CHICAGO – Patients with an inflammatory arthritis had significantly higher rates of infections, transfusions, and readmissions following total knee replacement than did patients without inflammatory arthritis in a study of more than 137,000 Americans who underwent this surgery.

A sampling of U.S. patients who underwent total knee arthroplasty (TKA) during 2007-2016 showed that among the small percentage of these patients who had an inflammatory arthritis (IA), the rate of periprosthetic joint or wound infection while hospitalized or out to 30 days after surgery was a statistically significant 64% higher relative to patients without inflammatory arthritis, after adjustment for several demographic and clinical confounders, including recent glucocorticoid treatment, Susan M. Goodman, MD, said at the annual meeting of the American College of Rheumatology. The analysis also showed a statistically significant 46% higher relative rate of hospital readmission for any cause during the 90 days after surgery, and a significant 39% relative increase in blood transfusions during the 30 days after TKA in the IA patients.

“These results have important implications for evolving bundled payment models” for TKA, said Dr. Goodman, a rheumatologist at the Hospital for Special Surgery in New York. “Hospitals should receive commensurate resources to maintain access to total TKA for patients with IA.”

For this analysis, Dr. Goodman and her associates classified IA as a patient with a recorded diagnosis of rheumatoid arthritis, spondyloarthritis, or systemic lupus erythematosus if the patient had also received treatment during the year before surgery with a disease-modifying antirheumatic drug, a biologic agent, or a drug that treats systemic lupus erythematosus.

Complications following TKA became a particular concern to hospitals starting in 2013 when the Centers for Medicare & Medicaid Services began a program that penalized hospitals for outcomes such as excessive readmissions following selected types of hospitalizations and also with recent steps to bundle TKA reimbursement with related 90-day outcomes.

“My concern is to ensure that patients with IA aren’t penalized and can maintain access” to TKA despite recent policy moves by the CMS. Faced with potential disincentives to treat patients with an IA, “hospitals might cherry pick patients,” Dr. Goodman said in an interview. The new findings “are a reason for administrators to argue for patients with IA to come out of the cost bundle.”

Dr. Goodman expressed hope that future policies will better reflect the higher levels of risk faced by patients with an IA undergoing TKA. CMS “is pretty responsive,” she said.

The study used data collected by Humana for about 25 million American health insurance beneficiaries during 2007-2016, which included 137,550 people who underwent a TKA. Of these, 3,067 (2%) met the study’s definition for IA, and 134,483 did not. Most of those who did not meet the definition likely had osteoarthritis, Dr. Goodman said. This low percentage of U.S. TKA patients with IA was consistent with numbers in prior reports.

The researchers calculated the relative risk of the IA patients, compared with all the others, for nine potential complications, including acute MI, pneumonia, sepsis, pulmonary embolism, and death. The complications with significantly higher rates among the IA patients after confounder adjustment were 30-day infections, 30-day transfusions, and 90-day readmissions.

Dr. Goodman had no relevant disclosures.

[email protected]

SOURCE: Richardson S et al. Arthritis Rheumatol. 2018;70(Suppl 10): Abstract 1932.

CHICAGO – Patients with an inflammatory arthritis had significantly higher rates of infections, transfusions, and readmissions following total knee replacement than did patients without inflammatory arthritis in a study of more than 137,000 Americans who underwent this surgery.

A sampling of U.S. patients who underwent total knee arthroplasty (TKA) during 2007-2016 showed that among the small percentage of these patients who had an inflammatory arthritis (IA), the rate of periprosthetic joint or wound infection while hospitalized or out to 30 days after surgery was a statistically significant 64% higher relative to patients without inflammatory arthritis, after adjustment for several demographic and clinical confounders, including recent glucocorticoid treatment, Susan M. Goodman, MD, said at the annual meeting of the American College of Rheumatology. The analysis also showed a statistically significant 46% higher relative rate of hospital readmission for any cause during the 90 days after surgery, and a significant 39% relative increase in blood transfusions during the 30 days after TKA in the IA patients.

“These results have important implications for evolving bundled payment models” for TKA, said Dr. Goodman, a rheumatologist at the Hospital for Special Surgery in New York. “Hospitals should receive commensurate resources to maintain access to total TKA for patients with IA.”

