CDC: Don’t vape, especially THC

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Thu, 10/24/2019 - 13:42

Federal health officials once again are warning individuals to refrain from using all e-cigarette and vaping products, especially those containing tetrahydrocannabinol (THC).

The restated warning, issued by the Centers for Disease Control and Prevention, is based on a study of 83 patients with e-cigarette, or vaping, product use–associated lung injury (EVALI) in Utah, where researchers found several common characteristics, most strikingly the use of THC-containing products.

Fifty-three patients were interviewed by researchers. Of them, 49 (92%) reported use of THC-containing e-cigarette or vaping products during the 3 months preceding illness; 35 (66%) reported using nicotine-containing products; and 32 (60%) reported using both THC- and nicotine-containing products.

In addition, 17 (32%) patients reported exclusive use of THC-containing products, whereas only 3 (6%) reported exclusive use of nicotine-containing products. Non-medical THC use is illegal in Utah.

The median age of patients was 26 years, 3 years older than the national median; more than one-third were aged 30 years or older, according to the researchers.

Utah is seeing a higher-than-average rate of EVALI cases, with 26/million cases, compared with 4/million nationally.

Vitamin E acetate has been considered to have a suspect role in EVALI and was identified in the majority of THC cartridge samples tested in this study; however, those samples represented only six patients, according to the researchers. They added that testing of different THC cartridge samples by the Food and Drug Administration and other laboratories has shown vitamin E acetate concentrations of 31%-88% and lower-than-expected THC concentrations (14%-76% versus the typically advertised 75%-95%).

“The potential role of vitamin E acetate in lung injury remains unknown; however, the identification of vitamin E acetate among products collected from patients in Utah and elsewhere indicates that the outbreak might be associated with cutting agents or adulterants. Ascertaining the potential contribution of diluents to the current outbreak will require data from multiple states and analysis at the national level,” the researchers concluded.

The authors reported that they had no conflicts.
 

SOURCE: Lewis N et al. MMWR Morb Mortal Wkly Rep. Early Release. Oct. 22, 2019. 68:1-5.

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Federal health officials once again are warning individuals to refrain from using all e-cigarette and vaping products, especially those containing tetrahydrocannabinol (THC).

The restated warning, issued by the Centers for Disease Control and Prevention, is based on a study of 83 patients with e-cigarette, or vaping, product use–associated lung injury (EVALI) in Utah, where researchers found several common characteristics, most strikingly the use of THC-containing products.

Fifty-three patients were interviewed by researchers. Of them, 49 (92%) reported use of THC-containing e-cigarette or vaping products during the 3 months preceding illness; 35 (66%) reported using nicotine-containing products; and 32 (60%) reported using both THC- and nicotine-containing products.

In addition, 17 (32%) patients reported exclusive use of THC-containing products, whereas only 3 (6%) reported exclusive use of nicotine-containing products. Non-medical THC use is illegal in Utah.

The median age of patients was 26 years, 3 years older than the national median; more than one-third were aged 30 years or older, according to the researchers.

Utah is seeing a higher-than-average rate of EVALI cases, with 26/million cases, compared with 4/million nationally.

Vitamin E acetate has been considered to have a suspect role in EVALI and was identified in the majority of THC cartridge samples tested in this study; however, those samples represented only six patients, according to the researchers. They added that testing of different THC cartridge samples by the Food and Drug Administration and other laboratories has shown vitamin E acetate concentrations of 31%-88% and lower-than-expected THC concentrations (14%-76% versus the typically advertised 75%-95%).

“The potential role of vitamin E acetate in lung injury remains unknown; however, the identification of vitamin E acetate among products collected from patients in Utah and elsewhere indicates that the outbreak might be associated with cutting agents or adulterants. Ascertaining the potential contribution of diluents to the current outbreak will require data from multiple states and analysis at the national level,” the researchers concluded.

The authors reported that they had no conflicts.
 

SOURCE: Lewis N et al. MMWR Morb Mortal Wkly Rep. Early Release. Oct. 22, 2019. 68:1-5.

Federal health officials once again are warning individuals to refrain from using all e-cigarette and vaping products, especially those containing tetrahydrocannabinol (THC).

The restated warning, issued by the Centers for Disease Control and Prevention, is based on a study of 83 patients with e-cigarette, or vaping, product use–associated lung injury (EVALI) in Utah, where researchers found several common characteristics, most strikingly the use of THC-containing products.

Fifty-three patients were interviewed by researchers. Of them, 49 (92%) reported use of THC-containing e-cigarette or vaping products during the 3 months preceding illness; 35 (66%) reported using nicotine-containing products; and 32 (60%) reported using both THC- and nicotine-containing products.

In addition, 17 (32%) patients reported exclusive use of THC-containing products, whereas only 3 (6%) reported exclusive use of nicotine-containing products. Non-medical THC use is illegal in Utah.

The median age of patients was 26 years, 3 years older than the national median; more than one-third were aged 30 years or older, according to the researchers.

Utah is seeing a higher-than-average rate of EVALI cases, with 26/million cases, compared with 4/million nationally.

Vitamin E acetate has been considered to have a suspect role in EVALI and was identified in the majority of THC cartridge samples tested in this study; however, those samples represented only six patients, according to the researchers. They added that testing of different THC cartridge samples by the Food and Drug Administration and other laboratories has shown vitamin E acetate concentrations of 31%-88% and lower-than-expected THC concentrations (14%-76% versus the typically advertised 75%-95%).

“The potential role of vitamin E acetate in lung injury remains unknown; however, the identification of vitamin E acetate among products collected from patients in Utah and elsewhere indicates that the outbreak might be associated with cutting agents or adulterants. Ascertaining the potential contribution of diluents to the current outbreak will require data from multiple states and analysis at the national level,” the researchers concluded.

The authors reported that they had no conflicts.
 

SOURCE: Lewis N et al. MMWR Morb Mortal Wkly Rep. Early Release. Oct. 22, 2019. 68:1-5.

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Recent COPD exacerbation did not affect aclidinium’s efficacy in high-risk patients

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Mon, 11/15/2021 - 13:41

– A history of recent exacerbations did not significantly affect the safety or efficacy of aclidinium bromide (Tudorza) in patients with moderate to severe chronic obstructive pulmonary disease and high cardiovascular risk, analysis of a postmarketing surveillance trial suggests.

Andrew D. Bowser/MDedge News
Dr. Robert A. Wise

Regardless of exacerbation history, the long-acting muscarinic antagonist reduced the rate of moderate or severe COPD exacerbations versus placebo in this subgroup analysis of the phase IV ASCENT-COPD trial, presented here at the annual meeting of the American College of Chest Physicians.

At the same time, there were no significant increases in the risk of mortality or major cardiac adverse events (MACE) for those patients who had an exacerbation in the past year versus those who did not, according to investigator Robert A. Wise, MD.

Those findings may be reassuring, given that COPD patients commonly have comorbidities and cardiovascular risk factors, according to Dr. Wise, professor of medicine at the Johns Hopkins University, Baltimore.

“There’s a concern and some evidence that patients who have a propensity to COPD exacerbations may also have an increased risk for cardiovascular events,” Dr. Wise said in a podium presentation.

Accordingly, he and coinvestigators sought to tease out the impact of COPD exacerbations on safety as well as efficacy in the randomized, placebo-controlled ASCENT-COPD trial, which included 3,630 patients with moderate to severe COPD plus a cardiovascular disease history or multiple atherothrombotic risk factors.

Of the patients who were analyzed in the study, 1,433 patients had at least one treated COPD exacerbation in the year before screening for the study, while 2,156 had no exacerbations in the prior year, Dr. Wise said.

Top-line results of that study, published several months ago, showed that aclidinium did not increase MACE risk over 3 years, and reduced the rate of moderate to severe COPD exacerbations over the first year (JAMA. 2019 7 May 7;321[17]:1693-701).

In this latest analysis, presented at the meeting, risk of MACE with aclidinium treatment was not increased versus placebo, irrespective of whether they had exacerbations in the prior year (interaction P = .233); likewise, the risk of all-cause mortality was similar between groups (P = .154).

In terms of reduction in moderate or severe COPD exacerbations in the first year, aclidinium was superior to placebo both for the patients who had at least one or exacerbation in the prior year (rate ratio, 0.80) and those who had no exacerbations in the prior year (RR, 0.69).

“This translates into a number-needed-to-treat to prevent one exacerbation of about 11 patients for those without an exacerbation, compared to about 6 patients for those with a prior exacerbation,” Dr. Wise said in his presentation.

The ASCENT-COPD study was funded initially by Forest Laboratories and later by AstraZeneca and Circassia. Dr. Wise provided disclosures related to AstraZeneca, GlaxoSmithKline, Boehringer Ingelheim, Sunovion, Mylan/Theravance, Contrafect, Pearl, Merck, Verona, Novartis, AbbVie, Syneos, Regeneron, and Kiniksa.

SOURCE: Wise R et al. CHEST 2019. Abstract, doi: 10.1016/j.chest.2019.08.231.

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– A history of recent exacerbations did not significantly affect the safety or efficacy of aclidinium bromide (Tudorza) in patients with moderate to severe chronic obstructive pulmonary disease and high cardiovascular risk, analysis of a postmarketing surveillance trial suggests.

Andrew D. Bowser/MDedge News
Dr. Robert A. Wise

Regardless of exacerbation history, the long-acting muscarinic antagonist reduced the rate of moderate or severe COPD exacerbations versus placebo in this subgroup analysis of the phase IV ASCENT-COPD trial, presented here at the annual meeting of the American College of Chest Physicians.

At the same time, there were no significant increases in the risk of mortality or major cardiac adverse events (MACE) for those patients who had an exacerbation in the past year versus those who did not, according to investigator Robert A. Wise, MD.

Those findings may be reassuring, given that COPD patients commonly have comorbidities and cardiovascular risk factors, according to Dr. Wise, professor of medicine at the Johns Hopkins University, Baltimore.

“There’s a concern and some evidence that patients who have a propensity to COPD exacerbations may also have an increased risk for cardiovascular events,” Dr. Wise said in a podium presentation.

Accordingly, he and coinvestigators sought to tease out the impact of COPD exacerbations on safety as well as efficacy in the randomized, placebo-controlled ASCENT-COPD trial, which included 3,630 patients with moderate to severe COPD plus a cardiovascular disease history or multiple atherothrombotic risk factors.

