms.”
Several ongoing studies are looking at triple therapy of a LABA-LAMA plus an inhaled corticosteroid, which may be useful in patients who continue to have exacerbations on dual bronchodilator therapy, according to Dr. Wedzicha. “I think we’ll move to the triple [therapy], because breathlessness is a problem,” she predicted, noting that bronchodilators address that symptom well. “As you get more severe, you are going to get short of breath. So I think the LABA-LAMA will stay and the inhaled corticosteroid will be added on top. That’s what I think COPD treatment will look like.”
Press conference moderator Dr. David Mannino, professor & chair (Preventive Medicine & Environmental Health) at the University of Kentucky College of Public Health in Lexington, praised the research but disagreed about its implications. “I think one very good study is just that – one very good study. Is that enough to change guidelines? I don’t think so,” he said in an interview. “I’d like to see this replicated, because in the U.S., for example, this medication isn’t even available. And if I write [a prescription] for one LABA-LAMA, what a patient actually gets may be dictated by their insurance and coverage and other things.”
“So I would like to see this done with other LABA-LAMAs, and see other head-to-head trials,” he elaborated. “And there is a great deal of boldness and risk on the part of drug companies to do head-to-head trials because they might not get a win. They lucked out in this one. You could do the same trial with products from different companies and not get the same results. And then you are left wondering what was wrong, was it patient characteristics or other things.”
The 3,362 patients studied in FLAME had disabling, symptomatic COPD and had experienced at least one exacerbation in the past year. They were randomized evenly to once-daily indacaterol-glycopyrronium (marketed outside the United States) or twice-daily salmeterol-fluticasone.
Results showed that the annual rate of any exacerbation was significantly lower with indacaterol-glycopyrronium than with salmeterol-fluticasone in the per protocol population (3.59 vs. 4.03; rate ratio, 0.89), with similar findings in the intent-to-treat population. Additionally, in a preplanned analysis, the findings were consistent regardless of patients’ blood levels of eosinophils, a possible marker of steroid sensitivity.
Indacaterol-glycopyrronium was also associated with a longer time to first exacerbation (71 vs. 51 days; hazard ratio, 0.84) and a lower annual rate of moderate or severe exacerbations (0.98 vs. 1.19; rate ratio, 0.83).
There was no difference between groups in the risk of death, but the study lasted only a year and was not powered for that endpoint, Dr. Wedzicha pointed out. “We are seeing less deaths in patients generally in COPD because we are monitoring them very carefully,” she added.
Indacaterol-glycopyrronium was also superior to salmeterol-fluticasone when it came to improvements in health status (assessed with the St. George’s Respiratory Questionnaire), use of rescue medication, and lung function.
The adverse event profiles of both drug combinations were essentially as expected, Dr. Wedzicha reported. Pneumonia was less common with indacaterol-glycopyrronium (3.2% vs. 4.8%).
The indacaterol-glycopyrronium formulation available in the United States, which contains lower doses of the drugs and is used twice-daily, would likely net results similar to those seen in the trial, she speculated. However, once-daily treatment is generally associated with better compliance.
The inflammatory component of COPD still needs attention, according to Dr. Wedzicha. “There is no good evidence that a LABA-LAMA is doing anything to the underlying airway inflammation ... I think a major unmet need now is novel anti-inflammatory agents,” she said.
Dr. Wedzicha disclosed that she received nonfinancial support from Novartis during the conduct of the study; grant support and personal fees from Johnson and Johnson and Vifor Pharma; grant support, personal fees, and nonfinancial support from GlaxoSmithKline, and Takeda; personal fees from Pfizer, Bayer, Chiesi, and Napp; and personal fees and nonfinancial support from Novartis, AstraZeneca, and Boehringer Ingelheim outside the trial. The trial was sponsored by Novartis.
SAN FRANCISCO – It may be time to revise guidelines when it comes to initial treatment of chronic obstructive pulmonary disease (COPD) complicated by exacerbations, based on data from a phase III trial reported at an international conference of the American Thoracic Society.
The trial, known as FLAME, undertook a head-to-head comparison of two inhaled drug combinations among more than 3,300 patients from 43 countries. Patients were randomized to once-daily indacaterol (a long-acting beta-agonist, or LABA, bronchodilator) and glycopyrronium (a long-acting muscarinic antagonist, or LAMA, bronchodilator), or to twice-daily salmeterol, also a LABA bronchodilator, and the inhaled glucocorticoid fluticasone.
After a year, the annual rate of exacerbations was 11% lower with indacaterol-glycopyrronium than with salmeterol-fluticasone, according to results reported in a press conference and simultaneously published (N Engl J Med. 2016 May 15. doi: 10.1056/NEJMoa1516385). The difference not only met the trial’s primary endpoint of noninferiority, but also established superiority.
The dual bronchodilator combination was also superior to salmeterol-fluticasone when it came to other outcomes, such as respiratory-related health status and rescue medication use, and it had a good safety profile.
“I think we can say that... a dual bronchodilator is the first-choice combination that can be used in patients with COPD,” commented lead author Dr. Jadwiga A. Wedzicha, a professor of respiratory medicine at the National Heart and Lung Institute, Imperial College London.
“This has a lot of implications. We are going to have to rewrite the guidelines and change our algorithms,” she said, noting that they currently recommend a LABA with an inhaled corticosteroid (the latter of which has adverse effects, especially in an aging population) or single-agent LAMA. “I’m pretty convinced by the data. We’ve got basically four LABA-LAMAs out there; we need to see other studies and look at different patient populations. But I think the data is pretty persuasive, so that we can now change our algorithms.”
Several ongoing studies are looking at triple therapy of a LABA-LAMA plus an inhaled corticosteroid, which may be useful in patients who continue to have exacerbations on dual bronchodilator therapy, according to Dr. Wedzicha. “I think we’ll move to the triple [therapy], because breathlessness is a problem,” she predicted, noting that bronchodilators address that symptom well. “As you get more severe, you are going to get short of breath. So I think the LABA-LAMA will stay and the inhaled corticosteroid will be added on top. That’s what I think COPD treatment will look like.”
Press conference moderator Dr. David Mannino, professor & chair (Preventive Medicine & Environmental Health) at the University of Kentucky College of Public Health in Lexington, praised the research but disagreed about its implications. “I think one very good study is just that – one very good study. Is that enough to change guidelines? I don’t think so,” he said in an interview. “I’d like to see this replicated, because in the U.S., for example, this medication isn’t even available. And if I write [a prescription] for one LABA-LAMA, what a patient actually gets may be dictated by their insurance and coverage and other things.”
“So I would like to see this done with other LABA-LAMAs, and see other head-to-head trials,” he elaborated. “And there is a great deal of boldness and risk on the part of drug companies to do head-to-head trials because they might not get a win. They lucked out in this one. You could do the same trial with products from different companies and not get the same results. And then you are left wondering what was wrong, was it patient characteristics or other things.”
The 3,362 patients studied in FLAME had disabling, symptomatic COPD and had experienced at least one exacerbation in the past year. They were randomized evenly to once-daily indacaterol-glycopyrronium (marketed outside the United States) or twice-daily salmeterol-fluticasone.
Results showed that the annual rate of any exacerbation was significantly lower with indacaterol-glycopyrronium than with salmeterol-fluticasone in the per protocol population (3.59 vs. 4.03; rate ratio, 0.89), with similar findings in the intent-to-treat population. Additionally, in a preplanned analysis, the findings were consistent regardless of patients’ blood levels of eosinophils, a possible marker of steroid sensitivity.
Indacaterol-glycopyrronium was also associated with a longer time to first exacerbation (71 vs. 51 days; hazard ratio, 0.84) and a lower annual rate of moderate or severe exacerbations (0.98 vs. 1.19; rate ratio, 0.83).
There was no difference between groups in the risk of death, but the study lasted only a year and was not powered for that endpoint, Dr. Wedzicha pointed out. “We are seeing less deaths in patients generally in COPD because we are monitoring them very carefully,” she added.
Indacaterol-glycopyrronium was also superior to salmeterol-fluticasone when it came to improvements in health status (assessed with the St. George’s Respiratory Questionnaire), use of rescue medication, and lung function.
The adverse event profiles of both drug combinations were essentially as expected, Dr. Wedzicha reported. Pneumonia was less common with indacaterol-glycopyrronium (3.2% vs. 4.8%).
The indacaterol-glycopyrronium formulation available in the United States, which contains lower doses of the drugs and is used twice-daily, would likely net results similar to those seen in the trial, she speculated. However, once-daily treatment is generally associated with better compliance.
The inflammatory component of COPD still needs attention, according to Dr. Wedzicha. “There is no good evidence that a LABA-LAMA is doing anything to the underlying airway inflammation ... I think a major unmet need now is novel anti-inflammatory agents,” she said.
Dr. Wedzicha disclosed that she received nonfinancial support from Novartis during the conduct of the study; grant support and personal fees from Johnson and Johnson and Vifor Pharma; grant support, personal fees, and nonfinancial support from GlaxoSmithKline, and Takeda; personal fees from Pfizer, Bayer, Chiesi, and Napp; and personal fees and nonfinancial support from Novartis, AstraZeneca, and Boehringer Ingelheim outside the trial. The trial was sponsored by Novartis.
SAN FRANCISCO – It may be time to revise guidelines when it comes to initial treatment of chronic obstructive pulmonary disease (COPD) complicated by exacerbations, based on data from a phase III trial reported at an international conference of the American Thoracic Society.
The trial, known as FLAME, undertook a head-to-head comparison of two inhaled drug combinations among more than 3,300 patients from 43 countries. Patients were randomized to once-daily indacaterol (a long-acting beta-agonist, or LABA, bronchodilator) and glycopyrronium (a long-acting muscarinic antagonist, or LAMA, bronchodilator), or to twice-daily salmeterol, also a LABA bronchodilator, and the inhaled glucocorticoid fluticasone.
After a year, the annual rate of exacerbations was 11% lower with indacaterol-glycopyrronium than with salmeterol-fluticasone, according to results reported in a press conference and simultaneously published (N Engl J Med. 2016 May 15. doi: 10.1056/NEJMoa1516385). The difference not only met the trial’s primary endpoint of noninferiority, but also established superiority.
The dual bronchodilator combination was also superior to salmeterol-fluticasone when it came to other outcomes, such as respiratory-related health status and rescue medication use, and it had a good safety profile.
“I think we can say that... a dual bronchodilator is the first-choice combination that can be used in patients with COPD,” commented lead author Dr. Jadwiga A. Wedzicha, a professor of respiratory medicine at the National Heart and Lung Institute, Imperial College London.
“This has a lot of implications. We are going to have to rewrite the guidelines and change our algorithms,” she said, noting that they currently recommend a LABA with an inhaled corticosteroid (the latter of which has adverse effects, especially in an aging population) or single-agent LAMA. “I’m pretty convinced by the data. We’ve got basically four LABA-LAMAs out there; we need to see other studies and look at different patient populations. But I think the data is pretty persuasive, so that we can now change our algorithms.”
Several ongoing studies are looking at triple therapy of a LABA-LAMA plus an inhaled corticosteroid, which may be useful in patients who continue to have exacerbations on dual bronchodilator therapy, according to Dr. Wedzicha. “I think we’ll move to the triple [therapy], because breathlessness is a problem,” she predicted, noting that bronchodilators address that symptom well. “As you get more severe, you are going to get short of breath. So I think the LABA-LAMA will stay and the inhaled corticosteroid will be added on top. That’s what I think COPD treatment will look like.”
Press conference moderator Dr. David Mannino, professor & chair (Preventive Medicine & Environmental Health) at the University of Kentucky College of Public Health in Lexington, praised the research but disagreed about its implications. “I think one very good study is just that – one very good study. Is that enough to change guidelines? I don’t think so,” he said in an interview. “I’d like to see this replicated, because in the U.S., for example, this medication isn’t even available. And if I write [a prescription] for one LABA-LAMA, what a patient actually gets may be dictated by their insurance and coverage and other things.”
“So I would like to see this done with other LABA-LAMAs, and see other head-to-head trials,” he elaborated. “And there is a great deal of boldness and risk on the part of drug companies to do head-to-head trials because they might not get a win. They lucked out in this one. You could do the same trial with products from different companies and not get the same results. And then you are left wondering what was wrong, was it patient characteristics or other things.”
The 3,362 patients studied in FLAME had disabling, symptomatic COPD and had experienced at least one exacerbation in the past year. They were randomized evenly to once-daily indacaterol-glycopyrronium (marketed outside the United States) or twice-daily salmeterol-fluticasone.
Results showed that the annual rate of any exacerbation was significantly lower with indacaterol-glycopyrronium than with salmeterol-fluticasone in the per protocol population (3.59 vs. 4.03; rate ratio, 0.89), with similar findings in the intent-to-treat population. Additionally, in a preplanned analysis, the findings were consistent regardless of patients’ blood levels of eosinophils, a possible marker of steroid sensitivity.
Indacaterol-glycopyrronium was also associated with a longer time to first exacerbation (71 vs. 51 days; hazard ratio, 0.84) and a lower annual rate of moderate or severe exacerbations (0.98 vs. 1.19; rate ratio, 0.83).
