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Improving swallowing may mitigate COPD exacerbations
Dysphagia treatment may be a way to reduce risk for chronic obstructive pulmonary disease (COPD) exacerbations, according to Yoshitaka Oku, MD, of Hyogo Medical University, Nishinomiya, Japan.
Gastroesophageal regurgitation disease (GERD) is known to be associated with exacerbations in COPD, but previous studies have shown little impact of standard GERD therapy on COPD exacerbations. However, additional research indicates that delayed swallowing contributes to COPD exacerbations, as reported in a research review.
In an article published recently in Respiratory Physiology & Neurobiology,
Swallowing disorder (dysphagia) is a common comorbidity in patients with COPD and has been reported at a 17%-20% greater prevalence in those with COPD, compared with controls, the researchers said.
Patients with COPD have altered swallowing behavior because of several factors, including decreased maximal laryngeal elevation, Dr. Oku said. Individuals with COPD “are also prone to laryngeal penetration and aspiration when swallowing large volumes of liquid and tend to follow an inspiratory-swallow-expiratory (I-SW-E) pattern when swallowing large volumes,” he explained.
Dr. Oku conducted prospective studies to investigate the impact of breathing-swallowing discoordination on COPD exacerbation. He found that discoordination in swallowing patterns and the inability to produce airway protective mechanism (such as the I-SW-E pattern) may contribute to more frequent aspirations and more frequent exacerbations.
Dr. Oku also examined whether CPAP and bilevel positive airway pressure (BiPAP) might affect breathing-swallowing coordination in healthy controls and patients with COPD. They found a decrease in breathing-swallowing coordination with CPAP, but not BiPAP, in both controls and stable COPD patients. “During BiPAP, a brief negative flow associated with relaxation of the pharyngeal constrictor muscle triggers inspiratory support, which results in the SW-I pattern,” Dr. Oku noted.
Dr. Oku also wrote that interferential current stimulation (IFC) has been used to stimulate muscles. Studies of transcutaneous electrical sensory stimulation using IFC (IFC-TESS) as an intervention to improve swallowing have shown some success, and also may improve airway protection.
“However, its safety and efficacy in patients with COPD remains unknown,” he wrote. Dr. Oku conducted a study of stable COPD patients and found that repeated salivary swallow test (RSST) scores improved significantly after an IFC-TESS intervention.
Breathing-swallowing discoordination may be an early indicator of swallowing disorder in COPD, and interventions can improve these disorders, Dr. Oku added. However, more research is needed to explore whether interventions to improve dysphagia reduce the frequency of exacerbations in COPD patients, he concluded.
The study was supported by a grant from JSPS KAKENHI. Dr. Oku serves as a senior managing director at EuSense Medical Co.
A version of this article originally appeared on Medscape.com.
Dysphagia treatment may be a way to reduce risk for chronic obstructive pulmonary disease (COPD) exacerbations, according to Yoshitaka Oku, MD, of Hyogo Medical University, Nishinomiya, Japan.
Gastroesophageal regurgitation disease (GERD) is known to be associated with exacerbations in COPD, but previous studies have shown little impact of standard GERD therapy on COPD exacerbations. However, additional research indicates that delayed swallowing contributes to COPD exacerbations, as reported in a research review.
In an article published recently in Respiratory Physiology & Neurobiology,
Swallowing disorder (dysphagia) is a common comorbidity in patients with COPD and has been reported at a 17%-20% greater prevalence in those with COPD, compared with controls, the researchers said.
Patients with COPD have altered swallowing behavior because of several factors, including decreased maximal laryngeal elevation, Dr. Oku said. Individuals with COPD “are also prone to laryngeal penetration and aspiration when swallowing large volumes of liquid and tend to follow an inspiratory-swallow-expiratory (I-SW-E) pattern when swallowing large volumes,” he explained.
Dr. Oku conducted prospective studies to investigate the impact of breathing-swallowing discoordination on COPD exacerbation. He found that discoordination in swallowing patterns and the inability to produce airway protective mechanism (such as the I-SW-E pattern) may contribute to more frequent aspirations and more frequent exacerbations.
Dr. Oku also examined whether CPAP and bilevel positive airway pressure (BiPAP) might affect breathing-swallowing coordination in healthy controls and patients with COPD. They found a decrease in breathing-swallowing coordination with CPAP, but not BiPAP, in both controls and stable COPD patients. “During BiPAP, a brief negative flow associated with relaxation of the pharyngeal constrictor muscle triggers inspiratory support, which results in the SW-I pattern,” Dr. Oku noted.
Dr. Oku also wrote that interferential current stimulation (IFC) has been used to stimulate muscles. Studies of transcutaneous electrical sensory stimulation using IFC (IFC-TESS) as an intervention to improve swallowing have shown some success, and also may improve airway protection.
“However, its safety and efficacy in patients with COPD remains unknown,” he wrote. Dr. Oku conducted a study of stable COPD patients and found that repeated salivary swallow test (RSST) scores improved significantly after an IFC-TESS intervention.
Breathing-swallowing discoordination may be an early indicator of swallowing disorder in COPD, and interventions can improve these disorders, Dr. Oku added. However, more research is needed to explore whether interventions to improve dysphagia reduce the frequency of exacerbations in COPD patients, he concluded.
The study was supported by a grant from JSPS KAKENHI. Dr. Oku serves as a senior managing director at EuSense Medical Co.
A version of this article originally appeared on Medscape.com.
Dysphagia treatment may be a way to reduce risk for chronic obstructive pulmonary disease (COPD) exacerbations, according to Yoshitaka Oku, MD, of Hyogo Medical University, Nishinomiya, Japan.
Gastroesophageal regurgitation disease (GERD) is known to be associated with exacerbations in COPD, but previous studies have shown little impact of standard GERD therapy on COPD exacerbations. However, additional research indicates that delayed swallowing contributes to COPD exacerbations, as reported in a research review.
In an article published recently in Respiratory Physiology & Neurobiology,
Swallowing disorder (dysphagia) is a common comorbidity in patients with COPD and has been reported at a 17%-20% greater prevalence in those with COPD, compared with controls, the researchers said.
Patients with COPD have altered swallowing behavior because of several factors, including decreased maximal laryngeal elevation, Dr. Oku said. Individuals with COPD “are also prone to laryngeal penetration and aspiration when swallowing large volumes of liquid and tend to follow an inspiratory-swallow-expiratory (I-SW-E) pattern when swallowing large volumes,” he explained.
Dr. Oku conducted prospective studies to investigate the impact of breathing-swallowing discoordination on COPD exacerbation. He found that discoordination in swallowing patterns and the inability to produce airway protective mechanism (such as the I-SW-E pattern) may contribute to more frequent aspirations and more frequent exacerbations.
Dr. Oku also examined whether CPAP and bilevel positive airway pressure (BiPAP) might affect breathing-swallowing coordination in healthy controls and patients with COPD. They found a decrease in breathing-swallowing coordination with CPAP, but not BiPAP, in both controls and stable COPD patients. “During BiPAP, a brief negative flow associated with relaxation of the pharyngeal constrictor muscle triggers inspiratory support, which results in the SW-I pattern,” Dr. Oku noted.
Dr. Oku also wrote that interferential current stimulation (IFC) has been used to stimulate muscles. Studies of transcutaneous electrical sensory stimulation using IFC (IFC-TESS) as an intervention to improve swallowing have shown some success, and also may improve airway protection.
“However, its safety and efficacy in patients with COPD remains unknown,” he wrote. Dr. Oku conducted a study of stable COPD patients and found that repeated salivary swallow test (RSST) scores improved significantly after an IFC-TESS intervention.
Breathing-swallowing discoordination may be an early indicator of swallowing disorder in COPD, and interventions can improve these disorders, Dr. Oku added. However, more research is needed to explore whether interventions to improve dysphagia reduce the frequency of exacerbations in COPD patients, he concluded.
The study was supported by a grant from JSPS KAKENHI. Dr. Oku serves as a senior managing director at EuSense Medical Co.
A version of this article originally appeared on Medscape.com.
Dupilumab moves forward as possible COPD treatment
of more than 900 adults with uncontrolled chronic obstructive pulmonary disease.
In the study, known as the BOREAS trial, dupilumab met its primary and secondary endpoints, with a significant reduction compared with placebo in exacerbations for adults with chronic obstructive pulmonary disease (COPD) that was uncontrolled despite use of the maximal standard-of-care inhaled therapy (triple therapy), according to a press release from manufacturers Regeneron and Sanofi.
Dupilumab, which inhibits the signaling of the interleukin-4 (IL-4) and interleukin-13 (IL-13) pathways, is currently approved in multiple countries for certain patients with conditions including atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyps, eosinophilic esophagitis, or prurigo nodularis in different age groups. The drug is not an immunosuppressant, and would be the first biologic approved for COPD, according to the manufacturers.
In the BOREAS trial, 468 adults with COPD who were current or former smokers aged 40-80 years were randomized to dupilumab and 471 to placebo; both groups continued to receive maximal standard of care.
Over 52 weeks, patients in the dupilumab group experienced a 30% reduction in moderate to severe COPD exacerbations compared with placebo (P = .0005).
In addition, patients treated with dupilumab met the key secondary endpoints of significant improvement in lung function from baseline to 12 weeks compared with placebo (160 mL vs. 77 mL, P < .0001); this difference persisted at 52 weeks (P = .0003).
Dupilumab also met endpoints for improvement in patient-reported health-related quality of life based on the St. George’s Respiratory Questionnaire (SGRQ) and reduction in the severity of respiratory symptoms of COPD based on the Evaluation Respiratory Symptoms: COPD (E-RS: COPD) Scale, according to the companies’ statement.
The results represent a previously unreported magnitude of improvement for COPD patients treated with a biologic, principal investigator George D. Yancopoulos, MD, said in the statement. “These results also validate the role type 2 inflammation plays in driving COPD in these patients, advancing the scientific community’s understanding of the underlying biology of this disease,” he added.
The safety results in the BOREAS trial were generally consistent with the known safety profile of Dupixent in its approved indications. Overall adverse event rates were similar for dupilumab and placebo patients (77% and 76%, respectively) and the overall safety profiles were consistent with the currently approved dupilumab indications, according to the manufacturers.
The adverse events that were more common in dupilumab patients compared with placebo patients were headache (8.1% vs. 6.8%), diarrhea (5.3% vs. 3.6%), and back pain (5.1% vs. 3.4%).
Adverse events leading to deaths were similar between the groups (1.7% in placebo patients and 1.5% in dupilumab patients).
Complete safety and efficacy results from the BOREAS trial are scheduled to be presented in a future scientific forum, and a second phase 3 trial of dupilumab for COPD, known as NOTUS, is ongoing, with data expected in 2024, according to the manufacturers.
The Boreas trial was sponsored by Sanofi and Regeneron Pharmaceuticals.
of more than 900 adults with uncontrolled chronic obstructive pulmonary disease.
In the study, known as the BOREAS trial, dupilumab met its primary and secondary endpoints, with a significant reduction compared with placebo in exacerbations for adults with chronic obstructive pulmonary disease (COPD) that was uncontrolled despite use of the maximal standard-of-care inhaled therapy (triple therapy), according to a press release from manufacturers Regeneron and Sanofi.
Dupilumab, which inhibits the signaling of the interleukin-4 (IL-4) and interleukin-13 (IL-13) pathways, is currently approved in multiple countries for certain patients with conditions including atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyps, eosinophilic esophagitis, or prurigo nodularis in different age groups. The drug is not an immunosuppressant, and would be the first biologic approved for COPD, according to the manufacturers.
In the BOREAS trial, 468 adults with COPD who were current or former smokers aged 40-80 years were randomized to dupilumab and 471 to placebo; both groups continued to receive maximal standard of care.
Over 52 weeks, patients in the dupilumab group experienced a 30% reduction in moderate to severe COPD exacerbations compared with placebo (P = .0005).
In addition, patients treated with dupilumab met the key secondary endpoints of significant improvement in lung function from baseline to 12 weeks compared with placebo (160 mL vs. 77 mL, P < .0001); this difference persisted at 52 weeks (P = .0003).
Dupilumab also met endpoints for improvement in patient-reported health-related quality of life based on the St. George’s Respiratory Questionnaire (SGRQ) and reduction in the severity of respiratory symptoms of COPD based on the Evaluation Respiratory Symptoms: COPD (E-RS: COPD) Scale, according to the companies’ statement.
The results represent a previously unreported magnitude of improvement for COPD patients treated with a biologic, principal investigator George D. Yancopoulos, MD, said in the statement. “These results also validate the role type 2 inflammation plays in driving COPD in these patients, advancing the scientific community’s understanding of the underlying biology of this disease,” he added.
The safety results in the BOREAS trial were generally consistent with the known safety profile of Dupixent in its approved indications. Overall adverse event rates were similar for dupilumab and placebo patients (77% and 76%, respectively) and the overall safety profiles were consistent with the currently approved dupilumab indications, according to the manufacturers.
The adverse events that were more common in dupilumab patients compared with placebo patients were headache (8.1% vs. 6.8%), diarrhea (5.3% vs. 3.6%), and back pain (5.1% vs. 3.4%).
Adverse events leading to deaths were similar between the groups (1.7% in placebo patients and 1.5% in dupilumab patients).
Complete safety and efficacy results from the BOREAS trial are scheduled to be presented in a future scientific forum, and a second phase 3 trial of dupilumab for COPD, known as NOTUS, is ongoing, with data expected in 2024, according to the manufacturers.
The Boreas trial was sponsored by Sanofi and Regeneron Pharmaceuticals.
of more than 900 adults with uncontrolled chronic obstructive pulmonary disease.
In the study, known as the BOREAS trial, dupilumab met its primary and secondary endpoints, with a significant reduction compared with placebo in exacerbations for adults with chronic obstructive pulmonary disease (COPD) that was uncontrolled despite use of the maximal standard-of-care inhaled therapy (triple therapy), according to a press release from manufacturers Regeneron and Sanofi.
Dupilumab, which inhibits the signaling of the interleukin-4 (IL-4) and interleukin-13 (IL-13) pathways, is currently approved in multiple countries for certain patients with conditions including atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyps, eosinophilic esophagitis, or prurigo nodularis in different age groups. The drug is not an immunosuppressant, and would be the first biologic approved for COPD, according to the manufacturers.
In the BOREAS trial, 468 adults with COPD who were current or former smokers aged 40-80 years were randomized to dupilumab and 471 to placebo; both groups continued to receive maximal standard of care.
Over 52 weeks, patients in the dupilumab group experienced a 30% reduction in moderate to severe COPD exacerbations compared with placebo (P = .0005).
In addition, patients treated with dupilumab met the key secondary endpoints of significant improvement in lung function from baseline to 12 weeks compared with placebo (160 mL vs. 77 mL, P < .0001); this difference persisted at 52 weeks (P = .0003).
Dupilumab also met endpoints for improvement in patient-reported health-related quality of life based on the St. George’s Respiratory Questionnaire (SGRQ) and reduction in the severity of respiratory symptoms of COPD based on the Evaluation Respiratory Symptoms: COPD (E-RS: COPD) Scale, according to the companies’ statement.
The results represent a previously unreported magnitude of improvement for COPD patients treated with a biologic, principal investigator George D. Yancopoulos, MD, said in the statement. “These results also validate the role type 2 inflammation plays in driving COPD in these patients, advancing the scientific community’s understanding of the underlying biology of this disease,” he added.
