Pulmonary Health Hub

CHICAGO – The novel immunotherapy ipilimumab was active in combination with paclitaxel and carboplatin chemotherapy in first-line advanced lung cancer, but a phase II trial did not deliver the blockbuster results recently observed in metastatic melanoma.

Researchers randomized 204 patients with stage IIIb/IV recurrent or metastatic non–small cell lung cancer to three arms in the study. One group received ipilimumab 10 mg/kg every 3 weeks concurrent with the first four cycles of chemotherapy, another was given ipilimumab at the same dose in combination with cycles three through six of chemotherapy, and a control group received chemotherapy alone.

The trial’s primary end point of immune-related progression-free survival showed significant improvement from a median of 4.63 months with chemotherapy alone to 5.52 months with ipilimumab and concurrent chemotherapy (hazard ratio, 0.77; P =.09) and 5.68 months with ipilimumab and phased chemotherapy (HR, 0.68; P = .02). Of note, statistical significance was calculated using a one-side log-rank test with an alpha of 0.10 and not the standard 0.05.

When traditional modified World Health Organization criteria were used, ipilimumab significantly extended progression-free survival only in the phased arm from 4.21 months in the control group to 5.13 months (HR, 0.69; P = .02), lead author Dr. Thomas J. Lynch Jr. reported in a poster at the Chicago Multidisciplinary Thoracic Oncology Symposium. The secondary end point fell short at 4.11 months in the ipilimumab concurrent arm (HR, 0.88; P = .25)

There was a trend toward improved overall survival in favor of ipilimumab plus chemotherapy, but it did not reach statistical significance. Median survival times were 9.69 months for the ipilimumab concurrent arm (HR, 0.98; P = .47), 12.2 months for the phased arm (HR, 0.86; P = .23), and 8.28 months for the chemotherapy-alone arm, reported Dr. Lynch, director of Yale Cancer Center and physician-in-chief of the Smilow Cancer Hospital in New Haven, Conn.

At the American Society of Clinical Oncology (ASCO) meeting earlier this year ipilimumab became the first drug in 30 years to demonstrate a significant survival advantage in metastatic melanoma in a phase III trial. A biologics license application for that indication is before the Food and Drug Administration, which must respond by March 26. The Oncologic Drugs Advisory Committee is to discuss the application on Feb. 9.

Despite the relatively lackluster performance in lung cancer, Dr. Lynch described the phase II data as intriguing and said they provide justification for a phase III trial that is being planned.

"I thought for ages that immunotherapy was, I don’t want to say hokey, but was highly unlikely to make a difference in non–small cell lung cancer," he said during a press briefing at the meeting. "I thought it was good in renal cell and melanoma disease.

"I have really begun to come around on this, partly because of ipilimumab and partly because of the anti-PD-1 [programmed death–1] strategy. It really comes down to the whole principle of changing the paradigm of how we interact with the immune system."

Ipilimumab is a fully human monoclonal antibody that potentiates immune response by specifically inhibiting CTLA-4 (cytotoxic T-lymphocyte–associated antigen-4). Suppression of CTLA-4 can augment the immune system’s T-cell response in fighting disease.

Bristol-Myers Squibb, which is developing ipilimumab, is also evaluating the anti-PD-1 human monoclonal antibody MDX-1106 in various refractory or relapsed malignancies including non–small cell lung cancer.

Patients in the current trial were maintained on ipilimumab 10 mg/kg every 3 months after completion of chemotherapy until disease progression or development of undue toxicity. Grade 3 or higher diarrhea, which has been a concern among some patients receiving ipilimumab, was reported in 7% of the concurrent arm, 5% of the phased arm, and 3% of the chemotherapy-alone arm. One fatal toxic epidermal necrolysis occurred in the concurrent arm, Dr. Lynch reported at the symposium, cosponsored by ASCO, the American Society for Radiation Oncology, the International Association for the Study of Lung Cancer, and the University of Chicago.

The study was sponsored by Bristol-Myers Squibb. Dr. Lynch disclosed serving as a consultant or advisory board member for BMS. One of his coauthors is an employee of BMS, and others report financial relationships with BMS and other firms.

CHICAGO – The novel immunotherapy ipilimumab was active in combination with paclitaxel and carboplatin chemotherapy in first-line advanced lung cancer, but a phase II trial did not deliver the blockbuster results recently observed in metastatic melanoma.

Researchers randomized 204 patients with stage IIIb/IV recurrent or metastatic non–small cell lung cancer to three arms in the study. One group received ipilimumab 10 mg/kg every 3 weeks concurrent with the first four cycles of chemotherapy, another was given ipilimumab at the same dose in combination with cycles three through six of chemotherapy, and a control group received chemotherapy alone.

The trial’s primary end point of immune-related progression-free survival showed significant improvement from a median of 4.63 months with chemotherapy alone to 5.52 months with ipilimumab and concurrent chemotherapy (hazard ratio, 0.77; P =.09) and 5.68 months with ipilimumab and phased chemotherapy (HR, 0.68; P = .02). Of note, statistical significance was calculated using a one-side log-rank test with an alpha of 0.10 and not the standard 0.05.

When traditional modified World Health Organization criteria were used, ipilimumab significantly extended progression-free survival only in the phased arm from 4.21 months in the control group to 5.13 months (HR, 0.69; P = .02), lead author Dr. Thomas J. Lynch Jr. reported in a poster at the Chicago Multidisciplinary Thoracic Oncology Symposium. The secondary end point fell short at 4.11 months in the ipilimumab concurrent arm (HR, 0.88; P = .25)

There was a trend toward improved overall survival in favor of ipilimumab plus chemotherapy, but it did not reach statistical significance. Median survival times were 9.69 months for the ipilimumab concurrent arm (HR, 0.98; P = .47), 12.2 months for the phased arm (HR, 0.86; P = .23), and 8.28 months for the chemotherapy-alone arm, reported Dr. Lynch, director of Yale Cancer Center and physician-in-chief of the Smilow Cancer Hospital in New Haven, Conn.

At the American Society of Clinical Oncology (ASCO) meeting earlier this year ipilimumab became the first drug in 30 years to demonstrate a significant survival advantage in metastatic melanoma in a phase III trial. A biologics license application for that indication is before the Food and Drug Administration, which must respond by March 26. The Oncologic Drugs Advisory Committee is to discuss the application on Feb. 9.

Despite the relatively lackluster performance in lung cancer, Dr. Lynch described the phase II data as intriguing and said they provide justification for a phase III trial that is being planned.

"I thought for ages that immunotherapy was, I don’t want to say hokey, but was highly unlikely to make a difference in non–small cell lung cancer," he said during a press briefing at the meeting. "I thought it was good in renal cell and melanoma disease.

"I have really begun to come around on this, partly because of ipilimumab and partly because of the anti-PD-1 [programmed death–1] strategy. It really comes down to the whole principle of changing the paradigm of how we interact with the immune system."

Ipilimumab is a fully human monoclonal antibody that potentiates immune response by specifically inhibiting CTLA-4 (cytotoxic T-lymphocyte–associated antigen-4). Suppression of CTLA-4 can augment the immune system’s T-cell response in fighting disease.

Bristol-Myers Squibb, which is developing ipilimumab, is also evaluating the anti-PD-1 human monoclonal antibody MDX-1106 in various refractory or relapsed malignancies including non–small cell lung cancer.

Patients in the current trial were maintained on ipilimumab 10 mg/kg every 3 months after completion of chemotherapy until disease progression or development of undue toxicity. Grade 3 or higher diarrhea, which has been a concern among some patients receiving ipilimumab, was reported in 7% of the concurrent arm, 5% of the phased arm, and 3% of the chemotherapy-alone arm. One fatal toxic epidermal necrolysis occurred in the concurrent arm, Dr. Lynch reported at the symposium, cosponsored by ASCO, the American Society for Radiation Oncology, the International Association for the Study of Lung Cancer, and the University of Chicago.

The study was sponsored by Bristol-Myers Squibb. Dr. Lynch disclosed serving as a consultant or advisory board member for BMS. One of his coauthors is an employee of BMS, and others report financial relationships with BMS and other firms.

CHICAGO – The novel immunotherapy ipilimumab was active in combination with paclitaxel and carboplatin chemotherapy in first-line advanced lung cancer, but a phase II trial did not deliver the blockbuster results recently observed in metastatic melanoma.

Researchers randomized 204 patients with stage IIIb/IV recurrent or metastatic non–small cell lung cancer to three arms in the study. One group received ipilimumab 10 mg/kg every 3 weeks concurrent with the first four cycles of chemotherapy, another was given ipilimumab at the same dose in combination with cycles three through six of chemotherapy, and a control group received chemotherapy alone.

The trial’s primary end point of immune-related progression-free survival showed significant improvement from a median of 4.63 months with chemotherapy alone to 5.52 months with ipilimumab and concurrent chemotherapy (hazard ratio, 0.77; P =.09) and 5.68 months with ipilimumab and phased chemotherapy (HR, 0.68; P = .02). Of note, statistical significance was calculated using a one-side log-rank test with an alpha of 0.10 and not the standard 0.05.

When traditional modified World Health Organization criteria were used, ipilimumab significantly extended progression-free survival only in the phased arm from 4.21 months in the control group to 5.13 months (HR, 0.69; P = .02), lead author Dr. Thomas J. Lynch Jr. reported in a poster at the Chicago Multidisciplinary Thoracic Oncology Symposium. The secondary end point fell short at 4.11 months in the ipilimumab concurrent arm (HR, 0.88; P = .25)

There was a trend toward improved overall survival in favor of ipilimumab plus chemotherapy, but it did not reach statistical significance. Median survival times were 9.69 months for the ipilimumab concurrent arm (HR, 0.98; P = .47), 12.2 months for the phased arm (HR, 0.86; P = .23), and 8.28 months for the chemotherapy-alone arm, reported Dr. Lynch, director of Yale Cancer Center and physician-in-chief of the Smilow Cancer Hospital in New Haven, Conn.

At the American Society of Clinical Oncology (ASCO) meeting earlier this year ipilimumab became the first drug in 30 years to demonstrate a significant survival advantage in metastatic melanoma in a phase III trial. A biologics license application for that indication is before the Food and Drug Administration, which must respond by March 26. The Oncologic Drugs Advisory Committee is to discuss the application on Feb. 9.

Despite the relatively lackluster performance in lung cancer, Dr. Lynch described the phase II data as intriguing and said they provide justification for a phase III trial that is being planned.

"I thought for ages that immunotherapy was, I don’t want to say hokey, but was highly unlikely to make a difference in non–small cell lung cancer," he said during a press briefing at the meeting. "I thought it was good in renal cell and melanoma disease.

"I have really begun to come around on this, partly because of ipilimumab and partly because of the anti-PD-1 [programmed death–1] strategy. It really comes down to the whole principle of changing the paradigm of how we interact with the immune system."

Ipilimumab is a fully human monoclonal antibody that potentiates immune response by specifically inhibiting CTLA-4 (cytotoxic T-lymphocyte–associated antigen-4). Suppression of CTLA-4 can augment the immune system’s T-cell response in fighting disease.

Bristol-Myers Squibb, which is developing ipilimumab, is also evaluating the anti-PD-1 human monoclonal antibody MDX-1106 in various refractory or relapsed malignancies including non–small cell lung cancer.

Patients in the current trial were maintained on ipilimumab 10 mg/kg every 3 months after completion of chemotherapy until disease progression or development of undue toxicity. Grade 3 or higher diarrhea, which has been a concern among some patients receiving ipilimumab, was reported in 7% of the concurrent arm, 5% of the phased arm, and 3% of the chemotherapy-alone arm. One fatal toxic epidermal necrolysis occurred in the concurrent arm, Dr. Lynch reported at the symposium, cosponsored by ASCO, the American Society for Radiation Oncology, the International Association for the Study of Lung Cancer, and the University of Chicago.

The study was sponsored by Bristol-Myers Squibb. Dr. Lynch disclosed serving as a consultant or advisory board member for BMS. One of his coauthors is an employee of BMS, and others report financial relationships with BMS and other firms.

LONDON – Primary care and emergency physicians face significant difficulties in the diagnosis and treatment of bronchiolitis, particularly during the winter months when the prevalence of the condition rises.

Part of the problem is making a differential diagnosis, compounded by the lack of available evidence-based treatments, experts said at the Excellence in Paediatrics annual meeting in London.

Primary care physicians and general practitioners (GPs) are often not comfortable making a diagnosis of bronchiolitis, said Dr. Mike Thomas, an Asthma UK senior research fellow at the University of Aberdeen (Scotland). "There isn’t a simple, gold-standard diagnostic test, which makes things rather difficult," he observed.

Bronchiolitis typically occurs in infants aged 3-6 months, and a diagnosis is often based on the presenting symptoms, which may include difficulty in breathing, wheeze, crackles on auscultation, cough, and even apnea in very young babies. General irritability and poor feeding may also be apparent.

These symptoms are shared with several other respiratory conditions, such as asthma, viral-induced wheeze, bacterial lower respiratory tract infection, pneumonia, and some rarer lung diseases such as cystic fibrosis.

Investigations – chest x-ray, hematology, and virology – are not routinely recommended, and even when a diagnosis is made, "we’re not 100% sure what to do," Dr. Thomas said.

Evidence-based treatments for the condition are lacking, Dr. Thomas said, with current practice guidelines set in 2006 in both the United Kingdom and United States tending to give advice on what not to do rather than what treatment to give.

"The bottom line is that there is no evidence-based specific treatment in prehospitalized infants ... and we’re left giving standard advice to children with viral illness on the use of fluids and antipyretics."

Dr. Joan L. Robinson, professor of pediatrics at Stollery Children’s Hospital in Edmonton, Alberta, noted that problems in diagnosing and treating bronchiolitis also exist in the ED.

Indeed, evidence shows that ED physicians and radiologists may interpret chest X-rays very differently, often misdiagnosing bronchiolitis as bacterial pneumonia (J. Pediatr. 2007;150:429-33; Pediatr. Pulmonol. 2009;44:122-7).

"Chest x-ray in a typical case of bronchiolitis leads to overdiagnosis of pneumonia and therefore overuse of antibiotics," Dr. Robinson cautioned.

Viral testing has its pros and cons, but it is probably not cost effective in the majority of non–high-risk outpatient cases, she added. "There is no clear correct answer as to whether hospitals should encourage routine testing for inpatients," Dr. Robinson observed.

Dr. Steve Cunningham, a consultant respiratory pediatrician at the Royal Hospital for Sick Children in Edinburgh, commented that treatments for bronchiolitis range from those that aim to improve airflow to those that reduce mucosal inflammation, lessen edema, or improve mucous movement.

Of all available treatments, however, only continuous positive airway pressure and nasal hypertonic saline had any, although still questionable, effect.

With the difficulties in diagnosis and treatment, it becomes all the more important for parents and other caregivers to be well informed about bronchiolitis and how to recognize the signs of a child’s possible deterioration.

"Most infants with bronchiolitis will have a mild illness that can be managed at home," Dr. Thomas said. Caregivers need to know, however, that there is "no cure," and that while symptoms may disappear at around 2 weeks in half of all affected infants, prolonged illness can result in others. It is unclear if there is a higher risk of developing asthma later in life.

Together with general advice on hygiene and regular hand-washing, physicians should remind caregivers that other factors, such as breast-feeding and passive smoking, can have an effect on the child’s health.

"There is also need for better education for GPs and a better evidence base for management," Dr. Thomas suggested. Primary care and general practitioners are uniquely placed to help monitor infants and young children, possibly preventing the need for emergency hospital admission.

Dr. Thomas, Dr. Robinson, and Dr. Cunningham said that they had no conflicts of interest.

LONDON – Primary care and emergency physicians face significant difficulties in the diagnosis and treatment of bronchiolitis, particularly during the winter months when the prevalence of the condition rises.

Part of the problem is making a differential diagnosis, compounded by the lack of available evidence-based treatments, experts said at the Excellence in Paediatrics annual meeting in London.

Primary care physicians and general practitioners (GPs) are often not comfortable making a diagnosis of bronchiolitis, said Dr. Mike Thomas, an Asthma UK senior research fellow at the University of Aberdeen (Scotland). "There isn’t a simple, gold-standard diagnostic test, which makes things rather difficult," he observed.

Bronchiolitis typically occurs in infants aged 3-6 months, and a diagnosis is often based on the presenting symptoms, which may include difficulty in breathing, wheeze, crackles on auscultation, cough, and even apnea in very young babies. General irritability and poor feeding may also be apparent.

These symptoms are shared with several other respiratory conditions, such as asthma, viral-induced wheeze, bacterial lower respiratory tract infection, pneumonia, and some rarer lung diseases such as cystic fibrosis.

Investigations – chest x-ray, hematology, and virology – are not routinely recommended, and even when a diagnosis is made, "we’re not 100% sure what to do," Dr. Thomas said.

Evidence-based treatments for the condition are lacking, Dr. Thomas said, with current practice guidelines set in 2006 in both the United Kingdom and United States tending to give advice on what not to do rather than what treatment to give.

"The bottom line is that there is no evidence-based specific treatment in prehospitalized infants ... and we’re left giving standard advice to children with viral illness on the use of fluids and antipyretics."

Dr. Joan L. Robinson, professor of pediatrics at Stollery Children’s Hospital in Edmonton, Alberta, noted that problems in diagnosing and treating bronchiolitis also exist in the ED.

Indeed, evidence shows that ED physicians and radiologists may interpret chest X-rays very differently, often misdiagnosing bronchiolitis as bacterial pneumonia (J. Pediatr. 2007;150:429-33; Pediatr. Pulmonol. 2009;44:122-7).

"Chest x-ray in a typical case of bronchiolitis leads to overdiagnosis of pneumonia and therefore overuse of antibiotics," Dr. Robinson cautioned.

Viral testing has its pros and cons, but it is probably not cost effective in the majority of non–high-risk outpatient cases, she added. "There is no clear correct answer as to whether hospitals should encourage routine testing for inpatients," Dr. Robinson observed.

Dr. Steve Cunningham, a consultant respiratory pediatrician at the Royal Hospital for Sick Children in Edinburgh, commented that treatments for bronchiolitis range from those that aim to improve airflow to those that reduce mucosal inflammation, lessen edema, or improve mucous movement.

