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FDA asked to approve add-on drug for eosinophilic COPD
GlaxoSmithKline asked the Food and Drug Administration to approve an interleuklin-5 antagonist as an add-on maintenance therapy for patients with eosinophilic chronic obstructive pulmonary disease (COPD).
The pharmaceutical and health care company is seeking approval of mepolizumab to be used specifically to treat COPD patients with an eosinophilic phenotype. The drug currently is indicated to treat patients aged 12 years or older with severe asthma and asthma with an eosinophilic phenotype and is sold under the name Nucala, according to a GlaxoSmithKline statement issued November 7.
Headache, injection site reaction, back pain, and fatigue are the most common adverse reactions seen in patients who took mepolizumab during clinical trials.
Mepolizumab is not approved for the treatment of COPD anywhere in the world, and GlaxoSmithKline intends to also ask other countries’ regulatory authorities to allow this drug to be sold as a therapy for COPD.
GlaxoSmithKline asked the Food and Drug Administration to approve an interleuklin-5 antagonist as an add-on maintenance therapy for patients with eosinophilic chronic obstructive pulmonary disease (COPD).
The pharmaceutical and health care company is seeking approval of mepolizumab to be used specifically to treat COPD patients with an eosinophilic phenotype. The drug currently is indicated to treat patients aged 12 years or older with severe asthma and asthma with an eosinophilic phenotype and is sold under the name Nucala, according to a GlaxoSmithKline statement issued November 7.
Headache, injection site reaction, back pain, and fatigue are the most common adverse reactions seen in patients who took mepolizumab during clinical trials.
Mepolizumab is not approved for the treatment of COPD anywhere in the world, and GlaxoSmithKline intends to also ask other countries’ regulatory authorities to allow this drug to be sold as a therapy for COPD.
GlaxoSmithKline asked the Food and Drug Administration to approve an interleuklin-5 antagonist as an add-on maintenance therapy for patients with eosinophilic chronic obstructive pulmonary disease (COPD).
The pharmaceutical and health care company is seeking approval of mepolizumab to be used specifically to treat COPD patients with an eosinophilic phenotype. The drug currently is indicated to treat patients aged 12 years or older with severe asthma and asthma with an eosinophilic phenotype and is sold under the name Nucala, according to a GlaxoSmithKline statement issued November 7.
Headache, injection site reaction, back pain, and fatigue are the most common adverse reactions seen in patients who took mepolizumab during clinical trials.
Mepolizumab is not approved for the treatment of COPD anywhere in the world, and GlaxoSmithKline intends to also ask other countries’ regulatory authorities to allow this drug to be sold as a therapy for COPD.
Nebulized LABA safe for long-term use in COPD
TORONTO – No long-term safety signals were seen in a randomized trial that tested the formoterol fumarate inhalation solution (Perforomist, Mylan) against placebo in patients with moderate to severe chronic obstructive pulmonary disease (COPD).
Safety was confirmed despite patients being permitted to remain on other background treatment for COPD, including inhaled corticosteroids and anticholinergics, in this study presented at the CHEST annual meeting. An additional benefit of the therapy was that it significantly improved lung function from baseline, according to some spirometry measures.
The Food and Drug Administration approved formoterol fumarate, a long-acting beta-2 agonist (LABA), as a nebulized maintenance treatment for bronchoconstriction in COPD. Because of a concern about long-term LABA safety in asthma patients, said Dr. Hanania, the FDA mandated this 1-year phase 4 study to evaluate the long-term safety of formoterol in patients with moderate to severe COPD.
This multicenter, double-blind, noninferiority study randomly assigned 1,071 patients with moderate to severe COPD (mean FEV1, 44.4% of predicted value, at least one exacerbation in the past 12 months) to receive either nebulized formoterol 20 mcg/2 mL twice daily or matching placebo for up to 12 months. Subjects were permitted to remain on stable COPD therapy, including inhaled corticosteroids and anticholinergics but excluding long-acting beta-agonists.
Formoterol was noninferior to placebo for the primary safety endpoint, defined as a first occurrence of respiratory-related death, COPD-related emergency department visit, or COPD-related hospitalization, with an estimated hazard ratio of 0.965.
Formoterol significantly improved trough forced expiratory volume in 1 second (FEV1), compared with placebo at 3 and 6 months of treatment, with (least squares) mean estimated differences of 42 mL (P = .007) and 41 mL (P = .025), respectively, but not at 9 or 12 months. Forced vital capacity was significantly improved with formoterol over placebo at all study visits (3, 6, 9, and 12 months), but improvements from baseline in inspiratory capacity did not significantly differ from placebo.
Mean age of study patients was 62.6 years and 48.5% were female. At baseline, about half of patients were still smokers, half were on inhaled corticosteroids, and about one-third were on concomitant long-acting muscarinic antagonists, mainly tiotropium, reported Dr. Hanania. The vast majority of patients had moderate or severe COPD, with less than 1% having very severe disease at baseline.
In response to a question on dosing, Dr. Hanania told attendees, “One thing we have to keep in mind is that formoterol is a full agonist, so there are dose-dependent adverse effects. So, even though you get better lung function as you go up on the dose, there’s no free lunch and always the potential for adverse effects.”
The safety data was previously presented at the American Thoracic Society meeting in May 2017 (Hanania N et al. Am J Respir Crit Care Med. 2017;195 A5473 [abstract]), while the lung function data are new, said Dr. Hanania.
Dr. Hanania reported being an adviser for several pharmaceutical companies, including Mylan. Four of the six authors of the study’s abstract are employees of Mylan.
TORONTO – No long-term safety signals were seen in a randomized trial that tested the formoterol fumarate inhalation solution (Perforomist, Mylan) against placebo in patients with moderate to severe chronic obstructive pulmonary disease (COPD).
Safety was confirmed despite patients being permitted to remain on other background treatment for COPD, including inhaled corticosteroids and anticholinergics, in this study presented at the CHEST annual meeting. An additional benefit of the therapy was that it significantly improved lung function from baseline, according to some spirometry measures.
The Food and Drug Administration approved formoterol fumarate, a long-acting beta-2 agonist (LABA), as a nebulized maintenance treatment for bronchoconstriction in COPD. Because of a concern about long-term LABA safety in asthma patients, said Dr. Hanania, the FDA mandated this 1-year phase 4 study to evaluate the long-term safety of formoterol in patients with moderate to severe COPD.
This multicenter, double-blind, noninferiority study randomly assigned 1,071 patients with moderate to severe COPD (mean FEV1, 44.4% of predicted value, at least one exacerbation in the past 12 months) to receive either nebulized formoterol 20 mcg/2 mL twice daily or matching placebo for up to 12 months. Subjects were permitted to remain on stable COPD therapy, including inhaled corticosteroids and anticholinergics but excluding long-acting beta-agonists.
Formoterol was noninferior to placebo for the primary safety endpoint, defined as a first occurrence of respiratory-related death, COPD-related emergency department visit, or COPD-related hospitalization, with an estimated hazard ratio of 0.965.
Formoterol significantly improved trough forced expiratory volume in 1 second (FEV1), compared with placebo at 3 and 6 months of treatment, with (least squares) mean estimated differences of 42 mL (P = .007) and 41 mL (P = .025), respectively, but not at 9 or 12 months. Forced vital capacity was significantly improved with formoterol over placebo at all study visits (3, 6, 9, and 12 months), but improvements from baseline in inspiratory capacity did not significantly differ from placebo.
Mean age of study patients was 62.6 years and 48.5% were female. At baseline, about half of patients were still smokers, half were on inhaled corticosteroids, and about one-third were on concomitant long-acting muscarinic antagonists, mainly tiotropium, reported Dr. Hanania. The vast majority of patients had moderate or severe COPD, with less than 1% having very severe disease at baseline.
In response to a question on dosing, Dr. Hanania told attendees, “One thing we have to keep in mind is that formoterol is a full agonist, so there are dose-dependent adverse effects. So, even though you get better lung function as you go up on the dose, there’s no free lunch and always the potential for adverse effects.”
The safety data was previously presented at the American Thoracic Society meeting in May 2017 (Hanania N et al. Am J Respir Crit Care Med. 2017;195 A5473 [abstract]), while the lung function data are new, said Dr. Hanania.
Dr. Hanania reported being an adviser for several pharmaceutical companies, including Mylan. Four of the six authors of the study’s abstract are employees of Mylan.
TORONTO – No long-term safety signals were seen in a randomized trial that tested the formoterol fumarate inhalation solution (Perforomist, Mylan) against placebo in patients with moderate to severe chronic obstructive pulmonary disease (COPD).
Safety was confirmed despite patients being permitted to remain on other background treatment for COPD, including inhaled corticosteroids and anticholinergics, in this study presented at the CHEST annual meeting. An additional benefit of the therapy was that it significantly improved lung function from baseline, according to some spirometry measures.
The Food and Drug Administration approved formoterol fumarate, a long-acting beta-2 agonist (LABA), as a nebulized maintenance treatment for bronchoconstriction in COPD. Because of a concern about long-term LABA safety in asthma patients, said Dr. Hanania, the FDA mandated this 1-year phase 4 study to evaluate the long-term safety of formoterol in patients with moderate to severe COPD.
This multicenter, double-blind, noninferiority study randomly assigned 1,071 patients with moderate to severe COPD (mean FEV1, 44.4% of predicted value, at least one exacerbation in the past 12 months) to receive either nebulized formoterol 20 mcg/2 mL twice daily or matching placebo for up to 12 months. Subjects were permitted to remain on stable COPD therapy, including inhaled corticosteroids and anticholinergics but excluding long-acting beta-agonists.
Formoterol was noninferior to placebo for the primary safety endpoint, defined as a first occurrence of respiratory-related death, COPD-related emergency department visit, or COPD-related hospitalization, with an estimated hazard ratio of 0.965.
Formoterol significantly improved trough forced expiratory volume in 1 second (FEV1), compared with placebo at 3 and 6 months of treatment, with (least squares) mean estimated differences of 42 mL (P = .007) and 41 mL (P = .025), respectively, but not at 9 or 12 months. Forced vital capacity was significantly improved with formoterol over placebo at all study visits (3, 6, 9, and 12 months), but improvements from baseline in inspiratory capacity did not significantly differ from placebo.