The safety results in the BOREAS trial were generally consistent with the known safety profile of Dupixent in its approved indications. Overall adverse event rates were similar for dupilumab and placebo patients (77% and 76%, respectively) and the overall safety profiles were consistent with the currently approved dupilumab indications, according to the manufacturers.
The adverse events that were more common in dupilumab patients compared with placebo patients were headache (8.1% vs. 6.8%), diarrhea (5.3% vs. 3.6%), and back pain (5.1% vs. 3.4%).
Adverse events leading to deaths were similar between the groups (1.7% in placebo patients and 1.5% in dupilumab patients).
Complete safety and efficacy results from the BOREAS trial are scheduled to be presented in a future scientific forum, and a second phase 3 trial of dupilumab for COPD, known as NOTUS, is ongoing, with data expected in 2024, according to the manufacturers.
The Boreas trial was sponsored by Sanofi and Regeneron Pharmaceuticals.
Liquid albuterol shortage effects reduced by alternative drugs, similar shortages may be increasingly common
The shortage of 0.5% albuterol sulfate inhalation solution, first reported by the FDA last October, gained increasing attention earlier this month when Akorn Pharmaceuticals – one of just two companies making the product – shut down after years of financial and regulatory troubles.
The other manufacturer, Nephron Pharmaceuticals, is producing 0.5% albuterol “as fast as possible” to overcome the shortage, CEO Lou Kennedy said in a written comment.
Meanwhile, the more commonly used version of liquid albuterol, with a concentration of 0.083%, remains in “good supply from several manufacturers,” according to an FDA spokesperson.
Still, headlines concerning the shortage have caused “a bit of a panic” for patients with asthma and parents with asthmatic children, according to David R. Stukus, MD, professor of clinical pediatrics in the division of allergy and immunology at Nationwide Children’s, Columbus, Ohio.
Much of the media coverage has lacked context, causing unnecessary worry, he said, as the shortage only affects one type of albuterol generally reserved for inpatient and emergency use.
“The shortage has not impacted our albuterol inhalers thus far,” Dr. Stukus said in an interview. “So I certainly don’t want people with asthma to panic that they’re going to run out of their inhaler anytime soon.”
Even infants and toddlers can use inhalers
Although Dr. Stukus noted that certain patients do require nebulizers, such as those with conditions that physically limit their breathing, like muscular dystrophy, most patients can use inhalers just fine. He said it’s a “pretty common misconception, even among medical professionals,” that infants and toddlers need nebulizers instead.
“In our institution, for example, we rarely ever start babies on a nebulizer when we diagnose them with asthma,” Dr. Stukus said. “We often just start right away with an inhaler with a spacer and a face mask.”
The shortage of liquid albuterol may therefore have a silver lining, he suggested, as it prompts clinicians to reconsider their routine practice.
“When situations like this arise, it’s a great opportunity for all of us to just take a step back and reevaluate the way we do things,” Dr. Stukus said. “Sometimes we just get caught up with inertia and we continue to do things the same way even though new options are available, or evidence has changed to the contrary.”
Nathan Rabinovitch, MD, professor of pediatrics in the division of pediatric allergy and clinical immunology at National Jewish Health, Denver, said that his center had trouble obtaining liquid albuterol about 2 weeks ago, so they pivoted to the more expensive levalbuterol for about a week and a half, until their albuterol supply was restored.
While Dr. Rabinovitch agreed that most children don’t need a nebulizer, he said about 5%-10% of kids with severe asthma should have one on hand in case their inhaler fails to control an exacerbation.
Personal preferences may also considered, he added.
“If [a parent] says, ‘I like to use the nebulizer. The kid likes it,’ I’m fine if they just use a nebulizer.”
One possible downside of relying on a nebulizer, however, is portability, according to Kelly O’Shea, MD, assistant professor in the division of allergy and clinical immunology at the University of Michigan, Ann Arbor.
“If you’re out at the park or out at a soccer game with your kids, and they are having trouble breathing ... and they need their albuterol, you don’t have that ability if you are tied to a nebulizer,” Dr. O’Shea said in an interview. “As long as a parent feels comfortable – they feel like [their child] can get deep breaths in, I agree that you can use [an inhaler] in the infant and toddler population.”
She also agreed that a nebulizer may serve as a kind of second step if an inhaler isn’t controlling an exacerbation; however, she emphasized that a nebulizer should not be considered a replacement for professional care, and should not give a false sense of security.
“I caution parents to make sure that when they need it, they also take the next step and head over to the emergency room,” Dr. O’Shea said.
Generic drug shortages becoming more common
While the present scarcity of liquid albuterol appears relatively mild in terms of clinical impact, it brings up broader concerns about generic drug supply, and why shortages like this are becoming more common, according to Katie J. Suda, PharmD, MS, professor of medicine and pharmacy, and associate director, center for pharmaceutical policy and prescribing at the University of Pittsburgh.
“Drug shortages continue to increase in frequency, and the duration and severity of the shortages are also getting worse,” Dr. Suda said in an interview.
The reasons for these shortages can be elusive, according to 2022 report by the American Society of Health-System Pharmacists, which found that more than half of shortages came with no explanation from manufacturers.
The same report showed that only 5% of shortages were due to a “business decision,” but this factor is likely more central than publicly stated.
A recent FDA analysis on drug shortages, for instance, lists “lack of incentives to produce less profitable drugs,” as the first “root cause,” and Dr. Suda agrees.
“It’s important that we have generic medicines to decrease costs to our health systems, as well as for our patients,” Dr. Suda said. “But frequently, with those generic products, the price is driven so low that it increases the risk of a shortage.”
The drive to maintain profit margins may motivate companies to cut corners in production, Dr. Suda explained. She emphasized that this connection is speculative, because motivations are effectively unknowable, but the rationale is supported by past and present shortages.
Akorn Pharmaceuticals, for example, received a warning letter from the FDA in 2019 because of a variety of manufacturing issues, including defective bottles, questionable data, and metal shavings on aseptic filling equipment.
When a manufacturer like Akorn fails, the effects can be far-reaching, Dr. Suda said, noting their broad catalog of agents. Beyond liquid albuterol, Akorn was producing cardiac drugs, antibiotics, vitamins, local anesthetics, eye products, and others.
Drug shortages cause “a significant strain on our health care system,” Dr. Suda said, and substituting other medications increases risk of medical errors.
Fortunately, the increasing number of drug shortages is not going unnoticed, according to Dr. Suda. The FDA and multiple other organizations, including the ASHP, American Medical Association, and National Academies of Sciences, Engineering, and Medicine, are all taking steps to ensure that essential medicines are in steady supply, including moves to gather more data from manufacturers.
“I hope that a lot of the efforts that are moving forward ... will help us decrease the impact of shortages on our patients,” Dr. Suda said.
Lou Kennedy is the CEO of Nephron Pharmaceuticals, which commercially produces liquid albuterol. The other interviewees disclosed no relevant conflicts of interest.
The shortage of 0.5% albuterol sulfate inhalation solution, first reported by the FDA last October, gained increasing attention earlier this month when Akorn Pharmaceuticals – one of just two companies making the product – shut down after years of financial and regulatory troubles.
The other manufacturer, Nephron Pharmaceuticals, is producing 0.5% albuterol “as fast as possible” to overcome the shortage, CEO Lou Kennedy said in a written comment.
Meanwhile, the more commonly used version of liquid albuterol, with a concentration of 0.083%, remains in “good supply from several manufacturers,” according to an FDA spokesperson.
Still, headlines concerning the shortage have caused “a bit of a panic” for patients with asthma and parents with asthmatic children, according to David R. Stukus, MD, professor of clinical pediatrics in the division of allergy and immunology at Nationwide Children’s, Columbus, Ohio.
Much of the media coverage has lacked context, causing unnecessary worry, he said, as the shortage only affects one type of albuterol generally reserved for inpatient and emergency use.
“The shortage has not impacted our albuterol inhalers thus far,” Dr. Stukus said in an interview. “So I certainly don’t want people with asthma to panic that they’re going to run out of their inhaler anytime soon.”
Even infants and toddlers can use inhalers
Although Dr. Stukus noted that certain patients do require nebulizers, such as those with conditions that physically limit their breathing, like muscular dystrophy, most patients can use inhalers just fine. He said it’s a “pretty common misconception, even among medical professionals,” that infants and toddlers need nebulizers instead.
“In our institution, for example, we rarely ever start babies on a nebulizer when we diagnose them with asthma,” Dr. Stukus said. “We often just start right away with an inhaler with a spacer and a face mask.”
The shortage of liquid albuterol may therefore have a silver lining, he suggested, as it prompts clinicians to reconsider their routine practice.
“When situations like this arise, it’s a great opportunity for all of us to just take a step back and reevaluate the way we do things,” Dr. Stukus said. “Sometimes we just get caught up with inertia and we continue to do things the same way even though new options are available, or evidence has changed to the contrary.”
Nathan Rabinovitch, MD, professor of pediatrics in the division of pediatric allergy and clinical immunology at National Jewish Health, Denver, said that his center had trouble obtaining liquid albuterol about 2 weeks ago, so they pivoted to the more expensive levalbuterol for about a week and a half, until their albuterol supply was restored.
While Dr. Rabinovitch agreed that most children don’t need a nebulizer, he said about 5%-10% of kids with severe asthma should have one on hand in case their inhaler fails to control an exacerbation.
Personal preferences may also considered, he added.
“If [a parent] says, ‘I like to use the nebulizer. The kid likes it,’ I’m fine if they just use a nebulizer.”
One possible downside of relying on a nebulizer, however, is portability, according to Kelly O’Shea, MD, assistant professor in the division of allergy and clinical immunology at the University of Michigan, Ann Arbor.
“If you’re out at the park or out at a soccer game with your kids, and they are having trouble breathing ... and they need their albuterol, you don’t have that ability if you are tied to a nebulizer,” Dr. O’Shea said in an interview. “As long as a parent feels comfortable – they feel like [their child] can get deep breaths in, I agree that you can use [an inhaler] in the infant and toddler population.”
She also agreed that a nebulizer may serve as a kind of second step if an inhaler isn’t controlling an exacerbation; however, she emphasized that a nebulizer should not be considered a replacement for professional care, and should not give a false sense of security.
“I caution parents to make sure that when they need it, they also take the next step and head over to the emergency room,” Dr. O’Shea said.
Generic drug shortages becoming more common
While the present scarcity of liquid albuterol appears relatively mild in terms of clinical impact, it brings up broader concerns about generic drug supply, and why shortages like this are becoming more common, according to Katie J. Suda, PharmD, MS, professor of medicine and pharmacy, and associate director, center for pharmaceutical policy and prescribing at the University of Pittsburgh.
“Drug shortages continue to increase in frequency, and the duration and severity of the shortages are also getting worse,” Dr. Suda said in an interview.
The reasons for these shortages can be elusive, according to 2022 report by the American Society of Health-System Pharmacists, which found that more than half of shortages came with no explanation from manufacturers.
The same report showed that only 5% of shortages were due to a “business decision,” but this factor is likely more central than publicly stated.
A recent FDA analysis on drug shortages, for instance, lists “lack of incentives to produce less profitable drugs,” as the first “root cause,” and Dr. Suda agrees.
“It’s important that we have generic medicines to decrease costs to our health systems, as well as for our patients,” Dr. Suda said. “But frequently, with those generic products, the price is driven so low that it increases the risk of a shortage.”
The drive to maintain profit margins may motivate companies to cut corners in production, Dr. Suda explained. She emphasized that this connection is speculative, because motivations are effectively unknowable, but the rationale is supported by past and present shortages.
Akorn Pharmaceuticals, for example, received a warning letter from the FDA in 2019 because of a variety of manufacturing issues, including defective bottles, questionable data, and metal shavings on aseptic filling equipment.
When a manufacturer like Akorn fails, the effects can be far-reaching, Dr. Suda said, noting their broad catalog of agents. Beyond liquid albuterol, Akorn was producing cardiac drugs, antibiotics, vitamins, local anesthetics, eye products, and others.
Drug shortages cause “a significant strain on our health care system,” Dr. Suda said, and substituting other medications increases risk of medical errors.
Fortunately, the increasing number of drug shortages is not going unnoticed, according to Dr. Suda. The FDA and multiple other organizations, including the ASHP, American Medical Association, and National Academies of Sciences, Engineering, and Medicine, are all taking steps to ensure that essential medicines are in steady supply, including moves to gather more data from manufacturers.
“I hope that a lot of the efforts that are moving forward ... will help us decrease the impact of shortages on our patients,” Dr. Suda said.
Lou Kennedy is the CEO of Nephron Pharmaceuticals, which commercially produces liquid albuterol. The other interviewees disclosed no relevant conflicts of interest.
The shortage of 0.5% albuterol sulfate inhalation solution, first reported by the FDA last October, gained increasing attention earlier this month when Akorn Pharmaceuticals – one of just two companies making the product – shut down after years of financial and regulatory troubles.
The other manufacturer, Nephron Pharmaceuticals, is producing 0.5% albuterol “as fast as possible” to overcome the shortage, CEO Lou Kennedy said in a written comment.
Meanwhile, the more commonly used version of liquid albuterol, with a concentration of 0.083%, remains in “good supply from several manufacturers,” according to an FDA spokesperson.
Still, headlines concerning the shortage have caused “a bit of a panic” for patients with asthma and parents with asthmatic children, according to David R. Stukus, MD, professor of clinical pediatrics in the division of allergy and immunology at Nationwide Children’s, Columbus, Ohio.
Much of the media coverage has lacked context, causing unnecessary worry, he said, as the shortage only affects one type of albuterol generally reserved for inpatient and emergency use.
“The shortage has not impacted our albuterol inhalers thus far,” Dr. Stukus said in an interview. “So I certainly don’t want people with asthma to panic that they’re going to run out of their inhaler anytime soon.”
Even infants and toddlers can use inhalers
Although Dr. Stukus noted that certain patients do require nebulizers, such as those with conditions that physically limit their breathing, like muscular dystrophy, most patients can use inhalers just fine. He said it’s a “pretty common misconception, even among medical professionals,” that infants and toddlers need nebulizers instead.
“In our institution, for example, we rarely ever start babies on a nebulizer when we diagnose them with asthma,” Dr. Stukus said. “We often just start right away with an inhaler with a spacer and a face mask.”
The shortage of liquid albuterol may therefore have a silver lining, he suggested, as it prompts clinicians to reconsider their routine practice.
“When situations like this arise, it’s a great opportunity for all of us to just take a step back and reevaluate the way we do things,” Dr. Stukus said. “Sometimes we just get caught up with inertia and we continue to do things the same way even though new options are available, or evidence has changed to the contrary.”
Nathan Rabinovitch, MD, professor of pediatrics in the division of pediatric allergy and clinical immunology at National Jewish Health, Denver, said that his center had trouble obtaining liquid albuterol about 2 weeks ago, so they pivoted to the more expensive levalbuterol for about a week and a half, until their albuterol supply was restored.
While Dr. Rabinovitch agreed that most children don’t need a nebulizer, he said about 5%-10% of kids with severe asthma should have one on hand in case their inhaler fails to control an exacerbation.
Personal preferences may also considered, he added.
“If [a parent] says, ‘I like to use the nebulizer. The kid likes it,’ I’m fine if they just use a nebulizer.”
One possible downside of relying on a nebulizer, however, is portability, according to Kelly O’Shea, MD, assistant professor in the division of allergy and clinical immunology at the University of Michigan, Ann Arbor.
