ALA report: Federal and state actions to limit tobacco use fall short

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Tobacco use is currently at an all-time low thanks to public and private efforts, but more aggressive action from federal, state, and local governments is needed to protect the public, according to a review of tobacco control trends in the United States.

The American Lung Association (ALA) released “State of Tobacco Control” 2019, its 17th annual state-by-state analysis and list of recommended policy priorities to limit tobacco use. Although the report notes some positive steps taken by the federal and state governments, shortfalls in policy and legislation also are highlighted. The report states, “We know how and are ready to save more lives, but we need our elected officials to do much more. To many, solving America’s tobacco crisis might seem like a complex puzzle with no solution. And yet we have known for years what pieces are needed to reduce the disease and death caused by tobacco use.”

In this report, the federal government and each state are graded on a scale, A through F, for policy actions and laws to limit tobacco use. The grading methodology is based on a detailed point system cataloging the implementation and strength of specific actions and policies to limit tobacco use.
 

Areas of Impact

The report focused on six areas of public policy that affect exposure to and use of tobacco:

  • Smoke-free air: Protecting the public from secondhand smoke should be a priority for policymakers, according the report, but 22 states have no smoke-free workplace laws in place. Laws restricting e-cigarettes in workplaces and public buildings have lagged behind tobacco laws in many states.
  • Tobacco prevention funding: Dedicated funds to prevent tobacco addiction before it starts is a key element of a public health attack on tobacco use, but no U.S. state currently spends what the Centers for Disease Control and Prevention has recommended. Twenty years ago, the Master Settlement Agreement between the tobacco industry and 46 states and the District of Columbia guaranteed ongoing payments to the states to be used for tobacco prevention and control. Although those funds have been collected in the states to the tune of $27 billion since 1998, overall only 2.4% of those funds have been spent for this purpose, and the rest has been budgeted for other purposes.
  • Tobacco taxes: Sales taxes on tobacco products have been highly effective in preventing young people from taking up tobacco use, but those taxation rates have remained unchanged in 2018 in all but the District of Columbia and Oklahoma. The tobacco industry spent $22 million in a successful effort to defeat ballot measures to increase sales taxes on tobacco in Montana and South Dakota.
  • Tobacco 21: “Increasing the legal age of sale for tobacco products to 21 would decrease tobacco use by 12% and could prevent 223,000 deaths among those born between 2000 and 2019,” the report noted, citing a 2015 report by the Institute of Medicine. So far, the this restriction has been legislated in six states, the District of Columbia, and numerous local governments. The ALA considers increasing the age for tobacco sales to 21 to be a public health priority.
  • Helping smokers quit: The addictive qualities of tobacco mean that many smokers struggle unsuccessfully to quit, and medical intervention is needed to help them. The report notes that current law requires that Medicaid expansion health plans and private insurance plans cover comprehensive smoking cessation treatment. However, not all states have the expanded Medicaid program, and many of those with Medicaid expansion don’t offer coverage of all Food and Drug–approved cessation treatments. Despite laws requiring smoking cessation coverage, many private insurance plans still do not include this coverage. The ALA recommends enforcement of the current law with regard to tobacco cessation insurance coverage.
  • FDA regulation of tobacco products: The FDA has announced plans to make a major effort to reduce tobacco use in young people, decrease nicotine in cigarettes, and to restrict flavored tobacco products. But these plans fall short of the aggressive action needed to curb the tobacco “epidemic,” according to the report. Delayed action and timid policy have “resulted in tobacco companies becoming more emboldened to devise new and egregious ways to addict youth and sustain addiction among current users.” The ALA report points to the steep rise in e-cigarette use among youth with a 20.8% rise in high school students using these products in 2018, a rise from 11.7% in 2017. This trend is not likely to be reversed by the FDA proposals to date, which rely on voluntary action by the industry to curb youth use, sales restrictions to youth, and restrictions on some flavored tobacco products.
 

 

The report card

Federal government efforts in regulation of tobacco products, taxation, and health insurance coverage of cessation all received an F in this report, while mass media campaigns were given an A.

The states didn’t fare much better. They were graded on prevention and control funding, smoke-free air, taxation, access to cessation services, and minimum age for sales. A total of 19 states received a grade of F in four or five of these areas.

Funding for prevention and control was evaluated as the percentage of the amount recommended by the CDC, adjusted for a variety of state-specific factors such as prevalence of tobacco use, cost and complexity of conducting mass media campaigns, and proportion of the audience below 200% of the federal poverty level. A limitation of this methodology of grading funding is that it doesn’t evaluate effectiveness of the spending or the level of spending in different program categories. The higher spenders on prevention and control were Alaska at 98.1% and California at 74.5% of the CDC recommended level. The lowest spenders were Georgia at 2.8% and Missouri at 3.0%.

All but eight states received an F on minimum age for tobacco sales because most have an age limit 18 instead of the ALA and CDC recommendation of age 21.

Harold Wimmer, the CEO of the American Lung Association, wrote, “Aggressive action by our country’s federal and state policymakers is urgently required. However, ‘State of Tobacco Control’ 2019 has found a disturbing failure by federal and state governments to take action to put in place meaningful and proven-effective policies that would have prevented, and reduced tobacco use during 2018. This failure to act places the lung health and lives of Americans at risk. We have also found that this lack of action has emboldened tobacco companies to be even more brazen in producing and marketing products squarely aimed at kids, such as the JUUL e-cigarettes that look like an easily concealed USB drive, which now dominate the market driven by youth use.”

The full report is available for download at the ALA website.

SOURCE: American Lung Association, “State of Tobacco Control 2019”.

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Tobacco use is currently at an all-time low thanks to public and private efforts, but more aggressive action from federal, state, and local governments is needed to protect the public, according to a review of tobacco control trends in the United States.

The American Lung Association (ALA) released “State of Tobacco Control” 2019, its 17th annual state-by-state analysis and list of recommended policy priorities to limit tobacco use. Although the report notes some positive steps taken by the federal and state governments, shortfalls in policy and legislation also are highlighted. The report states, “We know how and are ready to save more lives, but we need our elected officials to do much more. To many, solving America’s tobacco crisis might seem like a complex puzzle with no solution. And yet we have known for years what pieces are needed to reduce the disease and death caused by tobacco use.”

In this report, the federal government and each state are graded on a scale, A through F, for policy actions and laws to limit tobacco use. The grading methodology is based on a detailed point system cataloging the implementation and strength of specific actions and policies to limit tobacco use.
 

Areas of Impact

The report focused on six areas of public policy that affect exposure to and use of tobacco:

  • Smoke-free air: Protecting the public from secondhand smoke should be a priority for policymakers, according the report, but 22 states have no smoke-free workplace laws in place. Laws restricting e-cigarettes in workplaces and public buildings have lagged behind tobacco laws in many states.
  • Tobacco prevention funding: Dedicated funds to prevent tobacco addiction before it starts is a key element of a public health attack on tobacco use, but no U.S. state currently spends what the Centers for Disease Control and Prevention has recommended. Twenty years ago, the Master Settlement Agreement between the tobacco industry and 46 states and the District of Columbia guaranteed ongoing payments to the states to be used for tobacco prevention and control. Although those funds have been collected in the states to the tune of $27 billion since 1998, overall only 2.4% of those funds have been spent for this purpose, and the rest has been budgeted for other purposes.
  • Tobacco taxes: Sales taxes on tobacco products have been highly effective in preventing young people from taking up tobacco use, but those taxation rates have remained unchanged in 2018 in all but the District of Columbia and Oklahoma. The tobacco industry spent $22 million in a successful effort to defeat ballot measures to increase sales taxes on tobacco in Montana and South Dakota.
  • Tobacco 21: “Increasing the legal age of sale for tobacco products to 21 would decrease tobacco use by 12% and could prevent 223,000 deaths among those born between 2000 and 2019,” the report noted, citing a 2015 report by the Institute of Medicine. So far, the this restriction has been legislated in six states, the District of Columbia, and numerous local governments. The ALA considers increasing the age for tobacco sales to 21 to be a public health priority.
  • Helping smokers quit: The addictive qualities of tobacco mean that many smokers struggle unsuccessfully to quit, and medical intervention is needed to help them. The report notes that current law requires that Medicaid expansion health plans and private insurance plans cover comprehensive smoking cessation treatment. However, not all states have the expanded Medicaid program, and many of those with Medicaid expansion don’t offer coverage of all Food and Drug–approved cessation treatments. Despite laws requiring smoking cessation coverage, many private insurance plans still do not include this coverage. The ALA recommends enforcement of the current law with regard to tobacco cessation insurance coverage.
  • FDA regulation of tobacco products: The FDA has announced plans to make a major effort to reduce tobacco use in young people, decrease nicotine in cigarettes, and to restrict flavored tobacco products. But these plans fall short of the aggressive action needed to curb the tobacco “epidemic,” according to the report. Delayed action and timid policy have “resulted in tobacco companies becoming more emboldened to devise new and egregious ways to addict youth and sustain addiction among current users.” The ALA report points to the steep rise in e-cigarette use among youth with a 20.8% rise in high school students using these products in 2018, a rise from 11.7% in 2017. This trend is not likely to be reversed by the FDA proposals to date, which rely on voluntary action by the industry to curb youth use, sales restrictions to youth, and restrictions on some flavored tobacco products.
 

 

The report card

Federal government efforts in regulation of tobacco products, taxation, and health insurance coverage of cessation all received an F in this report, while mass media campaigns were given an A.

The states didn’t fare much better. They were graded on prevention and control funding, smoke-free air, taxation, access to cessation services, and minimum age for sales. A total of 19 states received a grade of F in four or five of these areas.

Funding for prevention and control was evaluated as the percentage of the amount recommended by the CDC, adjusted for a variety of state-specific factors such as prevalence of tobacco use, cost and complexity of conducting mass media campaigns, and proportion of the audience below 200% of the federal poverty level. A limitation of this methodology of grading funding is that it doesn’t evaluate effectiveness of the spending or the level of spending in different program categories. The higher spenders on prevention and control were Alaska at 98.1% and California at 74.5% of the CDC recommended level. The lowest spenders were Georgia at 2.8% and Missouri at 3.0%.

All but eight states received an F on minimum age for tobacco sales because most have an age limit 18 instead of the ALA and CDC recommendation of age 21.

Harold Wimmer, the CEO of the American Lung Association, wrote, “Aggressive action by our country’s federal and state policymakers is urgently required. However, ‘State of Tobacco Control’ 2019 has found a disturbing failure by federal and state governments to take action to put in place meaningful and proven-effective policies that would have prevented, and reduced tobacco use during 2018. This failure to act places the lung health and lives of Americans at risk. We have also found that this lack of action has emboldened tobacco companies to be even more brazen in producing and marketing products squarely aimed at kids, such as the JUUL e-cigarettes that look like an easily concealed USB drive, which now dominate the market driven by youth use.”

The full report is available for download at the ALA website.

SOURCE: American Lung Association, “State of Tobacco Control 2019”.

Tobacco use is currently at an all-time low thanks to public and private efforts, but more aggressive action from federal, state, and local governments is needed to protect the public, according to a review of tobacco control trends in the United States.

The American Lung Association (ALA) released “State of Tobacco Control” 2019, its 17th annual state-by-state analysis and list of recommended policy priorities to limit tobacco use. Although the report notes some positive steps taken by the federal and state governments, shortfalls in policy and legislation also are highlighted. The report states, “We know how and are ready to save more lives, but we need our elected officials to do much more. To many, solving America’s tobacco crisis might seem like a complex puzzle with no solution. And yet we have known for years what pieces are needed to reduce the disease and death caused by tobacco use.”

In this report, the federal government and each state are graded on a scale, A through F, for policy actions and laws to limit tobacco use. The grading methodology is based on a detailed point system cataloging the implementation and strength of specific actions and policies to limit tobacco use.
 

