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Don’t use cannabis to treat OSA, AASM recommends
, according to a position statement published in the Journal of Clinical Sleep Medicine’s April issue.
In the statement, the professional society recommends that state legislators, regulators, and health departments exclude obstructive sleep apnea (OSA) as an indication for medical cannabis programs.
The “unreliable delivery methods and insufficient evidence of treatment effectiveness, tolerability, and safety” of medical cannabis and its synthetic extracts are among the reasons the AASM gave for making its recommendations. “Further research is needed to better understand the mechanistic actions of medical cannabis and its synthetic extracts, the long-term role of these synthetic extracts on OSA treatment, and harms and benefits,” the AASM concluded in its statement, authored by Kannan Ramar, MD, and other members of a panel of experts on sleep medicine.
Dronabinol is the only cannabis product that has been tested on patients with OSA for the treatment of this disorder. While some synthetic cannabis products are approved by the Food and Drug Administration for other medical indications, the synthetic-based cannabis product dronabinol has not received FDA approval for the treatment of OSA.
Researchers have examined dronabinol’s use for treating OSA in small pilot and proof-of-concept studies and most patients in these studies reported experiencing treatment-related side effects, such as somnolence, wrote Dr. Ramar, of the division of pulmonary and critical care medicine at the Center for Sleep Medicine, Mayo Clinic, Rochester Minn., and his colleagues.
These trials involved patients having taken dronabinol pills in strengths ranging from 2.5 mg to 10 mg. One such study (Front Psychiatry. 2013 Jan 22. doi: 10.3389/fpsyt.2013.00001), authored by Bharati Prasad of the University of Illinois, Chicago, and colleagues, showed a significant improvement in apnea-hypopnea index (AHI) of 32%, after 17 patients used dronabinol for 3 weeks, when compared with baseline AHIs (–14.1; P = .007).
A placebo-controlled randomized study of 73 adults with moderate or severe OSA similarly found a 33% decline in AHI in patients following 6 weeks of treatment with 10-mg doses of dronabinol (Sleep. 2018 Jan 1. doi: 10.1093/sleep/zsx184).
In the placebo-controlled study, 73 patients were randomized to receive 2.5 mg of dronabinol or 10 mg of dronabinol daily for up to 6 weeks, or placebo. At the end of treatment, researchers saw significant increases in the AHI among the patients on placebo, while those who received dronabinol showed decreases in the number of apnea and hypopnea events per hour. Patients given the 2.5-mg dose of dronabinol had a mean decrease of 10.7 events per hour, and those on the 10-mg dose had a mean decrease of 12.9 events per hour compared with placebo. The difference between the placebo and treatment arms was significant for both dosages, and the AHI decreases were similar between the two dosages of dronabinol.
These effects were largely due to reductions in apnea events; the largest reduction was seen in the REM apnea index in patients treated with the 10-mg dose of dronabinol. However, there were few effects on the expression of hypopneas, except in the higher-dose group.
After adjustment for age, race, ethnicity, and baseline AHI, the increases seen in the placebo group were no longer significant, but the decreases from baseline seen in the treatment arms were greater. Dronabinol treatment also was associated with significant decreases, compared with placebo, in non-REM AHI and REM AHI.
Overall, nearly 90% of patients in this trial reported at least one adverse event, with the rates having not differed significantly between the treatment and placebo arms. The most frequently reported adverse events were “sleepiness/drowsiness” (n = 25; 8% of total adverse events reported), headache (n = 24; 8%), “nausea/vomiting” (n = 23; 8%), and “dizziness/lightheadedness” (n = 12; 4%). In addition, one patient experienced diarrhea and vomiting that required admission to a hospital, which was judged as possibly related to the study medication. There were six other withdrawals due to adverse events, including dizziness and vision changes, vertigo, ECG arrhythmias, and headache with dizziness and vomiting.
“Synthetic medical cannabis may have differential side effects, with variable efficacy and side effects in the treatment of OSA. Therefore, it is the position of the American Academy of Sleep Medicine that medical cannabis and/or its synthetic extracts should not be used for the treatment of OSA,” Dr. Ramar and his associates wrote.
, according to a position statement published in the Journal of Clinical Sleep Medicine’s April issue.
In the statement, the professional society recommends that state legislators, regulators, and health departments exclude obstructive sleep apnea (OSA) as an indication for medical cannabis programs.
The “unreliable delivery methods and insufficient evidence of treatment effectiveness, tolerability, and safety” of medical cannabis and its synthetic extracts are among the reasons the AASM gave for making its recommendations. “Further research is needed to better understand the mechanistic actions of medical cannabis and its synthetic extracts, the long-term role of these synthetic extracts on OSA treatment, and harms and benefits,” the AASM concluded in its statement, authored by Kannan Ramar, MD, and other members of a panel of experts on sleep medicine.
Dronabinol is the only cannabis product that has been tested on patients with OSA for the treatment of this disorder. While some synthetic cannabis products are approved by the Food and Drug Administration for other medical indications, the synthetic-based cannabis product dronabinol has not received FDA approval for the treatment of OSA.
Researchers have examined dronabinol’s use for treating OSA in small pilot and proof-of-concept studies and most patients in these studies reported experiencing treatment-related side effects, such as somnolence, wrote Dr. Ramar, of the division of pulmonary and critical care medicine at the Center for Sleep Medicine, Mayo Clinic, Rochester Minn., and his colleagues.
These trials involved patients having taken dronabinol pills in strengths ranging from 2.5 mg to 10 mg. One such study (Front Psychiatry. 2013 Jan 22. doi: 10.3389/fpsyt.2013.00001), authored by Bharati Prasad of the University of Illinois, Chicago, and colleagues, showed a significant improvement in apnea-hypopnea index (AHI) of 32%, after 17 patients used dronabinol for 3 weeks, when compared with baseline AHIs (–14.1; P = .007).
A placebo-controlled randomized study of 73 adults with moderate or severe OSA similarly found a 33% decline in AHI in patients following 6 weeks of treatment with 10-mg doses of dronabinol (Sleep. 2018 Jan 1. doi: 10.1093/sleep/zsx184).
In the placebo-controlled study, 73 patients were randomized to receive 2.5 mg of dronabinol or 10 mg of dronabinol daily for up to 6 weeks, or placebo. At the end of treatment, researchers saw significant increases in the AHI among the patients on placebo, while those who received dronabinol showed decreases in the number of apnea and hypopnea events per hour. Patients given the 2.5-mg dose of dronabinol had a mean decrease of 10.7 events per hour, and those on the 10-mg dose had a mean decrease of 12.9 events per hour compared with placebo. The difference between the placebo and treatment arms was significant for both dosages, and the AHI decreases were similar between the two dosages of dronabinol.
These effects were largely due to reductions in apnea events; the largest reduction was seen in the REM apnea index in patients treated with the 10-mg dose of dronabinol. However, there were few effects on the expression of hypopneas, except in the higher-dose group.
After adjustment for age, race, ethnicity, and baseline AHI, the increases seen in the placebo group were no longer significant, but the decreases from baseline seen in the treatment arms were greater. Dronabinol treatment also was associated with significant decreases, compared with placebo, in non-REM AHI and REM AHI.
Overall, nearly 90% of patients in this trial reported at least one adverse event, with the rates having not differed significantly between the treatment and placebo arms. The most frequently reported adverse events were “sleepiness/drowsiness” (n = 25; 8% of total adverse events reported), headache (n = 24; 8%), “nausea/vomiting” (n = 23; 8%), and “dizziness/lightheadedness” (n = 12; 4%). In addition, one patient experienced diarrhea and vomiting that required admission to a hospital, which was judged as possibly related to the study medication. There were six other withdrawals due to adverse events, including dizziness and vision changes, vertigo, ECG arrhythmias, and headache with dizziness and vomiting.
“Synthetic medical cannabis may have differential side effects, with variable efficacy and side effects in the treatment of OSA. Therefore, it is the position of the American Academy of Sleep Medicine that medical cannabis and/or its synthetic extracts should not be used for the treatment of OSA,” Dr. Ramar and his associates wrote.
, according to a position statement published in the Journal of Clinical Sleep Medicine’s April issue.
In the statement, the professional society recommends that state legislators, regulators, and health departments exclude obstructive sleep apnea (OSA) as an indication for medical cannabis programs.
The “unreliable delivery methods and insufficient evidence of treatment effectiveness, tolerability, and safety” of medical cannabis and its synthetic extracts are among the reasons the AASM gave for making its recommendations. “Further research is needed to better understand the mechanistic actions of medical cannabis and its synthetic extracts, the long-term role of these synthetic extracts on OSA treatment, and harms and benefits,” the AASM concluded in its statement, authored by Kannan Ramar, MD, and other members of a panel of experts on sleep medicine.
Dronabinol is the only cannabis product that has been tested on patients with OSA for the treatment of this disorder. While some synthetic cannabis products are approved by the Food and Drug Administration for other medical indications, the synthetic-based cannabis product dronabinol has not received FDA approval for the treatment of OSA.
Researchers have examined dronabinol’s use for treating OSA in small pilot and proof-of-concept studies and most patients in these studies reported experiencing treatment-related side effects, such as somnolence, wrote Dr. Ramar, of the division of pulmonary and critical care medicine at the Center for Sleep Medicine, Mayo Clinic, Rochester Minn., and his colleagues.
These trials involved patients having taken dronabinol pills in strengths ranging from 2.5 mg to 10 mg. One such study (Front Psychiatry. 2013 Jan 22. doi: 10.3389/fpsyt.2013.00001), authored by Bharati Prasad of the University of Illinois, Chicago, and colleagues, showed a significant improvement in apnea-hypopnea index (AHI) of 32%, after 17 patients used dronabinol for 3 weeks, when compared with baseline AHIs (–14.1; P = .007).
A placebo-controlled randomized study of 73 adults with moderate or severe OSA similarly found a 33% decline in AHI in patients following 6 weeks of treatment with 10-mg doses of dronabinol (Sleep. 2018 Jan 1. doi: 10.1093/sleep/zsx184).