“If you’re out at the park or out at a soccer game with your kids, and they are having trouble breathing ... and they need their albuterol, you don’t have that ability if you are tied to a nebulizer,” Dr. O’Shea said in an interview. “As long as a parent feels comfortable – they feel like [their child] can get deep breaths in, I agree that you can use [an inhaler] in the infant and toddler population.”
She also agreed that a nebulizer may serve as a kind of second step if an inhaler isn’t controlling an exacerbation; however, she emphasized that a nebulizer should not be considered a replacement for professional care, and should not give a false sense of security.
“I caution parents to make sure that when they need it, they also take the next step and head over to the emergency room,” Dr. O’Shea said.
Generic drug shortages becoming more common
While the present scarcity of liquid albuterol appears relatively mild in terms of clinical impact, it brings up broader concerns about generic drug supply, and why shortages like this are becoming more common, according to Katie J. Suda, PharmD, MS, professor of medicine and pharmacy, and associate director, center for pharmaceutical policy and prescribing at the University of Pittsburgh.
“Drug shortages continue to increase in frequency, and the duration and severity of the shortages are also getting worse,” Dr. Suda said in an interview.
The reasons for these shortages can be elusive, according to 2022 report by the American Society of Health-System Pharmacists, which found that more than half of shortages came with no explanation from manufacturers.
The same report showed that only 5% of shortages were due to a “business decision,” but this factor is likely more central than publicly stated.
A recent FDA analysis on drug shortages, for instance, lists “lack of incentives to produce less profitable drugs,” as the first “root cause,” and Dr. Suda agrees.
“It’s important that we have generic medicines to decrease costs to our health systems, as well as for our patients,” Dr. Suda said. “But frequently, with those generic products, the price is driven so low that it increases the risk of a shortage.”
The drive to maintain profit margins may motivate companies to cut corners in production, Dr. Suda explained. She emphasized that this connection is speculative, because motivations are effectively unknowable, but the rationale is supported by past and present shortages.
Akorn Pharmaceuticals, for example, received a warning letter from the FDA in 2019 because of a variety of manufacturing issues, including defective bottles, questionable data, and metal shavings on aseptic filling equipment.
When a manufacturer like Akorn fails, the effects can be far-reaching, Dr. Suda said, noting their broad catalog of agents. Beyond liquid albuterol, Akorn was producing cardiac drugs, antibiotics, vitamins, local anesthetics, eye products, and others.
Drug shortages cause “a significant strain on our health care system,” Dr. Suda said, and substituting other medications increases risk of medical errors.
Fortunately, the increasing number of drug shortages is not going unnoticed, according to Dr. Suda. The FDA and multiple other organizations, including the ASHP, American Medical Association, and National Academies of Sciences, Engineering, and Medicine, are all taking steps to ensure that essential medicines are in steady supply, including moves to gather more data from manufacturers.
“I hope that a lot of the efforts that are moving forward ... will help us decrease the impact of shortages on our patients,” Dr. Suda said.
Lou Kennedy is the CEO of Nephron Pharmaceuticals, which commercially produces liquid albuterol. The other interviewees disclosed no relevant conflicts of interest.
Brain imaging markers of breathlessness-expectation predict COPD rehabilitation success
In an experimental medicine study of D-cycloserine given during chronic obstructive pulmonary disease (COPD) rehabilitation, only models including brain imaging markers of breathlessness-expectation successfully predicted Dyspnea-12 score improvement. D-cycloserine was independently associated with breathlessness improvement, according to original research published in Thorax.
Chronic breathlessness persisting despite maximal medical therapy is a key feature of COPD. While pulmonary rehabilitation is the best treatment for chronic breathlessness in COPD, responses to treatment are variable, with 30% deriving no clinical benefit, Sarah L. Finnegan, PhD, with the Nuffield Department of Clinical Neurosciences, University of Oxford (England), and colleagues wrote.
While recent research has shown fear and anxiety to be key components of the expectation that plays an important role in the mechanisms and maintenance of breathlessness, expectation-related effects have not previously been considered in prediction studies of pulmonary rehabilitation outcomes. The authors’ prior research showed a clear correlation between improvements in breathlessness through pulmonary rehabilitation and expectation-related brain activity in areas that include the anterior insula, anterior cingulate cortex, and prefrontal cortex. That research methodology, however, did not attempt to predict individual responses.
The current study focused on brain activity changes within preselected regions associated with breathlessness-expectation and body and symptom perception. Its purpose was to predict improvements in breathlessness during pulmonary rehabilitation by analyzing baseline data from a longitudinal experimental medicine study of D-cycloserine on breathlessness during pulmonary rehabilitation. D-cycloserine, a partial agonist of brain N-methyl-D-aspartate receptors, was chosen because of its effects on neural plasticity and influence on brain expectation mechanisms associated with cognitive behavioral therapies. The authors hypothesized that baseline brain activity in response to breathlessness-related expectation would predict improvement in breathlessness through pulmonary rehabilitation, with D-cycloserine emerging as a significant factor in the prediction model.
The researchers recruited 71 participants (18 women, median age 71 years [46-85 years]) with mild to moderate COPD immediately prior to enrollment in a National Health Service–prescribed course of pulmonary rehabilitation. They were randomized double-blind to receive either 250 mg oral D-cycloserine or a matched placebo. Participants received a single dose on four occasions 30 minutes prior to the onset of the first four pulmonary rehabilitation sessions.
Baseline variables, including brain-activity, self-report questionnaires responses, clinical measures of respiratory function, and drug allocation were used to train three machine-learning models to predict the outcome, a minimally clinically relevant change in the Dyspnea-12 score.
Improvements in Dyspnea-12 score occurred only in the two models including brain imaging markers of breathlessness-expectation (sensitivity 0.88, specificity 0.77). The model that combined brain and behavior metrics produced the best classification performance (accuracy, 0.83 [95% confidence interval, 0.75-0.90]; sensitivity, 0.88; specificity, 0.77; P < 0.001). While the brain-only model was able to correctly categorize participants with statistically significant likelihood (accuracy, 0.70 [95% CI, 0.58-0.81]), it demonstrated poor goodness of fit, a measure of how well sample data fit a distribution from a population with a normal distribution. “By enriching the brain-only models with questionnaires and physiology measures improved performance considerably,” the researchers stated.
“Our findings demonstrate the first predictive model of change in breathlessness across pulmonary rehabilitation and, for the first time, the clinical relevance of expectation-related brain activity as a therapeutic target in the treatment of breathlessness. ... This was achieved using sensitive brain imaging techniques in order to capture personalized responses to breathlessness-expectation which has, until recently remained relatively unexplored.”
“This study raises interesting questions about breathlessness-expectations,” commented assistant professor of medicine Mary Jo S. Farmer, MD, PhD, director pulmonary hypertension service, University of Massachusetts, Worcester, in an interview. “There is much more to be understood about expectations pathways as to how these pathways are built upon prior experience and pave the way for reaction to future experiences. There is need for a similar study with larger sample size and clarification of the role of the effect of the agent D-cycloserine on breathlessness-expectation.”
The researchers noted their study’s limitations, pointing out that the small sample size precluded holding out a proportion of the original data to create an external validation dataset.
Dr. Finnegan and Dr. Farmer declared no disclosures relevant to this study. This work was supported by the JABBS Foundation and Dunhill Medical Trust. This research was funded in whole, or in part, by the Wellcome Trust.
In an experimental medicine study of D-cycloserine given during chronic obstructive pulmonary disease (COPD) rehabilitation, only models including brain imaging markers of breathlessness-expectation successfully predicted Dyspnea-12 score improvement. D-cycloserine was independently associated with breathlessness improvement, according to original research published in Thorax.
Chronic breathlessness persisting despite maximal medical therapy is a key feature of COPD. While pulmonary rehabilitation is the best treatment for chronic breathlessness in COPD, responses to treatment are variable, with 30% deriving no clinical benefit, Sarah L. Finnegan, PhD, with the Nuffield Department of Clinical Neurosciences, University of Oxford (England), and colleagues wrote.
While recent research has shown fear and anxiety to be key components of the expectation that plays an important role in the mechanisms and maintenance of breathlessness, expectation-related effects have not previously been considered in prediction studies of pulmonary rehabilitation outcomes. The authors’ prior research showed a clear correlation between improvements in breathlessness through pulmonary rehabilitation and expectation-related brain activity in areas that include the anterior insula, anterior cingulate cortex, and prefrontal cortex. That research methodology, however, did not attempt to predict individual responses.
The current study focused on brain activity changes within preselected regions associated with breathlessness-expectation and body and symptom perception. Its purpose was to predict improvements in breathlessness during pulmonary rehabilitation by analyzing baseline data from a longitudinal experimental medicine study of D-cycloserine on breathlessness during pulmonary rehabilitation. D-cycloserine, a partial agonist of brain N-methyl-D-aspartate receptors, was chosen because of its effects on neural plasticity and influence on brain expectation mechanisms associated with cognitive behavioral therapies. The authors hypothesized that baseline brain activity in response to breathlessness-related expectation would predict improvement in breathlessness through pulmonary rehabilitation, with D-cycloserine emerging as a significant factor in the prediction model.
The researchers recruited 71 participants (18 women, median age 71 years [46-85 years]) with mild to moderate COPD immediately prior to enrollment in a National Health Service–prescribed course of pulmonary rehabilitation. They were randomized double-blind to receive either 250 mg oral D-cycloserine or a matched placebo. Participants received a single dose on four occasions 30 minutes prior to the onset of the first four pulmonary rehabilitation sessions.
Baseline variables, including brain-activity, self-report questionnaires responses, clinical measures of respiratory function, and drug allocation were used to train three machine-learning models to predict the outcome, a minimally clinically relevant change in the Dyspnea-12 score.
Improvements in Dyspnea-12 score occurred only in the two models including brain imaging markers of breathlessness-expectation (sensitivity 0.88, specificity 0.77). The model that combined brain and behavior metrics produced the best classification performance (accuracy, 0.83 [95% confidence interval, 0.75-0.90]; sensitivity, 0.88; specificity, 0.77; P < 0.001). While the brain-only model was able to correctly categorize participants with statistically significant likelihood (accuracy, 0.70 [95% CI, 0.58-0.81]), it demonstrated poor goodness of fit, a measure of how well sample data fit a distribution from a population with a normal distribution. “By enriching the brain-only models with questionnaires and physiology measures improved performance considerably,” the researchers stated.
“Our findings demonstrate the first predictive model of change in breathlessness across pulmonary rehabilitation and, for the first time, the clinical relevance of expectation-related brain activity as a therapeutic target in the treatment of breathlessness. ... This was achieved using sensitive brain imaging techniques in order to capture personalized responses to breathlessness-expectation which has, until recently remained relatively unexplored.”
“This study raises interesting questions about breathlessness-expectations,” commented assistant professor of medicine Mary Jo S. Farmer, MD, PhD, director pulmonary hypertension service, University of Massachusetts, Worcester, in an interview. “There is much more to be understood about expectations pathways as to how these pathways are built upon prior experience and pave the way for reaction to future experiences. There is need for a similar study with larger sample size and clarification of the role of the effect of the agent D-cycloserine on breathlessness-expectation.”
The researchers noted their study’s limitations, pointing out that the small sample size precluded holding out a proportion of the original data to create an external validation dataset.
Dr. Finnegan and Dr. Farmer declared no disclosures relevant to this study. This work was supported by the JABBS Foundation and Dunhill Medical Trust. This research was funded in whole, or in part, by the Wellcome Trust.
In an experimental medicine study of D-cycloserine given during chronic obstructive pulmonary disease (COPD) rehabilitation, only models including brain imaging markers of breathlessness-expectation successfully predicted Dyspnea-12 score improvement. D-cycloserine was independently associated with breathlessness improvement, according to original research published in Thorax.
Chronic breathlessness persisting despite maximal medical therapy is a key feature of COPD. While pulmonary rehabilitation is the best treatment for chronic breathlessness in COPD, responses to treatment are variable, with 30% deriving no clinical benefit, Sarah L. Finnegan, PhD, with the Nuffield Department of Clinical Neurosciences, University of Oxford (England), and colleagues wrote.
While recent research has shown fear and anxiety to be key components of the expectation that plays an important role in the mechanisms and maintenance of breathlessness, expectation-related effects have not previously been considered in prediction studies of pulmonary rehabilitation outcomes. The authors’ prior research showed a clear correlation between improvements in breathlessness through pulmonary rehabilitation and expectation-related brain activity in areas that include the anterior insula, anterior cingulate cortex, and prefrontal cortex. That research methodology, however, did not attempt to predict individual responses.
The current study focused on brain activity changes within preselected regions associated with breathlessness-expectation and body and symptom perception. Its purpose was to predict improvements in breathlessness during pulmonary rehabilitation by analyzing baseline data from a longitudinal experimental medicine study of D-cycloserine on breathlessness during pulmonary rehabilitation. D-cycloserine, a partial agonist of brain N-methyl-D-aspartate receptors, was chosen because of its effects on neural plasticity and influence on brain expectation mechanisms associated with cognitive behavioral therapies. The authors hypothesized that baseline brain activity in response to breathlessness-related expectation would predict improvement in breathlessness through pulmonary rehabilitation, with D-cycloserine emerging as a significant factor in the prediction model.
The researchers recruited 71 participants (18 women, median age 71 years [46-85 years]) with mild to moderate COPD immediately prior to enrollment in a National Health Service–prescribed course of pulmonary rehabilitation. They were randomized double-blind to receive either 250 mg oral D-cycloserine or a matched placebo. Participants received a single dose on four occasions 30 minutes prior to the onset of the first four pulmonary rehabilitation sessions.
Baseline variables, including brain-activity, self-report questionnaires responses, clinical measures of respiratory function, and drug allocation were used to train three machine-learning models to predict the outcome, a minimally clinically relevant change in the Dyspnea-12 score.
Improvements in Dyspnea-12 score occurred only in the two models including brain imaging markers of breathlessness-expectation (sensitivity 0.88, specificity 0.77). The model that combined brain and behavior metrics produced the best classification performance (accuracy, 0.83 [95% confidence interval, 0.75-0.90]; sensitivity, 0.88; specificity, 0.77; P < 0.001). While the brain-only model was able to correctly categorize participants with statistically significant likelihood (accuracy, 0.70 [95% CI, 0.58-0.81]), it demonstrated poor goodness of fit, a measure of how well sample data fit a distribution from a population with a normal distribution. “By enriching the brain-only models with questionnaires and physiology measures improved performance considerably,” the researchers stated.
“Our findings demonstrate the first predictive model of change in breathlessness across pulmonary rehabilitation and, for the first time, the clinical relevance of expectation-related brain activity as a therapeutic target in the treatment of breathlessness. ... This was achieved using sensitive brain imaging techniques in order to capture personalized responses to breathlessness-expectation which has, until recently remained relatively unexplored.”
“This study raises interesting questions about breathlessness-expectations,” commented assistant professor of medicine Mary Jo S. Farmer, MD, PhD, director pulmonary hypertension service, University of Massachusetts, Worcester, in an interview. “There is much more to be understood about expectations pathways as to how these pathways are built upon prior experience and pave the way for reaction to future experiences. There is need for a similar study with larger sample size and clarification of the role of the effect of the agent D-cycloserine on breathlessness-expectation.”
The researchers noted their study’s limitations, pointing out that the small sample size precluded holding out a proportion of the original data to create an external validation dataset.
Dr. Finnegan and Dr. Farmer declared no disclosures relevant to this study. This work was supported by the JABBS Foundation and Dunhill Medical Trust. This research was funded in whole, or in part, by the Wellcome Trust.