Of all available treatments, however, only continuous positive airway pressure and nasal hypertonic saline had any, although still questionable, effect.

With the difficulties in diagnosis and treatment, it becomes all the more important for parents and other caregivers to be well informed about bronchiolitis and how to recognize the signs of a child’s possible deterioration.

"Most infants with bronchiolitis will have a mild illness that can be managed at home," Dr. Thomas said. Caregivers need to know, however, that there is "no cure," and that while symptoms may disappear at around 2 weeks in half of all affected infants, prolonged illness can result in others. It is unclear if there is a higher risk of developing asthma later in life.

Together with general advice on hygiene and regular hand-washing, physicians should remind caregivers that other factors, such as breast-feeding and passive smoking, can have an effect on the child’s health.

"There is also need for better education for GPs and a better evidence base for management," Dr. Thomas suggested. Primary care and general practitioners are uniquely placed to help monitor infants and young children, possibly preventing the need for emergency hospital admission.

Dr. Thomas, Dr. Robinson, and Dr. Cunningham said that they had no conflicts of interest.

LONDON – Primary care and emergency physicians face significant difficulties in the diagnosis and treatment of bronchiolitis, particularly during the winter months when the prevalence of the condition rises.

Part of the problem is making a differential diagnosis, compounded by the lack of available evidence-based treatments, experts said at the Excellence in Paediatrics annual meeting in London.

Primary care physicians and general practitioners (GPs) are often not comfortable making a diagnosis of bronchiolitis, said Dr. Mike Thomas, an Asthma UK senior research fellow at the University of Aberdeen (Scotland). "There isn’t a simple, gold-standard diagnostic test, which makes things rather difficult," he observed.

Bronchiolitis typically occurs in infants aged 3-6 months, and a diagnosis is often based on the presenting symptoms, which may include difficulty in breathing, wheeze, crackles on auscultation, cough, and even apnea in very young babies. General irritability and poor feeding may also be apparent.

These symptoms are shared with several other respiratory conditions, such as asthma, viral-induced wheeze, bacterial lower respiratory tract infection, pneumonia, and some rarer lung diseases such as cystic fibrosis.

Investigations – chest x-ray, hematology, and virology – are not routinely recommended, and even when a diagnosis is made, "we’re not 100% sure what to do," Dr. Thomas said.

Evidence-based treatments for the condition are lacking, Dr. Thomas said, with current practice guidelines set in 2006 in both the United Kingdom and United States tending to give advice on what not to do rather than what treatment to give.

"The bottom line is that there is no evidence-based specific treatment in prehospitalized infants ... and we’re left giving standard advice to children with viral illness on the use of fluids and antipyretics."

Dr. Joan L. Robinson, professor of pediatrics at Stollery Children’s Hospital in Edmonton, Alberta, noted that problems in diagnosing and treating bronchiolitis also exist in the ED.

Indeed, evidence shows that ED physicians and radiologists may interpret chest X-rays very differently, often misdiagnosing bronchiolitis as bacterial pneumonia (J. Pediatr. 2007;150:429-33; Pediatr. Pulmonol. 2009;44:122-7).

"Chest x-ray in a typical case of bronchiolitis leads to overdiagnosis of pneumonia and therefore overuse of antibiotics," Dr. Robinson cautioned.

Viral testing has its pros and cons, but it is probably not cost effective in the majority of non–high-risk outpatient cases, she added. "There is no clear correct answer as to whether hospitals should encourage routine testing for inpatients," Dr. Robinson observed.

Dr. Steve Cunningham, a consultant respiratory pediatrician at the Royal Hospital for Sick Children in Edinburgh, commented that treatments for bronchiolitis range from those that aim to improve airflow to those that reduce mucosal inflammation, lessen edema, or improve mucous movement.

Of all available treatments, however, only continuous positive airway pressure and nasal hypertonic saline had any, although still questionable, effect.

With the difficulties in diagnosis and treatment, it becomes all the more important for parents and other caregivers to be well informed about bronchiolitis and how to recognize the signs of a child’s possible deterioration.

"Most infants with bronchiolitis will have a mild illness that can be managed at home," Dr. Thomas said. Caregivers need to know, however, that there is "no cure," and that while symptoms may disappear at around 2 weeks in half of all affected infants, prolonged illness can result in others. It is unclear if there is a higher risk of developing asthma later in life.

Together with general advice on hygiene and regular hand-washing, physicians should remind caregivers that other factors, such as breast-feeding and passive smoking, can have an effect on the child’s health.

"There is also need for better education for GPs and a better evidence base for management," Dr. Thomas suggested. Primary care and general practitioners are uniquely placed to help monitor infants and young children, possibly preventing the need for emergency hospital admission.

Dr. Thomas, Dr. Robinson, and Dr. Cunningham said that they had no conflicts of interest.

The Department of Health and Human Services launched its Healthy People 2020 goals on Dec. 2, and among the objectives set forth in its “ambitious, yet achievable” 10-year agenda for improving the nation's health are substantial improvements in sleep health, respiratory disease outcomes, and levels of tobacco use.

Sleep Health

Sleep health is a new topic in the Healthy People initiative. The main focus is on increasing public knowledge of how adequate sleep and treatment of sleep disorders lead to improvements in health, productivity, wellness, quality of life, and safety on the roads and in the workplace.

“Poor sleep health is a common problem, with 25% of U.S. adults reporting insufficient sleep or rest at least 5 out of every 30 days,” the report states.

The public health burden is substantial, and awareness of the problem is lacking; thus, Healthy People 2020 seeks to provide a “well-coordinated strategy to improve sleep-related health.”

Objectives are to:

▸ Increase the proportion of persons with symptoms of obstructive sleep apnea who seek medical care (from 25.5% to 28%).

▸ Reduce the rate of vehicular crashes per 100 million miles traveled that are due to drowsy driving (from 2.7 to 2.1).

▸ Increase the proportion of students in grades 9-12 who get sufficient sleep, defined as 8 hours or more on an average school night (from 30.9% to 33.2%).

▸ Increase the proportion of adults who get sufficient sleep, defined as 8 or more hours for those aged 18-21 years, and 7 or more hours for those aged 22 years and older (from 69.6% to 70.9%).

Respiratory Disease

The respiratory disease category focuses on asthma and chronic obstructive pulmonary disease, and the main goal is to “promote respiratory health through better prevention, detection, treatment, and education efforts,” according to the report, which states that asthma affects 23 million people in the United States and COPD affects 13.6 million U.S. adults.

The cost to the health care system is high, and society pays through higher health insurance rates and lost productivity and tax dollars. Annual expenditures for asthma alone are estimated at nearly $21 billion.

Healthy People 2020 seeks to reduce asthma-related deaths, hospitalizations, emergency department visits, activity limitations, and missed school or work days, and to increase the proportion of asthma sufferers who receive appropriate care. Improved surveillance at the state level is another goal.

For example, goals for 2020 in regard to asthma-related deaths include reductions from 11.0 to 6.0 deaths per 1 million people aged 35-64 years, and from 43.3 to 22.9 per 1 million people aged 65 and older. Goals regarding annual asthma-related hospitalization include a reduction from 41.4 to 18.1 per 10,000 children under age 5, from 11.1 to 8.6 per 10,000 people aged 5-64 years, and from 25.3 to 20.3 per 10,000 adults aged 65 years and older.

Goals regarding appropriate asthma care include specific improvements in the number of patients who receive written asthma management plans, instructions for inhaler use, education about appropriate response to an asthma episode, and follow-up visits each year.

COPD-related objectives include reducing associated activity limitations, deaths, hospitalizations, and emergency department visits, and improving diagnosis among adults with abnormal lung function.

Specific goals include a reduction from 23.2 to 18.7 in the percentage of adults with COPD aged 45 years and older who experience activity limitations from COPD, and a reduction from 112.4 to 98.5 in the number of COPD-related deaths per 10,000 people aged 45 years and older.

Tobacco Use

Tobacco use is not a new topic in the Healthy People initiative, but ongoing efforts to reduce use are needed, according to the report, because tobacco use remains the single most preventable cause of death and disease in the United States. About 443,000 Americans die from tobacco-related illnesses each year, and for every 1 who dies, 20 more suffer with at least one serious tobacco-related illness.

Healthy People 2020 seeks to “provide a framework for action to reduce tobacco use to the point that it is no longer a public health problem for the nation.”

Based on more than 4 decades of evidence, it is clear, according to the report, that the toll tobacco use takes on families and communities can be significantly reduced by fully funding tobacco control programs, increasing the prices of tobacco products, enacting smoke-free policies, controlling access to products, reducing tobacco advertising and promotion, implementing antitobacco media campaigns, and encouraging and assisting users to quit.

Healthy People 2020 addresses tobacco use prevalence, health system changes, and social and environmental changes. Among the key goals for adults are:

▸ Reducing the percentage of adult cigarette smokers (from 20.6% to 12.0%).

▸ Reducing the percentage of adult users of smokeless tobacco (from 2.3% to 0.3%).

▸ Reducing the percentage of adult cigar smokers (from 2.2% to 0.2%).

In adolescents, goals include reducing the percentage of those who used tobacco in the past month from 26% to 21%, and reducing the percentages who said they used cigarettes, smokeless tobacco, and cigars in the past month from 19.5% to 16%, from 8.9% to 6.9%, and from 14% to 8%, respectively.

Initiation of tobacco use among children, adolescents, and young adults is also addressed, with a goal of reducing initiation of tobacco use in general among those aged 12-17 years from 7.7% to 5.7%, and among those aged 18-25 years from 10.8% to 8.8%.

Other goals regarding tobacco use include increasing smoking cessation attempts by adult and adolescent smokers, and increasing smoking cessation during pregnancy.

Numerous goals are also set in regard to health system changes, and social and environmental changes.

For example, the report calls for increases in comprehensive Medicaid insurance coverage for nicotine dependency treatment, increased tobacco screening and cessation counseling in health care settings, reductions in the proportion of nonsmokers exposed to secondhand smoke, increases in the proportion of persons covered by indoor worksite policies that prohibit smoking, and increases in tobacco-free environments in school facilities and at school events.

Additionally, efforts should be made to eliminate state laws that preempt stronger local tobacco control laws, to reduce illegal sales to minors, and to reduce exposure to tobacco advertising and promotion among 6th-12th graders.

Also, federal and state taxes on tobacco products should be increased, the report states.

Healthy People 2020 has been in development since 2007. A panel of health experts drew on input from public and private health officials, preventive medicine experts, representatives from 2,000 health organizations, and thousands of public comments.

The initiative expands upon topics from Healthy People 2010, includes a number of new topic areas, and will incorporate the Internet and other technology media in getting the message out about disease prevention and health promotion.

The ultimate goals, according to HHS officials, are to avoid preventable diseases in the first place and to promote improved quantity and quality of life for all Americans.

The Department of Health and Human Services launched its Healthy People 2020 goals on Dec. 2, and among the objectives set forth in its “ambitious, yet achievable” 10-year agenda for improving the nation's health are substantial improvements in sleep health, respiratory disease outcomes, and levels of tobacco use.

Sleep Health

Sleep health is a new topic in the Healthy People initiative. The main focus is on increasing public knowledge of how adequate sleep and treatment of sleep disorders lead to improvements in health, productivity, wellness, quality of life, and safety on the roads and in the workplace.

“Poor sleep health is a common problem, with 25% of U.S. adults reporting insufficient sleep or rest at least 5 out of every 30 days,” the report states.

The public health burden is substantial, and awareness of the problem is lacking; thus, Healthy People 2020 seeks to provide a “well-coordinated strategy to improve sleep-related health.”

Objectives are to:

▸ Increase the proportion of persons with symptoms of obstructive sleep apnea who seek medical care (from 25.5% to 28%).

▸ Reduce the rate of vehicular crashes per 100 million miles traveled that are due to drowsy driving (from 2.7 to 2.1).

▸ Increase the proportion of students in grades 9-12 who get sufficient sleep, defined as 8 hours or more on an average school night (from 30.9% to 33.2%).

▸ Increase the proportion of adults who get sufficient sleep, defined as 8 or more hours for those aged 18-21 years, and 7 or more hours for those aged 22 years and older (from 69.6% to 70.9%).

Respiratory Disease

The respiratory disease category focuses on asthma and chronic obstructive pulmonary disease, and the main goal is to “promote respiratory health through better prevention, detection, treatment, and education efforts,” according to the report, which states that asthma affects 23 million people in the United States and COPD affects 13.6 million U.S. adults.

The cost to the health care system is high, and society pays through higher health insurance rates and lost productivity and tax dollars. Annual expenditures for asthma alone are estimated at nearly $21 billion.

Healthy People 2020 seeks to reduce asthma-related deaths, hospitalizations, emergency department visits, activity limitations, and missed school or work days, and to increase the proportion of asthma sufferers who receive appropriate care. Improved surveillance at the state level is another goal.

For example, goals for 2020 in regard to asthma-related deaths include reductions from 11.0 to 6.0 deaths per 1 million people aged 35-64 years, and from 43.3 to 22.9 per 1 million people aged 65 and older. Goals regarding annual asthma-related hospitalization include a reduction from 41.4 to 18.1 per 10,000 children under age 5, from 11.1 to 8.6 per 10,000 people aged 5-64 years, and from 25.3 to 20.3 per 10,000 adults aged 65 years and older.

Goals regarding appropriate asthma care include specific improvements in the number of patients who receive written asthma management plans, instructions for inhaler use, education about appropriate response to an asthma episode, and follow-up visits each year.

COPD-related objectives include reducing associated activity limitations, deaths, hospitalizations, and emergency department visits, and improving diagnosis among adults with abnormal lung function.

Specific goals include a reduction from 23.2 to 18.7 in the percentage of adults with COPD aged 45 years and older who experience activity limitations from COPD, and a reduction from 112.4 to 98.5 in the number of COPD-related deaths per 10,000 people aged 45 years and older.

Tobacco Use

Tobacco use is not a new topic in the Healthy People initiative, but ongoing efforts to reduce use are needed, according to the report, because tobacco use remains the single most preventable cause of death and disease in the United States. About 443,000 Americans die from tobacco-related illnesses each year, and for every 1 who dies, 20 more suffer with at least one serious tobacco-related illness.

Healthy People 2020 seeks to “provide a framework for action to reduce tobacco use to the point that it is no longer a public health problem for the nation.”

Based on more than 4 decades of evidence, it is clear, according to the report, that the toll tobacco use takes on families and communities can be significantly reduced by fully funding tobacco control programs, increasing the prices of tobacco products, enacting smoke-free policies, controlling access to products, reducing tobacco advertising and promotion, implementing antitobacco media campaigns, and encouraging and assisting users to quit.

Healthy People 2020 addresses tobacco use prevalence, health system changes, and social and environmental changes. Among the key goals for adults are:

▸ Reducing the percentage of adult cigarette smokers (from 20.6% to 12.0%).

▸ Reducing the percentage of adult users of smokeless tobacco (from 2.3% to 0.3%).

▸ Reducing the percentage of adult cigar smokers (from 2.2% to 0.2%).

In adolescents, goals include reducing the percentage of those who used tobacco in the past month from 26% to 21%, and reducing the percentages who said they used cigarettes, smokeless tobacco, and cigars in the past month from 19.5% to 16%, from 8.9% to 6.9%, and from 14% to 8%, respectively.

Initiation of tobacco use among children, adolescents, and young adults is also addressed, with a goal of reducing initiation of tobacco use in general among those aged 12-17 years from 7.7% to 5.7%, and among those aged 18-25 years from 10.8% to 8.8%.

Other goals regarding tobacco use include increasing smoking cessation attempts by adult and adolescent smokers, and increasing smoking cessation during pregnancy.

Numerous goals are also set in regard to health system changes, and social and environmental changes.

For example, the report calls for increases in comprehensive Medicaid insurance coverage for nicotine dependency treatment, increased tobacco screening and cessation counseling in health care settings, reductions in the proportion of nonsmokers exposed to secondhand smoke, increases in the proportion of persons covered by indoor worksite policies that prohibit smoking, and increases in tobacco-free environments in school facilities and at school events.

Additionally, efforts should be made to eliminate state laws that preempt stronger local tobacco control laws, to reduce illegal sales to minors, and to reduce exposure to tobacco advertising and promotion among 6th-12th graders.

Also, federal and state taxes on tobacco products should be increased, the report states.

Healthy People 2020 has been in development since 2007. A panel of health experts drew on input from public and private health officials, preventive medicine experts, representatives from 2,000 health organizations, and thousands of public comments.

The initiative expands upon topics from Healthy People 2010, includes a number of new topic areas, and will incorporate the Internet and other technology media in getting the message out about disease prevention and health promotion.

The ultimate goals, according to HHS officials, are to avoid preventable diseases in the first place and to promote improved quantity and quality of life for all Americans.

The Department of Health and Human Services launched its Healthy People 2020 goals on Dec. 2, and among the objectives set forth in its “ambitious, yet achievable” 10-year agenda for improving the nation's health are substantial improvements in sleep health, respiratory disease outcomes, and levels of tobacco use.

Sleep Health

Sleep health is a new topic in the Healthy People initiative. The main focus is on increasing public knowledge of how adequate sleep and treatment of sleep disorders lead to improvements in health, productivity, wellness, quality of life, and safety on the roads and in the workplace.

“Poor sleep health is a common problem, with 25% of U.S. adults reporting insufficient sleep or rest at least 5 out of every 30 days,” the report states.

The public health burden is substantial, and awareness of the problem is lacking; thus, Healthy People 2020 seeks to provide a “well-coordinated strategy to improve sleep-related health.”

Objectives are to:

▸ Increase the proportion of persons with symptoms of obstructive sleep apnea who seek medical care (from 25.5% to 28%).

▸ Reduce the rate of vehicular crashes per 100 million miles traveled that are due to drowsy driving (from 2.7 to 2.1).

▸ Increase the proportion of students in grades 9-12 who get sufficient sleep, defined as 8 hours or more on an average school night (from 30.9% to 33.2%).

▸ Increase the proportion of adults who get sufficient sleep, defined as 8 or more hours for those aged 18-21 years, and 7 or more hours for those aged 22 years and older (from 69.6% to 70.9%).