In the placebo-controlled study, 73 patients were randomized to receive 2.5 mg of dronabinol or 10 mg of dronabinol daily for up to 6 weeks, or placebo. At the end of treatment, researchers saw significant increases in the AHI among the patients on placebo, while those who received dronabinol showed decreases in the number of apnea and hypopnea events per hour. Patients given the 2.5-mg dose of dronabinol had a mean decrease of 10.7 events per hour, and those on the 10-mg dose had a mean decrease of 12.9 events per hour compared with placebo. The difference between the placebo and treatment arms was significant for both dosages, and the AHI decreases were similar between the two dosages of dronabinol.
These effects were largely due to reductions in apnea events; the largest reduction was seen in the REM apnea index in patients treated with the 10-mg dose of dronabinol. However, there were few effects on the expression of hypopneas, except in the higher-dose group.
After adjustment for age, race, ethnicity, and baseline AHI, the increases seen in the placebo group were no longer significant, but the decreases from baseline seen in the treatment arms were greater. Dronabinol treatment also was associated with significant decreases, compared with placebo, in non-REM AHI and REM AHI.
Overall, nearly 90% of patients in this trial reported at least one adverse event, with the rates having not differed significantly between the treatment and placebo arms. The most frequently reported adverse events were “sleepiness/drowsiness” (n = 25; 8% of total adverse events reported), headache (n = 24; 8%), “nausea/vomiting” (n = 23; 8%), and “dizziness/lightheadedness” (n = 12; 4%). In addition, one patient experienced diarrhea and vomiting that required admission to a hospital, which was judged as possibly related to the study medication. There were six other withdrawals due to adverse events, including dizziness and vision changes, vertigo, ECG arrhythmias, and headache with dizziness and vomiting.
“Synthetic medical cannabis may have differential side effects, with variable efficacy and side effects in the treatment of OSA. Therefore, it is the position of the American Academy of Sleep Medicine that medical cannabis and/or its synthetic extracts should not be used for the treatment of OSA,” Dr. Ramar and his associates wrote.
FROM THE JOURNAL OF CLINICAL SLEEP MEDICINE
FDA meeting on medical devices for sleep apnea scheduled
In a statement sent to members, CHEST invited all to attend this open meeting, which will be held at the FDA White Oak Campus in Silver Spring, Md.
In a statement sent to members, CHEST invited all to attend this open meeting, which will be held at the FDA White Oak Campus in Silver Spring, Md.
In a statement sent to members, CHEST invited all to attend this open meeting, which will be held at the FDA White Oak Campus in Silver Spring, Md.
Adenotonsillectomy reduced hypertension in OSA subgroup
after surgery, according to a retrospective analysis.
This is one of the few studies to have ever examined whether adenotonsillectomy for children with OSA had any effects on blood pressure (BP) and was based on “one of the largest cohorts for evaluating postoperative BP changes in nonobese children with OSA,” noted Cho-Hsueh Lee, MD, and colleagues. The report was published in JAMA Otolaryngology–Head & Neck Surgery. Among the previous studies that evaluated BP in children with OSA before and after having this surgery, the results varied, they added.
The researchers analyzed the medical records of 240 nonobese children with clinical symptoms and polysomnography-confirmed OSA (having an apnea-hypopnea index of greater than 1) who underwent adenotonsillectomy. Prior to surgery, 169 patients (70.4%) of the patients were classified as nonhypertensive, while 71 (29.6%) were classified as hypertensive. The children had a mean age of 7.3 years, and 160 were males.
Patients participated in full-night polysomnography (PSG) before surgery and at 3-6 months after adenotonsillectomy in the National Taiwan University Hospital Sleep Center. Apnea episodes were defined as a 90% decrease in airflow for two consecutive breaths. Sleep center staff measured the study participants’ systolic and diastolic BP in a sleep center using an electronic sphygmomanometer, in the evening, prior to the PSG study, and in the morning. Pediatric hypertension was based on the nocturnal BP measurement and was defined as having mean systolic and diastolic BP greater or equal to the 95th percentile for age, sex, and height.
“Postoperatively, hypertensive children had a significant decrease in all BP measures, including nocturnal and morning [systolic] BP ... A total of 47 hypertensive patients (66.2%) became nonhypertensive after surgery,” the researchers said.
For patients who were hypertensive before surgery, the average nocturnal (before PSG) preop systolic BP was 114.3 mm Hg, versus 107.5 mm Hg after surgery. The mean nocturnal diastolic BP for this same group of patients decreased to 65.1 mm Hg from 74.3 mm Hg. Similarly, the average morning (after PSG) systolic BP and diastolic BP were 106.0 mm Hg and 64.4 mm Hg after these patients underwent adenotonsillectomy, compared with 111.8 mm Hg and 71.7 mm Hg prior to surgery, respectively.
The adenotonsillectomy didn’t improve all patients’ BP. For some who were nonhypertensive before surgery, blood pressure increased, with 36 (21.3%) of this group having become hypersensitive after surgery, the researchers acknowledged.
Overall, the cohort experienced significant improvements in several PSG measures, including the average apnea-hypopnea index, which decreased from 12.1 events per hour to 1.7. The total arousal index also declined, going from 6.1 events per hour to 4.2. In addition, the mean oxygen saturation improved from 96.8% to 97.7%.
The investigators described several limitations of the study, including their inability to collect patients’ arterial stiffness, carotid intima thickness, and other cardiovascular measures beyond BP.
They recommended a follow-up study. “Although we observed improvements in BP measures within 6 months after surgery for hypertensive children with OSA, the long-term effects of surgery on BP remain uncertain,” they explained.
The study was supported by grants from the Ministry of Science and Technology, Republic of China (Taiwan). The researchers disclosed no potential conflicts of interest.
SOURCE: Lee, C-H et al. JAMA Otolaryngol Head Neck Surg. 2018 Feb 15. doi: 10.1001/jamaoto.2017.3127.
after surgery, according to a retrospective analysis.
This is one of the few studies to have ever examined whether adenotonsillectomy for children with OSA had any effects on blood pressure (BP) and was based on “one of the largest cohorts for evaluating postoperative BP changes in nonobese children with OSA,” noted Cho-Hsueh Lee, MD, and colleagues. The report was published in JAMA Otolaryngology–Head & Neck Surgery. Among the previous studies that evaluated BP in children with OSA before and after having this surgery, the results varied, they added.
The researchers analyzed the medical records of 240 nonobese children with clinical symptoms and polysomnography-confirmed OSA (having an apnea-hypopnea index of greater than 1) who underwent adenotonsillectomy. Prior to surgery, 169 patients (70.4%) of the patients were classified as nonhypertensive, while 71 (29.6%) were classified as hypertensive. The children had a mean age of 7.3 years, and 160 were males.
Patients participated in full-night polysomnography (PSG) before surgery and at 3-6 months after adenotonsillectomy in the National Taiwan University Hospital Sleep Center. Apnea episodes were defined as a 90% decrease in airflow for two consecutive breaths. Sleep center staff measured the study participants’ systolic and diastolic BP in a sleep center using an electronic sphygmomanometer, in the evening, prior to the PSG study, and in the morning. Pediatric hypertension was based on the nocturnal BP measurement and was defined as having mean systolic and diastolic BP greater or equal to the 95th percentile for age, sex, and height.
“Postoperatively, hypertensive children had a significant decrease in all BP measures, including nocturnal and morning [systolic] BP ... A total of 47 hypertensive patients (66.2%) became nonhypertensive after surgery,” the researchers said.
For patients who were hypertensive before surgery, the average nocturnal (before PSG) preop systolic BP was 114.3 mm Hg, versus 107.5 mm Hg after surgery. The mean nocturnal diastolic BP for this same group of patients decreased to 65.1 mm Hg from 74.3 mm Hg. Similarly, the average morning (after PSG) systolic BP and diastolic BP were 106.0 mm Hg and 64.4 mm Hg after these patients underwent adenotonsillectomy, compared with 111.8 mm Hg and 71.7 mm Hg prior to surgery, respectively.
The adenotonsillectomy didn’t improve all patients’ BP. For some who were nonhypertensive before surgery, blood pressure increased, with 36 (21.3%) of this group having become hypersensitive after surgery, the researchers acknowledged.
Overall, the cohort experienced significant improvements in several PSG measures, including the average apnea-hypopnea index, which decreased from 12.1 events per hour to 1.7. The total arousal index also declined, going from 6.1 events per hour to 4.2. In addition, the mean oxygen saturation improved from 96.8% to 97.7%.
The investigators described several limitations of the study, including their inability to collect patients’ arterial stiffness, carotid intima thickness, and other cardiovascular measures beyond BP.
They recommended a follow-up study. “Although we observed improvements in BP measures within 6 months after surgery for hypertensive children with OSA, the long-term effects of surgery on BP remain uncertain,” they explained.
The study was supported by grants from the Ministry of Science and Technology, Republic of China (Taiwan). The researchers disclosed no potential conflicts of interest.
SOURCE: Lee, C-H et al. JAMA Otolaryngol Head Neck Surg. 2018 Feb 15. doi: 10.1001/jamaoto.2017.3127.
after surgery, according to a retrospective analysis.
This is one of the few studies to have ever examined whether adenotonsillectomy for children with OSA had any effects on blood pressure (BP) and was based on “one of the largest cohorts for evaluating postoperative BP changes in nonobese children with OSA,” noted Cho-Hsueh Lee, MD, and colleagues. The report was published in JAMA Otolaryngology–Head & Neck Surgery. Among the previous studies that evaluated BP in children with OSA before and after having this surgery, the results varied, they added.
The researchers analyzed the medical records of 240 nonobese children with clinical symptoms and polysomnography-confirmed OSA (having an apnea-hypopnea index of greater than 1) who underwent adenotonsillectomy. Prior to surgery, 169 patients (70.4%) of the patients were classified as nonhypertensive, while 71 (29.6%) were classified as hypertensive. The children had a mean age of 7.3 years, and 160 were males.
Patients participated in full-night polysomnography (PSG) before surgery and at 3-6 months after adenotonsillectomy in the National Taiwan University Hospital Sleep Center. Apnea episodes were defined as a 90% decrease in airflow for two consecutive breaths. Sleep center staff measured the study participants’ systolic and diastolic BP in a sleep center using an electronic sphygmomanometer, in the evening, prior to the PSG study, and in the morning. Pediatric hypertension was based on the nocturnal BP measurement and was defined as having mean systolic and diastolic BP greater or equal to the 95th percentile for age, sex, and height.