FROM THORAX
Adherence to DASH diet reduced risk of COPD
Greater adherence to the Dietary Approaches to Stop Hypertension (DASH) diet was associated with a significantly reduced risk of chronic obstructive pulmonary disease (COPD) and improved lung function, based on data from more than 28,000 individuals in the United States.
but the effects of specific diet models such as the DASH diet and Mediterranean diet on COPD in particular has not been well studied, Jingli Wen, MD, of Nanjing Medical University, Jiangsu, China, and colleagues wrote.
In a study published in Frontiers in Nutrition, the researchers reviewed data from 28,605 adult participants in the National Health and Nutrition Examination Survey from 1999 to 2018.
The study population included 2,488 individuals with COPD participants and 25,607 individuals without COPD; the mean ages of the COPD and non-COPD groups were 60.2 years and 56.9 years, and the proportion of women was 63.7% and 51.4%, respectively. The primary outcome was the prevalence of COPD, defined as self-reports of a diagnosis of chronic bronchitis or emphysema. DASH diet scores were based on consumption of nine target nutrients: saturated fat, total fat, protein, cholesterol, fiber, magnesium, calcium, potassium, and sodium. Scores for compliance with the Mediterranean diet were based on intake of eight food categories: fruits, vegetables, legumes, fish, red meat, dairy products, alcohol, and olive oil.
Overall, a higher score for adherence to the DASH diet was significantly associated with a lower COPD risk (odds ratio, 0.83; P = .021). This association remained significant in subgroups of younger adults (OR, 0.74), men (OR, 0.73), and smokers (OR, 0.82).
By contrast, adherence to the Mediterranean diet was not significantly associated with COPD prevalence (OR, 1.03; P = .697).
The researchers also found a correlation between DASH diet adherence and improved lung function, especially among individuals without COPD. The risk of FEV1: forced vital capacity decrease, as well as dyspnea, cough, and expectoration, were negatively associated with greater adherence to the DASH diet, but greater adherence to the Mediterranean diet was only negatively associated with cough risk.
The relationship between the DASH diet and reduced COPD risk persisted after adjusting for occupational exposure and excluding participants with cardiovascular disease, cancer, or diabetes.
The current study is the first known to focus on the association between DASH diet and the risk of COPD among adults in the United States, the researchers wrote. The lack of effect of the Mediterranean diet on COPD, in contrast to some studies in other countries, “suggests that regional differences in diet may affect the role of diet in the development of COPD.”
The study findings were limited by several factors including the cross-sectional design that prevented conclusions of causality, the researchers noted. Other limitations included the lack of data of the impact of poor living habits, such as smoking, on food decisions, the use of short-term 24-hour dietary recall, and the reliance of self-reports for a diagnosis of COPD.
However, the results support the role of diet in COPD pathogenesis and expand the knowledge of relationships between the DASH diet and major chronic diseases, the researchers said. More prospective studies and clinical intervention studies are needed, but the findings should encourage clinicians to consider the potential role of a healthy diet in promoting lung health.
The study was supported by the Department of Health, Jiangsu Province, China. The researchers had no financial conflicts to disclose.
Greater adherence to the Dietary Approaches to Stop Hypertension (DASH) diet was associated with a significantly reduced risk of chronic obstructive pulmonary disease (COPD) and improved lung function, based on data from more than 28,000 individuals in the United States.
but the effects of specific diet models such as the DASH diet and Mediterranean diet on COPD in particular has not been well studied, Jingli Wen, MD, of Nanjing Medical University, Jiangsu, China, and colleagues wrote.
In a study published in Frontiers in Nutrition, the researchers reviewed data from 28,605 adult participants in the National Health and Nutrition Examination Survey from 1999 to 2018.
The study population included 2,488 individuals with COPD participants and 25,607 individuals without COPD; the mean ages of the COPD and non-COPD groups were 60.2 years and 56.9 years, and the proportion of women was 63.7% and 51.4%, respectively. The primary outcome was the prevalence of COPD, defined as self-reports of a diagnosis of chronic bronchitis or emphysema. DASH diet scores were based on consumption of nine target nutrients: saturated fat, total fat, protein, cholesterol, fiber, magnesium, calcium, potassium, and sodium. Scores for compliance with the Mediterranean diet were based on intake of eight food categories: fruits, vegetables, legumes, fish, red meat, dairy products, alcohol, and olive oil.
Overall, a higher score for adherence to the DASH diet was significantly associated with a lower COPD risk (odds ratio, 0.83; P = .021). This association remained significant in subgroups of younger adults (OR, 0.74), men (OR, 0.73), and smokers (OR, 0.82).
By contrast, adherence to the Mediterranean diet was not significantly associated with COPD prevalence (OR, 1.03; P = .697).
The researchers also found a correlation between DASH diet adherence and improved lung function, especially among individuals without COPD. The risk of FEV1: forced vital capacity decrease, as well as dyspnea, cough, and expectoration, were negatively associated with greater adherence to the DASH diet, but greater adherence to the Mediterranean diet was only negatively associated with cough risk.
The relationship between the DASH diet and reduced COPD risk persisted after adjusting for occupational exposure and excluding participants with cardiovascular disease, cancer, or diabetes.
The current study is the first known to focus on the association between DASH diet and the risk of COPD among adults in the United States, the researchers wrote. The lack of effect of the Mediterranean diet on COPD, in contrast to some studies in other countries, “suggests that regional differences in diet may affect the role of diet in the development of COPD.”
The study findings were limited by several factors including the cross-sectional design that prevented conclusions of causality, the researchers noted. Other limitations included the lack of data of the impact of poor living habits, such as smoking, on food decisions, the use of short-term 24-hour dietary recall, and the reliance of self-reports for a diagnosis of COPD.
However, the results support the role of diet in COPD pathogenesis and expand the knowledge of relationships between the DASH diet and major chronic diseases, the researchers said. More prospective studies and clinical intervention studies are needed, but the findings should encourage clinicians to consider the potential role of a healthy diet in promoting lung health.
The study was supported by the Department of Health, Jiangsu Province, China. The researchers had no financial conflicts to disclose.
Greater adherence to the Dietary Approaches to Stop Hypertension (DASH) diet was associated with a significantly reduced risk of chronic obstructive pulmonary disease (COPD) and improved lung function, based on data from more than 28,000 individuals in the United States.
but the effects of specific diet models such as the DASH diet and Mediterranean diet on COPD in particular has not been well studied, Jingli Wen, MD, of Nanjing Medical University, Jiangsu, China, and colleagues wrote.
In a study published in Frontiers in Nutrition, the researchers reviewed data from 28,605 adult participants in the National Health and Nutrition Examination Survey from 1999 to 2018.
The study population included 2,488 individuals with COPD participants and 25,607 individuals without COPD; the mean ages of the COPD and non-COPD groups were 60.2 years and 56.9 years, and the proportion of women was 63.7% and 51.4%, respectively. The primary outcome was the prevalence of COPD, defined as self-reports of a diagnosis of chronic bronchitis or emphysema. DASH diet scores were based on consumption of nine target nutrients: saturated fat, total fat, protein, cholesterol, fiber, magnesium, calcium, potassium, and sodium. Scores for compliance with the Mediterranean diet were based on intake of eight food categories: fruits, vegetables, legumes, fish, red meat, dairy products, alcohol, and olive oil.
Overall, a higher score for adherence to the DASH diet was significantly associated with a lower COPD risk (odds ratio, 0.83; P = .021). This association remained significant in subgroups of younger adults (OR, 0.74), men (OR, 0.73), and smokers (OR, 0.82).
By contrast, adherence to the Mediterranean diet was not significantly associated with COPD prevalence (OR, 1.03; P = .697).
The researchers also found a correlation between DASH diet adherence and improved lung function, especially among individuals without COPD. The risk of FEV1: forced vital capacity decrease, as well as dyspnea, cough, and expectoration, were negatively associated with greater adherence to the DASH diet, but greater adherence to the Mediterranean diet was only negatively associated with cough risk.
The relationship between the DASH diet and reduced COPD risk persisted after adjusting for occupational exposure and excluding participants with cardiovascular disease, cancer, or diabetes.
The current study is the first known to focus on the association between DASH diet and the risk of COPD among adults in the United States, the researchers wrote. The lack of effect of the Mediterranean diet on COPD, in contrast to some studies in other countries, “suggests that regional differences in diet may affect the role of diet in the development of COPD.”
The study findings were limited by several factors including the cross-sectional design that prevented conclusions of causality, the researchers noted. Other limitations included the lack of data of the impact of poor living habits, such as smoking, on food decisions, the use of short-term 24-hour dietary recall, and the reliance of self-reports for a diagnosis of COPD.
However, the results support the role of diet in COPD pathogenesis and expand the knowledge of relationships between the DASH diet and major chronic diseases, the researchers said. More prospective studies and clinical intervention studies are needed, but the findings should encourage clinicians to consider the potential role of a healthy diet in promoting lung health.
The study was supported by the Department of Health, Jiangsu Province, China. The researchers had no financial conflicts to disclose.
FROM FRONTIERS IN NUTRITION
Beware risk of sedatives for respiratory patients
Both asthma and chronic obstructive pulmonary disease can be challenging to diagnose, and medication-driven episodes of sedation or hypoventilation are often overlooked as causes of acute exacerbations in these conditions, according to a letter published in The Lancet Respiratory Medicine.
write Christos V. Chalitsios, PhD, of the University of Nottingham, England, and colleagues.
The authors note that exacerbations are the main complications of both asthma and COPD, and stress the importance of identifying causes and preventive strategies.
Sedatives such as opioids have been shown to depress respiratory drive, reduce muscle tone, and increase the risk of pneumonia, they write. The authors also propose that the risk of sedative-induced aspiration or hypoventilation would be associated with medications including pregabalin, gabapentin, and amitriptyline.
Other mechanisms may be involved in the association between sedatives and exacerbations in asthma and COPD. For example, sedative medications can suppress coughing, which may promote airway mucous compaction and possible infection, the authors write.
Most research involving prevention of asthma and COPD exacerbations has not addressed the potential impact of sedatives taken for reasons outside of obstructive lung disease, the authors say.
“Although the risk of sedation and hypoventilation events are known to be increased by opioids and antipsychotic drugs, there has not been a systematic assessment of commonly prescribed medications with potential respiratory side-effects, including gabapentin, amitriptyline, and pregabalin,” they write.
Polypharmacy is increasingly common and results in many patients with asthma or COPD presenting for treatment of acute exacerbations while on a combination of gabapentin, pregabalin, amitriptyline, and opioids, the authors note; “however, there is little data or disease-specific guidance on how best to manage this problem, which often starts with a prescription in primary care,” they write. Simply stopping sedatives is not an option for many patients given the addictive nature of these drugs and the unlikely resolution of the condition for which the drugs were prescribed, the authors say. However, “cautious dose reduction” of sedatives is possible once patients understand the reason, they add.
Clinicians may be able to suggest reduced doses and alternative treatments to patients with asthma and COPD while highlighting the risk of respiratory depression and polypharmacy – “potentially reducing the number of exacerbations of obstructive lung disease,” the authors conclude.
The study received no outside funding. The authors have disclosed no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
Both asthma and chronic obstructive pulmonary disease can be challenging to diagnose, and medication-driven episodes of sedation or hypoventilation are often overlooked as causes of acute exacerbations in these conditions, according to a letter published in The Lancet Respiratory Medicine.
write Christos V. Chalitsios, PhD, of the University of Nottingham, England, and colleagues.
The authors note that exacerbations are the main complications of both asthma and COPD, and stress the importance of identifying causes and preventive strategies.
Sedatives such as opioids have been shown to depress respiratory drive, reduce muscle tone, and increase the risk of pneumonia, they write. The authors also propose that the risk of sedative-induced aspiration or hypoventilation would be associated with medications including pregabalin, gabapentin, and amitriptyline.
Other mechanisms may be involved in the association between sedatives and exacerbations in asthma and COPD. For example, sedative medications can suppress coughing, which may promote airway mucous compaction and possible infection, the authors write.
Most research involving prevention of asthma and COPD exacerbations has not addressed the potential impact of sedatives taken for reasons outside of obstructive lung disease, the authors say.
“Although the risk of sedation and hypoventilation events are known to be increased by opioids and antipsychotic drugs, there has not been a systematic assessment of commonly prescribed medications with potential respiratory side-effects, including gabapentin, amitriptyline, and pregabalin,” they write.
Polypharmacy is increasingly common and results in many patients with asthma or COPD presenting for treatment of acute exacerbations while on a combination of gabapentin, pregabalin, amitriptyline, and opioids, the authors note; “however, there is little data or disease-specific guidance on how best to manage this problem, which often starts with a prescription in primary care,” they write. Simply stopping sedatives is not an option for many patients given the addictive nature of these drugs and the unlikely resolution of the condition for which the drugs were prescribed, the authors say. However, “cautious dose reduction” of sedatives is possible once patients understand the reason, they add.
Clinicians may be able to suggest reduced doses and alternative treatments to patients with asthma and COPD while highlighting the risk of respiratory depression and polypharmacy – “potentially reducing the number of exacerbations of obstructive lung disease,” the authors conclude.
The study received no outside funding. The authors have disclosed no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
Both asthma and chronic obstructive pulmonary disease can be challenging to diagnose, and medication-driven episodes of sedation or hypoventilation are often overlooked as causes of acute exacerbations in these conditions, according to a letter published in The Lancet Respiratory Medicine.
write Christos V. Chalitsios, PhD, of the University of Nottingham, England, and colleagues.
The authors note that exacerbations are the main complications of both asthma and COPD, and stress the importance of identifying causes and preventive strategies.
Sedatives such as opioids have been shown to depress respiratory drive, reduce muscle tone, and increase the risk of pneumonia, they write. The authors also propose that the risk of sedative-induced aspiration or hypoventilation would be associated with medications including pregabalin, gabapentin, and amitriptyline.
Other mechanisms may be involved in the association between sedatives and exacerbations in asthma and COPD. For example, sedative medications can suppress coughing, which may promote airway mucous compaction and possible infection, the authors write.
Most research involving prevention of asthma and COPD exacerbations has not addressed the potential impact of sedatives taken for reasons outside of obstructive lung disease, the authors say.
“Although the risk of sedation and hypoventilation events are known to be increased by opioids and antipsychotic drugs, there has not been a systematic assessment of commonly prescribed medications with potential respiratory side-effects, including gabapentin, amitriptyline, and pregabalin,” they write.
Polypharmacy is increasingly common and results in many patients with asthma or COPD presenting for treatment of acute exacerbations while on a combination of gabapentin, pregabalin, amitriptyline, and opioids, the authors note; “however, there is little data or disease-specific guidance on how best to manage this problem, which often starts with a prescription in primary care,” they write. Simply stopping sedatives is not an option for many patients given the addictive nature of these drugs and the unlikely resolution of the condition for which the drugs were prescribed, the authors say. However, “cautious dose reduction” of sedatives is possible once patients understand the reason, they add.
Clinicians may be able to suggest reduced doses and alternative treatments to patients with asthma and COPD while highlighting the risk of respiratory depression and polypharmacy – “potentially reducing the number of exacerbations of obstructive lung disease,” the authors conclude.
The study received no outside funding. The authors have disclosed no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
Severe health diagnoses drive suicide risk
Individuals diagnosed with a severe physical health condition were significantly more likely to commit suicide at 6 months and at 1 year later, based on data from more than 47 million individuals in a national database.