Respiratory Disease

The respiratory disease category focuses on asthma and chronic obstructive pulmonary disease, and the main goal is to “promote respiratory health through better prevention, detection, treatment, and education efforts,” according to the report, which states that asthma affects 23 million people in the United States and COPD affects 13.6 million U.S. adults.

The cost to the health care system is high, and society pays through higher health insurance rates and lost productivity and tax dollars. Annual expenditures for asthma alone are estimated at nearly $21 billion.

Healthy People 2020 seeks to reduce asthma-related deaths, hospitalizations, emergency department visits, activity limitations, and missed school or work days, and to increase the proportion of asthma sufferers who receive appropriate care. Improved surveillance at the state level is another goal.

For example, goals for 2020 in regard to asthma-related deaths include reductions from 11.0 to 6.0 deaths per 1 million people aged 35-64 years, and from 43.3 to 22.9 per 1 million people aged 65 and older. Goals regarding annual asthma-related hospitalization include a reduction from 41.4 to 18.1 per 10,000 children under age 5, from 11.1 to 8.6 per 10,000 people aged 5-64 years, and from 25.3 to 20.3 per 10,000 adults aged 65 years and older.

Goals regarding appropriate asthma care include specific improvements in the number of patients who receive written asthma management plans, instructions for inhaler use, education about appropriate response to an asthma episode, and follow-up visits each year.

COPD-related objectives include reducing associated activity limitations, deaths, hospitalizations, and emergency department visits, and improving diagnosis among adults with abnormal lung function.

Specific goals include a reduction from 23.2 to 18.7 in the percentage of adults with COPD aged 45 years and older who experience activity limitations from COPD, and a reduction from 112.4 to 98.5 in the number of COPD-related deaths per 10,000 people aged 45 years and older.

Tobacco Use

Tobacco use is not a new topic in the Healthy People initiative, but ongoing efforts to reduce use are needed, according to the report, because tobacco use remains the single most preventable cause of death and disease in the United States. About 443,000 Americans die from tobacco-related illnesses each year, and for every 1 who dies, 20 more suffer with at least one serious tobacco-related illness.

Healthy People 2020 seeks to “provide a framework for action to reduce tobacco use to the point that it is no longer a public health problem for the nation.”

Based on more than 4 decades of evidence, it is clear, according to the report, that the toll tobacco use takes on families and communities can be significantly reduced by fully funding tobacco control programs, increasing the prices of tobacco products, enacting smoke-free policies, controlling access to products, reducing tobacco advertising and promotion, implementing antitobacco media campaigns, and encouraging and assisting users to quit.

Healthy People 2020 addresses tobacco use prevalence, health system changes, and social and environmental changes. Among the key goals for adults are:

▸ Reducing the percentage of adult cigarette smokers (from 20.6% to 12.0%).

▸ Reducing the percentage of adult users of smokeless tobacco (from 2.3% to 0.3%).

▸ Reducing the percentage of adult cigar smokers (from 2.2% to 0.2%).

In adolescents, goals include reducing the percentage of those who used tobacco in the past month from 26% to 21%, and reducing the percentages who said they used cigarettes, smokeless tobacco, and cigars in the past month from 19.5% to 16%, from 8.9% to 6.9%, and from 14% to 8%, respectively.

Initiation of tobacco use among children, adolescents, and young adults is also addressed, with a goal of reducing initiation of tobacco use in general among those aged 12-17 years from 7.7% to 5.7%, and among those aged 18-25 years from 10.8% to 8.8%.

Other goals regarding tobacco use include increasing smoking cessation attempts by adult and adolescent smokers, and increasing smoking cessation during pregnancy.

Numerous goals are also set in regard to health system changes, and social and environmental changes.

For example, the report calls for increases in comprehensive Medicaid insurance coverage for nicotine dependency treatment, increased tobacco screening and cessation counseling in health care settings, reductions in the proportion of nonsmokers exposed to secondhand smoke, increases in the proportion of persons covered by indoor worksite policies that prohibit smoking, and increases in tobacco-free environments in school facilities and at school events.

Additionally, efforts should be made to eliminate state laws that preempt stronger local tobacco control laws, to reduce illegal sales to minors, and to reduce exposure to tobacco advertising and promotion among 6th-12th graders.

Also, federal and state taxes on tobacco products should be increased, the report states.

Healthy People 2020 has been in development since 2007. A panel of health experts drew on input from public and private health officials, preventive medicine experts, representatives from 2,000 health organizations, and thousands of public comments.

The initiative expands upon topics from Healthy People 2010, includes a number of new topic areas, and will incorporate the Internet and other technology media in getting the message out about disease prevention and health promotion.

The ultimate goals, according to HHS officials, are to avoid preventable diseases in the first place and to promote improved quantity and quality of life for all Americans.

Major Finding: Participants were more likely than nonparticipants to know that alveolar destruction is a pathophysiologic feature of COPD (94% vs. 74%), to know that women are more susceptible than men to the harmful effects of smoking (90% vs. 54%), and to correctly identify COPD in patients with dyspnea (90% vs. 74%).

Data Source: A cross-sectional survey of 50 primary care physicians who participated in a COPD educational initiative and 50 similar primary care physicians who did not.

Disclosures: The initiative meetings were supported by an educational grant from Novartis Pharmaceuticals. Dr. Hanania did not have any conflicts of interest related to the study.

VANCOUVER, B.C. – A live, interactive, case-based educational initiative improved primary care physicians' knowledge of chronic obstructive pulmonary disease, according to study results reported at the meeting.

In a cross-sectional study of 50 primary care physicians who participated in the initiative and 50 similar nonparticipants, the former were more likely to know that alveolar destruction is a pathophysiologic feature of COPD (94% vs. 74%) and that women have greater susceptibility to the harmful effects of smoking (90% vs. 54%), according to Dr. Nicola A. Hanania and his coinvestigators.

Additionally, when presented with case vignettes, the participants were more likely to recognize the presence of COPD in dyspnea patients (90% vs. 74%).

“Even though this was sort of a one-time … cross-sectional survey, we believe that educational initiatives such as this one may at least improve the knowledge about COPD – both diagnosis and management,” commented Dr. Hanania, an associate professor of medicine at Baylor College of Medicine, Houston.

Explaining the need for primary care–focused efforts, he noted that “the majority of COPD patients are [seen] in the primary care arena.”

But statistics show that “COPD remains under-recognized and underdiagnosed in about 50% of the population out there, not only in the United States but in other countries as well. It also remains undertreated,” even though the GOLD (Global Initiative for Chronic Obstructive Lung Disease) guidelines now stress that it is a treatable disease.

The initiative studied – called Improving COPD Patient Outcomes: Breaking Down the Barriers to Optimal Care – was designed to improve primary care providers' knowledge and competency in the guideline-based diagnosis, staging, and management of COPD, Dr. Hanania said.

It consisted of a series of live half-day meetings conducted over a 3-month period that included short lectures, a video on correct use of inhaler devices, and small-group workshops that incorporated detailed case discussions and hands-on demonstrations and practice in the use of spirometry.

A total of 769 physicians attended the meetings. The investigators assessed the initiative's effectiveness with a case vignette–based survey, given to a randomly selected subset of 50 participants and 50 nonparticipants with similar demographics and practice characteristics.

The number of patients with COPD seen weekly was 11 for participants and 15 for nonparticipants. The mean number of years in practice was 28 and 24, respectively. And both groups were about equally divided between family physicians and internal medicine physicians. Participants were somewhat more likely to be in solo practice (45% vs. 38%) or work in a government facility (25% vs. 0%), and less likely to be in group practice (31% vs. 58%).

Survey results showed that in the area of diagnosis, the participants were more likely than the nonparticipants to recognize COPD in case vignettes of patients with dyspnea (90% vs. 74%, P = .007) and to be aware of the greater susceptibility of women compared with men to the harmful effects of smoking (90% vs. 54%, P less than .001).

Also, when asked which of several pathophysiologic features was one of COPD, participants were more likely to correctly answer alveolar destruction (94% vs. 74%, P = .007). (The other options were muscular deconditioning, synovial inflammation, and increased ventricular filling pressure.)

While the groups did not differ significantly in terms of how likely they were to use spirometry for diagnosis and staging of COPD, participants were more likely than nonparticipants to indicate that difficulty in obtaining spirometry results in the office setting was a very significant barrier to COPD management (27% vs. 12%). “Maybe they acknowledged that it is an important tool, but they cannot do it,” he commented.

The groups were statistically indistinguishable with respect to their approaches to caring for patients with repeated exacerbations and improving adherence, and their selection of appropriate maintenance therapy.

The survey also asked about barriers to managing COPD, according to Dr. Hanania.

In addition to difficulty with spirometry, the groups were similarly likely to rate as very significant a patient's nonadherence to a recommendation to stop smoking, the complexity of the medical regimen, and a lack of clarity about the staging of COPD severity.

A calculation of the initiative's quality of education index showed that participants were 50% more likely than nonparticipants to provide evidence-based, guideline-driven COPD care, Dr. Hanania reported. “We estimate that participation in this half-day program can potentially improve the care of many patients per week, but this needs to be further tested,” he commented.

“We did not attempt to look at long-term [outcomes] – retention of knowledge or practice change – which are very important,” Dr. Hanania acknowledged. But a similar, ongoing initiative, being conducted by the ACCP, is currently assessing impact on real-life practice.

That initiative is including not only physicians but also physician assistants and nurse practitioners, Dr. Hanania said. “In our primary care setting in the U.S., nonphysician extenders – PAs, nurse practitioners – play a major role in encountering COPD, and those are people we like to target.” Furthermore, their role will likely increase if health care reform proceeds and primary care physicians are overwhelmed by demand.

The initiative meetings were supported by an educational grant from Novartis Pharmaceuticals. Dr. Hanania had no relevant conflicts of interest.

Participants were 50% more likely than nonparticipants to provide evidence-based, guideline-driven COPD care.

Source DR. HANANIA

Major Finding: Participants were more likely than nonparticipants to know that alveolar destruction is a pathophysiologic feature of COPD (94% vs. 74%), to know that women are more susceptible than men to the harmful effects of smoking (90% vs. 54%), and to correctly identify COPD in patients with dyspnea (90% vs. 74%).

Data Source: A cross-sectional survey of 50 primary care physicians who participated in a COPD educational initiative and 50 similar primary care physicians who did not.

Disclosures: The initiative meetings were supported by an educational grant from Novartis Pharmaceuticals. Dr. Hanania did not have any conflicts of interest related to the study.

VANCOUVER, B.C. – A live, interactive, case-based educational initiative improved primary care physicians' knowledge of chronic obstructive pulmonary disease, according to study results reported at the meeting.

In a cross-sectional study of 50 primary care physicians who participated in the initiative and 50 similar nonparticipants, the former were more likely to know that alveolar destruction is a pathophysiologic feature of COPD (94% vs. 74%) and that women have greater susceptibility to the harmful effects of smoking (90% vs. 54%), according to Dr. Nicola A. Hanania and his coinvestigators.

Additionally, when presented with case vignettes, the participants were more likely to recognize the presence of COPD in dyspnea patients (90% vs. 74%).

“Even though this was sort of a one-time … cross-sectional survey, we believe that educational initiatives such as this one may at least improve the knowledge about COPD – both diagnosis and management,” commented Dr. Hanania, an associate professor of medicine at Baylor College of Medicine, Houston.

Explaining the need for primary care–focused efforts, he noted that “the majority of COPD patients are [seen] in the primary care arena.”

But statistics show that “COPD remains under-recognized and underdiagnosed in about 50% of the population out there, not only in the United States but in other countries as well. It also remains undertreated,” even though the GOLD (Global Initiative for Chronic Obstructive Lung Disease) guidelines now stress that it is a treatable disease.

The initiative studied – called Improving COPD Patient Outcomes: Breaking Down the Barriers to Optimal Care – was designed to improve primary care providers' knowledge and competency in the guideline-based diagnosis, staging, and management of COPD, Dr. Hanania said.

It consisted of a series of live half-day meetings conducted over a 3-month period that included short lectures, a video on correct use of inhaler devices, and small-group workshops that incorporated detailed case discussions and hands-on demonstrations and practice in the use of spirometry.

A total of 769 physicians attended the meetings. The investigators assessed the initiative's effectiveness with a case vignette–based survey, given to a randomly selected subset of 50 participants and 50 nonparticipants with similar demographics and practice characteristics.

The number of patients with COPD seen weekly was 11 for participants and 15 for nonparticipants. The mean number of years in practice was 28 and 24, respectively. And both groups were about equally divided between family physicians and internal medicine physicians. Participants were somewhat more likely to be in solo practice (45% vs. 38%) or work in a government facility (25% vs. 0%), and less likely to be in group practice (31% vs. 58%).

Survey results showed that in the area of diagnosis, the participants were more likely than the nonparticipants to recognize COPD in case vignettes of patients with dyspnea (90% vs. 74%, P = .007) and to be aware of the greater susceptibility of women compared with men to the harmful effects of smoking (90% vs. 54%, P less than .001).

Also, when asked which of several pathophysiologic features was one of COPD, participants were more likely to correctly answer alveolar destruction (94% vs. 74%, P = .007). (The other options were muscular deconditioning, synovial inflammation, and increased ventricular filling pressure.)

While the groups did not differ significantly in terms of how likely they were to use spirometry for diagnosis and staging of COPD, participants were more likely than nonparticipants to indicate that difficulty in obtaining spirometry results in the office setting was a very significant barrier to COPD management (27% vs. 12%). “Maybe they acknowledged that it is an important tool, but they cannot do it,” he commented.

The groups were statistically indistinguishable with respect to their approaches to caring for patients with repeated exacerbations and improving adherence, and their selection of appropriate maintenance therapy.

The survey also asked about barriers to managing COPD, according to Dr. Hanania.

In addition to difficulty with spirometry, the groups were similarly likely to rate as very significant a patient's nonadherence to a recommendation to stop smoking, the complexity of the medical regimen, and a lack of clarity about the staging of COPD severity.

A calculation of the initiative's quality of education index showed that participants were 50% more likely than nonparticipants to provide evidence-based, guideline-driven COPD care, Dr. Hanania reported. “We estimate that participation in this half-day program can potentially improve the care of many patients per week, but this needs to be further tested,” he commented.

“We did not attempt to look at long-term [outcomes] – retention of knowledge or practice change – which are very important,” Dr. Hanania acknowledged. But a similar, ongoing initiative, being conducted by the ACCP, is currently assessing impact on real-life practice.

That initiative is including not only physicians but also physician assistants and nurse practitioners, Dr. Hanania said. “In our primary care setting in the U.S., nonphysician extenders – PAs, nurse practitioners – play a major role in encountering COPD, and those are people we like to target.” Furthermore, their role will likely increase if health care reform proceeds and primary care physicians are overwhelmed by demand.

The initiative meetings were supported by an educational grant from Novartis Pharmaceuticals. Dr. Hanania had no relevant conflicts of interest.

Participants were 50% more likely than nonparticipants to provide evidence-based, guideline-driven COPD care.

Source DR. HANANIA

Major Finding: Participants were more likely than nonparticipants to know that alveolar destruction is a pathophysiologic feature of COPD (94% vs. 74%), to know that women are more susceptible than men to the harmful effects of smoking (90% vs. 54%), and to correctly identify COPD in patients with dyspnea (90% vs. 74%).

Data Source: A cross-sectional survey of 50 primary care physicians who participated in a COPD educational initiative and 50 similar primary care physicians who did not.

Disclosures: The initiative meetings were supported by an educational grant from Novartis Pharmaceuticals. Dr. Hanania did not have any conflicts of interest related to the study.

VANCOUVER, B.C. – A live, interactive, case-based educational initiative improved primary care physicians' knowledge of chronic obstructive pulmonary disease, according to study results reported at the meeting.

In a cross-sectional study of 50 primary care physicians who participated in the initiative and 50 similar nonparticipants, the former were more likely to know that alveolar destruction is a pathophysiologic feature of COPD (94% vs. 74%) and that women have greater susceptibility to the harmful effects of smoking (90% vs. 54%), according to Dr. Nicola A. Hanania and his coinvestigators.

Additionally, when presented with case vignettes, the participants were more likely to recognize the presence of COPD in dyspnea patients (90% vs. 74%).

“Even though this was sort of a one-time … cross-sectional survey, we believe that educational initiatives such as this one may at least improve the knowledge about COPD – both diagnosis and management,” commented Dr. Hanania, an associate professor of medicine at Baylor College of Medicine, Houston.

Explaining the need for primary care–focused efforts, he noted that “the majority of COPD patients are [seen] in the primary care arena.”

But statistics show that “COPD remains under-recognized and underdiagnosed in about 50% of the population out there, not only in the United States but in other countries as well. It also remains undertreated,” even though the GOLD (Global Initiative for Chronic Obstructive Lung Disease) guidelines now stress that it is a treatable disease.

The initiative studied – called Improving COPD Patient Outcomes: Breaking Down the Barriers to Optimal Care – was designed to improve primary care providers' knowledge and competency in the guideline-based diagnosis, staging, and management of COPD, Dr. Hanania said.

It consisted of a series of live half-day meetings conducted over a 3-month period that included short lectures, a video on correct use of inhaler devices, and small-group workshops that incorporated detailed case discussions and hands-on demonstrations and practice in the use of spirometry.

A total of 769 physicians attended the meetings. The investigators assessed the initiative's effectiveness with a case vignette–based survey, given to a randomly selected subset of 50 participants and 50 nonparticipants with similar demographics and practice characteristics.

The number of patients with COPD seen weekly was 11 for participants and 15 for nonparticipants. The mean number of years in practice was 28 and 24, respectively. And both groups were about equally divided between family physicians and internal medicine physicians. Participants were somewhat more likely to be in solo practice (45% vs. 38%) or work in a government facility (25% vs. 0%), and less likely to be in group practice (31% vs. 58%).

Survey results showed that in the area of diagnosis, the participants were more likely than the nonparticipants to recognize COPD in case vignettes of patients with dyspnea (90% vs. 74%, P = .007) and to be aware of the greater susceptibility of women compared with men to the harmful effects of smoking (90% vs. 54%, P less than .001).

Also, when asked which of several pathophysiologic features was one of COPD, participants were more likely to correctly answer alveolar destruction (94% vs. 74%, P = .007). (The other options were muscular deconditioning, synovial inflammation, and increased ventricular filling pressure.)