“Postoperatively, hypertensive children had a significant decrease in all BP measures, including nocturnal and morning [systolic] BP ... A total of 47 hypertensive patients (66.2%) became nonhypertensive after surgery,” the researchers said.
For patients who were hypertensive before surgery, the average nocturnal (before PSG) preop systolic BP was 114.3 mm Hg, versus 107.5 mm Hg after surgery. The mean nocturnal diastolic BP for this same group of patients decreased to 65.1 mm Hg from 74.3 mm Hg. Similarly, the average morning (after PSG) systolic BP and diastolic BP were 106.0 mm Hg and 64.4 mm Hg after these patients underwent adenotonsillectomy, compared with 111.8 mm Hg and 71.7 mm Hg prior to surgery, respectively.
The adenotonsillectomy didn’t improve all patients’ BP. For some who were nonhypertensive before surgery, blood pressure increased, with 36 (21.3%) of this group having become hypersensitive after surgery, the researchers acknowledged.
Overall, the cohort experienced significant improvements in several PSG measures, including the average apnea-hypopnea index, which decreased from 12.1 events per hour to 1.7. The total arousal index also declined, going from 6.1 events per hour to 4.2. In addition, the mean oxygen saturation improved from 96.8% to 97.7%.
The investigators described several limitations of the study, including their inability to collect patients’ arterial stiffness, carotid intima thickness, and other cardiovascular measures beyond BP.
They recommended a follow-up study. “Although we observed improvements in BP measures within 6 months after surgery for hypertensive children with OSA, the long-term effects of surgery on BP remain uncertain,” they explained.
The study was supported by grants from the Ministry of Science and Technology, Republic of China (Taiwan). The researchers disclosed no potential conflicts of interest.
SOURCE: Lee, C-H et al. JAMA Otolaryngol Head Neck Surg. 2018 Feb 15. doi: 10.1001/jamaoto.2017.3127.
FROM JAMA OTOLARYNGOLOGY-HEAD & NECK SURGERY
Key clinical point: Hypertensive children with obstructive sleep apnea (OSA) who had an adenotonsillectomy experienced significant improvements in their blood pressure after surgery.
Major finding: Sixty-six percent of hypertensive patients with OSA became nonhypertensive after adenotonsillectomy.
Study details: A retrospective analysis of 240 nonobese children with OSA who underwent adenotonsillectomy.
Disclosures: The study was supported by grants from the Ministry of Science and Technology, Republic of China (Taiwan). The researchers disclosed no potential conflicts of interest.
Source: Lee, C-H et al. JAMA Otolaryngol Head Neck Surg. 2018 Feb 15. doi: 10.1001/jamaoto.2017.3127.
FDA approves starting dose of roflumilast
The Food and Drug Administration has approved the use of a 250-mcg dose of roflumilast for patients with chronic obstructive pulmonary disease (COPD) for 4 weeks, followed by the use of 500-mcg therapeutic doses, according to a statement from the drug’s marketer, AstraZeneca.
The larger doses of roflumilast (Daliresp) are currently indicated for reducing the risk of COPD exacerbations in patients with severe COPD associated with chronic bronchitis and a history of exacerbations, according to the statement. The selective phosphodiesterase-4 inhibitor, roflumilast, was approved for this use in 500-mcg doses in 2011. The new smaller doses of the drug are being offered to help reduce the rate of treatment discontinuation with use of the higher therapeutic dosing. The 250-mcg doses of roflumilast are not to be used as treatment for COPD.
“As the only once-daily tablet to provide enhanced protection against COPD exacerbations when added to current bronchodilator therapy, this is an important new dosing option to help patients start and stay on treatment. Exacerbations are associated with hospitalizations and an accelerated decline in lung function, and these patients living with COPD need effective treatment options,” Tosh Butt, vice president, respiratory, at AstraZeneca, said in the press release.
The approval of use of the 250-mcg doses was based on data from the OPTIMIZE study (Evaluation of Tolerability and Pharmacokinetics of Roflumilast trial, 250 mcg and 500 mcg, as an add-on to Standard COPD Treatment to Treat Severe COPD), according to the statement.
Over 12 weeks, the percentage of patients stopping treatment was significantly lower in those first given 250 mcg of roflumilast daily for 4 weeks, followed by 500 mcg once a week for 8 weeks (18.4%), compared with those given 500 mcg of roflumilast daily for 12 weeks (24.6%; odds ratio, 0.66; 95% confidence interval, 0.47-0.93; P = .017).
In eight controlled clinical trials, the most common adverse effects were diarrhea, weight loss, nausea, headache, back pain, influenza, insomnia, dizziness, and decreased appetite.
The Food and Drug Administration has approved the use of a 250-mcg dose of roflumilast for patients with chronic obstructive pulmonary disease (COPD) for 4 weeks, followed by the use of 500-mcg therapeutic doses, according to a statement from the drug’s marketer, AstraZeneca.
The larger doses of roflumilast (Daliresp) are currently indicated for reducing the risk of COPD exacerbations in patients with severe COPD associated with chronic bronchitis and a history of exacerbations, according to the statement. The selective phosphodiesterase-4 inhibitor, roflumilast, was approved for this use in 500-mcg doses in 2011. The new smaller doses of the drug are being offered to help reduce the rate of treatment discontinuation with use of the higher therapeutic dosing. The 250-mcg doses of roflumilast are not to be used as treatment for COPD.
“As the only once-daily tablet to provide enhanced protection against COPD exacerbations when added to current bronchodilator therapy, this is an important new dosing option to help patients start and stay on treatment. Exacerbations are associated with hospitalizations and an accelerated decline in lung function, and these patients living with COPD need effective treatment options,” Tosh Butt, vice president, respiratory, at AstraZeneca, said in the press release.
The approval of use of the 250-mcg doses was based on data from the OPTIMIZE study (Evaluation of Tolerability and Pharmacokinetics of Roflumilast trial, 250 mcg and 500 mcg, as an add-on to Standard COPD Treatment to Treat Severe COPD), according to the statement.
Over 12 weeks, the percentage of patients stopping treatment was significantly lower in those first given 250 mcg of roflumilast daily for 4 weeks, followed by 500 mcg once a week for 8 weeks (18.4%), compared with those given 500 mcg of roflumilast daily for 12 weeks (24.6%; odds ratio, 0.66; 95% confidence interval, 0.47-0.93; P = .017).
In eight controlled clinical trials, the most common adverse effects were diarrhea, weight loss, nausea, headache, back pain, influenza, insomnia, dizziness, and decreased appetite.
The Food and Drug Administration has approved the use of a 250-mcg dose of roflumilast for patients with chronic obstructive pulmonary disease (COPD) for 4 weeks, followed by the use of 500-mcg therapeutic doses, according to a statement from the drug’s marketer, AstraZeneca.
The larger doses of roflumilast (Daliresp) are currently indicated for reducing the risk of COPD exacerbations in patients with severe COPD associated with chronic bronchitis and a history of exacerbations, according to the statement. The selective phosphodiesterase-4 inhibitor, roflumilast, was approved for this use in 500-mcg doses in 2011. The new smaller doses of the drug are being offered to help reduce the rate of treatment discontinuation with use of the higher therapeutic dosing. The 250-mcg doses of roflumilast are not to be used as treatment for COPD.
“As the only once-daily tablet to provide enhanced protection against COPD exacerbations when added to current bronchodilator therapy, this is an important new dosing option to help patients start and stay on treatment. Exacerbations are associated with hospitalizations and an accelerated decline in lung function, and these patients living with COPD need effective treatment options,” Tosh Butt, vice president, respiratory, at AstraZeneca, said in the press release.
The approval of use of the 250-mcg doses was based on data from the OPTIMIZE study (Evaluation of Tolerability and Pharmacokinetics of Roflumilast trial, 250 mcg and 500 mcg, as an add-on to Standard COPD Treatment to Treat Severe COPD), according to the statement.
Over 12 weeks, the percentage of patients stopping treatment was significantly lower in those first given 250 mcg of roflumilast daily for 4 weeks, followed by 500 mcg once a week for 8 weeks (18.4%), compared with those given 500 mcg of roflumilast daily for 12 weeks (24.6%; odds ratio, 0.66; 95% confidence interval, 0.47-0.93; P = .017).
In eight controlled clinical trials, the most common adverse effects were diarrhea, weight loss, nausea, headache, back pain, influenza, insomnia, dizziness, and decreased appetite.
FDA axes asthma drugs’ boxed warning
The Food and Drug Administration has eliminated the boxed warning for risk of asthma-related death from the labels of products containing both an inhaled corticosteroid (ICS) and a long-acting beta agonist (LABA), the agency announced.
In 2011, the FDA required companies manufacturing fixed-dose LABA-ICS combination products to conduct 26-week clinical safety trials to evaluate the risks of serious adverse asthma-related events in patients treated with these drugs. Specifically, the companies had to compare the risks of taking a LABA in combination with an ICS with the risks of taking an ICS alone.
The removal of the boxed warning follows the FDA’s review of these trials, which found that treating asthma with LABAs in combination with ICS did not result in patients experiencing significantly more serious asthma-related side effects and asthma-related deaths, compared with those being treated with an ICS alone, according to the FDA announcement. “Results of subgroup analyses for gender, adolescents 12-18 years, and African Americans are consistent with the primary endpoint results,” the statement added.
“These trials showed that LABAs, when used with ICS, did not significantly increase the risk of asthma-related hospitalizations, the need to insert a breathing tube known as intubation, or asthma-related deaths, compared to ICS alone,” the FDA said in the statement.
The trials also demonstrated that using the combination reduced asthma exacerbations, compared with using ICS alone, and that most of the exacerbations “were those that required at least 3 days of systemic corticosteroids” – information that is being added the product labels, according to the FDA.
The products that will no longer carry this boxed warning in their labels include AstraZeneca’s budesonide/formoterol fumarate dihydrate (Symbicort) and GlaxoSmithKline’s fluticasone furoate/vilanterol (Breo Ellipta) and fluticasone propionate/salmeterol (Advair Diskus and Advair HFA).
The FDA also approved updates to the Warnings and Precautions section of labeling for the ICS/LABA class, which now includes a description of the four trials. Information on the efficacy of the drugs, found in the trials, has been added to the Clinical Studies section of the labels as well.