Of the patients who were analyzed in the study, 1,433 patients had at least one treated COPD exacerbation in the year before screening for the study, while 2,156 had no exacerbations in the prior year, Dr. Wise said.

Top-line results of that study, published several months ago, showed that aclidinium did not increase MACE risk over 3 years, and reduced the rate of moderate to severe COPD exacerbations over the first year (JAMA. 2019 7 May 7;321[17]:1693-701).

In this latest analysis, presented at the meeting, risk of MACE with aclidinium treatment was not increased versus placebo, irrespective of whether they had exacerbations in the prior year (interaction P = .233); likewise, the risk of all-cause mortality was similar between groups (P = .154).

In terms of reduction in moderate or severe COPD exacerbations in the first year, aclidinium was superior to placebo both for the patients who had at least one or exacerbation in the prior year (rate ratio, 0.80) and those who had no exacerbations in the prior year (RR, 0.69).

“This translates into a number-needed-to-treat to prevent one exacerbation of about 11 patients for those without an exacerbation, compared to about 6 patients for those with a prior exacerbation,” Dr. Wise said in his presentation.

The ASCENT-COPD study was funded initially by Forest Laboratories and later by AstraZeneca and Circassia. Dr. Wise provided disclosures related to AstraZeneca, GlaxoSmithKline, Boehringer Ingelheim, Sunovion, Mylan/Theravance, Contrafect, Pearl, Merck, Verona, Novartis, AbbVie, Syneos, Regeneron, and Kiniksa.

SOURCE: Wise R et al. CHEST 2019. Abstract, doi: 10.1016/j.chest.2019.08.231.

– A history of recent exacerbations did not significantly affect the safety or efficacy of aclidinium bromide (Tudorza) in patients with moderate to severe chronic obstructive pulmonary disease and high cardiovascular risk, analysis of a postmarketing surveillance trial suggests.

Andrew D. Bowser/MDedge News
Dr. Robert A. Wise

Regardless of exacerbation history, the long-acting muscarinic antagonist reduced the rate of moderate or severe COPD exacerbations versus placebo in this subgroup analysis of the phase IV ASCENT-COPD trial, presented here at the annual meeting of the American College of Chest Physicians.

At the same time, there were no significant increases in the risk of mortality or major cardiac adverse events (MACE) for those patients who had an exacerbation in the past year versus those who did not, according to investigator Robert A. Wise, MD.

Those findings may be reassuring, given that COPD patients commonly have comorbidities and cardiovascular risk factors, according to Dr. Wise, professor of medicine at the Johns Hopkins University, Baltimore.

“There’s a concern and some evidence that patients who have a propensity to COPD exacerbations may also have an increased risk for cardiovascular events,” Dr. Wise said in a podium presentation.

Accordingly, he and coinvestigators sought to tease out the impact of COPD exacerbations on safety as well as efficacy in the randomized, placebo-controlled ASCENT-COPD trial, which included 3,630 patients with moderate to severe COPD plus a cardiovascular disease history or multiple atherothrombotic risk factors.

Of the patients who were analyzed in the study, 1,433 patients had at least one treated COPD exacerbation in the year before screening for the study, while 2,156 had no exacerbations in the prior year, Dr. Wise said.

Top-line results of that study, published several months ago, showed that aclidinium did not increase MACE risk over 3 years, and reduced the rate of moderate to severe COPD exacerbations over the first year (JAMA. 2019 7 May 7;321[17]:1693-701).

In this latest analysis, presented at the meeting, risk of MACE with aclidinium treatment was not increased versus placebo, irrespective of whether they had exacerbations in the prior year (interaction P = .233); likewise, the risk of all-cause mortality was similar between groups (P = .154).

In terms of reduction in moderate or severe COPD exacerbations in the first year, aclidinium was superior to placebo both for the patients who had at least one or exacerbation in the prior year (rate ratio, 0.80) and those who had no exacerbations in the prior year (RR, 0.69).

“This translates into a number-needed-to-treat to prevent one exacerbation of about 11 patients for those without an exacerbation, compared to about 6 patients for those with a prior exacerbation,” Dr. Wise said in his presentation.

The ASCENT-COPD study was funded initially by Forest Laboratories and later by AstraZeneca and Circassia. Dr. Wise provided disclosures related to AstraZeneca, GlaxoSmithKline, Boehringer Ingelheim, Sunovion, Mylan/Theravance, Contrafect, Pearl, Merck, Verona, Novartis, AbbVie, Syneos, Regeneron, and Kiniksa.

SOURCE: Wise R et al. CHEST 2019. Abstract, doi: 10.1016/j.chest.2019.08.231.

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Macitentan, tadalafil combo found effective for newly diagnosed PAH

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Tue, 10/29/2019 - 15:43

 

– Treatment with macitentan and tadalafil can elicit improvements in patients with newly diagnosed pulmonary arterial hypertension (PAH), trial results suggest.

Jennifer Smith/MDedge News
Dr. Olivier Sitbon

In the phase 4 OPTIMA trial, the combination significantly improved cardiopulmonary hemodynamics, functional class, 6-minute walk distance, and N-terminal pro B-type natriuretic peptide (NT-proBNP).

Olivier Sitbon, MD, PhD, of Université Paris–Sud in France, presented these results at the annual meeting of the American College of Chest Physicians.

The OPTIMA trial (NCT02968901) enrolled 46 adults who were newly diagnosed with PAH and had medium functional ability (WHO functional class II-III). The patients’ mean age was 57.4 ± 14.9 years, and 65% of them were female.

The mean time from PAH diagnosis was 29.6 ± 55.2 days. Patients had idiopathic PAH (63%), PAH associated with connective tissue disease (19.6%), heritable PAH (6.5%), drug- or toxin-induced PAH (4.4%), HIV-associated PAH (2.2%), and “other” PAH (4.4%).

Patients initially received macitentan at 10 mg once daily and tadalafil at 20 mg once daily. After 8 ± 3 days, the tadalafil dose was increased to 40 mg once daily. The median duration of treatment was 19.9 months.

The researchers assessed efficacy at week 16, but patients were monitored for safety until the study was closed by the sponsor. There were 44 patients who remained on study through week 16, and 39 patients completed the study.
 

Results

The study’s primary endpoint was the change in pulmonary vascular resistance (PVR). The ratio of week 16 to baseline PVR was 0.53, which translates to a significant 47% reduction in PVR. In fact, 87% of patients had a 30% or greater decrease in PVR from baseline to week 16.

Patients had improvements in other endpoints as well. The mean cardiac index increased from 2.2 to 3.1 L/min/m2 (P less than .0001) from baseline to week 16. The mean pulmonary arterial pressure decreased from 50.0 to 42.2 mm Hg (P = .0002), and the mean right atrial pressure decreased from 8.1 to 7.8 mm Hg (P = .7321).

The mean mixed venous oxygen saturation increased from 63.0% to 68.2% (P = .0003). The mean total pulmonary resistance decreased from 1109.4 to 677.4 dynes/sec/cm-5 (P less than .0001).

NT-proBNP decreased 68% from baseline to week 16. The geometric mean ratio was 0.32 (P less than .0001). The 6-minute walk distance increased from 352.2 to 388.1 m (P = .0008).

None of the patients experienced a worsening of WHO functional class from baseline to week 16, and 63% of patients experienced an improvement.

Nearly 94% of patients (n = 43) had at least one adverse event, 28% (n = 13) had serious adverse events, and 6.5% (n = 3) stopped treatment because of adverse events. The most frequent events were peripheral edema (n = 13), headache (n = 11), diarrhea (n = 9), and dyspnea (n = 7).

Three patients died during follow-up, one due to multiorgan failure and two due to underlying disease.

Actelion Pharmaceuticals funded the trial. Dr. Sitbon disclosed relationships with Actelion, Bayer, GSK, Merck, Arena Pharmaceuticals, Gossamer Bio, and Ferrer.

SOURCE: Sitbon O et al. CHEST 2019. Abstract, doi: 10.1016/j.chest.2019.08.825.

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– Treatment with macitentan and tadalafil can elicit improvements in patients with newly diagnosed pulmonary arterial hypertension (PAH), trial results suggest.

Jennifer Smith/MDedge News
Dr. Olivier Sitbon

In the phase 4 OPTIMA trial, the combination significantly improved cardiopulmonary hemodynamics, functional class, 6-minute walk distance, and N-terminal pro B-type natriuretic peptide (NT-proBNP).

Olivier Sitbon, MD, PhD, of Université Paris–Sud in France, presented these results at the annual meeting of the American College of Chest Physicians.

The OPTIMA trial (NCT02968901) enrolled 46 adults who were newly diagnosed with PAH and had medium functional ability (WHO functional class II-III). The patients’ mean age was 57.4 ± 14.9 years, and 65% of them were female.

The mean time from PAH diagnosis was 29.6 ± 55.2 days. Patients had idiopathic PAH (63%), PAH associated with connective tissue disease (19.6%), heritable PAH (6.5%), drug- or toxin-induced PAH (4.4%), HIV-associated PAH (2.2%), and “other” PAH (4.4%).

Patients initially received macitentan at 10 mg once daily and tadalafil at 20 mg once daily. After 8 ± 3 days, the tadalafil dose was increased to 40 mg once daily. The median duration of treatment was 19.9 months.

The researchers assessed efficacy at week 16, but patients were monitored for safety until the study was closed by the sponsor. There were 44 patients who remained on study through week 16, and 39 patients completed the study.
 

Results

The study’s primary endpoint was the change in pulmonary vascular resistance (PVR). The ratio of week 16 to baseline PVR was 0.53, which translates to a significant 47% reduction in PVR. In fact, 87% of patients had a 30% or greater decrease in PVR from baseline to week 16.

Patients had improvements in other endpoints as well. The mean cardiac index increased from 2.2 to 3.1 L/min/m2 (P less than .0001) from baseline to week 16. The mean pulmonary arterial pressure decreased from 50.0 to 42.2 mm Hg (P = .0002), and the mean right atrial pressure decreased from 8.1 to 7.8 mm Hg (P = .7321).