Areas of Impact

The report focused on six areas of public policy that affect exposure to and use of tobacco:

  • Smoke-free air: Protecting the public from secondhand smoke should be a priority for policymakers, according the report, but 22 states have no smoke-free workplace laws in place. Laws restricting e-cigarettes in workplaces and public buildings have lagged behind tobacco laws in many states.
  • Tobacco prevention funding: Dedicated funds to prevent tobacco addiction before it starts is a key element of a public health attack on tobacco use, but no U.S. state currently spends what the Centers for Disease Control and Prevention has recommended. Twenty years ago, the Master Settlement Agreement between the tobacco industry and 46 states and the District of Columbia guaranteed ongoing payments to the states to be used for tobacco prevention and control. Although those funds have been collected in the states to the tune of $27 billion since 1998, overall only 2.4% of those funds have been spent for this purpose, and the rest has been budgeted for other purposes.
  • Tobacco taxes: Sales taxes on tobacco products have been highly effective in preventing young people from taking up tobacco use, but those taxation rates have remained unchanged in 2018 in all but the District of Columbia and Oklahoma. The tobacco industry spent $22 million in a successful effort to defeat ballot measures to increase sales taxes on tobacco in Montana and South Dakota.
  • Tobacco 21: “Increasing the legal age of sale for tobacco products to 21 would decrease tobacco use by 12% and could prevent 223,000 deaths among those born between 2000 and 2019,” the report noted, citing a 2015 report by the Institute of Medicine. So far, the this restriction has been legislated in six states, the District of Columbia, and numerous local governments. The ALA considers increasing the age for tobacco sales to 21 to be a public health priority.
  • Helping smokers quit: The addictive qualities of tobacco mean that many smokers struggle unsuccessfully to quit, and medical intervention is needed to help them. The report notes that current law requires that Medicaid expansion health plans and private insurance plans cover comprehensive smoking cessation treatment. However, not all states have the expanded Medicaid program, and many of those with Medicaid expansion don’t offer coverage of all Food and Drug–approved cessation treatments. Despite laws requiring smoking cessation coverage, many private insurance plans still do not include this coverage. The ALA recommends enforcement of the current law with regard to tobacco cessation insurance coverage.
  • FDA regulation of tobacco products: The FDA has announced plans to make a major effort to reduce tobacco use in young people, decrease nicotine in cigarettes, and to restrict flavored tobacco products. But these plans fall short of the aggressive action needed to curb the tobacco “epidemic,” according to the report. Delayed action and timid policy have “resulted in tobacco companies becoming more emboldened to devise new and egregious ways to addict youth and sustain addiction among current users.” The ALA report points to the steep rise in e-cigarette use among youth with a 20.8% rise in high school students using these products in 2018, a rise from 11.7% in 2017. This trend is not likely to be reversed by the FDA proposals to date, which rely on voluntary action by the industry to curb youth use, sales restrictions to youth, and restrictions on some flavored tobacco products.
 

 

The report card

Federal government efforts in regulation of tobacco products, taxation, and health insurance coverage of cessation all received an F in this report, while mass media campaigns were given an A.

The states didn’t fare much better. They were graded on prevention and control funding, smoke-free air, taxation, access to cessation services, and minimum age for sales. A total of 19 states received a grade of F in four or five of these areas.

Funding for prevention and control was evaluated as the percentage of the amount recommended by the CDC, adjusted for a variety of state-specific factors such as prevalence of tobacco use, cost and complexity of conducting mass media campaigns, and proportion of the audience below 200% of the federal poverty level. A limitation of this methodology of grading funding is that it doesn’t evaluate effectiveness of the spending or the level of spending in different program categories. The higher spenders on prevention and control were Alaska at 98.1% and California at 74.5% of the CDC recommended level. The lowest spenders were Georgia at 2.8% and Missouri at 3.0%.

All but eight states received an F on minimum age for tobacco sales because most have an age limit 18 instead of the ALA and CDC recommendation of age 21.

Harold Wimmer, the CEO of the American Lung Association, wrote, “Aggressive action by our country’s federal and state policymakers is urgently required. However, ‘State of Tobacco Control’ 2019 has found a disturbing failure by federal and state governments to take action to put in place meaningful and proven-effective policies that would have prevented, and reduced tobacco use during 2018. This failure to act places the lung health and lives of Americans at risk. We have also found that this lack of action has emboldened tobacco companies to be even more brazen in producing and marketing products squarely aimed at kids, such as the JUUL e-cigarettes that look like an easily concealed USB drive, which now dominate the market driven by youth use.”

The full report is available for download at the ALA website.

SOURCE: American Lung Association, “State of Tobacco Control 2019”.

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An update on chronic thromboembolic pulmonary hypertension

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The “fixable” form of PH that you don’t want to miss

Chronic thromboembolic pulmonary hypertension (CTEPH) is an elevation in pulmonary vascular resistance (PVR) resulting from chronic, “scarred-in” thromboembolic material partially occluding the pulmonary arteries. This vascular obstruction, over time, results in failure of the right ventricle and early mortality.

Dr. Sonja Bartolome

CTEPH was first characterized in an autopsy series from the Massachusetts General Hospital in 1931. On these postmortem examinations, it was noted that the affected patients had large pulmonary artery vascular obstruction, but also normal pulmonary parenchyma distal to this vascular obstruction and extensive bronchial collateral blood flow (Means J. Ann Intern Med. 1931;5:417). Although this observation set the groundwork for the theory that surgically removing the vascular obstruction to this preserved lung tissue could improve the condition of these patients, it would take until the mid-20th century until imaging and cardiac catheterization techniques allowed the recognition of the disease in real time.

CTEPH is thought to begin with an acute pulmonary embolus, but in approximately 3.4% of patients, rather than resolving over time, the thrombus will organize and incorporate into the pulmonary artery intimal layer (Simonneau G, et al. Eur Respir Rev. 2017;26:160112) A history of venous thromboembolism in a patient with persistent dyspnea should spur a screening evaluation for CTEPH; 75% of patients with CTEPH have a history of prior known acute pulmonary embolus and 56% of patients report a prior diagnosis of deep venous thrombosis. An acute pulmonary embolus will fibrinolyse early with the vast majority of the vascular obstruction resolving by the third month. Therefore, if the patient continues to report a significant exercise limitation after 3 months of therapeutic anticoagulation therapy, or has concerning physical exam signs, a workup should be pursued. The initial evaluation for CTEPH begins with a transthoracic echocardiogram (TTE) and ventilation/perfusion (V/Q) scintigraphy. A retrospective study comparing V/Q scan and multidetector CT scan revealed that V/Q scanning had a sensitivity and specificity of 97% and 95% for CTEPH, while CTPA had good specificity at 99% but only 51% sensitivity (Tunariu N, et al. J Nuc Med. 2007;48(5):680). If these are abnormal, then right-sided heart catheterization and invasive biplane digital subtraction pulmonary angiography are recommended. These studies confirm the diagnosis, grade its severity, and allow an evaluation for surgically accessible vs distal disease. Some CTEPH centers utilize additional imaging techniques, such as magnetic resonance angiography, optical resonance imaging, spectral CT scanning with iodine perfusion images, and intravascular ultrasound. These modalities and their place in the diagnostic algorithm are under investigation.

The goal of the initial evaluation process is to determine if the patient can undergo surgical pulmonary thromboendarterectomy (PTE), because in experienced hands, this procedure ensures the best long-term outcome for the patient. The first pulmonary thromboendarterectomy was performed at the University of California San Diego in 1970. Because the disease involves the intimal layer of the pulmonary artery, the surgery had to involve not just removal of the intravascular obstruction but also a pulmonary artery intimectomy. Surgical mortality rates were high in the initial experience. In 1984, a review of 85 worldwide cases reported an average mortality rate of 22%, and as high as 40% in some centers (Chitwood WR, Jr, et al. Clin Chest Med. 1984;5(3):507).

 

 


Over the ensuing years, refinements in surgical technique, the utilization of deep hypothermia and cardiac arrest during the procedure, development of new surgical instruments, and standardization of surgical selection and postoperative care have improved surgical mortality to <5% in experienced centers. Long-term outcomes of successful PTE surgery remain good, with 90% 3-year survival vs 70% for those who do not undergo surgery and are medically treated. Importantly, 90% of postoperative patients report functional class I or II symptoms at 1 year (Condliffe R, et al. Am J Reslpir Crit Care Med. 2008:177(10);1122). Because of this difference in early mortality and symptoms, PTE surgery remains the treatment of choice for CTEPH.

Despite the advances in PTE surgery, some patients are not operative candidates either due to surgically inaccessible disease or due to comorbidities. In 2001, Feinstein and colleagues described a series of 18 CTEPH cases treated with balloon pulmonary angioplasty (BPA). Promising hemodynamics effects were reported; however, the procedure had an unacceptable complication rate in which 11 patients developed reperfusion lung injury, 3 patients required mechanical ventilation, and 1 patient died. In the ensuing years, Japanese and Norwegian groups have independently developed and improved techniques for BPA. The procedure is done in a series of sessions (average four to six), 1 to 4 weeks apart, where small (2-3 mm) balloons are directed toward distal, diseased pulmonary vessels. Common complications include reperfusion injury, vessel injury, hemoptysis, and, more rarely, respiratory failure. Still, early experience suggests this procedure decreases pulmonary vascular resistance over time, improves right ventricular function, and improves patients’ symptoms (Andreassen A, et al. Heart. 2013;99(19):1415). The experience with this procedure is limited but growing in the United States, with only a handful of centers currently performing BPAs and collecting data.

Lifelong anticoagulation, oxygen, and diuretics for right-sided heart failure are recommended for patients with CTEPH. The first successful large phase III medication study for CTEPH was the CHEST-1 trial published in 2013. This was a multicenter, randomized, placebo-controlled trial of the soluble guanylate cyclase stimulator riociguat. The study enrolled 261 patients with inoperable CTEPH or persistent pulmonary hypertension after surgery. The primary end point was 6-minute walk distance at 12 weeks. The treatment group showed a 46 m improvement (P<.001). Secondary end points of pulmonary vascular resistance, NT-proBNP level, and functional class also improved. This pivotal trial led to the FDA approval of riociguat for inoperable or persistent postoperative CTEPH.

MERIT-1, a phase II, randomized placebo-controlled double trial of macitentan (an oral endothelin receptor antagonist) was recently completed. It enrolled 80 patients with inoperable CTEPH. The primary endpoint was pulmonary vascular resistance at week 16, expressed as a percentage of baseline. At week 16, the patients in the treatment arm had a PVR 73% of baseline vs 87.2% in the treatment group. This medication is not yet FDA-approved for the treatment of inoperable CTEPH (Ghofrani H, et al. Lancet Respir Med. 2017;5(10):785-794).

Pulmonary hypertension medication has been postulated as a possible way to “pretreat” patients before pulmonary thromboendarterectomy surgery, perhaps lowering preoperative pulmonary vascular resistance and surgical risk. However, there are currently no convincing data to support this practice, and medical treatment has been associated with a possible counterproductive delay in surgery. A phase II study including CTEPH patients with high PVR for preoperative treatment with riociguat vs placebo is currently enrolling to determine if “induction” treatment with medication prior to surgery reduces risk or delays definitive surgery. Occasionally, patients are found who have persistent thrombus but not pulmonary hypertension. Chronic thromboembolic disease (CTED) is a recently coined term describing patients who have chronic thromboembolism on imaging but have normal resting hemodynamics. Whether CTED represents simply unresolved clot that will never progress to CTEPH or is an early point on the continuum of disease not well-defined and a controversial topic among experts. At many centers, patients with CTED and symptoms will undergo exercise testing to look for exercise -induced pulmonary hypertension or an increase in dead space ventilation as a cause of their symptoms. A retrospective series of carefully chosen CTED patients who underwent PTE surgery reported improvements in symptoms and overall quality of life, without increased complications (Taboada D, et al. Eur Respir J. 2014 44(6):1635). The operation carries risk, however, and further work into the epidemiology and prognosis of CTED is required before operative intervention can be recommended.

In conclusion, CTEPH is a disease that rarely occurs after an acute PE but when undiagnosed and untreated portends a poor prognosis. The definitive treatment for this disease is surgical PTE, but to achieve the best outcomes, this procedure needs to be performed at expert centers with multidisciplinary team experience. Patients who are poor operative candidates or with surgically inaccessible disease may be considered for balloon pulmonary angioplasty. For patients without more curative options, medication improves exercise tolerance. The field of CTEPH has been rapidly expanding over the last decade, leading to better patient outcomes and more treatment options.

Dr. Bartolome is Associate Professor, Pulmonary and Critical Care Medicine; Director, CTEPH Program; and Associate Director, PH Program; UT Southwestern Medical Center, Dallas, Texas.

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The “fixable” form of PH that you don’t want to miss

The “fixable” form of PH that you don’t want to miss

Chronic thromboembolic pulmonary hypertension (CTEPH) is an elevation in pulmonary vascular resistance (PVR) resulting from chronic, “scarred-in” thromboembolic material partially occluding the pulmonary arteries. This vascular obstruction, over time, results in failure of the right ventricle and early mortality.

Dr. Sonja Bartolome

CTEPH was first characterized in an autopsy series from the Massachusetts General Hospital in 1931. On these postmortem examinations, it was noted that the affected patients had large pulmonary artery vascular obstruction, but also normal pulmonary parenchyma distal to this vascular obstruction and extensive bronchial collateral blood flow (Means J. Ann Intern Med. 1931;5:417). Although this observation set the groundwork for the theory that surgically removing the vascular obstruction to this preserved lung tissue could improve the condition of these patients, it would take until the mid-20th century until imaging and cardiac catheterization techniques allowed the recognition of the disease in real time.