In a related safety announcement, the FDA stated the following: “Using LABAs alone to treat asthma without an ICS to treat lung inflammation is associated with an increased risk of asthma-related death. Therefore, the Boxed Warning stating this will remain in the labels of all single-ingredient LABA medicines, which are approved to treat asthma, chronic obstructive pulmonary disease (COPD), and wheezing caused by exercise. The labels of medicines that contain both an ICS and LABA also retain a Warning and Precaution related to the increased risk of asthma-related death when LABAs are used without an ICS to treat asthma.
The Food and Drug Administration has eliminated the boxed warning for risk of asthma-related death from the labels of products containing both an inhaled corticosteroid (ICS) and a long-acting beta agonist (LABA), the agency announced.
In 2011, the FDA required companies manufacturing fixed-dose LABA-ICS combination products to conduct 26-week clinical safety trials to evaluate the risks of serious adverse asthma-related events in patients treated with these drugs. Specifically, the companies had to compare the risks of taking a LABA in combination with an ICS with the risks of taking an ICS alone.
The removal of the boxed warning follows the FDA’s review of these trials, which found that treating asthma with LABAs in combination with ICS did not result in patients experiencing significantly more serious asthma-related side effects and asthma-related deaths, compared with those being treated with an ICS alone, according to the FDA announcement. “Results of subgroup analyses for gender, adolescents 12-18 years, and African Americans are consistent with the primary endpoint results,” the statement added.
“These trials showed that LABAs, when used with ICS, did not significantly increase the risk of asthma-related hospitalizations, the need to insert a breathing tube known as intubation, or asthma-related deaths, compared to ICS alone,” the FDA said in the statement.
The trials also demonstrated that using the combination reduced asthma exacerbations, compared with using ICS alone, and that most of the exacerbations “were those that required at least 3 days of systemic corticosteroids” – information that is being added the product labels, according to the FDA.
The products that will no longer carry this boxed warning in their labels include AstraZeneca’s budesonide/formoterol fumarate dihydrate (Symbicort) and GlaxoSmithKline’s fluticasone furoate/vilanterol (Breo Ellipta) and fluticasone propionate/salmeterol (Advair Diskus and Advair HFA).
The FDA also approved updates to the Warnings and Precautions section of labeling for the ICS/LABA class, which now includes a description of the four trials. Information on the efficacy of the drugs, found in the trials, has been added to the Clinical Studies section of the labels as well.
In a related safety announcement, the FDA stated the following: “Using LABAs alone to treat asthma without an ICS to treat lung inflammation is associated with an increased risk of asthma-related death. Therefore, the Boxed Warning stating this will remain in the labels of all single-ingredient LABA medicines, which are approved to treat asthma, chronic obstructive pulmonary disease (COPD), and wheezing caused by exercise. The labels of medicines that contain both an ICS and LABA also retain a Warning and Precaution related to the increased risk of asthma-related death when LABAs are used without an ICS to treat asthma.
The Food and Drug Administration has eliminated the boxed warning for risk of asthma-related death from the labels of products containing both an inhaled corticosteroid (ICS) and a long-acting beta agonist (LABA), the agency announced.
In 2011, the FDA required companies manufacturing fixed-dose LABA-ICS combination products to conduct 26-week clinical safety trials to evaluate the risks of serious adverse asthma-related events in patients treated with these drugs. Specifically, the companies had to compare the risks of taking a LABA in combination with an ICS with the risks of taking an ICS alone.
The removal of the boxed warning follows the FDA’s review of these trials, which found that treating asthma with LABAs in combination with ICS did not result in patients experiencing significantly more serious asthma-related side effects and asthma-related deaths, compared with those being treated with an ICS alone, according to the FDA announcement. “Results of subgroup analyses for gender, adolescents 12-18 years, and African Americans are consistent with the primary endpoint results,” the statement added.
“These trials showed that LABAs, when used with ICS, did not significantly increase the risk of asthma-related hospitalizations, the need to insert a breathing tube known as intubation, or asthma-related deaths, compared to ICS alone,” the FDA said in the statement.
The trials also demonstrated that using the combination reduced asthma exacerbations, compared with using ICS alone, and that most of the exacerbations “were those that required at least 3 days of systemic corticosteroids” – information that is being added the product labels, according to the FDA.
The products that will no longer carry this boxed warning in their labels include AstraZeneca’s budesonide/formoterol fumarate dihydrate (Symbicort) and GlaxoSmithKline’s fluticasone furoate/vilanterol (Breo Ellipta) and fluticasone propionate/salmeterol (Advair Diskus and Advair HFA).
The FDA also approved updates to the Warnings and Precautions section of labeling for the ICS/LABA class, which now includes a description of the four trials. Information on the efficacy of the drugs, found in the trials, has been added to the Clinical Studies section of the labels as well.
In a related safety announcement, the FDA stated the following: “Using LABAs alone to treat asthma without an ICS to treat lung inflammation is associated with an increased risk of asthma-related death. Therefore, the Boxed Warning stating this will remain in the labels of all single-ingredient LABA medicines, which are approved to treat asthma, chronic obstructive pulmonary disease (COPD), and wheezing caused by exercise. The labels of medicines that contain both an ICS and LABA also retain a Warning and Precaution related to the increased risk of asthma-related death when LABAs are used without an ICS to treat asthma.
FDA asked to approve add-on drug for eosinophilic COPD
GlaxoSmithKline asked the Food and Drug Administration to approve an interleuklin-5 antagonist as an add-on maintenance therapy for patients with eosinophilic chronic obstructive pulmonary disease (COPD).
The pharmaceutical and health care company is seeking approval of mepolizumab to be used specifically to treat COPD patients with an eosinophilic phenotype. The drug currently is indicated to treat patients aged 12 years or older with severe asthma and asthma with an eosinophilic phenotype and is sold under the name Nucala, according to a GlaxoSmithKline statement issued November 7.
Headache, injection site reaction, back pain, and fatigue are the most common adverse reactions seen in patients who took mepolizumab during clinical trials.
Mepolizumab is not approved for the treatment of COPD anywhere in the world, and GlaxoSmithKline intends to also ask other countries’ regulatory authorities to allow this drug to be sold as a therapy for COPD.
GlaxoSmithKline asked the Food and Drug Administration to approve an interleuklin-5 antagonist as an add-on maintenance therapy for patients with eosinophilic chronic obstructive pulmonary disease (COPD).
The pharmaceutical and health care company is seeking approval of mepolizumab to be used specifically to treat COPD patients with an eosinophilic phenotype. The drug currently is indicated to treat patients aged 12 years or older with severe asthma and asthma with an eosinophilic phenotype and is sold under the name Nucala, according to a GlaxoSmithKline statement issued November 7.
Headache, injection site reaction, back pain, and fatigue are the most common adverse reactions seen in patients who took mepolizumab during clinical trials.
Mepolizumab is not approved for the treatment of COPD anywhere in the world, and GlaxoSmithKline intends to also ask other countries’ regulatory authorities to allow this drug to be sold as a therapy for COPD.
GlaxoSmithKline asked the Food and Drug Administration to approve an interleuklin-5 antagonist as an add-on maintenance therapy for patients with eosinophilic chronic obstructive pulmonary disease (COPD).
The pharmaceutical and health care company is seeking approval of mepolizumab to be used specifically to treat COPD patients with an eosinophilic phenotype. The drug currently is indicated to treat patients aged 12 years or older with severe asthma and asthma with an eosinophilic phenotype and is sold under the name Nucala, according to a GlaxoSmithKline statement issued November 7.
Headache, injection site reaction, back pain, and fatigue are the most common adverse reactions seen in patients who took mepolizumab during clinical trials.
Mepolizumab is not approved for the treatment of COPD anywhere in the world, and GlaxoSmithKline intends to also ask other countries’ regulatory authorities to allow this drug to be sold as a therapy for COPD.
Aspirin responsiveness improved in some with OSA
Obstructive sleep apnea patients with endothelial dysfunction gained aspirin responsiveness after using continuous positive airway pressure (CPAP) therapy, according to the findings from a small study scheduled to be presented at CHEST 2017.
“Endothelial dysfunction is an important phenomenon implicated in cardiovascular morbidity in obstructive sleep apnea (OSA) patients. While it has been demonstrated that CPAP improves endothelial function, our understanding of the pathophysiologic links between CPAP therapy and cardiovascular outcomes remain limited,” researchers wrote in the study’s abstract.
The researchers examined 18 patients’ endothelial function before and after using CPAP therapy for a median of 37 days, along with the relationship between endothelial function and aspirin responsiveness in these same patients. All study participants had been recently diagnosed with moderate to severe OSA and underwent modified peripheral artery tonometry and platelet aggregometry before and after beginning CPAP therapy. Most of the patients (14) demonstrated aspirin resistance at baseline.
Endothelial dysfunction was defined as having a reactive hyperemia index (RHI) of less than or equal to 1.67, while aspirin resistance was defined as having a reading of at least 550 aspirin reaction units (ARU).
At baseline, the average RHI of patients was 1.79 (standard deviation = 0.3), with 8 of the patients having had endothelial dysfunction. Following CPAP use, patients’ mean RHI increased to 1.94 (SD = 0.36), and endothelial dysfunction was present in just 5 of the study participants.*
After using CPAP, those patients with endothelial dysfunction at baseline were responsive to aspirin, with their average ARU reading at 520 following therapy. In contrast, those patients with normal endothelial function at baseline remained resistant to aspirin following CPAP use, based on mean ARU values before and after therapy.
Lirim Krveshi, DO, of Danbury (Conn.) Hospital, is scheduled to present this study, “A Prospective Cohort Study of Endothelial Function and its Relationship to Aspirin Responsiveness in OSA Patients,” on Sunday, Oct. 29, at 1:45 p.m. in Convention Center, room 601A. This presentation is part of the Obstructive Sleep Apnea: Insights & Management session, running from 1:30 p.m. to 3:00 p.m.
The study’s authors reported no conflicts of interest.
*This article was updated Oct. 27, 2017.
Obstructive sleep apnea patients with endothelial dysfunction gained aspirin responsiveness after using continuous positive airway pressure (CPAP) therapy, according to the findings from a small study scheduled to be presented at CHEST 2017.