The mean mixed venous oxygen saturation increased from 63.0% to 68.2% (P = .0003). The mean total pulmonary resistance decreased from 1109.4 to 677.4 dynes/sec/cm-5 (P less than .0001).

NT-proBNP decreased 68% from baseline to week 16. The geometric mean ratio was 0.32 (P less than .0001). The 6-minute walk distance increased from 352.2 to 388.1 m (P = .0008).

None of the patients experienced a worsening of WHO functional class from baseline to week 16, and 63% of patients experienced an improvement.

Nearly 94% of patients (n = 43) had at least one adverse event, 28% (n = 13) had serious adverse events, and 6.5% (n = 3) stopped treatment because of adverse events. The most frequent events were peripheral edema (n = 13), headache (n = 11), diarrhea (n = 9), and dyspnea (n = 7).

Three patients died during follow-up, one due to multiorgan failure and two due to underlying disease.

Actelion Pharmaceuticals funded the trial. Dr. Sitbon disclosed relationships with Actelion, Bayer, GSK, Merck, Arena Pharmaceuticals, Gossamer Bio, and Ferrer.

SOURCE: Sitbon O et al. CHEST 2019. Abstract, doi: 10.1016/j.chest.2019.08.825.

 

– Treatment with macitentan and tadalafil can elicit improvements in patients with newly diagnosed pulmonary arterial hypertension (PAH), trial results suggest.

Jennifer Smith/MDedge News
Dr. Olivier Sitbon

In the phase 4 OPTIMA trial, the combination significantly improved cardiopulmonary hemodynamics, functional class, 6-minute walk distance, and N-terminal pro B-type natriuretic peptide (NT-proBNP).

Olivier Sitbon, MD, PhD, of Université Paris–Sud in France, presented these results at the annual meeting of the American College of Chest Physicians.

The OPTIMA trial (NCT02968901) enrolled 46 adults who were newly diagnosed with PAH and had medium functional ability (WHO functional class II-III). The patients’ mean age was 57.4 ± 14.9 years, and 65% of them were female.

The mean time from PAH diagnosis was 29.6 ± 55.2 days. Patients had idiopathic PAH (63%), PAH associated with connective tissue disease (19.6%), heritable PAH (6.5%), drug- or toxin-induced PAH (4.4%), HIV-associated PAH (2.2%), and “other” PAH (4.4%).

Patients initially received macitentan at 10 mg once daily and tadalafil at 20 mg once daily. After 8 ± 3 days, the tadalafil dose was increased to 40 mg once daily. The median duration of treatment was 19.9 months.

The researchers assessed efficacy at week 16, but patients were monitored for safety until the study was closed by the sponsor. There were 44 patients who remained on study through week 16, and 39 patients completed the study.
 

Results

The study’s primary endpoint was the change in pulmonary vascular resistance (PVR). The ratio of week 16 to baseline PVR was 0.53, which translates to a significant 47% reduction in PVR. In fact, 87% of patients had a 30% or greater decrease in PVR from baseline to week 16.

Patients had improvements in other endpoints as well. The mean cardiac index increased from 2.2 to 3.1 L/min/m2 (P less than .0001) from baseline to week 16. The mean pulmonary arterial pressure decreased from 50.0 to 42.2 mm Hg (P = .0002), and the mean right atrial pressure decreased from 8.1 to 7.8 mm Hg (P = .7321).

The mean mixed venous oxygen saturation increased from 63.0% to 68.2% (P = .0003). The mean total pulmonary resistance decreased from 1109.4 to 677.4 dynes/sec/cm-5 (P less than .0001).

NT-proBNP decreased 68% from baseline to week 16. The geometric mean ratio was 0.32 (P less than .0001). The 6-minute walk distance increased from 352.2 to 388.1 m (P = .0008).

None of the patients experienced a worsening of WHO functional class from baseline to week 16, and 63% of patients experienced an improvement.

Nearly 94% of patients (n = 43) had at least one adverse event, 28% (n = 13) had serious adverse events, and 6.5% (n = 3) stopped treatment because of adverse events. The most frequent events were peripheral edema (n = 13), headache (n = 11), diarrhea (n = 9), and dyspnea (n = 7).

Three patients died during follow-up, one due to multiorgan failure and two due to underlying disease.

Actelion Pharmaceuticals funded the trial. Dr. Sitbon disclosed relationships with Actelion, Bayer, GSK, Merck, Arena Pharmaceuticals, Gossamer Bio, and Ferrer.

SOURCE: Sitbon O et al. CHEST 2019. Abstract, doi: 10.1016/j.chest.2019.08.825.

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In-hospital flu shot reduced readmissions in pneumonia patients

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Wed, 10/23/2019 - 10:12

 

– In-hospital flu shots were rare, yet linked to a lower readmission rate for patients hospitalized with community-acquired pneumonia in a recent retrospective study, suggesting a “missed opportunity” to improve outcomes for these patients, an investigator said.

Andrew D. Bowser/MDedge News
Dr. Kam Sing Ho

Less than 2% of patients admitted for community-acquired pneumonia (CAP) received in-hospital influenza vaccination, yet receiving it was linked to a 20% reduction in readmissions, according to investigator Kam Sing Ho, MD, a resident at Mount Sinai St. Luke’s, New York.

Those patients who were readmitted had a significantly higher death rate vs. index admissions, Dr. Ho said in a poster discussion session at the annual meeting of the American College of Chest Physicians.

“I know (vaccines) are pretty much pushed out to the outpatient setting, but given what we showed here in this abstract, I think there’s a role for influenza vaccines to be a discussion in the hospital,” Dr. Ho said in his presentation.

The retrospective analysis was based on 825,906 adult hospital admissions with a primary diagnosis of CAP in data from the Agency for Healthcare Research and Quality Healthcare Cost and Utilization Project (HCUP). Of that large cohort, just 14,047 (1.91%) received in-hospital influenza vaccination, according to Dr. Ho.

In-hospital influenza vaccination independently predicted a lower risk of readmission (hazard ratio, 0.821; 95% confidence interval, 0.69-0.98; P less than .02) in a propensity score matching analysis that included 9,777 CAP patients who received the vaccination and 9,777 with similar demographic and clinical characteristics.

Private insurance and high-income status also predicted lower risk of readmission in the analysis, while by contrast, factors associated with higher risk of readmission included advanced age, Medicare insurance, and respiratory failure, among other factors, Dr. Ho reported.

The overall 30-day rate of readmission in the study was 11.9%, and of those readmissions, the great majority (about 80%) were due to pneumonia, he said.

The rate of death in the hospital was 2.96% for CAP patients who were readmitted, versus 1.11% for the index admissions (P less than .001), Dr. Ho reported. Moreover, readmissions were associated with nearly half a million hospital days and $1 billion in costs and $3.67 billion in charges.  

Based on these findings, Dr. Ho and colleagues hope to incorporate routine influenza vaccination for all adults hospitalized with CAP.

“We’re always under pressure to do so much for patients that we can’t comprehensively do everything. But the 20% reduction in the risk of coming back, I think that’s significant,” Dr. Ho said in an interview.

The authors reported having no disclosures related to this research.

This article was updated 10/23/2019.

SOURCE: Ho KS, et al. CHEST 2019. doi: 10.1016/j.chest.2019.08.450.

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– In-hospital flu shots were rare, yet linked to a lower readmission rate for patients hospitalized with community-acquired pneumonia in a recent retrospective study, suggesting a “missed opportunity” to improve outcomes for these patients, an investigator said.

Andrew D. Bowser/MDedge News
Dr. Kam Sing Ho

Less than 2% of patients admitted for community-acquired pneumonia (CAP) received in-hospital influenza vaccination, yet receiving it was linked to a 20% reduction in readmissions, according to investigator Kam Sing Ho, MD, a resident at Mount Sinai St. Luke’s, New York.

Those patients who were readmitted had a significantly higher death rate vs. index admissions, Dr. Ho said in a poster discussion session at the annual meeting of the American College of Chest Physicians.

“I know (vaccines) are pretty much pushed out to the outpatient setting, but given what we showed here in this abstract, I think there’s a role for influenza vaccines to be a discussion in the hospital,” Dr. Ho said in his presentation.

The retrospective analysis was based on 825,906 adult hospital admissions with a primary diagnosis of CAP in data from the Agency for Healthcare Research and Quality Healthcare Cost and Utilization Project (HCUP). Of that large cohort, just 14,047 (1.91%) received in-hospital influenza vaccination, according to Dr. Ho.

In-hospital influenza vaccination independently predicted a lower risk of readmission (hazard ratio, 0.821; 95% confidence interval, 0.69-0.98; P less than .02) in a propensity score matching analysis that included 9,777 CAP patients who received the vaccination and 9,777 with similar demographic and clinical characteristics.

Private insurance and high-income status also predicted lower risk of readmission in the analysis, while by contrast, factors associated with higher risk of readmission included advanced age, Medicare insurance, and respiratory failure, among other factors, Dr. Ho reported.

The overall 30-day rate of readmission in the study was 11.9%, and of those readmissions, the great majority (about 80%) were due to pneumonia, he said.

The rate of death in the hospital was 2.96% for CAP patients who were readmitted, versus 1.11% for the index admissions (P less than .001), Dr. Ho reported. Moreover, readmissions were associated with nearly half a million hospital days and $1 billion in costs and $3.67 billion in charges.  

Based on these findings, Dr. Ho and colleagues hope to incorporate routine influenza vaccination for all adults hospitalized with CAP.

“We’re always under pressure to do so much for patients that we can’t comprehensively do everything. But the 20% reduction in the risk of coming back, I think that’s significant,” Dr. Ho said in an interview.

The authors reported having no disclosures related to this research.

This article was updated 10/23/2019.

SOURCE: Ho KS, et al. CHEST 2019. doi: 10.1016/j.chest.2019.08.450.

 

– In-hospital flu shots were rare, yet linked to a lower readmission rate for patients hospitalized with community-acquired pneumonia in a recent retrospective study, suggesting a “missed opportunity” to improve outcomes for these patients, an investigator said.

Andrew D. Bowser/MDedge News
Dr. Kam Sing Ho

Less than 2% of patients admitted for community-acquired pneumonia (CAP) received in-hospital influenza vaccination, yet receiving it was linked to a 20% reduction in readmissions, according to investigator Kam Sing Ho, MD, a resident at Mount Sinai St. Luke’s, New York.