There was no difference between groups in the risk of death, but the study lasted only a year and was not powered for that endpoint, Dr. Wedzicha pointed out. “We are seeing less deaths in patients generally in COPD because we are monitoring them very carefully,” she added.
Indacaterol-glycopyrronium was also superior to salmeterol-fluticasone when it came to improvements in health status (assessed with the St. George’s Respiratory Questionnaire), use of rescue medication, and lung function.
The adverse event profiles of both drug combinations were essentially as expected, Dr. Wedzicha reported. Pneumonia was less common with indacaterol-glycopyrronium (3.2% vs. 4.8%).
The indacaterol-glycopyrronium formulation available in the United States, which contains lower doses of the drugs and is used twice-daily, would likely net results similar to those seen in the trial, she speculated. However, once-daily treatment is generally associated with better compliance.
The inflammatory component of COPD still needs attention, according to Dr. Wedzicha. “There is no good evidence that a LABA-LAMA is doing anything to the underlying airway inflammation ... I think a major unmet need now is novel anti-inflammatory agents,” she said.
Dr. Wedzicha disclosed that she received nonfinancial support from Novartis during the conduct of the study; grant support and personal fees from Johnson and Johnson and Vifor Pharma; grant support, personal fees, and nonfinancial support from GlaxoSmithKline, and Takeda; personal fees from Pfizer, Bayer, Chiesi, and Napp; and personal fees and nonfinancial support from Novartis, AstraZeneca, and Boehringer Ingelheim outside the trial. The trial was sponsored by Novartis.
AT ATS 2016
Key clinical point: The combination of indacaterol and glycopyrronium is more efficacious than the combination of salmeterol and fluticasone for preventing exacerbations in patients with high-risk COPD.
Major finding: The annual rate of exacerbations with indacaterol-glycopyrronium was not inferior – and was in fact superior – to that with salmeterol-fluticasone (rate ratio, 0.89).
Data source: A randomized noninferiority phase III trial among 3,362 patients with COPD who had experienced at least one exacerbation in the past year (FLAME trial).
Disclosures: Dr. Wedzicha disclosed that she received nonfinancial support from Novartis during the conduct of the study; grant support and personal fees from Johnson and Johnson and Vifor Pharma; grant support, personal fees, and nonfinancial support from GlaxoSmithKline and Takeda; personal fees from Pfizer, Bayer, Chiesi, and Napp; and personal fees and nonfinancial support from Novartis, AstraZeneca, and Boehringer Ingelheim outside the trial. The trial was sponsored by Novartis.
Implanted phrenic-nerve stimulator improves central sleep apnea
FLORENCE, ITALY – In patients with moderate to severe central sleep apnea, an implanted device that stimulates the phrenic nerve to optimize diaphragm-driven breathing met its efficacy and safety goals, based on results from a multicenter, controlled trial with 151 patients.
Among the 68 patients randomized to active treatment with the device and available for follow-up after 6 months on treatment, 35 patients (51%) had a 50% or better reduction in their apnea-hypopnea index compared with 8 of 73 patients (11%) who had this level of response following device implantation but without its active use.
This statistically significant difference in response to the study’s primary endpoint should pave the way for the device’s approval, Dr. Maria Rosa Costanzo said at a meeting held by the Heart Failure Association of the European Society of Cardiology.
Although the trial enrolled patients with a mix of disorders that caused their central sleep apnea, the majority, 80 patients, had heart failure. Other enrollees had their breathing disorder secondary to atrial fibrillation, hypertension, and other diseases, suggesting that the implanted device, called the remede System, is suitable for patients with moderate to severe central sleep apnea regardless of the etiology, said Dr. Costanzo, medical director for heart failure at the Advocate Medical Group in Naperville, Ill. Among the 80 heart failure patients in the trial, the percentage of patients on active treatment who had a 50% or better reduction in their apnea-hypopnea index closely matched the rate in the entire study group.
The results also demonstrated the treatment’s safety, with a 9% rate of serious adverse events secondary to either the device’s implantation or function during the 12 months following placement in all 151 patients enrolled. Patients in the control arm had a device implanted but not turned on during the first 6 months of the study. The device was turned on and they received active treatment during the next 6 months. The trial’s prespecified safety goal, developed in conjunction with the Food and Drug Administration, was a 1-year rate of freedom from a serious adverse event of at least 80%; the actual rate achieved was 91%.
Successful implantation of the device by electrophysiology cardiologists occurred in 97% of enrolled patients, a procedure that took an average of nearly 3 hours. Need for a lead revision, one of the serious adverse events tallied during follow-up, occurred in 3% of patients. No patients in the study died during 1-year follow-up. Most other serious adverse events involved lead reposition (but not revision) to better optimize the phrenic nerve stimulation. Dr. Costanzo likened the complexity of implanting and operating the device to placement and use of a cardiac resynchronization device.
The efficacy and safety of the device shown in this pivotal trial “should be plenty” for obtaining FDA approval, predicted Dr. Costanzo, the study’s lead investigator, which would make it the first approved intervention for central sleep apnea. “I think this is a game changer,” she said in an interview.
But coming less than a year after a report of an unexpected excess-mortality rate in heart failure patients treated for central sleep apnea with an adaptive servo-ventilation device (N Engl J Med. 2015 Sept 17;373[12]:1095-1105), heart-failure specialists are now more demanding about the data needed to prove safety and clinical benefit from an intervention that targets central sleep apnea and sleep-disordered breathing.
“I think we need an endpoint that involves hospitalizations and death” to more clearly demonstrate meaningful clinical benefit and safety, said Dr. Mariell Jessup, a professor of medicine and heart failure specialist at the University of Pennsylvania in Philadelphia. Following the experience with increased mortality from servo-ventilation “we now need to demand” more comprehensive safety data in sleep trials. Also, the approach tested in this study involves “putting a device into patients, so it’s not completely benign,” she said in an interview. “A lot of things that we thought made a lot of sense, like treating a heart-failure patient’s sleep apnea, turned out to cause things we didn’t expect. We need to be cautious.”
Dr. Costanzo agreed that there is need for additional studies of the phrenic-nerve stimulating device in larger number of heart failure patients that involve heart-failure-specific endpoints. But she also stressed how life changing this intervention was for some of the patients in the study. “The transformation of their lives was unbelievable. They said things like ‘I feel I have my life back.’ ”
She also stressed that the mechanism of action of phrenic nerve stimulation is dramatically different from more traditional sleep-apnea treatments that have relied on positive air pressure devices.
Phrenic nerve stimulation causes contraction of a patient’s diaphragm that creates negative pressure within the chest cavity in a manner similar to that of natural breathing. The stimulation is adjusted to make it imperceptible to patients, and stimulation does not occur when a patient is standing or sitting, only when lying down. “With positive airway pressure in patients with advanced heart failure you reduce venous return, and when a patient’s heart is sick and depends on preload this can hurt the patient. Phrenic nerve stimulation does the opposite. It contracts the diaphragm and creates negative pressure, so it anything it facilitates venous return,” she explained.
The trial, run at 31 centers, mostly in the United States with the others in Europe, enrolled patients with moderate to severe central sleep apnea with an average apnea-hypopnea index of 45 episodes per hour while sleeping. The average age was 65 years, about 90% of the patients were men, and average body mass index was 31 kg/m2.
In addition to the primary efficacy endpoint of reduced apnea-hypopnea index, the patients on active treatment also showed statistically significant reductions compared with baseline in central apnea episodes and in daytime sleepiness measured on the Epworth Sleepiness Scale and an improvement in the patients’ global assessment of their condition. The changes did not occur in the control patients. In the treated patients central apnea episodes fell from an average of 32 episodes per hour at baseline to an average of 6 central episodes an hour after 6 months on treatment.
Dr. Costanzo is a consultant to and has received research support from Respicardia, the company developing the tested phrenic-nerve stimulation device. Dr. Jessup had no disclosures.
On Twitter @mitchelzoler
This is a really interesting and provocative study that tests a concept that flies in the face of conventional wisdom. In the past, we tried our best to avoid phrenic nerve stimulation when implanting pacemakers or other devices; it was considered a side effect. With the approach studied in this new trial, phrenic-nerve stimulation is the goal.
 |
Dr. Frank Ruschitzka |
I see inherent drawbacks with a treatment that requires implantation of a device. Implanted devices never deliver an unmitigated good; there is always a downside. I am very interested in seeing more complete safety data to better judge the potential risks from this treatment. The report from the SERVE-HF trial last year (N Engl J Med. 2015 Sept 17;373[12]:1095-1105), which showed excess mortality from a different treatment for central sleep apnea, further highlighted the importance of fully evaluating safety when treating central sleep apnea.
Another important issue is does the reduction in apnea-hypopnea index seen in this trial translate into a clinically-meaningful benefit? Ultimately that is what is important, but so far it hasn’t been shown. The treatment did, on average, decrease the apnea-hypopnea index, but does it decrease outcomes like hospitalizations or deaths? We need to see is more data specifically in heart failure patients. When judging the value of a device what we want to see are no safety concerns and fewer clinical events.
Dr. Frank Ruschitzka is professor of cardiology and head of the heart failure unit at University Hospital in Zurich. He made these comments in an interview. He had no disclosures.
This is a really interesting and provocative study that tests a concept that flies in the face of conventional wisdom. In the past, we tried our best to avoid phrenic nerve stimulation when implanting pacemakers or other devices; it was considered a side effect. With the approach studied in this new trial, phrenic-nerve stimulation is the goal.
|
Dr. Frank Ruschitzka |
I see inherent drawbacks with a treatment that requires implantation of a device. Implanted devices never deliver an unmitigated good; there is always a downside. I am very interested in seeing more complete safety data to better judge the potential risks from this treatment. The report from the SERVE-HF trial last year (N Engl J Med. 2015 Sept 17;373[12]:1095-1105), which showed excess mortality from a different treatment for central sleep apnea, further highlighted the importance of fully evaluating safety when treating central sleep apnea.
Another important issue is does the reduction in apnea-hypopnea index seen in this trial translate into a clinically-meaningful benefit? Ultimately that is what is important, but so far it hasn’t been shown. The treatment did, on average, decrease the apnea-hypopnea index, but does it decrease outcomes like hospitalizations or deaths? We need to see is more data specifically in heart failure patients. When judging the value of a device what we want to see are no safety concerns and fewer clinical events.
Dr. Frank Ruschitzka is professor of cardiology and head of the heart failure unit at University Hospital in Zurich. He made these comments in an interview. He had no disclosures.
This is a really interesting and provocative study that tests a concept that flies in the face of conventional wisdom. In the past, we tried our best to avoid phrenic nerve stimulation when implanting pacemakers or other devices; it was considered a side effect. With the approach studied in this new trial, phrenic-nerve stimulation is the goal.
|
Dr. Frank Ruschitzka |
I see inherent drawbacks with a treatment that requires implantation of a device. Implanted devices never deliver an unmitigated good; there is always a downside. I am very interested in seeing more complete safety data to better judge the potential risks from this treatment. The report from the SERVE-HF trial last year (N Engl J Med. 2015 Sept 17;373[12]:1095-1105), which showed excess mortality from a different treatment for central sleep apnea, further highlighted the importance of fully evaluating safety when treating central sleep apnea.
Another important issue is does the reduction in apnea-hypopnea index seen in this trial translate into a clinically-meaningful benefit? Ultimately that is what is important, but so far it hasn’t been shown. The treatment did, on average, decrease the apnea-hypopnea index, but does it decrease outcomes like hospitalizations or deaths? We need to see is more data specifically in heart failure patients. When judging the value of a device what we want to see are no safety concerns and fewer clinical events.
Dr. Frank Ruschitzka is professor of cardiology and head of the heart failure unit at University Hospital in Zurich. He made these comments in an interview. He had no disclosures.
FLORENCE, ITALY – In patients with moderate to severe central sleep apnea, an implanted device that stimulates the phrenic nerve to optimize diaphragm-driven breathing met its efficacy and safety goals, based on results from a multicenter, controlled trial with 151 patients.
Among the 68 patients randomized to active treatment with the device and available for follow-up after 6 months on treatment, 35 patients (51%) had a 50% or better reduction in their apnea-hypopnea index compared with 8 of 73 patients (11%) who had this level of response following device implantation but without its active use.
This statistically significant difference in response to the study’s primary endpoint should pave the way for the device’s approval, Dr. Maria Rosa Costanzo said at a meeting held by the Heart Failure Association of the European Society of Cardiology.
Although the trial enrolled patients with a mix of disorders that caused their central sleep apnea, the majority, 80 patients, had heart failure. Other enrollees had their breathing disorder secondary to atrial fibrillation, hypertension, and other diseases, suggesting that the implanted device, called the remede System, is suitable for patients with moderate to severe central sleep apnea regardless of the etiology, said Dr. Costanzo, medical director for heart failure at the Advocate Medical Group in Naperville, Ill. Among the 80 heart failure patients in the trial, the percentage of patients on active treatment who had a 50% or better reduction in their apnea-hypopnea index closely matched the rate in the entire study group.