“Endothelial dysfunction is an important phenomenon implicated in cardiovascular morbidity in obstructive sleep apnea (OSA) patients. While it has been demonstrated that CPAP improves endothelial function, our understanding of the pathophysiologic links between CPAP therapy and cardiovascular outcomes remain limited,” researchers wrote in the study’s abstract.
The researchers examined 18 patients’ endothelial function before and after using CPAP therapy for a median of 37 days, along with the relationship between endothelial function and aspirin responsiveness in these same patients. All study participants had been recently diagnosed with moderate to severe OSA and underwent modified peripheral artery tonometry and platelet aggregometry before and after beginning CPAP therapy. Most of the patients (14) demonstrated aspirin resistance at baseline.
Endothelial dysfunction was defined as having a reactive hyperemia index (RHI) of less than or equal to 1.67, while aspirin resistance was defined as having a reading of at least 550 aspirin reaction units (ARU).
At baseline, the average RHI of patients was 1.79 (standard deviation = 0.3), with 8 of the patients having had endothelial dysfunction. Following CPAP use, patients’ mean RHI increased to 1.94 (SD = 0.36), and endothelial dysfunction was present in just 5 of the study participants.*
After using CPAP, those patients with endothelial dysfunction at baseline were responsive to aspirin, with their average ARU reading at 520 following therapy. In contrast, those patients with normal endothelial function at baseline remained resistant to aspirin following CPAP use, based on mean ARU values before and after therapy.
Lirim Krveshi, DO, of Danbury (Conn.) Hospital, is scheduled to present this study, “A Prospective Cohort Study of Endothelial Function and its Relationship to Aspirin Responsiveness in OSA Patients,” on Sunday, Oct. 29, at 1:45 p.m. in Convention Center, room 601A. This presentation is part of the Obstructive Sleep Apnea: Insights & Management session, running from 1:30 p.m. to 3:00 p.m.
The study’s authors reported no conflicts of interest.
*This article was updated Oct. 27, 2017.
Obstructive sleep apnea patients with endothelial dysfunction gained aspirin responsiveness after using continuous positive airway pressure (CPAP) therapy, according to the findings from a small study scheduled to be presented at CHEST 2017.
“Endothelial dysfunction is an important phenomenon implicated in cardiovascular morbidity in obstructive sleep apnea (OSA) patients. While it has been demonstrated that CPAP improves endothelial function, our understanding of the pathophysiologic links between CPAP therapy and cardiovascular outcomes remain limited,” researchers wrote in the study’s abstract.
The researchers examined 18 patients’ endothelial function before and after using CPAP therapy for a median of 37 days, along with the relationship between endothelial function and aspirin responsiveness in these same patients. All study participants had been recently diagnosed with moderate to severe OSA and underwent modified peripheral artery tonometry and platelet aggregometry before and after beginning CPAP therapy. Most of the patients (14) demonstrated aspirin resistance at baseline.
Endothelial dysfunction was defined as having a reactive hyperemia index (RHI) of less than or equal to 1.67, while aspirin resistance was defined as having a reading of at least 550 aspirin reaction units (ARU).
At baseline, the average RHI of patients was 1.79 (standard deviation = 0.3), with 8 of the patients having had endothelial dysfunction. Following CPAP use, patients’ mean RHI increased to 1.94 (SD = 0.36), and endothelial dysfunction was present in just 5 of the study participants.*
After using CPAP, those patients with endothelial dysfunction at baseline were responsive to aspirin, with their average ARU reading at 520 following therapy. In contrast, those patients with normal endothelial function at baseline remained resistant to aspirin following CPAP use, based on mean ARU values before and after therapy.
Lirim Krveshi, DO, of Danbury (Conn.) Hospital, is scheduled to present this study, “A Prospective Cohort Study of Endothelial Function and its Relationship to Aspirin Responsiveness in OSA Patients,” on Sunday, Oct. 29, at 1:45 p.m. in Convention Center, room 601A. This presentation is part of the Obstructive Sleep Apnea: Insights & Management session, running from 1:30 p.m. to 3:00 p.m.
The study’s authors reported no conflicts of interest.
*This article was updated Oct. 27, 2017.
FROM CHEST 2017
Key clinical point:
Major finding: The average aspirin reaction units reading for patients who had endothelial dysfunction at baseline was 520 following therapy.
Data source: A prospective cohort study of 18 patients with newly diagnosed moderate to severe OSA.
Disclosures: The study’s authors reported no conflicts of interest.
CHEST Physician’s planned coverage of CHEST 2017
CHEST Physician is providing on-site coverage of the CHEST annual meeting in Toronto from Oct. 29 through Nov. 1.
We are planning to share findings from the latest research on treating COPD, sleep apnea, pulmonary hypertension, severe asthma, and other diseases that are part of pulmonary, critical care, and sleep medicine. Any improved methods for managing an ICU and updated recommendations on screening for lung cancer will also be on our radar.
The meeting’s agenda includes presentations of hundreds of study abstracts, and we thought you would be interested in hearing which ones grabbed the attention of some of CHEST Physician’s editorial advisory board members.
Board member Susan L. Millard, MD, FCCP, suggested attendees check out presentations of the following two studies:
- Impact of Race on Quality of Life of Families of Children with Asthma when Asthma Guidelines are Followed: Long-Term Follow-Up
- Results Of A Phase 3, Multicenter, Randomized, Placebo-controlled Trial of Remimazolam: A New Ultra Short Acting Benzodiazepine for Bronchoscopy
The first study is part of a session entitled Pediatrics, scheduled to run from 3:15 to 4:15 p.m. on Sunday, Oct. 29, in Convention Center - 606. Shahid Sheikh, MD, of Nationwide Children’s Hospital in New Albany, Ohio, is scheduled to present the abstract at 4:00 p.m.
Dr. Millard, who is Therapeutic Development Network director for the Pediatric CF Care Center and director of research for pediatric pulmonary and sleep medicine at the Helen DeVos Children’s Hospital in Grand Rapids, Mich., noted that she is interested in Dr. Sheikh’s research, “because cultural diversity is such a hot topic in general.”
Her other recommendation is part of the Late Breaking Abstracts 2 session, scheduled to occur on Wednesday, Nov. 1, from 2:45 to 4:15 p.m. in Convention Center - 603. CHEST President, Gerard A. Silvestri, MD, MS, FCCP, will present the abstract at 4:00 p.m.
Dr. Millard said she is interested in this study, because new drug options are so helpful for the frequently performed bronchoscopy.
Two sleep medicine experts on CHEST Physician’s editorial advisory board also selected a few presentations they expect to be newsworthy.
David Schulman, MD, MPH, FCCP, and professor of medicine at Emory University School of Medicine in Atlanta suggested CHEST Physician cover the following studies:
- Results of a Randomized, Placebo-Controlled, Double-Blind, 12-Week, Multicenter Study of JZP-110 for the Treatment Of Excessive Sleepiness in Patients with OSA, scheduled to be presented on Sunday, Oct. 29, at 1:30 p.m. in Convention Center - 601A. Dr. Kingman Strohl, MD, FCCP, of University Hospitals Case Medical Center-Sleep Center in Shaker Heights, Ohio, will present this research during a session entitled, Obstructive Sleep Apnea: Insights & Management, running from 1:30 to 3:00 p.m.
- History of Sleep Apnea and Cardiovascular Disease may Portend Improved Mortality in Patients With Acute Ischemic Stroke, scheduled to be presented on Tuesday, Oct. 31, at 11:15 a.m., in Convention Center - 601A. Nura Festic will present this research during the session, “Sleep, Heart, Brain and More,” running from 11:00 a.m. to 12:15 p.m.
- Ischemic Preconditioning in OSA Patients Manifested after Surviving a Cardiac Arrest? John Moss, MD, of Jacksonville, Fla., will present this study on Tuesday, Oct. 31, at 11:30 a.m., in Convention Center - 601A as part of the session “Sleep, Heart, Brain and More.”
Krishna M. Sundar, MD, FCCP, also recommended that CHEST Physician cover “A Prospective Cohort Study of Endothelial Function and its Relationship to Aspirin Responsiveness in OSA Patients.” Lirim Krveshi is scheduled to present this study on Sunday, Oct. 29, at 1:45 p.m. in Convention Center - 601A. This presentation is part of the Obstructive Sleep Apnea: Insights & Management session.
Dr. Sundar is an associate clinical professor of pulmonary, critical care and sleep medicine and medical director of the Sleep-Wake Center at the University of Utah, Salt Lake City.
To view the full agenda of the CHEST annual meeting, visit: chestmeeting.chestnet.org.
Look for CHEST Physician’s coverage of CHEST 2017 on our conference coverage page.
CHEST Physician is providing on-site coverage of the CHEST annual meeting in Toronto from Oct. 29 through Nov. 1.
We are planning to share findings from the latest research on treating COPD, sleep apnea, pulmonary hypertension, severe asthma, and other diseases that are part of pulmonary, critical care, and sleep medicine. Any improved methods for managing an ICU and updated recommendations on screening for lung cancer will also be on our radar.
The meeting’s agenda includes presentations of hundreds of study abstracts, and we thought you would be interested in hearing which ones grabbed the attention of some of CHEST Physician’s editorial advisory board members.
Board member Susan L. Millard, MD, FCCP, suggested attendees check out presentations of the following two studies:
- Impact of Race on Quality of Life of Families of Children with Asthma when Asthma Guidelines are Followed: Long-Term Follow-Up
- Results Of A Phase 3, Multicenter, Randomized, Placebo-controlled Trial of Remimazolam: A New Ultra Short Acting Benzodiazepine for Bronchoscopy
The first study is part of a session entitled Pediatrics, scheduled to run from 3:15 to 4:15 p.m. on Sunday, Oct. 29, in Convention Center - 606. Shahid Sheikh, MD, of Nationwide Children’s Hospital in New Albany, Ohio, is scheduled to present the abstract at 4:00 p.m.
Dr. Millard, who is Therapeutic Development Network director for the Pediatric CF Care Center and director of research for pediatric pulmonary and sleep medicine at the Helen DeVos Children’s Hospital in Grand Rapids, Mich., noted that she is interested in Dr. Sheikh’s research, “because cultural diversity is such a hot topic in general.”