Previous smaller studies have shown a link between increased risk for suicide and a range of health conditions including cancer, coronary heart disease, neurologic conditions, diabetes, and osteoporosis, Vahé Nafilyan, PhD, of the Office for National Statistics, Newport, England, and colleagues wrote.
However, large-scale population-level studies of the association between specific diagnoses and suicide are lacking, they said.
In a study published in The Lancet Regional Health–Europe, the researchers reviewed a dataset that combined the 2011 Census, death registration records, and the Hospital Episode Statistics. The study population included 47,354,696 individuals aged 6 years and older living in England in 2017. The mean age of the study population was 39.6 years, and 52% were female. The researchers examined deaths that occurred between Jan. 1, 2017, and Dec. 31, 2021.
The health conditions included in the analysis were low-survival cancers, chronic ischemic heart disease, chronic obstructive pulmonary disease, and degenerative neurological disease.
The diagnosis of any of these conditions significantly increased the risk for suicide compared with controls. The highest risk appeared within 6 months of a diagnosis or first treatment, but the increased risk persisted at 1 year.
The suicide rate among low-survival cancer patients was 16.6 per 100,000 patients, compared with 5.7 per 100,000 controls; at 1 year, these rates were 21.6 and 9.5 per 100,000 patients and controls, respectively.
For COPD patients, the suicide rate at 6 months after diagnosis was 13.7 per 100,000 patients versus 5.6 per 100,000 matched controls; the suicide rates at 1 year were 22.4 per 100,000 patients and 10.6 per 100,000 matched controls.
The suicide rate at 6 months for individuals diagnosed with chronic ischemic heart disease was 11.0 per 100,000 patients and 4.2 per 100,000 matched controls; at 1 year, the suicide rates were 16.1 per 100,000 patients and 8.8 per 100,000 matched controls.
The 1-year suicide rate was especially high among patients with degenerative neurological conditions (114.5 per 100,000 patients); however, the estimate was considered imprecise because of the rarity of these diseases and subsequent low number of suicides, the researchers noted.
The results support data from previous studies showing links between increased risk of suicide and severe physical conditions, the researchers wrote. Patterns of suicide were similar between men and women and after adjusting for sociodemographic factors.
The findings were limited by the inability to fully control for a history of depression or self-harm, and by the imprecise estimates given the rare occurrence of suicide overall, the researchers noted. Other limitations included the late registration of deaths from external causes and the focus only on suicides that occurred in England and Wales, meaning that individuals who traveled abroad for assisted suicide were not captured in the dataset.
“Further research is needed to understand the mechanisms driving the elevated risk of suicide and help provide the best support to these patients,” the researchers concluded.
However, the current results enhance the literature with a large, population-based review of the elevated suicide risk among individuals newly diagnosed with severe health conditions, and reflect the need for better support for these patients to help with coping, they said.
The study was funded by the Office for National Statistics. The researchers reported no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
Individuals diagnosed with a severe physical health condition were significantly more likely to commit suicide at 6 months and at 1 year later, based on data from more than 47 million individuals in a national database.
Previous smaller studies have shown a link between increased risk for suicide and a range of health conditions including cancer, coronary heart disease, neurologic conditions, diabetes, and osteoporosis, Vahé Nafilyan, PhD, of the Office for National Statistics, Newport, England, and colleagues wrote.
However, large-scale population-level studies of the association between specific diagnoses and suicide are lacking, they said.
In a study published in The Lancet Regional Health–Europe, the researchers reviewed a dataset that combined the 2011 Census, death registration records, and the Hospital Episode Statistics. The study population included 47,354,696 individuals aged 6 years and older living in England in 2017. The mean age of the study population was 39.6 years, and 52% were female. The researchers examined deaths that occurred between Jan. 1, 2017, and Dec. 31, 2021.
The health conditions included in the analysis were low-survival cancers, chronic ischemic heart disease, chronic obstructive pulmonary disease, and degenerative neurological disease.
The diagnosis of any of these conditions significantly increased the risk for suicide compared with controls. The highest risk appeared within 6 months of a diagnosis or first treatment, but the increased risk persisted at 1 year.
The suicide rate among low-survival cancer patients was 16.6 per 100,000 patients, compared with 5.7 per 100,000 controls; at 1 year, these rates were 21.6 and 9.5 per 100,000 patients and controls, respectively.
For COPD patients, the suicide rate at 6 months after diagnosis was 13.7 per 100,000 patients versus 5.6 per 100,000 matched controls; the suicide rates at 1 year were 22.4 per 100,000 patients and 10.6 per 100,000 matched controls.
The suicide rate at 6 months for individuals diagnosed with chronic ischemic heart disease was 11.0 per 100,000 patients and 4.2 per 100,000 matched controls; at 1 year, the suicide rates were 16.1 per 100,000 patients and 8.8 per 100,000 matched controls.
The 1-year suicide rate was especially high among patients with degenerative neurological conditions (114.5 per 100,000 patients); however, the estimate was considered imprecise because of the rarity of these diseases and subsequent low number of suicides, the researchers noted.
The results support data from previous studies showing links between increased risk of suicide and severe physical conditions, the researchers wrote. Patterns of suicide were similar between men and women and after adjusting for sociodemographic factors.
The findings were limited by the inability to fully control for a history of depression or self-harm, and by the imprecise estimates given the rare occurrence of suicide overall, the researchers noted. Other limitations included the late registration of deaths from external causes and the focus only on suicides that occurred in England and Wales, meaning that individuals who traveled abroad for assisted suicide were not captured in the dataset.
“Further research is needed to understand the mechanisms driving the elevated risk of suicide and help provide the best support to these patients,” the researchers concluded.
However, the current results enhance the literature with a large, population-based review of the elevated suicide risk among individuals newly diagnosed with severe health conditions, and reflect the need for better support for these patients to help with coping, they said.
The study was funded by the Office for National Statistics. The researchers reported no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
Individuals diagnosed with a severe physical health condition were significantly more likely to commit suicide at 6 months and at 1 year later, based on data from more than 47 million individuals in a national database.
Previous smaller studies have shown a link between increased risk for suicide and a range of health conditions including cancer, coronary heart disease, neurologic conditions, diabetes, and osteoporosis, Vahé Nafilyan, PhD, of the Office for National Statistics, Newport, England, and colleagues wrote.
However, large-scale population-level studies of the association between specific diagnoses and suicide are lacking, they said.
In a study published in The Lancet Regional Health–Europe, the researchers reviewed a dataset that combined the 2011 Census, death registration records, and the Hospital Episode Statistics. The study population included 47,354,696 individuals aged 6 years and older living in England in 2017. The mean age of the study population was 39.6 years, and 52% were female. The researchers examined deaths that occurred between Jan. 1, 2017, and Dec. 31, 2021.
The health conditions included in the analysis were low-survival cancers, chronic ischemic heart disease, chronic obstructive pulmonary disease, and degenerative neurological disease.
The diagnosis of any of these conditions significantly increased the risk for suicide compared with controls. The highest risk appeared within 6 months of a diagnosis or first treatment, but the increased risk persisted at 1 year.
The suicide rate among low-survival cancer patients was 16.6 per 100,000 patients, compared with 5.7 per 100,000 controls; at 1 year, these rates were 21.6 and 9.5 per 100,000 patients and controls, respectively.
For COPD patients, the suicide rate at 6 months after diagnosis was 13.7 per 100,000 patients versus 5.6 per 100,000 matched controls; the suicide rates at 1 year were 22.4 per 100,000 patients and 10.6 per 100,000 matched controls.
The suicide rate at 6 months for individuals diagnosed with chronic ischemic heart disease was 11.0 per 100,000 patients and 4.2 per 100,000 matched controls; at 1 year, the suicide rates were 16.1 per 100,000 patients and 8.8 per 100,000 matched controls.
The 1-year suicide rate was especially high among patients with degenerative neurological conditions (114.5 per 100,000 patients); however, the estimate was considered imprecise because of the rarity of these diseases and subsequent low number of suicides, the researchers noted.
The results support data from previous studies showing links between increased risk of suicide and severe physical conditions, the researchers wrote. Patterns of suicide were similar between men and women and after adjusting for sociodemographic factors.
The findings were limited by the inability to fully control for a history of depression or self-harm, and by the imprecise estimates given the rare occurrence of suicide overall, the researchers noted. Other limitations included the late registration of deaths from external causes and the focus only on suicides that occurred in England and Wales, meaning that individuals who traveled abroad for assisted suicide were not captured in the dataset.
“Further research is needed to understand the mechanisms driving the elevated risk of suicide and help provide the best support to these patients,” the researchers concluded.
However, the current results enhance the literature with a large, population-based review of the elevated suicide risk among individuals newly diagnosed with severe health conditions, and reflect the need for better support for these patients to help with coping, they said.
The study was funded by the Office for National Statistics. The researchers reported no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
FROM THE LANCET REGIONAL HEALTH–EUROPE
Patients with COPD at higher risk of death 1 year after surgery
Patients with chronic obstructive pulmonary disease (COPD) are more likely to die within a year of undergoing elective surgery and to incur higher health care costs than are similar patients without COPD, data suggest.
An analysis of close to a million patient records found that, after adjustment for sociodemographic factors, procedure type, and comorbidities, patients with COPD were 26% more likely to die in the year after surgery than were those without COPD. Moreover, COPD was associated with a 4.6% increase in health care costs.
Previous studies have evaluated outcomes for the first 30 days after surgery. Those data “may not adequately capture the overall burden of surgery and how long it may take patients to recover,” study author Ashwin Sankar, MD, a clinician-investigator at St. Michael’s Hospital and assistant professor of anesthesia at the University of Toronto, told this news organization.
“We found that COPD often coexists with other conditions, like diabetes, coronary artery disease, and frailty,” Dr. Sankar added.
The study was published online in the Canadian Medical Association Journal.
Additional recovery support
The authors analyzed data from 932,616 patients who underwent intermediate-risk to high-risk elective noncardiac surgeries from 2005 to 2019 in Ontario. Procedures included carotid endarterectomy, open or endovascular abdominal aortic aneurysm repair, peripheral arterial bypass, total hip replacement, total knee replacement, shoulder surgery, large-bowel surgery, partial liver resection, pancreaticoduodenectomy, gastrectomy, esophagectomy, nephrectomy, cystectomy, prostatectomy, and hysterectomy.
The researchers quantified the associations of COPD with survival and costs. Their analyses included partial adjustment for sociodemographic factors and procedure type and full adjustment, which included comorbidities.
The primary outcome was all-cause death in the year after surgery; the secondary outcome was total health care costs in that year.
The mean age of the population was 65 years, and 60% of patients were women. A total of 170,482 (18%) patients had COPD. Compared with those without COPD, the patients with COPD were older and were more likely to be male, to be in a lower income quintile, to be residents of long-term care facilities, and to have been admitted to the hospital before surgery. They were also more likely to have comorbidities, including coronary artery disease, heart failure, and lung cancer.
A larger proportion of patients with COPD had frailty and medium to high comorbidity. They also more frequently underwent orthopedic, open upper abdominal, and vascular surgery.
During the year after surgery, 52,021 (5.6%) patients died, including 18,007 (10.6%) with COPD and 34,014 (4.5%) without. Those with COPD were more likely to die within 30 days of surgery (3.4% vs 1.2%).
For patients with COPD, the partially adjusted hazard ratio (HR) was 1.61 for risk of death; the fully adjusted HR was 1.26. COPD also was associated with a partially adjusted relative increase of 13.1% in health care costs and an increase of 4.6% with full adjustment.
Frailty, cancer, and procedure type were factors that modified the association between COPD and outcomes. “Procedures such as open aortic and upper abdominal surgery are associated with higher postoperative risks irrespective of COPD status, whereas others, such as orthopedic and lower abdominal surgery, may be of significantly greater risk for patients with COPD,” the authors wrote. “Our results suggest that perioperative management of patients with COPD requires careful consideration of the multiple domains that contribute to their elevated perioperative risk.
“Our finding that patients with COPD are at risk beyond 30 days after surgery suggests that it may be worthwhile to additionally support these patients’ recovery well beyond the first month after the procedure,” said Dr. Sankar.
Shared decision-making
Commenting on the study, William Whalen, MD, a pulmonary critical care specialist at Weill Cornell Medicine in New York, said, “I echo the authors’ sentiments that these findings highlight how chronically ill COPD patients are, which may be playing a role in the elevated mortality seen in this study.”
One caveat is in regard to the interpretation of the interaction effects of the study, he said. “Clinicians are unlikely to send patients who are frail or have multiple comorbidities to overly complex surgeries. Therefore, these effects may be misestimated due to selection bias.”
Two questions remain after reading the study, he added. “The first is how the degree of obstruction (i.e., the severity of COPD) impacts long-term mortality. Previous observational studies in nonsurgical COPD patients have shown increased mortality as the severity of obstruction increases. The second is how much of the long-term mortality observed in this study is related to respiratory disease from COPD. Patients with COPD are complex, and many die from nonrespiratory-related causes.”
Dr. Whalen suggests that discussion be held with the surgical team about the long-term morbidity and mortality with and without surgical intervention. Such a discussion could inform a shared decision-making process with the patient.
“Some procedures may be necessary to reduce immediate mortality, such as aortic aneurysmal repair, so [the risk of] longer-term mortality may be more acceptable in this setting,” he said. “Less straightforward are procedures that may improve quality of life. Would a patient accept an increased long-term mortality [risk] if that meant living without orthopedic-related pain?”
The study was funded by the Government of Ontario. Dr. Sankar and Dr. Whalen have disclosed no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
Patients with chronic obstructive pulmonary disease (COPD) are more likely to die within a year of undergoing elective surgery and to incur higher health care costs than are similar patients without COPD, data suggest.
An analysis of close to a million patient records found that, after adjustment for sociodemographic factors, procedure type, and comorbidities, patients with COPD were 26% more likely to die in the year after surgery than were those without COPD. Moreover, COPD was associated with a 4.6% increase in health care costs.
Previous studies have evaluated outcomes for the first 30 days after surgery. Those data “may not adequately capture the overall burden of surgery and how long it may take patients to recover,” study author Ashwin Sankar, MD, a clinician-investigator at St. Michael’s Hospital and assistant professor of anesthesia at the University of Toronto, told this news organization.
“We found that COPD often coexists with other conditions, like diabetes, coronary artery disease, and frailty,” Dr. Sankar added.
The study was published online in the Canadian Medical Association Journal.
Additional recovery support
The authors analyzed data from 932,616 patients who underwent intermediate-risk to high-risk elective noncardiac surgeries from 2005 to 2019 in Ontario. Procedures included carotid endarterectomy, open or endovascular abdominal aortic aneurysm repair, peripheral arterial bypass, total hip replacement, total knee replacement, shoulder surgery, large-bowel surgery, partial liver resection, pancreaticoduodenectomy, gastrectomy, esophagectomy, nephrectomy, cystectomy, prostatectomy, and hysterectomy.
The researchers quantified the associations of COPD with survival and costs. Their analyses included partial adjustment for sociodemographic factors and procedure type and full adjustment, which included comorbidities.
The primary outcome was all-cause death in the year after surgery; the secondary outcome was total health care costs in that year.
The mean age of the population was 65 years, and 60% of patients were women. A total of 170,482 (18%) patients had COPD. Compared with those without COPD, the patients with COPD were older and were more likely to be male, to be in a lower income quintile, to be residents of long-term care facilities, and to have been admitted to the hospital before surgery. They were also more likely to have comorbidities, including coronary artery disease, heart failure, and lung cancer.