Those patients who were readmitted had a significantly higher death rate vs. index admissions, Dr. Ho said in a poster discussion session at the annual meeting of the American College of Chest Physicians.

“I know (vaccines) are pretty much pushed out to the outpatient setting, but given what we showed here in this abstract, I think there’s a role for influenza vaccines to be a discussion in the hospital,” Dr. Ho said in his presentation.

The retrospective analysis was based on 825,906 adult hospital admissions with a primary diagnosis of CAP in data from the Agency for Healthcare Research and Quality Healthcare Cost and Utilization Project (HCUP). Of that large cohort, just 14,047 (1.91%) received in-hospital influenza vaccination, according to Dr. Ho.

In-hospital influenza vaccination independently predicted a lower risk of readmission (hazard ratio, 0.821; 95% confidence interval, 0.69-0.98; P less than .02) in a propensity score matching analysis that included 9,777 CAP patients who received the vaccination and 9,777 with similar demographic and clinical characteristics.

Private insurance and high-income status also predicted lower risk of readmission in the analysis, while by contrast, factors associated with higher risk of readmission included advanced age, Medicare insurance, and respiratory failure, among other factors, Dr. Ho reported.

The overall 30-day rate of readmission in the study was 11.9%, and of those readmissions, the great majority (about 80%) were due to pneumonia, he said.

The rate of death in the hospital was 2.96% for CAP patients who were readmitted, versus 1.11% for the index admissions (P less than .001), Dr. Ho reported. Moreover, readmissions were associated with nearly half a million hospital days and $1 billion in costs and $3.67 billion in charges.  

Based on these findings, Dr. Ho and colleagues hope to incorporate routine influenza vaccination for all adults hospitalized with CAP.

“We’re always under pressure to do so much for patients that we can’t comprehensively do everything. But the 20% reduction in the risk of coming back, I think that’s significant,” Dr. Ho said in an interview.

The authors reported having no disclosures related to this research.

This article was updated 10/23/2019.

SOURCE: Ho KS, et al. CHEST 2019. doi: 10.1016/j.chest.2019.08.450.

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FDA approves Trikafta for treatment of cystic fibrosis

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Wed, 10/23/2019 - 08:52

 

The Food and Drug Administration has approved elexacaftor/ivacaftor/tezacaftor (Trikafta) for the treatment of the most common type of cystic fibrosis in patients aged 12 years or older, the first triple-combination therapy approved for that indication.

Olivier Le Moal/Getty Images

Approval for Trikafta was based on results from two clinical trials in patients with cystic fibrosis with an F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene. In the first trial, a 24-week, randomized, double-blind, placebo-controlled study of 403 patients, the mean percent predicted forced expiratory volume in 1 second increased by 14% from baseline, compared with placebo. In the second trial, a 4-week, randomized, double-blind, active-controlled study of 107 patients, mean percent predicted forced expiratory volume in 1 second was increased 10% from baseline, compared with tezacaftor/ivacaftor, according to the FDA press release.

In the first trial, patients who received Trikafta also saw improvement in sweat chloride, reduction in the number of pulmonary exacerbations, and reduction of body mass index, compared with placebo.

The most common adverse events associated with Trikafta during the trials were headaches, upper respiratory tract infections, abdominal pains, diarrhea, rashes, and rhinorrhea, among others. The label includes a warning related to elevated liver function tests, use at the same time with products that induce or inhibit a liver enzyme called cytochrome P450 3A4, and cataract risk.

“At the FDA, we’re consistently looking for ways to help speed the development of new therapies for complex diseases, while maintaining our high standards of review. Today’s landmark approval is a testament to these efforts, making a novel treatment available to most cystic fibrosis patients, including adolescents, who previously had no options and giving others in the cystic fibrosis community access to an additional effective therapy,” said acting FDA Commissioner Ned Sharpless, MD.

Find the full press release on the FDA website.

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The Food and Drug Administration has approved elexacaftor/ivacaftor/tezacaftor (Trikafta) for the treatment of the most common type of cystic fibrosis in patients aged 12 years or older, the first triple-combination therapy approved for that indication.

Olivier Le Moal/Getty Images

Approval for Trikafta was based on results from two clinical trials in patients with cystic fibrosis with an F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene. In the first trial, a 24-week, randomized, double-blind, placebo-controlled study of 403 patients, the mean percent predicted forced expiratory volume in 1 second increased by 14% from baseline, compared with placebo. In the second trial, a 4-week, randomized, double-blind, active-controlled study of 107 patients, mean percent predicted forced expiratory volume in 1 second was increased 10% from baseline, compared with tezacaftor/ivacaftor, according to the FDA press release.

In the first trial, patients who received Trikafta also saw improvement in sweat chloride, reduction in the number of pulmonary exacerbations, and reduction of body mass index, compared with placebo.

The most common adverse events associated with Trikafta during the trials were headaches, upper respiratory tract infections, abdominal pains, diarrhea, rashes, and rhinorrhea, among others. The label includes a warning related to elevated liver function tests, use at the same time with products that induce or inhibit a liver enzyme called cytochrome P450 3A4, and cataract risk.

“At the FDA, we’re consistently looking for ways to help speed the development of new therapies for complex diseases, while maintaining our high standards of review. Today’s landmark approval is a testament to these efforts, making a novel treatment available to most cystic fibrosis patients, including adolescents, who previously had no options and giving others in the cystic fibrosis community access to an additional effective therapy,” said acting FDA Commissioner Ned Sharpless, MD.

Find the full press release on the FDA website.

 

The Food and Drug Administration has approved elexacaftor/ivacaftor/tezacaftor (Trikafta) for the treatment of the most common type of cystic fibrosis in patients aged 12 years or older, the first triple-combination therapy approved for that indication.

Olivier Le Moal/Getty Images

Approval for Trikafta was based on results from two clinical trials in patients with cystic fibrosis with an F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene. In the first trial, a 24-week, randomized, double-blind, placebo-controlled study of 403 patients, the mean percent predicted forced expiratory volume in 1 second increased by 14% from baseline, compared with placebo. In the second trial, a 4-week, randomized, double-blind, active-controlled study of 107 patients, mean percent predicted forced expiratory volume in 1 second was increased 10% from baseline, compared with tezacaftor/ivacaftor, according to the FDA press release.

In the first trial, patients who received Trikafta also saw improvement in sweat chloride, reduction in the number of pulmonary exacerbations, and reduction of body mass index, compared with placebo.

The most common adverse events associated with Trikafta during the trials were headaches, upper respiratory tract infections, abdominal pains, diarrhea, rashes, and rhinorrhea, among others. The label includes a warning related to elevated liver function tests, use at the same time with products that induce or inhibit a liver enzyme called cytochrome P450 3A4, and cataract risk.

“At the FDA, we’re consistently looking for ways to help speed the development of new therapies for complex diseases, while maintaining our high standards of review. Today’s landmark approval is a testament to these efforts, making a novel treatment available to most cystic fibrosis patients, including adolescents, who previously had no options and giving others in the cystic fibrosis community access to an additional effective therapy,” said acting FDA Commissioner Ned Sharpless, MD.

Find the full press release on the FDA website.

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Race mismatch may affect survival in lung transplant setting

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Wed, 10/23/2019 - 11:31

– Race compatibility is a factor that can affect survival and needs to be considered when matching lung transplant candidates to potential donors, results from a large retrospective analysis suggest.

Andrew D. Bowser/MDedge News
Dr. Alexis Kofi Okoh

Specifically, whites had significantly worse survival when receiving lungs from African American donors in this registry analysis, according to study investigator Alexis Kofi Okoh, MD.

By contrast, donor-to-recipient race compatibility (DRRC) did not affect posttransplant survival among African American or Hispanic patients, said Dr. Okoh, who is with the lung transplant division at the Rutgers Robert Wood Johnson Medical School, New Brunswick, N.J.

While race mismatch has been shown to affect outcomes in kidney, heart, and liver transplant settings, the data for DRRC in lung transplant prior to this analysis generally has been limited to small, single-center studies, according to Dr. Okoh.

“If you do have the option, [race compatibility] should highly be considered, because it clearly has an impact on outcomes,” Dr. Okoh said in an interview here at the annual meeting of the American College of Chest Physicians.

Considering the race of both donor and recipient is especially important now that the lung transplant population is becoming more ethnically diverse, he added.

The study was based on an analysis of 19,504 lung transplant recipients in the prospectively maintained United Network for Organ Sharing (UNOS) database during 2006-2018. In that cohort, 16,485 recipients were white, 1,787 were African American, and 1,232 were Hispanic.

Race-matched donor organs were used in two-thirds (66.2%) of white recipients, about one-quarter (26.8%) of African American recipients, and one-third (33.0%) of Hispanic recipients.

Overall, survival post–lung transplant was significantly poorer among recipients who did not receive a race-matched organ in Kaplan-Meier survival estimates, Dr. Okoh said, though, that this effect was diminished after they adjusted for patient baseline characteristics (P = 0.2809).

For African American recipients, the unadjusted and adjusted survival estimates were no different regardless of donor race, and likewise, there were no apparent survival differences between Hispanic recipients who received race matched or mismatched organs.

Survival among white recipients, however, was significantly affected by race of the recipient, with decreased survival estimates noted even after adjustment for patient characteristics, according to Dr. Okoh’s presentation.

Results of regression analysis showed that white recipient/African American donor was the only race mismatch to significantly affect survival, Dr. Okoh said in the interview.

The posttransplant survival hazard ratios (and 95% confidence intervals) reported by Dr. Okoh with a no race mismatch serving as reference were 1.15 (1.08-1.23) for whites with African American donors, and 1.09 (1.01-1.18) for whites with Hispanic donors.

Dr. Okoh and coinvestigators reported no relevant conflicts in relation to their study.

SOURCE: Okoh A et al. CHEST 2019. Abstract, doi: 10.1016/j.chest.2019.08.220.

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– Race compatibility is a factor that can affect survival and needs to be considered when matching lung transplant candidates to potential donors, results from a large retrospective analysis suggest.

Andrew D. Bowser/MDedge News
Dr. Alexis Kofi Okoh

Specifically, whites had significantly worse survival when receiving lungs from African American donors in this registry analysis, according to study investigator Alexis Kofi Okoh, MD.