Mean age of study patients was 62.6 years and 48.5% were female. At baseline, about half of patients were still smokers, half were on inhaled corticosteroids, and about one-third were on concomitant long-acting muscarinic antagonists, mainly tiotropium, reported Dr. Hanania. The vast majority of patients had moderate or severe COPD, with less than 1% having very severe disease at baseline.
In response to a question on dosing, Dr. Hanania told attendees, “One thing we have to keep in mind is that formoterol is a full agonist, so there are dose-dependent adverse effects. So, even though you get better lung function as you go up on the dose, there’s no free lunch and always the potential for adverse effects.”
The safety data was previously presented at the American Thoracic Society meeting in May 2017 (Hanania N et al. Am J Respir Crit Care Med. 2017;195 A5473 [abstract]), while the lung function data are new, said Dr. Hanania.
Dr. Hanania reported being an adviser for several pharmaceutical companies, including Mylan. Four of the six authors of the study’s abstract are employees of Mylan.
AT CHEST 2017
Key clinical point: The long-term safety of formoterol fumarate inhaled solution was confirmed in an FDA-mandated randomized trial in patients with moderate to severe COPD.
Major finding: Formoterol fumarate was noninferior to placebo for the primary safety endpoint of respiratory-related death, COPD-related emergency department visit, or COPD-related hospitalization, with an estimated hazard ratio of 0.965.
Data source: Multicenter, randomized, double-blind, placebo-controlled trial including 1,071 patients with moderate or severe COPD, with at least one exacerbation recorded in the last year.
Disclosures: Dr. Hanania reported being an adviser for several pharmaceutical companies, including Mylan. Four of the six authors of the study’s abstract are employees of Mylan.
Nebulized glycopyrrolate improves lung function in COPD
TORONTO – Glycopyrrolate, a novel nebulized long-acting muscarinic antagonist (LAMA) in development, was well-tolerated and significantly improved lung function and health status in COPD patients regardless of baseline lung function or age, according to a subgroup analysis of pooled results from two randomized trials.*
There are currently no nebulized LAMAs approved for use in the U.S.
Jill Ohar, MD, from Wake Forest University School of Medicine (Winston-Salem, N.C.), presented this secondary analysis of the GOLDEN-3 and GOLDEN-4 trials at the CHEST annual meeting. She and her colleagues evaluated the efficacy and safety of glycopyrrolate in patients with a forced expiratory volume 1(FEV1) % predicted of less than 50 and an FEV1 % predicted of greater than or equal to 50, in age ranges of less than 65 years, greater than or equal to 65 years and at least 75 years, as measured by trough FEV1.
Similarly, both glycopyrrolate doses produced significant (P less than .05) and clinically meaningful lung function improvements vs. placebo in participants less than 65 years of age, at least 65 years, and greater than or equal to 75 years.
Glycopyrrolate use for 12 weeks led to greater improvements over placebo in St. George’s Respiratory Questionnaire (SGRQ) total score, in patients in both lung function classes. There were a higher percentage of SGRQ responders in the treatment arms compared to placebo arms.
The highest SGRQ improvement in SGRQ (−6.287) was seen in the 47 patients that comprised the at-least-75 years of age subgroup receiving glycopyrrolate 25 mcg BID. “It’s a small number of people, but I think it’s [valuable] to see if the very aged act in any way differently than the entire greater than or equal to 65-year-old group,” said Dr. Ohar.
Adverse event rates were similar for placebo and both glycopyrrolate doses, with no safety signals seen according to baseline lung function or age. Few cardiovascular events of special interest were seen.
“Looking at major adverse cardiovascular events, such as fatal MIs, other cardiovascular deaths, arrhythmias, etc., we see nothing that would suggest that the drug overall is associated with an undue number of these versus placebo,” reported Dr. Ohar.
GOLDEN 3 and 4 were replicate, 12-week, phase 3, randomized, double-blind, placebo-controlled studies that evaluated glycopyrrolate solution administered by an investigational eFlow Close System (eFLOW CS) nebulizer in individuals with moderate-to-very severe COPD, including those with continued background use of a long-acting beta2-agonist (LABA), with or without an inhaled corticosteroid (ICS). In each of the trials, about 30% of patients were on LABA ICS, noted Dr. Ohar in her presentation. A total of 653 subjects were randomized in GOLDEN 3 and 641 in GOLDEN 4.
Its manufacturer, Sunovion Pharmaceuticals, resubmitted the product to the FDA in June 2017 in response to a Complete Response Letter received from the FDA in May 2017. The FDA is expected to act on the new submission on December 15, 2017. The novel agent is being considered for the long-term, maintenance treatment of airflow obstruction in people with COPD, including chronic bronchitis and/or emphysema.
Dr. Ohar reported that she serves on the advisory boards of several pharmaceutical companies. The other three authors are employees of Sunovion Pharmaceuticals Inc.
*This article was updated on Nov. 6, 2017.
Eric Gartman, MD, FCCP, comments: If approved, this would represent the first nebulized LAMA available in the U.S. – so in the small population of patients that is unable to utilize standard delivery devices, this would provide an option. It is unclear if this medication must be administered via the proprietary nebulizer that was used in the study – but if so, this would certainly add to the already extremely high cost of respiratory medications and further limit access for many patients. 
Eric Gartman, MD, FCCP, comments: If approved, this would represent the first nebulized LAMA available in the U.S. – so in the small population of patients that is unable to utilize standard delivery devices, this would provide an option. It is unclear if this medication must be administered via the proprietary nebulizer that was used in the study – but if so, this would certainly add to the already extremely high cost of respiratory medications and further limit access for many patients.
Eric Gartman, MD, FCCP, comments: If approved, this would represent the first nebulized LAMA available in the U.S. – so in the small population of patients that is unable to utilize standard delivery devices, this would provide an option. It is unclear if this medication must be administered via the proprietary nebulizer that was used in the study – but if so, this would certainly add to the already extremely high cost of respiratory medications and further limit access for many patients.
TORONTO – Glycopyrrolate, a novel nebulized long-acting muscarinic antagonist (LAMA) in development, was well-tolerated and significantly improved lung function and health status in COPD patients regardless of baseline lung function or age, according to a subgroup analysis of pooled results from two randomized trials.*
There are currently no nebulized LAMAs approved for use in the U.S.
Jill Ohar, MD, from Wake Forest University School of Medicine (Winston-Salem, N.C.), presented this secondary analysis of the GOLDEN-3 and GOLDEN-4 trials at the CHEST annual meeting. She and her colleagues evaluated the efficacy and safety of glycopyrrolate in patients with a forced expiratory volume 1(FEV1) % predicted of less than 50 and an FEV1 % predicted of greater than or equal to 50, in age ranges of less than 65 years, greater than or equal to 65 years and at least 75 years, as measured by trough FEV1.
Similarly, both glycopyrrolate doses produced significant (P less than .05) and clinically meaningful lung function improvements vs. placebo in participants less than 65 years of age, at least 65 years, and greater than or equal to 75 years.
Glycopyrrolate use for 12 weeks led to greater improvements over placebo in St. George’s Respiratory Questionnaire (SGRQ) total score, in patients in both lung function classes. There were a higher percentage of SGRQ responders in the treatment arms compared to placebo arms.
The highest SGRQ improvement in SGRQ (−6.287) was seen in the 47 patients that comprised the at-least-75 years of age subgroup receiving glycopyrrolate 25 mcg BID. “It’s a small number of people, but I think it’s [valuable] to see if the very aged act in any way differently than the entire greater than or equal to 65-year-old group,” said Dr. Ohar.
Adverse event rates were similar for placebo and both glycopyrrolate doses, with no safety signals seen according to baseline lung function or age. Few cardiovascular events of special interest were seen.
“Looking at major adverse cardiovascular events, such as fatal MIs, other cardiovascular deaths, arrhythmias, etc., we see nothing that would suggest that the drug overall is associated with an undue number of these versus placebo,” reported Dr. Ohar.
GOLDEN 3 and 4 were replicate, 12-week, phase 3, randomized, double-blind, placebo-controlled studies that evaluated glycopyrrolate solution administered by an investigational eFlow Close System (eFLOW CS) nebulizer in individuals with moderate-to-very severe COPD, including those with continued background use of a long-acting beta2-agonist (LABA), with or without an inhaled corticosteroid (ICS). In each of the trials, about 30% of patients were on LABA ICS, noted Dr. Ohar in her presentation. A total of 653 subjects were randomized in GOLDEN 3 and 641 in GOLDEN 4.
Its manufacturer, Sunovion Pharmaceuticals, resubmitted the product to the FDA in June 2017 in response to a Complete Response Letter received from the FDA in May 2017. The FDA is expected to act on the new submission on December 15, 2017. The novel agent is being considered for the long-term, maintenance treatment of airflow obstruction in people with COPD, including chronic bronchitis and/or emphysema.
Dr. Ohar reported that she serves on the advisory boards of several pharmaceutical companies. The other three authors are employees of Sunovion Pharmaceuticals Inc.
*This article was updated on Nov. 6, 2017.
TORONTO – Glycopyrrolate, a novel nebulized long-acting muscarinic antagonist (LAMA) in development, was well-tolerated and significantly improved lung function and health status in COPD patients regardless of baseline lung function or age, according to a subgroup analysis of pooled results from two randomized trials.*
There are currently no nebulized LAMAs approved for use in the U.S.
Jill Ohar, MD, from Wake Forest University School of Medicine (Winston-Salem, N.C.), presented this secondary analysis of the GOLDEN-3 and GOLDEN-4 trials at the CHEST annual meeting. She and her colleagues evaluated the efficacy and safety of glycopyrrolate in patients with a forced expiratory volume 1(FEV1) % predicted of less than 50 and an FEV1 % predicted of greater than or equal to 50, in age ranges of less than 65 years, greater than or equal to 65 years and at least 75 years, as measured by trough FEV1.
Similarly, both glycopyrrolate doses produced significant (P less than .05) and clinically meaningful lung function improvements vs. placebo in participants less than 65 years of age, at least 65 years, and greater than or equal to 75 years.
Glycopyrrolate use for 12 weeks led to greater improvements over placebo in St. George’s Respiratory Questionnaire (SGRQ) total score, in patients in both lung function classes. There were a higher percentage of SGRQ responders in the treatment arms compared to placebo arms.