The results also demonstrated the treatment’s safety, with a 9% rate of serious adverse events secondary to either the device’s implantation or function during the 12 months following placement in all 151 patients enrolled. Patients in the control arm had a device implanted but not turned on during the first 6 months of the study. The device was turned on and they received active treatment during the next 6 months. The trial’s prespecified safety goal, developed in conjunction with the Food and Drug Administration, was a 1-year rate of freedom from a serious adverse event of at least 80%; the actual rate achieved was 91%.
Successful implantation of the device by electrophysiology cardiologists occurred in 97% of enrolled patients, a procedure that took an average of nearly 3 hours. Need for a lead revision, one of the serious adverse events tallied during follow-up, occurred in 3% of patients. No patients in the study died during 1-year follow-up. Most other serious adverse events involved lead reposition (but not revision) to better optimize the phrenic nerve stimulation. Dr. Costanzo likened the complexity of implanting and operating the device to placement and use of a cardiac resynchronization device.
The efficacy and safety of the device shown in this pivotal trial “should be plenty” for obtaining FDA approval, predicted Dr. Costanzo, the study’s lead investigator, which would make it the first approved intervention for central sleep apnea. “I think this is a game changer,” she said in an interview.
But coming less than a year after a report of an unexpected excess-mortality rate in heart failure patients treated for central sleep apnea with an adaptive servo-ventilation device (N Engl J Med. 2015 Sept 17;373[12]:1095-1105), heart-failure specialists are now more demanding about the data needed to prove safety and clinical benefit from an intervention that targets central sleep apnea and sleep-disordered breathing.
“I think we need an endpoint that involves hospitalizations and death” to more clearly demonstrate meaningful clinical benefit and safety, said Dr. Mariell Jessup, a professor of medicine and heart failure specialist at the University of Pennsylvania in Philadelphia. Following the experience with increased mortality from servo-ventilation “we now need to demand” more comprehensive safety data in sleep trials. Also, the approach tested in this study involves “putting a device into patients, so it’s not completely benign,” she said in an interview. “A lot of things that we thought made a lot of sense, like treating a heart-failure patient’s sleep apnea, turned out to cause things we didn’t expect. We need to be cautious.”
Dr. Costanzo agreed that there is need for additional studies of the phrenic-nerve stimulating device in larger number of heart failure patients that involve heart-failure-specific endpoints. But she also stressed how life changing this intervention was for some of the patients in the study. “The transformation of their lives was unbelievable. They said things like ‘I feel I have my life back.’ ”
She also stressed that the mechanism of action of phrenic nerve stimulation is dramatically different from more traditional sleep-apnea treatments that have relied on positive air pressure devices.
Phrenic nerve stimulation causes contraction of a patient’s diaphragm that creates negative pressure within the chest cavity in a manner similar to that of natural breathing. The stimulation is adjusted to make it imperceptible to patients, and stimulation does not occur when a patient is standing or sitting, only when lying down. “With positive airway pressure in patients with advanced heart failure you reduce venous return, and when a patient’s heart is sick and depends on preload this can hurt the patient. Phrenic nerve stimulation does the opposite. It contracts the diaphragm and creates negative pressure, so it anything it facilitates venous return,” she explained.
The trial, run at 31 centers, mostly in the United States with the others in Europe, enrolled patients with moderate to severe central sleep apnea with an average apnea-hypopnea index of 45 episodes per hour while sleeping. The average age was 65 years, about 90% of the patients were men, and average body mass index was 31 kg/m2.
In addition to the primary efficacy endpoint of reduced apnea-hypopnea index, the patients on active treatment also showed statistically significant reductions compared with baseline in central apnea episodes and in daytime sleepiness measured on the Epworth Sleepiness Scale and an improvement in the patients’ global assessment of their condition. The changes did not occur in the control patients. In the treated patients central apnea episodes fell from an average of 32 episodes per hour at baseline to an average of 6 central episodes an hour after 6 months on treatment.
Dr. Costanzo is a consultant to and has received research support from Respicardia, the company developing the tested phrenic-nerve stimulation device. Dr. Jessup had no disclosures.
On Twitter @mitchelzoler
FLORENCE, ITALY – In patients with moderate to severe central sleep apnea, an implanted device that stimulates the phrenic nerve to optimize diaphragm-driven breathing met its efficacy and safety goals, based on results from a multicenter, controlled trial with 151 patients.
Among the 68 patients randomized to active treatment with the device and available for follow-up after 6 months on treatment, 35 patients (51%) had a 50% or better reduction in their apnea-hypopnea index compared with 8 of 73 patients (11%) who had this level of response following device implantation but without its active use.
This statistically significant difference in response to the study’s primary endpoint should pave the way for the device’s approval, Dr. Maria Rosa Costanzo said at a meeting held by the Heart Failure Association of the European Society of Cardiology.
Although the trial enrolled patients with a mix of disorders that caused their central sleep apnea, the majority, 80 patients, had heart failure. Other enrollees had their breathing disorder secondary to atrial fibrillation, hypertension, and other diseases, suggesting that the implanted device, called the remede System, is suitable for patients with moderate to severe central sleep apnea regardless of the etiology, said Dr. Costanzo, medical director for heart failure at the Advocate Medical Group in Naperville, Ill. Among the 80 heart failure patients in the trial, the percentage of patients on active treatment who had a 50% or better reduction in their apnea-hypopnea index closely matched the rate in the entire study group.
The results also demonstrated the treatment’s safety, with a 9% rate of serious adverse events secondary to either the device’s implantation or function during the 12 months following placement in all 151 patients enrolled. Patients in the control arm had a device implanted but not turned on during the first 6 months of the study. The device was turned on and they received active treatment during the next 6 months. The trial’s prespecified safety goal, developed in conjunction with the Food and Drug Administration, was a 1-year rate of freedom from a serious adverse event of at least 80%; the actual rate achieved was 91%.
Successful implantation of the device by electrophysiology cardiologists occurred in 97% of enrolled patients, a procedure that took an average of nearly 3 hours. Need for a lead revision, one of the serious adverse events tallied during follow-up, occurred in 3% of patients. No patients in the study died during 1-year follow-up. Most other serious adverse events involved lead reposition (but not revision) to better optimize the phrenic nerve stimulation. Dr. Costanzo likened the complexity of implanting and operating the device to placement and use of a cardiac resynchronization device.
The efficacy and safety of the device shown in this pivotal trial “should be plenty” for obtaining FDA approval, predicted Dr. Costanzo, the study’s lead investigator, which would make it the first approved intervention for central sleep apnea. “I think this is a game changer,” she said in an interview.
But coming less than a year after a report of an unexpected excess-mortality rate in heart failure patients treated for central sleep apnea with an adaptive servo-ventilation device (N Engl J Med. 2015 Sept 17;373[12]:1095-1105), heart-failure specialists are now more demanding about the data needed to prove safety and clinical benefit from an intervention that targets central sleep apnea and sleep-disordered breathing.
“I think we need an endpoint that involves hospitalizations and death” to more clearly demonstrate meaningful clinical benefit and safety, said Dr. Mariell Jessup, a professor of medicine and heart failure specialist at the University of Pennsylvania in Philadelphia. Following the experience with increased mortality from servo-ventilation “we now need to demand” more comprehensive safety data in sleep trials. Also, the approach tested in this study involves “putting a device into patients, so it’s not completely benign,” she said in an interview. “A lot of things that we thought made a lot of sense, like treating a heart-failure patient’s sleep apnea, turned out to cause things we didn’t expect. We need to be cautious.”
Dr. Costanzo agreed that there is need for additional studies of the phrenic-nerve stimulating device in larger number of heart failure patients that involve heart-failure-specific endpoints. But she also stressed how life changing this intervention was for some of the patients in the study. “The transformation of their lives was unbelievable. They said things like ‘I feel I have my life back.’ ”
She also stressed that the mechanism of action of phrenic nerve stimulation is dramatically different from more traditional sleep-apnea treatments that have relied on positive air pressure devices.
Phrenic nerve stimulation causes contraction of a patient’s diaphragm that creates negative pressure within the chest cavity in a manner similar to that of natural breathing. The stimulation is adjusted to make it imperceptible to patients, and stimulation does not occur when a patient is standing or sitting, only when lying down. “With positive airway pressure in patients with advanced heart failure you reduce venous return, and when a patient’s heart is sick and depends on preload this can hurt the patient. Phrenic nerve stimulation does the opposite. It contracts the diaphragm and creates negative pressure, so it anything it facilitates venous return,” she explained.
The trial, run at 31 centers, mostly in the United States with the others in Europe, enrolled patients with moderate to severe central sleep apnea with an average apnea-hypopnea index of 45 episodes per hour while sleeping. The average age was 65 years, about 90% of the patients were men, and average body mass index was 31 kg/m2.
In addition to the primary efficacy endpoint of reduced apnea-hypopnea index, the patients on active treatment also showed statistically significant reductions compared with baseline in central apnea episodes and in daytime sleepiness measured on the Epworth Sleepiness Scale and an improvement in the patients’ global assessment of their condition. The changes did not occur in the control patients. In the treated patients central apnea episodes fell from an average of 32 episodes per hour at baseline to an average of 6 central episodes an hour after 6 months on treatment.
Dr. Costanzo is a consultant to and has received research support from Respicardia, the company developing the tested phrenic-nerve stimulation device. Dr. Jessup had no disclosures.
On Twitter @mitchelzoler
AT HEART FAILURE 2016
Key clinical point: An implanted device that cuts patients’ apnea-hypopnea index was safe and effective, based on results from a pivotal trial.
Major finding: A 50% or greater reduction in apnea-hypopnea index was seen in 51% of patients who received a phrenic-nerve stimulation device and 11% of control patients.
Data source: Randomized, multicenter trial with 151 patients with central sleep apnea of various etiologies.
Disclosures: Dr. Costanzo is a consultant to and has received research support from Respicardia, the company developing the tested phrenic-nerve stimulation device. Dr. Jessup had no disclosures.
Aspirin falls short for the prevention of ARDS
SAN FRANCISCO – Despite evidence implicating platelets in the development and resolution of acute respiratory distress syndrome (ARDS), the antiplatelet agent aspirin was not efficacious for prevention, according to the findings from a phase IIb trial reported at an international conference of the American Thoracic Society.
A total of 400 at-risk patients from emergency departments were enrolled in the trial, known as LIPS-A (Lung Injury Prevention Study With Aspirin), and randomized evenly to aspirin or placebo, started within 24 hours of presentation.
Overall, about 10% of patients developed ARDS by day 7, with no significant difference between the groups, according to results reported at the conference and simultaneously published in JAMA (2016 May 15. doi: 10.1001/jama.2016.6330).
“In patients at risk for ARDS, aspirin therapy administered within 24 hours of presentation to the emergency department was safe. However, it did not decrease the primary outcome of ARDS development or improve any of the secondary outcomes,” commented lead author Dr. Daryl J. Kor, an associate professor of anesthesiology at the Mayo Clinic, Rochester, Minn. “The results of this phase IIb trial do not support continuation to a larger phase III trial.”
Nonetheless, as the first large multicenter ARDS prevention trial, LIPS-A provided an abundance of information about research in this challenging area, he stressed. For example, the information gleaned will help inform future trials on issues related to timely enrollment, risk prediction, and work flow modifications.
“In terms of limitations, we should note that there was a very low rate of ARDS, much lower than we anticipated,” Dr. Kor said. Patients also had less severe disease than expected. “There are always questions about the dose and duration [of treatment], as well as whether or not the ED environment is early enough for an ARDS prevention trial. Almost 15% of our patient population had prevalent bilateral infiltrates by the time they presented to the emergency department,” he noted.
Despite the negative LIPS-A findings, there may still be a role for aspirin in the treatment of ARDS, according to conference attendee Dr. Ivor S. Douglas, chief of pulmonary sciences and critical care medicine, and director of the medical intensive care unit, at the Denver Health Medical Center and the University of Colorado.
ARDS lacks a good biomarker similar to the troponin used to identify and guide aspirin treatment in myocardial infarction, he explained in an interview.
“I continue to believe that there are several endophenotypes, subgroups of the disease where an endothelial vascular phenotype is predominant,” Dr. Douglas explained. “And as we understand more about the fundamental biology of the disease, I suspect that many of these things that have been shown in unselected populations not to have efficacy – you didn’t hear me say negative, but not to have efficacy – may well be revisited within the context of a more well defined phenotype for the disease.
“I think it’s imperative that we don’t just call the balls and strikes here,” Dr. Douglas added. “The idea is to move the science forward and to do it in a really thoughtful and rigorous way.”
LIPS-A enrolled adult patients from 16 U.S. academic hospitals who were at risk for ARDS, defined as having a Lung Injury Prediction Score of 4 or greater (corresponding to a risk of about 18%), in the emergency department and were planned to be hospitalized.
They were randomized to receive aspirin (a 325-mg loading dose, followed by 81 mg/day) or placebo within 24 hours of emergency department presentation, with continuation out to hospital day 7, discharge, or death.
On average, patients received their first dose of the study drug slightly less than 13 hours after randomization, Dr. Kor reported.