By contrast, donor-to-recipient race compatibility (DRRC) did not affect posttransplant survival among African American or Hispanic patients, said Dr. Okoh, who is with the lung transplant division at the Rutgers Robert Wood Johnson Medical School, New Brunswick, N.J.

While race mismatch has been shown to affect outcomes in kidney, heart, and liver transplant settings, the data for DRRC in lung transplant prior to this analysis generally has been limited to small, single-center studies, according to Dr. Okoh.

“If you do have the option, [race compatibility] should highly be considered, because it clearly has an impact on outcomes,” Dr. Okoh said in an interview here at the annual meeting of the American College of Chest Physicians.

Considering the race of both donor and recipient is especially important now that the lung transplant population is becoming more ethnically diverse, he added.

The study was based on an analysis of 19,504 lung transplant recipients in the prospectively maintained United Network for Organ Sharing (UNOS) database during 2006-2018. In that cohort, 16,485 recipients were white, 1,787 were African American, and 1,232 were Hispanic.

Race-matched donor organs were used in two-thirds (66.2%) of white recipients, about one-quarter (26.8%) of African American recipients, and one-third (33.0%) of Hispanic recipients.

Overall, survival post–lung transplant was significantly poorer among recipients who did not receive a race-matched organ in Kaplan-Meier survival estimates, Dr. Okoh said, though, that this effect was diminished after they adjusted for patient baseline characteristics (P = 0.2809).

For African American recipients, the unadjusted and adjusted survival estimates were no different regardless of donor race, and likewise, there were no apparent survival differences between Hispanic recipients who received race matched or mismatched organs.

Survival among white recipients, however, was significantly affected by race of the recipient, with decreased survival estimates noted even after adjustment for patient characteristics, according to Dr. Okoh’s presentation.

Results of regression analysis showed that white recipient/African American donor was the only race mismatch to significantly affect survival, Dr. Okoh said in the interview.

The posttransplant survival hazard ratios (and 95% confidence intervals) reported by Dr. Okoh with a no race mismatch serving as reference were 1.15 (1.08-1.23) for whites with African American donors, and 1.09 (1.01-1.18) for whites with Hispanic donors.

Dr. Okoh and coinvestigators reported no relevant conflicts in relation to their study.

SOURCE: Okoh A et al. CHEST 2019. Abstract, doi: 10.1016/j.chest.2019.08.220.

– Race compatibility is a factor that can affect survival and needs to be considered when matching lung transplant candidates to potential donors, results from a large retrospective analysis suggest.

Andrew D. Bowser/MDedge News
Dr. Alexis Kofi Okoh

Specifically, whites had significantly worse survival when receiving lungs from African American donors in this registry analysis, according to study investigator Alexis Kofi Okoh, MD.

By contrast, donor-to-recipient race compatibility (DRRC) did not affect posttransplant survival among African American or Hispanic patients, said Dr. Okoh, who is with the lung transplant division at the Rutgers Robert Wood Johnson Medical School, New Brunswick, N.J.

While race mismatch has been shown to affect outcomes in kidney, heart, and liver transplant settings, the data for DRRC in lung transplant prior to this analysis generally has been limited to small, single-center studies, according to Dr. Okoh.

“If you do have the option, [race compatibility] should highly be considered, because it clearly has an impact on outcomes,” Dr. Okoh said in an interview here at the annual meeting of the American College of Chest Physicians.

Considering the race of both donor and recipient is especially important now that the lung transplant population is becoming more ethnically diverse, he added.

The study was based on an analysis of 19,504 lung transplant recipients in the prospectively maintained United Network for Organ Sharing (UNOS) database during 2006-2018. In that cohort, 16,485 recipients were white, 1,787 were African American, and 1,232 were Hispanic.

Race-matched donor organs were used in two-thirds (66.2%) of white recipients, about one-quarter (26.8%) of African American recipients, and one-third (33.0%) of Hispanic recipients.

Overall, survival post–lung transplant was significantly poorer among recipients who did not receive a race-matched organ in Kaplan-Meier survival estimates, Dr. Okoh said, though, that this effect was diminished after they adjusted for patient baseline characteristics (P = 0.2809).

For African American recipients, the unadjusted and adjusted survival estimates were no different regardless of donor race, and likewise, there were no apparent survival differences between Hispanic recipients who received race matched or mismatched organs.

Survival among white recipients, however, was significantly affected by race of the recipient, with decreased survival estimates noted even after adjustment for patient characteristics, according to Dr. Okoh’s presentation.

Results of regression analysis showed that white recipient/African American donor was the only race mismatch to significantly affect survival, Dr. Okoh said in the interview.

The posttransplant survival hazard ratios (and 95% confidence intervals) reported by Dr. Okoh with a no race mismatch serving as reference were 1.15 (1.08-1.23) for whites with African American donors, and 1.09 (1.01-1.18) for whites with Hispanic donors.

Dr. Okoh and coinvestigators reported no relevant conflicts in relation to their study.

SOURCE: Okoh A et al. CHEST 2019. Abstract, doi: 10.1016/j.chest.2019.08.220.

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Study suggests physicians and patients overestimate asthma control

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Tue, 10/22/2019 - 14:47

Physicians and patients both overestimate control of severe asthma, according to an observational study.

Jennifer Smith/MDedge News
Dr. Reynold Panettieri Jr.

More than half (53%) of cases physicians rated as controlled were actually uncontrolled according to the Asthma Control Test (ACT), and 30% of patients who considered their asthma controlled actually had uncontrolled asthma according to the ACT.

Reynold A. Panettieri Jr., MD, of Rutgers University in New Brunswick, N.J., presented these findings at the annual meeting of the American College of Chest Physicians.

The findings are from the CHRONICLE study, an ongoing observational study of adults with severe asthma who are being treated by U.S. allergists or pulmonologists. The study enrolled 796 patients from Feb. 2018 to Feb. 2019, and 482 of them were evaluable because they completed the necessary surveys.

The patients’ median age at enrollment was 55 years, and 68% of patients were female. Most were white (82%), 12% were black, 6% were an “other” race, and 7% had Hispanic ethnicity. The median body mass index was 31 kg/m2.

Patients received care from an allergist (49%), a pulmonologist (38%), or both (13%). Patients were treated with biologics (n = 370), maintenance systemic corticosteroids (n = 64), or high-dosage inhaled corticosteroids with additional controllers (n = 90).

At patient enrollment, physicians reported their assessment of patients’ asthma control and completed the 5-point Global Evaluation of Treatment Effectiveness (GETE). The physicians’ assessments of patients were informed by patients’ verbal reports (50%), lung function testing (44%), in-office ACT (41%), and recent exacerbations (39%).

Patients also completed the ACT and GETE online at the time of enrollment. Neither patients nor physicians were privy to the other group’s responses.

Overall, physicians said 279 patients had controlled asthma. However, according to the ACT, 27% of these cases were very poorly controlled, 26% were not well controlled, and 47% were well controlled.

“So [when] we as a provider say the patient’s controlled, we’re wrong half the time,” Dr. Panettieri said.

However, physicians were more accurate when deeming patients’ asthma uncontrolled. Physicians said 201 cases of asthma were uncontrolled, and the ACT said 64% of these cases were very poorly controlled, 22% were not well controlled, and 13% were well controlled.

Compared with the physicians’ results, the patients’ reports were more in line with ACT results. However, the patients still overestimated control.

In all, 222 patients said their asthma was controlled. According to the ACT, 70% of these cases were well controlled, 23% were not well controlled, and 7% were very poorly controlled.

Patients were even more accurate when deeming their asthma uncontrolled. A total of 258 patients said their asthma was uncontrolled. According to the ACT, 74% of these cases were very poorly controlled, 25% were not well controlled, and 1% were well controlled.

“About 99% of the time, when a patient tells you they’re uncontrolled, they’re uncontrolled by the ACT,” Dr. Panettieri said.

Though patients were fairly accurate when assessing asthma control, they were less accurate when gauging treatment effectiveness. A majority of patients overestimated the effectiveness of treatment.

There were 124 patients who did not have any improvement after treatment, according to physicians. Although 23% of the patients concurred with this assessment, 77% said they did experience some improvement.

On the other hand, there were 355 patients who had some improvement after treatment according to physicians, and most of these patients (96%) agreed that they had some improvement.

Dr. Panettieri said these results support use of the ACT and similar tools. When using these tools isn’t feasible, Dr. Panettieri recommends simply asking patients how they are feeling. However, he said, providers should not rely on a patient’s report of treatment effectiveness to assess asthma control.

This study is supported by AstraZeneca. Dr. Panettieri disclosed relationships with AstraZeneca, Sanofi, Regeneron, Genentech, and Novartis.

SOURCE: Panettieri R et al. CHEST 2019. Abstract, doi. 10.1016/j.chest.2019.08.272.
 

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Physicians and patients both overestimate control of severe asthma, according to an observational study.

Jennifer Smith/MDedge News
Dr. Reynold Panettieri Jr.

More than half (53%) of cases physicians rated as controlled were actually uncontrolled according to the Asthma Control Test (ACT), and 30% of patients who considered their asthma controlled actually had uncontrolled asthma according to the ACT.

Reynold A. Panettieri Jr., MD, of Rutgers University in New Brunswick, N.J., presented these findings at the annual meeting of the American College of Chest Physicians.

The findings are from the CHRONICLE study, an ongoing observational study of adults with severe asthma who are being treated by U.S. allergists or pulmonologists. The study enrolled 796 patients from Feb. 2018 to Feb. 2019, and 482 of them were evaluable because they completed the necessary surveys.

The patients’ median age at enrollment was 55 years, and 68% of patients were female. Most were white (82%), 12% were black, 6% were an “other” race, and 7% had Hispanic ethnicity. The median body mass index was 31 kg/m2.

Patients received care from an allergist (49%), a pulmonologist (38%), or both (13%). Patients were treated with biologics (n = 370), maintenance systemic corticosteroids (n = 64), or high-dosage inhaled corticosteroids with additional controllers (n = 90).

At patient enrollment, physicians reported their assessment of patients’ asthma control and completed the 5-point Global Evaluation of Treatment Effectiveness (GETE). The physicians’ assessments of patients were informed by patients’ verbal reports (50%), lung function testing (44%), in-office ACT (41%), and recent exacerbations (39%).