CTEPH is thought to begin with an acute pulmonary embolus, but in approximately 3.4% of patients, rather than resolving over time, the thrombus will organize and incorporate into the pulmonary artery intimal layer (Simonneau G, et al. Eur Respir Rev. 2017;26:160112) A history of venous thromboembolism in a patient with persistent dyspnea should spur a screening evaluation for CTEPH; 75% of patients with CTEPH have a history of prior known acute pulmonary embolus and 56% of patients report a prior diagnosis of deep venous thrombosis. An acute pulmonary embolus will fibrinolyse early with the vast majority of the vascular obstruction resolving by the third month. Therefore, if the patient continues to report a significant exercise limitation after 3 months of therapeutic anticoagulation therapy, or has concerning physical exam signs, a workup should be pursued. The initial evaluation for CTEPH begins with a transthoracic echocardiogram (TTE) and ventilation/perfusion (V/Q) scintigraphy. A retrospective study comparing V/Q scan and multidetector CT scan revealed that V/Q scanning had a sensitivity and specificity of 97% and 95% for CTEPH, while CTPA had good specificity at 99% but only 51% sensitivity (Tunariu N, et al. J Nuc Med. 2007;48(5):680). If these are abnormal, then right-sided heart catheterization and invasive biplane digital subtraction pulmonary angiography are recommended. These studies confirm the diagnosis, grade its severity, and allow an evaluation for surgically accessible vs distal disease. Some CTEPH centers utilize additional imaging techniques, such as magnetic resonance angiography, optical resonance imaging, spectral CT scanning with iodine perfusion images, and intravascular ultrasound. These modalities and their place in the diagnostic algorithm are under investigation.

The goal of the initial evaluation process is to determine if the patient can undergo surgical pulmonary thromboendarterectomy (PTE), because in experienced hands, this procedure ensures the best long-term outcome for the patient. The first pulmonary thromboendarterectomy was performed at the University of California San Diego in 1970. Because the disease involves the intimal layer of the pulmonary artery, the surgery had to involve not just removal of the intravascular obstruction but also a pulmonary artery intimectomy. Surgical mortality rates were high in the initial experience. In 1984, a review of 85 worldwide cases reported an average mortality rate of 22%, and as high as 40% in some centers (Chitwood WR, Jr, et al. Clin Chest Med. 1984;5(3):507).

 

 


Over the ensuing years, refinements in surgical technique, the utilization of deep hypothermia and cardiac arrest during the procedure, development of new surgical instruments, and standardization of surgical selection and postoperative care have improved surgical mortality to <5% in experienced centers. Long-term outcomes of successful PTE surgery remain good, with 90% 3-year survival vs 70% for those who do not undergo surgery and are medically treated. Importantly, 90% of postoperative patients report functional class I or II symptoms at 1 year (Condliffe R, et al. Am J Reslpir Crit Care Med. 2008:177(10);1122). Because of this difference in early mortality and symptoms, PTE surgery remains the treatment of choice for CTEPH.

Despite the advances in PTE surgery, some patients are not operative candidates either due to surgically inaccessible disease or due to comorbidities. In 2001, Feinstein and colleagues described a series of 18 CTEPH cases treated with balloon pulmonary angioplasty (BPA). Promising hemodynamics effects were reported; however, the procedure had an unacceptable complication rate in which 11 patients developed reperfusion lung injury, 3 patients required mechanical ventilation, and 1 patient died. In the ensuing years, Japanese and Norwegian groups have independently developed and improved techniques for BPA. The procedure is done in a series of sessions (average four to six), 1 to 4 weeks apart, where small (2-3 mm) balloons are directed toward distal, diseased pulmonary vessels. Common complications include reperfusion injury, vessel injury, hemoptysis, and, more rarely, respiratory failure. Still, early experience suggests this procedure decreases pulmonary vascular resistance over time, improves right ventricular function, and improves patients’ symptoms (Andreassen A, et al. Heart. 2013;99(19):1415). The experience with this procedure is limited but growing in the United States, with only a handful of centers currently performing BPAs and collecting data.

Lifelong anticoagulation, oxygen, and diuretics for right-sided heart failure are recommended for patients with CTEPH. The first successful large phase III medication study for CTEPH was the CHEST-1 trial published in 2013. This was a multicenter, randomized, placebo-controlled trial of the soluble guanylate cyclase stimulator riociguat. The study enrolled 261 patients with inoperable CTEPH or persistent pulmonary hypertension after surgery. The primary end point was 6-minute walk distance at 12 weeks. The treatment group showed a 46 m improvement (P<.001). Secondary end points of pulmonary vascular resistance, NT-proBNP level, and functional class also improved. This pivotal trial led to the FDA approval of riociguat for inoperable or persistent postoperative CTEPH.

MERIT-1, a phase II, randomized placebo-controlled double trial of macitentan (an oral endothelin receptor antagonist) was recently completed. It enrolled 80 patients with inoperable CTEPH. The primary endpoint was pulmonary vascular resistance at week 16, expressed as a percentage of baseline. At week 16, the patients in the treatment arm had a PVR 73% of baseline vs 87.2% in the treatment group. This medication is not yet FDA-approved for the treatment of inoperable CTEPH (Ghofrani H, et al. Lancet Respir Med. 2017;5(10):785-794).

Pulmonary hypertension medication has been postulated as a possible way to “pretreat” patients before pulmonary thromboendarterectomy surgery, perhaps lowering preoperative pulmonary vascular resistance and surgical risk. However, there are currently no convincing data to support this practice, and medical treatment has been associated with a possible counterproductive delay in surgery. A phase II study including CTEPH patients with high PVR for preoperative treatment with riociguat vs placebo is currently enrolling to determine if “induction” treatment with medication prior to surgery reduces risk or delays definitive surgery. Occasionally, patients are found who have persistent thrombus but not pulmonary hypertension. Chronic thromboembolic disease (CTED) is a recently coined term describing patients who have chronic thromboembolism on imaging but have normal resting hemodynamics. Whether CTED represents simply unresolved clot that will never progress to CTEPH or is an early point on the continuum of disease not well-defined and a controversial topic among experts. At many centers, patients with CTED and symptoms will undergo exercise testing to look for exercise -induced pulmonary hypertension or an increase in dead space ventilation as a cause of their symptoms. A retrospective series of carefully chosen CTED patients who underwent PTE surgery reported improvements in symptoms and overall quality of life, without increased complications (Taboada D, et al. Eur Respir J. 2014 44(6):1635). The operation carries risk, however, and further work into the epidemiology and prognosis of CTED is required before operative intervention can be recommended.

In conclusion, CTEPH is a disease that rarely occurs after an acute PE but when undiagnosed and untreated portends a poor prognosis. The definitive treatment for this disease is surgical PTE, but to achieve the best outcomes, this procedure needs to be performed at expert centers with multidisciplinary team experience. Patients who are poor operative candidates or with surgically inaccessible disease may be considered for balloon pulmonary angioplasty. For patients without more curative options, medication improves exercise tolerance. The field of CTEPH has been rapidly expanding over the last decade, leading to better patient outcomes and more treatment options.

Dr. Bartolome is Associate Professor, Pulmonary and Critical Care Medicine; Director, CTEPH Program; and Associate Director, PH Program; UT Southwestern Medical Center, Dallas, Texas.

Chronic thromboembolic pulmonary hypertension (CTEPH) is an elevation in pulmonary vascular resistance (PVR) resulting from chronic, “scarred-in” thromboembolic material partially occluding the pulmonary arteries. This vascular obstruction, over time, results in failure of the right ventricle and early mortality.

Dr. Sonja Bartolome

CTEPH was first characterized in an autopsy series from the Massachusetts General Hospital in 1931. On these postmortem examinations, it was noted that the affected patients had large pulmonary artery vascular obstruction, but also normal pulmonary parenchyma distal to this vascular obstruction and extensive bronchial collateral blood flow (Means J. Ann Intern Med. 1931;5:417). Although this observation set the groundwork for the theory that surgically removing the vascular obstruction to this preserved lung tissue could improve the condition of these patients, it would take until the mid-20th century until imaging and cardiac catheterization techniques allowed the recognition of the disease in real time.

CTEPH is thought to begin with an acute pulmonary embolus, but in approximately 3.4% of patients, rather than resolving over time, the thrombus will organize and incorporate into the pulmonary artery intimal layer (Simonneau G, et al. Eur Respir Rev. 2017;26:160112) A history of venous thromboembolism in a patient with persistent dyspnea should spur a screening evaluation for CTEPH; 75% of patients with CTEPH have a history of prior known acute pulmonary embolus and 56% of patients report a prior diagnosis of deep venous thrombosis. An acute pulmonary embolus will fibrinolyse early with the vast majority of the vascular obstruction resolving by the third month. Therefore, if the patient continues to report a significant exercise limitation after 3 months of therapeutic anticoagulation therapy, or has concerning physical exam signs, a workup should be pursued. The initial evaluation for CTEPH begins with a transthoracic echocardiogram (TTE) and ventilation/perfusion (V/Q) scintigraphy. A retrospective study comparing V/Q scan and multidetector CT scan revealed that V/Q scanning had a sensitivity and specificity of 97% and 95% for CTEPH, while CTPA had good specificity at 99% but only 51% sensitivity (Tunariu N, et al. J Nuc Med. 2007;48(5):680). If these are abnormal, then right-sided heart catheterization and invasive biplane digital subtraction pulmonary angiography are recommended. These studies confirm the diagnosis, grade its severity, and allow an evaluation for surgically accessible vs distal disease. Some CTEPH centers utilize additional imaging techniques, such as magnetic resonance angiography, optical resonance imaging, spectral CT scanning with iodine perfusion images, and intravascular ultrasound. These modalities and their place in the diagnostic algorithm are under investigation.

The goal of the initial evaluation process is to determine if the patient can undergo surgical pulmonary thromboendarterectomy (PTE), because in experienced hands, this procedure ensures the best long-term outcome for the patient. The first pulmonary thromboendarterectomy was performed at the University of California San Diego in 1970. Because the disease involves the intimal layer of the pulmonary artery, the surgery had to involve not just removal of the intravascular obstruction but also a pulmonary artery intimectomy. Surgical mortality rates were high in the initial experience. In 1984, a review of 85 worldwide cases reported an average mortality rate of 22%, and as high as 40% in some centers (Chitwood WR, Jr, et al. Clin Chest Med. 1984;5(3):507).

 

 


Over the ensuing years, refinements in surgical technique, the utilization of deep hypothermia and cardiac arrest during the procedure, development of new surgical instruments, and standardization of surgical selection and postoperative care have improved surgical mortality to <5% in experienced centers. Long-term outcomes of successful PTE surgery remain good, with 90% 3-year survival vs 70% for those who do not undergo surgery and are medically treated. Importantly, 90% of postoperative patients report functional class I or II symptoms at 1 year (Condliffe R, et al. Am J Reslpir Crit Care Med. 2008:177(10);1122). Because of this difference in early mortality and symptoms, PTE surgery remains the treatment of choice for CTEPH.

Despite the advances in PTE surgery, some patients are not operative candidates either due to surgically inaccessible disease or due to comorbidities. In 2001, Feinstein and colleagues described a series of 18 CTEPH cases treated with balloon pulmonary angioplasty (BPA). Promising hemodynamics effects were reported; however, the procedure had an unacceptable complication rate in which 11 patients developed reperfusion lung injury, 3 patients required mechanical ventilation, and 1 patient died. In the ensuing years, Japanese and Norwegian groups have independently developed and improved techniques for BPA. The procedure is done in a series of sessions (average four to six), 1 to 4 weeks apart, where small (2-3 mm) balloons are directed toward distal, diseased pulmonary vessels. Common complications include reperfusion injury, vessel injury, hemoptysis, and, more rarely, respiratory failure. Still, early experience suggests this procedure decreases pulmonary vascular resistance over time, improves right ventricular function, and improves patients’ symptoms (Andreassen A, et al. Heart. 2013;99(19):1415). The experience with this procedure is limited but growing in the United States, with only a handful of centers currently performing BPAs and collecting data.

Lifelong anticoagulation, oxygen, and diuretics for right-sided heart failure are recommended for patients with CTEPH. The first successful large phase III medication study for CTEPH was the CHEST-1 trial published in 2013. This was a multicenter, randomized, placebo-controlled trial of the soluble guanylate cyclase stimulator riociguat. The study enrolled 261 patients with inoperable CTEPH or persistent pulmonary hypertension after surgery. The primary end point was 6-minute walk distance at 12 weeks. The treatment group showed a 46 m improvement (P<.001). Secondary end points of pulmonary vascular resistance, NT-proBNP level, and functional class also improved. This pivotal trial led to the FDA approval of riociguat for inoperable or persistent postoperative CTEPH.