Incident ARDS by day 7 was seen in 10.3% of the aspirin group and 8.7% of the placebo group, a nonsignificant difference. Findings were similar for each study site individually.
The groups were also statistically indistinguishable with respect to mean number of ventilator-free days out to day 28 (24.9 vs. 25.2), mean intensive care unit length of stay (5.2 vs. 5.4 days), and the 28-day rate of survival (90% vs. 90%), among other secondary outcomes.
In terms of safety, the incidence of bleeding-related adverse events was not significantly greater with aspirin than with placebo (5.6% vs. 2.6%). Measures of renal function were also essentially the same.
Analyses of a host of biomarkers associated with injury, inflammation, and thrombosis generally showed no differences in levels between groups. The possible exception was a trend toward a higher level of interleukin-2 in the aspirin group.
Dr. Kor disclosed that he receives personal fees from UpToDate.
SAN FRANCISCO – Despite evidence implicating platelets in the development and resolution of acute respiratory distress syndrome (ARDS), the antiplatelet agent aspirin was not efficacious for prevention, according to the findings from a phase IIb trial reported at an international conference of the American Thoracic Society.
A total of 400 at-risk patients from emergency departments were enrolled in the trial, known as LIPS-A (Lung Injury Prevention Study With Aspirin), and randomized evenly to aspirin or placebo, started within 24 hours of presentation.
Overall, about 10% of patients developed ARDS by day 7, with no significant difference between the groups, according to results reported at the conference and simultaneously published in JAMA (2016 May 15. doi: 10.1001/jama.2016.6330).
“In patients at risk for ARDS, aspirin therapy administered within 24 hours of presentation to the emergency department was safe. However, it did not decrease the primary outcome of ARDS development or improve any of the secondary outcomes,” commented lead author Dr. Daryl J. Kor, an associate professor of anesthesiology at the Mayo Clinic, Rochester, Minn. “The results of this phase IIb trial do not support continuation to a larger phase III trial.”
Nonetheless, as the first large multicenter ARDS prevention trial, LIPS-A provided an abundance of information about research in this challenging area, he stressed. For example, the information gleaned will help inform future trials on issues related to timely enrollment, risk prediction, and work flow modifications.
“In terms of limitations, we should note that there was a very low rate of ARDS, much lower than we anticipated,” Dr. Kor said. Patients also had less severe disease than expected. “There are always questions about the dose and duration [of treatment], as well as whether or not the ED environment is early enough for an ARDS prevention trial. Almost 15% of our patient population had prevalent bilateral infiltrates by the time they presented to the emergency department,” he noted.
Despite the negative LIPS-A findings, there may still be a role for aspirin in the treatment of ARDS, according to conference attendee Dr. Ivor S. Douglas, chief of pulmonary sciences and critical care medicine, and director of the medical intensive care unit, at the Denver Health Medical Center and the University of Colorado.
ARDS lacks a good biomarker similar to the troponin used to identify and guide aspirin treatment in myocardial infarction, he explained in an interview.
“I continue to believe that there are several endophenotypes, subgroups of the disease where an endothelial vascular phenotype is predominant,” Dr. Douglas explained. “And as we understand more about the fundamental biology of the disease, I suspect that many of these things that have been shown in unselected populations not to have efficacy – you didn’t hear me say negative, but not to have efficacy – may well be revisited within the context of a more well defined phenotype for the disease.
“I think it’s imperative that we don’t just call the balls and strikes here,” Dr. Douglas added. “The idea is to move the science forward and to do it in a really thoughtful and rigorous way.”
LIPS-A enrolled adult patients from 16 U.S. academic hospitals who were at risk for ARDS, defined as having a Lung Injury Prediction Score of 4 or greater (corresponding to a risk of about 18%), in the emergency department and were planned to be hospitalized.
They were randomized to receive aspirin (a 325-mg loading dose, followed by 81 mg/day) or placebo within 24 hours of emergency department presentation, with continuation out to hospital day 7, discharge, or death.
On average, patients received their first dose of the study drug slightly less than 13 hours after randomization, Dr. Kor reported.
Incident ARDS by day 7 was seen in 10.3% of the aspirin group and 8.7% of the placebo group, a nonsignificant difference. Findings were similar for each study site individually.
The groups were also statistically indistinguishable with respect to mean number of ventilator-free days out to day 28 (24.9 vs. 25.2), mean intensive care unit length of stay (5.2 vs. 5.4 days), and the 28-day rate of survival (90% vs. 90%), among other secondary outcomes.
In terms of safety, the incidence of bleeding-related adverse events was not significantly greater with aspirin than with placebo (5.6% vs. 2.6%). Measures of renal function were also essentially the same.
Analyses of a host of biomarkers associated with injury, inflammation, and thrombosis generally showed no differences in levels between groups. The possible exception was a trend toward a higher level of interleukin-2 in the aspirin group.
Dr. Kor disclosed that he receives personal fees from UpToDate.
SAN FRANCISCO – Despite evidence implicating platelets in the development and resolution of acute respiratory distress syndrome (ARDS), the antiplatelet agent aspirin was not efficacious for prevention, according to the findings from a phase IIb trial reported at an international conference of the American Thoracic Society.
A total of 400 at-risk patients from emergency departments were enrolled in the trial, known as LIPS-A (Lung Injury Prevention Study With Aspirin), and randomized evenly to aspirin or placebo, started within 24 hours of presentation.
Overall, about 10% of patients developed ARDS by day 7, with no significant difference between the groups, according to results reported at the conference and simultaneously published in JAMA (2016 May 15. doi: 10.1001/jama.2016.6330).
“In patients at risk for ARDS, aspirin therapy administered within 24 hours of presentation to the emergency department was safe. However, it did not decrease the primary outcome of ARDS development or improve any of the secondary outcomes,” commented lead author Dr. Daryl J. Kor, an associate professor of anesthesiology at the Mayo Clinic, Rochester, Minn. “The results of this phase IIb trial do not support continuation to a larger phase III trial.”
Nonetheless, as the first large multicenter ARDS prevention trial, LIPS-A provided an abundance of information about research in this challenging area, he stressed. For example, the information gleaned will help inform future trials on issues related to timely enrollment, risk prediction, and work flow modifications.
“In terms of limitations, we should note that there was a very low rate of ARDS, much lower than we anticipated,” Dr. Kor said. Patients also had less severe disease than expected. “There are always questions about the dose and duration [of treatment], as well as whether or not the ED environment is early enough for an ARDS prevention trial. Almost 15% of our patient population had prevalent bilateral infiltrates by the time they presented to the emergency department,” he noted.
Despite the negative LIPS-A findings, there may still be a role for aspirin in the treatment of ARDS, according to conference attendee Dr. Ivor S. Douglas, chief of pulmonary sciences and critical care medicine, and director of the medical intensive care unit, at the Denver Health Medical Center and the University of Colorado.
ARDS lacks a good biomarker similar to the troponin used to identify and guide aspirin treatment in myocardial infarction, he explained in an interview.
“I continue to believe that there are several endophenotypes, subgroups of the disease where an endothelial vascular phenotype is predominant,” Dr. Douglas explained. “And as we understand more about the fundamental biology of the disease, I suspect that many of these things that have been shown in unselected populations not to have efficacy – you didn’t hear me say negative, but not to have efficacy – may well be revisited within the context of a more well defined phenotype for the disease.
“I think it’s imperative that we don’t just call the balls and strikes here,” Dr. Douglas added. “The idea is to move the science forward and to do it in a really thoughtful and rigorous way.”
LIPS-A enrolled adult patients from 16 U.S. academic hospitals who were at risk for ARDS, defined as having a Lung Injury Prediction Score of 4 or greater (corresponding to a risk of about 18%), in the emergency department and were planned to be hospitalized.
They were randomized to receive aspirin (a 325-mg loading dose, followed by 81 mg/day) or placebo within 24 hours of emergency department presentation, with continuation out to hospital day 7, discharge, or death.
On average, patients received their first dose of the study drug slightly less than 13 hours after randomization, Dr. Kor reported.
Incident ARDS by day 7 was seen in 10.3% of the aspirin group and 8.7% of the placebo group, a nonsignificant difference. Findings were similar for each study site individually.
The groups were also statistically indistinguishable with respect to mean number of ventilator-free days out to day 28 (24.9 vs. 25.2), mean intensive care unit length of stay (5.2 vs. 5.4 days), and the 28-day rate of survival (90% vs. 90%), among other secondary outcomes.
In terms of safety, the incidence of bleeding-related adverse events was not significantly greater with aspirin than with placebo (5.6% vs. 2.6%). Measures of renal function were also essentially the same.
Analyses of a host of biomarkers associated with injury, inflammation, and thrombosis generally showed no differences in levels between groups. The possible exception was a trend toward a higher level of interleukin-2 in the aspirin group.
Dr. Kor disclosed that he receives personal fees from UpToDate.
AT ATS 2016
Key clinical point: Aspirin therapy did not reduce the incidence of ARDS in at-risk patients.
Major finding: Roughly 10% of patients developed ARDS, with no significant difference between the aspirin and placebo groups.
Data source: A multicenter, randomized, phase IIb trial among 400 emergency department patients at risk for ARDS.
Disclosures: Dr. Kor disclosed that he receives personal fees from UpToDate.
VIDEO: Telehealth program cuts cost, hospitalizations for chronic patients
It’s well known that complex, chronic patients are some of the costliest patients in the health care system and utilize a disproportionate amount of health care resources.
To address this population, Banner Health Network (BHN) recently began a series of innovative programs that incorporate telehealth, including Banner iCare, which uses advanced technology and high-touch services to treat patients with multiple, chronic conditions.
Banner Health is a multihospital health system that operates in seven Western states and includes primary care clinics, skilled nursing facilities, surgery centers, hospitals, and home health care services. BHN is an accountable care organization of Banner Health based in the broader Phoenix area.
In a video interview at the American Telemedicine Association annual conference, Deb Dahl, BHN vice president of patient innovation, discussed how Banner’s telehealth program was designed, its operations, and the challenges faced by leaders along the way.
She also highlighted the program’s progress thus far, which includes a 27% reduction in cost of care and a 45% reduction in hospitalizations. Finally, Ms. Dahl spoke on reimbursement within the program and whether the initiative can work for other practices and health systems.
On Twitter @legal_med
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
It’s well known that complex, chronic patients are some of the costliest patients in the health care system and utilize a disproportionate amount of health care resources.
To address this population, Banner Health Network (BHN) recently began a series of innovative programs that incorporate telehealth, including Banner iCare, which uses advanced technology and high-touch services to treat patients with multiple, chronic conditions.
Banner Health is a multihospital health system that operates in seven Western states and includes primary care clinics, skilled nursing facilities, surgery centers, hospitals, and home health care services. BHN is an accountable care organization of Banner Health based in the broader Phoenix area.
In a video interview at the American Telemedicine Association annual conference, Deb Dahl, BHN vice president of patient innovation, discussed how Banner’s telehealth program was designed, its operations, and the challenges faced by leaders along the way.
She also highlighted the program’s progress thus far, which includes a 27% reduction in cost of care and a 45% reduction in hospitalizations. Finally, Ms. Dahl spoke on reimbursement within the program and whether the initiative can work for other practices and health systems.
On Twitter @legal_med
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
It’s well known that complex, chronic patients are some of the costliest patients in the health care system and utilize a disproportionate amount of health care resources.
To address this population, Banner Health Network (BHN) recently began a series of innovative programs that incorporate telehealth, including Banner iCare, which uses advanced technology and high-touch services to treat patients with multiple, chronic conditions.
Banner Health is a multihospital health system that operates in seven Western states and includes primary care clinics, skilled nursing facilities, surgery centers, hospitals, and home health care services. BHN is an accountable care organization of Banner Health based in the broader Phoenix area.
In a video interview at the American Telemedicine Association annual conference, Deb Dahl, BHN vice president of patient innovation, discussed how Banner’s telehealth program was designed, its operations, and the challenges faced by leaders along the way.
She also highlighted the program’s progress thus far, which includes a 27% reduction in cost of care and a 45% reduction in hospitalizations. Finally, Ms. Dahl spoke on reimbursement within the program and whether the initiative can work for other practices and health systems.
On Twitter @legal_med
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
AT ATA 2016
Fungi May Exacerbate Asthma, Chronic Sinusitis
LOS ANGELES – Fungi might play a far larger role in asthma and chronic sinusitis than previously thought, according to investigators at Baylor College of Medicine in Houston.
With the help of a special culturing technique to wash antifungal elements out of sputum samples, six or more fungal colony-forming units grew out of the sputum of 112 of 134 patients (83.5%) at the Houston Veterans Affairs Medical Center; about a third of the patients had asthma, a third had chronic sinusitis, and a third had both. Although Aspergillus and Candida species were common, more than 30 fungal species were identified. Only a handful of patients had positive results on IgE testing.
Of 62 patients treated with standard-dose voriconazole or terbinafine, sometimes for more than a year, 54 (87%) reported symptomatic benefit including 31 (50%) with decreased sputum production, 24 (39%) with improved breathing, 20 (32%) with less cough, and nine (14.5%) with less rescue inhaler use.