The highest SGRQ improvement in SGRQ (−6.287) was seen in the 47 patients that comprised the at-least-75 years of age subgroup receiving glycopyrrolate 25 mcg BID. “It’s a small number of people, but I think it’s [valuable] to see if the very aged act in any way differently than the entire greater than or equal to 65-year-old group,” said Dr. Ohar.
Adverse event rates were similar for placebo and both glycopyrrolate doses, with no safety signals seen according to baseline lung function or age. Few cardiovascular events of special interest were seen.
“Looking at major adverse cardiovascular events, such as fatal MIs, other cardiovascular deaths, arrhythmias, etc., we see nothing that would suggest that the drug overall is associated with an undue number of these versus placebo,” reported Dr. Ohar.
GOLDEN 3 and 4 were replicate, 12-week, phase 3, randomized, double-blind, placebo-controlled studies that evaluated glycopyrrolate solution administered by an investigational eFlow Close System (eFLOW CS) nebulizer in individuals with moderate-to-very severe COPD, including those with continued background use of a long-acting beta2-agonist (LABA), with or without an inhaled corticosteroid (ICS). In each of the trials, about 30% of patients were on LABA ICS, noted Dr. Ohar in her presentation. A total of 653 subjects were randomized in GOLDEN 3 and 641 in GOLDEN 4.
Its manufacturer, Sunovion Pharmaceuticals, resubmitted the product to the FDA in June 2017 in response to a Complete Response Letter received from the FDA in May 2017. The FDA is expected to act on the new submission on December 15, 2017. The novel agent is being considered for the long-term, maintenance treatment of airflow obstruction in people with COPD, including chronic bronchitis and/or emphysema.
Dr. Ohar reported that she serves on the advisory boards of several pharmaceutical companies. The other three authors are employees of Sunovion Pharmaceuticals Inc.
*This article was updated on Nov. 6, 2017.
AT CHEST 2017
Key clinical point: Nebulized glycopyrrolate improved lung function and was well tolerated irrespective of baseline lung function or age.
Major finding: Statistically and clinically meaningful improvements in trough FEV1 at 12 weeks were seen in individuals, regardless of their baseline FEV1 % predicted.
Data source: Pooled findings from 2 RCTs, GOLDEN 3 and GOLDEN 4, that together included 1,294 moderate-to-very severe COPD patients.
Disclosures: Dr. Ohar reported that she serves on the advisory boards of several pharmaceutical companies. The other three authors are employees of Sunovion Pharmaceuticals Inc.
Cardiogenic shock boosts PAH readmissions 10-fold
TORONTO – Cardiogenic shock, acute kidney injury, and chronic obstructive pulmonary disease were the top drivers of 30-day rehospitalizations in U.S. patients after an index hospitalization for pulmonary artery hypertension, based on an analysis of U.S. national data from 2013.
An episode of cardiogenic shock boosted 30-day rehospitalizations nearly 10-fold in recently discharged pulmonary artery hypertension (PAH) patients. A history of chronic obstructive pulmonary disease (COPD) linked with a threefold higher rehospitalization rate, and acute kidney injury linked with a doubled number of 30-day rehospitalizations, Kshitij Chatterjee, MD, said at the CHEST annual meeting.
The powerful impact of cardiogenic shock in particular suggests that interventions that improve patient compliance with stabilizing treatments following an index PAH hospitalization might be effective at preventing a patient’s quick return to the hospital. Contacting PAH patients a week after their index hospitalization discharge to make sure they are compliant with their diuretic regimen, for example, might help prevent a decompensation that then leads to cardiogenic shock and a return trip to the hospital, Dr. Chatterjee suggested.
Follow-up of PAH patients after an index hospitalization “is probably the single most important thing, because it can help with compliance,” he said in an interview.
The rehospitalizations he studied could be for any cause. His analysis showed that the most common cause of rehospitalization was heart failure, which caused 23% of the rehospitalizations, followed by pulmonary hypertension that caused 20%, and acute kidney injury, responsible for 11% of the 30-day rehospitalizations.
Dr. Chatterjee’s study used data collected during 2013 in the National Readmissions Database, run by the federal Agency for Healthcare Quality and Research. During that period, 776 patients entered a U.S. hospital with a primary diagnosis of PAH. During the 30 days following discharge, 114 (15%) returned to the hospital. During the second hospitalization 8% died, and the median length of stay for those who remained alive was 7 days.
Dr. Chatterjee highlighted that the modest number of index hospitalizations for PAH, as well as 30-day rehospitalizations he found in 2013, make it highly unlikely that PAH rehospitalizations will become a target for Medicare penalties as has been done for heart failure, pneumonia, COPD, and a few other disorders. But he stressed that patients with PAH who need rehospitalization generally have a highly compromised quality of life that potentially could be avoided by better management, which could prevent the need for rehospitalization.
Dr. Chatterjee had no disclosures.
mzoler@frontlinemedcom.com
On Twitter @mitchelzoler
TORONTO – Cardiogenic shock, acute kidney injury, and chronic obstructive pulmonary disease were the top drivers of 30-day rehospitalizations in U.S. patients after an index hospitalization for pulmonary artery hypertension, based on an analysis of U.S. national data from 2013.
An episode of cardiogenic shock boosted 30-day rehospitalizations nearly 10-fold in recently discharged pulmonary artery hypertension (PAH) patients. A history of chronic obstructive pulmonary disease (COPD) linked with a threefold higher rehospitalization rate, and acute kidney injury linked with a doubled number of 30-day rehospitalizations, Kshitij Chatterjee, MD, said at the CHEST annual meeting.
The powerful impact of cardiogenic shock in particular suggests that interventions that improve patient compliance with stabilizing treatments following an index PAH hospitalization might be effective at preventing a patient’s quick return to the hospital. Contacting PAH patients a week after their index hospitalization discharge to make sure they are compliant with their diuretic regimen, for example, might help prevent a decompensation that then leads to cardiogenic shock and a return trip to the hospital, Dr. Chatterjee suggested.
Follow-up of PAH patients after an index hospitalization “is probably the single most important thing, because it can help with compliance,” he said in an interview.
The rehospitalizations he studied could be for any cause. His analysis showed that the most common cause of rehospitalization was heart failure, which caused 23% of the rehospitalizations, followed by pulmonary hypertension that caused 20%, and acute kidney injury, responsible for 11% of the 30-day rehospitalizations.
Dr. Chatterjee’s study used data collected during 2013 in the National Readmissions Database, run by the federal Agency for Healthcare Quality and Research. During that period, 776 patients entered a U.S. hospital with a primary diagnosis of PAH. During the 30 days following discharge, 114 (15%) returned to the hospital. During the second hospitalization 8% died, and the median length of stay for those who remained alive was 7 days.
Dr. Chatterjee highlighted that the modest number of index hospitalizations for PAH, as well as 30-day rehospitalizations he found in 2013, make it highly unlikely that PAH rehospitalizations will become a target for Medicare penalties as has been done for heart failure, pneumonia, COPD, and a few other disorders. But he stressed that patients with PAH who need rehospitalization generally have a highly compromised quality of life that potentially could be avoided by better management, which could prevent the need for rehospitalization.
Dr. Chatterjee had no disclosures.
mzoler@frontlinemedcom.com
On Twitter @mitchelzoler
TORONTO – Cardiogenic shock, acute kidney injury, and chronic obstructive pulmonary disease were the top drivers of 30-day rehospitalizations in U.S. patients after an index hospitalization for pulmonary artery hypertension, based on an analysis of U.S. national data from 2013.
An episode of cardiogenic shock boosted 30-day rehospitalizations nearly 10-fold in recently discharged pulmonary artery hypertension (PAH) patients. A history of chronic obstructive pulmonary disease (COPD) linked with a threefold higher rehospitalization rate, and acute kidney injury linked with a doubled number of 30-day rehospitalizations, Kshitij Chatterjee, MD, said at the CHEST annual meeting.
The powerful impact of cardiogenic shock in particular suggests that interventions that improve patient compliance with stabilizing treatments following an index PAH hospitalization might be effective at preventing a patient’s quick return to the hospital. Contacting PAH patients a week after their index hospitalization discharge to make sure they are compliant with their diuretic regimen, for example, might help prevent a decompensation that then leads to cardiogenic shock and a return trip to the hospital, Dr. Chatterjee suggested.
Follow-up of PAH patients after an index hospitalization “is probably the single most important thing, because it can help with compliance,” he said in an interview.
The rehospitalizations he studied could be for any cause. His analysis showed that the most common cause of rehospitalization was heart failure, which caused 23% of the rehospitalizations, followed by pulmonary hypertension that caused 20%, and acute kidney injury, responsible for 11% of the 30-day rehospitalizations.
Dr. Chatterjee’s study used data collected during 2013 in the National Readmissions Database, run by the federal Agency for Healthcare Quality and Research. During that period, 776 patients entered a U.S. hospital with a primary diagnosis of PAH. During the 30 days following discharge, 114 (15%) returned to the hospital. During the second hospitalization 8% died, and the median length of stay for those who remained alive was 7 days.
Dr. Chatterjee highlighted that the modest number of index hospitalizations for PAH, as well as 30-day rehospitalizations he found in 2013, make it highly unlikely that PAH rehospitalizations will become a target for Medicare penalties as has been done for heart failure, pneumonia, COPD, and a few other disorders. But he stressed that patients with PAH who need rehospitalization generally have a highly compromised quality of life that potentially could be avoided by better management, which could prevent the need for rehospitalization.
Dr. Chatterjee had no disclosures.
mzoler@frontlinemedcom.com
On Twitter @mitchelzoler
AT CHEST 2017
Key clinical point:
Major finding: Patients with cardiogenic shock following PAH hospitalization had a 9.7-fold increased rate of 30-day rehospitalization, compared with patients without shock.
Data source: The National Readmissions Database, which included 776 index U.S. hospitalizations for pulmonary arterial hospitalization during 2013.
Disclosures: Dr. Chatterjee had no disclosures.
CHEST Physician’s planned coverage of CHEST 2017
CHEST Physician is providing on-site coverage of the CHEST annual meeting in Toronto from Oct. 29 through Nov. 1.
We are planning to share findings from the latest research on treating COPD, sleep apnea, pulmonary hypertension, severe asthma, and other diseases that are part of pulmonary, critical care, and sleep medicine. Any improved methods for managing an ICU and updated recommendations on screening for lung cancer will also be on our radar.