MERIT-1, a phase II, randomized placebo-controlled double trial of macitentan (an oral endothelin receptor antagonist) was recently completed. It enrolled 80 patients with inoperable CTEPH. The primary endpoint was pulmonary vascular resistance at week 16, expressed as a percentage of baseline. At week 16, the patients in the treatment arm had a PVR 73% of baseline vs 87.2% in the treatment group. This medication is not yet FDA-approved for the treatment of inoperable CTEPH (Ghofrani H, et al. Lancet Respir Med. 2017;5(10):785-794).

Pulmonary hypertension medication has been postulated as a possible way to “pretreat” patients before pulmonary thromboendarterectomy surgery, perhaps lowering preoperative pulmonary vascular resistance and surgical risk. However, there are currently no convincing data to support this practice, and medical treatment has been associated with a possible counterproductive delay in surgery. A phase II study including CTEPH patients with high PVR for preoperative treatment with riociguat vs placebo is currently enrolling to determine if “induction” treatment with medication prior to surgery reduces risk or delays definitive surgery. Occasionally, patients are found who have persistent thrombus but not pulmonary hypertension. Chronic thromboembolic disease (CTED) is a recently coined term describing patients who have chronic thromboembolism on imaging but have normal resting hemodynamics. Whether CTED represents simply unresolved clot that will never progress to CTEPH or is an early point on the continuum of disease not well-defined and a controversial topic among experts. At many centers, patients with CTED and symptoms will undergo exercise testing to look for exercise -induced pulmonary hypertension or an increase in dead space ventilation as a cause of their symptoms. A retrospective series of carefully chosen CTED patients who underwent PTE surgery reported improvements in symptoms and overall quality of life, without increased complications (Taboada D, et al. Eur Respir J. 2014 44(6):1635). The operation carries risk, however, and further work into the epidemiology and prognosis of CTED is required before operative intervention can be recommended.

In conclusion, CTEPH is a disease that rarely occurs after an acute PE but when undiagnosed and untreated portends a poor prognosis. The definitive treatment for this disease is surgical PTE, but to achieve the best outcomes, this procedure needs to be performed at expert centers with multidisciplinary team experience. Patients who are poor operative candidates or with surgically inaccessible disease may be considered for balloon pulmonary angioplasty. For patients without more curative options, medication improves exercise tolerance. The field of CTEPH has been rapidly expanding over the last decade, leading to better patient outcomes and more treatment options.

Dr. Bartolome is Associate Professor, Pulmonary and Critical Care Medicine; Director, CTEPH Program; and Associate Director, PH Program; UT Southwestern Medical Center, Dallas, Texas.

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Flu activity hits seasonal high

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Influenza activity increased for the third consecutive week and has now reached its highest point for the 2018-2019 flu season, according to the Centers for Disease Control and Prevention.

The proportion of outpatient visits for influenza-like illness (ILI) hit 4.3% for the week ending Feb. 2, which topped the previous high of 4.0% that was reached in late December (the national baseline rate is 2.2%). Outpatient ILI visits then dipped down to 3.1% after 2 weeks of decreases before rising again in mid-January, the CDC’s influenza division reported Feb. 8.



Season-high activity also was seen at the state level for the week ending Feb. 2. There were 18 states at level 10 on the CDC’s 1-10 scale of ILI activity, which was up from 16 the week before, and a total of 24 states were in the high range from 8-10, compared with 23 for the previous week. The geographic spread of influenza was reported as widespread in 47 states and Puerto Rico, the CDC said.

Four flu-related pediatric deaths were reported during the week ending Feb. 2, two of which occurred the previous week, which brings the total for the 2018-2019 season to 28, the CDC said.



There were 158 flu-related deaths among all ages during the week ending Jan. 26 – the latest for which such data are available – with reporting almost 75% complete. The previous week saw 177 overall flu deaths, with reporting for that week over 90% complete. During the corresponding weeks of the very severe 2017-2018 flu season, the overall death totals were 1,448 and 1,626, CDC data show.

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Influenza activity increased for the third consecutive week and has now reached its highest point for the 2018-2019 flu season, according to the Centers for Disease Control and Prevention.

The proportion of outpatient visits for influenza-like illness (ILI) hit 4.3% for the week ending Feb. 2, which topped the previous high of 4.0% that was reached in late December (the national baseline rate is 2.2%). Outpatient ILI visits then dipped down to 3.1% after 2 weeks of decreases before rising again in mid-January, the CDC’s influenza division reported Feb. 8.



Season-high activity also was seen at the state level for the week ending Feb. 2. There were 18 states at level 10 on the CDC’s 1-10 scale of ILI activity, which was up from 16 the week before, and a total of 24 states were in the high range from 8-10, compared with 23 for the previous week. The geographic spread of influenza was reported as widespread in 47 states and Puerto Rico, the CDC said.

Four flu-related pediatric deaths were reported during the week ending Feb. 2, two of which occurred the previous week, which brings the total for the 2018-2019 season to 28, the CDC said.



There were 158 flu-related deaths among all ages during the week ending Jan. 26 – the latest for which such data are available – with reporting almost 75% complete. The previous week saw 177 overall flu deaths, with reporting for that week over 90% complete. During the corresponding weeks of the very severe 2017-2018 flu season, the overall death totals were 1,448 and 1,626, CDC data show.

 

Influenza activity increased for the third consecutive week and has now reached its highest point for the 2018-2019 flu season, according to the Centers for Disease Control and Prevention.

The proportion of outpatient visits for influenza-like illness (ILI) hit 4.3% for the week ending Feb. 2, which topped the previous high of 4.0% that was reached in late December (the national baseline rate is 2.2%). Outpatient ILI visits then dipped down to 3.1% after 2 weeks of decreases before rising again in mid-January, the CDC’s influenza division reported Feb. 8.



Season-high activity also was seen at the state level for the week ending Feb. 2. There were 18 states at level 10 on the CDC’s 1-10 scale of ILI activity, which was up from 16 the week before, and a total of 24 states were in the high range from 8-10, compared with 23 for the previous week. The geographic spread of influenza was reported as widespread in 47 states and Puerto Rico, the CDC said.

Four flu-related pediatric deaths were reported during the week ending Feb. 2, two of which occurred the previous week, which brings the total for the 2018-2019 season to 28, the CDC said.



There were 158 flu-related deaths among all ages during the week ending Jan. 26 – the latest for which such data are available – with reporting almost 75% complete. The previous week saw 177 overall flu deaths, with reporting for that week over 90% complete. During the corresponding weeks of the very severe 2017-2018 flu season, the overall death totals were 1,448 and 1,626, CDC data show.

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Marijuana smoking is an independent risk factor for lung disease in HIV+

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Long-term marijuana smoking was associated with lung disease in HIV-infected (HIV+) but not HIV uninfected (HIV–) men who have sex with men (MSM), according to the results of a large, prospective cohort study.

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“There were no significant interactions between marijuana and tobacco smoking in any multivariable model tested for HIV+ participants, indicating independent effects of these factors,” wrote David R. Lorenz, PhD, of the Dana-Farber Cancer Institute, Boston, and his colleagues.

These findings are especially important given that the proportion of HIV+ individuals who frequently smoke marijuana is higher than in the general population in the United States, and has increased in recent years, according to the report, published online in EClinicalMedicine.

The study examined 2,704 MSM who met eligibility criteria (1,352 HIV+ and 1,352 HIV− individuals), with a median age of 44 years at baseline and a median follow-up of 10.5 years. A total of 27% of HIV+ participants reported daily or weekly marijuana smoking for 1 year or more during follow-up, compared with 18% of the HIV− participants.

HIV+ participants who smoked marijuana were more likely to report one or more pulmonary diagnoses, versus nonsmoking HIV+ individuals during follow-up (41.0% vs. 30.0% infectious, and 24.8% vs. 19.0% noninfectious), according to the authors. In contrast, there was no association between marijuana smoking and either an infectious or noninfectious pulmonary diagnosis among HIV− participants (24.2% vs. 20.9%, and 14.8% vs. 17.7%, respectively).

For HIV+ individuals, each 10 days/month increase in marijuana smoking in the prior 2-year period was found to be associated with a 6% increased risk of infectious pulmonary diagnosis (hazard risk 1.06 [95% confidence interval 1.00-1.11]; P = .041). Overall, they found that from the 53,000 person-visits in the study, marijuana smoking was associated with increased risk of both infectious and noninfectious pulmonary diagnoses among the 1,352 HIV-infected participants independent of CD4 count, antiretroviral therapy (ART) adherence, and demographic factors as well.

In particular, viral suppression did not seem to interfere with this association between marijuana smoking and infectious pulmonary diagnoses, as it remained significant in models restricted to those person-visits with suppressed HIV viral load (HR 1.41 [1.03-1.91], P = .029).

The authors suggested that HIV-specific factors such as lung immune cell depletion and dysfunction, persistent immune cell activation, systemic inflammation, respiratory microbiome alterations, and oxidative stress, or a combination of these effects, may interact with the alveolar macrophage dysfunction seen in both humans and mouse models exposed to marijuana smoke. Thus, “a potential additive risk of marijuana smoking and HIV disease may explain the increased prevalence of infectious pulmonary diagnoses in our adjusted analyses,” Dr. Lorenz and his colleagues stated.

“These findings suggest that marijuana smoking is a modifiable risk factor that healthcare providers should consider when seeking to prevent or treat lung disease in people infected with HIV, particularly those with other known risk factors including heavy tobacco smoking, and low CD4 T cell count or advanced HIV disease,” they concluded.

The National Institutes of Health funded the study. The authors reported that they had no relevant disclosures.

SOURCE: Lorenz DR et al. EClinicalMedicine. 2019 Jan 24. doi: 10.1016/j.eclinm.2019.01.003.

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Long-term marijuana smoking was associated with lung disease in HIV-infected (HIV+) but not HIV uninfected (HIV–) men who have sex with men (MSM), according to the results of a large, prospective cohort study.

Scott Harms/iStockphoto


“There were no significant interactions between marijuana and tobacco smoking in any multivariable model tested for HIV+ participants, indicating independent effects of these factors,” wrote David R. Lorenz, PhD, of the Dana-Farber Cancer Institute, Boston, and his colleagues.

These findings are especially important given that the proportion of HIV+ individuals who frequently smoke marijuana is higher than in the general population in the United States, and has increased in recent years, according to the report, published online in EClinicalMedicine.

The study examined 2,704 MSM who met eligibility criteria (1,352 HIV+ and 1,352 HIV− individuals), with a median age of 44 years at baseline and a median follow-up of 10.5 years. A total of 27% of HIV+ participants reported daily or weekly marijuana smoking for 1 year or more during follow-up, compared with 18% of the HIV− participants.

HIV+ participants who smoked marijuana were more likely to report one or more pulmonary diagnoses, versus nonsmoking HIV+ individuals during follow-up (41.0% vs. 30.0% infectious, and 24.8% vs. 19.0% noninfectious), according to the authors. In contrast, there was no association between marijuana smoking and either an infectious or noninfectious pulmonary diagnosis among HIV− participants (24.2% vs. 20.9%, and 14.8% vs. 17.7%, respectively).

For HIV+ individuals, each 10 days/month increase in marijuana smoking in the prior 2-year period was found to be associated with a 6% increased risk of infectious pulmonary diagnosis (hazard risk 1.06 [95% confidence interval 1.00-1.11]; P = .041). Overall, they found that from the 53,000 person-visits in the study, marijuana smoking was associated with increased risk of both infectious and noninfectious pulmonary diagnoses among the 1,352 HIV-infected participants independent of CD4 count, antiretroviral therapy (ART) adherence, and demographic factors as well.

In particular, viral suppression did not seem to interfere with this association between marijuana smoking and infectious pulmonary diagnoses, as it remained significant in models restricted to those person-visits with suppressed HIV viral load (HR 1.41 [1.03-1.91], P = .029).

The authors suggested that HIV-specific factors such as lung immune cell depletion and dysfunction, persistent immune cell activation, systemic inflammation, respiratory microbiome alterations, and oxidative stress, or a combination of these effects, may interact with the alveolar macrophage dysfunction seen in both humans and mouse models exposed to marijuana smoke. Thus, “a potential additive risk of marijuana smoking and HIV disease may explain the increased prevalence of infectious pulmonary diagnoses in our adjusted analyses,” Dr. Lorenz and his colleagues stated.