For this analysis, Dr. Goodman and her associates classified IA as a patient with a recorded diagnosis of rheumatoid arthritis, spondyloarthritis, or systemic lupus erythematosus if the patient had also received treatment during the year before surgery with a disease-modifying antirheumatic drug, a biologic agent, or a drug that treats systemic lupus erythematosus.

Complications following TKA became a particular concern to hospitals starting in 2013 when the Centers for Medicare & Medicaid Services began a program that penalized hospitals for outcomes such as excessive readmissions following selected types of hospitalizations and also with recent steps to bundle TKA reimbursement with related 90-day outcomes.

“My concern is to ensure that patients with IA aren’t penalized and can maintain access” to TKA despite recent policy moves by the CMS. Faced with potential disincentives to treat patients with an IA, “hospitals might cherry pick patients,” Dr. Goodman said in an interview. The new findings “are a reason for administrators to argue for patients with IA to come out of the cost bundle.”

Dr. Goodman expressed hope that future policies will better reflect the higher levels of risk faced by patients with an IA undergoing TKA. CMS “is pretty responsive,” she said.

The study used data collected by Humana for about 25 million American health insurance beneficiaries during 2007-2016, which included 137,550 people who underwent a TKA. Of these, 3,067 (2%) met the study’s definition for IA, and 134,483 did not. Most of those who did not meet the definition likely had osteoarthritis, Dr. Goodman said. This low percentage of U.S. TKA patients with IA was consistent with numbers in prior reports.

The researchers calculated the relative risk of the IA patients, compared with all the others, for nine potential complications, including acute MI, pneumonia, sepsis, pulmonary embolism, and death. The complications with significantly higher rates among the IA patients after confounder adjustment were 30-day infections, 30-day transfusions, and 90-day readmissions.

Dr. Goodman had no relevant disclosures.

[email protected]

SOURCE: Richardson S et al. Arthritis Rheumatol. 2018;70(Suppl 10): Abstract 1932.

CHICAGO – Patients with an inflammatory arthritis had significantly higher rates of infections, transfusions, and readmissions following total knee replacement than did patients without inflammatory arthritis in a study of more than 137,000 Americans who underwent this surgery.

A sampling of U.S. patients who underwent total knee arthroplasty (TKA) during 2007-2016 showed that among the small percentage of these patients who had an inflammatory arthritis (IA), the rate of periprosthetic joint or wound infection while hospitalized or out to 30 days after surgery was a statistically significant 64% higher relative to patients without inflammatory arthritis, after adjustment for several demographic and clinical confounders, including recent glucocorticoid treatment, Susan M. Goodman, MD, said at the annual meeting of the American College of Rheumatology. The analysis also showed a statistically significant 46% higher relative rate of hospital readmission for any cause during the 90 days after surgery, and a significant 39% relative increase in blood transfusions during the 30 days after TKA in the IA patients.

“These results have important implications for evolving bundled payment models” for TKA, said Dr. Goodman, a rheumatologist at the Hospital for Special Surgery in New York. “Hospitals should receive commensurate resources to maintain access to total TKA for patients with IA.”

For this analysis, Dr. Goodman and her associates classified IA as a patient with a recorded diagnosis of rheumatoid arthritis, spondyloarthritis, or systemic lupus erythematosus if the patient had also received treatment during the year before surgery with a disease-modifying antirheumatic drug, a biologic agent, or a drug that treats systemic lupus erythematosus.

Complications following TKA became a particular concern to hospitals starting in 2013 when the Centers for Medicare & Medicaid Services began a program that penalized hospitals for outcomes such as excessive readmissions following selected types of hospitalizations and also with recent steps to bundle TKA reimbursement with related 90-day outcomes.

“My concern is to ensure that patients with IA aren’t penalized and can maintain access” to TKA despite recent policy moves by the CMS. Faced with potential disincentives to treat patients with an IA, “hospitals might cherry pick patients,” Dr. Goodman said in an interview. The new findings “are a reason for administrators to argue for patients with IA to come out of the cost bundle.”

Dr. Goodman expressed hope that future policies will better reflect the higher levels of risk faced by patients with an IA undergoing TKA. CMS “is pretty responsive,” she said.