While the groups did not differ significantly in terms of how likely they were to use spirometry for diagnosis and staging of COPD, participants were more likely than nonparticipants to indicate that difficulty in obtaining spirometry results in the office setting was a very significant barrier to COPD management (27% vs. 12%). “Maybe they acknowledged that it is an important tool, but they cannot do it,” he commented.

The groups were statistically indistinguishable with respect to their approaches to caring for patients with repeated exacerbations and improving adherence, and their selection of appropriate maintenance therapy.

The survey also asked about barriers to managing COPD, according to Dr. Hanania.

In addition to difficulty with spirometry, the groups were similarly likely to rate as very significant a patient's nonadherence to a recommendation to stop smoking, the complexity of the medical regimen, and a lack of clarity about the staging of COPD severity.

A calculation of the initiative's quality of education index showed that participants were 50% more likely than nonparticipants to provide evidence-based, guideline-driven COPD care, Dr. Hanania reported. “We estimate that participation in this half-day program can potentially improve the care of many patients per week, but this needs to be further tested,” he commented.

“We did not attempt to look at long-term [outcomes] – retention of knowledge or practice change – which are very important,” Dr. Hanania acknowledged. But a similar, ongoing initiative, being conducted by the ACCP, is currently assessing impact on real-life practice.

That initiative is including not only physicians but also physician assistants and nurse practitioners, Dr. Hanania said. “In our primary care setting in the U.S., nonphysician extenders – PAs, nurse practitioners – play a major role in encountering COPD, and those are people we like to target.” Furthermore, their role will likely increase if health care reform proceeds and primary care physicians are overwhelmed by demand.

The initiative meetings were supported by an educational grant from Novartis Pharmaceuticals. Dr. Hanania had no relevant conflicts of interest.

Participants were 50% more likely than nonparticipants to provide evidence-based, guideline-driven COPD care.

Source DR. HANANIA

WASHINGTON — For the first time, there is evidence of immediate and direct harm done by smoking even one cigarette, according to the 30th annual United States Surgeon General's Office report on smoking, issued Dec. 9.

Surgeon General Regina M. Benjamin said at a press briefing that previous reports from her office honed in on the various diseases that smoking could cause. “This report focuses on how tobacco smoke causes damage to every organ in your body,” she said.

When asked why this report could make a difference when so many previous warnings have not convinced all Americans to quit smoking, Dr. Benjamin said that she thinks that the direct evidence of harm will personalize the message.

“I believe it's very important that every American knows what's happening in their bodies, particularly those who are trying to quit.” She said it might be helpful for people to know the various biological reasons why quitting is so hard.

Dr. Benjamin said she knew that even President Obama was trying very hard to quit and that she'd told him about the new findings.

The 700-page “Report of the Surgeon General: How Tobacco Smoke Causes Disease: The Biology and Behavioral Basis for Smoking-Attributable Disease” determined that tobacco smoke contains 7,000 chemicals, hundreds of which are known to be toxic and 70 of which are carcinogenic, she noted.

The report describes multiple insults to the body from those chemicals, including changes in DNA that can lead to cancer; damage to the lining of the lungs; obstructive pulmonary disease and bronchitis; stress on the vasculature and cardiovascular disease; and an increased risk of heart attack, stroke, and aortic aneurysm.

Smoking also interferes with the effectiveness of chemotherapy and the control of blood sugar and leads to fertility problems, including difficulty conceiving, miscarriage, and preterm birth. Just one cigarette can trigger a heart attack or stroke, she said.

In addition, the report examined the effects of secondhand smoke, finding that even brief exposure can cause cardiovascular disease and can also trigger acute cardiac events, such as heart attack. Babies exposed to secondhand smoke are more likely to die of sudden infant death syndrome.

The report highlights the increasingly addictive properties of today's cigarettes, many of which are designed to enhance nicotine absorption and its crossing of the blood-brain barrier, Dr. Benjamin said. Some cigarettes also allow smokers to inhale more deeply into the lungs, increasing the disease risk.

Department of Health and Human Services Secretary Kathleen Sebelius said at the briefing that the report shows that “there is no safe level of exposure to tobacco smoke,” and, she added, “If you're a smoker, the best time to quit is right now.”

John R. Seffrin, Ph.D., CEO of the American Cancer Society Cancer Action Network, agreed. “Today's report makes it clear, once again, that there is no such thing as a safe cigarette and no such thing as a safe level of exposure to secondhand smoke for nonsmokers,” he said in a statement.

Ms. Sebelius noted that, every day, 4,000 Americans under the age of 18 years try their first cigarette, and that 1,000 of them become daily smokers. Some 1,200 Americans die every day as a result of tobacco-related causes, she said, and the report is part of the Obama administration's ongoing strategy to completely eliminate tobacco use.

Smoking rates declined until 2003, but since that time the rate has plateaued, with 20% of adults admitting they currently smoke. The administration has launched a multipronged attack, including giving the Food and Drug Administration the power to regulate tobacco and increasing funding to state and local programs for intervention and outreach programs. Medicare and the Federal Employees Health Benefits Program both now offer coverage of tobacco-cessation strategies, Ms. Sebelius said.

Tobacco-related disease is a big reason why America is less healthy than other countries, and that has consequences. “If we're a less healthy nation, we're not competitive in a global economy,” she added.

The Surgeon General's report is available at www.surgeongeneral.gov.

The report focuses on smoking's effects only on adults. The office is working on another report on adolescents and teenagers, Dr. Benjamin said.

WASHINGTON — For the first time, there is evidence of immediate and direct harm done by smoking even one cigarette, according to the 30th annual United States Surgeon General's Office report on smoking, issued Dec. 9.

Surgeon General Regina M. Benjamin said at a press briefing that previous reports from her office honed in on the various diseases that smoking could cause. “This report focuses on how tobacco smoke causes damage to every organ in your body,” she said.

When asked why this report could make a difference when so many previous warnings have not convinced all Americans to quit smoking, Dr. Benjamin said that she thinks that the direct evidence of harm will personalize the message.

“I believe it's very important that every American knows what's happening in their bodies, particularly those who are trying to quit.” She said it might be helpful for people to know the various biological reasons why quitting is so hard.

Dr. Benjamin said she knew that even President Obama was trying very hard to quit and that she'd told him about the new findings.

The 700-page “Report of the Surgeon General: How Tobacco Smoke Causes Disease: The Biology and Behavioral Basis for Smoking-Attributable Disease” determined that tobacco smoke contains 7,000 chemicals, hundreds of which are known to be toxic and 70 of which are carcinogenic, she noted.

The report describes multiple insults to the body from those chemicals, including changes in DNA that can lead to cancer; damage to the lining of the lungs; obstructive pulmonary disease and bronchitis; stress on the vasculature and cardiovascular disease; and an increased risk of heart attack, stroke, and aortic aneurysm.

Smoking also interferes with the effectiveness of chemotherapy and the control of blood sugar and leads to fertility problems, including difficulty conceiving, miscarriage, and preterm birth. Just one cigarette can trigger a heart attack or stroke, she said.

In addition, the report examined the effects of secondhand smoke, finding that even brief exposure can cause cardiovascular disease and can also trigger acute cardiac events, such as heart attack. Babies exposed to secondhand smoke are more likely to die of sudden infant death syndrome.

The report highlights the increasingly addictive properties of today's cigarettes, many of which are designed to enhance nicotine absorption and its crossing of the blood-brain barrier, Dr. Benjamin said. Some cigarettes also allow smokers to inhale more deeply into the lungs, increasing the disease risk.

Department of Health and Human Services Secretary Kathleen Sebelius said at the briefing that the report shows that “there is no safe level of exposure to tobacco smoke,” and, she added, “If you're a smoker, the best time to quit is right now.”

John R. Seffrin, Ph.D., CEO of the American Cancer Society Cancer Action Network, agreed. “Today's report makes it clear, once again, that there is no such thing as a safe cigarette and no such thing as a safe level of exposure to secondhand smoke for nonsmokers,” he said in a statement.

Ms. Sebelius noted that, every day, 4,000 Americans under the age of 18 years try their first cigarette, and that 1,000 of them become daily smokers. Some 1,200 Americans die every day as a result of tobacco-related causes, she said, and the report is part of the Obama administration's ongoing strategy to completely eliminate tobacco use.

Smoking rates declined until 2003, but since that time the rate has plateaued, with 20% of adults admitting they currently smoke. The administration has launched a multipronged attack, including giving the Food and Drug Administration the power to regulate tobacco and increasing funding to state and local programs for intervention and outreach programs. Medicare and the Federal Employees Health Benefits Program both now offer coverage of tobacco-cessation strategies, Ms. Sebelius said.

Tobacco-related disease is a big reason why America is less healthy than other countries, and that has consequences. “If we're a less healthy nation, we're not competitive in a global economy,” she added.

The Surgeon General's report is available at www.surgeongeneral.gov.

The report focuses on smoking's effects only on adults. The office is working on another report on adolescents and teenagers, Dr. Benjamin said.

WASHINGTON — For the first time, there is evidence of immediate and direct harm done by smoking even one cigarette, according to the 30th annual United States Surgeon General's Office report on smoking, issued Dec. 9.

Surgeon General Regina M. Benjamin said at a press briefing that previous reports from her office honed in on the various diseases that smoking could cause. “This report focuses on how tobacco smoke causes damage to every organ in your body,” she said.

When asked why this report could make a difference when so many previous warnings have not convinced all Americans to quit smoking, Dr. Benjamin said that she thinks that the direct evidence of harm will personalize the message.

“I believe it's very important that every American knows what's happening in their bodies, particularly those who are trying to quit.” She said it might be helpful for people to know the various biological reasons why quitting is so hard.

Dr. Benjamin said she knew that even President Obama was trying very hard to quit and that she'd told him about the new findings.

The 700-page “Report of the Surgeon General: How Tobacco Smoke Causes Disease: The Biology and Behavioral Basis for Smoking-Attributable Disease” determined that tobacco smoke contains 7,000 chemicals, hundreds of which are known to be toxic and 70 of which are carcinogenic, she noted.

The report describes multiple insults to the body from those chemicals, including changes in DNA that can lead to cancer; damage to the lining of the lungs; obstructive pulmonary disease and bronchitis; stress on the vasculature and cardiovascular disease; and an increased risk of heart attack, stroke, and aortic aneurysm.

Smoking also interferes with the effectiveness of chemotherapy and the control of blood sugar and leads to fertility problems, including difficulty conceiving, miscarriage, and preterm birth. Just one cigarette can trigger a heart attack or stroke, she said.

In addition, the report examined the effects of secondhand smoke, finding that even brief exposure can cause cardiovascular disease and can also trigger acute cardiac events, such as heart attack. Babies exposed to secondhand smoke are more likely to die of sudden infant death syndrome.

The report highlights the increasingly addictive properties of today's cigarettes, many of which are designed to enhance nicotine absorption and its crossing of the blood-brain barrier, Dr. Benjamin said. Some cigarettes also allow smokers to inhale more deeply into the lungs, increasing the disease risk.

Department of Health and Human Services Secretary Kathleen Sebelius said at the briefing that the report shows that “there is no safe level of exposure to tobacco smoke,” and, she added, “If you're a smoker, the best time to quit is right now.”

John R. Seffrin, Ph.D., CEO of the American Cancer Society Cancer Action Network, agreed. “Today's report makes it clear, once again, that there is no such thing as a safe cigarette and no such thing as a safe level of exposure to secondhand smoke for nonsmokers,” he said in a statement.

Ms. Sebelius noted that, every day, 4,000 Americans under the age of 18 years try their first cigarette, and that 1,000 of them become daily smokers. Some 1,200 Americans die every day as a result of tobacco-related causes, she said, and the report is part of the Obama administration's ongoing strategy to completely eliminate tobacco use.

Smoking rates declined until 2003, but since that time the rate has plateaued, with 20% of adults admitting they currently smoke. The administration has launched a multipronged attack, including giving the Food and Drug Administration the power to regulate tobacco and increasing funding to state and local programs for intervention and outreach programs. Medicare and the Federal Employees Health Benefits Program both now offer coverage of tobacco-cessation strategies, Ms. Sebelius said.

Tobacco-related disease is a big reason why America is less healthy than other countries, and that has consequences. “If we're a less healthy nation, we're not competitive in a global economy,” she added.

The Surgeon General's report is available at www.surgeongeneral.gov.

The report focuses on smoking's effects only on adults. The office is working on another report on adolescents and teenagers, Dr. Benjamin said.

NEW YORK – A standardized extract of American ginseng (Panax quinquefolium) has been shown to be safe and effective in reducing the incidence and severity of acute respiratory infections among both community-dwelling and institutionalized elderly people.

However, the same product was not effective in decreasing respiratory infections among people with chronic lymphocytic leukemia (CLL), a condition that leaves patients particularly vulnerable to influenza and other acute respiratory infections (ARIs), reported Dr. Edward G. Shaw at an international conference sponsored by the Society for Integrative Oncology.

The promising findings from three studies among otherwise healthy elderly individuals led to the hope that this particular extract, known as CVT-E002 and marketed as an over-the-counter product called COLD-FX, might be similarly effective in patients with CLL, said Dr. Shaw of the Comprehensive Cancer Center, Wake Forest University, Winston-Salem, N.C.

CLL is the most common adult form of leukemia, affecting roughly 20/100,000 Americans. Because of the associated anemia, thrombocytopenia, and compromised immune system function, CLL survivors are at substantially increased risk of infections, especially respiratory infections. Common drug therapies like chlorambucil and fluorouracil increase this risk.

"There is a pressing need for effective, relatively low-cost interventions to reduce infection risk in CCL patients," Dr. Shaw said.

Panax ginseng is a reasonable botanical candidate for that job. Although it is indigenous to the United States and Canada, it is commonly used in traditional Chinese medicine and other Asian healing traditions. It is widely promoted as an immune system booster, and a number of preclinical and clinical studies support this claim.

The CVT-E002 extract, marketed by Afexa Life Sciences, is standardized to provide consistent doses of immunologically active compounds poly-furanosyl-pyranosyl-saccharides, which enhance natural killer cell activity, Dr. Shaw said. It is the only American ginseng extract that has been granted investigational new drug clearance by the U.S. Food and Drug Administration.

In 2004, Dr. Janet McElhaney of Eastern Virginia Medical School, Norfolk, published data from two studies of 89 and 109 people (mean age, 81 and 83.5 years, respectively) in nursing home and assisted living settings. The subjects were randomized to the ginseng extract (200 mg twice daily) or to placebo. The first trial lasted 8 weeks, and the second ran for 12. In both study cohorts, upward of 90% of the subjects had been vaccinated against influenza infections.

An episode of ARI was defined as two or more concurrent respiratory symptoms or one respiratory plus one constitutional symptom. Infectious diagnoses were confirmed by culture and serology.

Using an intent-to-treat analysis, Dr. McElhaney and her colleagues pooled the data from the two distinct trials. They found that lab-confirmed influenza was more common among the placebo group (seven cases in 101 subjects), compared with the ginseng-treated group (one case in 97 subjects). Incidence of influenza and respiratory syncytial virus infections combined was also higher in the placebo vs. the ginseng group (nine cases vs. one case). These differences were statistically significant (J. Am. Geriatr. Soc. 2004;52:13-9).

Interestingly, the investigators found no difference between the active treatment and placebo groups in terms of subjective reporting of ARI symptoms; roughly one-third of the people in each group reported ARI episodes, though the incidence of actual lab-confirmed infections was far lower.

Approximately 90% of the subjects in both groups reported adverse effects, the most common being gastrointestinal related. A total of 8% of the placebo group and 4% of the ginseng group required hospitalization, but none of these admissions was related to the study medications.

In 2006, Dr. McElhaney – now at the Center for Immunotherapy of Cancer and Infectious Diseases, University of Connecticut, Farmington – published a trial of the same COLD-FX ginseng formula vs. placebo in a cohort of 43 community-dwelling adults aged 65 years and older. As in the previous trial, the ginseng dose was two 200-mg extract capsules daily, for a period of 4 months. After the first month of the trial, all subjects in both groups were immunized against influenza.

The investigators observed a significant reduction in episodes of ARI during November and December, the closing months of the trial. Of the placebo-treated group, 62% had an ARI episode, compared with 32% among those taking the CV-E002 extract. Duration of symptoms was also considerably longer in the placebo group (12.6 days vs. 5.6 days). Lab confirmation of infection was not done in this study (J. Altern. Complement. Med. 2006;12:153-7).

Adverse effects were few in both groups, and there was no significant difference between them. All of these studies were funded in part by CV Technologies, the company that manufactures the CVT-E002 extract.

These data, along with positive results from a Canadian study (CMAJ 2005;173:1043-8), prompted the Wake Forest group to look at the potential of the ginseng extract to reduce infection risk in CLL patients.

A total of 293 untreated CLL patients were randomized to take COLD-FX, 200 mg twice daily, or matching placebo for 3 months. The patients were instructed to keep a daily record of ARI symptoms in written diaries and to rate their symptoms on a 0-3 scale of severity. Subjects also recorded activity limitations, episodes of fever, and antibiotic use.

The patients had a mean age in the mid-60s; 75% of the active treatment group and 78% of the placebo group had been vaccinated against influenza. The investigators excluded people with HIV, cirrhosis, cardiovascular disease, multiple sclerosis, other malignancies, and liver enzyme abnormalities. They also excluded people on immunomodulatory drugs, hematopoietic stem cell recipients, and those on corticosteroids, antibiotics, or warfarin.

Of all subjects, 53% had an ARI during the study period from January to March. On average, ARI days occurred at a rate of 0.1/patient-day. Put another way, 1 of every 10 days is an ARI day for these patients, Dr. Shaw explained. Since only about half of the subjects actually had ARIs, this means that for them 1 out of every 5 days is an ARI symptom day.

Overall, there were no major differences between the treatment and placebo groups in terms of the primary study end points. In the ginseng-treated group, 50% had at least one ARI episode, compared with 55% in the placebo group, but this difference was not statistically significant.

In terms of symptom duration, the ginseng group had a mean total of 8.9 ARI days vs. 6.9 days, but this difference was also deemed not statistically significant.

There were no differences in use of antibiotics or other secondary end points. While there was a trend toward lower incidence of moderate to severe ARIs in patients taking the ginseng supplement (31% vs. 39%), it did not reach significance.