“These findings suggest that marijuana smoking is a modifiable risk factor that healthcare providers should consider when seeking to prevent or treat lung disease in people infected with HIV, particularly those with other known risk factors including heavy tobacco smoking, and low CD4 T cell count or advanced HIV disease,” they concluded.

The National Institutes of Health funded the study. The authors reported that they had no relevant disclosures.

SOURCE: Lorenz DR et al. EClinicalMedicine. 2019 Jan 24. doi: 10.1016/j.eclinm.2019.01.003.

 

Long-term marijuana smoking was associated with lung disease in HIV-infected (HIV+) but not HIV uninfected (HIV–) men who have sex with men (MSM), according to the results of a large, prospective cohort study.

Scott Harms/iStockphoto


“There were no significant interactions between marijuana and tobacco smoking in any multivariable model tested for HIV+ participants, indicating independent effects of these factors,” wrote David R. Lorenz, PhD, of the Dana-Farber Cancer Institute, Boston, and his colleagues.

These findings are especially important given that the proportion of HIV+ individuals who frequently smoke marijuana is higher than in the general population in the United States, and has increased in recent years, according to the report, published online in EClinicalMedicine.

The study examined 2,704 MSM who met eligibility criteria (1,352 HIV+ and 1,352 HIV− individuals), with a median age of 44 years at baseline and a median follow-up of 10.5 years. A total of 27% of HIV+ participants reported daily or weekly marijuana smoking for 1 year or more during follow-up, compared with 18% of the HIV− participants.

HIV+ participants who smoked marijuana were more likely to report one or more pulmonary diagnoses, versus nonsmoking HIV+ individuals during follow-up (41.0% vs. 30.0% infectious, and 24.8% vs. 19.0% noninfectious), according to the authors. In contrast, there was no association between marijuana smoking and either an infectious or noninfectious pulmonary diagnosis among HIV− participants (24.2% vs. 20.9%, and 14.8% vs. 17.7%, respectively).

For HIV+ individuals, each 10 days/month increase in marijuana smoking in the prior 2-year period was found to be associated with a 6% increased risk of infectious pulmonary diagnosis (hazard risk 1.06 [95% confidence interval 1.00-1.11]; P = .041). Overall, they found that from the 53,000 person-visits in the study, marijuana smoking was associated with increased risk of both infectious and noninfectious pulmonary diagnoses among the 1,352 HIV-infected participants independent of CD4 count, antiretroviral therapy (ART) adherence, and demographic factors as well.

In particular, viral suppression did not seem to interfere with this association between marijuana smoking and infectious pulmonary diagnoses, as it remained significant in models restricted to those person-visits with suppressed HIV viral load (HR 1.41 [1.03-1.91], P = .029).

The authors suggested that HIV-specific factors such as lung immune cell depletion and dysfunction, persistent immune cell activation, systemic inflammation, respiratory microbiome alterations, and oxidative stress, or a combination of these effects, may interact with the alveolar macrophage dysfunction seen in both humans and mouse models exposed to marijuana smoke. Thus, “a potential additive risk of marijuana smoking and HIV disease may explain the increased prevalence of infectious pulmonary diagnoses in our adjusted analyses,” Dr. Lorenz and his colleagues stated.

“These findings suggest that marijuana smoking is a modifiable risk factor that healthcare providers should consider when seeking to prevent or treat lung disease in people infected with HIV, particularly those with other known risk factors including heavy tobacco smoking, and low CD4 T cell count or advanced HIV disease,” they concluded.

The National Institutes of Health funded the study. The authors reported that they had no relevant disclosures.

SOURCE: Lorenz DR et al. EClinicalMedicine. 2019 Jan 24. doi: 10.1016/j.eclinm.2019.01.003.

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Key clinical point: HIV+ but not HIV– marijuana smokers had an increased rate of pulmonary diagnoses.

Major finding: HIV+ marijuana smokers were more likely to report one or more infectious or noninfectious pulmonary diagnoses, compared with nonsmoking HIV+ individuals (41.0% vs. 30.0%, and 24.8% vs. 19.0%, respectively).

Study details: A prospective cohort study of 1,352 HIV+ vs. 1,352 HIV– men who have sex with men.

Disclosures: The National Institutes of Health funded the study. The authors reported that they had no relevant disclosures.

Source: Lorenz DR et al. EClinicalMedicine. 2019 Jan 24. doi: 10.1016/j.eclinm.2019.01.003.

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Socioeconomic status, race found to impact CPAP compliance

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Positive indicators of compliance with continuous positive airway pressure (CPAP) included higher apnea-hypopnea index, white race, and higher median household income, results from a large single-center cohort study showed.

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“CPAP is the gold standard treatment for OSA [obstructive sleep apnea] and is very effective, especially for those with severe disease,” researchers led by Philip S. LoSavio, MD, wrote in an abstract presented at the Triological Society’s Combined Sections Meeting. “However, CPAP is a significant challenge for patients for various reasons, with reports of only 46%-80% of OSA patients using CPAP for more than 4 consecutive hours on two out of three nights.”

In an effort to identify and define different factors associated with CPAP compliance, Dr. LoSavio and his colleagues collected data on 578 patients with OSA on CPAP who were treated at Rush University Medical Center, Chicago. The mean patient age was 58 years, 52% were female, 43% were African American, 40% were white, their mean body mass index was 36.91 kg/m2, and their mean apnea-hypopnea index was 37.25 events per hour. The researchers recorded CPAP use at office visits via CPAP module or card, and patients were considered CPAP compliant if their machines logged 4 consecutive hours of use for 70% or more of nights. During the office visits, patients completed a questionnaire asking if they were suffering from different otolaryngology-related diseases, including sinus headaches, gastroesophageal reflex, and enlarged tonsils. Dr. LoSavio, who heads the section of sleep surgery in the department of otorhinolaryngology at Rush University Medical Center, and his colleagues performed logistic regression to ascertain the effects of race and socioeconomic status on CPAP compliance while adjusting for OSA severity. They also analyzed the adjusted association of median income and self-reported symptoms of sinus headaches, GERD, and enlarged tonsils, on CPAP compliance.



They found that African American patients were less compliant with CPAP, compared with their white counterparts (OR 0.42; P less than .01). In addition, patients with mild OSA were less likely to be compliant compared with those who had severe disease (OR 0.57; P less than .03). Self-reported symptoms of sinus headaches, GERD, and enlarged tonsils were associated with significantly lower levels of compliance, while higher median income was positively associated with higher levels of compliance. When the researchers grouped incomes based on the 2018 federal tax classification brackets, they observed a significant association between compliance and median income (P less than .001), with a likelihood ratio of 20.4.

“Previous studies have shown that with increases in OSA disease severity, defined by higher [apnea-hypopnea index], comes increases in CPAP compliance, while other studies have alluded to the fact that lower socioeconomic status can affect CPAP compliance,” Dr. LoSavio and his associates wrote in their abstract. “A novel aspect of our study hoped to shed light on different otolaryngology-related diseases and how they might affect compliance. The patients with comorbid GERD, sinus headaches, and enlarged tonsils were less CPAP compliant in our study. These conditions are relatively easily treated and could therefore provide an avenue to increase CPAP compliance if addressed.” They acknowledged certain limitations of the study, including its single-center design and the self-reported nature of the patient questionnaire.

The researchers reported having no financial disclosures. The meeting was jointly sponsored by the Triological Society and the American College of Surgeons.

SOURCE: LoSavio P et al. Triological CSM 2019, Abstracts.

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Positive indicators of compliance with continuous positive airway pressure (CPAP) included higher apnea-hypopnea index, white race, and higher median household income, results from a large single-center cohort study showed.

©David Cannings-Bushell/iStockphoto.com

“CPAP is the gold standard treatment for OSA [obstructive sleep apnea] and is very effective, especially for those with severe disease,” researchers led by Philip S. LoSavio, MD, wrote in an abstract presented at the Triological Society’s Combined Sections Meeting. “However, CPAP is a significant challenge for patients for various reasons, with reports of only 46%-80% of OSA patients using CPAP for more than 4 consecutive hours on two out of three nights.”

In an effort to identify and define different factors associated with CPAP compliance, Dr. LoSavio and his colleagues collected data on 578 patients with OSA on CPAP who were treated at Rush University Medical Center, Chicago. The mean patient age was 58 years, 52% were female, 43% were African American, 40% were white, their mean body mass index was 36.91 kg/m2, and their mean apnea-hypopnea index was 37.25 events per hour. The researchers recorded CPAP use at office visits via CPAP module or card, and patients were considered CPAP compliant if their machines logged 4 consecutive hours of use for 70% or more of nights. During the office visits, patients completed a questionnaire asking if they were suffering from different otolaryngology-related diseases, including sinus headaches, gastroesophageal reflex, and enlarged tonsils. Dr. LoSavio, who heads the section of sleep surgery in the department of otorhinolaryngology at Rush University Medical Center, and his colleagues performed logistic regression to ascertain the effects of race and socioeconomic status on CPAP compliance while adjusting for OSA severity. They also analyzed the adjusted association of median income and self-reported symptoms of sinus headaches, GERD, and enlarged tonsils, on CPAP compliance.



They found that African American patients were less compliant with CPAP, compared with their white counterparts (OR 0.42; P less than .01). In addition, patients with mild OSA were less likely to be compliant compared with those who had severe disease (OR 0.57; P less than .03). Self-reported symptoms of sinus headaches, GERD, and enlarged tonsils were associated with significantly lower levels of compliance, while higher median income was positively associated with higher levels of compliance. When the researchers grouped incomes based on the 2018 federal tax classification brackets, they observed a significant association between compliance and median income (P less than .001), with a likelihood ratio of 20.4.

“Previous studies have shown that with increases in OSA disease severity, defined by higher [apnea-hypopnea index], comes increases in CPAP compliance, while other studies have alluded to the fact that lower socioeconomic status can affect CPAP compliance,” Dr. LoSavio and his associates wrote in their abstract. “A novel aspect of our study hoped to shed light on different otolaryngology-related diseases and how they might affect compliance. The patients with comorbid GERD, sinus headaches, and enlarged tonsils were less CPAP compliant in our study. These conditions are relatively easily treated and could therefore provide an avenue to increase CPAP compliance if addressed.” They acknowledged certain limitations of the study, including its single-center design and the self-reported nature of the patient questionnaire.

The researchers reported having no financial disclosures. The meeting was jointly sponsored by the Triological Society and the American College of Surgeons.

SOURCE: LoSavio P et al. Triological CSM 2019, Abstracts.

 

Positive indicators of compliance with continuous positive airway pressure (CPAP) included higher apnea-hypopnea index, white race, and higher median household income, results from a large single-center cohort study showed.

©David Cannings-Bushell/iStockphoto.com

“CPAP is the gold standard treatment for OSA [obstructive sleep apnea] and is very effective, especially for those with severe disease,” researchers led by Philip S. LoSavio, MD, wrote in an abstract presented at the Triological Society’s Combined Sections Meeting. “However, CPAP is a significant challenge for patients for various reasons, with reports of only 46%-80% of OSA patients using CPAP for more than 4 consecutive hours on two out of three nights.”

In an effort to identify and define different factors associated with CPAP compliance, Dr. LoSavio and his colleagues collected data on 578 patients with OSA on CPAP who were treated at Rush University Medical Center, Chicago. The mean patient age was 58 years, 52% were female, 43% were African American, 40% were white, their mean body mass index was 36.91 kg/m2, and their mean apnea-hypopnea index was 37.25 events per hour. The researchers recorded CPAP use at office visits via CPAP module or card, and patients were considered CPAP compliant if their machines logged 4 consecutive hours of use for 70% or more of nights. During the office visits, patients completed a questionnaire asking if they were suffering from different otolaryngology-related diseases, including sinus headaches, gastroesophageal reflex, and enlarged tonsils. Dr. LoSavio, who heads the section of sleep surgery in the department of otorhinolaryngology at Rush University Medical Center, and his colleagues performed logistic regression to ascertain the effects of race and socioeconomic status on CPAP compliance while adjusting for OSA severity. They also analyzed the adjusted association of median income and self-reported symptoms of sinus headaches, GERD, and enlarged tonsils, on CPAP compliance.



They found that African American patients were less compliant with CPAP, compared with their white counterparts (OR 0.42; P less than .01). In addition, patients with mild OSA were less likely to be compliant compared with those who had severe disease (OR 0.57; P less than .03). Self-reported symptoms of sinus headaches, GERD, and enlarged tonsils were associated with significantly lower levels of compliance, while higher median income was positively associated with higher levels of compliance. When the researchers grouped incomes based on the 2018 federal tax classification brackets, they observed a significant association between compliance and median income (P less than .001), with a likelihood ratio of 20.4.