The study used data collected by Humana for about 25 million American health insurance beneficiaries during 2007-2016, which included 137,550 people who underwent a TKA. Of these, 3,067 (2%) met the study’s definition for IA, and 134,483 did not. Most of those who did not meet the definition likely had osteoarthritis, Dr. Goodman said. This low percentage of U.S. TKA patients with IA was consistent with numbers in prior reports.

The researchers calculated the relative risk of the IA patients, compared with all the others, for nine potential complications, including acute MI, pneumonia, sepsis, pulmonary embolism, and death. The complications with significantly higher rates among the IA patients after confounder adjustment were 30-day infections, 30-day transfusions, and 90-day readmissions.

Dr. Goodman had no relevant disclosures.

[email protected]

SOURCE: Richardson S et al. Arthritis Rheumatol. 2018;70(Suppl 10): Abstract 1932.

Financial conflicts are often underreported by authors of clinical practice guidelines (CPGs) in several specialties including oncology, rheumatology, and gastroenterology, according to a pair of research letters published in JAMA Internal Medicine. The Institute of Medicine recommends that guideline authors include no more than 50% individuals with financial conflicts.

In one research letter, Rishad Khan, BSc, of the University of Toronto in Ontario and his colleagues reviewed data on undeclared financial conflicts of interest among authors of guidelines related to high-revenue medications.

The researchers identified CPGs via the National Guideline Clearinghouse and selected 18 CPGs for 10 high-revenue medications published between 2013 and 2017. Financial conflicts of interest were based on the Centers for Medicare & Medicaid Services Open Payments.

Of the 160 authors involved in the various guidelines, 79 (49.4%) disclosed a payment in the CPG or supplemental materials, and 50 (31.3%) disclosed payments from companies marketing 1 of the 10 high-revenue medications in the related guidelines.

Another 41 authors (25.6%) received but did not disclose payments from companies marketing 1 of the 10 high-revenue medications in CPGs.

Overall, 91 authors (56.9%) were found to have financial conflicts of interest that involved 1 of the 10 high-revenue medications, and “the median value of undeclared payments from companies marketing 1 of the 10 high-revenue medications recommended in the CPGs was $522 (interquartile range, $0-$40,444) from two companies,” the researchers said.

The study findings were limited by several factors including “potential inaccuracies in CMS-OP reporting, which are rarely corrected, and lack of generalizability outside the United States” and by the limited time frame for data collection, which may have led to underestimation of conflicts for the guidelines, the researchers noted. In addition, “we did not have access to guideline voting records and thus did not know when conflicted panel members recommended against a medication or recused themselves from voting,” they said.

Mr. Khan disclosed research funding from AbbVie and Ferring Pharmaceuticals.

SOURCE: Combs T et al. JAMA Intern Med. 2018 Oct 29. doi: 10.1001/jamainternmed.2018.4730. Khan R et al. JAMA Intern Med. 2018 Oct 29. doi: 10.1001/jamainternmed.2018.5106.

Financial conflicts are often underreported by authors of clinical practice guidelines (CPGs) in several specialties including oncology, rheumatology, and gastroenterology, according to a pair of research letters published in JAMA Internal Medicine. The Institute of Medicine recommends that guideline authors include no more than 50% individuals with financial conflicts.

In one research letter, Rishad Khan, BSc, of the University of Toronto in Ontario and his colleagues reviewed data on undeclared financial conflicts of interest among authors of guidelines related to high-revenue medications.

The researchers identified CPGs via the National Guideline Clearinghouse and selected 18 CPGs for 10 high-revenue medications published between 2013 and 2017. Financial conflicts of interest were based on the Centers for Medicare & Medicaid Services Open Payments.

Of the 160 authors involved in the various guidelines, 79 (49.4%) disclosed a payment in the CPG or supplemental materials, and 50 (31.3%) disclosed payments from companies marketing 1 of the 10 high-revenue medications in the related guidelines.

Another 41 authors (25.6%) received but did not disclose payments from companies marketing 1 of the 10 high-revenue medications in CPGs.