At Baylor, prescribing antifungals for patients with recalcitrant asthma and chronic sinusitis “has evolved into something we pretty much do all the time now regardless of sensitivity results. I’m pretty certain we are the only institution that does this,” said allergy and immunology fellow Dr. Evan Li.
“Fungi, we think, are important initiating factors in many cases of asthma. They set up chronic mucosal infection. Our [treatment] experience is extremely positive; it may be in the future that if you have significant asthma or sinusitis, you just go on an antifungal, but more research and clinical trials are needed,” said senior investigator Dr. David Corry, professor and chief of medical immunology, allergy, and rheumatology at Baylor.
“The standard culture techniques that have been used for 100 years are inadequate when it comes to culturing fungi from sputum, and why results almost invariably come back negative,” Dr. Corry said at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.
The problem is that “almost everything in sputum” – eosinophils, macrophages, cytokines, and so on – “is designed to kill fungi.” Those elements have to be removed before plating. At Baylor, “we solubilize [sputum] with the reducing agent dithiothreitol, and vigorously stir the mixture to disperse the organisms and wash away the cellular elements and the other things.” The process leaves behind “a sandy material that’s basically fibrin clots mixed with a lot of fungal elements. You spread that on a plate, and it grows like wildfire,” he said.
“It’s easy to do, but time consuming. People are actually shipping their samples to us now from around the country, and we are happy to do those cultures,” Dr. Corry said. There’s no patent on the technique because “we want the community to use it. We want people to be helped,” he said.
Voriconazole seems to be the most effective option, and the team opts for it when possible, Dr. Corry noted. Terbinafine is the go-to drug for patients who can’t tolerate voriconazole. Fluconazole is sometimes added when monotherapy doesn’t seem to be doing the trick.
The work began as a search for household proteases. “One of our first discoveries was that” most are fungal. “The twist is that you are not inhaling the proteases, you are inhaling the fungus,” Dr. Corry said.
There have been both positive and negative results from the few prior investigations of antifungals for asthma. The team suspects that negative findings were a result of patients not being treated long enough, among other reasons.
The Baylor team is looking for funding for a prospective trial. The investigators hope to develop a protocol for diagnosis and treatment of fungal airway disease, but “there’s a lot of work that needs to get done,” Dr. Corry said.
The investigators had no relevant financial disclosures, and there was no outside funding for the work.
LOS ANGELES – Fungi might play a far larger role in asthma and chronic sinusitis than previously thought, according to investigators at Baylor College of Medicine in Houston.
With the help of a special culturing technique to wash antifungal elements out of sputum samples, six or more fungal colony-forming units grew out of the sputum of 112 of 134 patients (83.5%) at the Houston Veterans Affairs Medical Center; about a third of the patients had asthma, a third had chronic sinusitis, and a third had both. Although Aspergillus and Candida species were common, more than 30 fungal species were identified. Only a handful of patients had positive results on IgE testing.
Of 62 patients treated with standard-dose voriconazole or terbinafine, sometimes for more than a year, 54 (87%) reported symptomatic benefit including 31 (50%) with decreased sputum production, 24 (39%) with improved breathing, 20 (32%) with less cough, and nine (14.5%) with less rescue inhaler use.
At Baylor, prescribing antifungals for patients with recalcitrant asthma and chronic sinusitis “has evolved into something we pretty much do all the time now regardless of sensitivity results. I’m pretty certain we are the only institution that does this,” said allergy and immunology fellow Dr. Evan Li.
“Fungi, we think, are important initiating factors in many cases of asthma. They set up chronic mucosal infection. Our [treatment] experience is extremely positive; it may be in the future that if you have significant asthma or sinusitis, you just go on an antifungal, but more research and clinical trials are needed,” said senior investigator Dr. David Corry, professor and chief of medical immunology, allergy, and rheumatology at Baylor.
“The standard culture techniques that have been used for 100 years are inadequate when it comes to culturing fungi from sputum, and why results almost invariably come back negative,” Dr. Corry said at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.
The problem is that “almost everything in sputum” – eosinophils, macrophages, cytokines, and so on – “is designed to kill fungi.” Those elements have to be removed before plating. At Baylor, “we solubilize [sputum] with the reducing agent dithiothreitol, and vigorously stir the mixture to disperse the organisms and wash away the cellular elements and the other things.” The process leaves behind “a sandy material that’s basically fibrin clots mixed with a lot of fungal elements. You spread that on a plate, and it grows like wildfire,” he said.
“It’s easy to do, but time consuming. People are actually shipping their samples to us now from around the country, and we are happy to do those cultures,” Dr. Corry said. There’s no patent on the technique because “we want the community to use it. We want people to be helped,” he said.
Voriconazole seems to be the most effective option, and the team opts for it when possible, Dr. Corry noted. Terbinafine is the go-to drug for patients who can’t tolerate voriconazole. Fluconazole is sometimes added when monotherapy doesn’t seem to be doing the trick.
The work began as a search for household proteases. “One of our first discoveries was that” most are fungal. “The twist is that you are not inhaling the proteases, you are inhaling the fungus,” Dr. Corry said.
There have been both positive and negative results from the few prior investigations of antifungals for asthma. The team suspects that negative findings were a result of patients not being treated long enough, among other reasons.
The Baylor team is looking for funding for a prospective trial. The investigators hope to develop a protocol for diagnosis and treatment of fungal airway disease, but “there’s a lot of work that needs to get done,” Dr. Corry said.
The investigators had no relevant financial disclosures, and there was no outside funding for the work.
LOS ANGELES – Fungi might play a far larger role in asthma and chronic sinusitis than previously thought, according to investigators at Baylor College of Medicine in Houston.
With the help of a special culturing technique to wash antifungal elements out of sputum samples, six or more fungal colony-forming units grew out of the sputum of 112 of 134 patients (83.5%) at the Houston Veterans Affairs Medical Center; about a third of the patients had asthma, a third had chronic sinusitis, and a third had both. Although Aspergillus and Candida species were common, more than 30 fungal species were identified. Only a handful of patients had positive results on IgE testing.
Of 62 patients treated with standard-dose voriconazole or terbinafine, sometimes for more than a year, 54 (87%) reported symptomatic benefit including 31 (50%) with decreased sputum production, 24 (39%) with improved breathing, 20 (32%) with less cough, and nine (14.5%) with less rescue inhaler use.
At Baylor, prescribing antifungals for patients with recalcitrant asthma and chronic sinusitis “has evolved into something we pretty much do all the time now regardless of sensitivity results. I’m pretty certain we are the only institution that does this,” said allergy and immunology fellow Dr. Evan Li.
“Fungi, we think, are important initiating factors in many cases of asthma. They set up chronic mucosal infection. Our [treatment] experience is extremely positive; it may be in the future that if you have significant asthma or sinusitis, you just go on an antifungal, but more research and clinical trials are needed,” said senior investigator Dr. David Corry, professor and chief of medical immunology, allergy, and rheumatology at Baylor.
“The standard culture techniques that have been used for 100 years are inadequate when it comes to culturing fungi from sputum, and why results almost invariably come back negative,” Dr. Corry said at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.
The problem is that “almost everything in sputum” – eosinophils, macrophages, cytokines, and so on – “is designed to kill fungi.” Those elements have to be removed before plating. At Baylor, “we solubilize [sputum] with the reducing agent dithiothreitol, and vigorously stir the mixture to disperse the organisms and wash away the cellular elements and the other things.” The process leaves behind “a sandy material that’s basically fibrin clots mixed with a lot of fungal elements. You spread that on a plate, and it grows like wildfire,” he said.
“It’s easy to do, but time consuming. People are actually shipping their samples to us now from around the country, and we are happy to do those cultures,” Dr. Corry said. There’s no patent on the technique because “we want the community to use it. We want people to be helped,” he said.
Voriconazole seems to be the most effective option, and the team opts for it when possible, Dr. Corry noted. Terbinafine is the go-to drug for patients who can’t tolerate voriconazole. Fluconazole is sometimes added when monotherapy doesn’t seem to be doing the trick.
The work began as a search for household proteases. “One of our first discoveries was that” most are fungal. “The twist is that you are not inhaling the proteases, you are inhaling the fungus,” Dr. Corry said.
There have been both positive and negative results from the few prior investigations of antifungals for asthma. The team suspects that negative findings were a result of patients not being treated long enough, among other reasons.
The Baylor team is looking for funding for a prospective trial. The investigators hope to develop a protocol for diagnosis and treatment of fungal airway disease, but “there’s a lot of work that needs to get done,” Dr. Corry said.
The investigators had no relevant financial disclosures, and there was no outside funding for the work.
AT AAAAI
Fungi may exacerbate asthma, chronic sinusitis
LOS ANGELES – Fungi might play a far larger role in asthma and chronic sinusitis than previously thought, according to investigators at Baylor College of Medicine in Houston.
With the help of a special culturing technique to wash antifungal elements out of sputum samples, six or more fungal colony-forming units grew out of the sputum of 112 of 134 patients (83.5%) at the Houston Veterans Affairs Medical Center; about a third of the patients had asthma, a third had chronic sinusitis, and a third had both. Although Aspergillus and Candida species were common, more than 30 fungal species were identified. Only a handful of patients had positive results on IgE testing.
Of 62 patients treated with standard-dose voriconazole or terbinafine, sometimes for more than a year, 54 (87%) reported symptomatic benefit including 31 (50%) with decreased sputum production, 24 (39%) with improved breathing, 20 (32%) with less cough, and nine (14.5%) with less rescue inhaler use.
At Baylor, prescribing antifungals for patients with recalcitrant asthma and chronic sinusitis “has evolved into something we pretty much do all the time now regardless of sensitivity results. I’m pretty certain we are the only institution that does this,” said allergy and immunology fellow Dr. Evan Li.
“Fungi, we think, are important initiating factors in many cases of asthma. They set up chronic mucosal infection. Our [treatment] experience is extremely positive; it may be in the future that if you have significant asthma or sinusitis, you just go on an antifungal, but more research and clinical trials are needed,” said senior investigator Dr. David Corry, professor and chief of medical immunology, allergy, and rheumatology at Baylor.
“The standard culture techniques that have been used for 100 years are inadequate when it comes to culturing fungi from sputum, and why results almost invariably come back negative,” Dr. Corry said at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.
The problem is that “almost everything in sputum” – eosinophils, macrophages, cytokines, and so on – “is designed to kill fungi.” Those elements have to be removed before plating. At Baylor, “we solubilize [sputum] with the reducing agent dithiothreitol, and vigorously stir the mixture to disperse the organisms and wash away the cellular elements and the other things.” The process leaves behind “a sandy material that’s basically fibrin clots mixed with a lot of fungal elements. You spread that on a plate, and it grows like wildfire,” he said.
“It’s easy to do, but time consuming. People are actually shipping their samples to us now from around the country, and we are happy to do those cultures,” Dr. Corry said. There’s no patent on the technique because “we want the community to use it. We want people to be helped,” he said.
Voriconazole seems to be the most effective option, and the team opts for it when possible, Dr. Corry noted. Terbinafine is the go-to drug for patients who can’t tolerate voriconazole. Fluconazole is sometimes added when monotherapy doesn’t seem to be doing the trick.
The work began as a search for household proteases. “One of our first discoveries was that” most are fungal. “The twist is that you are not inhaling the proteases, you are inhaling the fungus,” Dr. Corry said.
There have been both positive and negative results from the few prior investigations of antifungals for asthma. The team suspects that negative findings were a result of patients not being treated long enough, among other reasons.
The Baylor team is looking for funding for a prospective trial. The investigators hope to develop a protocol for diagnosis and treatment of fungal airway disease, but “there’s a lot of work that needs to get done,” Dr. Corry said.
The investigators had no relevant financial disclosures, and there was no outside funding for the work.
LOS ANGELES – Fungi might play a far larger role in asthma and chronic sinusitis than previously thought, according to investigators at Baylor College of Medicine in Houston.
With the help of a special culturing technique to wash antifungal elements out of sputum samples, six or more fungal colony-forming units grew out of the sputum of 112 of 134 patients (83.5%) at the Houston Veterans Affairs Medical Center; about a third of the patients had asthma, a third had chronic sinusitis, and a third had both. Although Aspergillus and Candida species were common, more than 30 fungal species were identified. Only a handful of patients had positive results on IgE testing.
Of 62 patients treated with standard-dose voriconazole or terbinafine, sometimes for more than a year, 54 (87%) reported symptomatic benefit including 31 (50%) with decreased sputum production, 24 (39%) with improved breathing, 20 (32%) with less cough, and nine (14.5%) with less rescue inhaler use.
At Baylor, prescribing antifungals for patients with recalcitrant asthma and chronic sinusitis “has evolved into something we pretty much do all the time now regardless of sensitivity results. I’m pretty certain we are the only institution that does this,” said allergy and immunology fellow Dr. Evan Li.
“Fungi, we think, are important initiating factors in many cases of asthma. They set up chronic mucosal infection. Our [treatment] experience is extremely positive; it may be in the future that if you have significant asthma or sinusitis, you just go on an antifungal, but more research and clinical trials are needed,” said senior investigator Dr. David Corry, professor and chief of medical immunology, allergy, and rheumatology at Baylor.