“Previous studies have shown that with increases in OSA disease severity, defined by higher [apnea-hypopnea index], comes increases in CPAP compliance, while other studies have alluded to the fact that lower socioeconomic status can affect CPAP compliance,” Dr. LoSavio and his associates wrote in their abstract. “A novel aspect of our study hoped to shed light on different otolaryngology-related diseases and how they might affect compliance. The patients with comorbid GERD, sinus headaches, and enlarged tonsils were less CPAP compliant in our study. These conditions are relatively easily treated and could therefore provide an avenue to increase CPAP compliance if addressed.” They acknowledged certain limitations of the study, including its single-center design and the self-reported nature of the patient questionnaire.

The researchers reported having no financial disclosures. The meeting was jointly sponsored by the Triological Society and the American College of Surgeons.

SOURCE: LoSavio P et al. Triological CSM 2019, Abstracts.

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Key clinical point: Compliance with continuous positive airway pressure is affected by patient socioeconomic status and race.

Major finding: African American patients were less compliant with CPAP, compared with their white counterparts (OR 0.42; P less than .01).

Study details: A retrospective study of 578 obstructive sleep apnea patients on CPAP.

Disclosures: The researchers reported having no financial disclosures.

Source: LoSavio P et al. Triological CSM 2019, Abstracts.

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Nonsurgical OSA treatment ineffective in children with Down syndrome

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– Resolution of mild obstructive sleep apnea (OSA) in children with Down syndrome who were treated nonsurgically with either medication, observation, or supplemental oxygen was low, results from a small cohort study showed.

Dr. Stacey L. Ishman

“This suggests that we should consider early treatment options, including multimodal approaches, for children with mild OSA and Down syndrome,” one of the study authors, Javier J.M. Howard, MPH, said at the Triological Society’s Combined Sections Meeting. “Prospective studies with longer follow-up are needed to better understand treatment outcomes in children with Down syndrome and mild OSA.”

An estimated 1%-6% of otherwise healthy children have obstructive sleep apnea, but the prevalence in children with Down syndrome is estimated to be between 30% and 70%, said Mr. Howard, a medical student at the University of Cincinnati. Additionally, those with Down syndrome tend to have more severe phenotypes, including significant hypoxemia and hypoventilation, compared with children without Down syndrome. “Nasal steroids, oral antileukotrienes, and supplemental oxygen have shown efficacy in the treatment of mild OSA in otherwise healthy children,” he said. “Observation is also employed in children with mild OSA, as a proportion of them will resolve spontaneously. The efficacy of these approaches in children with Down syndrome is unknown.”



In a study led by senior author Stacey L. Ishman, MD, MPH, researchers set out to examine the efficacy of single-medication therapy with either montelukast or intransal steroids versus observation versus oxygen on polysomnographic (PSG) outcomes in children with Down syndrome. They conducted a retrospective chart review of 24 children diagnosed with Down syndrome and mild OSA. The children were surgically naive and were treated between 2012 and 2017 with either supplemental oxygen, a single medication, or were observed. They had a follow-up PSG 3-12 months after initiation of treatment. The primary outcome was obstructive apnea hypopnea index (AHI), while secondary outcomes were oxygen saturation nadir, percent of total sleep time in rapid eye movement, and percentage of total sleep time with end-tidal carbon dioxide of greater than 50 mm Hg.

Of the 24 children, 58% were female, 67% were white, 13 were treated with observation, one was treated with oxygen, and 10 were treated with medication. Their baseline obstructive AHIs were 2.9, 3.5, and 3.3 events per hour, respectively. The follow-up PSGs revealed no statistically significant changes in obstructive AHI, oxygen saturation nadir, percentage of total sleep time in rapid eye movement, or percentage of total sleep time with end-tidal carbon dioxide greater than 50 mm Hg for any treatment group. OSA resolved in one patient in the observation group and in two patients in the medication group. At the same time, OSA worsened in two patients each in the medication and observation groups. Resolution of OSA was observed in 20% of patients in the medication group, compared with 7.1% of those in the observation or oxygen group (P = .82).

Mr. Howard acknowledged certain limitations of the study, including the potential for selection bias, its retrospective design, and its small sample size. “Resolution of mild OSA was low for all of our treatment groups after 3-12 months of treatment,” he said. “Resolution with medication was lower in our study, compared to published studies in otherwise healthy children.”

The researchers reported having no financial disclosures. The meeting was jointly sponsored by the Triological Society and the American College of Surgeons.

SOURCE: Howard J et al .Triological CSM, Abstracts.

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– Resolution of mild obstructive sleep apnea (OSA) in children with Down syndrome who were treated nonsurgically with either medication, observation, or supplemental oxygen was low, results from a small cohort study showed.

Dr. Stacey L. Ishman

“This suggests that we should consider early treatment options, including multimodal approaches, for children with mild OSA and Down syndrome,” one of the study authors, Javier J.M. Howard, MPH, said at the Triological Society’s Combined Sections Meeting. “Prospective studies with longer follow-up are needed to better understand treatment outcomes in children with Down syndrome and mild OSA.”

An estimated 1%-6% of otherwise healthy children have obstructive sleep apnea, but the prevalence in children with Down syndrome is estimated to be between 30% and 70%, said Mr. Howard, a medical student at the University of Cincinnati. Additionally, those with Down syndrome tend to have more severe phenotypes, including significant hypoxemia and hypoventilation, compared with children without Down syndrome. “Nasal steroids, oral antileukotrienes, and supplemental oxygen have shown efficacy in the treatment of mild OSA in otherwise healthy children,” he said. “Observation is also employed in children with mild OSA, as a proportion of them will resolve spontaneously. The efficacy of these approaches in children with Down syndrome is unknown.”



In a study led by senior author Stacey L. Ishman, MD, MPH, researchers set out to examine the efficacy of single-medication therapy with either montelukast or intransal steroids versus observation versus oxygen on polysomnographic (PSG) outcomes in children with Down syndrome. They conducted a retrospective chart review of 24 children diagnosed with Down syndrome and mild OSA. The children were surgically naive and were treated between 2012 and 2017 with either supplemental oxygen, a single medication, or were observed. They had a follow-up PSG 3-12 months after initiation of treatment. The primary outcome was obstructive apnea hypopnea index (AHI), while secondary outcomes were oxygen saturation nadir, percent of total sleep time in rapid eye movement, and percentage of total sleep time with end-tidal carbon dioxide of greater than 50 mm Hg.

Of the 24 children, 58% were female, 67% were white, 13 were treated with observation, one was treated with oxygen, and 10 were treated with medication. Their baseline obstructive AHIs were 2.9, 3.5, and 3.3 events per hour, respectively. The follow-up PSGs revealed no statistically significant changes in obstructive AHI, oxygen saturation nadir, percentage of total sleep time in rapid eye movement, or percentage of total sleep time with end-tidal carbon dioxide greater than 50 mm Hg for any treatment group. OSA resolved in one patient in the observation group and in two patients in the medication group. At the same time, OSA worsened in two patients each in the medication and observation groups. Resolution of OSA was observed in 20% of patients in the medication group, compared with 7.1% of those in the observation or oxygen group (P = .82).

Mr. Howard acknowledged certain limitations of the study, including the potential for selection bias, its retrospective design, and its small sample size. “Resolution of mild OSA was low for all of our treatment groups after 3-12 months of treatment,” he said. “Resolution with medication was lower in our study, compared to published studies in otherwise healthy children.”

The researchers reported having no financial disclosures. The meeting was jointly sponsored by the Triological Society and the American College of Surgeons.

SOURCE: Howard J et al .Triological CSM, Abstracts.

 

– Resolution of mild obstructive sleep apnea (OSA) in children with Down syndrome who were treated nonsurgically with either medication, observation, or supplemental oxygen was low, results from a small cohort study showed.

Dr. Stacey L. Ishman

“This suggests that we should consider early treatment options, including multimodal approaches, for children with mild OSA and Down syndrome,” one of the study authors, Javier J.M. Howard, MPH, said at the Triological Society’s Combined Sections Meeting. “Prospective studies with longer follow-up are needed to better understand treatment outcomes in children with Down syndrome and mild OSA.”

An estimated 1%-6% of otherwise healthy children have obstructive sleep apnea, but the prevalence in children with Down syndrome is estimated to be between 30% and 70%, said Mr. Howard, a medical student at the University of Cincinnati. Additionally, those with Down syndrome tend to have more severe phenotypes, including significant hypoxemia and hypoventilation, compared with children without Down syndrome. “Nasal steroids, oral antileukotrienes, and supplemental oxygen have shown efficacy in the treatment of mild OSA in otherwise healthy children,” he said. “Observation is also employed in children with mild OSA, as a proportion of them will resolve spontaneously. The efficacy of these approaches in children with Down syndrome is unknown.”



In a study led by senior author Stacey L. Ishman, MD, MPH, researchers set out to examine the efficacy of single-medication therapy with either montelukast or intransal steroids versus observation versus oxygen on polysomnographic (PSG) outcomes in children with Down syndrome. They conducted a retrospective chart review of 24 children diagnosed with Down syndrome and mild OSA. The children were surgically naive and were treated between 2012 and 2017 with either supplemental oxygen, a single medication, or were observed. They had a follow-up PSG 3-12 months after initiation of treatment. The primary outcome was obstructive apnea hypopnea index (AHI), while secondary outcomes were oxygen saturation nadir, percent of total sleep time in rapid eye movement, and percentage of total sleep time with end-tidal carbon dioxide of greater than 50 mm Hg.

Of the 24 children, 58% were female, 67% were white, 13 were treated with observation, one was treated with oxygen, and 10 were treated with medication. Their baseline obstructive AHIs were 2.9, 3.5, and 3.3 events per hour, respectively. The follow-up PSGs revealed no statistically significant changes in obstructive AHI, oxygen saturation nadir, percentage of total sleep time in rapid eye movement, or percentage of total sleep time with end-tidal carbon dioxide greater than 50 mm Hg for any treatment group. OSA resolved in one patient in the observation group and in two patients in the medication group. At the same time, OSA worsened in two patients each in the medication and observation groups. Resolution of OSA was observed in 20% of patients in the medication group, compared with 7.1% of those in the observation or oxygen group (P = .82).

Mr. Howard acknowledged certain limitations of the study, including the potential for selection bias, its retrospective design, and its small sample size. “Resolution of mild OSA was low for all of our treatment groups after 3-12 months of treatment,” he said. “Resolution with medication was lower in our study, compared to published studies in otherwise healthy children.”

The researchers reported having no financial disclosures. The meeting was jointly sponsored by the Triological Society and the American College of Surgeons.

SOURCE: Howard J et al .Triological CSM, Abstracts.

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Key clinical point: Resolution of mild OSA was low for all treatment groups after 3-12 months of treatment.

Major finding: Resolution of OSA was observed in 20% of patients in the medication group, compared with 7.1% of those in the observation or oxygen group (P = .82).

Study details: A retrospective chart review of 24 children diagnosed with Down syndrome and mild OSA.

Disclosures: The researchers reported having no financial disclosures.

Source: Howard J et al. Triological CSM, Abstracts.

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Asthma, obesity, and the risk for severe sleep apnea in children

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Among a large cohort of children referred for polysomnography, the presence of asthma reduced the likelihood of severe obstructive sleep apnea (OSA), while the presence of obesity increased it.

deyangeorgiev/thinkstockphotos.com

“We have a good idea that obesity and asthma independently increase the risk of OSA, but a lot of the time in the pediatric population, these risk factors are found comorbid,” Ajay Narayanan at the Triological Society’s Combined Sections Meeting. “For this study we asked, how does the presence of asthma change the likelihood of having severe OSA in a cohort of obese patients? Knowing that both asthma and obesity independently increase the risk for OSA, we hypothesized that when they were comorbid, asthma would have a synergistic effect with obesity, causing severe OSA.”

Mr. Narayanan, a third-year student at the University of Texas Southwestern Medical Center, Dallas, and his colleagues performed a retrospective chart review of 367 children aged 9-17 years referred for a full-night polysomnography (PSG) for suspicion of having OSA. Demographic variables recorded included race, body mass index, rhinitis, gastroesophageal reflux disease, and tonsillar hypertrophy. Sleep variables recorded included apnea hypopnea index (AHI), sleep efficiency, rapid eye movement, and the peripheral capillary oxygen saturation (SpO2) nadir. The primary outcome was severe OSA defined as an AHI of 10 or greater on the PSG. They used logistic modeling to determine the association between asthma, obesity, and severe OSA.