Patients also completed the ACT and GETE online at the time of enrollment. Neither patients nor physicians were privy to the other group’s responses.

Overall, physicians said 279 patients had controlled asthma. However, according to the ACT, 27% of these cases were very poorly controlled, 26% were not well controlled, and 47% were well controlled.

“So [when] we as a provider say the patient’s controlled, we’re wrong half the time,” Dr. Panettieri said.

However, physicians were more accurate when deeming patients’ asthma uncontrolled. Physicians said 201 cases of asthma were uncontrolled, and the ACT said 64% of these cases were very poorly controlled, 22% were not well controlled, and 13% were well controlled.

Compared with the physicians’ results, the patients’ reports were more in line with ACT results. However, the patients still overestimated control.

In all, 222 patients said their asthma was controlled. According to the ACT, 70% of these cases were well controlled, 23% were not well controlled, and 7% were very poorly controlled.

Patients were even more accurate when deeming their asthma uncontrolled. A total of 258 patients said their asthma was uncontrolled. According to the ACT, 74% of these cases were very poorly controlled, 25% were not well controlled, and 1% were well controlled.

“About 99% of the time, when a patient tells you they’re uncontrolled, they’re uncontrolled by the ACT,” Dr. Panettieri said.

Though patients were fairly accurate when assessing asthma control, they were less accurate when gauging treatment effectiveness. A majority of patients overestimated the effectiveness of treatment.

There were 124 patients who did not have any improvement after treatment, according to physicians. Although 23% of the patients concurred with this assessment, 77% said they did experience some improvement.

On the other hand, there were 355 patients who had some improvement after treatment according to physicians, and most of these patients (96%) agreed that they had some improvement.

Dr. Panettieri said these results support use of the ACT and similar tools. When using these tools isn’t feasible, Dr. Panettieri recommends simply asking patients how they are feeling. However, he said, providers should not rely on a patient’s report of treatment effectiveness to assess asthma control.

This study is supported by AstraZeneca. Dr. Panettieri disclosed relationships with AstraZeneca, Sanofi, Regeneron, Genentech, and Novartis.

SOURCE: Panettieri R et al. CHEST 2019. Abstract, doi. 10.1016/j.chest.2019.08.272.
 

Physicians and patients both overestimate control of severe asthma, according to an observational study.

Jennifer Smith/MDedge News
Dr. Reynold Panettieri Jr.

More than half (53%) of cases physicians rated as controlled were actually uncontrolled according to the Asthma Control Test (ACT), and 30% of patients who considered their asthma controlled actually had uncontrolled asthma according to the ACT.

Reynold A. Panettieri Jr., MD, of Rutgers University in New Brunswick, N.J., presented these findings at the annual meeting of the American College of Chest Physicians.

The findings are from the CHRONICLE study, an ongoing observational study of adults with severe asthma who are being treated by U.S. allergists or pulmonologists. The study enrolled 796 patients from Feb. 2018 to Feb. 2019, and 482 of them were evaluable because they completed the necessary surveys.

The patients’ median age at enrollment was 55 years, and 68% of patients were female. Most were white (82%), 12% were black, 6% were an “other” race, and 7% had Hispanic ethnicity. The median body mass index was 31 kg/m2.

Patients received care from an allergist (49%), a pulmonologist (38%), or both (13%). Patients were treated with biologics (n = 370), maintenance systemic corticosteroids (n = 64), or high-dosage inhaled corticosteroids with additional controllers (n = 90).

At patient enrollment, physicians reported their assessment of patients’ asthma control and completed the 5-point Global Evaluation of Treatment Effectiveness (GETE). The physicians’ assessments of patients were informed by patients’ verbal reports (50%), lung function testing (44%), in-office ACT (41%), and recent exacerbations (39%).

Patients also completed the ACT and GETE online at the time of enrollment. Neither patients nor physicians were privy to the other group’s responses.

Overall, physicians said 279 patients had controlled asthma. However, according to the ACT, 27% of these cases were very poorly controlled, 26% were not well controlled, and 47% were well controlled.

“So [when] we as a provider say the patient’s controlled, we’re wrong half the time,” Dr. Panettieri said.

However, physicians were more accurate when deeming patients’ asthma uncontrolled. Physicians said 201 cases of asthma were uncontrolled, and the ACT said 64% of these cases were very poorly controlled, 22% were not well controlled, and 13% were well controlled.

Compared with the physicians’ results, the patients’ reports were more in line with ACT results. However, the patients still overestimated control.

In all, 222 patients said their asthma was controlled. According to the ACT, 70% of these cases were well controlled, 23% were not well controlled, and 7% were very poorly controlled.

Patients were even more accurate when deeming their asthma uncontrolled. A total of 258 patients said their asthma was uncontrolled. According to the ACT, 74% of these cases were very poorly controlled, 25% were not well controlled, and 1% were well controlled.

“About 99% of the time, when a patient tells you they’re uncontrolled, they’re uncontrolled by the ACT,” Dr. Panettieri said.

Though patients were fairly accurate when assessing asthma control, they were less accurate when gauging treatment effectiveness. A majority of patients overestimated the effectiveness of treatment.

There were 124 patients who did not have any improvement after treatment, according to physicians. Although 23% of the patients concurred with this assessment, 77% said they did experience some improvement.

On the other hand, there were 355 patients who had some improvement after treatment according to physicians, and most of these patients (96%) agreed that they had some improvement.

Dr. Panettieri said these results support use of the ACT and similar tools. When using these tools isn’t feasible, Dr. Panettieri recommends simply asking patients how they are feeling. However, he said, providers should not rely on a patient’s report of treatment effectiveness to assess asthma control.

This study is supported by AstraZeneca. Dr. Panettieri disclosed relationships with AstraZeneca, Sanofi, Regeneron, Genentech, and Novartis.

SOURCE: Panettieri R et al. CHEST 2019. Abstract, doi. 10.1016/j.chest.2019.08.272.
 

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Checklist may improve quality measures in the surgical ICU

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Mon, 10/21/2019 - 12:49

 

– A standardized checklist may help reduce errors and improve common quality measures in critically ill patients, results of a recent retrospective analysis of 200 consecutive patients suggest.

Use of the checklist was linked to significantly shorter hospital length of stay and ICU length of stay as well as fewer days on a ventilator in the analysis, which was presented here at the annual meeting of the American College of Chest Physicians. The 10-item standardized checklist covered a variety topics ranging from comfort, prophylaxis, and sedation to infection control and prevention, nutrition, and medication management review.

Although health economics weren’t evaluated in this analysis, changes in those quality measures might also impact the bottom line, according to study coauthor Priscilla Chow, DO, a resident at Suburban Community Hospital in East Norriton, Pa.

“Obviously, if the patient is spending less time in the hospital and fewer days on the ventilator and in the ICU, then we can potentially also be more cost effective in our care,” Dr. Chow said in a podium presentation at the meeting.

The use of checklists to standardize processes and reduce errors is a “relatively simple approach” that was adopted from the airline industry and now has been evaluated in a variety of medical care settings, according to Dr. Chow.

Previous studies have demonstrated that checklist-driven care may reduce the incidence of postoperative complications, central line–associated bloodstream infection, ventilator-associated pneumonia, and catheter associated–urinary tract infection.

The present retrospective data analysis by Dr. Chow and colleagues included 200 consecutive patients admitted to the surgical ICU at an urban level 1 trauma center, including 100 patients managed according to the checklist and 100 managed according to standard processes.

Though survival to discharge was comparable between the groups, use of the checklist was associated with a significantly shorter hospital length of stay versus standard care (23.9 vs. 9.5 days). Likewise, the ICU length of stay was shorter in the checklist group (13.0 vs. 6.5 days), and the checklist group had fewer ventilator days (7.7 to 2.8).

Injury Severity Score did not differ between groups, though overall, use of the checklist resulted in more of the underlying topics being addressed in clinical documentation (5.0 vs. 8.7 items).

Dr. Chow and colleagues disclosed that they had no relationships relevant to their study.

SOURCE: Akella K et al. CHEST 2019. Abstract, doi: 10.1016/j.chest.2019.08.201.

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– A standardized checklist may help reduce errors and improve common quality measures in critically ill patients, results of a recent retrospective analysis of 200 consecutive patients suggest.

Use of the checklist was linked to significantly shorter hospital length of stay and ICU length of stay as well as fewer days on a ventilator in the analysis, which was presented here at the annual meeting of the American College of Chest Physicians. The 10-item standardized checklist covered a variety topics ranging from comfort, prophylaxis, and sedation to infection control and prevention, nutrition, and medication management review.

Although health economics weren’t evaluated in this analysis, changes in those quality measures might also impact the bottom line, according to study coauthor Priscilla Chow, DO, a resident at Suburban Community Hospital in East Norriton, Pa.

“Obviously, if the patient is spending less time in the hospital and fewer days on the ventilator and in the ICU, then we can potentially also be more cost effective in our care,” Dr. Chow said in a podium presentation at the meeting.

The use of checklists to standardize processes and reduce errors is a “relatively simple approach” that was adopted from the airline industry and now has been evaluated in a variety of medical care settings, according to Dr. Chow.

Previous studies have demonstrated that checklist-driven care may reduce the incidence of postoperative complications, central line–associated bloodstream infection, ventilator-associated pneumonia, and catheter associated–urinary tract infection.

The present retrospective data analysis by Dr. Chow and colleagues included 200 consecutive patients admitted to the surgical ICU at an urban level 1 trauma center, including 100 patients managed according to the checklist and 100 managed according to standard processes.

Though survival to discharge was comparable between the groups, use of the checklist was associated with a significantly shorter hospital length of stay versus standard care (23.9 vs. 9.5 days). Likewise, the ICU length of stay was shorter in the checklist group (13.0 vs. 6.5 days), and the checklist group had fewer ventilator days (7.7 to 2.8).

Injury Severity Score did not differ between groups, though overall, use of the checklist resulted in more of the underlying topics being addressed in clinical documentation (5.0 vs. 8.7 items).

Dr. Chow and colleagues disclosed that they had no relationships relevant to their study.

SOURCE: Akella K et al. CHEST 2019. Abstract, doi: 10.1016/j.chest.2019.08.201.