“The standard culture techniques that have been used for 100 years are inadequate when it comes to culturing fungi from sputum, and why results almost invariably come back negative,” Dr. Corry said at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.
The problem is that “almost everything in sputum” – eosinophils, macrophages, cytokines, and so on – “is designed to kill fungi.” Those elements have to be removed before plating. At Baylor, “we solubilize [sputum] with the reducing agent dithiothreitol, and vigorously stir the mixture to disperse the organisms and wash away the cellular elements and the other things.” The process leaves behind “a sandy material that’s basically fibrin clots mixed with a lot of fungal elements. You spread that on a plate, and it grows like wildfire,” he said.
“It’s easy to do, but time consuming. People are actually shipping their samples to us now from around the country, and we are happy to do those cultures,” Dr. Corry said. There’s no patent on the technique because “we want the community to use it. We want people to be helped,” he said.
Voriconazole seems to be the most effective option, and the team opts for it when possible, Dr. Corry noted. Terbinafine is the go-to drug for patients who can’t tolerate voriconazole. Fluconazole is sometimes added when monotherapy doesn’t seem to be doing the trick.
The work began as a search for household proteases. “One of our first discoveries was that” most are fungal. “The twist is that you are not inhaling the proteases, you are inhaling the fungus,” Dr. Corry said.
There have been both positive and negative results from the few prior investigations of antifungals for asthma. The team suspects that negative findings were a result of patients not being treated long enough, among other reasons.
The Baylor team is looking for funding for a prospective trial. The investigators hope to develop a protocol for diagnosis and treatment of fungal airway disease, but “there’s a lot of work that needs to get done,” Dr. Corry said.
The investigators had no relevant financial disclosures, and there was no outside funding for the work.
LOS ANGELES – Fungi might play a far larger role in asthma and chronic sinusitis than previously thought, according to investigators at Baylor College of Medicine in Houston.
With the help of a special culturing technique to wash antifungal elements out of sputum samples, six or more fungal colony-forming units grew out of the sputum of 112 of 134 patients (83.5%) at the Houston Veterans Affairs Medical Center; about a third of the patients had asthma, a third had chronic sinusitis, and a third had both. Although Aspergillus and Candida species were common, more than 30 fungal species were identified. Only a handful of patients had positive results on IgE testing.
Of 62 patients treated with standard-dose voriconazole or terbinafine, sometimes for more than a year, 54 (87%) reported symptomatic benefit including 31 (50%) with decreased sputum production, 24 (39%) with improved breathing, 20 (32%) with less cough, and nine (14.5%) with less rescue inhaler use.
At Baylor, prescribing antifungals for patients with recalcitrant asthma and chronic sinusitis “has evolved into something we pretty much do all the time now regardless of sensitivity results. I’m pretty certain we are the only institution that does this,” said allergy and immunology fellow Dr. Evan Li.
“Fungi, we think, are important initiating factors in many cases of asthma. They set up chronic mucosal infection. Our [treatment] experience is extremely positive; it may be in the future that if you have significant asthma or sinusitis, you just go on an antifungal, but more research and clinical trials are needed,” said senior investigator Dr. David Corry, professor and chief of medical immunology, allergy, and rheumatology at Baylor.
“The standard culture techniques that have been used for 100 years are inadequate when it comes to culturing fungi from sputum, and why results almost invariably come back negative,” Dr. Corry said at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.
The problem is that “almost everything in sputum” – eosinophils, macrophages, cytokines, and so on – “is designed to kill fungi.” Those elements have to be removed before plating. At Baylor, “we solubilize [sputum] with the reducing agent dithiothreitol, and vigorously stir the mixture to disperse the organisms and wash away the cellular elements and the other things.” The process leaves behind “a sandy material that’s basically fibrin clots mixed with a lot of fungal elements. You spread that on a plate, and it grows like wildfire,” he said.
“It’s easy to do, but time consuming. People are actually shipping their samples to us now from around the country, and we are happy to do those cultures,” Dr. Corry said. There’s no patent on the technique because “we want the community to use it. We want people to be helped,” he said.
Voriconazole seems to be the most effective option, and the team opts for it when possible, Dr. Corry noted. Terbinafine is the go-to drug for patients who can’t tolerate voriconazole. Fluconazole is sometimes added when monotherapy doesn’t seem to be doing the trick.
The work began as a search for household proteases. “One of our first discoveries was that” most are fungal. “The twist is that you are not inhaling the proteases, you are inhaling the fungus,” Dr. Corry said.
There have been both positive and negative results from the few prior investigations of antifungals for asthma. The team suspects that negative findings were a result of patients not being treated long enough, among other reasons.
The Baylor team is looking for funding for a prospective trial. The investigators hope to develop a protocol for diagnosis and treatment of fungal airway disease, but “there’s a lot of work that needs to get done,” Dr. Corry said.
The investigators had no relevant financial disclosures, and there was no outside funding for the work.
AT AAAAI
Key clinical point: Consider antifungal therapy if asthma or chronic sinusitis patients don’t respond well to conventional treatment.
Major finding: With the help of a special culturing technique to wash antifungal elements out of sputum samples, six or more fungal colony-forming units grew out of the sputum of 112 of 134 patients (83.5%) at the Houston Veterans Affairs Medical Center.
Data source: A single-center case review.
Disclosures: The investigators had no relevant financial disclosures, and there was no outside funding for the work.
Serious infections are increasing among psoriasis inpatients
SCOTTSDALE, ARIZ. – From enterocolitis to MRSA, serious infections are on the rise among inpatients with psoriasis, and psoriasis is an independent risk factor for serious infections, according to findings from large retrospective studies from the United States and the United Kingdom.
Inpatients with psoriasis in the United States also were at greater risk of serious infections, compared with nonpsoriatic inpatients at every time point studied, and serious infections were associated with increased hospital costs, length of stay, and risk of mortality, reported Derek Hsu, a medical student at Northwestern University, Chicago, and his associates. “Research is needed to determine how to reduce the risk of serious infections in patients with psoriasis,” the investigators emphasized.
Psoriasis affects some 7 million adults in the United States. Biologics, which are transforming the treatment landscape for moderate-to-severe psoriasis, “should reduce inherent infectious risk by controlling the inflammatory process and reducing disease severity, [but] these effects may be immunosuppressing and increase the risk of infection in other ways,” according to Mr. Hsu and his associates. For their study, they analyzed data for 2002-2012 from the Nationwide Inpatient Sample, which covers 20% of hospitalizations in the United States. They extracted validated ICD-9 codes for psoriasis and serious infections, and calculated costs of care after adjusting for 2014 inflation, based on the United States Consumer Price Index.
Overall rates of serious infection and rates of pneumonia, MRSA, septicemia, diverticulitis, enterocolitis, encephalitis, and any viral or fungal infection rose significantly among inpatients with psoriasis between 2002 and 2012 (all P-values less than .05). Predictors of serious infections among inpatients with psoriasis included diabetes mellitus, obesity, and being of non-Caucasian race or ethnicity, female, older than 60 years, and on Medicare or Medicaid, the researchers reported at the annual meeting of the Society for Investigative Dermatology.
Furthermore, after controlling for age, sex, and race, psoriasis was a significant risk factor for many different types of serious infections. Among these were cellulitis, herpes simplex virus, infectious arthritis, osteomyelitis, meningitis, influenza, encephalitis, septicemia, enterocolitis, MRSA, methicillin-sensitive Staphylococcus aureus infections, and Clostridium difficile. Further, inpatients with psoriasis were more prone to urinary tract infection, peritonitis or intestinal abscess, appendicitis, tuberculosis, and viral and fungal infections (all P-values less than .05). The average cost of hospital stay for inpatients with psoriasis was more than $2,200 greater when they were diagnosed with one or more serious infections than otherwise, and their average length of hospital stay was 2 days longer.
The study in the United Kingdom included nearly 200,000 patients with psoriasis and almost 1 million patients without psoriasis from The Health Improvement Network electronic medical record database. Between 2002 and 2013, patients without psoriasis developed an estimated 78.5 serious infections per 100,000 person-years, compared with 88.9, 85.7, and 145.7 serious infections per 100,000 person-years, respectively, for all psoriasis patients, patients with mild disease, and patients with severe disease requiring systemic or phototherapy, said Dr. Junko Takeshita and her colleagues at the University of Pennsylvania in Philadelphia. After controlling for many potential demographic and clinical confounders, psoriasis increased the risk of serious infection by about 21% (hazard ratio, 1.21; 95% confidence interval, 1.18-1.23). Patients with severe psoriasis had a 63% greater risk of infection than patients without psoriasis, compared with an 18% increase for patients with mild psoriasis.
The findings show “serious infection, particularly respiratory and skin or soft tissue infections, to be an important and common cause of morbidity among patients with psoriasis, especially those with more severe disease,” Dr. Takeshita and her associates said. Notably, the link between psoriasis and risk of serious infection persisted after excluding patients on immunosuppressive therapies, suggesting “that the greater infection risk is at least partially attributable to more severe psoriasis, itself,” they added.
The analysis of Nationwide Inpatient Sample data was funded by the Agency for Healthcare Research and Quality and by the Dermatology Foundation. The analysis of Health Improvement Network data was funded by the National Institute of Arthritis and Musculoskeletal and Skin Diseases, which is part of the National Institutes of Health, and by the Dermatology Foundation. None of the investigators reported conflicts of interest.
SCOTTSDALE, ARIZ. – From enterocolitis to MRSA, serious infections are on the rise among inpatients with psoriasis, and psoriasis is an independent risk factor for serious infections, according to findings from large retrospective studies from the United States and the United Kingdom.
Inpatients with psoriasis in the United States also were at greater risk of serious infections, compared with nonpsoriatic inpatients at every time point studied, and serious infections were associated with increased hospital costs, length of stay, and risk of mortality, reported Derek Hsu, a medical student at Northwestern University, Chicago, and his associates. “Research is needed to determine how to reduce the risk of serious infections in patients with psoriasis,” the investigators emphasized.
Psoriasis affects some 7 million adults in the United States. Biologics, which are transforming the treatment landscape for moderate-to-severe psoriasis, “should reduce inherent infectious risk by controlling the inflammatory process and reducing disease severity, [but] these effects may be immunosuppressing and increase the risk of infection in other ways,” according to Mr. Hsu and his associates. For their study, they analyzed data for 2002-2012 from the Nationwide Inpatient Sample, which covers 20% of hospitalizations in the United States. They extracted validated ICD-9 codes for psoriasis and serious infections, and calculated costs of care after adjusting for 2014 inflation, based on the United States Consumer Price Index.
Overall rates of serious infection and rates of pneumonia, MRSA, septicemia, diverticulitis, enterocolitis, encephalitis, and any viral or fungal infection rose significantly among inpatients with psoriasis between 2002 and 2012 (all P-values less than .05). Predictors of serious infections among inpatients with psoriasis included diabetes mellitus, obesity, and being of non-Caucasian race or ethnicity, female, older than 60 years, and on Medicare or Medicaid, the researchers reported at the annual meeting of the Society for Investigative Dermatology.
Furthermore, after controlling for age, sex, and race, psoriasis was a significant risk factor for many different types of serious infections. Among these were cellulitis, herpes simplex virus, infectious arthritis, osteomyelitis, meningitis, influenza, encephalitis, septicemia, enterocolitis, MRSA, methicillin-sensitive Staphylococcus aureus infections, and Clostridium difficile. Further, inpatients with psoriasis were more prone to urinary tract infection, peritonitis or intestinal abscess, appendicitis, tuberculosis, and viral and fungal infections (all P-values less than .05). The average cost of hospital stay for inpatients with psoriasis was more than $2,200 greater when they were diagnosed with one or more serious infections than otherwise, and their average length of hospital stay was 2 days longer.
The study in the United Kingdom included nearly 200,000 patients with psoriasis and almost 1 million patients without psoriasis from The Health Improvement Network electronic medical record database. Between 2002 and 2013, patients without psoriasis developed an estimated 78.5 serious infections per 100,000 person-years, compared with 88.9, 85.7, and 145.7 serious infections per 100,000 person-years, respectively, for all psoriasis patients, patients with mild disease, and patients with severe disease requiring systemic or phototherapy, said Dr. Junko Takeshita and her colleagues at the University of Pennsylvania in Philadelphia. After controlling for many potential demographic and clinical confounders, psoriasis increased the risk of serious infection by about 21% (hazard ratio, 1.21; 95% confidence interval, 1.18-1.23). Patients with severe psoriasis had a 63% greater risk of infection than patients without psoriasis, compared with an 18% increase for patients with mild psoriasis.
The findings show “serious infection, particularly respiratory and skin or soft tissue infections, to be an important and common cause of morbidity among patients with psoriasis, especially those with more severe disease,” Dr. Takeshita and her associates said. Notably, the link between psoriasis and risk of serious infection persisted after excluding patients on immunosuppressive therapies, suggesting “that the greater infection risk is at least partially attributable to more severe psoriasis, itself,” they added.