Her other recommendation is part of the Late Breaking Abstracts 2 session, scheduled to occur on Wednesday, Nov. 1, from 2:45 to 4:15 p.m. in Convention Center - 603. CHEST President, Gerard A. Silvestri, MD, MS, FCCP, will present the abstract at 4:00 p.m.
Dr. Millard said she is interested in this study, because new drug options are so helpful for the frequently performed bronchoscopy.
Two sleep medicine experts on CHEST Physician’s editorial advisory board also selected a few presentations they expect to be newsworthy.
David Schulman, MD, MPH, FCCP, and professor of medicine at Emory University School of Medicine in Atlanta suggested CHEST Physician cover the following studies:
- Results of a Randomized, Placebo-Controlled, Double-Blind, 12-Week, Multicenter Study of JZP-110 for the Treatment Of Excessive Sleepiness in Patients with OSA, scheduled to be presented on Sunday, Oct. 29, at 1:30 p.m. in Convention Center - 601A. Dr. Kingman Strohl, MD, FCCP, of University Hospitals Case Medical Center-Sleep Center in Shaker Heights, Ohio, will present this research during a session entitled, Obstructive Sleep Apnea: Insights & Management, running from 1:30 to 3:00 p.m.
- History of Sleep Apnea and Cardiovascular Disease may Portend Improved Mortality in Patients With Acute Ischemic Stroke, scheduled to be presented on Tuesday, Oct. 31, at 11:15 a.m., in Convention Center - 601A. Nura Festic will present this research during the session, “Sleep, Heart, Brain and More,” running from 11:00 a.m. to 12:15 p.m.
- Ischemic Preconditioning in OSA Patients Manifested after Surviving a Cardiac Arrest? John Moss, MD, of Jacksonville, Fla., will present this study on Tuesday, Oct. 31, at 11:30 a.m., in Convention Center - 601A as part of the session “Sleep, Heart, Brain and More.”
Krishna M. Sundar, MD, FCCP, also recommended that CHEST Physician cover “A Prospective Cohort Study of Endothelial Function and its Relationship to Aspirin Responsiveness in OSA Patients.” Lirim Krveshi is scheduled to present this study on Sunday, Oct. 29, at 1:45 p.m. in Convention Center - 601A. This presentation is part of the Obstructive Sleep Apnea: Insights & Management session.
Dr. Sundar is an associate clinical professor of pulmonary, critical care and sleep medicine and medical director of the Sleep-Wake Center at the University of Utah, Salt Lake City.
To view the full agenda of the CHEST annual meeting, visit: chestmeeting.chestnet.org.
Look for CHEST Physician’s coverage of CHEST 2017 on our conference coverage page.
CHEST Physician is providing on-site coverage of the CHEST annual meeting in Toronto from Oct. 29 through Nov. 1.
We are planning to share findings from the latest research on treating COPD, sleep apnea, pulmonary hypertension, severe asthma, and other diseases that are part of pulmonary, critical care, and sleep medicine. Any improved methods for managing an ICU and updated recommendations on screening for lung cancer will also be on our radar.
The meeting’s agenda includes presentations of hundreds of study abstracts, and we thought you would be interested in hearing which ones grabbed the attention of some of CHEST Physician’s editorial advisory board members.
Board member Susan L. Millard, MD, FCCP, suggested attendees check out presentations of the following two studies:
- Impact of Race on Quality of Life of Families of Children with Asthma when Asthma Guidelines are Followed: Long-Term Follow-Up
- Results Of A Phase 3, Multicenter, Randomized, Placebo-controlled Trial of Remimazolam: A New Ultra Short Acting Benzodiazepine for Bronchoscopy
The first study is part of a session entitled Pediatrics, scheduled to run from 3:15 to 4:15 p.m. on Sunday, Oct. 29, in Convention Center - 606. Shahid Sheikh, MD, of Nationwide Children’s Hospital in New Albany, Ohio, is scheduled to present the abstract at 4:00 p.m.
Dr. Millard, who is Therapeutic Development Network director for the Pediatric CF Care Center and director of research for pediatric pulmonary and sleep medicine at the Helen DeVos Children’s Hospital in Grand Rapids, Mich., noted that she is interested in Dr. Sheikh’s research, “because cultural diversity is such a hot topic in general.”
Her other recommendation is part of the Late Breaking Abstracts 2 session, scheduled to occur on Wednesday, Nov. 1, from 2:45 to 4:15 p.m. in Convention Center - 603. CHEST President, Gerard A. Silvestri, MD, MS, FCCP, will present the abstract at 4:00 p.m.
Dr. Millard said she is interested in this study, because new drug options are so helpful for the frequently performed bronchoscopy.
Two sleep medicine experts on CHEST Physician’s editorial advisory board also selected a few presentations they expect to be newsworthy.
David Schulman, MD, MPH, FCCP, and professor of medicine at Emory University School of Medicine in Atlanta suggested CHEST Physician cover the following studies:
- Results of a Randomized, Placebo-Controlled, Double-Blind, 12-Week, Multicenter Study of JZP-110 for the Treatment Of Excessive Sleepiness in Patients with OSA, scheduled to be presented on Sunday, Oct. 29, at 1:30 p.m. in Convention Center - 601A. Dr. Kingman Strohl, MD, FCCP, of University Hospitals Case Medical Center-Sleep Center in Shaker Heights, Ohio, will present this research during a session entitled, Obstructive Sleep Apnea: Insights & Management, running from 1:30 to 3:00 p.m.
- History of Sleep Apnea and Cardiovascular Disease may Portend Improved Mortality in Patients With Acute Ischemic Stroke, scheduled to be presented on Tuesday, Oct. 31, at 11:15 a.m., in Convention Center - 601A. Nura Festic will present this research during the session, “Sleep, Heart, Brain and More,” running from 11:00 a.m. to 12:15 p.m.
- Ischemic Preconditioning in OSA Patients Manifested after Surviving a Cardiac Arrest? John Moss, MD, of Jacksonville, Fla., will present this study on Tuesday, Oct. 31, at 11:30 a.m., in Convention Center - 601A as part of the session “Sleep, Heart, Brain and More.”
Krishna M. Sundar, MD, FCCP, also recommended that CHEST Physician cover “A Prospective Cohort Study of Endothelial Function and its Relationship to Aspirin Responsiveness in OSA Patients.” Lirim Krveshi is scheduled to present this study on Sunday, Oct. 29, at 1:45 p.m. in Convention Center - 601A. This presentation is part of the Obstructive Sleep Apnea: Insights & Management session.
Dr. Sundar is an associate clinical professor of pulmonary, critical care and sleep medicine and medical director of the Sleep-Wake Center at the University of Utah, Salt Lake City.
To view the full agenda of the CHEST annual meeting, visit: chestmeeting.chestnet.org.
Look for CHEST Physician’s coverage of CHEST 2017 on our conference coverage page.
FROM CHEST 2017
New test could cause OSA’s treatment success rate to rise
A novel device has shown a high rate of accuracy in predicting which patients with obstructive sleep apnea (OSA) will improve with oral appliance therapy, according to a study.
“At the present time CPAP is our go-to standard medical therapy [for treating OSA]. While it is a wonderful therapy, it has a very serious drawback, which is poor compliance, and that undercuts its long-term effectiveness in reducing the incidence of cardiovascular disease,” said John E. Remmers, MD, the principal investigator, in an interview.
Referring to the Sleep Apnea Cardiovascular Endpoints (SAVE) trial’s finding that continuous positive airway pressure (CPAP) did not reduce long-term cardiovascular incidents, he claimed that “these incidents are not being reduced by CPAP, because people don’t use it” (N Engl J Med. 2016 Sept 8;375[10]:919-31).
In Dr. Remmers’ new two-part study, 202 adults – primarily overweight, middle-aged men, diagnosed with moderate sleep apnea – were divided into two groups. The first included 149 people who were given a two-night, in-home, feedback controlled mandibular positioner (FCMP) test, using equipment manufactured by Zephyr Sleep Technologies. In this test, a custom-fit oral appliance is simulated using a temporary set of trays and impression material. The trays are connected to a small motor controlled by a little computer that sits on the stomach and moves the mandible when the patient has a problem breathing.
All patients received a custom oral appliance designed using data acquired from the test. The patients then wore the custom oral appliances while connected to a validated monitor as an outcomes study.
Finally, the researchers fed all of the data they collected from this first group of patients into a machine learning model. Then the second set of patients participated in the testing. Outcomes data on the appliance’s performance in each individual in the first group were used to create a classification system to predict therapeutic outcomes for the 53 patients in the second group. The patients in the second group then received their custom oral appliances, connected to the same type of monitor used by the first group.
Therapeutic success or failure was defined as having mean oxygen desaturation index values of less than or greater than 10 events/hour, respectively. The investigators determined that the test had an 85% sensitivity level with 93% specificity, a positive predictive value of 97%, and a negative predictive value of 72%. Of those who were predicted to respond to therapy, the mandibular protrusive position was efficacious in 86% of patients.
The high rate of accuracy for predicting who will derive the most benefit from the appliance, along with the demonstrated preference for oral appliances compared to continuous positive airway pressure devices among patients, increases the clinical utility of the appliance, and expands options for clinical management of sleep apnea, according to the study authors (Clin Sleep Med. 2017;13[7]:871-80).
“Our test allows the physician to prescribe the therapy knowing it will get rid of sleep apnea, and it tells the dentist how far the mandible needs to be pulled out by the custom fit device,” Dr. Remmers explained.
Dentists will also benefit from the test, because it allows them to make an appliance that will not need to be adjusted and will have a higher success rate than the current 60% success rate that oral appliances have at treating sleep apnea, he noted.
“This opens up a new an alternative clinical avenue at a critical time, when we have just learned over the past few years that there are serious questions about the effectiveness of CPAP in the long term,” Dr. Remmers added. “[With oral appliance therapy] you have an opportunity for higher compliance, because people prefer the less obtrusive oral appliance therapy over CPAP, and they use it more than CPAP. ... Because our product says you don’t treat everybody, you only undertake oral appliance therapy for those who we know in advance will have a favorable outcome, it removes a major barrier to oral appliance therapy that has been the barrier for many years.”
Dr. Remmers noted that his test was not nearly as good at identifying people who would be failures as it was at identifying people who would be successes and that he is carrying out another trial with a similar device.