The meeting’s agenda includes presentations of hundreds of study abstracts, and we thought you would be interested in hearing which ones grabbed the attention of some of CHEST Physician’s editorial advisory board members.
Board member Susan L. Millard, MD, FCCP, suggested attendees check out presentations of the following two studies:
- Impact of Race on Quality of Life of Families of Children with Asthma when Asthma Guidelines are Followed: Long-Term Follow-Up
- Results Of A Phase 3, Multicenter, Randomized, Placebo-controlled Trial of Remimazolam: A New Ultra Short Acting Benzodiazepine for Bronchoscopy
The first study is part of a session entitled Pediatrics, scheduled to run from 3:15 to 4:15 p.m. on Sunday, Oct. 29, in Convention Center - 606. Shahid Sheikh, MD, of Nationwide Children’s Hospital in New Albany, Ohio, is scheduled to present the abstract at 4:00 p.m.
Dr. Millard, who is Therapeutic Development Network director for the Pediatric CF Care Center and director of research for pediatric pulmonary and sleep medicine at the Helen DeVos Children’s Hospital in Grand Rapids, Mich., noted that she is interested in Dr. Sheikh’s research, “because cultural diversity is such a hot topic in general.”
Her other recommendation is part of the Late Breaking Abstracts 2 session, scheduled to occur on Wednesday, Nov. 1, from 2:45 to 4:15 p.m. in Convention Center - 603. CHEST President, Gerard A. Silvestri, MD, MS, FCCP, will present the abstract at 4:00 p.m.
Dr. Millard said she is interested in this study, because new drug options are so helpful for the frequently performed bronchoscopy.
Two sleep medicine experts on CHEST Physician’s editorial advisory board also selected a few presentations they expect to be newsworthy.
David Schulman, MD, MPH, FCCP, and professor of medicine at Emory University School of Medicine in Atlanta suggested CHEST Physician cover the following studies:
- Results of a Randomized, Placebo-Controlled, Double-Blind, 12-Week, Multicenter Study of JZP-110 for the Treatment Of Excessive Sleepiness in Patients with OSA, scheduled to be presented on Sunday, Oct. 29, at 1:30 p.m. in Convention Center - 601A. Dr. Kingman Strohl, MD, FCCP, of University Hospitals Case Medical Center-Sleep Center in Shaker Heights, Ohio, will present this research during a session entitled, Obstructive Sleep Apnea: Insights & Management, running from 1:30 to 3:00 p.m.
- History of Sleep Apnea and Cardiovascular Disease may Portend Improved Mortality in Patients With Acute Ischemic Stroke, scheduled to be presented on Tuesday, Oct. 31, at 11:15 a.m., in Convention Center - 601A. Nura Festic will present this research during the session, “Sleep, Heart, Brain and More,” running from 11:00 a.m. to 12:15 p.m.
- Ischemic Preconditioning in OSA Patients Manifested after Surviving a Cardiac Arrest? John Moss, MD, of Jacksonville, Fla., will present this study on Tuesday, Oct. 31, at 11:30 a.m., in Convention Center - 601A as part of the session “Sleep, Heart, Brain and More.”
Krishna M. Sundar, MD, FCCP, also recommended that CHEST Physician cover “A Prospective Cohort Study of Endothelial Function and its Relationship to Aspirin Responsiveness in OSA Patients.” Lirim Krveshi is scheduled to present this study on Sunday, Oct. 29, at 1:45 p.m. in Convention Center - 601A. This presentation is part of the Obstructive Sleep Apnea: Insights & Management session.
Dr. Sundar is an associate clinical professor of pulmonary, critical care and sleep medicine and medical director of the Sleep-Wake Center at the University of Utah, Salt Lake City.
To view the full agenda of the CHEST annual meeting, visit: chestmeeting.chestnet.org.
Look for CHEST Physician’s coverage of CHEST 2017 on our conference coverage page.
CHEST Physician is providing on-site coverage of the CHEST annual meeting in Toronto from Oct. 29 through Nov. 1.
We are planning to share findings from the latest research on treating COPD, sleep apnea, pulmonary hypertension, severe asthma, and other diseases that are part of pulmonary, critical care, and sleep medicine. Any improved methods for managing an ICU and updated recommendations on screening for lung cancer will also be on our radar.
The meeting’s agenda includes presentations of hundreds of study abstracts, and we thought you would be interested in hearing which ones grabbed the attention of some of CHEST Physician’s editorial advisory board members.
Board member Susan L. Millard, MD, FCCP, suggested attendees check out presentations of the following two studies:
- Impact of Race on Quality of Life of Families of Children with Asthma when Asthma Guidelines are Followed: Long-Term Follow-Up
- Results Of A Phase 3, Multicenter, Randomized, Placebo-controlled Trial of Remimazolam: A New Ultra Short Acting Benzodiazepine for Bronchoscopy
The first study is part of a session entitled Pediatrics, scheduled to run from 3:15 to 4:15 p.m. on Sunday, Oct. 29, in Convention Center - 606. Shahid Sheikh, MD, of Nationwide Children’s Hospital in New Albany, Ohio, is scheduled to present the abstract at 4:00 p.m.
Dr. Millard, who is Therapeutic Development Network director for the Pediatric CF Care Center and director of research for pediatric pulmonary and sleep medicine at the Helen DeVos Children’s Hospital in Grand Rapids, Mich., noted that she is interested in Dr. Sheikh’s research, “because cultural diversity is such a hot topic in general.”
Her other recommendation is part of the Late Breaking Abstracts 2 session, scheduled to occur on Wednesday, Nov. 1, from 2:45 to 4:15 p.m. in Convention Center - 603. CHEST President, Gerard A. Silvestri, MD, MS, FCCP, will present the abstract at 4:00 p.m.
Dr. Millard said she is interested in this study, because new drug options are so helpful for the frequently performed bronchoscopy.
Two sleep medicine experts on CHEST Physician’s editorial advisory board also selected a few presentations they expect to be newsworthy.
David Schulman, MD, MPH, FCCP, and professor of medicine at Emory University School of Medicine in Atlanta suggested CHEST Physician cover the following studies:
- Results of a Randomized, Placebo-Controlled, Double-Blind, 12-Week, Multicenter Study of JZP-110 for the Treatment Of Excessive Sleepiness in Patients with OSA, scheduled to be presented on Sunday, Oct. 29, at 1:30 p.m. in Convention Center - 601A. Dr. Kingman Strohl, MD, FCCP, of University Hospitals Case Medical Center-Sleep Center in Shaker Heights, Ohio, will present this research during a session entitled, Obstructive Sleep Apnea: Insights & Management, running from 1:30 to 3:00 p.m.
- History of Sleep Apnea and Cardiovascular Disease may Portend Improved Mortality in Patients With Acute Ischemic Stroke, scheduled to be presented on Tuesday, Oct. 31, at 11:15 a.m., in Convention Center - 601A. Nura Festic will present this research during the session, “Sleep, Heart, Brain and More,” running from 11:00 a.m. to 12:15 p.m.
- Ischemic Preconditioning in OSA Patients Manifested after Surviving a Cardiac Arrest? John Moss, MD, of Jacksonville, Fla., will present this study on Tuesday, Oct. 31, at 11:30 a.m., in Convention Center - 601A as part of the session “Sleep, Heart, Brain and More.”
Krishna M. Sundar, MD, FCCP, also recommended that CHEST Physician cover “A Prospective Cohort Study of Endothelial Function and its Relationship to Aspirin Responsiveness in OSA Patients.” Lirim Krveshi is scheduled to present this study on Sunday, Oct. 29, at 1:45 p.m. in Convention Center - 601A. This presentation is part of the Obstructive Sleep Apnea: Insights & Management session.
Dr. Sundar is an associate clinical professor of pulmonary, critical care and sleep medicine and medical director of the Sleep-Wake Center at the University of Utah, Salt Lake City.
To view the full agenda of the CHEST annual meeting, visit: chestmeeting.chestnet.org.
Look for CHEST Physician’s coverage of CHEST 2017 on our conference coverage page.
CHEST Physician is providing on-site coverage of the CHEST annual meeting in Toronto from Oct. 29 through Nov. 1.
We are planning to share findings from the latest research on treating COPD, sleep apnea, pulmonary hypertension, severe asthma, and other diseases that are part of pulmonary, critical care, and sleep medicine. Any improved methods for managing an ICU and updated recommendations on screening for lung cancer will also be on our radar.
The meeting’s agenda includes presentations of hundreds of study abstracts, and we thought you would be interested in hearing which ones grabbed the attention of some of CHEST Physician’s editorial advisory board members.
Board member Susan L. Millard, MD, FCCP, suggested attendees check out presentations of the following two studies:
- Impact of Race on Quality of Life of Families of Children with Asthma when Asthma Guidelines are Followed: Long-Term Follow-Up
- Results Of A Phase 3, Multicenter, Randomized, Placebo-controlled Trial of Remimazolam: A New Ultra Short Acting Benzodiazepine for Bronchoscopy
The first study is part of a session entitled Pediatrics, scheduled to run from 3:15 to 4:15 p.m. on Sunday, Oct. 29, in Convention Center - 606. Shahid Sheikh, MD, of Nationwide Children’s Hospital in New Albany, Ohio, is scheduled to present the abstract at 4:00 p.m.
Dr. Millard, who is Therapeutic Development Network director for the Pediatric CF Care Center and director of research for pediatric pulmonary and sleep medicine at the Helen DeVos Children’s Hospital in Grand Rapids, Mich., noted that she is interested in Dr. Sheikh’s research, “because cultural diversity is such a hot topic in general.”
Her other recommendation is part of the Late Breaking Abstracts 2 session, scheduled to occur on Wednesday, Nov. 1, from 2:45 to 4:15 p.m. in Convention Center - 603. CHEST President, Gerard A. Silvestri, MD, MS, FCCP, will present the abstract at 4:00 p.m.
Dr. Millard said she is interested in this study, because new drug options are so helpful for the frequently performed bronchoscopy.
Two sleep medicine experts on CHEST Physician’s editorial advisory board also selected a few presentations they expect to be newsworthy.