The analysis of Nationwide Inpatient Sample data was funded by the Agency for Healthcare Research and Quality and by the Dermatology Foundation. The analysis of Health Improvement Network data was funded by the National Institute of Arthritis and Musculoskeletal and Skin Diseases, which is part of the National Institutes of Health, and by the Dermatology Foundation. None of the investigators reported conflicts of interest.
SCOTTSDALE, ARIZ. – From enterocolitis to MRSA, serious infections are on the rise among inpatients with psoriasis, and psoriasis is an independent risk factor for serious infections, according to findings from large retrospective studies from the United States and the United Kingdom.
Inpatients with psoriasis in the United States also were at greater risk of serious infections, compared with nonpsoriatic inpatients at every time point studied, and serious infections were associated with increased hospital costs, length of stay, and risk of mortality, reported Derek Hsu, a medical student at Northwestern University, Chicago, and his associates. “Research is needed to determine how to reduce the risk of serious infections in patients with psoriasis,” the investigators emphasized.
Psoriasis affects some 7 million adults in the United States. Biologics, which are transforming the treatment landscape for moderate-to-severe psoriasis, “should reduce inherent infectious risk by controlling the inflammatory process and reducing disease severity, [but] these effects may be immunosuppressing and increase the risk of infection in other ways,” according to Mr. Hsu and his associates. For their study, they analyzed data for 2002-2012 from the Nationwide Inpatient Sample, which covers 20% of hospitalizations in the United States. They extracted validated ICD-9 codes for psoriasis and serious infections, and calculated costs of care after adjusting for 2014 inflation, based on the United States Consumer Price Index.
Overall rates of serious infection and rates of pneumonia, MRSA, septicemia, diverticulitis, enterocolitis, encephalitis, and any viral or fungal infection rose significantly among inpatients with psoriasis between 2002 and 2012 (all P-values less than .05). Predictors of serious infections among inpatients with psoriasis included diabetes mellitus, obesity, and being of non-Caucasian race or ethnicity, female, older than 60 years, and on Medicare or Medicaid, the researchers reported at the annual meeting of the Society for Investigative Dermatology.
Furthermore, after controlling for age, sex, and race, psoriasis was a significant risk factor for many different types of serious infections. Among these were cellulitis, herpes simplex virus, infectious arthritis, osteomyelitis, meningitis, influenza, encephalitis, septicemia, enterocolitis, MRSA, methicillin-sensitive Staphylococcus aureus infections, and Clostridium difficile. Further, inpatients with psoriasis were more prone to urinary tract infection, peritonitis or intestinal abscess, appendicitis, tuberculosis, and viral and fungal infections (all P-values less than .05). The average cost of hospital stay for inpatients with psoriasis was more than $2,200 greater when they were diagnosed with one or more serious infections than otherwise, and their average length of hospital stay was 2 days longer.
The study in the United Kingdom included nearly 200,000 patients with psoriasis and almost 1 million patients without psoriasis from The Health Improvement Network electronic medical record database. Between 2002 and 2013, patients without psoriasis developed an estimated 78.5 serious infections per 100,000 person-years, compared with 88.9, 85.7, and 145.7 serious infections per 100,000 person-years, respectively, for all psoriasis patients, patients with mild disease, and patients with severe disease requiring systemic or phototherapy, said Dr. Junko Takeshita and her colleagues at the University of Pennsylvania in Philadelphia. After controlling for many potential demographic and clinical confounders, psoriasis increased the risk of serious infection by about 21% (hazard ratio, 1.21; 95% confidence interval, 1.18-1.23). Patients with severe psoriasis had a 63% greater risk of infection than patients without psoriasis, compared with an 18% increase for patients with mild psoriasis.
The findings show “serious infection, particularly respiratory and skin or soft tissue infections, to be an important and common cause of morbidity among patients with psoriasis, especially those with more severe disease,” Dr. Takeshita and her associates said. Notably, the link between psoriasis and risk of serious infection persisted after excluding patients on immunosuppressive therapies, suggesting “that the greater infection risk is at least partially attributable to more severe psoriasis, itself,” they added.
The analysis of Nationwide Inpatient Sample data was funded by the Agency for Healthcare Research and Quality and by the Dermatology Foundation. The analysis of Health Improvement Network data was funded by the National Institute of Arthritis and Musculoskeletal and Skin Diseases, which is part of the National Institutes of Health, and by the Dermatology Foundation. None of the investigators reported conflicts of interest.
AT THE 2016 SID ANNUAL MEETING
Key clinical point: Psoriasis is an independent risk factor for serious infections, and serious infections are increasing among inpatients with psoriasis.
Major finding: Overall rates of serious infection and rates of pneumonia, MRSA, septicemia, diverticulitis, enterocolitis, encephalitis, and any viral or fungal infection rose significantly among inpatients in the United States with psoriasis between 2002 and 2012 (all P-values less than .05). In the United Kingdom during the same time period, patients with severe psoriasis had a 63% greater risk of serious infection than patients without psoriasis.
Data source: Analyses of data from the Nationwide Inpatient Sample for 2002 through 2012, and from The Health Improvement Network for 2003 through 2012.
Disclosures: The Nationwide Inpatient Sample analysis was funded by the Agency for Healthcare Research and Quality and the Dermatology Foundation. The analysis of The Health Improvement Network was funded by the National Institute of Arthritis and Musculoskeletal and Skin Diseases, which is part of the National Institutes of Health, and by the Dermatology Foundation. None of the investigators reported conflicts of interest.
FDA warns against routine fluoroquinolone use
The U.S. Food and Drug Administration has issued a warning to health care providers against the routine prescribing of fluoroquinolone antibiotics to those patients with sinusitis, bronchitis, and uncomplicated urinary tract infections who have other treatment options.
After conducting a safety review of the drugs, the FDA concluded that fluoroquinolone should be reserved for those patients who do not have alternative treatment options, in light of the findings that the antibiotics – when used systemically in either tablet, capsule, or injectable form – are associated with “disabling and potentially permanent serious side effects” that can occur together. These side effects can involve the tendons, muscles, joints, nerves, and central nervous system, according to the agency.
The FDA says health care providers should stop systemic fluoroquinolone treatment immediately in patients reporting serious side effects and switch to a non-fluoroquinolone antibacterial drug to complete the patient’s treatment course. The drug labels and medication guides for all fluoroquinolone antibiotics will be updated to reflect the new safety information.
The FDA had previously communicated safety information associated with systemic fluoroquinolone antibacterial drugs in August 2013 and July 2008, and the safety issues described in the current warning were discussed at an FDA Advisory Committee meeting in November 2015.
On Twitter @richpizzi
The U.S. Food and Drug Administration has issued a warning to health care providers against the routine prescribing of fluoroquinolone antibiotics to those patients with sinusitis, bronchitis, and uncomplicated urinary tract infections who have other treatment options.
After conducting a safety review of the drugs, the FDA concluded that fluoroquinolone should be reserved for those patients who do not have alternative treatment options, in light of the findings that the antibiotics – when used systemically in either tablet, capsule, or injectable form – are associated with “disabling and potentially permanent serious side effects” that can occur together. These side effects can involve the tendons, muscles, joints, nerves, and central nervous system, according to the agency.
The FDA says health care providers should stop systemic fluoroquinolone treatment immediately in patients reporting serious side effects and switch to a non-fluoroquinolone antibacterial drug to complete the patient’s treatment course. The drug labels and medication guides for all fluoroquinolone antibiotics will be updated to reflect the new safety information.
The FDA had previously communicated safety information associated with systemic fluoroquinolone antibacterial drugs in August 2013 and July 2008, and the safety issues described in the current warning were discussed at an FDA Advisory Committee meeting in November 2015.
On Twitter @richpizzi
The U.S. Food and Drug Administration has issued a warning to health care providers against the routine prescribing of fluoroquinolone antibiotics to those patients with sinusitis, bronchitis, and uncomplicated urinary tract infections who have other treatment options.
After conducting a safety review of the drugs, the FDA concluded that fluoroquinolone should be reserved for those patients who do not have alternative treatment options, in light of the findings that the antibiotics – when used systemically in either tablet, capsule, or injectable form – are associated with “disabling and potentially permanent serious side effects” that can occur together. These side effects can involve the tendons, muscles, joints, nerves, and central nervous system, according to the agency.
The FDA says health care providers should stop systemic fluoroquinolone treatment immediately in patients reporting serious side effects and switch to a non-fluoroquinolone antibacterial drug to complete the patient’s treatment course. The drug labels and medication guides for all fluoroquinolone antibiotics will be updated to reflect the new safety information.
The FDA had previously communicated safety information associated with systemic fluoroquinolone antibacterial drugs in August 2013 and July 2008, and the safety issues described in the current warning were discussed at an FDA Advisory Committee meeting in November 2015.
On Twitter @richpizzi
Crisaborole’s safety holds up in long-term atopic dermatitis trial
SCOTTSDALE, ARIZ. – The phosphodiesterase-4 inhibitor crisaborole was well tolerated over 6 to 12 months, yielding no major safety signals during a multicenter, open-label extension study of patients with mild-to-moderate atopic dermatitis.
These safety results held up across age groups and over time, said Dr. Lawrence Eichenfield, a dermatologist at Children’s Hospital, San Diego, and at the University of San Diego School of Medicine. “The majority of treatment-emergent adverse events were considered mild to moderate and not related to treatment. There were no reports of long-term cutaneous reactions, such as atrophy or telangiectasia,” he and his associates added.
Atopic dermatitis has lacked widely accepted treatment options. Despite attempts to educate patients and parents about topical steroids, many are afraid to use them, and topical calcineurin inhibitors have a black box warning for cancer risk. Not surprisingly, therefore, a 2% ointment of crisaborole made headlines in 2015 after meeting its efficacy and safety endpoints in two pivotal phase III trials of patients with mild-to-moderate atopic dermatitis. Based on those results, Anacor Pharmaceuticals filed a new drug application for the novel boron-based small molecule in January 2016.
The pivotal trials lasted just 28 days, so to assess long-term safety, Dr. Eichenfield and his associates enrolled a subgroup of 517 patients aged 2 to 72 years into a single-arm, open-label, 48-week extension study of crisaborole. About 31% of participants had received the control vehicle during the pivotal trials, while the rest had received crisaborole and tolerated it well enough to continue using it. Patients applied crisaborole twice daily during treatment cycles of 28 days, and were evaluated on days 1, 8, and 29 for up to 12 treatment cycles. Patients whose skin became clear or almost clear went off treatment, but they were still assessed for adverse effects at the same frequency.
In all, 396 patients used crisaborole for at least 6 months, and 271 completed 12 months of treatment, the researchers reported at the annual meeting of the Society for Investigative Dermatology. Only nine (1.7%) patients stopped treatment during the extension study because of treatment-emergent adverse effects. A total of 65% of patients had at least one treatment-emergent adverse event during the initial phase III trials, the extension study, or both. These were usually mildly or moderately severe and included nasopharyngitis, upper respiratory infections, cough, and/or fever, all of which were considered unrelated to treatment.
Treatment-related adverse events included flares of atopic dermatitis, burning or stinging at the application site, and application site infection, which affected 3.1%, 2.3%, and 1.2%, respectively, of patients in the extension study. None of these events were considered serious. Notably, 11% of patients experienced atopic dermatitis flares in the original phase III trials, the researchers reported. Patients who could not tolerate crisaborole were excluded from the extension study, which might help explain the lower flare rate (3%) with long-term treatment.
“Crisaborole topical ointment, 2%, demonstrated a favorable long-term safety profile for the treatment of patients aged 2 years and older with mild-to-moderate atopic dermatitis,” the researchers concluded. The Food and Drug Administration accepted the new drug application in March.
Anacor Pharmaceuticals makes crisaborole and funded the study. Dr. Eichenfield has served as an investigator and consultant to Anacor. Three coinvestigators also reported affiliations with Anacor.
SCOTTSDALE, ARIZ. – The phosphodiesterase-4 inhibitor crisaborole was well tolerated over 6 to 12 months, yielding no major safety signals during a multicenter, open-label extension study of patients with mild-to-moderate atopic dermatitis.
These safety results held up across age groups and over time, said Dr. Lawrence Eichenfield, a dermatologist at Children’s Hospital, San Diego, and at the University of San Diego School of Medicine. “The majority of treatment-emergent adverse events were considered mild to moderate and not related to treatment. There were no reports of long-term cutaneous reactions, such as atrophy or telangiectasia,” he and his associates added.
Atopic dermatitis has lacked widely accepted treatment options. Despite attempts to educate patients and parents about topical steroids, many are afraid to use them, and topical calcineurin inhibitors have a black box warning for cancer risk. Not surprisingly, therefore, a 2% ointment of crisaborole made headlines in 2015 after meeting its efficacy and safety endpoints in two pivotal phase III trials of patients with mild-to-moderate atopic dermatitis. Based on those results, Anacor Pharmaceuticals filed a new drug application for the novel boron-based small molecule in January 2016.