Some participants reported sore gums when using the device, but there were no long-lasting adverse events reported.
The mandibular positioner home test has not been approved or cleared for use by the Food and Drug Administration, but is currently being sold in Canada, according to Dr. Remmers.
Zephyr Sleep Technologies and Alberta Innovates Technology Futures sponsored the study. It is registered on clinicaltrials.gov as NCT03011762. All of the investigators, other than Nikola Vranjes, are employed or associated with Zephyr Sleep Technologies.
Whitney McKnight contributed to this report.
A novel device has shown a high rate of accuracy in predicting which patients with obstructive sleep apnea (OSA) will improve with oral appliance therapy, according to a study.
“At the present time CPAP is our go-to standard medical therapy [for treating OSA]. While it is a wonderful therapy, it has a very serious drawback, which is poor compliance, and that undercuts its long-term effectiveness in reducing the incidence of cardiovascular disease,” said John E. Remmers, MD, the principal investigator, in an interview.
Referring to the Sleep Apnea Cardiovascular Endpoints (SAVE) trial’s finding that continuous positive airway pressure (CPAP) did not reduce long-term cardiovascular incidents, he claimed that “these incidents are not being reduced by CPAP, because people don’t use it” (N Engl J Med. 2016 Sept 8;375[10]:919-31).
In Dr. Remmers’ new two-part study, 202 adults – primarily overweight, middle-aged men, diagnosed with moderate sleep apnea – were divided into two groups. The first included 149 people who were given a two-night, in-home, feedback controlled mandibular positioner (FCMP) test, using equipment manufactured by Zephyr Sleep Technologies. In this test, a custom-fit oral appliance is simulated using a temporary set of trays and impression material. The trays are connected to a small motor controlled by a little computer that sits on the stomach and moves the mandible when the patient has a problem breathing.
All patients received a custom oral appliance designed using data acquired from the test. The patients then wore the custom oral appliances while connected to a validated monitor as an outcomes study.
Finally, the researchers fed all of the data they collected from this first group of patients into a machine learning model. Then the second set of patients participated in the testing. Outcomes data on the appliance’s performance in each individual in the first group were used to create a classification system to predict therapeutic outcomes for the 53 patients in the second group. The patients in the second group then received their custom oral appliances, connected to the same type of monitor used by the first group.
Therapeutic success or failure was defined as having mean oxygen desaturation index values of less than or greater than 10 events/hour, respectively. The investigators determined that the test had an 85% sensitivity level with 93% specificity, a positive predictive value of 97%, and a negative predictive value of 72%. Of those who were predicted to respond to therapy, the mandibular protrusive position was efficacious in 86% of patients.
The high rate of accuracy for predicting who will derive the most benefit from the appliance, along with the demonstrated preference for oral appliances compared to continuous positive airway pressure devices among patients, increases the clinical utility of the appliance, and expands options for clinical management of sleep apnea, according to the study authors (Clin Sleep Med. 2017;13[7]:871-80).
“Our test allows the physician to prescribe the therapy knowing it will get rid of sleep apnea, and it tells the dentist how far the mandible needs to be pulled out by the custom fit device,” Dr. Remmers explained.
Dentists will also benefit from the test, because it allows them to make an appliance that will not need to be adjusted and will have a higher success rate than the current 60% success rate that oral appliances have at treating sleep apnea, he noted.
“This opens up a new an alternative clinical avenue at a critical time, when we have just learned over the past few years that there are serious questions about the effectiveness of CPAP in the long term,” Dr. Remmers added. “[With oral appliance therapy] you have an opportunity for higher compliance, because people prefer the less obtrusive oral appliance therapy over CPAP, and they use it more than CPAP. ... Because our product says you don’t treat everybody, you only undertake oral appliance therapy for those who we know in advance will have a favorable outcome, it removes a major barrier to oral appliance therapy that has been the barrier for many years.”
Dr. Remmers noted that his test was not nearly as good at identifying people who would be failures as it was at identifying people who would be successes and that he is carrying out another trial with a similar device.
Some participants reported sore gums when using the device, but there were no long-lasting adverse events reported.
The mandibular positioner home test has not been approved or cleared for use by the Food and Drug Administration, but is currently being sold in Canada, according to Dr. Remmers.
Zephyr Sleep Technologies and Alberta Innovates Technology Futures sponsored the study. It is registered on clinicaltrials.gov as NCT03011762. All of the investigators, other than Nikola Vranjes, are employed or associated with Zephyr Sleep Technologies.
Whitney McKnight contributed to this report.
A novel device has shown a high rate of accuracy in predicting which patients with obstructive sleep apnea (OSA) will improve with oral appliance therapy, according to a study.
“At the present time CPAP is our go-to standard medical therapy [for treating OSA]. While it is a wonderful therapy, it has a very serious drawback, which is poor compliance, and that undercuts its long-term effectiveness in reducing the incidence of cardiovascular disease,” said John E. Remmers, MD, the principal investigator, in an interview.
Referring to the Sleep Apnea Cardiovascular Endpoints (SAVE) trial’s finding that continuous positive airway pressure (CPAP) did not reduce long-term cardiovascular incidents, he claimed that “these incidents are not being reduced by CPAP, because people don’t use it” (N Engl J Med. 2016 Sept 8;375[10]:919-31).
In Dr. Remmers’ new two-part study, 202 adults – primarily overweight, middle-aged men, diagnosed with moderate sleep apnea – were divided into two groups. The first included 149 people who were given a two-night, in-home, feedback controlled mandibular positioner (FCMP) test, using equipment manufactured by Zephyr Sleep Technologies. In this test, a custom-fit oral appliance is simulated using a temporary set of trays and impression material. The trays are connected to a small motor controlled by a little computer that sits on the stomach and moves the mandible when the patient has a problem breathing.
All patients received a custom oral appliance designed using data acquired from the test. The patients then wore the custom oral appliances while connected to a validated monitor as an outcomes study.
Finally, the researchers fed all of the data they collected from this first group of patients into a machine learning model. Then the second set of patients participated in the testing. Outcomes data on the appliance’s performance in each individual in the first group were used to create a classification system to predict therapeutic outcomes for the 53 patients in the second group. The patients in the second group then received their custom oral appliances, connected to the same type of monitor used by the first group.
Therapeutic success or failure was defined as having mean oxygen desaturation index values of less than or greater than 10 events/hour, respectively. The investigators determined that the test had an 85% sensitivity level with 93% specificity, a positive predictive value of 97%, and a negative predictive value of 72%. Of those who were predicted to respond to therapy, the mandibular protrusive position was efficacious in 86% of patients.
The high rate of accuracy for predicting who will derive the most benefit from the appliance, along with the demonstrated preference for oral appliances compared to continuous positive airway pressure devices among patients, increases the clinical utility of the appliance, and expands options for clinical management of sleep apnea, according to the study authors (Clin Sleep Med. 2017;13[7]:871-80).
“Our test allows the physician to prescribe the therapy knowing it will get rid of sleep apnea, and it tells the dentist how far the mandible needs to be pulled out by the custom fit device,” Dr. Remmers explained.
Dentists will also benefit from the test, because it allows them to make an appliance that will not need to be adjusted and will have a higher success rate than the current 60% success rate that oral appliances have at treating sleep apnea, he noted.
“This opens up a new an alternative clinical avenue at a critical time, when we have just learned over the past few years that there are serious questions about the effectiveness of CPAP in the long term,” Dr. Remmers added. “[With oral appliance therapy] you have an opportunity for higher compliance, because people prefer the less obtrusive oral appliance therapy over CPAP, and they use it more than CPAP. ... Because our product says you don’t treat everybody, you only undertake oral appliance therapy for those who we know in advance will have a favorable outcome, it removes a major barrier to oral appliance therapy that has been the barrier for many years.”
Dr. Remmers noted that his test was not nearly as good at identifying people who would be failures as it was at identifying people who would be successes and that he is carrying out another trial with a similar device.
Some participants reported sore gums when using the device, but there were no long-lasting adverse events reported.
The mandibular positioner home test has not been approved or cleared for use by the Food and Drug Administration, but is currently being sold in Canada, according to Dr. Remmers.
Zephyr Sleep Technologies and Alberta Innovates Technology Futures sponsored the study. It is registered on clinicaltrials.gov as NCT03011762. All of the investigators, other than Nikola Vranjes, are employed or associated with Zephyr Sleep Technologies.
Whitney McKnight contributed to this report.
Patients report issues with home O2
WASHINGTON – Patient education in the use of home oxygen halves the number of system use issues reported by patients, based on results of a survey of nearly 2,000 patients.
Pulmonary clinicians and patients report “intolerable barriers to home oxygen services,” lead researcher Susan S. Jacobs, RN, MS, said in a poster session at an international conference of the American Thoracic Society. These barriers include insufficient oxygen supply, inadequate and physically unmanageable portable options, and equipment malfunction.
“We’ve demonstrated that, if the patients are educated by a health care professional, the problems with oxygen go down, Ms. Jacobs, who is a nurse coordinator in the division of pulmonary and critical care medicine at Stanford (Calif.) University, said in an interview. “While physicians can provide oxygen for their patients, the patient oxygen education will most likely lie with the nurses and respiratory therapists.”
Of patients who responded to the survey question "Do you have oxygen problems?" 51% (899) said yes*. On average, these patients said they had experienced 3.5 types of problems with their systems.
Patients who were educated by a health care professional reported fewer problems and were more likely to report having no problems with their oxygen system. Of the patients who received oxygen therapy instruction from a health care professional, 76 (57%) did not report having any issues with their system. In contrast, of the patients who received no instruction, 116 (64%) said they had problems with their oxygen.
Most survey participants (1,113 patients) received oxygen therapy instruction from an oxygen delivery person instead of a health care professional. This group’s opinions about their oxygen systems were split, with 51% (563 patients) experiencing issues with their systems. The other 49% reported no problems.
Survey participants most frequently complained that their equipment was not working; 499 selected this response to the question, “What types of oxygen problems do you have?”
Many patients also reported being unable to spend as much time out of their homes as they wanted. This limitation resulted from their lack of access to functioning, manageable, high flow, portable oxygen systems, according to the researchers. Further, 43% of patients reported that their portable system limited their activity outside the home frequently or all of the time.