David Schulman, MD, MPH, FCCP, and professor of medicine at Emory University School of Medicine in Atlanta suggested CHEST Physician cover the following studies:
- Results of a Randomized, Placebo-Controlled, Double-Blind, 12-Week, Multicenter Study of JZP-110 for the Treatment Of Excessive Sleepiness in Patients with OSA, scheduled to be presented on Sunday, Oct. 29, at 1:30 p.m. in Convention Center - 601A. Dr. Kingman Strohl, MD, FCCP, of University Hospitals Case Medical Center-Sleep Center in Shaker Heights, Ohio, will present this research during a session entitled, Obstructive Sleep Apnea: Insights & Management, running from 1:30 to 3:00 p.m.
- History of Sleep Apnea and Cardiovascular Disease may Portend Improved Mortality in Patients With Acute Ischemic Stroke, scheduled to be presented on Tuesday, Oct. 31, at 11:15 a.m., in Convention Center - 601A. Nura Festic will present this research during the session, “Sleep, Heart, Brain and More,” running from 11:00 a.m. to 12:15 p.m.
- Ischemic Preconditioning in OSA Patients Manifested after Surviving a Cardiac Arrest? John Moss, MD, of Jacksonville, Fla., will present this study on Tuesday, Oct. 31, at 11:30 a.m., in Convention Center - 601A as part of the session “Sleep, Heart, Brain and More.”
Krishna M. Sundar, MD, FCCP, also recommended that CHEST Physician cover “A Prospective Cohort Study of Endothelial Function and its Relationship to Aspirin Responsiveness in OSA Patients.” Lirim Krveshi is scheduled to present this study on Sunday, Oct. 29, at 1:45 p.m. in Convention Center - 601A. This presentation is part of the Obstructive Sleep Apnea: Insights & Management session.
Dr. Sundar is an associate clinical professor of pulmonary, critical care and sleep medicine and medical director of the Sleep-Wake Center at the University of Utah, Salt Lake City.
To view the full agenda of the CHEST annual meeting, visit: chestmeeting.chestnet.org.
Look for CHEST Physician’s coverage of CHEST 2017 on our conference coverage page.
FROM CHEST 2017
Only half of appropriate COPD patients get long-acting bronchodilators
Nearly half of Medicare beneficiaries with COPD are not being treated with recommended long-acting bronchodilator (LABD) maintenance therapy, based on study results scheduled to be presented at CHEST 2017.
Bartolome R. Celli, MD, FCCP, of Brigham and Women’s Hospital, Boston, and his colleagues will report results based on Medicare administrative data from 2010 to 2014 on 11,886 patients who had at least two outpatient visits for COPD within 30 days or at least one COPD-related hospitalization and received nebulized arformoterol therapy.
The findings should stimulate further study on why clinicians overrely on short-acting rather than the recommended long-acting bronchodilators for maintenance treatment of appropriate patients, according to the researchers’ abstract. Additionally, studies should examine triggers for initiating arformoterol, and link outcomes to arformoterol monotherapy vs. combination therapy. Such analyses could help advance clinical decision making, particularly for COPD patients with a history of exacerbations and hospitalizations.
Rates of medication initiation and treatment continuation or discontinuation within these classes were determined based on refill patterns following the start of arformoterol therapy. The researchers note that 42% of the patient cohort was 75 years or older, and 37% were dually eligible for Medicaid.
Overall, 46% of the cohort had received no LABD maintenance treatment in the 90 days prior to initiating arformoterol. Instead, they were being treated with a nebulized (50%) or an inhaled (37%) short-acting bronchodilator, a systemic corticosteroid (46%), and antibiotics (37%).
After starting arformoteral, 58% of beneficiaries received dual therapy. More than half of them, 52%, received LABA and inhaled/nebulized corticosteroids, 6% received LAMA/LAMA therapy, and 21% received triple-therapy (LABA/LAMA plus inhaled or nebulized corticosteroids). The other 20% received only arformoterol.
After initiating arformoterol, 41% of the cohort discontinued one or more classes of their pre-arformoteral medications. The largest decrease was a 23% drop in use of corticosteroids.
Dr. Celli is scheduled to present his research on Tuesday, Oct. 31, from 2:45 to 3:00 pm in Convention Center - 602B at the CHEST annual meeting. His presentation will be part of a session entitled “COPD: Lessons for the Real-World Management of Disease,” running from 2:45 to 4:15 pm.
One of the researchers is an employee of Sunovion Pharmaceuticals, and two others are with Advance Health Solutions.
Nearly half of Medicare beneficiaries with COPD are not being treated with recommended long-acting bronchodilator (LABD) maintenance therapy, based on study results scheduled to be presented at CHEST 2017.
Bartolome R. Celli, MD, FCCP, of Brigham and Women’s Hospital, Boston, and his colleagues will report results based on Medicare administrative data from 2010 to 2014 on 11,886 patients who had at least two outpatient visits for COPD within 30 days or at least one COPD-related hospitalization and received nebulized arformoterol therapy.
The findings should stimulate further study on why clinicians overrely on short-acting rather than the recommended long-acting bronchodilators for maintenance treatment of appropriate patients, according to the researchers’ abstract. Additionally, studies should examine triggers for initiating arformoterol, and link outcomes to arformoterol monotherapy vs. combination therapy. Such analyses could help advance clinical decision making, particularly for COPD patients with a history of exacerbations and hospitalizations.
Rates of medication initiation and treatment continuation or discontinuation within these classes were determined based on refill patterns following the start of arformoterol therapy. The researchers note that 42% of the patient cohort was 75 years or older, and 37% were dually eligible for Medicaid.
Overall, 46% of the cohort had received no LABD maintenance treatment in the 90 days prior to initiating arformoterol. Instead, they were being treated with a nebulized (50%) or an inhaled (37%) short-acting bronchodilator, a systemic corticosteroid (46%), and antibiotics (37%).
After starting arformoteral, 58% of beneficiaries received dual therapy. More than half of them, 52%, received LABA and inhaled/nebulized corticosteroids, 6% received LAMA/LAMA therapy, and 21% received triple-therapy (LABA/LAMA plus inhaled or nebulized corticosteroids). The other 20% received only arformoterol.
After initiating arformoterol, 41% of the cohort discontinued one or more classes of their pre-arformoteral medications. The largest decrease was a 23% drop in use of corticosteroids.
Dr. Celli is scheduled to present his research on Tuesday, Oct. 31, from 2:45 to 3:00 pm in Convention Center - 602B at the CHEST annual meeting. His presentation will be part of a session entitled “COPD: Lessons for the Real-World Management of Disease,” running from 2:45 to 4:15 pm.
One of the researchers is an employee of Sunovion Pharmaceuticals, and two others are with Advance Health Solutions.
Nearly half of Medicare beneficiaries with COPD are not being treated with recommended long-acting bronchodilator (LABD) maintenance therapy, based on study results scheduled to be presented at CHEST 2017.
Bartolome R. Celli, MD, FCCP, of Brigham and Women’s Hospital, Boston, and his colleagues will report results based on Medicare administrative data from 2010 to 2014 on 11,886 patients who had at least two outpatient visits for COPD within 30 days or at least one COPD-related hospitalization and received nebulized arformoterol therapy.
The findings should stimulate further study on why clinicians overrely on short-acting rather than the recommended long-acting bronchodilators for maintenance treatment of appropriate patients, according to the researchers’ abstract. Additionally, studies should examine triggers for initiating arformoterol, and link outcomes to arformoterol monotherapy vs. combination therapy. Such analyses could help advance clinical decision making, particularly for COPD patients with a history of exacerbations and hospitalizations.
Rates of medication initiation and treatment continuation or discontinuation within these classes were determined based on refill patterns following the start of arformoterol therapy. The researchers note that 42% of the patient cohort was 75 years or older, and 37% were dually eligible for Medicaid.
Overall, 46% of the cohort had received no LABD maintenance treatment in the 90 days prior to initiating arformoterol. Instead, they were being treated with a nebulized (50%) or an inhaled (37%) short-acting bronchodilator, a systemic corticosteroid (46%), and antibiotics (37%).
After starting arformoteral, 58% of beneficiaries received dual therapy. More than half of them, 52%, received LABA and inhaled/nebulized corticosteroids, 6% received LAMA/LAMA therapy, and 21% received triple-therapy (LABA/LAMA plus inhaled or nebulized corticosteroids). The other 20% received only arformoterol.
After initiating arformoterol, 41% of the cohort discontinued one or more classes of their pre-arformoteral medications. The largest decrease was a 23% drop in use of corticosteroids.
Dr. Celli is scheduled to present his research on Tuesday, Oct. 31, from 2:45 to 3:00 pm in Convention Center - 602B at the CHEST annual meeting. His presentation will be part of a session entitled “COPD: Lessons for the Real-World Management of Disease,” running from 2:45 to 4:15 pm.
One of the researchers is an employee of Sunovion Pharmaceuticals, and two others are with Advance Health Solutions.
FROM CHEST 2017
Key clinical point:
Major finding: Overall, 46% of COPD patients on Medicare had received no long-acting bronchodilator maintenance treatment in the 90 days before they started arformoterol therapy.
Data source: Medicare administrative data from 2010 to 2014 on 11,886 patients who had at least two outpatient visits for COPD within 30 days or at least one COPD-related hospitalization and received nebulized arformoteral therapy.
Disclosures: One of the researchers is an employee of Sunovion Pharmaceuticals, and two others are with Advance Health Solutions.
Rheumatoid arthritis increases risk of COPD hospitalizations
Individuals with rheumatoid arthritis (RA) had an increased risk of hospitalizations from chronic obstructive pulmonary disease (COPD) when compared with the general population in a Canadian retrospective, population-based cohort study.
The risk of COPD hospitalizations was 47% higher in individuals with RA. “This finding emphasizes the need to control inflammation in rheumatoid arthritis, not only to prevent joint damage, but also to prevent complications of systemic inflammation, including the development of comorbidities such as cardiovascular diseases and COPD,” wrote Diane Lacaille, MD, of the University of British Columbia, Vancouver, and her coauthors (Arthritis Care Res. 2017 Oct 19. doi: 10.1002/acr.23410).
Several previous studies have suggested a link between COPD and inflammation, Dr. Lacaille and her colleagues said. Accordingly, they sought to evaluate the risk of COPD hospitalizations in a cohort of 24,625 individuals with RA as compared with 25,396 general population controls randomly selected and matched based on age, sex, and index year. Most subjects in the analysis were female, and the mean age at onset of RA was 57.2 years.