The pivotal trials lasted just 28 days, so to assess long-term safety, Dr. Eichenfield and his associates enrolled a subgroup of 517 patients aged 2 to 72 years into a single-arm, open-label, 48-week extension study of crisaborole. About 31% of participants had received the control vehicle during the pivotal trials, while the rest had received crisaborole and tolerated it well enough to continue using it. Patients applied crisaborole twice daily during treatment cycles of 28 days, and were evaluated on days 1, 8, and 29 for up to 12 treatment cycles. Patients whose skin became clear or almost clear went off treatment, but they were still assessed for adverse effects at the same frequency.
In all, 396 patients used crisaborole for at least 6 months, and 271 completed 12 months of treatment, the researchers reported at the annual meeting of the Society for Investigative Dermatology. Only nine (1.7%) patients stopped treatment during the extension study because of treatment-emergent adverse effects. A total of 65% of patients had at least one treatment-emergent adverse event during the initial phase III trials, the extension study, or both. These were usually mildly or moderately severe and included nasopharyngitis, upper respiratory infections, cough, and/or fever, all of which were considered unrelated to treatment.
Treatment-related adverse events included flares of atopic dermatitis, burning or stinging at the application site, and application site infection, which affected 3.1%, 2.3%, and 1.2%, respectively, of patients in the extension study. None of these events were considered serious. Notably, 11% of patients experienced atopic dermatitis flares in the original phase III trials, the researchers reported. Patients who could not tolerate crisaborole were excluded from the extension study, which might help explain the lower flare rate (3%) with long-term treatment.
“Crisaborole topical ointment, 2%, demonstrated a favorable long-term safety profile for the treatment of patients aged 2 years and older with mild-to-moderate atopic dermatitis,” the researchers concluded. The Food and Drug Administration accepted the new drug application in March.
Anacor Pharmaceuticals makes crisaborole and funded the study. Dr. Eichenfield has served as an investigator and consultant to Anacor. Three coinvestigators also reported affiliations with Anacor.
SCOTTSDALE, ARIZ. – The phosphodiesterase-4 inhibitor crisaborole was well tolerated over 6 to 12 months, yielding no major safety signals during a multicenter, open-label extension study of patients with mild-to-moderate atopic dermatitis.
These safety results held up across age groups and over time, said Dr. Lawrence Eichenfield, a dermatologist at Children’s Hospital, San Diego, and at the University of San Diego School of Medicine. “The majority of treatment-emergent adverse events were considered mild to moderate and not related to treatment. There were no reports of long-term cutaneous reactions, such as atrophy or telangiectasia,” he and his associates added.
Atopic dermatitis has lacked widely accepted treatment options. Despite attempts to educate patients and parents about topical steroids, many are afraid to use them, and topical calcineurin inhibitors have a black box warning for cancer risk. Not surprisingly, therefore, a 2% ointment of crisaborole made headlines in 2015 after meeting its efficacy and safety endpoints in two pivotal phase III trials of patients with mild-to-moderate atopic dermatitis. Based on those results, Anacor Pharmaceuticals filed a new drug application for the novel boron-based small molecule in January 2016.
The pivotal trials lasted just 28 days, so to assess long-term safety, Dr. Eichenfield and his associates enrolled a subgroup of 517 patients aged 2 to 72 years into a single-arm, open-label, 48-week extension study of crisaborole. About 31% of participants had received the control vehicle during the pivotal trials, while the rest had received crisaborole and tolerated it well enough to continue using it. Patients applied crisaborole twice daily during treatment cycles of 28 days, and were evaluated on days 1, 8, and 29 for up to 12 treatment cycles. Patients whose skin became clear or almost clear went off treatment, but they were still assessed for adverse effects at the same frequency.
In all, 396 patients used crisaborole for at least 6 months, and 271 completed 12 months of treatment, the researchers reported at the annual meeting of the Society for Investigative Dermatology. Only nine (1.7%) patients stopped treatment during the extension study because of treatment-emergent adverse effects. A total of 65% of patients had at least one treatment-emergent adverse event during the initial phase III trials, the extension study, or both. These were usually mildly or moderately severe and included nasopharyngitis, upper respiratory infections, cough, and/or fever, all of which were considered unrelated to treatment.
Treatment-related adverse events included flares of atopic dermatitis, burning or stinging at the application site, and application site infection, which affected 3.1%, 2.3%, and 1.2%, respectively, of patients in the extension study. None of these events were considered serious. Notably, 11% of patients experienced atopic dermatitis flares in the original phase III trials, the researchers reported. Patients who could not tolerate crisaborole were excluded from the extension study, which might help explain the lower flare rate (3%) with long-term treatment.
“Crisaborole topical ointment, 2%, demonstrated a favorable long-term safety profile for the treatment of patients aged 2 years and older with mild-to-moderate atopic dermatitis,” the researchers concluded. The Food and Drug Administration accepted the new drug application in March.
Anacor Pharmaceuticals makes crisaborole and funded the study. Dr. Eichenfield has served as an investigator and consultant to Anacor. Three coinvestigators also reported affiliations with Anacor.
AT THE 2016 SID ANNUAL MEETING
Key clinical point: The topical phosphodiesterase-4 inhibitor crisaborole was safe and well tolerated for up to 48 weeks in patients with mild-to-moderate atopic dermatitis.
Major finding: The most common treatment–related adverse events were atopic dermatitis flare (3%), stinging and burning at the application site (2%), and application site infection (1%). None were serious.
Data source: A single-arm, multicenter, open-label, 48-week extension study of 517 patients with mild-to-moderate atopic dermatitis.
Disclosures: Anacor Pharmaceuticals makes crisaborole and funded the study. Dr. Eichenfield has served as an investigator and consultant to Anacor. Three coinvestigators also reported affiliations with Anacor.
Yoga Improves Asthmatics’ Quality of Life, Data Review Suggests
Yoga seems to improve the quality of life and symptoms of people with asthma, suggests a review of 15 randomized controlled trials comprising 1,048 patients with varying degrees of asthma severity.
The studies generally compared the outcomes for asthma patients participating in at least 2 weeks of yoga with the outcomes for those who were treated with usual care for asthma, a sham intervention, or no intervention.
Average improvements in the Asthma Quality of Life Questionnaire scores of 0.57 units per item on a 7-point scale were found through an analysis of responses from 375 individuals, with each person having participated in one of the five randomized controlled trials (RCTs). While the average increase exceeded the minimal clinically important difference (MCID) for this questionnaire, outcomes of two of the trials raise questions about whether the reported improvements in patients’ quality of life can be attributed to yoga. In those two trials, which included a placebo or sham intervention for some of the participants, no differences in these questionnaire scores were found following the interventions.
For 243 asthma patients who participated in three of the RCTs, on average, yoga improved their symptoms by 0.37 standard deviation units of the disease severity scores used.
“Our findings are preliminary and suggestive, rather than conclusive, and therefore should be interpreted cautiously. Yoga probably improves quality of life and symptoms in people with asthma to some extent. However, whether or not the improvements in symptoms exceed the MCID is uncertain due to lack of an established MCID for the severity scores used in the included studies,” noted Zu-Yao Yang of the Chinese University of Hong Kong, and colleagues.
They used various methods to collect data, including searching the Cochrane Airways Group Register of Trials, which is derived from systematic searches of bibliographic databases, and hand-searching respiratory journals and meeting abstracts. They searched all databases from their inception to July 22, 2015, and placed no restriction on language of publication. All studies were parallel-group trials, except for one cross-over trial.
While two of the studies reported adverse events, four of the studies reported having investigated the occurrences of such types of incidents. One of the studies said three participants in its control group required oral steroids because of acute exacerbations of their asthma, but that these adverse events could not be counted as having been caused by yoga. Another study showed that one participant in its yoga group, who used the Pink City Lung Exerciser (a medical device used to mimic the typical patterns of yoga breathing), reported mild dyspnea during the exercise.
“[As] the included studies were mostly small in sample size and at high risk of bias, high-quality RCTs with large sample sizes are needed to confirm the effects of yoga,” the researchers said.
They reported that they had no known declarations of interest. The project was supported by the National Institute for Health Research, via Cochrane Infrastructure funding to the Cochrane Airways Group.
The full review is available in the Cochrane Database of Systematic Reviews (doi: 10.1002/14651858.CD010346.pub2).
Yoga seems to improve the quality of life and symptoms of people with asthma, suggests a review of 15 randomized controlled trials comprising 1,048 patients with varying degrees of asthma severity.
The studies generally compared the outcomes for asthma patients participating in at least 2 weeks of yoga with the outcomes for those who were treated with usual care for asthma, a sham intervention, or no intervention.
Average improvements in the Asthma Quality of Life Questionnaire scores of 0.57 units per item on a 7-point scale were found through an analysis of responses from 375 individuals, with each person having participated in one of the five randomized controlled trials (RCTs). While the average increase exceeded the minimal clinically important difference (MCID) for this questionnaire, outcomes of two of the trials raise questions about whether the reported improvements in patients’ quality of life can be attributed to yoga. In those two trials, which included a placebo or sham intervention for some of the participants, no differences in these questionnaire scores were found following the interventions.
For 243 asthma patients who participated in three of the RCTs, on average, yoga improved their symptoms by 0.37 standard deviation units of the disease severity scores used.
“Our findings are preliminary and suggestive, rather than conclusive, and therefore should be interpreted cautiously. Yoga probably improves quality of life and symptoms in people with asthma to some extent. However, whether or not the improvements in symptoms exceed the MCID is uncertain due to lack of an established MCID for the severity scores used in the included studies,” noted Zu-Yao Yang of the Chinese University of Hong Kong, and colleagues.
They used various methods to collect data, including searching the Cochrane Airways Group Register of Trials, which is derived from systematic searches of bibliographic databases, and hand-searching respiratory journals and meeting abstracts. They searched all databases from their inception to July 22, 2015, and placed no restriction on language of publication. All studies were parallel-group trials, except for one cross-over trial.
While two of the studies reported adverse events, four of the studies reported having investigated the occurrences of such types of incidents. One of the studies said three participants in its control group required oral steroids because of acute exacerbations of their asthma, but that these adverse events could not be counted as having been caused by yoga. Another study showed that one participant in its yoga group, who used the Pink City Lung Exerciser (a medical device used to mimic the typical patterns of yoga breathing), reported mild dyspnea during the exercise.
“[As] the included studies were mostly small in sample size and at high risk of bias, high-quality RCTs with large sample sizes are needed to confirm the effects of yoga,” the researchers said.
They reported that they had no known declarations of interest. The project was supported by the National Institute for Health Research, via Cochrane Infrastructure funding to the Cochrane Airways Group.
The full review is available in the Cochrane Database of Systematic Reviews (doi: 10.1002/14651858.CD010346.pub2).
Yoga seems to improve the quality of life and symptoms of people with asthma, suggests a review of 15 randomized controlled trials comprising 1,048 patients with varying degrees of asthma severity.
The studies generally compared the outcomes for asthma patients participating in at least 2 weeks of yoga with the outcomes for those who were treated with usual care for asthma, a sham intervention, or no intervention.
Average improvements in the Asthma Quality of Life Questionnaire scores of 0.57 units per item on a 7-point scale were found through an analysis of responses from 375 individuals, with each person having participated in one of the five randomized controlled trials (RCTs). While the average increase exceeded the minimal clinically important difference (MCID) for this questionnaire, outcomes of two of the trials raise questions about whether the reported improvements in patients’ quality of life can be attributed to yoga. In those two trials, which included a placebo or sham intervention for some of the participants, no differences in these questionnaire scores were found following the interventions.
For 243 asthma patients who participated in three of the RCTs, on average, yoga improved their symptoms by 0.37 standard deviation units of the disease severity scores used.
“Our findings are preliminary and suggestive, rather than conclusive, and therefore should be interpreted cautiously. Yoga probably improves quality of life and symptoms in people with asthma to some extent. However, whether or not the improvements in symptoms exceed the MCID is uncertain due to lack of an established MCID for the severity scores used in the included studies,” noted Zu-Yao Yang of the Chinese University of Hong Kong, and colleagues.
They used various methods to collect data, including searching the Cochrane Airways Group Register of Trials, which is derived from systematic searches of bibliographic databases, and hand-searching respiratory journals and meeting abstracts. They searched all databases from their inception to July 22, 2015, and placed no restriction on language of publication. All studies were parallel-group trials, except for one cross-over trial.
While two of the studies reported adverse events, four of the studies reported having investigated the occurrences of such types of incidents. One of the studies said three participants in its control group required oral steroids because of acute exacerbations of their asthma, but that these adverse events could not be counted as having been caused by yoga. Another study showed that one participant in its yoga group, who used the Pink City Lung Exerciser (a medical device used to mimic the typical patterns of yoga breathing), reported mild dyspnea during the exercise.
“[As] the included studies were mostly small in sample size and at high risk of bias, high-quality RCTs with large sample sizes are needed to confirm the effects of yoga,” the researchers said.
They reported that they had no known declarations of interest. The project was supported by the National Institute for Health Research, via Cochrane Infrastructure funding to the Cochrane Airways Group.
The full review is available in the Cochrane Database of Systematic Reviews (doi: 10.1002/14651858.CD010346.pub2).
FROM THE COCHRANE DATABASE OF SYSTEMATIC REVIEWS