The mean age of the study population was 14 years, 56% were male, and 43% were Hispanic. Of the 367 patients, 77 were neither obese nor asthmatic, 93 were nonobese but were asthmatic, 102 were obese but were nonasthmatic, and 95 were both obese and asthmatic. PSG results confirmed that obesity was associated with more signs of sleep apnea. For example, the nonobese, nonasthmatic group had a mean AHI of 11 events per hour, while the obese, nonasthmatic group had a mean AHI of 19 events per hour. “We observed a similar trend amongst our asthmatic population,” Mr. Narayanan said. “We observed an increase in the mean AHI amongst our asthmatic kids when we added obesity to the picture. Surprisingly, we found that asthma was associated with having fewer signs of sleep apnea.” Specifically, while the nonobese, nonasthmatic group had a mean AHI of 11 events per hour, those in the nonobese, asthmatic group had a mean of 5.6 events per hour (P = .005). “The finding was similar amongst our obese kids,” he said. “We saw a decrease in the mean AHI of our obese kids when we added asthma to the picture.”



On logistic regression analysis using obesity and asthma as independent variables, the researchers found that obesity increased the risk of severe OSA by 2.4-fold, but asthma decreased the odds of having severe OSA by about half (0.55). On multiple logistic regression controlling for commonly associated factors such as tonsillar hypertrophy, black race, and Hispanic ethnicity, obesity increased the risk of severe OSA by 2.2-fold, while asthma decreased the odds of having severe OSA by about half (0.51).

“In trying to explain this finding, we can turn to how these diseases are treated,” Mr. Narayanan said. “I say this because of the proven association between preexisting asthma and new onset OSA. Some of the reasons for this association include the tendency for airway collapsibility and systemwide inflammation seen in asthma, which then might contribute to the development of OSA. If we treat asthma symptoms early on, it might prevent the progression to sleep apnea down the line.”

Considering how prevalent comorbid asthma and OSA is, he continued, “we need to confirm that it is in fact well-controlled asthma that is associated with lowering the risk of severe OSA. Once we do this, we can ask the question: Can we use asthma pharmacotherapy to treat OSA? Some studies have shown that inhaled corticosteroids and montelukast (Singulair) may be effective treatment options for kids with OSA, but there’s definitely room for more research in this field, [such as determining] which patients would most benefit from this pharmacotherapy.” The researchers reported having no financial disclosures.

SOURCE: Narayanan A et al. Triological CSM, Abstracts.

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Among a large cohort of children referred for polysomnography, the presence of asthma reduced the likelihood of severe obstructive sleep apnea (OSA), while the presence of obesity increased it.

deyangeorgiev/thinkstockphotos.com

“We have a good idea that obesity and asthma independently increase the risk of OSA, but a lot of the time in the pediatric population, these risk factors are found comorbid,” Ajay Narayanan at the Triological Society’s Combined Sections Meeting. “For this study we asked, how does the presence of asthma change the likelihood of having severe OSA in a cohort of obese patients? Knowing that both asthma and obesity independently increase the risk for OSA, we hypothesized that when they were comorbid, asthma would have a synergistic effect with obesity, causing severe OSA.”

Mr. Narayanan, a third-year student at the University of Texas Southwestern Medical Center, Dallas, and his colleagues performed a retrospective chart review of 367 children aged 9-17 years referred for a full-night polysomnography (PSG) for suspicion of having OSA. Demographic variables recorded included race, body mass index, rhinitis, gastroesophageal reflux disease, and tonsillar hypertrophy. Sleep variables recorded included apnea hypopnea index (AHI), sleep efficiency, rapid eye movement, and the peripheral capillary oxygen saturation (SpO2) nadir. The primary outcome was severe OSA defined as an AHI of 10 or greater on the PSG. They used logistic modeling to determine the association between asthma, obesity, and severe OSA.

The mean age of the study population was 14 years, 56% were male, and 43% were Hispanic. Of the 367 patients, 77 were neither obese nor asthmatic, 93 were nonobese but were asthmatic, 102 were obese but were nonasthmatic, and 95 were both obese and asthmatic. PSG results confirmed that obesity was associated with more signs of sleep apnea. For example, the nonobese, nonasthmatic group had a mean AHI of 11 events per hour, while the obese, nonasthmatic group had a mean AHI of 19 events per hour. “We observed a similar trend amongst our asthmatic population,” Mr. Narayanan said. “We observed an increase in the mean AHI amongst our asthmatic kids when we added obesity to the picture. Surprisingly, we found that asthma was associated with having fewer signs of sleep apnea.” Specifically, while the nonobese, nonasthmatic group had a mean AHI of 11 events per hour, those in the nonobese, asthmatic group had a mean of 5.6 events per hour (P = .005). “The finding was similar amongst our obese kids,” he said. “We saw a decrease in the mean AHI of our obese kids when we added asthma to the picture.”



On logistic regression analysis using obesity and asthma as independent variables, the researchers found that obesity increased the risk of severe OSA by 2.4-fold, but asthma decreased the odds of having severe OSA by about half (0.55). On multiple logistic regression controlling for commonly associated factors such as tonsillar hypertrophy, black race, and Hispanic ethnicity, obesity increased the risk of severe OSA by 2.2-fold, while asthma decreased the odds of having severe OSA by about half (0.51).

“In trying to explain this finding, we can turn to how these diseases are treated,” Mr. Narayanan said. “I say this because of the proven association between preexisting asthma and new onset OSA. Some of the reasons for this association include the tendency for airway collapsibility and systemwide inflammation seen in asthma, which then might contribute to the development of OSA. If we treat asthma symptoms early on, it might prevent the progression to sleep apnea down the line.”

Considering how prevalent comorbid asthma and OSA is, he continued, “we need to confirm that it is in fact well-controlled asthma that is associated with lowering the risk of severe OSA. Once we do this, we can ask the question: Can we use asthma pharmacotherapy to treat OSA? Some studies have shown that inhaled corticosteroids and montelukast (Singulair) may be effective treatment options for kids with OSA, but there’s definitely room for more research in this field, [such as determining] which patients would most benefit from this pharmacotherapy.” The researchers reported having no financial disclosures.

SOURCE: Narayanan A et al. Triological CSM, Abstracts.

 

Among a large cohort of children referred for polysomnography, the presence of asthma reduced the likelihood of severe obstructive sleep apnea (OSA), while the presence of obesity increased it.

deyangeorgiev/thinkstockphotos.com

“We have a good idea that obesity and asthma independently increase the risk of OSA, but a lot of the time in the pediatric population, these risk factors are found comorbid,” Ajay Narayanan at the Triological Society’s Combined Sections Meeting. “For this study we asked, how does the presence of asthma change the likelihood of having severe OSA in a cohort of obese patients? Knowing that both asthma and obesity independently increase the risk for OSA, we hypothesized that when they were comorbid, asthma would have a synergistic effect with obesity, causing severe OSA.”

Mr. Narayanan, a third-year student at the University of Texas Southwestern Medical Center, Dallas, and his colleagues performed a retrospective chart review of 367 children aged 9-17 years referred for a full-night polysomnography (PSG) for suspicion of having OSA. Demographic variables recorded included race, body mass index, rhinitis, gastroesophageal reflux disease, and tonsillar hypertrophy. Sleep variables recorded included apnea hypopnea index (AHI), sleep efficiency, rapid eye movement, and the peripheral capillary oxygen saturation (SpO2) nadir. The primary outcome was severe OSA defined as an AHI of 10 or greater on the PSG. They used logistic modeling to determine the association between asthma, obesity, and severe OSA.

The mean age of the study population was 14 years, 56% were male, and 43% were Hispanic. Of the 367 patients, 77 were neither obese nor asthmatic, 93 were nonobese but were asthmatic, 102 were obese but were nonasthmatic, and 95 were both obese and asthmatic. PSG results confirmed that obesity was associated with more signs of sleep apnea. For example, the nonobese, nonasthmatic group had a mean AHI of 11 events per hour, while the obese, nonasthmatic group had a mean AHI of 19 events per hour. “We observed a similar trend amongst our asthmatic population,” Mr. Narayanan said. “We observed an increase in the mean AHI amongst our asthmatic kids when we added obesity to the picture. Surprisingly, we found that asthma was associated with having fewer signs of sleep apnea.” Specifically, while the nonobese, nonasthmatic group had a mean AHI of 11 events per hour, those in the nonobese, asthmatic group had a mean of 5.6 events per hour (P = .005). “The finding was similar amongst our obese kids,” he said. “We saw a decrease in the mean AHI of our obese kids when we added asthma to the picture.”



On logistic regression analysis using obesity and asthma as independent variables, the researchers found that obesity increased the risk of severe OSA by 2.4-fold, but asthma decreased the odds of having severe OSA by about half (0.55). On multiple logistic regression controlling for commonly associated factors such as tonsillar hypertrophy, black race, and Hispanic ethnicity, obesity increased the risk of severe OSA by 2.2-fold, while asthma decreased the odds of having severe OSA by about half (0.51).

“In trying to explain this finding, we can turn to how these diseases are treated,” Mr. Narayanan said. “I say this because of the proven association between preexisting asthma and new onset OSA. Some of the reasons for this association include the tendency for airway collapsibility and systemwide inflammation seen in asthma, which then might contribute to the development of OSA. If we treat asthma symptoms early on, it might prevent the progression to sleep apnea down the line.”

Considering how prevalent comorbid asthma and OSA is, he continued, “we need to confirm that it is in fact well-controlled asthma that is associated with lowering the risk of severe OSA. Once we do this, we can ask the question: Can we use asthma pharmacotherapy to treat OSA? Some studies have shown that inhaled corticosteroids and montelukast (Singulair) may be effective treatment options for kids with OSA, but there’s definitely room for more research in this field, [such as determining] which patients would most benefit from this pharmacotherapy.” The researchers reported having no financial disclosures.

SOURCE: Narayanan A et al. Triological CSM, Abstracts.

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Key clinical point: In children, having asthma could decrease the risk of having severe obstructive sleep apnea, regardless of their obesity status.

Major finding: On multiple logistic regression, obesity increased the risk of severe OSA by 2.2-fold, while asthma decreased the odds of having severe OSA by about half.

Study details: A retrospective review of 367 children referred for a full-night polysomnography for suspicion of having OSA.

Disclosures: The researchers reported having no financial disclosures.

Source: Narayanan A et al. Triological CSM, Abstracts.

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No increase in severe community-acquired pneumonia after PCV13

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Despite concern about the rise of nonvaccine serotypes following widespread PCV13 immunization, cases of community-acquired pneumonia (CAP) remain nearly as low as after initial implementation of the vaccine and severe cases have not risen at all.

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This was the finding of a prospective time-series analysis study from eight French pediatric emergency departments between June 2009 and May 2017.

The 12,587 children with CAP enrolled in the study between June 2009 and May 2017 were all aged 15 years or younger and came from one of eight French pediatric EDs.

Pediatric pneumonia cases per 1,000 ED visits dropped 44% after PCV13 was implemented, a decrease from 6.3 to 3.5 cases of CAP per 1,000 pediatric visits from June 2011 to May 2014, with a slight but statistically significant increase to 3.8 cases of CAP per 1,000 pediatric visits from June 2014 to May 2017. However, there was no statistically significant increase in cases with pleural effusion, hospitalization, or high inflammatory biomarkers.

“These results contrast with the recent increase in frequency of invasive pneumococcal disease observed in several countries during the same period linked to serotype replacement beyond 5 years after PCV13 implementation,” reported Naïm Ouldali, MD, of the Association Clinique et Thérapeutique Infantile du Val-de-Marne in France, and associates. The report is in JAMA Pediatrics.

“This difference in the trends suggests different consequences of serotype replacement on pneumococcal CAP vs invasive pneumococcal disease,” they wrote. “The recent slight increase in the number of all CAP cases and virus involvement may reflect changes in the epidemiology of other pathogens and/or serotype replacement with less pathogenic serotypes.”

This latter point arose from discovering no dominant serotype during the study period. Of the 11 serotypes not covered by PCV13, none appeared in more than four cases.

“The implementation of PCV13 has led to the quasi-disappearance of the more invasive serotypes and increase in others in nasopharyngeal flora, which greatly reduces the frequency of the more severe forms of CAP, but could also play a role in the slight increase in frequency of the more benign forms,” the authors reported.

Among the study’s limitations was lack of a control group, precluding the ability to attribute findings to any changes in case reporting. And “participating physicians were encouraged to not change their practice, including test use, and no other potential interfering intervention.”

Funding sources for this study included the Pediatric Infectious Diseases Group of the French Pediatrics Society, Association Clinique et Thérapeutique Infantile du Val-de-Marne, the Foundation for Medical Research and a Pfizer Investigator Initiated Research grant.

Dr Ouldali has received grants from GlaxoSmithKline, and many of the authors have financial ties and/or have received non-financial support from AstraZeneca, Biocodex, GlaxoSmithKline, Merck, Novartis, Pfizer and/or Sanofi Pasteur.