The investigators reported an increased incidence of COPD in individuals with RA, compared with controls, based on an incident rate ratio (IRR) of 1.58 (95% confidence interval, 1.34-1.87) that dropped to 1.47 (95% CI, 1.24-1.74) after adjustment for potential confounders, including comorbidities and health services usage at baseline. The overall incidence rate for COPD was 2.07 per 1,000 patient-years for RA patients and 1.31 per 1,000 patient-years for controls.
When the model was stratified based on sex, COPD hospitalization risk was significantly increased in women (adjusted hazard ratio [HR], 1.61; 95% CI, 1.30-1.98), but not in men (adjusted HR, 1.25; 95% CI, 0.95-1.66), they said.
Data were not available on smoking, the main COPD risk factor, for the patients in this study; however, the increased risk of COPD hospitalizations in the RA group remained significant after modeling for smoking, according to the investigators.
Combined, these results have “notable implications for the clinical care of RA and COPD,” Dr. Lacaille and her coinvestigators said.
Both clinicians and people living with RA “should be aware of the increased risk of developing COPD and be vigilant in watching for early symptoms of COPD, so that appropriate diagnostic tests can be administered at the onset of early symptoms,” they wrote. “Early detection of COPD is essential so that effective treatments can be initiated before irreversible damage to the lungs occurs, to improve long-term outcomes.”
These findings strengthen the conclusions of two previous cross-sectional studies showing an association between RA and COPD prevalence, according to the investigators. In one study, RA patients in Israel who were receiving disease-modifying antirheumatic drugs had double the prevalence of COPD, compared with general population controls, according to authors of that study (Immunol Res. 2013;56[2-3]:261-6). Similarly, U.K. investigators compared 421 RA patients against controls and reported a twofold increase in obstructive pattern on screening spirometry in the RA group (Ann Rheum Dis. 2013;72:1517-23).
The current study from Dr. Lacaille and her coinvestigators was supported by funding from the Canadian Institute for Health Research. The authors reported that they had no financial disclosures, conflicts of interest, or benefits from commercial sources.
Individuals with rheumatoid arthritis (RA) had an increased risk of hospitalizations from chronic obstructive pulmonary disease (COPD) when compared with the general population in a Canadian retrospective, population-based cohort study.
The risk of COPD hospitalizations was 47% higher in individuals with RA. “This finding emphasizes the need to control inflammation in rheumatoid arthritis, not only to prevent joint damage, but also to prevent complications of systemic inflammation, including the development of comorbidities such as cardiovascular diseases and COPD,” wrote Diane Lacaille, MD, of the University of British Columbia, Vancouver, and her coauthors (Arthritis Care Res. 2017 Oct 19. doi: 10.1002/acr.23410).
Several previous studies have suggested a link between COPD and inflammation, Dr. Lacaille and her colleagues said. Accordingly, they sought to evaluate the risk of COPD hospitalizations in a cohort of 24,625 individuals with RA as compared with 25,396 general population controls randomly selected and matched based on age, sex, and index year. Most subjects in the analysis were female, and the mean age at onset of RA was 57.2 years.
The investigators reported an increased incidence of COPD in individuals with RA, compared with controls, based on an incident rate ratio (IRR) of 1.58 (95% confidence interval, 1.34-1.87) that dropped to 1.47 (95% CI, 1.24-1.74) after adjustment for potential confounders, including comorbidities and health services usage at baseline. The overall incidence rate for COPD was 2.07 per 1,000 patient-years for RA patients and 1.31 per 1,000 patient-years for controls.
When the model was stratified based on sex, COPD hospitalization risk was significantly increased in women (adjusted hazard ratio [HR], 1.61; 95% CI, 1.30-1.98), but not in men (adjusted HR, 1.25; 95% CI, 0.95-1.66), they said.
Data were not available on smoking, the main COPD risk factor, for the patients in this study; however, the increased risk of COPD hospitalizations in the RA group remained significant after modeling for smoking, according to the investigators.
Combined, these results have “notable implications for the clinical care of RA and COPD,” Dr. Lacaille and her coinvestigators said.
Both clinicians and people living with RA “should be aware of the increased risk of developing COPD and be vigilant in watching for early symptoms of COPD, so that appropriate diagnostic tests can be administered at the onset of early symptoms,” they wrote. “Early detection of COPD is essential so that effective treatments can be initiated before irreversible damage to the lungs occurs, to improve long-term outcomes.”
These findings strengthen the conclusions of two previous cross-sectional studies showing an association between RA and COPD prevalence, according to the investigators. In one study, RA patients in Israel who were receiving disease-modifying antirheumatic drugs had double the prevalence of COPD, compared with general population controls, according to authors of that study (Immunol Res. 2013;56[2-3]:261-6). Similarly, U.K. investigators compared 421 RA patients against controls and reported a twofold increase in obstructive pattern on screening spirometry in the RA group (Ann Rheum Dis. 2013;72:1517-23).
The current study from Dr. Lacaille and her coinvestigators was supported by funding from the Canadian Institute for Health Research. The authors reported that they had no financial disclosures, conflicts of interest, or benefits from commercial sources.
Individuals with rheumatoid arthritis (RA) had an increased risk of hospitalizations from chronic obstructive pulmonary disease (COPD) when compared with the general population in a Canadian retrospective, population-based cohort study.
The risk of COPD hospitalizations was 47% higher in individuals with RA. “This finding emphasizes the need to control inflammation in rheumatoid arthritis, not only to prevent joint damage, but also to prevent complications of systemic inflammation, including the development of comorbidities such as cardiovascular diseases and COPD,” wrote Diane Lacaille, MD, of the University of British Columbia, Vancouver, and her coauthors (Arthritis Care Res. 2017 Oct 19. doi: 10.1002/acr.23410).
Several previous studies have suggested a link between COPD and inflammation, Dr. Lacaille and her colleagues said. Accordingly, they sought to evaluate the risk of COPD hospitalizations in a cohort of 24,625 individuals with RA as compared with 25,396 general population controls randomly selected and matched based on age, sex, and index year. Most subjects in the analysis were female, and the mean age at onset of RA was 57.2 years.
The investigators reported an increased incidence of COPD in individuals with RA, compared with controls, based on an incident rate ratio (IRR) of 1.58 (95% confidence interval, 1.34-1.87) that dropped to 1.47 (95% CI, 1.24-1.74) after adjustment for potential confounders, including comorbidities and health services usage at baseline. The overall incidence rate for COPD was 2.07 per 1,000 patient-years for RA patients and 1.31 per 1,000 patient-years for controls.
When the model was stratified based on sex, COPD hospitalization risk was significantly increased in women (adjusted hazard ratio [HR], 1.61; 95% CI, 1.30-1.98), but not in men (adjusted HR, 1.25; 95% CI, 0.95-1.66), they said.
Data were not available on smoking, the main COPD risk factor, for the patients in this study; however, the increased risk of COPD hospitalizations in the RA group remained significant after modeling for smoking, according to the investigators.
Combined, these results have “notable implications for the clinical care of RA and COPD,” Dr. Lacaille and her coinvestigators said.
Both clinicians and people living with RA “should be aware of the increased risk of developing COPD and be vigilant in watching for early symptoms of COPD, so that appropriate diagnostic tests can be administered at the onset of early symptoms,” they wrote. “Early detection of COPD is essential so that effective treatments can be initiated before irreversible damage to the lungs occurs, to improve long-term outcomes.”
These findings strengthen the conclusions of two previous cross-sectional studies showing an association between RA and COPD prevalence, according to the investigators. In one study, RA patients in Israel who were receiving disease-modifying antirheumatic drugs had double the prevalence of COPD, compared with general population controls, according to authors of that study (Immunol Res. 2013;56[2-3]:261-6). Similarly, U.K. investigators compared 421 RA patients against controls and reported a twofold increase in obstructive pattern on screening spirometry in the RA group (Ann Rheum Dis. 2013;72:1517-23).
The current study from Dr. Lacaille and her coinvestigators was supported by funding from the Canadian Institute for Health Research. The authors reported that they had no financial disclosures, conflicts of interest, or benefits from commercial sources.
FROM Arthritis Care AND Research
Key clinical point:
Major finding: The risk of COPD hospitalizations was 47% higher in individuals with rheumatoid arthritis (adjusted hazard ratio, 1.47; 95% confidence interval, 1.34-1.87).
Data source: A retrospective cohort study including approximately 25,000 RA patients seen in British Columbia and a roughly equal number of controls.
Disclosures: The Canadian Institute for Health Research provided funding for the study. The authors reported that they had no financial disclosures, conflicts of interest, or benefits from commercial sources.
Connect with the CHEST Foundation at CHEST 2017
Be sure to check out our ever-growing presence at CHEST 2017, showcasing the numerous ways we support CHEST members, patients, and the community. Have time for a break or interested in networking with leaders in CHEST medicine? Stop by one of our many open invitation activities listed below to learn more about how the CHEST Foundation can support you in your efforts to champion lung health through clinical research grants, community service, and patient education.
SATURDAY OCTOBER 28
2:00 PM – 4:00 PM (Open Invitation)
Nathan Phillips Square
100 Queen St W, Toronto, ON M5H 2N2, Canada
SUNDAY OCTOBER 29
9:00 AM - 5:00 PM
Donor Lounge
Convention Center, 803B
3:15 PM - 4:15 PM
Foundation Session: Severe Asthma Care at Its Best: Shared Decision Making
Convention Center, 716A
4:30 PM - 5:30 PM
Foundation Session: No Money, No Mission: Tips for Getting Your Grant Funded
Convention Center, 716B
MONDAY OCTOBER 30
9:00 AM - 5:00 PM
Convention Center, 803B
8:45 AM – 10:00 AM
Opening Session/CHEST Foundation
Awards Convocation
Convention Center, Hall G, Level 800
6:30 PM - 8:00 PM
Boehringer Ingelheim and CHEST Foundation Patient Engagement Summit
Sheraton, Grand Ballroom Centre
8:00 PM – 10:00 PM
Young Professionals Reception
(RSVP chestfoundation.org/youngprofessionals)
225 Richmond St W Suite 100
Toronto, ON M5V 1W2, Canada
TUESDAY OCTOBER 31
9:00 AM - 5:00 PM
Donor Lounge
Convention Center, 803B
WEDNESDAY NOVEMBER 1
9:00 AM - 12:00 PM
Donor Lounge
Convention Center, 803B
ADD YOUR VOICE
and champion lung health at the Actelion Booth #1322. For every addition to the graffiti wall, Actelion will donate $25 to the CHEST Foundation.