 

– A standardized checklist may help reduce errors and improve common quality measures in critically ill patients, results of a recent retrospective analysis of 200 consecutive patients suggest.

Use of the checklist was linked to significantly shorter hospital length of stay and ICU length of stay as well as fewer days on a ventilator in the analysis, which was presented here at the annual meeting of the American College of Chest Physicians. The 10-item standardized checklist covered a variety topics ranging from comfort, prophylaxis, and sedation to infection control and prevention, nutrition, and medication management review.

Although health economics weren’t evaluated in this analysis, changes in those quality measures might also impact the bottom line, according to study coauthor Priscilla Chow, DO, a resident at Suburban Community Hospital in East Norriton, Pa.

“Obviously, if the patient is spending less time in the hospital and fewer days on the ventilator and in the ICU, then we can potentially also be more cost effective in our care,” Dr. Chow said in a podium presentation at the meeting.

The use of checklists to standardize processes and reduce errors is a “relatively simple approach” that was adopted from the airline industry and now has been evaluated in a variety of medical care settings, according to Dr. Chow.

Previous studies have demonstrated that checklist-driven care may reduce the incidence of postoperative complications, central line–associated bloodstream infection, ventilator-associated pneumonia, and catheter associated–urinary tract infection.

The present retrospective data analysis by Dr. Chow and colleagues included 200 consecutive patients admitted to the surgical ICU at an urban level 1 trauma center, including 100 patients managed according to the checklist and 100 managed according to standard processes.

Though survival to discharge was comparable between the groups, use of the checklist was associated with a significantly shorter hospital length of stay versus standard care (23.9 vs. 9.5 days). Likewise, the ICU length of stay was shorter in the checklist group (13.0 vs. 6.5 days), and the checklist group had fewer ventilator days (7.7 to 2.8).

Injury Severity Score did not differ between groups, though overall, use of the checklist resulted in more of the underlying topics being addressed in clinical documentation (5.0 vs. 8.7 items).

Dr. Chow and colleagues disclosed that they had no relationships relevant to their study.

SOURCE: Akella K et al. CHEST 2019. Abstract, doi: 10.1016/j.chest.2019.08.201.

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Beta-blocker treatment did not reduce exacerbation risk in COPD

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Mon, 10/28/2019 - 12:11

A new study has found that beta-blocker treatment did not prevent exacerbations in patients with moderate or severe chronic obstructive pulmonary disease (COPD).

decade3d/Thinkstock

“These results differ from previously reported findings from observational studies suggesting that beta-blockers reduce the risks of exacerbation and death from any cause in patients with COPD,” wrote Mark T. Dransfield, MD, of the University of Alabama at Birmingham and coauthors. Their findings were presented at the annual meeting of the American College of Chest Physicians and also were published simultaneously in the New England Journal of Medicine.

To determine the value of beta-blockers as a potential treatment for COPD, the researchers launched a prospective randomized trial called BLOCK COPD, consisting of 532 patients with moderate or severe COPD. They were assigned to two groups: those receiving extended-release metoprolol (n = 268) and those receiving placebo (n = 264). The mean age of all patients was 65 years.

The groups saw no significant difference in median time until the first exacerbation, which was 202 days (95% confidence interval, 162-282) in the metoprolol group and 222 days (95% CI, 189-295) in the placebo group (hazard ratio, 1.05; 95% CI, 0.84-1.32; P = .66). Metoprolol was associated with a higher risk of severe or very severe exacerbations leading to hospitalization (HR, 1.91; 95% CI, 1.29-2.83). During treatment, there were 11 deaths in the metoprolol group and 5 deaths in the placebo group.

Though there was no evidence of increases in patient-reported adverse events related to metoprolol, more discontinuations did occur in the metoprolol group compared with placebo (11.2% vs. 6.1%).

The authors acknowledged their study’s limitations, chiefly including the fact that the trial was ended early “on the basis of the conditional power analyses and concern about safety.” In addition, the reduction of heart rate and blood pressure in the metoprolol group made it impossible to fully blind the study. Finally, many patients in the trial had already suffered the effects of moderate to severe COPD, including previous hospitalization and the need for supplemental oxygen, leading to uncertainty as to “whether our results would apply to patients with mild airflow obstruction or a lower exacerbation risk.”

The study was supported by a grant from the Department of Defense. The authors reported numerous potential conflicts of interest, including receiving grants, personal fees and research funds from various pharmaceutical companies and government entities.
 

SOURCE: Dransfield MT et al. CHEST 2019. 2019 Oct 20. doi: 10.1056/NEJMoa1908142.

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A new study has found that beta-blocker treatment did not prevent exacerbations in patients with moderate or severe chronic obstructive pulmonary disease (COPD).

decade3d/Thinkstock

“These results differ from previously reported findings from observational studies suggesting that beta-blockers reduce the risks of exacerbation and death from any cause in patients with COPD,” wrote Mark T. Dransfield, MD, of the University of Alabama at Birmingham and coauthors. Their findings were presented at the annual meeting of the American College of Chest Physicians and also were published simultaneously in the New England Journal of Medicine.

To determine the value of beta-blockers as a potential treatment for COPD, the researchers launched a prospective randomized trial called BLOCK COPD, consisting of 532 patients with moderate or severe COPD. They were assigned to two groups: those receiving extended-release metoprolol (n = 268) and those receiving placebo (n = 264). The mean age of all patients was 65 years.

The groups saw no significant difference in median time until the first exacerbation, which was 202 days (95% confidence interval, 162-282) in the metoprolol group and 222 days (95% CI, 189-295) in the placebo group (hazard ratio, 1.05; 95% CI, 0.84-1.32; P = .66). Metoprolol was associated with a higher risk of severe or very severe exacerbations leading to hospitalization (HR, 1.91; 95% CI, 1.29-2.83). During treatment, there were 11 deaths in the metoprolol group and 5 deaths in the placebo group.

Though there was no evidence of increases in patient-reported adverse events related to metoprolol, more discontinuations did occur in the metoprolol group compared with placebo (11.2% vs. 6.1%).

The authors acknowledged their study’s limitations, chiefly including the fact that the trial was ended early “on the basis of the conditional power analyses and concern about safety.” In addition, the reduction of heart rate and blood pressure in the metoprolol group made it impossible to fully blind the study. Finally, many patients in the trial had already suffered the effects of moderate to severe COPD, including previous hospitalization and the need for supplemental oxygen, leading to uncertainty as to “whether our results would apply to patients with mild airflow obstruction or a lower exacerbation risk.”

The study was supported by a grant from the Department of Defense. The authors reported numerous potential conflicts of interest, including receiving grants, personal fees and research funds from various pharmaceutical companies and government entities.
 

SOURCE: Dransfield MT et al. CHEST 2019. 2019 Oct 20. doi: 10.1056/NEJMoa1908142.

A new study has found that beta-blocker treatment did not prevent exacerbations in patients with moderate or severe chronic obstructive pulmonary disease (COPD).

decade3d/Thinkstock

“These results differ from previously reported findings from observational studies suggesting that beta-blockers reduce the risks of exacerbation and death from any cause in patients with COPD,” wrote Mark T. Dransfield, MD, of the University of Alabama at Birmingham and coauthors. Their findings were presented at the annual meeting of the American College of Chest Physicians and also were published simultaneously in the New England Journal of Medicine.

To determine the value of beta-blockers as a potential treatment for COPD, the researchers launched a prospective randomized trial called BLOCK COPD, consisting of 532 patients with moderate or severe COPD. They were assigned to two groups: those receiving extended-release metoprolol (n = 268) and those receiving placebo (n = 264). The mean age of all patients was 65 years.

The groups saw no significant difference in median time until the first exacerbation, which was 202 days (95% confidence interval, 162-282) in the metoprolol group and 222 days (95% CI, 189-295) in the placebo group (hazard ratio, 1.05; 95% CI, 0.84-1.32; P = .66). Metoprolol was associated with a higher risk of severe or very severe exacerbations leading to hospitalization (HR, 1.91; 95% CI, 1.29-2.83). During treatment, there were 11 deaths in the metoprolol group and 5 deaths in the placebo group.

Though there was no evidence of increases in patient-reported adverse events related to metoprolol, more discontinuations did occur in the metoprolol group compared with placebo (11.2% vs. 6.1%).

The authors acknowledged their study’s limitations, chiefly including the fact that the trial was ended early “on the basis of the conditional power analyses and concern about safety.” In addition, the reduction of heart rate and blood pressure in the metoprolol group made it impossible to fully blind the study. Finally, many patients in the trial had already suffered the effects of moderate to severe COPD, including previous hospitalization and the need for supplemental oxygen, leading to uncertainty as to “whether our results would apply to patients with mild airflow obstruction or a lower exacerbation risk.”

The study was supported by a grant from the Department of Defense. The authors reported numerous potential conflicts of interest, including receiving grants, personal fees and research funds from various pharmaceutical companies and government entities.
 

SOURCE: Dransfield MT et al. CHEST 2019. 2019 Oct 20. doi: 10.1056/NEJMoa1908142.

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The effect of smoking lingers

No smoking is safe
Article Type
Changed
Mon, 10/21/2019 - 09:46

Lung function appears to continue to decline even decades after smoking cessation, according to new data from the National Heart, Lung, and Blood Institute Pooled Cohort Study. Compared with never-smokers, former smokers had a decline in forced expiratory volume in 1 second (FEV1) about 20% as severe as current smokers, but nevertheless higher than never-smokers. Low-intensity smokers also fared worse than never-smokers, suggesting that no amount of smoke exposure should be considered safe.

bilderbox/fotolia.com

The increased decline occurred even decades after smoking cessation, according to the study published in Lancet Respiratory Medicine, which was led by Elizabeth Oelsner, MD, MPH, of Columbia University, New York. Smoking prevalence has decreased from 42% to 16% in the past 50 years, and many smokers report that they smoke fewer cigarettes per day, from an average of 21 to 14, according to the authors. Despite those trends, the prevalence of chronic obstructive pulmonary disease has continued to increase, and is now the third-leading cause of death worldwide.

A meta-analysis of 47 studies and 88,887 adults found no association between smoking and FEV1 decline, but many of the studies were small or focused on nonrepresentative populations, and they used variably standardized spirometry.