SOURCE: Ouldali N et al. JAMA Pediatrics. 2019 Feb 4. doi: 10.1001/jamapediatrics.2018.5273.

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Despite concern about the rise of nonvaccine serotypes following widespread PCV13 immunization, cases of community-acquired pneumonia (CAP) remain nearly as low as after initial implementation of the vaccine and severe cases have not risen at all.

luiscar/Thinkstock

This was the finding of a prospective time-series analysis study from eight French pediatric emergency departments between June 2009 and May 2017.

The 12,587 children with CAP enrolled in the study between June 2009 and May 2017 were all aged 15 years or younger and came from one of eight French pediatric EDs.

Pediatric pneumonia cases per 1,000 ED visits dropped 44% after PCV13 was implemented, a decrease from 6.3 to 3.5 cases of CAP per 1,000 pediatric visits from June 2011 to May 2014, with a slight but statistically significant increase to 3.8 cases of CAP per 1,000 pediatric visits from June 2014 to May 2017. However, there was no statistically significant increase in cases with pleural effusion, hospitalization, or high inflammatory biomarkers.

“These results contrast with the recent increase in frequency of invasive pneumococcal disease observed in several countries during the same period linked to serotype replacement beyond 5 years after PCV13 implementation,” reported Naïm Ouldali, MD, of the Association Clinique et Thérapeutique Infantile du Val-de-Marne in France, and associates. The report is in JAMA Pediatrics.

“This difference in the trends suggests different consequences of serotype replacement on pneumococcal CAP vs invasive pneumococcal disease,” they wrote. “The recent slight increase in the number of all CAP cases and virus involvement may reflect changes in the epidemiology of other pathogens and/or serotype replacement with less pathogenic serotypes.”

This latter point arose from discovering no dominant serotype during the study period. Of the 11 serotypes not covered by PCV13, none appeared in more than four cases.

“The implementation of PCV13 has led to the quasi-disappearance of the more invasive serotypes and increase in others in nasopharyngeal flora, which greatly reduces the frequency of the more severe forms of CAP, but could also play a role in the slight increase in frequency of the more benign forms,” the authors reported.

Among the study’s limitations was lack of a control group, precluding the ability to attribute findings to any changes in case reporting. And “participating physicians were encouraged to not change their practice, including test use, and no other potential interfering intervention.”

Funding sources for this study included the Pediatric Infectious Diseases Group of the French Pediatrics Society, Association Clinique et Thérapeutique Infantile du Val-de-Marne, the Foundation for Medical Research and a Pfizer Investigator Initiated Research grant.

Dr Ouldali has received grants from GlaxoSmithKline, and many of the authors have financial ties and/or have received non-financial support from AstraZeneca, Biocodex, GlaxoSmithKline, Merck, Novartis, Pfizer and/or Sanofi Pasteur.

SOURCE: Ouldali N et al. JAMA Pediatrics. 2019 Feb 4. doi: 10.1001/jamapediatrics.2018.5273.

Despite concern about the rise of nonvaccine serotypes following widespread PCV13 immunization, cases of community-acquired pneumonia (CAP) remain nearly as low as after initial implementation of the vaccine and severe cases have not risen at all.

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This was the finding of a prospective time-series analysis study from eight French pediatric emergency departments between June 2009 and May 2017.

The 12,587 children with CAP enrolled in the study between June 2009 and May 2017 were all aged 15 years or younger and came from one of eight French pediatric EDs.

Pediatric pneumonia cases per 1,000 ED visits dropped 44% after PCV13 was implemented, a decrease from 6.3 to 3.5 cases of CAP per 1,000 pediatric visits from June 2011 to May 2014, with a slight but statistically significant increase to 3.8 cases of CAP per 1,000 pediatric visits from June 2014 to May 2017. However, there was no statistically significant increase in cases with pleural effusion, hospitalization, or high inflammatory biomarkers.

“These results contrast with the recent increase in frequency of invasive pneumococcal disease observed in several countries during the same period linked to serotype replacement beyond 5 years after PCV13 implementation,” reported Naïm Ouldali, MD, of the Association Clinique et Thérapeutique Infantile du Val-de-Marne in France, and associates. The report is in JAMA Pediatrics.

“This difference in the trends suggests different consequences of serotype replacement on pneumococcal CAP vs invasive pneumococcal disease,” they wrote. “The recent slight increase in the number of all CAP cases and virus involvement may reflect changes in the epidemiology of other pathogens and/or serotype replacement with less pathogenic serotypes.”

This latter point arose from discovering no dominant serotype during the study period. Of the 11 serotypes not covered by PCV13, none appeared in more than four cases.

“The implementation of PCV13 has led to the quasi-disappearance of the more invasive serotypes and increase in others in nasopharyngeal flora, which greatly reduces the frequency of the more severe forms of CAP, but could also play a role in the slight increase in frequency of the more benign forms,” the authors reported.

Among the study’s limitations was lack of a control group, precluding the ability to attribute findings to any changes in case reporting. And “participating physicians were encouraged to not change their practice, including test use, and no other potential interfering intervention.”

Funding sources for this study included the Pediatric Infectious Diseases Group of the French Pediatrics Society, Association Clinique et Thérapeutique Infantile du Val-de-Marne, the Foundation for Medical Research and a Pfizer Investigator Initiated Research grant.

Dr Ouldali has received grants from GlaxoSmithKline, and many of the authors have financial ties and/or have received non-financial support from AstraZeneca, Biocodex, GlaxoSmithKline, Merck, Novartis, Pfizer and/or Sanofi Pasteur.

SOURCE: Ouldali N et al. JAMA Pediatrics. 2019 Feb 4. doi: 10.1001/jamapediatrics.2018.5273.

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Key clinical point: PCV13 implementation has not led to increased severe pneumonia cases from nonvaccine serotypes.

Major finding: Pediatric community-acquired pneumonia cases dropped from 6.3 to 3.5 cases per 1,000 visits from 2010 to 2014 and increased to 3.8 cases per 1,000 visits in May 2017.

Study details: The findings are based on a prospective time series analysis of 12,587 pediatric pneumonia cases (under 15 years old) in eight French emergency departments from June 2009 to May 2017.

Disclosures: Funding sources for this study included the Pediatric Infectious Diseases Group of the French Pediatrics Society, Association Clinique et Thérapeutique Infantile du Val-de-Marne, the Foundation for Medical Research, and a Pfizer Investigator Initiated Research grant. Dr. Ouldali has received grants from GlaxoSmithKline, and many of the authors have financial ties and/or have received nonfinancial support from AstraZeneca, Biocodex, GlaxoSmithKline, Merck, Novartis, Pfizer, and/or Sanofi Pasteur.

Source: Ouldali N et al. JAMA Pediatrics. 2019 Feb 4. doi: 10.1001/jamapediatrics.2018.5273.

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Click for Credit: Missed HIV screening opps; aspirin & preeclampsia; more

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Here are 5 articles from the February issue of Clinician Reviews (individual articles are valid for one year from date of publication—expiration dates below):

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4. Missed HIV screening opportunities found among subsequently infected youth

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Here are 5 articles from the February issue of Clinician Reviews (individual articles are valid for one year from date of publication—expiration dates below):

1. Short-term lung function better predicts mortality risk in SSc

To take the posttest, go to: https://bit.ly/2RrRuIY
Expires November 26, 2019

2. Healthier lifestyle in midlife women reduces subclinical carotid atherosclerosis

To take the posttest, go to: https://bit.ly/2TvDH5G
Expires November 28, 2019

3. Three commonly used quick cognitive assessments often yield flawed results

To take the posttest, go to: https://bit.ly/2G1qkHn
Expires November 28, 2019

4. Missed HIV screening opportunities found among subsequently infected youth

To take the posttest, go to: https://bit.ly/2HGa8Nm
Expires November 29, 2019

5. Aspirin appears underused to prevent preeclampsia in SLE patients

To take the posttest, go to: https://bit.ly/2G0dU2v
Expires January 2, 2019

Here are 5 articles from the February issue of Clinician Reviews (individual articles are valid for one year from date of publication—expiration dates below):

1. Short-term lung function better predicts mortality risk in SSc

To take the posttest, go to: https://bit.ly/2RrRuIY
Expires November 26, 2019

2. Healthier lifestyle in midlife women reduces subclinical carotid atherosclerosis

To take the posttest, go to: https://bit.ly/2TvDH5G
Expires November 28, 2019

3. Three commonly used quick cognitive assessments often yield flawed results

To take the posttest, go to: https://bit.ly/2G1qkHn
Expires November 28, 2019

4. Missed HIV screening opportunities found among subsequently infected youth

To take the posttest, go to: https://bit.ly/2HGa8Nm
Expires November 29, 2019

5. Aspirin appears underused to prevent preeclampsia in SLE patients

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FDA approves generic Advair Diskus

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The Food and Drug Administration has approved a generic version of the Advair Diskus, a complex device-drug combination containing fluticasone propionate and salmeterol inhalation powder.

The generic device will be available in three strengths: fluticasone propionate 100 mcg/ salmeterol 50 mcg, fluticasone propionate 250 mcg/ salmeterol 50 mcg and fluticasone propionate 500 mcg/ salmeterol 50 mcg, according to the FDA announcement. It will be marketed by Mylan as Wixela Inhub and will launch in late February, according to a statement from Mylan.

Advair Diskus is among the most commonly used treatments for asthma and for chronic obstructive pulmonary disease (COPD), so it’s hoped this approval will increase access to the therapy, FDA officials said in a statement.

This approval is part of the FDA’s “longstanding commitment to advance access to lower cost, high quality generic alternatives,” Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research, said in a statement. “People living with asthma and COPD know too well the critical importance of having access to the treatment they need to feel better. Today’s approval will bring more competition to the market which will ultimately benefit the patients who rely on this drug.”

Wixela Inhub is indicated for twice-daily treatment of asthma in patients aged 4 years and older who are not adequately controlled by long-term asthma control treatments or whose disease warrants treatment with a combination of inhaled corticosteroids and long-acting beta agonists. It also is indicated for maintenance of COPD and reduction of COPD exacerbations.

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The Food and Drug Administration has approved a generic version of the Advair Diskus, a complex device-drug combination containing fluticasone propionate and salmeterol inhalation powder.

The generic device will be available in three strengths: fluticasone propionate 100 mcg/ salmeterol 50 mcg, fluticasone propionate 250 mcg/ salmeterol 50 mcg and fluticasone propionate 500 mcg/ salmeterol 50 mcg, according to the FDA announcement. It will be marketed by Mylan as Wixela Inhub and will launch in late February, according to a statement from Mylan.

Advair Diskus is among the most commonly used treatments for asthma and for chronic obstructive pulmonary disease (COPD), so it’s hoped this approval will increase access to the therapy, FDA officials said in a statement.

This approval is part of the FDA’s “longstanding commitment to advance access to lower cost, high quality generic alternatives,” Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research, said in a statement. “People living with asthma and COPD know too well the critical importance of having access to the treatment they need to feel better. Today’s approval will bring more competition to the market which will ultimately benefit the patients who rely on this drug.”

Wixela Inhub is indicated for twice-daily treatment of asthma in patients aged 4 years and older who are not adequately controlled by long-term asthma control treatments or whose disease warrants treatment with a combination of inhaled corticosteroids and long-acting beta agonists. It also is indicated for maintenance of COPD and reduction of COPD exacerbations.

The Food and Drug Administration has approved a generic version of the Advair Diskus, a complex device-drug combination containing fluticasone propionate and salmeterol inhalation powder.

The generic device will be available in three strengths: fluticasone propionate 100 mcg/ salmeterol 50 mcg, fluticasone propionate 250 mcg/ salmeterol 50 mcg and fluticasone propionate 500 mcg/ salmeterol 50 mcg, according to the FDA announcement. It will be marketed by Mylan as Wixela Inhub and will launch in late February, according to a statement from Mylan.

Advair Diskus is among the most commonly used treatments for asthma and for chronic obstructive pulmonary disease (COPD), so it’s hoped this approval will increase access to the therapy, FDA officials said in a statement.

This approval is part of the FDA’s “longstanding commitment to advance access to lower cost, high quality generic alternatives,” Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research, said in a statement. “People living with asthma and COPD know too well the critical importance of having access to the treatment they need to feel better. Today’s approval will bring more competition to the market which will ultimately benefit the patients who rely on this drug.”

Wixela Inhub is indicated for twice-daily treatment of asthma in patients aged 4 years and older who are not adequately controlled by long-term asthma control treatments or whose disease warrants treatment with a combination of inhaled corticosteroids and long-acting beta agonists. It also is indicated for maintenance of COPD and reduction of COPD exacerbations.

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