In terms of adverse events, there were 13 "serious" episodes in the ginseng group versus 27 in the placebo group. Diarrhea, dizziness, hyperglycemia, and joint pain were among the most common reported adverse effects, but these were rare, and only 2 of the 40 episodes were considered "possibly related to the treatment."

Both the ginseng-treated and placebo-treated groups showed a mean increase in total white blood cells, with the increase being slightly higher in the placebo group. However, both groups showed a decrease in absolute neutrophil counts. Peripheral blood CD4 cell counts decreased in the active treatment group but increased in the placebo group. None of these differences were statistically or clinically significant.

The study was funded by the National Cancer Institute and Afexa Life Sciences.

The researchers said they did not know why the ginseng extract failed to produce the expected reductions in ARI among these CLL patients, but suggested that it may be a dosing issue. "We went with the dose used in the previous studies of healthy elderly, noncancer patients. It might not have been enough for CLL patients with impaired immune function." Dr. Shaw added that dose-escalation studies are in the works.

NEW YORK – A standardized extract of American ginseng (Panax quinquefolium) has been shown to be safe and effective in reducing the incidence and severity of acute respiratory infections among both community-dwelling and institutionalized elderly people.

However, the same product was not effective in decreasing respiratory infections among people with chronic lymphocytic leukemia (CLL), a condition that leaves patients particularly vulnerable to influenza and other acute respiratory infections (ARIs), reported Dr. Edward G. Shaw at an international conference sponsored by the Society for Integrative Oncology.

The promising findings from three studies among otherwise healthy elderly individuals led to the hope that this particular extract, known as CVT-E002 and marketed as an over-the-counter product called COLD-FX, might be similarly effective in patients with CLL, said Dr. Shaw of the Comprehensive Cancer Center, Wake Forest University, Winston-Salem, N.C.

CLL is the most common adult form of leukemia, affecting roughly 20/100,000 Americans. Because of the associated anemia, thrombocytopenia, and compromised immune system function, CLL survivors are at substantially increased risk of infections, especially respiratory infections. Common drug therapies like chlorambucil and fluorouracil increase this risk.

"There is a pressing need for effective, relatively low-cost interventions to reduce infection risk in CCL patients," Dr. Shaw said.

Panax ginseng is a reasonable botanical candidate for that job. Although it is indigenous to the United States and Canada, it is commonly used in traditional Chinese medicine and other Asian healing traditions. It is widely promoted as an immune system booster, and a number of preclinical and clinical studies support this claim.

The CVT-E002 extract, marketed by Afexa Life Sciences, is standardized to provide consistent doses of immunologically active compounds poly-furanosyl-pyranosyl-saccharides, which enhance natural killer cell activity, Dr. Shaw said. It is the only American ginseng extract that has been granted investigational new drug clearance by the U.S. Food and Drug Administration.

In 2004, Dr. Janet McElhaney of Eastern Virginia Medical School, Norfolk, published data from two studies of 89 and 109 people (mean age, 81 and 83.5 years, respectively) in nursing home and assisted living settings. The subjects were randomized to the ginseng extract (200 mg twice daily) or to placebo. The first trial lasted 8 weeks, and the second ran for 12. In both study cohorts, upward of 90% of the subjects had been vaccinated against influenza infections.

An episode of ARI was defined as two or more concurrent respiratory symptoms or one respiratory plus one constitutional symptom. Infectious diagnoses were confirmed by culture and serology.

Using an intent-to-treat analysis, Dr. McElhaney and her colleagues pooled the data from the two distinct trials. They found that lab-confirmed influenza was more common among the placebo group (seven cases in 101 subjects), compared with the ginseng-treated group (one case in 97 subjects). Incidence of influenza and respiratory syncytial virus infections combined was also higher in the placebo vs. the ginseng group (nine cases vs. one case). These differences were statistically significant (J. Am. Geriatr. Soc. 2004;52:13-9).

Interestingly, the investigators found no difference between the active treatment and placebo groups in terms of subjective reporting of ARI symptoms; roughly one-third of the people in each group reported ARI episodes, though the incidence of actual lab-confirmed infections was far lower.

Approximately 90% of the subjects in both groups reported adverse effects, the most common being gastrointestinal related. A total of 8% of the placebo group and 4% of the ginseng group required hospitalization, but none of these admissions was related to the study medications.

In 2006, Dr. McElhaney – now at the Center for Immunotherapy of Cancer and Infectious Diseases, University of Connecticut, Farmington – published a trial of the same COLD-FX ginseng formula vs. placebo in a cohort of 43 community-dwelling adults aged 65 years and older. As in the previous trial, the ginseng dose was two 200-mg extract capsules daily, for a period of 4 months. After the first month of the trial, all subjects in both groups were immunized against influenza.

The investigators observed a significant reduction in episodes of ARI during November and December, the closing months of the trial. Of the placebo-treated group, 62% had an ARI episode, compared with 32% among those taking the CV-E002 extract. Duration of symptoms was also considerably longer in the placebo group (12.6 days vs. 5.6 days). Lab confirmation of infection was not done in this study (J. Altern. Complement. Med. 2006;12:153-7).

Adverse effects were few in both groups, and there was no significant difference between them. All of these studies were funded in part by CV Technologies, the company that manufactures the CVT-E002 extract.

These data, along with positive results from a Canadian study (CMAJ 2005;173:1043-8), prompted the Wake Forest group to look at the potential of the ginseng extract to reduce infection risk in CLL patients.

A total of 293 untreated CLL patients were randomized to take COLD-FX, 200 mg twice daily, or matching placebo for 3 months. The patients were instructed to keep a daily record of ARI symptoms in written diaries and to rate their symptoms on a 0-3 scale of severity. Subjects also recorded activity limitations, episodes of fever, and antibiotic use.

The patients had a mean age in the mid-60s; 75% of the active treatment group and 78% of the placebo group had been vaccinated against influenza. The investigators excluded people with HIV, cirrhosis, cardiovascular disease, multiple sclerosis, other malignancies, and liver enzyme abnormalities. They also excluded people on immunomodulatory drugs, hematopoietic stem cell recipients, and those on corticosteroids, antibiotics, or warfarin.

Of all subjects, 53% had an ARI during the study period from January to March. On average, ARI days occurred at a rate of 0.1/patient-day. Put another way, 1 of every 10 days is an ARI day for these patients, Dr. Shaw explained. Since only about half of the subjects actually had ARIs, this means that for them 1 out of every 5 days is an ARI symptom day.

Overall, there were no major differences between the treatment and placebo groups in terms of the primary study end points. In the ginseng-treated group, 50% had at least one ARI episode, compared with 55% in the placebo group, but this difference was not statistically significant.

In terms of symptom duration, the ginseng group had a mean total of 8.9 ARI days vs. 6.9 days, but this difference was also deemed not statistically significant.

There were no differences in use of antibiotics or other secondary end points. While there was a trend toward lower incidence of moderate to severe ARIs in patients taking the ginseng supplement (31% vs. 39%), it did not reach significance.

In terms of adverse events, there were 13 "serious" episodes in the ginseng group versus 27 in the placebo group. Diarrhea, dizziness, hyperglycemia, and joint pain were among the most common reported adverse effects, but these were rare, and only 2 of the 40 episodes were considered "possibly related to the treatment."

Both the ginseng-treated and placebo-treated groups showed a mean increase in total white blood cells, with the increase being slightly higher in the placebo group. However, both groups showed a decrease in absolute neutrophil counts. Peripheral blood CD4 cell counts decreased in the active treatment group but increased in the placebo group. None of these differences were statistically or clinically significant.

The study was funded by the National Cancer Institute and Afexa Life Sciences.

The researchers said they did not know why the ginseng extract failed to produce the expected reductions in ARI among these CLL patients, but suggested that it may be a dosing issue. "We went with the dose used in the previous studies of healthy elderly, noncancer patients. It might not have been enough for CLL patients with impaired immune function." Dr. Shaw added that dose-escalation studies are in the works.

NEW YORK – A standardized extract of American ginseng (Panax quinquefolium) has been shown to be safe and effective in reducing the incidence and severity of acute respiratory infections among both community-dwelling and institutionalized elderly people.

However, the same product was not effective in decreasing respiratory infections among people with chronic lymphocytic leukemia (CLL), a condition that leaves patients particularly vulnerable to influenza and other acute respiratory infections (ARIs), reported Dr. Edward G. Shaw at an international conference sponsored by the Society for Integrative Oncology.

The promising findings from three studies among otherwise healthy elderly individuals led to the hope that this particular extract, known as CVT-E002 and marketed as an over-the-counter product called COLD-FX, might be similarly effective in patients with CLL, said Dr. Shaw of the Comprehensive Cancer Center, Wake Forest University, Winston-Salem, N.C.

CLL is the most common adult form of leukemia, affecting roughly 20/100,000 Americans. Because of the associated anemia, thrombocytopenia, and compromised immune system function, CLL survivors are at substantially increased risk of infections, especially respiratory infections. Common drug therapies like chlorambucil and fluorouracil increase this risk.

"There is a pressing need for effective, relatively low-cost interventions to reduce infection risk in CCL patients," Dr. Shaw said.

Panax ginseng is a reasonable botanical candidate for that job. Although it is indigenous to the United States and Canada, it is commonly used in traditional Chinese medicine and other Asian healing traditions. It is widely promoted as an immune system booster, and a number of preclinical and clinical studies support this claim.

The CVT-E002 extract, marketed by Afexa Life Sciences, is standardized to provide consistent doses of immunologically active compounds poly-furanosyl-pyranosyl-saccharides, which enhance natural killer cell activity, Dr. Shaw said. It is the only American ginseng extract that has been granted investigational new drug clearance by the U.S. Food and Drug Administration.

In 2004, Dr. Janet McElhaney of Eastern Virginia Medical School, Norfolk, published data from two studies of 89 and 109 people (mean age, 81 and 83.5 years, respectively) in nursing home and assisted living settings. The subjects were randomized to the ginseng extract (200 mg twice daily) or to placebo. The first trial lasted 8 weeks, and the second ran for 12. In both study cohorts, upward of 90% of the subjects had been vaccinated against influenza infections.

An episode of ARI was defined as two or more concurrent respiratory symptoms or one respiratory plus one constitutional symptom. Infectious diagnoses were confirmed by culture and serology.

Using an intent-to-treat analysis, Dr. McElhaney and her colleagues pooled the data from the two distinct trials. They found that lab-confirmed influenza was more common among the placebo group (seven cases in 101 subjects), compared with the ginseng-treated group (one case in 97 subjects). Incidence of influenza and respiratory syncytial virus infections combined was also higher in the placebo vs. the ginseng group (nine cases vs. one case). These differences were statistically significant (J. Am. Geriatr. Soc. 2004;52:13-9).

Interestingly, the investigators found no difference between the active treatment and placebo groups in terms of subjective reporting of ARI symptoms; roughly one-third of the people in each group reported ARI episodes, though the incidence of actual lab-confirmed infections was far lower.

Approximately 90% of the subjects in both groups reported adverse effects, the most common being gastrointestinal related. A total of 8% of the placebo group and 4% of the ginseng group required hospitalization, but none of these admissions was related to the study medications.

In 2006, Dr. McElhaney – now at the Center for Immunotherapy of Cancer and Infectious Diseases, University of Connecticut, Farmington – published a trial of the same COLD-FX ginseng formula vs. placebo in a cohort of 43 community-dwelling adults aged 65 years and older. As in the previous trial, the ginseng dose was two 200-mg extract capsules daily, for a period of 4 months. After the first month of the trial, all subjects in both groups were immunized against influenza.

The investigators observed a significant reduction in episodes of ARI during November and December, the closing months of the trial. Of the placebo-treated group, 62% had an ARI episode, compared with 32% among those taking the CV-E002 extract. Duration of symptoms was also considerably longer in the placebo group (12.6 days vs. 5.6 days). Lab confirmation of infection was not done in this study (J. Altern. Complement. Med. 2006;12:153-7).

Adverse effects were few in both groups, and there was no significant difference between them. All of these studies were funded in part by CV Technologies, the company that manufactures the CVT-E002 extract.

These data, along with positive results from a Canadian study (CMAJ 2005;173:1043-8), prompted the Wake Forest group to look at the potential of the ginseng extract to reduce infection risk in CLL patients.

A total of 293 untreated CLL patients were randomized to take COLD-FX, 200 mg twice daily, or matching placebo for 3 months. The patients were instructed to keep a daily record of ARI symptoms in written diaries and to rate their symptoms on a 0-3 scale of severity. Subjects also recorded activity limitations, episodes of fever, and antibiotic use.

The patients had a mean age in the mid-60s; 75% of the active treatment group and 78% of the placebo group had been vaccinated against influenza. The investigators excluded people with HIV, cirrhosis, cardiovascular disease, multiple sclerosis, other malignancies, and liver enzyme abnormalities. They also excluded people on immunomodulatory drugs, hematopoietic stem cell recipients, and those on corticosteroids, antibiotics, or warfarin.

Of all subjects, 53% had an ARI during the study period from January to March. On average, ARI days occurred at a rate of 0.1/patient-day. Put another way, 1 of every 10 days is an ARI day for these patients, Dr. Shaw explained. Since only about half of the subjects actually had ARIs, this means that for them 1 out of every 5 days is an ARI symptom day.

Overall, there were no major differences between the treatment and placebo groups in terms of the primary study end points. In the ginseng-treated group, 50% had at least one ARI episode, compared with 55% in the placebo group, but this difference was not statistically significant.

In terms of symptom duration, the ginseng group had a mean total of 8.9 ARI days vs. 6.9 days, but this difference was also deemed not statistically significant.

There were no differences in use of antibiotics or other secondary end points. While there was a trend toward lower incidence of moderate to severe ARIs in patients taking the ginseng supplement (31% vs. 39%), it did not reach significance.

In terms of adverse events, there were 13 "serious" episodes in the ginseng group versus 27 in the placebo group. Diarrhea, dizziness, hyperglycemia, and joint pain were among the most common reported adverse effects, but these were rare, and only 2 of the 40 episodes were considered "possibly related to the treatment."

Both the ginseng-treated and placebo-treated groups showed a mean increase in total white blood cells, with the increase being slightly higher in the placebo group. However, both groups showed a decrease in absolute neutrophil counts. Peripheral blood CD4 cell counts decreased in the active treatment group but increased in the placebo group. None of these differences were statistically or clinically significant.

The study was funded by the National Cancer Institute and Afexa Life Sciences.

The researchers said they did not know why the ginseng extract failed to produce the expected reductions in ARI among these CLL patients, but suggested that it may be a dosing issue. "We went with the dose used in the previous studies of healthy elderly, noncancer patients. It might not have been enough for CLL patients with impaired immune function." Dr. Shaw added that dose-escalation studies are in the works.

VANCOUVER, B.C. – Chest physicians must consider a slew of diagnostic possibilities when evaluating patients with rheumatoid arthritis who have developed pulmonary abnormalities, according to Dr. Kevin R. Flaherty.

"We have to keep in mind all the different things that can go wrong in these patients when we are trying to treat them: Is this progression of the underlying disease? Is this a complication of the therapy? Or is this the development of something new, like a cancer, that’s now causing the patient’s symptoms?" he commented.

"Trying to keep all those things in our mind to sort that out is difficult, and it’s an exercise that we have to go through each and every time we see one of these patients," he told attendees at the annual meeting of the American College of Chest Physicians.

Pulmonary Manifestations of RA

"The lung is a common site for extra-articular rheumatoid arthritis," noted Dr. Flaherty, who is a pulmonologist and associate professor at the University of Michigan Health System in Ann Arbor. Of the many pulmonary manifestations of RA, interstitial lung disease causes the greatest morbidity and mortality.

The lifetime risk of interstitial lung disease is nearly 8% in patients with RA, compared with 1% in the general population (Arthritis Rheum. 2010;62:1583-91). And this disease confers a poor prognosis, with a near tripling of the risk of death and with a median survival after diagnosis of only about 2.5 years.

High-resolution computed tomography (HRCT) and pulmonary functioning testing appear to be useful for identifying interstitial lung disease early in its course, according to Dr. Flaherty.

For example, among patients within 2 years of a RA diagnosis, 44% have been found to have HRCT, pulmonary function test, and other abnormalities consistent with interstitial lung disease in the absence of symptoms (Am. J. Respir. Crit. Care Med. 1997;156:528-35).

"The [HRCT] features were mild – reticular thickening, ground glass, and not much honeycombing – suggesting maybe that we might be able to impact the disease, because I think once you get to honeycomb lung and end-stage fibrosis, our ability to impact this disease is likely to be lower," he said.

Another study among patients with recent-onset RA found abnormalities on HRCT but normal results on pulmonary function tests (Scand. J. Rheumatol. 2007;36:338-44), "suggesting that symptoms and pulmonary screening are not going to be as sensitive as HRCT screening."

As for which patients to screen for interstitial lung disease, the predictors of abnormal pulmonary function testing in the RA population are respiratory symptoms, smoking, anti–cyclic citrullinated peptide positivity, and use of prednisone (Arthritis Res. Ther. 2010;12:R104).

When it comes to monitoring interstitial lung disease, HRCT appears to be more sensitive than pulmonary function testing for detecting disease progression (Arch. Intern. Med. 2008;168:159-66). And carbon monoxide diffusing capacity at diagnosis is the best predictor of progression (Ann. Rheum. Dis. 2002;61:517-21).

"We are starting ... to see data emerging that really mirrors what we see in idiopathic lung disease, that the histopathology and the CT appearance can help us in terms of stratifying patients for risk of subsequent mortality," Dr. Flaherty said.

For example, a study of patients with RA-associated interstitial lung disease found 50% mortality in those with a usual interstitial pneumonia (UIP) histology, compared with none in those with a nonspecific interstitial pneumonia (NSIP) histology after a similar median follow-up of about 4 years (Chest 2005;127:2019-27).

A honeycomb pattern on HRCT was found only in the UIP group, suggesting that this radiographic pattern is a good surrogate for this histology, Dr. Flaherty noted. And indeed, patients having a definite UIP radiographic appearance have poorer survival (Eur. Respir. J. 2010;35:1322-8).