A larger proportion of patients with COPD had frailty and medium to high comorbidity. They also more frequently underwent orthopedic, open upper abdominal, and vascular surgery.
During the year after surgery, 52,021 (5.6%) patients died, including 18,007 (10.6%) with COPD and 34,014 (4.5%) without. Those with COPD were more likely to die within 30 days of surgery (3.4% vs 1.2%).
For patients with COPD, the partially adjusted hazard ratio (HR) was 1.61 for risk of death; the fully adjusted HR was 1.26. COPD also was associated with a partially adjusted relative increase of 13.1% in health care costs and an increase of 4.6% with full adjustment.
Frailty, cancer, and procedure type were factors that modified the association between COPD and outcomes. “Procedures such as open aortic and upper abdominal surgery are associated with higher postoperative risks irrespective of COPD status, whereas others, such as orthopedic and lower abdominal surgery, may be of significantly greater risk for patients with COPD,” the authors wrote. “Our results suggest that perioperative management of patients with COPD requires careful consideration of the multiple domains that contribute to their elevated perioperative risk.
“Our finding that patients with COPD are at risk beyond 30 days after surgery suggests that it may be worthwhile to additionally support these patients’ recovery well beyond the first month after the procedure,” said Dr. Sankar.
Shared decision-making
Commenting on the study, William Whalen, MD, a pulmonary critical care specialist at Weill Cornell Medicine in New York, said, “I echo the authors’ sentiments that these findings highlight how chronically ill COPD patients are, which may be playing a role in the elevated mortality seen in this study.”
One caveat is in regard to the interpretation of the interaction effects of the study, he said. “Clinicians are unlikely to send patients who are frail or have multiple comorbidities to overly complex surgeries. Therefore, these effects may be misestimated due to selection bias.”
Two questions remain after reading the study, he added. “The first is how the degree of obstruction (i.e., the severity of COPD) impacts long-term mortality. Previous observational studies in nonsurgical COPD patients have shown increased mortality as the severity of obstruction increases. The second is how much of the long-term mortality observed in this study is related to respiratory disease from COPD. Patients with COPD are complex, and many die from nonrespiratory-related causes.”
Dr. Whalen suggests that discussion be held with the surgical team about the long-term morbidity and mortality with and without surgical intervention. Such a discussion could inform a shared decision-making process with the patient.
“Some procedures may be necessary to reduce immediate mortality, such as aortic aneurysmal repair, so [the risk of] longer-term mortality may be more acceptable in this setting,” he said. “Less straightforward are procedures that may improve quality of life. Would a patient accept an increased long-term mortality [risk] if that meant living without orthopedic-related pain?”
The study was funded by the Government of Ontario. Dr. Sankar and Dr. Whalen have disclosed no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
Patients with chronic obstructive pulmonary disease (COPD) are more likely to die within a year of undergoing elective surgery and to incur higher health care costs than are similar patients without COPD, data suggest.
An analysis of close to a million patient records found that, after adjustment for sociodemographic factors, procedure type, and comorbidities, patients with COPD were 26% more likely to die in the year after surgery than were those without COPD. Moreover, COPD was associated with a 4.6% increase in health care costs.
Previous studies have evaluated outcomes for the first 30 days after surgery. Those data “may not adequately capture the overall burden of surgery and how long it may take patients to recover,” study author Ashwin Sankar, MD, a clinician-investigator at St. Michael’s Hospital and assistant professor of anesthesia at the University of Toronto, told this news organization.
“We found that COPD often coexists with other conditions, like diabetes, coronary artery disease, and frailty,” Dr. Sankar added.
The study was published online in the Canadian Medical Association Journal.
Additional recovery support
The authors analyzed data from 932,616 patients who underwent intermediate-risk to high-risk elective noncardiac surgeries from 2005 to 2019 in Ontario. Procedures included carotid endarterectomy, open or endovascular abdominal aortic aneurysm repair, peripheral arterial bypass, total hip replacement, total knee replacement, shoulder surgery, large-bowel surgery, partial liver resection, pancreaticoduodenectomy, gastrectomy, esophagectomy, nephrectomy, cystectomy, prostatectomy, and hysterectomy.
The researchers quantified the associations of COPD with survival and costs. Their analyses included partial adjustment for sociodemographic factors and procedure type and full adjustment, which included comorbidities.
The primary outcome was all-cause death in the year after surgery; the secondary outcome was total health care costs in that year.
The mean age of the population was 65 years, and 60% of patients were women. A total of 170,482 (18%) patients had COPD. Compared with those without COPD, the patients with COPD were older and were more likely to be male, to be in a lower income quintile, to be residents of long-term care facilities, and to have been admitted to the hospital before surgery. They were also more likely to have comorbidities, including coronary artery disease, heart failure, and lung cancer.
A larger proportion of patients with COPD had frailty and medium to high comorbidity. They also more frequently underwent orthopedic, open upper abdominal, and vascular surgery.
During the year after surgery, 52,021 (5.6%) patients died, including 18,007 (10.6%) with COPD and 34,014 (4.5%) without. Those with COPD were more likely to die within 30 days of surgery (3.4% vs 1.2%).
For patients with COPD, the partially adjusted hazard ratio (HR) was 1.61 for risk of death; the fully adjusted HR was 1.26. COPD also was associated with a partially adjusted relative increase of 13.1% in health care costs and an increase of 4.6% with full adjustment.
Frailty, cancer, and procedure type were factors that modified the association between COPD and outcomes. “Procedures such as open aortic and upper abdominal surgery are associated with higher postoperative risks irrespective of COPD status, whereas others, such as orthopedic and lower abdominal surgery, may be of significantly greater risk for patients with COPD,” the authors wrote. “Our results suggest that perioperative management of patients with COPD requires careful consideration of the multiple domains that contribute to their elevated perioperative risk.
“Our finding that patients with COPD are at risk beyond 30 days after surgery suggests that it may be worthwhile to additionally support these patients’ recovery well beyond the first month after the procedure,” said Dr. Sankar.
Shared decision-making
Commenting on the study, William Whalen, MD, a pulmonary critical care specialist at Weill Cornell Medicine in New York, said, “I echo the authors’ sentiments that these findings highlight how chronically ill COPD patients are, which may be playing a role in the elevated mortality seen in this study.”
One caveat is in regard to the interpretation of the interaction effects of the study, he said. “Clinicians are unlikely to send patients who are frail or have multiple comorbidities to overly complex surgeries. Therefore, these effects may be misestimated due to selection bias.”
Two questions remain after reading the study, he added. “The first is how the degree of obstruction (i.e., the severity of COPD) impacts long-term mortality. Previous observational studies in nonsurgical COPD patients have shown increased mortality as the severity of obstruction increases. The second is how much of the long-term mortality observed in this study is related to respiratory disease from COPD. Patients with COPD are complex, and many die from nonrespiratory-related causes.”
Dr. Whalen suggests that discussion be held with the surgical team about the long-term morbidity and mortality with and without surgical intervention. Such a discussion could inform a shared decision-making process with the patient.
“Some procedures may be necessary to reduce immediate mortality, such as aortic aneurysmal repair, so [the risk of] longer-term mortality may be more acceptable in this setting,” he said. “Less straightforward are procedures that may improve quality of life. Would a patient accept an increased long-term mortality [risk] if that meant living without orthopedic-related pain?”
The study was funded by the Government of Ontario. Dr. Sankar and Dr. Whalen have disclosed no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
Exacerbation history found flawed as COPD risk predictor
Clinical guidelines recommend use of exacerbation history in choosing therapies to predict the risk for chronic obstructive pulmonary disease exacerbations, but an analysis of data from three different clinical studies has found that exacerbation history alone is not the most accurate risk-prediction tool – and that it may even cause harm in some situations.
“Our results present a cautionary tale for the potential risk of harm to patients when naively applying risk stratification algorithms across different clinical settings,” lead author Joseph Khoa Ho, PharmD, a master’s candidate in pharmaceutical sciences at the University of British Columbia, Vancouver, told this news organization.
he said. “However, the prediction models required re-evaluation and setting-specific recalibration in order to yield higher clinical utility.”
The study, known as IMPACT, analyzed three trials that enrolled 4,107 patients at varying levels of moderate or severe exacerbation risks: the placebo arm of the Study to Understand Mortality and Morbidity in COPD (SUMMIT; N = 2,421); the Long-term Oxygen Treatment Trial (LOTT; N = 595); and the placebo arm of the Towards a Revolution in COPD Health trial (TORCH; N = 1,091). The exacerbation risks were low, medium, and high in the three respective trials.
The study, published online in the journal CHEST, compared the performance of three risk-stratification algorithms: exacerbation history; the model that Loes C.M. Bertens, PhD, and colleagues in the Netherlands developed in 2013; and the latest version of the Acute COPD Exacerbation Prediction Tool, known as ACCEPT.
Results of the analysis
The study used area under the curve (AUC), a method of evaluating effectiveness or efficiency, to compare performance of the prediction algorithms. ACCEPT outperformed exacerbation history and the Bertens algorithm in all the LOTT (medium risk) and TORCH (high risk) samples, both of which were statistically significant. In SUMMIT (low risk), Bertens and ACCEPT outperformed exacerbation history, which was statistically significant.
The AUC for exacerbation history alone in predicting future exacerbations in SUMMIT, LOTT, and TORCH was 0.59 (95% confidence interval, 0.57-0.61), 0.63 (95% CI, 0.59-0.67), and 0.65 (95% CI, 0.63-0.68), respectively. Bertens had a higher AUC, compared with exacerbation history alone in SUMMIT (increase of 0.10, P < .001) and TORCH (increase of 0.05, P < .001), but not in LOTT (increase of 0.01, P = .84).
ACCEPT had higher AUC, compared with exacerbation history alone in all study samples, by 0.08 (P < .001), 0.07 (P = .001) and 0.10 (P < .001), respectively. Compared with Bertens, ACCEPT had higher AUC by 0.06 (P = .001) in LOTT and 0.05 (P < .001) in TORCH, whereas the AUCs were not different in SUMMIT (change of –0.02, P = .16).
Study rationale
Senior author Mohsen Sadatsafavi, MD, PhD, associate professor of pharmaceutical sciences at the University of British Columbia, told this news organization that this study was inspired by a study in cardiology earlier in 2022 that found that the performance of the multitude of risk-prediction tools used to evaluate cardiovascular disease risk can vary widely if they’re not calibrated for new patient populations.
“The main finding was that exacerbation history alone can be harmful even if it is applied at different risk levels,” Dr. Sadatsafavi said of the IMPACT study. “No algorithm could be universally applicable, but exacerbation history has a very high chance of being worse than not doing any risk stratification at all and simply giving medication to all patients.”
Exacerbation history was considered harmful because it generated a lower net benefit than the either Bertens or ACCEPT, the IMPACT study found.
The benefit of the two risk-prediction tools is that they can be recalibrated, Dr. Sadatsafavi said. “You don’t have that luxury with exacerbation history, because it’s just a fixed positive or negative history,” he said. “We need to be quite cognizant of the difference in lung attacks in different populations and the fact that exacerbation history has very different performance in different groups and might be harmful when applied in certain populations. We suggest the use of the risk-stratification tools as a better proper statistical model.”
Expert comment
“As the authors point out, current guidelines for COPD management recommend preventive exacerbation therapy considering the patient’s exacerbation history,” Mary Jo S. Farmer, MD, PhD, assistant professor at the University of Massachusetts Chan Medical School-Baystate, Worcester, said via email. “However, this strategy has demonstrated harm in some situations.”
She noted that the multivariable prediction models were more accurate than exacerbation history alone for predicting 12-month risk of moderate/severe COPD exacerbations but that no algorithm was superior in clinical utility across all samples.
“The authors conclude that the highest accuracy of a risk prediction model can be achieved when the model is recalibrated based on the baseline exacerbation risk of the study population in question,” Dr. Farmer added.
The study received funding from the Canadian Institutes of Health Research. Dr. Ho, Dr. Sadatsafavi, and Dr. Farmer report no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Clinical guidelines recommend use of exacerbation history in choosing therapies to predict the risk for chronic obstructive pulmonary disease exacerbations, but an analysis of data from three different clinical studies has found that exacerbation history alone is not the most accurate risk-prediction tool – and that it may even cause harm in some situations.
“Our results present a cautionary tale for the potential risk of harm to patients when naively applying risk stratification algorithms across different clinical settings,” lead author Joseph Khoa Ho, PharmD, a master’s candidate in pharmaceutical sciences at the University of British Columbia, Vancouver, told this news organization.
he said. “However, the prediction models required re-evaluation and setting-specific recalibration in order to yield higher clinical utility.”
The study, known as IMPACT, analyzed three trials that enrolled 4,107 patients at varying levels of moderate or severe exacerbation risks: the placebo arm of the Study to Understand Mortality and Morbidity in COPD (SUMMIT; N = 2,421); the Long-term Oxygen Treatment Trial (LOTT; N = 595); and the placebo arm of the Towards a Revolution in COPD Health trial (TORCH; N = 1,091). The exacerbation risks were low, medium, and high in the three respective trials.
The study, published online in the journal CHEST, compared the performance of three risk-stratification algorithms: exacerbation history; the model that Loes C.M. Bertens, PhD, and colleagues in the Netherlands developed in 2013; and the latest version of the Acute COPD Exacerbation Prediction Tool, known as ACCEPT.
Results of the analysis
The study used area under the curve (AUC), a method of evaluating effectiveness or efficiency, to compare performance of the prediction algorithms. ACCEPT outperformed exacerbation history and the Bertens algorithm in all the LOTT (medium risk) and TORCH (high risk) samples, both of which were statistically significant. In SUMMIT (low risk), Bertens and ACCEPT outperformed exacerbation history, which was statistically significant.
The AUC for exacerbation history alone in predicting future exacerbations in SUMMIT, LOTT, and TORCH was 0.59 (95% confidence interval, 0.57-0.61), 0.63 (95% CI, 0.59-0.67), and 0.65 (95% CI, 0.63-0.68), respectively. Bertens had a higher AUC, compared with exacerbation history alone in SUMMIT (increase of 0.10, P < .001) and TORCH (increase of 0.05, P < .001), but not in LOTT (increase of 0.01, P = .84).
ACCEPT had higher AUC, compared with exacerbation history alone in all study samples, by 0.08 (P < .001), 0.07 (P = .001) and 0.10 (P < .001), respectively. Compared with Bertens, ACCEPT had higher AUC by 0.06 (P = .001) in LOTT and 0.05 (P < .001) in TORCH, whereas the AUCs were not different in SUMMIT (change of –0.02, P = .16).
Study rationale
Senior author Mohsen Sadatsafavi, MD, PhD, associate professor of pharmaceutical sciences at the University of British Columbia, told this news organization that this study was inspired by a study in cardiology earlier in 2022 that found that the performance of the multitude of risk-prediction tools used to evaluate cardiovascular disease risk can vary widely if they’re not calibrated for new patient populations.
“The main finding was that exacerbation history alone can be harmful even if it is applied at different risk levels,” Dr. Sadatsafavi said of the IMPACT study. “No algorithm could be universally applicable, but exacerbation history has a very high chance of being worse than not doing any risk stratification at all and simply giving medication to all patients.”
Exacerbation history was considered harmful because it generated a lower net benefit than the either Bertens or ACCEPT, the IMPACT study found.
The benefit of the two risk-prediction tools is that they can be recalibrated, Dr. Sadatsafavi said. “You don’t have that luxury with exacerbation history, because it’s just a fixed positive or negative history,” he said. “We need to be quite cognizant of the difference in lung attacks in different populations and the fact that exacerbation history has very different performance in different groups and might be harmful when applied in certain populations. We suggest the use of the risk-stratification tools as a better proper statistical model.”