The study pooled data from nine individual U.S. cohorts, with 25,352 participants recruited during 1983-2016. Subjects included those who underwent at least two prebronchodilator spirometry tests following American Thoracic Society standards. After adjustment, former smokers had increased FEV1 decline of 1.82 mL/year (P less than .0001), compared with never-smokers. Current smokers had an increased decline of 9.21 mL/year (P less than .0001).

Even after decades of abstinence, the effects of smoking appeared to linger: 20-30 years later, FEV1 loss was accelerated by 2.50 mL/year (P less than .0001), and by 0.93 mL/year (P = .0104) after 30 years, compared with never-smokers.

Even low-intensity smokers (cumulative less than 10 pack-years) had an significantly accelerated FEV1 decline (0.87 mL; P = .0153).

The researchers also found a relationship between FEV1 decline and intensity of current smoking: Those smoking fewer than 5 cigarettes per day had a lower decline than those smoking 30 or more (7.65 mL; 95% confidence interval, 6.21-9.09 vs. 11.24 mL; 95% CI, 9.86-12.62).

The study is limited by the fact that smoking status and daily tobacco reporting were self-reported, which could result in information bias.

The study was funded by the National Institutes of Health, National Heart Lung and Blood Institute, and U.S. Environmental Protection Agency. The authors report personal fees, consultancy fees, or grants from a wide variety of pharmaceutical companies.
 

SOURCE: Oelsner EC et al. Lancet Respir Med. 2019 Oct 9. doi: 10.1016/S2213-2600(19)30276-0.

Body

It is unclear whether the small increase in FEV1 decline (1.82 mL) seen among former smokers is clinically significant, though it suggests lasting damage from smoking. The increased decline in low-intensity smokers is an important observation confirming accumulating evidence that no amount of smoking is free of harm. This is a key message because some physicians and members of the public believe that low-intensity smoking and use of low-dose tobacco products can reduce or eliminate risk, according to Yunus Çolak, MD, and Peter Lange, MD, in their accompanying commentary (Lancet Respir Med. 2019 Oct 9. doi. org/10.1016/S2213-2600[19]30349-2). “More information is needed to manage patients with COPD [chronic obstructive pulmonary disease] in an era with decreasing smoking prevalence and an increasing proportion of smokers with low,” they added. “We should begin by questioning the arbitrary cutoff of 10 pack-years of cumulated tobacco exposure, which is currently the rule in most clinical trials of COPD. Additionally, we should not promote low-intensity smoking and use of low-dose tobacco products as a means of harm reduction but instead promote early smoking cessation,” they concluded.

Dr. Çolak and Dr. Lange are at the University of Copenhagen. The remarks are from their online commentary to the article. The reported receiving fees and grants from a variety of pharmaceutical companies.
 

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It is unclear whether the small increase in FEV1 decline (1.82 mL) seen among former smokers is clinically significant, though it suggests lasting damage from smoking. The increased decline in low-intensity smokers is an important observation confirming accumulating evidence that no amount of smoking is free of harm. This is a key message because some physicians and members of the public believe that low-intensity smoking and use of low-dose tobacco products can reduce or eliminate risk, according to Yunus Çolak, MD, and Peter Lange, MD, in their accompanying commentary (Lancet Respir Med. 2019 Oct 9. doi. org/10.1016/S2213-2600[19]30349-2). “More information is needed to manage patients with COPD [chronic obstructive pulmonary disease] in an era with decreasing smoking prevalence and an increasing proportion of smokers with low,” they added. “We should begin by questioning the arbitrary cutoff of 10 pack-years of cumulated tobacco exposure, which is currently the rule in most clinical trials of COPD. Additionally, we should not promote low-intensity smoking and use of low-dose tobacco products as a means of harm reduction but instead promote early smoking cessation,” they concluded.

Dr. Çolak and Dr. Lange are at the University of Copenhagen. The remarks are from their online commentary to the article. The reported receiving fees and grants from a variety of pharmaceutical companies.
 

Body

It is unclear whether the small increase in FEV1 decline (1.82 mL) seen among former smokers is clinically significant, though it suggests lasting damage from smoking. The increased decline in low-intensity smokers is an important observation confirming accumulating evidence that no amount of smoking is free of harm. This is a key message because some physicians and members of the public believe that low-intensity smoking and use of low-dose tobacco products can reduce or eliminate risk, according to Yunus Çolak, MD, and Peter Lange, MD, in their accompanying commentary (Lancet Respir Med. 2019 Oct 9. doi. org/10.1016/S2213-2600[19]30349-2). “More information is needed to manage patients with COPD [chronic obstructive pulmonary disease] in an era with decreasing smoking prevalence and an increasing proportion of smokers with low,” they added. “We should begin by questioning the arbitrary cutoff of 10 pack-years of cumulated tobacco exposure, which is currently the rule in most clinical trials of COPD. Additionally, we should not promote low-intensity smoking and use of low-dose tobacco products as a means of harm reduction but instead promote early smoking cessation,” they concluded.

Dr. Çolak and Dr. Lange are at the University of Copenhagen. The remarks are from their online commentary to the article. The reported receiving fees and grants from a variety of pharmaceutical companies.
 

Title
No smoking is safe
No smoking is safe

Lung function appears to continue to decline even decades after smoking cessation, according to new data from the National Heart, Lung, and Blood Institute Pooled Cohort Study. Compared with never-smokers, former smokers had a decline in forced expiratory volume in 1 second (FEV1) about 20% as severe as current smokers, but nevertheless higher than never-smokers. Low-intensity smokers also fared worse than never-smokers, suggesting that no amount of smoke exposure should be considered safe.

bilderbox/fotolia.com

The increased decline occurred even decades after smoking cessation, according to the study published in Lancet Respiratory Medicine, which was led by Elizabeth Oelsner, MD, MPH, of Columbia University, New York. Smoking prevalence has decreased from 42% to 16% in the past 50 years, and many smokers report that they smoke fewer cigarettes per day, from an average of 21 to 14, according to the authors. Despite those trends, the prevalence of chronic obstructive pulmonary disease has continued to increase, and is now the third-leading cause of death worldwide.

A meta-analysis of 47 studies and 88,887 adults found no association between smoking and FEV1 decline, but many of the studies were small or focused on nonrepresentative populations, and they used variably standardized spirometry.

The study pooled data from nine individual U.S. cohorts, with 25,352 participants recruited during 1983-2016. Subjects included those who underwent at least two prebronchodilator spirometry tests following American Thoracic Society standards. After adjustment, former smokers had increased FEV1 decline of 1.82 mL/year (P less than .0001), compared with never-smokers. Current smokers had an increased decline of 9.21 mL/year (P less than .0001).

Even after decades of abstinence, the effects of smoking appeared to linger: 20-30 years later, FEV1 loss was accelerated by 2.50 mL/year (P less than .0001), and by 0.93 mL/year (P = .0104) after 30 years, compared with never-smokers.

Even low-intensity smokers (cumulative less than 10 pack-years) had an significantly accelerated FEV1 decline (0.87 mL; P = .0153).

The researchers also found a relationship between FEV1 decline and intensity of current smoking: Those smoking fewer than 5 cigarettes per day had a lower decline than those smoking 30 or more (7.65 mL; 95% confidence interval, 6.21-9.09 vs. 11.24 mL; 95% CI, 9.86-12.62).

The study is limited by the fact that smoking status and daily tobacco reporting were self-reported, which could result in information bias.

The study was funded by the National Institutes of Health, National Heart Lung and Blood Institute, and U.S. Environmental Protection Agency. The authors report personal fees, consultancy fees, or grants from a wide variety of pharmaceutical companies.
 

SOURCE: Oelsner EC et al. Lancet Respir Med. 2019 Oct 9. doi: 10.1016/S2213-2600(19)30276-0.

Lung function appears to continue to decline even decades after smoking cessation, according to new data from the National Heart, Lung, and Blood Institute Pooled Cohort Study. Compared with never-smokers, former smokers had a decline in forced expiratory volume in 1 second (FEV1) about 20% as severe as current smokers, but nevertheless higher than never-smokers. Low-intensity smokers also fared worse than never-smokers, suggesting that no amount of smoke exposure should be considered safe.

bilderbox/fotolia.com

The increased decline occurred even decades after smoking cessation, according to the study published in Lancet Respiratory Medicine, which was led by Elizabeth Oelsner, MD, MPH, of Columbia University, New York. Smoking prevalence has decreased from 42% to 16% in the past 50 years, and many smokers report that they smoke fewer cigarettes per day, from an average of 21 to 14, according to the authors. Despite those trends, the prevalence of chronic obstructive pulmonary disease has continued to increase, and is now the third-leading cause of death worldwide.

A meta-analysis of 47 studies and 88,887 adults found no association between smoking and FEV1 decline, but many of the studies were small or focused on nonrepresentative populations, and they used variably standardized spirometry.

The study pooled data from nine individual U.S. cohorts, with 25,352 participants recruited during 1983-2016. Subjects included those who underwent at least two prebronchodilator spirometry tests following American Thoracic Society standards. After adjustment, former smokers had increased FEV1 decline of 1.82 mL/year (P less than .0001), compared with never-smokers. Current smokers had an increased decline of 9.21 mL/year (P less than .0001).

Even after decades of abstinence, the effects of smoking appeared to linger: 20-30 years later, FEV1 loss was accelerated by 2.50 mL/year (P less than .0001), and by 0.93 mL/year (P = .0104) after 30 years, compared with never-smokers.

Even low-intensity smokers (cumulative less than 10 pack-years) had an significantly accelerated FEV1 decline (0.87 mL; P = .0153).

The researchers also found a relationship between FEV1 decline and intensity of current smoking: Those smoking fewer than 5 cigarettes per day had a lower decline than those smoking 30 or more (7.65 mL; 95% confidence interval, 6.21-9.09 vs. 11.24 mL; 95% CI, 9.86-12.62).

The study is limited by the fact that smoking status and daily tobacco reporting were self-reported, which could result in information bias.

The study was funded by the National Institutes of Health, National Heart Lung and Blood Institute, and U.S. Environmental Protection Agency. The authors report personal fees, consultancy fees, or grants from a wide variety of pharmaceutical companies.
 

SOURCE: Oelsner EC et al. Lancet Respir Med. 2019 Oct 9. doi: 10.1016/S2213-2600(19)30276-0.

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