Rigorous studies are lacking when it comes to treating interstitial lung disease in the RA population, according to Dr. Flaherty. Case reports, case series, and retrospective analyses have assessed many immunomodulating and immunosuppressive agents, but "what we are really begging for are some prospective, well done clinical trials to help us sort all of these potential treatments out," he said.

Pulmonary Adverse Effects of RA Therapy

Pneumonitis is often a concern in patients using methotrexate to treat RA. But with low-dose therapy, only 3% of patients develop this complication after a mean treatment duration of 23 months (Chest 1996;109:933-8). "So we worry about it, but yet it’s actually a very small number of patients that develop methotrexate toxicity," Dr. Flaherty pointed out.

Anti–tumor necrosis factor (TNF) agents such as infliximab have been associated with pulmonary adverse effects and complications, including infection, atypical presentation of tuberculosis, and pulmonary fibrosis. With the last, "patients have cough and dyspnea, it can occur within months of initiating treatment, and it can be associated with high mortality," he said.

Some reports have also raised concern that anti-TNF agents may hasten progression of interstitial lung disease in patients with RA and thus increase mortality.

"The data on that are still out," Dr. Flaherty said. Evidence thus far suggests that mortality in patients treated with these agents is similar to that in their counterparts treated with traditional disease-modifying antirheumatic drugs (Ann. Rheum. Dis. 2010;69:1086-91).

Rituximab has been linked to severe infections in patients with RA, the largest share of which (40%) are pulmonary (Arthritis Rheum. 2010;62:2625-32). Only a single infection was opportunistic, and most were bacterial.

Pulmonary Cancers

Patients with RA have increased risk of lung cancer (standardized incidence ratio, 1.63) as well as for another malignancy that can involve the lung, lymphoma (Arthritis Res. Ther. 2008;10:R45), as a result of their underlying disease, long-term immunosuppression, or both.

Treatment with biologic agents has not been associated with a significantly elevated risk of lung cancer among patients with RA, according to Dr. Flaherty. But treatment with methotrexate has, with the incidence of lung cancer among methotrexate users about triple that of the general population (Arthritis Rheum. 2008;59:794-9). Users of this drug also have sharply increased rates of non-Hodgkin’s lymphoma and melanoma.

"So as we are seeing [patients] with pulmonary manifestations, we have to keep in mind their risk of cancers as well," he recommended.

Dr. Flaherty did not report any disclosures.

VANCOUVER, B.C. – Chest physicians must consider a slew of diagnostic possibilities when evaluating patients with rheumatoid arthritis who have developed pulmonary abnormalities, according to Dr. Kevin R. Flaherty.

"We have to keep in mind all the different things that can go wrong in these patients when we are trying to treat them: Is this progression of the underlying disease? Is this a complication of the therapy? Or is this the development of something new, like a cancer, that’s now causing the patient’s symptoms?" he commented.

"Trying to keep all those things in our mind to sort that out is difficult, and it’s an exercise that we have to go through each and every time we see one of these patients," he told attendees at the annual meeting of the American College of Chest Physicians.

Pulmonary Manifestations of RA

"The lung is a common site for extra-articular rheumatoid arthritis," noted Dr. Flaherty, who is a pulmonologist and associate professor at the University of Michigan Health System in Ann Arbor. Of the many pulmonary manifestations of RA, interstitial lung disease causes the greatest morbidity and mortality.

The lifetime risk of interstitial lung disease is nearly 8% in patients with RA, compared with 1% in the general population (Arthritis Rheum. 2010;62:1583-91). And this disease confers a poor prognosis, with a near tripling of the risk of death and with a median survival after diagnosis of only about 2.5 years.

High-resolution computed tomography (HRCT) and pulmonary functioning testing appear to be useful for identifying interstitial lung disease early in its course, according to Dr. Flaherty.

For example, among patients within 2 years of a RA diagnosis, 44% have been found to have HRCT, pulmonary function test, and other abnormalities consistent with interstitial lung disease in the absence of symptoms (Am. J. Respir. Crit. Care Med. 1997;156:528-35).

"The [HRCT] features were mild – reticular thickening, ground glass, and not much honeycombing – suggesting maybe that we might be able to impact the disease, because I think once you get to honeycomb lung and end-stage fibrosis, our ability to impact this disease is likely to be lower," he said.

Another study among patients with recent-onset RA found abnormalities on HRCT but normal results on pulmonary function tests (Scand. J. Rheumatol. 2007;36:338-44), "suggesting that symptoms and pulmonary screening are not going to be as sensitive as HRCT screening."

As for which patients to screen for interstitial lung disease, the predictors of abnormal pulmonary function testing in the RA population are respiratory symptoms, smoking, anti–cyclic citrullinated peptide positivity, and use of prednisone (Arthritis Res. Ther. 2010;12:R104).

When it comes to monitoring interstitial lung disease, HRCT appears to be more sensitive than pulmonary function testing for detecting disease progression (Arch. Intern. Med. 2008;168:159-66). And carbon monoxide diffusing capacity at diagnosis is the best predictor of progression (Ann. Rheum. Dis. 2002;61:517-21).

"We are starting ... to see data emerging that really mirrors what we see in idiopathic lung disease, that the histopathology and the CT appearance can help us in terms of stratifying patients for risk of subsequent mortality," Dr. Flaherty said.

For example, a study of patients with RA-associated interstitial lung disease found 50% mortality in those with a usual interstitial pneumonia (UIP) histology, compared with none in those with a nonspecific interstitial pneumonia (NSIP) histology after a similar median follow-up of about 4 years (Chest 2005;127:2019-27).

A honeycomb pattern on HRCT was found only in the UIP group, suggesting that this radiographic pattern is a good surrogate for this histology, Dr. Flaherty noted. And indeed, patients having a definite UIP radiographic appearance have poorer survival (Eur. Respir. J. 2010;35:1322-8).

Rigorous studies are lacking when it comes to treating interstitial lung disease in the RA population, according to Dr. Flaherty. Case reports, case series, and retrospective analyses have assessed many immunomodulating and immunosuppressive agents, but "what we are really begging for are some prospective, well done clinical trials to help us sort all of these potential treatments out," he said.

Pulmonary Adverse Effects of RA Therapy

Pneumonitis is often a concern in patients using methotrexate to treat RA. But with low-dose therapy, only 3% of patients develop this complication after a mean treatment duration of 23 months (Chest 1996;109:933-8). "So we worry about it, but yet it’s actually a very small number of patients that develop methotrexate toxicity," Dr. Flaherty pointed out.

Anti–tumor necrosis factor (TNF) agents such as infliximab have been associated with pulmonary adverse effects and complications, including infection, atypical presentation of tuberculosis, and pulmonary fibrosis. With the last, "patients have cough and dyspnea, it can occur within months of initiating treatment, and it can be associated with high mortality," he said.

Some reports have also raised concern that anti-TNF agents may hasten progression of interstitial lung disease in patients with RA and thus increase mortality.

"The data on that are still out," Dr. Flaherty said. Evidence thus far suggests that mortality in patients treated with these agents is similar to that in their counterparts treated with traditional disease-modifying antirheumatic drugs (Ann. Rheum. Dis. 2010;69:1086-91).

Rituximab has been linked to severe infections in patients with RA, the largest share of which (40%) are pulmonary (Arthritis Rheum. 2010;62:2625-32). Only a single infection was opportunistic, and most were bacterial.

Pulmonary Cancers

Patients with RA have increased risk of lung cancer (standardized incidence ratio, 1.63) as well as for another malignancy that can involve the lung, lymphoma (Arthritis Res. Ther. 2008;10:R45), as a result of their underlying disease, long-term immunosuppression, or both.

Treatment with biologic agents has not been associated with a significantly elevated risk of lung cancer among patients with RA, according to Dr. Flaherty. But treatment with methotrexate has, with the incidence of lung cancer among methotrexate users about triple that of the general population (Arthritis Rheum. 2008;59:794-9). Users of this drug also have sharply increased rates of non-Hodgkin’s lymphoma and melanoma.

"So as we are seeing [patients] with pulmonary manifestations, we have to keep in mind their risk of cancers as well," he recommended.

Dr. Flaherty did not report any disclosures.

VANCOUVER, B.C. – Chest physicians must consider a slew of diagnostic possibilities when evaluating patients with rheumatoid arthritis who have developed pulmonary abnormalities, according to Dr. Kevin R. Flaherty.

"We have to keep in mind all the different things that can go wrong in these patients when we are trying to treat them: Is this progression of the underlying disease? Is this a complication of the therapy? Or is this the development of something new, like a cancer, that’s now causing the patient’s symptoms?" he commented.

"Trying to keep all those things in our mind to sort that out is difficult, and it’s an exercise that we have to go through each and every time we see one of these patients," he told attendees at the annual meeting of the American College of Chest Physicians.

Pulmonary Manifestations of RA

"The lung is a common site for extra-articular rheumatoid arthritis," noted Dr. Flaherty, who is a pulmonologist and associate professor at the University of Michigan Health System in Ann Arbor. Of the many pulmonary manifestations of RA, interstitial lung disease causes the greatest morbidity and mortality.

The lifetime risk of interstitial lung disease is nearly 8% in patients with RA, compared with 1% in the general population (Arthritis Rheum. 2010;62:1583-91). And this disease confers a poor prognosis, with a near tripling of the risk of death and with a median survival after diagnosis of only about 2.5 years.

High-resolution computed tomography (HRCT) and pulmonary functioning testing appear to be useful for identifying interstitial lung disease early in its course, according to Dr. Flaherty.

For example, among patients within 2 years of a RA diagnosis, 44% have been found to have HRCT, pulmonary function test, and other abnormalities consistent with interstitial lung disease in the absence of symptoms (Am. J. Respir. Crit. Care Med. 1997;156:528-35).

"The [HRCT] features were mild – reticular thickening, ground glass, and not much honeycombing – suggesting maybe that we might be able to impact the disease, because I think once you get to honeycomb lung and end-stage fibrosis, our ability to impact this disease is likely to be lower," he said.

Another study among patients with recent-onset RA found abnormalities on HRCT but normal results on pulmonary function tests (Scand. J. Rheumatol. 2007;36:338-44), "suggesting that symptoms and pulmonary screening are not going to be as sensitive as HRCT screening."

As for which patients to screen for interstitial lung disease, the predictors of abnormal pulmonary function testing in the RA population are respiratory symptoms, smoking, anti–cyclic citrullinated peptide positivity, and use of prednisone (Arthritis Res. Ther. 2010;12:R104).

When it comes to monitoring interstitial lung disease, HRCT appears to be more sensitive than pulmonary function testing for detecting disease progression (Arch. Intern. Med. 2008;168:159-66). And carbon monoxide diffusing capacity at diagnosis is the best predictor of progression (Ann. Rheum. Dis. 2002;61:517-21).

"We are starting ... to see data emerging that really mirrors what we see in idiopathic lung disease, that the histopathology and the CT appearance can help us in terms of stratifying patients for risk of subsequent mortality," Dr. Flaherty said.

For example, a study of patients with RA-associated interstitial lung disease found 50% mortality in those with a usual interstitial pneumonia (UIP) histology, compared with none in those with a nonspecific interstitial pneumonia (NSIP) histology after a similar median follow-up of about 4 years (Chest 2005;127:2019-27).

A honeycomb pattern on HRCT was found only in the UIP group, suggesting that this radiographic pattern is a good surrogate for this histology, Dr. Flaherty noted. And indeed, patients having a definite UIP radiographic appearance have poorer survival (Eur. Respir. J. 2010;35:1322-8).

Rigorous studies are lacking when it comes to treating interstitial lung disease in the RA population, according to Dr. Flaherty. Case reports, case series, and retrospective analyses have assessed many immunomodulating and immunosuppressive agents, but "what we are really begging for are some prospective, well done clinical trials to help us sort all of these potential treatments out," he said.

Pulmonary Adverse Effects of RA Therapy

Pneumonitis is often a concern in patients using methotrexate to treat RA. But with low-dose therapy, only 3% of patients develop this complication after a mean treatment duration of 23 months (Chest 1996;109:933-8). "So we worry about it, but yet it’s actually a very small number of patients that develop methotrexate toxicity," Dr. Flaherty pointed out.

Anti–tumor necrosis factor (TNF) agents such as infliximab have been associated with pulmonary adverse effects and complications, including infection, atypical presentation of tuberculosis, and pulmonary fibrosis. With the last, "patients have cough and dyspnea, it can occur within months of initiating treatment, and it can be associated with high mortality," he said.

Some reports have also raised concern that anti-TNF agents may hasten progression of interstitial lung disease in patients with RA and thus increase mortality.

"The data on that are still out," Dr. Flaherty said. Evidence thus far suggests that mortality in patients treated with these agents is similar to that in their counterparts treated with traditional disease-modifying antirheumatic drugs (Ann. Rheum. Dis. 2010;69:1086-91).

Rituximab has been linked to severe infections in patients with RA, the largest share of which (40%) are pulmonary (Arthritis Rheum. 2010;62:2625-32). Only a single infection was opportunistic, and most were bacterial.

Pulmonary Cancers

Patients with RA have increased risk of lung cancer (standardized incidence ratio, 1.63) as well as for another malignancy that can involve the lung, lymphoma (Arthritis Res. Ther. 2008;10:R45), as a result of their underlying disease, long-term immunosuppression, or both.

Treatment with biologic agents has not been associated with a significantly elevated risk of lung cancer among patients with RA, according to Dr. Flaherty. But treatment with methotrexate has, with the incidence of lung cancer among methotrexate users about triple that of the general population (Arthritis Rheum. 2008;59:794-9). Users of this drug also have sharply increased rates of non-Hodgkin’s lymphoma and melanoma.

"So as we are seeing [patients] with pulmonary manifestations, we have to keep in mind their risk of cancers as well," he recommended.

Dr. Flaherty did not report any disclosures.

Obstructive sleep apnea may be an additional risk factor in the pathogenesis of retinal vein occlusion or a frequently associated condition that could be a triggering factor, researchers said in the December 2010 issue of Archives of Ophthalmology.

Dr. Agnès Glacet-Bernard of Intercommunal and Henri Mondor Hospitals/Assistance Publique des Hôpitaux de Paris, and her colleagues reviewed records of 63 consecutive patients with retinal vein occlusion (RVO) and chose 30 patients with two out of three risk factors for obstructive sleep apnea (OSA) – cardiovascular disease, snoring, and daytime sleepiness with an Epworth Sleepiness Scale score of higher than 10 – to receive further evaluation with respiratory polygraphy.

Twenty-three of the 30 patients (77%) selected for further evaluation had OSA, with a mean apnea-hypopnea index (AHI) of 21.3. Only one patient was previously diagnosed as having OSA. Ten patients required treatment with nasal continuous positive airway pressure with a mask during sleep, the researchers say, but because the treatment occurred several weeks or months after the onset of the RVO, it was impossible to determine whether treatment might play a beneficial role in visual outcome, the researchers say (Arch. Ophthalmol. 2010;128:1533-8).

Assuming the patients not evaluated did not have OSA, the estimated prevalence of OSA in this series of patients with RVO would be 37%. This lower estimate remains higher than the 2%-7% prevalence that is expected in the general population, according to the researchers.

Sleep apnea results in hemodynamic changes that contribute to a cascade of events leading to RVO. "These events may directly affect the retinal microcirculation, or they can act in concert with other predisposing conditions to RVO," the researchers say. "The immediate physiologic effects of OSA involve nocturnal hypoxemia, hypercapnia, and inspiratory efforts."

The study was limited in that researchers used historical control subjects and only evaluated a subset of patients with RVO who were at increased risk for OSA. Further studies are needed to determine if a causal relationship between OSA and RVO, and to determine the exact prevalence of OSA among patients with RVO, they stated.

"This study suggests that OSA, by acting on retinal microcirculation, could be an additional risk factor for the occurrence of RVO or, at least in older patients with a vascular profile, an associated condition that could play a determinant role in the development of RVO and that could act as a triggering factor," the researchers indicated.

"It is too early to know whether OSA treatment could modify the course of RVO or at least prevent its recurrence or the involvement of the second eye. Nevertheless, in clinical practice, it seems vital for the physician to be aware of this association because OSA treatment has demonstrated its efficacy in reducing the risk of cardiovascular and cerebrovascular disease in virtually any patient," they concluded.

The authors reported having no financial disclosures.

Obstructive sleep apnea may be an additional risk factor in the pathogenesis of retinal vein occlusion or a frequently associated condition that could be a triggering factor, researchers said in the December 2010 issue of Archives of Ophthalmology.

Dr. Agnès Glacet-Bernard of Intercommunal and Henri Mondor Hospitals/Assistance Publique des Hôpitaux de Paris, and her colleagues reviewed records of 63 consecutive patients with retinal vein occlusion (RVO) and chose 30 patients with two out of three risk factors for obstructive sleep apnea (OSA) – cardiovascular disease, snoring, and daytime sleepiness with an Epworth Sleepiness Scale score of higher than 10 – to receive further evaluation with respiratory polygraphy.

Twenty-three of the 30 patients (77%) selected for further evaluation had OSA, with a mean apnea-hypopnea index (AHI) of 21.3. Only one patient was previously diagnosed as having OSA. Ten patients required treatment with nasal continuous positive airway pressure with a mask during sleep, the researchers say, but because the treatment occurred several weeks or months after the onset of the RVO, it was impossible to determine whether treatment might play a beneficial role in visual outcome, the researchers say (Arch. Ophthalmol. 2010;128:1533-8).

Assuming the patients not evaluated did not have OSA, the estimated prevalence of OSA in this series of patients with RVO would be 37%. This lower estimate remains higher than the 2%-7% prevalence that is expected in the general population, according to the researchers.

Sleep apnea results in hemodynamic changes that contribute to a cascade of events leading to RVO. "These events may directly affect the retinal microcirculation, or they can act in concert with other predisposing conditions to RVO," the researchers say. "The immediate physiologic effects of OSA involve nocturnal hypoxemia, hypercapnia, and inspiratory efforts."

The study was limited in that researchers used historical control subjects and only evaluated a subset of patients with RVO who were at increased risk for OSA. Further studies are needed to determine if a causal relationship between OSA and RVO, and to determine the exact prevalence of OSA among patients with RVO, they stated.

"This study suggests that OSA, by acting on retinal microcirculation, could be an additional risk factor for the occurrence of RVO or, at least in older patients with a vascular profile, an associated condition that could play a determinant role in the development of RVO and that could act as a triggering factor," the researchers indicated.