Expert comment
“As the authors point out, current guidelines for COPD management recommend preventive exacerbation therapy considering the patient’s exacerbation history,” Mary Jo S. Farmer, MD, PhD, assistant professor at the University of Massachusetts Chan Medical School-Baystate, Worcester, said via email. “However, this strategy has demonstrated harm in some situations.”
She noted that the multivariable prediction models were more accurate than exacerbation history alone for predicting 12-month risk of moderate/severe COPD exacerbations but that no algorithm was superior in clinical utility across all samples.
“The authors conclude that the highest accuracy of a risk prediction model can be achieved when the model is recalibrated based on the baseline exacerbation risk of the study population in question,” Dr. Farmer added.
The study received funding from the Canadian Institutes of Health Research. Dr. Ho, Dr. Sadatsafavi, and Dr. Farmer report no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Clinical guidelines recommend use of exacerbation history in choosing therapies to predict the risk for chronic obstructive pulmonary disease exacerbations, but an analysis of data from three different clinical studies has found that exacerbation history alone is not the most accurate risk-prediction tool – and that it may even cause harm in some situations.
“Our results present a cautionary tale for the potential risk of harm to patients when naively applying risk stratification algorithms across different clinical settings,” lead author Joseph Khoa Ho, PharmD, a master’s candidate in pharmaceutical sciences at the University of British Columbia, Vancouver, told this news organization.
he said. “However, the prediction models required re-evaluation and setting-specific recalibration in order to yield higher clinical utility.”
The study, known as IMPACT, analyzed three trials that enrolled 4,107 patients at varying levels of moderate or severe exacerbation risks: the placebo arm of the Study to Understand Mortality and Morbidity in COPD (SUMMIT; N = 2,421); the Long-term Oxygen Treatment Trial (LOTT; N = 595); and the placebo arm of the Towards a Revolution in COPD Health trial (TORCH; N = 1,091). The exacerbation risks were low, medium, and high in the three respective trials.
The study, published online in the journal CHEST, compared the performance of three risk-stratification algorithms: exacerbation history; the model that Loes C.M. Bertens, PhD, and colleagues in the Netherlands developed in 2013; and the latest version of the Acute COPD Exacerbation Prediction Tool, known as ACCEPT.
Results of the analysis
The study used area under the curve (AUC), a method of evaluating effectiveness or efficiency, to compare performance of the prediction algorithms. ACCEPT outperformed exacerbation history and the Bertens algorithm in all the LOTT (medium risk) and TORCH (high risk) samples, both of which were statistically significant. In SUMMIT (low risk), Bertens and ACCEPT outperformed exacerbation history, which was statistically significant.
The AUC for exacerbation history alone in predicting future exacerbations in SUMMIT, LOTT, and TORCH was 0.59 (95% confidence interval, 0.57-0.61), 0.63 (95% CI, 0.59-0.67), and 0.65 (95% CI, 0.63-0.68), respectively. Bertens had a higher AUC, compared with exacerbation history alone in SUMMIT (increase of 0.10, P < .001) and TORCH (increase of 0.05, P < .001), but not in LOTT (increase of 0.01, P = .84).
ACCEPT had higher AUC, compared with exacerbation history alone in all study samples, by 0.08 (P < .001), 0.07 (P = .001) and 0.10 (P < .001), respectively. Compared with Bertens, ACCEPT had higher AUC by 0.06 (P = .001) in LOTT and 0.05 (P < .001) in TORCH, whereas the AUCs were not different in SUMMIT (change of –0.02, P = .16).
Study rationale
Senior author Mohsen Sadatsafavi, MD, PhD, associate professor of pharmaceutical sciences at the University of British Columbia, told this news organization that this study was inspired by a study in cardiology earlier in 2022 that found that the performance of the multitude of risk-prediction tools used to evaluate cardiovascular disease risk can vary widely if they’re not calibrated for new patient populations.
“The main finding was that exacerbation history alone can be harmful even if it is applied at different risk levels,” Dr. Sadatsafavi said of the IMPACT study. “No algorithm could be universally applicable, but exacerbation history has a very high chance of being worse than not doing any risk stratification at all and simply giving medication to all patients.”
Exacerbation history was considered harmful because it generated a lower net benefit than the either Bertens or ACCEPT, the IMPACT study found.
The benefit of the two risk-prediction tools is that they can be recalibrated, Dr. Sadatsafavi said. “You don’t have that luxury with exacerbation history, because it’s just a fixed positive or negative history,” he said. “We need to be quite cognizant of the difference in lung attacks in different populations and the fact that exacerbation history has very different performance in different groups and might be harmful when applied in certain populations. We suggest the use of the risk-stratification tools as a better proper statistical model.”
Expert comment
“As the authors point out, current guidelines for COPD management recommend preventive exacerbation therapy considering the patient’s exacerbation history,” Mary Jo S. Farmer, MD, PhD, assistant professor at the University of Massachusetts Chan Medical School-Baystate, Worcester, said via email. “However, this strategy has demonstrated harm in some situations.”
She noted that the multivariable prediction models were more accurate than exacerbation history alone for predicting 12-month risk of moderate/severe COPD exacerbations but that no algorithm was superior in clinical utility across all samples.
“The authors conclude that the highest accuracy of a risk prediction model can be achieved when the model is recalibrated based on the baseline exacerbation risk of the study population in question,” Dr. Farmer added.
The study received funding from the Canadian Institutes of Health Research. Dr. Ho, Dr. Sadatsafavi, and Dr. Farmer report no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM THE JOURNAL CHEST
Comorbidities and the prognosis of chronic obstructive pulmonary disease
Strict control of comorbidities in patients with chronic obstructive pulmonary disease decreases exacerbations and morbimortality, and avoids readmissions. An increasing number of women have the disease, which progresses differently in women than in men and even has different comorbidities.
said Belén Alonso, MD, PhD, coordinator of the COPD Working Group of the Spanish Society of Internal Medicine. Up to 73 comorbidities associated with chronic obstructive pulmonary disease have been described. Dr. Alonso made these remarks during her presentation at the Comorbidities in Chronic Obstructive Pulmonary Disease Panel, which took place during the 43rd Conference of the Spanish Society of Internal Medicine (SEMI), in Gijón, Spain.
According to the scientific society’s press release, moderator María Gómez Antúnez, MD, stated, “The correct approach and treatment of these comorbidities is fundamental to improve the quality of life of the patient, decrease exacerbations, avoid readmissions, and decrease morbimortality in people with chronic obstructive pulmonary disease.”
The different works published, two of them by the SEMI COPD Working Group (ECCO and ESMI studies), indicate that the main comorbidities of patients with that pneumopathy are arterial hypertension, dyslipidemia, diabetes, heart failure, atrial fibrillation, ischemic heart disease, chronic kidney disease, peripheral arterial disease, and osteoporosis. Chronic hepatopathy, pulmonary neoplasm, depression, and cerebrovascular disease are less common.
73 comorbidities described
Dr. Alonso told this news organization, “Of those 73 comorbidities, some of the lesser known or less attention grabbing, according to a paper that we brought to the panel, include sleep disorders that encompass insomnia, nightmares, night terrors, sleep apneas, or hypopneas. Other lesser-known comorbidities related to cognitive decline, with patterns that reflect that up to 60% [of patients] may have some degree of deterioration, involve the disease phase, hypoxemia, or degree of inflammation. On the other hand, it has also been associated with Parkinson’s disease and gastroesophageal reflux, among many more that arise from the cardiovascular sphere.”
One paper reveals that more than 78% of patients with chronic obstructive pulmonary disease have one associated comorbidity, almost 69% have two, and 47.9% have three.
“Based on gender, comorbidities are different. In women, it is well observed that anxiety, depression, and osteoporosis are more common. However, hypertension, ischemic heart disease, and diabetes are more common in men with chronic obstructive pulmonary disease,” she stated.
“The pulmonary disease in question also progresses differently in men and women. In women, onset is at younger ages – between 40 and 50 years – and in men, after 50. Likewise, it appears that the disease progresses more quickly, which coincides with a worse quality of life (since dyspnea is tolerated less) and exceeds the anatomical differences, where hormonal influences play a dominant role,” Dr. Alonso stressed.
Reciprocal prognosis
Dr. Alonso stated, “The prognostic importance of comorbidities in the disease is reciprocal. In other words, if there are comorbidities that we do not look for or treat, they are going to have a negative influence on the chronic obstructive pulmonary disease. The disease will progress more and elevate the risk of exacerbations (the most important prognostic factor of that disease). In turn, if we are not treating the disease well, not only pharmacologically, it will have negative repercussions on the comorbidities. It will progress and have negative connotations, such as diabetes or ischemic heart disease.”
The aforementioned ECCO and ESMI studies include patients in internal medicine with exacerbations where the most common comorbidities have been mapped out, although there is also extensive research on comorbidities in patients who are admitted to departments other than internal medicine. “With regard to prognostic implications, our working group very clearly observed the comorbidities and the comorbidome, that solar system that appears so much in medical conferences and forums, which implies that proximity to the center of that solar system is related more to mortality, anxiety, depression, and breast cancer. Other pathologies, such as ischemic heart disease or dyslipidemia, are outside of that territory of greater risk, in which we have been more pioneering than other groups,” said Dr. Alonso.
The current trend is that the age of these patients is increasing, and there are more and more women with this pathology. According to the latest report from the Ministry of Health on respiratory diseases, the prevalence of chronic obstructive pulmonary disease among the population 40 years and older is around 33.9 cases per 1,000 inhabitants, more than twice as common in men than in women (47.7 vs. 21.3). Prevalence increases with age after 40 years progressively until reaching the greatest frequency in the 80- to 84-year-old age group.
In 2019, the number of deaths due to chronic obstructive pulmonary disease in Spain was 13,808 (9,907 men and 3,901 women), with a crude mortality rate of 29.3 deaths per 100,000 inhabitants. This toll decreased in comparison with that of 2018. Chronic obstructive pulmonary disease causes 2.5 times more deaths in men than in women. From 2001 to 2019, mortality due to that pathology declined by 43% in men and women. The decrease was almost 50% in men and 33% in women.
Overlap syndrome prevalent
Javier Sánchez Lora, MD, of the internal medicine department of the Virgen de la Victoria de Málaga University Clinical Hospital, discussed chronic obstructive pulmonary disease and sleep disorders. More concretely, he spoke about overlap syndrome: chronic obstructive pulmonary disease plus obstructive sleep apnea. According to the international consensus document on obstructive sleep apnea, the diagnosis requires an apnea-hypopnea index (AHI) equal to or greater than 15 per hour or equal to or greater than 5. The patient must also have one or more of the following factors: excessive daytime sleepiness, sleep that is not restful, excessive fatigue, and deterioration in quality of life related to sleep and not justified by other causes.
“The overlap syndrome affects 3%-66% of chronic obstructive pulmonary diseases and 7%-55% of obstructive sleep apnea,” said Dr. Sánchez Lora. This syndrome has important effects on different systems: at the cardiovascular level (arterial and pulmonary hypertension, heart failure, stroke, arrhythmias, ischemic heart disease, pulmonary thromboembolism), metabolic (insulin resistance, diabetes, metabolic syndrome), neurocognitive (dementia, depression), and neoplastic (lung, pancreas, esophagus) effects.
“These patients have a worse prognosis than those that have these pathologies alone. During sleep, they experience more frequent episodes of oxygen desaturation and they have a longer total period of sleep with hypoxemia and hypercapnia than those with obstructive apnea alone without chronic obstructive pulmonary disease,” said Dr. Sánchez Lora.
The apneic events of patients with the syndrome have a more profound hypoxemia and more arrhythmias, in addition to them being more susceptible to developing pulmonary hypertension than those with chronic obstructive pulmonary disease or sleep apnea alone. “The good news is that in patients with overlap, the use of ventilation with positive pressure reduces all causes of hospitalization and the visits to the emergency room, as well as the moderate and severe exacerbations of the disease.”
Dr. Sánchez Lora referred to a series of recommendations in clinical practice for the diagnosis and treatment of overlap syndrome: screening, combined therapy of hygienic-dietary measures, and the use of continuous positive respiratory pressure. Oxygen therapy to correct isolated nocturnal desaturations has not shown benefits in survival, although a benefit trial of symptoms attributed to nocturnal hypoxemia in patients with significant comorbidity can be conducted.
Underdiagnosis
“During the panel, we also spoke about the importance that as part of internal medicine we need to make an effort to reduce the underdiagnosis of chronic pulmonary disease and its comorbidities. Specialists in internal medicine need to become aware that this pathology is not only pulmonary, but also multisystemic, complex, heterogenous, and very variable even in the same patient,” said Dr. Sánchez Lora.
Dr. Alonso said, “Regarding the importance of diagnosis of this disease, we continue with an underdiagnosis greater than 70% for men and 80% for women. Secondly, we need to actively seek out the comorbidities associated with chronic obstructive pulmonary disease, even taking advantage of the admission of these patients with exacerbations, which are undesired and common.
“Regarding ongoing trials, we have a study that started during the COVID-19 pandemic, ADEG-EPOC, that involves the adaptation to and impact of severe and very severe exacerbations in patients admitted to our departments,” the specialist indicated.
“In the group, we are also planning to publish an updated agreement, which we already made in 2014, on the most common and important comorbidities associated with chronic obstructive pulmonary disease.” The agreement discusses the 20 most important comorbidities. In addition, the 2023 Gold Guide, which appeared in November 2022, includes a new chapter on updated treatment and the latest developments.
In the last 5 years, Dr. Alonso has collaborated with Abbott, AstraZeneca, Boehringer Ingelheim, Chiesi, FAES, Ferrer, Fresenius Kabi, GSK, Nestlé, Novo Nordisk, Nutricia, and Menarini. Dr. Sánchez Lora has collaborated with AstraZeneca, Boehringer Ingelheim, Chiesi, FAES, GSK, and Menarini.
This article was translated from the Medscape Spanish edition. A version of this article appeared on Medscape.com.
Strict control of comorbidities in patients with chronic obstructive pulmonary disease decreases exacerbations and morbimortality, and avoids readmissions. An increasing number of women have the disease, which progresses differently in women than in men and even has different comorbidities.
said Belén Alonso, MD, PhD, coordinator of the COPD Working Group of the Spanish Society of Internal Medicine. Up to 73 comorbidities associated with chronic obstructive pulmonary disease have been described. Dr. Alonso made these remarks during her presentation at the Comorbidities in Chronic Obstructive Pulmonary Disease Panel, which took place during the 43rd Conference of the Spanish Society of Internal Medicine (SEMI), in Gijón, Spain.
According to the scientific society’s press release, moderator María Gómez Antúnez, MD, stated, “The correct approach and treatment of these comorbidities is fundamental to improve the quality of life of the patient, decrease exacerbations, avoid readmissions, and decrease morbimortality in people with chronic obstructive pulmonary disease.”
The different works published, two of them by the SEMI COPD Working Group (ECCO and ESMI studies), indicate that the main comorbidities of patients with that pneumopathy are arterial hypertension, dyslipidemia, diabetes, heart failure, atrial fibrillation, ischemic heart disease, chronic kidney disease, peripheral arterial disease, and osteoporosis. Chronic hepatopathy, pulmonary neoplasm, depression, and cerebrovascular disease are less common.