Thank you for your support of the CHEST Foundation and our mission of championing lung health!
Be sure to check out our ever-growing presence at CHEST 2017, showcasing the numerous ways we support CHEST members, patients, and the community. Have time for a break or interested in networking with leaders in CHEST medicine? Stop by one of our many open invitation activities listed below to learn more about how the CHEST Foundation can support you in your efforts to champion lung health through clinical research grants, community service, and patient education.
SATURDAY OCTOBER 28
2:00 PM – 4:00 PM (Open Invitation)
Nathan Phillips Square
100 Queen St W, Toronto, ON M5H 2N2, Canada
SUNDAY OCTOBER 29
9:00 AM - 5:00 PM
Donor Lounge
Convention Center, 803B
3:15 PM - 4:15 PM
Foundation Session: Severe Asthma Care at Its Best: Shared Decision Making
Convention Center, 716A
4:30 PM - 5:30 PM
Foundation Session: No Money, No Mission: Tips for Getting Your Grant Funded
Convention Center, 716B
MONDAY OCTOBER 30
9:00 AM - 5:00 PM
Convention Center, 803B
8:45 AM – 10:00 AM
Opening Session/CHEST Foundation
Awards Convocation
Convention Center, Hall G, Level 800
6:30 PM - 8:00 PM
Boehringer Ingelheim and CHEST Foundation Patient Engagement Summit
Sheraton, Grand Ballroom Centre
8:00 PM – 10:00 PM
Young Professionals Reception
(RSVP chestfoundation.org/youngprofessionals)
225 Richmond St W Suite 100
Toronto, ON M5V 1W2, Canada
TUESDAY OCTOBER 31
9:00 AM - 5:00 PM
Donor Lounge
Convention Center, 803B
WEDNESDAY NOVEMBER 1
9:00 AM - 12:00 PM
Donor Lounge
Convention Center, 803B
ADD YOUR VOICE
and champion lung health at the Actelion Booth #1322. For every addition to the graffiti wall, Actelion will donate $25 to the CHEST Foundation.
Thank you for your support of the CHEST Foundation and our mission of championing lung health!
Be sure to check out our ever-growing presence at CHEST 2017, showcasing the numerous ways we support CHEST members, patients, and the community. Have time for a break or interested in networking with leaders in CHEST medicine? Stop by one of our many open invitation activities listed below to learn more about how the CHEST Foundation can support you in your efforts to champion lung health through clinical research grants, community service, and patient education.
SATURDAY OCTOBER 28
2:00 PM – 4:00 PM (Open Invitation)
Nathan Phillips Square
100 Queen St W, Toronto, ON M5H 2N2, Canada
SUNDAY OCTOBER 29
9:00 AM - 5:00 PM
Donor Lounge
Convention Center, 803B
3:15 PM - 4:15 PM
Foundation Session: Severe Asthma Care at Its Best: Shared Decision Making
Convention Center, 716A
4:30 PM - 5:30 PM
Foundation Session: No Money, No Mission: Tips for Getting Your Grant Funded
Convention Center, 716B
MONDAY OCTOBER 30
9:00 AM - 5:00 PM
Convention Center, 803B
8:45 AM – 10:00 AM
Opening Session/CHEST Foundation
Awards Convocation
Convention Center, Hall G, Level 800
6:30 PM - 8:00 PM
Boehringer Ingelheim and CHEST Foundation Patient Engagement Summit
Sheraton, Grand Ballroom Centre
8:00 PM – 10:00 PM
Young Professionals Reception
(RSVP chestfoundation.org/youngprofessionals)
225 Richmond St W Suite 100
Toronto, ON M5V 1W2, Canada
TUESDAY OCTOBER 31
9:00 AM - 5:00 PM
Donor Lounge
Convention Center, 803B
WEDNESDAY NOVEMBER 1
9:00 AM - 12:00 PM
Donor Lounge
Convention Center, 803B
ADD YOUR VOICE
and champion lung health at the Actelion Booth #1322. For every addition to the graffiti wall, Actelion will donate $25 to the CHEST Foundation.
Thank you for your support of the CHEST Foundation and our mission of championing lung health!
Statins linked to lower death rates in COPD
Receiving a statin prescription within a year after diagnosis of chronic obstructive pulmonary disease was associated with a 21% decrease in the subsequent risk of all-cause mortality and a 45% drop in risk of pulmonary mortality, according to the results of a large retrospective administrative database study.
The findings belie those of the recent Simvastatin in the Prevention of COPD Exacerbation (STATCOPE) trial, in which daily simvastatin (40 mg) did not affect exacerbation rates or time to first exacerbation in high-risk COPD patients, wrote Larry D. Lynd, PhD, a professor at the at the University of British Columbia, Vancouver, and his associates. Their study was observational, but the association between statin use and decreased mortality “persisted across several measures of statin exposure,” they wrote. “Our findings, in conjunction with previously reported evidence, suggest that there may be a specific subtype of COPD patients that may benefit from statin use.” The study appears in the September issue of CHEST (2017;152;486-93).
To further explore the question, the researchers analyzed linked health databases from nearly 40,000 patients aged 50 years and older who had received at least three prescriptions for an anticholinergic or a short-acting beta agonist in 12 months some time between 1998 and 2007. The first prescription was considered the date of COPD “diagnosis.” The average age of the patients was 71 years; 55% were female.
A total of 7,775 patients (19.6%) who met this definition of incident COPD were prescribed a statin at least once during the subsequent year. These patients had a significantly reduced risk of subsequent all-cause mortality in univariate and multivariate analyses, with hazard ratios of 0.79 (95% confidence intervals, 0.68-0.91; P less than .002). Statins also showed a protective effect against pulmonary mortality, with univariate and multivariate hazard ratios of 0.52 (P = .01) and 0.55 (P = .03), respectively.
The protective effect of statins held up when the investigators narrowed the exposure period to 6 months after COPD diagnosis and when they expanded it to 18 months. Exposure to statins for 80% of the 1-year window after COPD diagnosis – a proxy for statin adherence – also led to a reduced risk of all-cause mortality, but the 95% confidence interval for the hazard ratio did not reach statistical significance (0.71- 1.01; P = .06).
The most common prescription was for atorvastatin (49%), usually for 90 days (23%), 100 days (20%), or 30 days (15%), the researchers said. While the “possibility of the ‘healthy user’ or the ‘healthy adherer’ cannot be ignored,” they adjusted for other prescriptions, comorbidities, and income level, which should have helped eliminate this effect, they added. However, they lacked data on smoking and lung function assessments, both of which are “important confounders and contributors to mortality,” they acknowledged.
Despite [its] limitations, the study results are intriguing and in line with findings from other retrospective cohorts, noted Or Kalchiem-Dekel, MD, and Robert M. Reed, MD, in an editorial published in CHEST (2017;152:456-7. doi: 10.1016/j.chest.2017.04.156).
How then can we reconcile the apparent benefits observed in retrospective studies with the lack of clinical effect seen in prospective trials, particularly the in the STATCOPE study? Could it be that both negative and positive studies are “correct”? Prospective studies have thus far not been adequately powered for mortality as an endpoint, said the editorialists, who are both at the pulmonary and critical care medicine division, University of Maryland, Baltimore.This most recent study reinforces the idea that statins may play a beneficial role in COPD, but it isn’t clear which patients to target for therapy. It is unlikely that the findings will reverse recent recommendations by the American College of Chest Physicians and Canadian Thoracic Society against the use of statins for the purpose of prevention of COPD exacerbations, but the suggestion of survival advantage related to statins certainly may breathe new life into an enthusiasm greatly tempered by STATCOPE, they said.
Canadian Institutes of Health Research supported the study. One coinvestigator disclosed consulting relationships with Teva, Pfizer, and Novartis; the others had no conflicts of interest. Neither editorialist had conflicts of interest.
Receiving a statin prescription within a year after diagnosis of chronic obstructive pulmonary disease was associated with a 21% decrease in the subsequent risk of all-cause mortality and a 45% drop in risk of pulmonary mortality, according to the results of a large retrospective administrative database study.
The findings belie those of the recent Simvastatin in the Prevention of COPD Exacerbation (STATCOPE) trial, in which daily simvastatin (40 mg) did not affect exacerbation rates or time to first exacerbation in high-risk COPD patients, wrote Larry D. Lynd, PhD, a professor at the at the University of British Columbia, Vancouver, and his associates. Their study was observational, but the association between statin use and decreased mortality “persisted across several measures of statin exposure,” they wrote. “Our findings, in conjunction with previously reported evidence, suggest that there may be a specific subtype of COPD patients that may benefit from statin use.” The study appears in the September issue of CHEST (2017;152;486-93).
To further explore the question, the researchers analyzed linked health databases from nearly 40,000 patients aged 50 years and older who had received at least three prescriptions for an anticholinergic or a short-acting beta agonist in 12 months some time between 1998 and 2007. The first prescription was considered the date of COPD “diagnosis.” The average age of the patients was 71 years; 55% were female.
A total of 7,775 patients (19.6%) who met this definition of incident COPD were prescribed a statin at least once during the subsequent year. These patients had a significantly reduced risk of subsequent all-cause mortality in univariate and multivariate analyses, with hazard ratios of 0.79 (95% confidence intervals, 0.68-0.91; P less than .002). Statins also showed a protective effect against pulmonary mortality, with univariate and multivariate hazard ratios of 0.52 (P = .01) and 0.55 (P = .03), respectively.
The protective effect of statins held up when the investigators narrowed the exposure period to 6 months after COPD diagnosis and when they expanded it to 18 months. Exposure to statins for 80% of the 1-year window after COPD diagnosis – a proxy for statin adherence – also led to a reduced risk of all-cause mortality, but the 95% confidence interval for the hazard ratio did not reach statistical significance (0.71- 1.01; P = .06).
The most common prescription was for atorvastatin (49%), usually for 90 days (23%), 100 days (20%), or 30 days (15%), the researchers said. While the “possibility of the ‘healthy user’ or the ‘healthy adherer’ cannot be ignored,” they adjusted for other prescriptions, comorbidities, and income level, which should have helped eliminate this effect, they added. However, they lacked data on smoking and lung function assessments, both of which are “important confounders and contributors to mortality,” they acknowledged.