"It is too early to know whether OSA treatment could modify the course of RVO or at least prevent its recurrence or the involvement of the second eye. Nevertheless, in clinical practice, it seems vital for the physician to be aware of this association because OSA treatment has demonstrated its efficacy in reducing the risk of cardiovascular and cerebrovascular disease in virtually any patient," they concluded.

The authors reported having no financial disclosures.

Obstructive sleep apnea may be an additional risk factor in the pathogenesis of retinal vein occlusion or a frequently associated condition that could be a triggering factor, researchers said in the December 2010 issue of Archives of Ophthalmology.

Dr. Agnès Glacet-Bernard of Intercommunal and Henri Mondor Hospitals/Assistance Publique des Hôpitaux de Paris, and her colleagues reviewed records of 63 consecutive patients with retinal vein occlusion (RVO) and chose 30 patients with two out of three risk factors for obstructive sleep apnea (OSA) – cardiovascular disease, snoring, and daytime sleepiness with an Epworth Sleepiness Scale score of higher than 10 – to receive further evaluation with respiratory polygraphy.

Twenty-three of the 30 patients (77%) selected for further evaluation had OSA, with a mean apnea-hypopnea index (AHI) of 21.3. Only one patient was previously diagnosed as having OSA. Ten patients required treatment with nasal continuous positive airway pressure with a mask during sleep, the researchers say, but because the treatment occurred several weeks or months after the onset of the RVO, it was impossible to determine whether treatment might play a beneficial role in visual outcome, the researchers say (Arch. Ophthalmol. 2010;128:1533-8).

Assuming the patients not evaluated did not have OSA, the estimated prevalence of OSA in this series of patients with RVO would be 37%. This lower estimate remains higher than the 2%-7% prevalence that is expected in the general population, according to the researchers.

Sleep apnea results in hemodynamic changes that contribute to a cascade of events leading to RVO. "These events may directly affect the retinal microcirculation, or they can act in concert with other predisposing conditions to RVO," the researchers say. "The immediate physiologic effects of OSA involve nocturnal hypoxemia, hypercapnia, and inspiratory efforts."

The study was limited in that researchers used historical control subjects and only evaluated a subset of patients with RVO who were at increased risk for OSA. Further studies are needed to determine if a causal relationship between OSA and RVO, and to determine the exact prevalence of OSA among patients with RVO, they stated.

"This study suggests that OSA, by acting on retinal microcirculation, could be an additional risk factor for the occurrence of RVO or, at least in older patients with a vascular profile, an associated condition that could play a determinant role in the development of RVO and that could act as a triggering factor," the researchers indicated.

"It is too early to know whether OSA treatment could modify the course of RVO or at least prevent its recurrence or the involvement of the second eye. Nevertheless, in clinical practice, it seems vital for the physician to be aware of this association because OSA treatment has demonstrated its efficacy in reducing the risk of cardiovascular and cerebrovascular disease in virtually any patient," they concluded.

The authors reported having no financial disclosures.

The Department of Health and Human Services launched its Healthy People 2020 goals on Dec. 2, and among the objectives set forth in its "ambitious, yet achievable" 10-year agenda for improving the nation’s health are substantial improvements in sleep health, respiratory disease outcomes, and levels of tobacco use.

[Healthy People Launches 2020 Goals]

Sleep Health

Sleep health is a new topic in the Healthy People initiative. The main focus is on increasing public knowledge of how adequate sleep and treatment of sleep disorders improves health, productivity, wellness, quality of life, and safety on the roads and in the workplace.

"Poor sleep health is a common problem, with 25% of U.S. adults reporting insufficient sleep or rest at least 5 out of every 30 days," the report states.

The public health burden is substantial, and awareness of the problem is lacking; thus, Healthy People 2020 seeks to provide a "well-coordinated strategy to improve sleep-related health."

Objectives are to:

• Increase the proportion of persons with symptoms of obstructive sleep apnea who seek medical care (from 25.5% to 28%).

• Reduce the rate of vehicular crashes per 100 million miles traveled that are due to drowsy driving (from 2.7 to 2.1).

• Increase the proportion of students in grades 9-12 who get sufficient sleep, defined as 8 hours or more on an average school night (from 30.9% to 33.2%).

• Increase the proportion of adults who get sufficient sleep, defined as 8 or more hours for those aged 18-21 years, and 7 or more hours for those aged 22 years and older (from 69.6% to 70.9%).

Respiratory Disease

The respiratory disease category focuses on asthma and chronic obstructive pulmonary disease, and the main goal is to "promote respiratory health through better prevention, detection, treatment, and education efforts," according to the report, which states that asthma affects 23 million people in the United States and COPD affects 13.6 million U.S. adults.

The cost to the health care system is high, and society pays through higher health insurance rates and lost productivity and tax dollars. Annual expenditures for asthma alone are estimated at nearly $21 billion.

Healthy People 2020 seeks to reduce asthma-related deaths, hospitalizations, emergency department visits, activity limitations, and missed school or work days, and to increase the proportion of asthma sufferers who receive appropriate care. Improved surveillance at the state level is another goal.

For example, goals for 2020 in regard to asthma-related deaths include reductions from 11.0 to 6.0 deaths per 1 million people aged 35-64 years, and from 43.3 to 22.9 per 1 million people aged 65 and older. Goals regarding annual asthma-related hospitalization include a reduction from 41.4 to 18.1 per 10,000 children under age 5, from 11.1 to 8.6 per 10,000 people aged 5-64 years, and from 25.3 to 20.3 per 10,000 adults aged 65 years and older.

Goals regarding appropriate asthma care include specific improvements in the number of patients who receive written asthma management plans, instructions for inhaler use, education about appropriate response to an asthma episode, and follow-up visits each year.

COPD-related objectives include reducing associated activity limitations, deaths, hospitalizations, and emergency department visits, and improving diagnosis among adults with abnormal lung function.

Specific goals include a reduction from 23.2 to 18.7 in the percentage of adults with COPD aged 45 years and older who experience activity limitations from COPD, and a reduction from 112.4 to 98.5 in the number of COPD-related deaths per 10,000 people aged 45 years and older.

Tobacco Use

Tobacco use is not a new topic in the Healthy People initiative, but ongoing efforts to reduce use are needed, according to the report, because tobacco use remains the single most preventable cause of death and disease in the United States. About 443,000 Americans die from tobacco-related illnesses each year, and for every 1 who dies, 20 more suffer with at least one serious tobacco-related illness.

Healthy People 2020 seeks to "provide a framework for action to reduce tobacco use to the point that it is no longer a public health problem for the nation."

Based on more than 4 decades of evidence, it is clear, according to the report, that the toll tobacco use takes on families and communities can be significantly reduced by fully funding tobacco control programs, increasing the prices of tobacco products, enacting smoke-free policies, controlling access to products, reducing tobacco advertising and promotion, implementing antitobacco media campaigns, and encouraging and assisting users to quit.

Healthy People 2020 addresses tobacco use prevalence, health system changes, and social and environmental changes. Among the key goals for adults are:

• Reducing the percentage of adult cigarette smokers (from 20.6% to 12.0%).

• Reducing the percentage of adult users of smokeless tobacco (from 2.3% to 0.3%).

• Reducing the percentage of adult cigar smokers (from 2.2% to 0.2%).

In adolescents, goals include reducing the percentage of those who used tobacco in the past month from 26% to 21%, and reducing the percentages who said they used cigarettes, smokeless tobacco, and cigars in the past month from 19.5% to 16%, from 8.9% to 6.9%, and from 14% to 8%, respectively.

Initiation of tobacco use among children, adolescents, and young adults is also addressed, with a goal of reducing initiation of tobacco use in general among those aged 12-17 years from 7.7% to 5.7%, and among those aged 18-25 years from 10.8% to 8.8%.

Other goals regarding tobacco use include increasing smoking cessation attempts by adult and adolescent smokers, and increasing smoking cessation during pregnancy.

Numerous goals are also set in regard to health system changes, and social and environmental changes.

For example, the report calls for increases in comprehensive Medicaid insurance coverage for nicotine dependency treatment, increased tobacco screening and cessation counseling in health care settings, reductions in the proportion of nonsmokers exposed to secondhand smoke, increases in the proportion of persons covered by indoor worksite policies that prohibit smoking, and increases in tobacco-free environments in school facilities and at school events.

Additionally, efforts should be made to eliminate state laws that preempt stronger local tobacco control laws, to reduce illegal sales to minors, and to reduce exposure to tobacco advertising and promotion among 6th-12th graders.

Also, federal and state taxes on tobacco products should be increased, the report states.

Healthy People 2020 has been in development since 2007. A panel of health experts drew on input from public and private health officials, preventive medicine experts, representatives from 2,000 health organizations, and thousands of public comments.

The initiative expands upon topics from Healthy People 2010, includes a number of new topic areas, and will incorporate the Internet and other technology media in getting the message out about disease prevention and health promotion. The ultimate goals, according to HHS officials, are to avoid preventable diseases in the first place and to promote improved quantity and quality of life for all Americans.

The Department of Health and Human Services launched its Healthy People 2020 goals on Dec. 2, and among the objectives set forth in its "ambitious, yet achievable" 10-year agenda for improving the nation’s health are substantial improvements in sleep health, respiratory disease outcomes, and levels of tobacco use.

[Healthy People Launches 2020 Goals]

Sleep Health

Sleep health is a new topic in the Healthy People initiative. The main focus is on increasing public knowledge of how adequate sleep and treatment of sleep disorders improves health, productivity, wellness, quality of life, and safety on the roads and in the workplace.

"Poor sleep health is a common problem, with 25% of U.S. adults reporting insufficient sleep or rest at least 5 out of every 30 days," the report states.

The public health burden is substantial, and awareness of the problem is lacking; thus, Healthy People 2020 seeks to provide a "well-coordinated strategy to improve sleep-related health."

Objectives are to:

• Increase the proportion of persons with symptoms of obstructive sleep apnea who seek medical care (from 25.5% to 28%).

• Reduce the rate of vehicular crashes per 100 million miles traveled that are due to drowsy driving (from 2.7 to 2.1).

• Increase the proportion of students in grades 9-12 who get sufficient sleep, defined as 8 hours or more on an average school night (from 30.9% to 33.2%).

• Increase the proportion of adults who get sufficient sleep, defined as 8 or more hours for those aged 18-21 years, and 7 or more hours for those aged 22 years and older (from 69.6% to 70.9%).

Respiratory Disease

The respiratory disease category focuses on asthma and chronic obstructive pulmonary disease, and the main goal is to "promote respiratory health through better prevention, detection, treatment, and education efforts," according to the report, which states that asthma affects 23 million people in the United States and COPD affects 13.6 million U.S. adults.

The cost to the health care system is high, and society pays through higher health insurance rates and lost productivity and tax dollars. Annual expenditures for asthma alone are estimated at nearly $21 billion.

Healthy People 2020 seeks to reduce asthma-related deaths, hospitalizations, emergency department visits, activity limitations, and missed school or work days, and to increase the proportion of asthma sufferers who receive appropriate care. Improved surveillance at the state level is another goal.

For example, goals for 2020 in regard to asthma-related deaths include reductions from 11.0 to 6.0 deaths per 1 million people aged 35-64 years, and from 43.3 to 22.9 per 1 million people aged 65 and older. Goals regarding annual asthma-related hospitalization include a reduction from 41.4 to 18.1 per 10,000 children under age 5, from 11.1 to 8.6 per 10,000 people aged 5-64 years, and from 25.3 to 20.3 per 10,000 adults aged 65 years and older.

Goals regarding appropriate asthma care include specific improvements in the number of patients who receive written asthma management plans, instructions for inhaler use, education about appropriate response to an asthma episode, and follow-up visits each year.

COPD-related objectives include reducing associated activity limitations, deaths, hospitalizations, and emergency department visits, and improving diagnosis among adults with abnormal lung function.

Specific goals include a reduction from 23.2 to 18.7 in the percentage of adults with COPD aged 45 years and older who experience activity limitations from COPD, and a reduction from 112.4 to 98.5 in the number of COPD-related deaths per 10,000 people aged 45 years and older.

Tobacco Use

Tobacco use is not a new topic in the Healthy People initiative, but ongoing efforts to reduce use are needed, according to the report, because tobacco use remains the single most preventable cause of death and disease in the United States. About 443,000 Americans die from tobacco-related illnesses each year, and for every 1 who dies, 20 more suffer with at least one serious tobacco-related illness.

Healthy People 2020 seeks to "provide a framework for action to reduce tobacco use to the point that it is no longer a public health problem for the nation."

Based on more than 4 decades of evidence, it is clear, according to the report, that the toll tobacco use takes on families and communities can be significantly reduced by fully funding tobacco control programs, increasing the prices of tobacco products, enacting smoke-free policies, controlling access to products, reducing tobacco advertising and promotion, implementing antitobacco media campaigns, and encouraging and assisting users to quit.

Healthy People 2020 addresses tobacco use prevalence, health system changes, and social and environmental changes. Among the key goals for adults are:

• Reducing the percentage of adult cigarette smokers (from 20.6% to 12.0%).

• Reducing the percentage of adult users of smokeless tobacco (from 2.3% to 0.3%).

• Reducing the percentage of adult cigar smokers (from 2.2% to 0.2%).

In adolescents, goals include reducing the percentage of those who used tobacco in the past month from 26% to 21%, and reducing the percentages who said they used cigarettes, smokeless tobacco, and cigars in the past month from 19.5% to 16%, from 8.9% to 6.9%, and from 14% to 8%, respectively.

Initiation of tobacco use among children, adolescents, and young adults is also addressed, with a goal of reducing initiation of tobacco use in general among those aged 12-17 years from 7.7% to 5.7%, and among those aged 18-25 years from 10.8% to 8.8%.

Other goals regarding tobacco use include increasing smoking cessation attempts by adult and adolescent smokers, and increasing smoking cessation during pregnancy.

Numerous goals are also set in regard to health system changes, and social and environmental changes.

For example, the report calls for increases in comprehensive Medicaid insurance coverage for nicotine dependency treatment, increased tobacco screening and cessation counseling in health care settings, reductions in the proportion of nonsmokers exposed to secondhand smoke, increases in the proportion of persons covered by indoor worksite policies that prohibit smoking, and increases in tobacco-free environments in school facilities and at school events.

Additionally, efforts should be made to eliminate state laws that preempt stronger local tobacco control laws, to reduce illegal sales to minors, and to reduce exposure to tobacco advertising and promotion among 6th-12th graders.

Also, federal and state taxes on tobacco products should be increased, the report states.

Healthy People 2020 has been in development since 2007. A panel of health experts drew on input from public and private health officials, preventive medicine experts, representatives from 2,000 health organizations, and thousands of public comments.

The initiative expands upon topics from Healthy People 2010, includes a number of new topic areas, and will incorporate the Internet and other technology media in getting the message out about disease prevention and health promotion. The ultimate goals, according to HHS officials, are to avoid preventable diseases in the first place and to promote improved quantity and quality of life for all Americans.

The Department of Health and Human Services launched its Healthy People 2020 goals on Dec. 2, and among the objectives set forth in its "ambitious, yet achievable" 10-year agenda for improving the nation’s health are substantial improvements in sleep health, respiratory disease outcomes, and levels of tobacco use.

[Healthy People Launches 2020 Goals]

Sleep Health

Sleep health is a new topic in the Healthy People initiative. The main focus is on increasing public knowledge of how adequate sleep and treatment of sleep disorders improves health, productivity, wellness, quality of life, and safety on the roads and in the workplace.

"Poor sleep health is a common problem, with 25% of U.S. adults reporting insufficient sleep or rest at least 5 out of every 30 days," the report states.

The public health burden is substantial, and awareness of the problem is lacking; thus, Healthy People 2020 seeks to provide a "well-coordinated strategy to improve sleep-related health."

Objectives are to:

• Increase the proportion of persons with symptoms of obstructive sleep apnea who seek medical care (from 25.5% to 28%).

• Reduce the rate of vehicular crashes per 100 million miles traveled that are due to drowsy driving (from 2.7 to 2.1).

• Increase the proportion of students in grades 9-12 who get sufficient sleep, defined as 8 hours or more on an average school night (from 30.9% to 33.2%).

• Increase the proportion of adults who get sufficient sleep, defined as 8 or more hours for those aged 18-21 years, and 7 or more hours for those aged 22 years and older (from 69.6% to 70.9%).

Respiratory Disease

The respiratory disease category focuses on asthma and chronic obstructive pulmonary disease, and the main goal is to "promote respiratory health through better prevention, detection, treatment, and education efforts," according to the report, which states that asthma affects 23 million people in the United States and COPD affects 13.6 million U.S. adults.

The cost to the health care system is high, and society pays through higher health insurance rates and lost productivity and tax dollars. Annual expenditures for asthma alone are estimated at nearly $21 billion.

Healthy People 2020 seeks to reduce asthma-related deaths, hospitalizations, emergency department visits, activity limitations, and missed school or work days, and to increase the proportion of asthma sufferers who receive appropriate care. Improved surveillance at the state level is another goal.

For example, goals for 2020 in regard to asthma-related deaths include reductions from 11.0 to 6.0 deaths per 1 million people aged 35-64 years, and from 43.3 to 22.9 per 1 million people aged 65 and older. Goals regarding annual asthma-related hospitalization include a reduction from 41.4 to 18.1 per 10,000 children under age 5, from 11.1 to 8.6 per 10,000 people aged 5-64 years, and from 25.3 to 20.3 per 10,000 adults aged 65 years and older.

Goals regarding appropriate asthma care include specific improvements in the number of patients who receive written asthma management plans, instructions for inhaler use, education about appropriate response to an asthma episode, and follow-up visits each year.

COPD-related objectives include reducing associated activity limitations, deaths, hospitalizations, and emergency department visits, and improving diagnosis among adults with abnormal lung function.

Specific goals include a reduction from 23.2 to 18.7 in the percentage of adults with COPD aged 45 years and older who experience activity limitations from COPD, and a reduction from 112.4 to 98.5 in the number of COPD-related deaths per 10,000 people aged 45 years and older.