73 comorbidities described
Dr. Alonso told this news organization, “Of those 73 comorbidities, some of the lesser known or less attention grabbing, according to a paper that we brought to the panel, include sleep disorders that encompass insomnia, nightmares, night terrors, sleep apneas, or hypopneas. Other lesser-known comorbidities related to cognitive decline, with patterns that reflect that up to 60% [of patients] may have some degree of deterioration, involve the disease phase, hypoxemia, or degree of inflammation. On the other hand, it has also been associated with Parkinson’s disease and gastroesophageal reflux, among many more that arise from the cardiovascular sphere.”
One paper reveals that more than 78% of patients with chronic obstructive pulmonary disease have one associated comorbidity, almost 69% have two, and 47.9% have three.
“Based on gender, comorbidities are different. In women, it is well observed that anxiety, depression, and osteoporosis are more common. However, hypertension, ischemic heart disease, and diabetes are more common in men with chronic obstructive pulmonary disease,” she stated.
“The pulmonary disease in question also progresses differently in men and women. In women, onset is at younger ages – between 40 and 50 years – and in men, after 50. Likewise, it appears that the disease progresses more quickly, which coincides with a worse quality of life (since dyspnea is tolerated less) and exceeds the anatomical differences, where hormonal influences play a dominant role,” Dr. Alonso stressed.
Reciprocal prognosis
Dr. Alonso stated, “The prognostic importance of comorbidities in the disease is reciprocal. In other words, if there are comorbidities that we do not look for or treat, they are going to have a negative influence on the chronic obstructive pulmonary disease. The disease will progress more and elevate the risk of exacerbations (the most important prognostic factor of that disease). In turn, if we are not treating the disease well, not only pharmacologically, it will have negative repercussions on the comorbidities. It will progress and have negative connotations, such as diabetes or ischemic heart disease.”
The aforementioned ECCO and ESMI studies include patients in internal medicine with exacerbations where the most common comorbidities have been mapped out, although there is also extensive research on comorbidities in patients who are admitted to departments other than internal medicine. “With regard to prognostic implications, our working group very clearly observed the comorbidities and the comorbidome, that solar system that appears so much in medical conferences and forums, which implies that proximity to the center of that solar system is related more to mortality, anxiety, depression, and breast cancer. Other pathologies, such as ischemic heart disease or dyslipidemia, are outside of that territory of greater risk, in which we have been more pioneering than other groups,” said Dr. Alonso.
The current trend is that the age of these patients is increasing, and there are more and more women with this pathology. According to the latest report from the Ministry of Health on respiratory diseases, the prevalence of chronic obstructive pulmonary disease among the population 40 years and older is around 33.9 cases per 1,000 inhabitants, more than twice as common in men than in women (47.7 vs. 21.3). Prevalence increases with age after 40 years progressively until reaching the greatest frequency in the 80- to 84-year-old age group.
In 2019, the number of deaths due to chronic obstructive pulmonary disease in Spain was 13,808 (9,907 men and 3,901 women), with a crude mortality rate of 29.3 deaths per 100,000 inhabitants. This toll decreased in comparison with that of 2018. Chronic obstructive pulmonary disease causes 2.5 times more deaths in men than in women. From 2001 to 2019, mortality due to that pathology declined by 43% in men and women. The decrease was almost 50% in men and 33% in women.
Overlap syndrome prevalent
Javier Sánchez Lora, MD, of the internal medicine department of the Virgen de la Victoria de Málaga University Clinical Hospital, discussed chronic obstructive pulmonary disease and sleep disorders. More concretely, he spoke about overlap syndrome: chronic obstructive pulmonary disease plus obstructive sleep apnea. According to the international consensus document on obstructive sleep apnea, the diagnosis requires an apnea-hypopnea index (AHI) equal to or greater than 15 per hour or equal to or greater than 5. The patient must also have one or more of the following factors: excessive daytime sleepiness, sleep that is not restful, excessive fatigue, and deterioration in quality of life related to sleep and not justified by other causes.
“The overlap syndrome affects 3%-66% of chronic obstructive pulmonary diseases and 7%-55% of obstructive sleep apnea,” said Dr. Sánchez Lora. This syndrome has important effects on different systems: at the cardiovascular level (arterial and pulmonary hypertension, heart failure, stroke, arrhythmias, ischemic heart disease, pulmonary thromboembolism), metabolic (insulin resistance, diabetes, metabolic syndrome), neurocognitive (dementia, depression), and neoplastic (lung, pancreas, esophagus) effects.
“These patients have a worse prognosis than those that have these pathologies alone. During sleep, they experience more frequent episodes of oxygen desaturation and they have a longer total period of sleep with hypoxemia and hypercapnia than those with obstructive apnea alone without chronic obstructive pulmonary disease,” said Dr. Sánchez Lora.
The apneic events of patients with the syndrome have a more profound hypoxemia and more arrhythmias, in addition to them being more susceptible to developing pulmonary hypertension than those with chronic obstructive pulmonary disease or sleep apnea alone. “The good news is that in patients with overlap, the use of ventilation with positive pressure reduces all causes of hospitalization and the visits to the emergency room, as well as the moderate and severe exacerbations of the disease.”
Dr. Sánchez Lora referred to a series of recommendations in clinical practice for the diagnosis and treatment of overlap syndrome: screening, combined therapy of hygienic-dietary measures, and the use of continuous positive respiratory pressure. Oxygen therapy to correct isolated nocturnal desaturations has not shown benefits in survival, although a benefit trial of symptoms attributed to nocturnal hypoxemia in patients with significant comorbidity can be conducted.
Underdiagnosis
“During the panel, we also spoke about the importance that as part of internal medicine we need to make an effort to reduce the underdiagnosis of chronic pulmonary disease and its comorbidities. Specialists in internal medicine need to become aware that this pathology is not only pulmonary, but also multisystemic, complex, heterogenous, and very variable even in the same patient,” said Dr. Sánchez Lora.
Dr. Alonso said, “Regarding the importance of diagnosis of this disease, we continue with an underdiagnosis greater than 70% for men and 80% for women. Secondly, we need to actively seek out the comorbidities associated with chronic obstructive pulmonary disease, even taking advantage of the admission of these patients with exacerbations, which are undesired and common.
“Regarding ongoing trials, we have a study that started during the COVID-19 pandemic, ADEG-EPOC, that involves the adaptation to and impact of severe and very severe exacerbations in patients admitted to our departments,” the specialist indicated.
“In the group, we are also planning to publish an updated agreement, which we already made in 2014, on the most common and important comorbidities associated with chronic obstructive pulmonary disease.” The agreement discusses the 20 most important comorbidities. In addition, the 2023 Gold Guide, which appeared in November 2022, includes a new chapter on updated treatment and the latest developments.
In the last 5 years, Dr. Alonso has collaborated with Abbott, AstraZeneca, Boehringer Ingelheim, Chiesi, FAES, Ferrer, Fresenius Kabi, GSK, Nestlé, Novo Nordisk, Nutricia, and Menarini. Dr. Sánchez Lora has collaborated with AstraZeneca, Boehringer Ingelheim, Chiesi, FAES, GSK, and Menarini.
This article was translated from the Medscape Spanish edition. A version of this article appeared on Medscape.com.
Strict control of comorbidities in patients with chronic obstructive pulmonary disease decreases exacerbations and morbimortality, and avoids readmissions. An increasing number of women have the disease, which progresses differently in women than in men and even has different comorbidities.
said Belén Alonso, MD, PhD, coordinator of the COPD Working Group of the Spanish Society of Internal Medicine. Up to 73 comorbidities associated with chronic obstructive pulmonary disease have been described. Dr. Alonso made these remarks during her presentation at the Comorbidities in Chronic Obstructive Pulmonary Disease Panel, which took place during the 43rd Conference of the Spanish Society of Internal Medicine (SEMI), in Gijón, Spain.
According to the scientific society’s press release, moderator María Gómez Antúnez, MD, stated, “The correct approach and treatment of these comorbidities is fundamental to improve the quality of life of the patient, decrease exacerbations, avoid readmissions, and decrease morbimortality in people with chronic obstructive pulmonary disease.”
The different works published, two of them by the SEMI COPD Working Group (ECCO and ESMI studies), indicate that the main comorbidities of patients with that pneumopathy are arterial hypertension, dyslipidemia, diabetes, heart failure, atrial fibrillation, ischemic heart disease, chronic kidney disease, peripheral arterial disease, and osteoporosis. Chronic hepatopathy, pulmonary neoplasm, depression, and cerebrovascular disease are less common.
73 comorbidities described
Dr. Alonso told this news organization, “Of those 73 comorbidities, some of the lesser known or less attention grabbing, according to a paper that we brought to the panel, include sleep disorders that encompass insomnia, nightmares, night terrors, sleep apneas, or hypopneas. Other lesser-known comorbidities related to cognitive decline, with patterns that reflect that up to 60% [of patients] may have some degree of deterioration, involve the disease phase, hypoxemia, or degree of inflammation. On the other hand, it has also been associated with Parkinson’s disease and gastroesophageal reflux, among many more that arise from the cardiovascular sphere.”
One paper reveals that more than 78% of patients with chronic obstructive pulmonary disease have one associated comorbidity, almost 69% have two, and 47.9% have three.
“Based on gender, comorbidities are different. In women, it is well observed that anxiety, depression, and osteoporosis are more common. However, hypertension, ischemic heart disease, and diabetes are more common in men with chronic obstructive pulmonary disease,” she stated.
“The pulmonary disease in question also progresses differently in men and women. In women, onset is at younger ages – between 40 and 50 years – and in men, after 50. Likewise, it appears that the disease progresses more quickly, which coincides with a worse quality of life (since dyspnea is tolerated less) and exceeds the anatomical differences, where hormonal influences play a dominant role,” Dr. Alonso stressed.
Reciprocal prognosis
Dr. Alonso stated, “The prognostic importance of comorbidities in the disease is reciprocal. In other words, if there are comorbidities that we do not look for or treat, they are going to have a negative influence on the chronic obstructive pulmonary disease. The disease will progress more and elevate the risk of exacerbations (the most important prognostic factor of that disease). In turn, if we are not treating the disease well, not only pharmacologically, it will have negative repercussions on the comorbidities. It will progress and have negative connotations, such as diabetes or ischemic heart disease.”
The aforementioned ECCO and ESMI studies include patients in internal medicine with exacerbations where the most common comorbidities have been mapped out, although there is also extensive research on comorbidities in patients who are admitted to departments other than internal medicine. “With regard to prognostic implications, our working group very clearly observed the comorbidities and the comorbidome, that solar system that appears so much in medical conferences and forums, which implies that proximity to the center of that solar system is related more to mortality, anxiety, depression, and breast cancer. Other pathologies, such as ischemic heart disease or dyslipidemia, are outside of that territory of greater risk, in which we have been more pioneering than other groups,” said Dr. Alonso.
The current trend is that the age of these patients is increasing, and there are more and more women with this pathology. According to the latest report from the Ministry of Health on respiratory diseases, the prevalence of chronic obstructive pulmonary disease among the population 40 years and older is around 33.9 cases per 1,000 inhabitants, more than twice as common in men than in women (47.7 vs. 21.3). Prevalence increases with age after 40 years progressively until reaching the greatest frequency in the 80- to 84-year-old age group.
In 2019, the number of deaths due to chronic obstructive pulmonary disease in Spain was 13,808 (9,907 men and 3,901 women), with a crude mortality rate of 29.3 deaths per 100,000 inhabitants. This toll decreased in comparison with that of 2018. Chronic obstructive pulmonary disease causes 2.5 times more deaths in men than in women. From 2001 to 2019, mortality due to that pathology declined by 43% in men and women. The decrease was almost 50% in men and 33% in women.
Overlap syndrome prevalent
Javier Sánchez Lora, MD, of the internal medicine department of the Virgen de la Victoria de Málaga University Clinical Hospital, discussed chronic obstructive pulmonary disease and sleep disorders. More concretely, he spoke about overlap syndrome: chronic obstructive pulmonary disease plus obstructive sleep apnea. According to the international consensus document on obstructive sleep apnea, the diagnosis requires an apnea-hypopnea index (AHI) equal to or greater than 15 per hour or equal to or greater than 5. The patient must also have one or more of the following factors: excessive daytime sleepiness, sleep that is not restful, excessive fatigue, and deterioration in quality of life related to sleep and not justified by other causes.
“The overlap syndrome affects 3%-66% of chronic obstructive pulmonary diseases and 7%-55% of obstructive sleep apnea,” said Dr. Sánchez Lora. This syndrome has important effects on different systems: at the cardiovascular level (arterial and pulmonary hypertension, heart failure, stroke, arrhythmias, ischemic heart disease, pulmonary thromboembolism), metabolic (insulin resistance, diabetes, metabolic syndrome), neurocognitive (dementia, depression), and neoplastic (lung, pancreas, esophagus) effects.
“These patients have a worse prognosis than those that have these pathologies alone. During sleep, they experience more frequent episodes of oxygen desaturation and they have a longer total period of sleep with hypoxemia and hypercapnia than those with obstructive apnea alone without chronic obstructive pulmonary disease,” said Dr. Sánchez Lora.
The apneic events of patients with the syndrome have a more profound hypoxemia and more arrhythmias, in addition to them being more susceptible to developing pulmonary hypertension than those with chronic obstructive pulmonary disease or sleep apnea alone. “The good news is that in patients with overlap, the use of ventilation with positive pressure reduces all causes of hospitalization and the visits to the emergency room, as well as the moderate and severe exacerbations of the disease.”
Dr. Sánchez Lora referred to a series of recommendations in clinical practice for the diagnosis and treatment of overlap syndrome: screening, combined therapy of hygienic-dietary measures, and the use of continuous positive respiratory pressure. Oxygen therapy to correct isolated nocturnal desaturations has not shown benefits in survival, although a benefit trial of symptoms attributed to nocturnal hypoxemia in patients with significant comorbidity can be conducted.
Underdiagnosis
“During the panel, we also spoke about the importance that as part of internal medicine we need to make an effort to reduce the underdiagnosis of chronic pulmonary disease and its comorbidities. Specialists in internal medicine need to become aware that this pathology is not only pulmonary, but also multisystemic, complex, heterogenous, and very variable even in the same patient,” said Dr. Sánchez Lora.
Dr. Alonso said, “Regarding the importance of diagnosis of this disease, we continue with an underdiagnosis greater than 70% for men and 80% for women. Secondly, we need to actively seek out the comorbidities associated with chronic obstructive pulmonary disease, even taking advantage of the admission of these patients with exacerbations, which are undesired and common.
“Regarding ongoing trials, we have a study that started during the COVID-19 pandemic, ADEG-EPOC, that involves the adaptation to and impact of severe and very severe exacerbations in patients admitted to our departments,” the specialist indicated.
“In the group, we are also planning to publish an updated agreement, which we already made in 2014, on the most common and important comorbidities associated with chronic obstructive pulmonary disease.” The agreement discusses the 20 most important comorbidities. In addition, the 2023 Gold Guide, which appeared in November 2022, includes a new chapter on updated treatment and the latest developments.
In the last 5 years, Dr. Alonso has collaborated with Abbott, AstraZeneca, Boehringer Ingelheim, Chiesi, FAES, Ferrer, Fresenius Kabi, GSK, Nestlé, Novo Nordisk, Nutricia, and Menarini. Dr. Sánchez Lora has collaborated with AstraZeneca, Boehringer Ingelheim, Chiesi, FAES, GSK, and Menarini.
This article was translated from the Medscape Spanish edition. A version of this article appeared on Medscape.com.