Despite [its] limitations, the study results are intriguing and in line with findings from other retrospective cohorts, noted Or Kalchiem-Dekel, MD, and Robert M. Reed, MD, in an editorial published in CHEST (2017;152:456-7. doi: 10.1016/j.chest.2017.04.156).
How then can we reconcile the apparent benefits observed in retrospective studies with the lack of clinical effect seen in prospective trials, particularly the in the STATCOPE study? Could it be that both negative and positive studies are “correct”? Prospective studies have thus far not been adequately powered for mortality as an endpoint, said the editorialists, who are both at the pulmonary and critical care medicine division, University of Maryland, Baltimore.This most recent study reinforces the idea that statins may play a beneficial role in COPD, but it isn’t clear which patients to target for therapy. It is unlikely that the findings will reverse recent recommendations by the American College of Chest Physicians and Canadian Thoracic Society against the use of statins for the purpose of prevention of COPD exacerbations, but the suggestion of survival advantage related to statins certainly may breathe new life into an enthusiasm greatly tempered by STATCOPE, they said.
Canadian Institutes of Health Research supported the study. One coinvestigator disclosed consulting relationships with Teva, Pfizer, and Novartis; the others had no conflicts of interest. Neither editorialist had conflicts of interest.
Receiving a statin prescription within a year after diagnosis of chronic obstructive pulmonary disease was associated with a 21% decrease in the subsequent risk of all-cause mortality and a 45% drop in risk of pulmonary mortality, according to the results of a large retrospective administrative database study.
The findings belie those of the recent Simvastatin in the Prevention of COPD Exacerbation (STATCOPE) trial, in which daily simvastatin (40 mg) did not affect exacerbation rates or time to first exacerbation in high-risk COPD patients, wrote Larry D. Lynd, PhD, a professor at the at the University of British Columbia, Vancouver, and his associates. Their study was observational, but the association between statin use and decreased mortality “persisted across several measures of statin exposure,” they wrote. “Our findings, in conjunction with previously reported evidence, suggest that there may be a specific subtype of COPD patients that may benefit from statin use.” The study appears in the September issue of CHEST (2017;152;486-93).
To further explore the question, the researchers analyzed linked health databases from nearly 40,000 patients aged 50 years and older who had received at least three prescriptions for an anticholinergic or a short-acting beta agonist in 12 months some time between 1998 and 2007. The first prescription was considered the date of COPD “diagnosis.” The average age of the patients was 71 years; 55% were female.
A total of 7,775 patients (19.6%) who met this definition of incident COPD were prescribed a statin at least once during the subsequent year. These patients had a significantly reduced risk of subsequent all-cause mortality in univariate and multivariate analyses, with hazard ratios of 0.79 (95% confidence intervals, 0.68-0.91; P less than .002). Statins also showed a protective effect against pulmonary mortality, with univariate and multivariate hazard ratios of 0.52 (P = .01) and 0.55 (P = .03), respectively.
The protective effect of statins held up when the investigators narrowed the exposure period to 6 months after COPD diagnosis and when they expanded it to 18 months. Exposure to statins for 80% of the 1-year window after COPD diagnosis – a proxy for statin adherence – also led to a reduced risk of all-cause mortality, but the 95% confidence interval for the hazard ratio did not reach statistical significance (0.71- 1.01; P = .06).
The most common prescription was for atorvastatin (49%), usually for 90 days (23%), 100 days (20%), or 30 days (15%), the researchers said. While the “possibility of the ‘healthy user’ or the ‘healthy adherer’ cannot be ignored,” they adjusted for other prescriptions, comorbidities, and income level, which should have helped eliminate this effect, they added. However, they lacked data on smoking and lung function assessments, both of which are “important confounders and contributors to mortality,” they acknowledged.
Despite [its] limitations, the study results are intriguing and in line with findings from other retrospective cohorts, noted Or Kalchiem-Dekel, MD, and Robert M. Reed, MD, in an editorial published in CHEST (2017;152:456-7. doi: 10.1016/j.chest.2017.04.156).
How then can we reconcile the apparent benefits observed in retrospective studies with the lack of clinical effect seen in prospective trials, particularly the in the STATCOPE study? Could it be that both negative and positive studies are “correct”? Prospective studies have thus far not been adequately powered for mortality as an endpoint, said the editorialists, who are both at the pulmonary and critical care medicine division, University of Maryland, Baltimore.This most recent study reinforces the idea that statins may play a beneficial role in COPD, but it isn’t clear which patients to target for therapy. It is unlikely that the findings will reverse recent recommendations by the American College of Chest Physicians and Canadian Thoracic Society against the use of statins for the purpose of prevention of COPD exacerbations, but the suggestion of survival advantage related to statins certainly may breathe new life into an enthusiasm greatly tempered by STATCOPE, they said.
Canadian Institutes of Health Research supported the study. One coinvestigator disclosed consulting relationships with Teva, Pfizer, and Novartis; the others had no conflicts of interest. Neither editorialist had conflicts of interest.
FROM CHEST
FDA approves triple-therapy inhaler for COPD
The Food and Drug Administration has approved Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol), a triple-therapy inhaler for the treatment of chronic obstructive pulmonary disease (COPD) in adult patients, according to a press release from GlaxoSmithKline and Innoviva.
Trelegy Ellipta combines an inhaled corticosteroid, a long-acting muscarinic antagonist, and a long-acting beta2-adrenergic agonist into an inhaler meant for once-daily use in people with COPD. Chronic bronchitis and/or emphysema patients are also indicated for treatment. The FDA-approved dosage is 100 mcg of fluticasone furoate, 62.5 mcg of umeclidinium, and 25 mcg of vilanterol.
“This approval represents a significant therapeutic convenience for those appropriate patients already on Breo Ellipta, that require additional bronchodilation or for those patients already on a combination of Breo Ellipta and Incruse Ellipta,” Mike Aguiar, CEO of Innoviva said in the press release.
In results supporting the FDA approval, the IMPACT study, a 52-week phase 3 clinical trial including 10,355 COPD patients sponsored by GSK, found that patients receiving Trelegy Ellipta experienced a 25% reduction in moderate to severe exacerbations compared to patients receiving Anoro Ellipta, and a 15% reduction in moderate to severe exacerbations, compared with patients receiving Relvar/Breo Ellipta. Change from baseline FEV1, change from baseline scores on the St George’s Respiratory Questionnaire, and time to first moderate/severe COPD exacerbation also were improved in the Trelegy Ellipta study group compared to the others.
“This is the first study to report a comparison of a single inhaler triple therapy with two dual therapies, providing much needed clinical evidence about the ability of a single inhaler triple therapy to reduce exacerbations,” Patrick Vallance, President of R&D at GSK, noted in a press release announcing the results of the IMPACT study.
The Food and Drug Administration has approved Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol), a triple-therapy inhaler for the treatment of chronic obstructive pulmonary disease (COPD) in adult patients, according to a press release from GlaxoSmithKline and Innoviva.
Trelegy Ellipta combines an inhaled corticosteroid, a long-acting muscarinic antagonist, and a long-acting beta2-adrenergic agonist into an inhaler meant for once-daily use in people with COPD. Chronic bronchitis and/or emphysema patients are also indicated for treatment. The FDA-approved dosage is 100 mcg of fluticasone furoate, 62.5 mcg of umeclidinium, and 25 mcg of vilanterol.
“This approval represents a significant therapeutic convenience for those appropriate patients already on Breo Ellipta, that require additional bronchodilation or for those patients already on a combination of Breo Ellipta and Incruse Ellipta,” Mike Aguiar, CEO of Innoviva said in the press release.
In results supporting the FDA approval, the IMPACT study, a 52-week phase 3 clinical trial including 10,355 COPD patients sponsored by GSK, found that patients receiving Trelegy Ellipta experienced a 25% reduction in moderate to severe exacerbations compared to patients receiving Anoro Ellipta, and a 15% reduction in moderate to severe exacerbations, compared with patients receiving Relvar/Breo Ellipta. Change from baseline FEV1, change from baseline scores on the St George’s Respiratory Questionnaire, and time to first moderate/severe COPD exacerbation also were improved in the Trelegy Ellipta study group compared to the others.
“This is the first study to report a comparison of a single inhaler triple therapy with two dual therapies, providing much needed clinical evidence about the ability of a single inhaler triple therapy to reduce exacerbations,” Patrick Vallance, President of R&D at GSK, noted in a press release announcing the results of the IMPACT study.
The Food and Drug Administration has approved Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol), a triple-therapy inhaler for the treatment of chronic obstructive pulmonary disease (COPD) in adult patients, according to a press release from GlaxoSmithKline and Innoviva.
Trelegy Ellipta combines an inhaled corticosteroid, a long-acting muscarinic antagonist, and a long-acting beta2-adrenergic agonist into an inhaler meant for once-daily use in people with COPD. Chronic bronchitis and/or emphysema patients are also indicated for treatment. The FDA-approved dosage is 100 mcg of fluticasone furoate, 62.5 mcg of umeclidinium, and 25 mcg of vilanterol.
“This approval represents a significant therapeutic convenience for those appropriate patients already on Breo Ellipta, that require additional bronchodilation or for those patients already on a combination of Breo Ellipta and Incruse Ellipta,” Mike Aguiar, CEO of Innoviva said in the press release.
In results supporting the FDA approval, the IMPACT study, a 52-week phase 3 clinical trial including 10,355 COPD patients sponsored by GSK, found that patients receiving Trelegy Ellipta experienced a 25% reduction in moderate to severe exacerbations compared to patients receiving Anoro Ellipta, and a 15% reduction in moderate to severe exacerbations, compared with patients receiving Relvar/Breo Ellipta. Change from baseline FEV1, change from baseline scores on the St George’s Respiratory Questionnaire, and time to first moderate/severe COPD exacerbation also were improved in the Trelegy Ellipta study group compared to the others.
“This is the first study to report a comparison of a single inhaler triple therapy with two dual therapies, providing much needed clinical evidence about the ability of a single inhaler triple therapy to reduce exacerbations,” Patrick Vallance, President of R&D at GSK, noted in a press release announcing the results of the IMPACT study.