Tobacco Use

Tobacco use is not a new topic in the Healthy People initiative, but ongoing efforts to reduce use are needed, according to the report, because tobacco use remains the single most preventable cause of death and disease in the United States. About 443,000 Americans die from tobacco-related illnesses each year, and for every 1 who dies, 20 more suffer with at least one serious tobacco-related illness.

Healthy People 2020 seeks to "provide a framework for action to reduce tobacco use to the point that it is no longer a public health problem for the nation."

Based on more than 4 decades of evidence, it is clear, according to the report, that the toll tobacco use takes on families and communities can be significantly reduced by fully funding tobacco control programs, increasing the prices of tobacco products, enacting smoke-free policies, controlling access to products, reducing tobacco advertising and promotion, implementing antitobacco media campaigns, and encouraging and assisting users to quit.

Healthy People 2020 addresses tobacco use prevalence, health system changes, and social and environmental changes. Among the key goals for adults are:

• Reducing the percentage of adult cigarette smokers (from 20.6% to 12.0%).

• Reducing the percentage of adult users of smokeless tobacco (from 2.3% to 0.3%).

• Reducing the percentage of adult cigar smokers (from 2.2% to 0.2%).

In adolescents, goals include reducing the percentage of those who used tobacco in the past month from 26% to 21%, and reducing the percentages who said they used cigarettes, smokeless tobacco, and cigars in the past month from 19.5% to 16%, from 8.9% to 6.9%, and from 14% to 8%, respectively.

Initiation of tobacco use among children, adolescents, and young adults is also addressed, with a goal of reducing initiation of tobacco use in general among those aged 12-17 years from 7.7% to 5.7%, and among those aged 18-25 years from 10.8% to 8.8%.

Other goals regarding tobacco use include increasing smoking cessation attempts by adult and adolescent smokers, and increasing smoking cessation during pregnancy.

Numerous goals are also set in regard to health system changes, and social and environmental changes.

For example, the report calls for increases in comprehensive Medicaid insurance coverage for nicotine dependency treatment, increased tobacco screening and cessation counseling in health care settings, reductions in the proportion of nonsmokers exposed to secondhand smoke, increases in the proportion of persons covered by indoor worksite policies that prohibit smoking, and increases in tobacco-free environments in school facilities and at school events.

Additionally, efforts should be made to eliminate state laws that preempt stronger local tobacco control laws, to reduce illegal sales to minors, and to reduce exposure to tobacco advertising and promotion among 6th-12th graders.

Also, federal and state taxes on tobacco products should be increased, the report states.

Healthy People 2020 has been in development since 2007. A panel of health experts drew on input from public and private health officials, preventive medicine experts, representatives from 2,000 health organizations, and thousands of public comments.

The initiative expands upon topics from Healthy People 2010, includes a number of new topic areas, and will incorporate the Internet and other technology media in getting the message out about disease prevention and health promotion. The ultimate goals, according to HHS officials, are to avoid preventable diseases in the first place and to promote improved quantity and quality of life for all Americans.

VANCOUVER, B.C. – Recent research on the use of home testing for the diagnosis of obstructive sleep apnea and initiation of therapy suggests that "home testing is here to stay," Dr. Charles W. Atwood Jr. told attendees at the annual meeting of the American College of Chest Physicians.

For more than 30 years, physicians have relied on the traditional polysomnography performed in the sleep laboratory to diagnose sleep apnea, according to Dr. Atwood. But with growing awareness of the condition and its prevalence, the number of people needing testing could overwhelm capacity.

"If you take the millions and millions and millions of people in the United States alone who have sleep apnea and try to feed them through the relatively small funnel of traditional sleep labs, then you are going to have big bottlenecks," he said, adding that such bottlenecks already exist in some areas.

However, home-testing devices must meet certain key requirements before they are ready for widespread use. For example, they have to be simpler than those used in the lab. "Perhaps we can get by with fewer [physiological] signals, but we need to understand what the key signals are," commented Dr. Atwood, a pulmonologist and sleep medicine specialist with the VA Pittsburgh Healthcare System and the University of Pittsburgh Medical Center.

Home testing devices will also need to be accurate, with high sensitivity and specificity, and "there is no single device I would say today that is perfect in both these regards," he noted. Finally, they must be easy to use and durable, given the demands of in-home use.

Roughly 95 studies conducted between 1990 and 2006 evaluated home testing (also called portable monitoring) for the diagnosis of obstructive sleep apnea. Collectively, they had some limitations, such as their single-site nature, small and usually homogeneous populations, and varying degrees of rigor in design.

"And they frequently focused on the highest-risk subjects: These were middle-aged men who were overweight, snored, and were sleepy, so [they were] the very low-hanging fruit for typical sleep apnea," Dr. Atwood said.

These studies showed mixed results when it came to the diagnostic performance of home testing relative to lab testing. "There is no perfect study, at least so far, in this area, but some have come pretty close," he commented.

Three more recent studies suggest that home testing is at least not inferior to lab testing for sleep apnea diagnosis and initiation of continuous positive airway pressure (CPAP) therapy, according to Dr. Atwood.

In the first study, conducted among 68 people with a high likelihood of sleep apnea, the apnea-hypopnea index on CPAP and Sleep Apnea Quality of Life Index scores at 3 months did not differ significantly between a sleep lab approach and an ambulatory approach (Ann. Intern. Med. 2007;146:157-66). The rate of adherence to CPAP was better with the latter.

In the second study, which involved 102 patients with sleep apnea symptoms and no major comorbidities, all of a variety of sleep and quality of life outcomes after 4 weeks of CPAP were similar with a standard lab diagnosis and treatment approach vs. a home approach (Chest 2010;138:257-63).

The third study, the Veterans Sleep Apnea Treatment Trial (VSATT), is the largest study of home testing in North America to date, according to Dr. Atwood, who is one of the principal investigators.

"The VA is ill equipped to manage sleep apnea in a conventional way because we have relatively few numbers of traditional sleep labs, and those sleep labs that do exist tend to be kind of small," he noted. Also, there are geographic disparities, with some veterans having virtually no access to sleep labs.

"Our study differed from basically all of the other studies in the literature in that we had very broad inclusion criteria and very nonrestrictive exclusion criteria," Dr. Atwood noted. For example, patients with comorbidities could participate as long as their condition was stable.

The patients were randomized to lab testing or home testing, followed by initiation of CPAP for those with positive results.

Among the 223 who were started on CPAP, the home and lab groups had similar demographics. The average apnea-hypopnea index was 41 for the former and 45 for the latter. The Functional Outcomes of Sleep Questionnaire (FOSQ) total score was about 15 in each group.

Results showed that the mean adjusted improvement in FOSQ total score between baseline and 3 months was identical in the two groups, at 1.79 points. And within each group, patients had significant improvements in the total score as well as its individual components.

Both home and lab groups also had significant improvements on the Epworth Sleepiness Scale (–2.6 and –2.9, respectively), the mental health component of the 12-item Short Form Health Survey (+2.5 and +3.0), and the Center for Epidemiologic Studies–Depression scale (–1.4 and –2.2). Neither group improved significantly on the psychovigilance task or the physical health component of the 12-item Short Form Health Survey.

When it came to adherence, which was monitored with smart cards, the mean adjusted number of CPAP hours daily was 3.42 in the home group and 2.99 in the lab group, a difference that was not significant. Cost-effectiveness analyses are still ongoing.

"We concluded that the functional improvement with CPAP for sleep apnea is not worse when treated in the home setting vs. the sleep lab," Dr. Atwood said. "We believe that the implication is that home-based sleep apnea diagnosis and initiation of CPAP therapy is an effective way to treat sleep apnea."

Despite all of the accumulating favorable findings for home testing, Dr. Atwood was skeptical that it will entirely replace laboratory polysomnography.

"Home sleep apnea testing is part of the future, but it’s unlikely to be the whole future," he contended. "The way to think about home sleep apnea testing now is not ‘either/or,’ but really to begin to integrate home sleep testing with full polysomnography in a clinically rational way."

Dr. Atwood reported that he received research support from Embla, Resmed, and Respironics, and is a consultant to Embla and Itamar Medical, all of which manufacture testing and treatment devices for sleep disorders.

VANCOUVER, B.C. – Recent research on the use of home testing for the diagnosis of obstructive sleep apnea and initiation of therapy suggests that "home testing is here to stay," Dr. Charles W. Atwood Jr. told attendees at the annual meeting of the American College of Chest Physicians.

For more than 30 years, physicians have relied on the traditional polysomnography performed in the sleep laboratory to diagnose sleep apnea, according to Dr. Atwood. But with growing awareness of the condition and its prevalence, the number of people needing testing could overwhelm capacity.

"If you take the millions and millions and millions of people in the United States alone who have sleep apnea and try to feed them through the relatively small funnel of traditional sleep labs, then you are going to have big bottlenecks," he said, adding that such bottlenecks already exist in some areas.

However, home-testing devices must meet certain key requirements before they are ready for widespread use. For example, they have to be simpler than those used in the lab. "Perhaps we can get by with fewer [physiological] signals, but we need to understand what the key signals are," commented Dr. Atwood, a pulmonologist and sleep medicine specialist with the VA Pittsburgh Healthcare System and the University of Pittsburgh Medical Center.

Home testing devices will also need to be accurate, with high sensitivity and specificity, and "there is no single device I would say today that is perfect in both these regards," he noted. Finally, they must be easy to use and durable, given the demands of in-home use.

Roughly 95 studies conducted between 1990 and 2006 evaluated home testing (also called portable monitoring) for the diagnosis of obstructive sleep apnea. Collectively, they had some limitations, such as their single-site nature, small and usually homogeneous populations, and varying degrees of rigor in design.

"And they frequently focused on the highest-risk subjects: These were middle-aged men who were overweight, snored, and were sleepy, so [they were] the very low-hanging fruit for typical sleep apnea," Dr. Atwood said.

These studies showed mixed results when it came to the diagnostic performance of home testing relative to lab testing. "There is no perfect study, at least so far, in this area, but some have come pretty close," he commented.

Three more recent studies suggest that home testing is at least not inferior to lab testing for sleep apnea diagnosis and initiation of continuous positive airway pressure (CPAP) therapy, according to Dr. Atwood.

In the first study, conducted among 68 people with a high likelihood of sleep apnea, the apnea-hypopnea index on CPAP and Sleep Apnea Quality of Life Index scores at 3 months did not differ significantly between a sleep lab approach and an ambulatory approach (Ann. Intern. Med. 2007;146:157-66). The rate of adherence to CPAP was better with the latter.

In the second study, which involved 102 patients with sleep apnea symptoms and no major comorbidities, all of a variety of sleep and quality of life outcomes after 4 weeks of CPAP were similar with a standard lab diagnosis and treatment approach vs. a home approach (Chest 2010;138:257-63).

The third study, the Veterans Sleep Apnea Treatment Trial (VSATT), is the largest study of home testing in North America to date, according to Dr. Atwood, who is one of the principal investigators.

"The VA is ill equipped to manage sleep apnea in a conventional way because we have relatively few numbers of traditional sleep labs, and those sleep labs that do exist tend to be kind of small," he noted. Also, there are geographic disparities, with some veterans having virtually no access to sleep labs.

"Our study differed from basically all of the other studies in the literature in that we had very broad inclusion criteria and very nonrestrictive exclusion criteria," Dr. Atwood noted. For example, patients with comorbidities could participate as long as their condition was stable.

The patients were randomized to lab testing or home testing, followed by initiation of CPAP for those with positive results.

Among the 223 who were started on CPAP, the home and lab groups had similar demographics. The average apnea-hypopnea index was 41 for the former and 45 for the latter. The Functional Outcomes of Sleep Questionnaire (FOSQ) total score was about 15 in each group.

Results showed that the mean adjusted improvement in FOSQ total score between baseline and 3 months was identical in the two groups, at 1.79 points. And within each group, patients had significant improvements in the total score as well as its individual components.

Both home and lab groups also had significant improvements on the Epworth Sleepiness Scale (–2.6 and –2.9, respectively), the mental health component of the 12-item Short Form Health Survey (+2.5 and +3.0), and the Center for Epidemiologic Studies–Depression scale (–1.4 and –2.2). Neither group improved significantly on the psychovigilance task or the physical health component of the 12-item Short Form Health Survey.

When it came to adherence, which was monitored with smart cards, the mean adjusted number of CPAP hours daily was 3.42 in the home group and 2.99 in the lab group, a difference that was not significant. Cost-effectiveness analyses are still ongoing.

"We concluded that the functional improvement with CPAP for sleep apnea is not worse when treated in the home setting vs. the sleep lab," Dr. Atwood said. "We believe that the implication is that home-based sleep apnea diagnosis and initiation of CPAP therapy is an effective way to treat sleep apnea."

Despite all of the accumulating favorable findings for home testing, Dr. Atwood was skeptical that it will entirely replace laboratory polysomnography.

"Home sleep apnea testing is part of the future, but it’s unlikely to be the whole future," he contended. "The way to think about home sleep apnea testing now is not ‘either/or,’ but really to begin to integrate home sleep testing with full polysomnography in a clinically rational way."

Dr. Atwood reported that he received research support from Embla, Resmed, and Respironics, and is a consultant to Embla and Itamar Medical, all of which manufacture testing and treatment devices for sleep disorders.

VANCOUVER, B.C. – Recent research on the use of home testing for the diagnosis of obstructive sleep apnea and initiation of therapy suggests that "home testing is here to stay," Dr. Charles W. Atwood Jr. told attendees at the annual meeting of the American College of Chest Physicians.

For more than 30 years, physicians have relied on the traditional polysomnography performed in the sleep laboratory to diagnose sleep apnea, according to Dr. Atwood. But with growing awareness of the condition and its prevalence, the number of people needing testing could overwhelm capacity.

"If you take the millions and millions and millions of people in the United States alone who have sleep apnea and try to feed them through the relatively small funnel of traditional sleep labs, then you are going to have big bottlenecks," he said, adding that such bottlenecks already exist in some areas.

However, home-testing devices must meet certain key requirements before they are ready for widespread use. For example, they have to be simpler than those used in the lab. "Perhaps we can get by with fewer [physiological] signals, but we need to understand what the key signals are," commented Dr. Atwood, a pulmonologist and sleep medicine specialist with the VA Pittsburgh Healthcare System and the University of Pittsburgh Medical Center.

Home testing devices will also need to be accurate, with high sensitivity and specificity, and "there is no single device I would say today that is perfect in both these regards," he noted. Finally, they must be easy to use and durable, given the demands of in-home use.

Roughly 95 studies conducted between 1990 and 2006 evaluated home testing (also called portable monitoring) for the diagnosis of obstructive sleep apnea. Collectively, they had some limitations, such as their single-site nature, small and usually homogeneous populations, and varying degrees of rigor in design.

"And they frequently focused on the highest-risk subjects: These were middle-aged men who were overweight, snored, and were sleepy, so [they were] the very low-hanging fruit for typical sleep apnea," Dr. Atwood said.

These studies showed mixed results when it came to the diagnostic performance of home testing relative to lab testing. "There is no perfect study, at least so far, in this area, but some have come pretty close," he commented.

Three more recent studies suggest that home testing is at least not inferior to lab testing for sleep apnea diagnosis and initiation of continuous positive airway pressure (CPAP) therapy, according to Dr. Atwood.

In the first study, conducted among 68 people with a high likelihood of sleep apnea, the apnea-hypopnea index on CPAP and Sleep Apnea Quality of Life Index scores at 3 months did not differ significantly between a sleep lab approach and an ambulatory approach (Ann. Intern. Med. 2007;146:157-66). The rate of adherence to CPAP was better with the latter.

In the second study, which involved 102 patients with sleep apnea symptoms and no major comorbidities, all of a variety of sleep and quality of life outcomes after 4 weeks of CPAP were similar with a standard lab diagnosis and treatment approach vs. a home approach (Chest 2010;138:257-63).

The third study, the Veterans Sleep Apnea Treatment Trial (VSATT), is the largest study of home testing in North America to date, according to Dr. Atwood, who is one of the principal investigators.

"The VA is ill equipped to manage sleep apnea in a conventional way because we have relatively few numbers of traditional sleep labs, and those sleep labs that do exist tend to be kind of small," he noted. Also, there are geographic disparities, with some veterans having virtually no access to sleep labs.

"Our study differed from basically all of the other studies in the literature in that we had very broad inclusion criteria and very nonrestrictive exclusion criteria," Dr. Atwood noted. For example, patients with comorbidities could participate as long as their condition was stable.

The patients were randomized to lab testing or home testing, followed by initiation of CPAP for those with positive results.

Among the 223 who were started on CPAP, the home and lab groups had similar demographics. The average apnea-hypopnea index was 41 for the former and 45 for the latter. The Functional Outcomes of Sleep Questionnaire (FOSQ) total score was about 15 in each group.

Results showed that the mean adjusted improvement in FOSQ total score between baseline and 3 months was identical in the two groups, at 1.79 points. And within each group, patients had significant improvements in the total score as well as its individual components.

Both home and lab groups also had significant improvements on the Epworth Sleepiness Scale (–2.6 and –2.9, respectively), the mental health component of the 12-item Short Form Health Survey (+2.5 and +3.0), and the Center for Epidemiologic Studies–Depression scale (–1.4 and –2.2). Neither group improved significantly on the psychovigilance task or the physical health component of the 12-item Short Form Health Survey.

When it came to adherence, which was monitored with smart cards, the mean adjusted number of CPAP hours daily was 3.42 in the home group and 2.99 in the lab group, a difference that was not significant. Cost-effectiveness analyses are still ongoing.

"We concluded that the functional improvement with CPAP for sleep apnea is not worse when treated in the home setting vs. the sleep lab," Dr. Atwood said. "We believe that the implication is that home-based sleep apnea diagnosis and initiation of CPAP therapy is an effective way to treat sleep apnea."

Despite all of the accumulating favorable findings for home testing, Dr. Atwood was skeptical that it will entirely replace laboratory polysomnography.

"Home sleep apnea testing is part of the future, but it’s unlikely to be the whole future," he contended. "The way to think about home sleep apnea testing now is not ‘either/or,’ but really to begin to integrate home sleep testing with full polysomnography in a clinically rational way."

Dr. Atwood reported that he received research support from Embla, Resmed, and Respironics, and is a consultant to Embla and Itamar Medical, all of which manufacture testing and treatment devices for sleep disorders.