“Most of the reported problems were related to respondents not having portable systems that let them be out of their house for more than 2 to 4 hours or [to systems that] were too heavy for the patients to lift up and down their stairs and out of their cars, and they had problems operating them,” said Ms. Jacobs, who is a nurse coordinator in the division of pulmonary and critical care medicine at Stanford (Calif.) University.
The survey respondents also reported experiencing delivery problems, not being able to change the company providing them with oxygen, receiving incorrect or delayed orders from a physician, or being unable to get liquid oxygen. These responses were provided by 267, 177, 166, and 68 patients, respectively.
“There is a lot of confusion for the physicians as well as the nurses about what types of systems the patients can use [and] the pros and cons of each system. There’s lots of confusion and time spent about getting the initial orders right, getting them set up with a supplier, and ensuring the patient gets the equipment that was ordered. There is a lot of back and forth, which results in a delay to the patient, and the patients are upset because they are waiting for their oxygen supply,” she explained. “So, I think that physicians are very much wanting clarification to streamline the process and identify what patient systems are appropriate, which are high flow, [and] what their patients’ needs are to help physicians spend less time on this and help the patients get their oxygen set up in a timely manner.”
The study participants came from all 50 states and were 64 years of age on average and mostly women. A high percentage (39%) of the sample had chronic obstructive pulmonary disease, while 26% had interstitial lung diseases, 18% had pulmonary arterial hypertension, 8% had alpha-1 antitrypsin deficiency, and 4% had lymphangioleiomyomatosis.
Ms. Jacobs noted that she thought patients would benefit from greater physician knowledge of their prescribing options.
“A physician can dictate exactly what system they want. ... You can try to give [patients] a lighter system, a backpack, a smaller tank, more tanks per week, depending on their lifestyle and their needs. But physicians, a lot of times, like all of us and our patients, [are] not aware of all these choices,” she said, during the interview.
An online resource providing all of the pros and cons of the different types of portable oxygen systems that would be appropriate for physicians, nurses, and patients, as well as an examination of the quality standards of the oxygen suppliers, are needed, she noted
Ms. Jacobs reported no financial disclosures.
*This article was corrected June 16, 2017
WASHINGTON – Patient education in the use of home oxygen halves the number of system use issues reported by patients, based on results of a survey of nearly 2,000 patients.
Pulmonary clinicians and patients report “intolerable barriers to home oxygen services,” lead researcher Susan S. Jacobs, RN, MS, said in a poster session at an international conference of the American Thoracic Society. These barriers include insufficient oxygen supply, inadequate and physically unmanageable portable options, and equipment malfunction.
“We’ve demonstrated that, if the patients are educated by a health care professional, the problems with oxygen go down, Ms. Jacobs, who is a nurse coordinator in the division of pulmonary and critical care medicine at Stanford (Calif.) University, said in an interview. “While physicians can provide oxygen for their patients, the patient oxygen education will most likely lie with the nurses and respiratory therapists.”
Of patients who responded to the survey question "Do you have oxygen problems?" 51% (899) said yes*. On average, these patients said they had experienced 3.5 types of problems with their systems.
Patients who were educated by a health care professional reported fewer problems and were more likely to report having no problems with their oxygen system. Of the patients who received oxygen therapy instruction from a health care professional, 76 (57%) did not report having any issues with their system. In contrast, of the patients who received no instruction, 116 (64%) said they had problems with their oxygen.
Most survey participants (1,113 patients) received oxygen therapy instruction from an oxygen delivery person instead of a health care professional. This group’s opinions about their oxygen systems were split, with 51% (563 patients) experiencing issues with their systems. The other 49% reported no problems.
Survey participants most frequently complained that their equipment was not working; 499 selected this response to the question, “What types of oxygen problems do you have?”
Many patients also reported being unable to spend as much time out of their homes as they wanted. This limitation resulted from their lack of access to functioning, manageable, high flow, portable oxygen systems, according to the researchers. Further, 43% of patients reported that their portable system limited their activity outside the home frequently or all of the time.
“Most of the reported problems were related to respondents not having portable systems that let them be out of their house for more than 2 to 4 hours or [to systems that] were too heavy for the patients to lift up and down their stairs and out of their cars, and they had problems operating them,” said Ms. Jacobs, who is a nurse coordinator in the division of pulmonary and critical care medicine at Stanford (Calif.) University.
The survey respondents also reported experiencing delivery problems, not being able to change the company providing them with oxygen, receiving incorrect or delayed orders from a physician, or being unable to get liquid oxygen. These responses were provided by 267, 177, 166, and 68 patients, respectively.
“There is a lot of confusion for the physicians as well as the nurses about what types of systems the patients can use [and] the pros and cons of each system. There’s lots of confusion and time spent about getting the initial orders right, getting them set up with a supplier, and ensuring the patient gets the equipment that was ordered. There is a lot of back and forth, which results in a delay to the patient, and the patients are upset because they are waiting for their oxygen supply,” she explained. “So, I think that physicians are very much wanting clarification to streamline the process and identify what patient systems are appropriate, which are high flow, [and] what their patients’ needs are to help physicians spend less time on this and help the patients get their oxygen set up in a timely manner.”
The study participants came from all 50 states and were 64 years of age on average and mostly women. A high percentage (39%) of the sample had chronic obstructive pulmonary disease, while 26% had interstitial lung diseases, 18% had pulmonary arterial hypertension, 8% had alpha-1 antitrypsin deficiency, and 4% had lymphangioleiomyomatosis.
Ms. Jacobs noted that she thought patients would benefit from greater physician knowledge of their prescribing options.
“A physician can dictate exactly what system they want. ... You can try to give [patients] a lighter system, a backpack, a smaller tank, more tanks per week, depending on their lifestyle and their needs. But physicians, a lot of times, like all of us and our patients, [are] not aware of all these choices,” she said, during the interview.
An online resource providing all of the pros and cons of the different types of portable oxygen systems that would be appropriate for physicians, nurses, and patients, as well as an examination of the quality standards of the oxygen suppliers, are needed, she noted
Ms. Jacobs reported no financial disclosures.
*This article was corrected June 16, 2017
WASHINGTON – Patient education in the use of home oxygen halves the number of system use issues reported by patients, based on results of a survey of nearly 2,000 patients.
Pulmonary clinicians and patients report “intolerable barriers to home oxygen services,” lead researcher Susan S. Jacobs, RN, MS, said in a poster session at an international conference of the American Thoracic Society. These barriers include insufficient oxygen supply, inadequate and physically unmanageable portable options, and equipment malfunction.
“We’ve demonstrated that, if the patients are educated by a health care professional, the problems with oxygen go down, Ms. Jacobs, who is a nurse coordinator in the division of pulmonary and critical care medicine at Stanford (Calif.) University, said in an interview. “While physicians can provide oxygen for their patients, the patient oxygen education will most likely lie with the nurses and respiratory therapists.”
Of patients who responded to the survey question "Do you have oxygen problems?" 51% (899) said yes*. On average, these patients said they had experienced 3.5 types of problems with their systems.
Patients who were educated by a health care professional reported fewer problems and were more likely to report having no problems with their oxygen system. Of the patients who received oxygen therapy instruction from a health care professional, 76 (57%) did not report having any issues with their system. In contrast, of the patients who received no instruction, 116 (64%) said they had problems with their oxygen.
Most survey participants (1,113 patients) received oxygen therapy instruction from an oxygen delivery person instead of a health care professional. This group’s opinions about their oxygen systems were split, with 51% (563 patients) experiencing issues with their systems. The other 49% reported no problems.
Survey participants most frequently complained that their equipment was not working; 499 selected this response to the question, “What types of oxygen problems do you have?”
Many patients also reported being unable to spend as much time out of their homes as they wanted. This limitation resulted from their lack of access to functioning, manageable, high flow, portable oxygen systems, according to the researchers. Further, 43% of patients reported that their portable system limited their activity outside the home frequently or all of the time.
“Most of the reported problems were related to respondents not having portable systems that let them be out of their house for more than 2 to 4 hours or [to systems that] were too heavy for the patients to lift up and down their stairs and out of their cars, and they had problems operating them,” said Ms. Jacobs, who is a nurse coordinator in the division of pulmonary and critical care medicine at Stanford (Calif.) University.
The survey respondents also reported experiencing delivery problems, not being able to change the company providing them with oxygen, receiving incorrect or delayed orders from a physician, or being unable to get liquid oxygen. These responses were provided by 267, 177, 166, and 68 patients, respectively.
“There is a lot of confusion for the physicians as well as the nurses about what types of systems the patients can use [and] the pros and cons of each system. There’s lots of confusion and time spent about getting the initial orders right, getting them set up with a supplier, and ensuring the patient gets the equipment that was ordered. There is a lot of back and forth, which results in a delay to the patient, and the patients are upset because they are waiting for their oxygen supply,” she explained. “So, I think that physicians are very much wanting clarification to streamline the process and identify what patient systems are appropriate, which are high flow, [and] what their patients’ needs are to help physicians spend less time on this and help the patients get their oxygen set up in a timely manner.”
The study participants came from all 50 states and were 64 years of age on average and mostly women. A high percentage (39%) of the sample had chronic obstructive pulmonary disease, while 26% had interstitial lung diseases, 18% had pulmonary arterial hypertension, 8% had alpha-1 antitrypsin deficiency, and 4% had lymphangioleiomyomatosis.
Ms. Jacobs noted that she thought patients would benefit from greater physician knowledge of their prescribing options.
“A physician can dictate exactly what system they want. ... You can try to give [patients] a lighter system, a backpack, a smaller tank, more tanks per week, depending on their lifestyle and their needs. But physicians, a lot of times, like all of us and our patients, [are] not aware of all these choices,” she said, during the interview.
An online resource providing all of the pros and cons of the different types of portable oxygen systems that would be appropriate for physicians, nurses, and patients, as well as an examination of the quality standards of the oxygen suppliers, are needed, she noted
Ms. Jacobs reported no financial disclosures.
*This article was corrected June 16, 2017
AT ATS 2017
Key clinical point:
Major finding: Patients reported experiencing an average of 3.5 types of problems with their home oxygen systems.
Data source: An analysis of 1,926 home-oxygen users’ responses to an online, 60-question survey.
Disclosures: Ms. Jacobs reported no financial disclosures.