Overall, 91 authors (56.9%) were found to have financial conflicts of interest that involved 1 of the 10 high-revenue medications, and “the median value of undeclared payments from companies marketing 1 of the 10 high-revenue medications recommended in the CPGs was $522 (interquartile range, $0-$40,444) from two companies,” the researchers said.

The study findings were limited by several factors including “potential inaccuracies in CMS-OP reporting, which are rarely corrected, and lack of generalizability outside the United States” and by the limited time frame for data collection, which may have led to underestimation of conflicts for the guidelines, the researchers noted. In addition, “we did not have access to guideline voting records and thus did not know when conflicted panel members recommended against a medication or recused themselves from voting,” they said.

Mr. Khan disclosed research funding from AbbVie and Ferring Pharmaceuticals.

SOURCE: Combs T et al. JAMA Intern Med. 2018 Oct 29. doi: 10.1001/jamainternmed.2018.4730. Khan R et al. JAMA Intern Med. 2018 Oct 29. doi: 10.1001/jamainternmed.2018.5106.

Financial conflicts are often underreported by authors of clinical practice guidelines (CPGs) in several specialties including oncology, rheumatology, and gastroenterology, according to a pair of research letters published in JAMA Internal Medicine. The Institute of Medicine recommends that guideline authors include no more than 50% individuals with financial conflicts.

In one research letter, Rishad Khan, BSc, of the University of Toronto in Ontario and his colleagues reviewed data on undeclared financial conflicts of interest among authors of guidelines related to high-revenue medications.

The researchers identified CPGs via the National Guideline Clearinghouse and selected 18 CPGs for 10 high-revenue medications published between 2013 and 2017. Financial conflicts of interest were based on the Centers for Medicare & Medicaid Services Open Payments.

Of the 160 authors involved in the various guidelines, 79 (49.4%) disclosed a payment in the CPG or supplemental materials, and 50 (31.3%) disclosed payments from companies marketing 1 of the 10 high-revenue medications in the related guidelines.

Another 41 authors (25.6%) received but did not disclose payments from companies marketing 1 of the 10 high-revenue medications in CPGs.

Overall, 91 authors (56.9%) were found to have financial conflicts of interest that involved 1 of the 10 high-revenue medications, and “the median value of undeclared payments from companies marketing 1 of the 10 high-revenue medications recommended in the CPGs was $522 (interquartile range, $0-$40,444) from two companies,” the researchers said.

The study findings were limited by several factors including “potential inaccuracies in CMS-OP reporting, which are rarely corrected, and lack of generalizability outside the United States” and by the limited time frame for data collection, which may have led to underestimation of conflicts for the guidelines, the researchers noted. In addition, “we did not have access to guideline voting records and thus did not know when conflicted panel members recommended against a medication or recused themselves from voting,” they said.

Mr. Khan disclosed research funding from AbbVie and Ferring Pharmaceuticals.

SOURCE: Combs T et al. JAMA Intern Med. 2018 Oct 29. doi: 10.1001/jamainternmed.2018.4730. Khan R et al. JAMA Intern Med. 2018 Oct 29. doi: 10.1001/jamainternmed.2018.5106.

MONTREAL—The optimal length for dual antiplatelet therapy (DAPT) in patients with mild stroke or transient ischemic attack (TIA) is 21 days, according to a prespecified analysis of data from the Platelet-Oriented Inhibition in New TIA and Minor Ischemic Stroke (POINT) trial that was presented at the 11th World Stroke Congress. This duration of combined treatment maximizes protection against major ischemic events while minimizing the extra risk of a major hemorrhage, the researchers said.

Clopidogrel Plus Aspirin or Aspirin Alone

The POINT trial randomized 4,881 patients with a recent mild stroke or TIA and without atrial fibrillation to treatment with either clopidogrel plus aspirin or aspirin alone for 90 days. Compared with aspirin alone, DAPT decreased the incidence of a major ischemic event by 25% and more than doubled the rate of major hemorrhage.

The new prespecified analysis looked at outcomes on a weekly basis during 90 days of treatment. During the first 21 days, the rate of major hemorrhage events was 5.6% among those patients on aspirin alone and 3.6% among those on DAPT. Thus, DAPT was associated with a statistically significant 35% decrease in these adverse outcomes, said Jordan J. Elm, PhD, Associate Professor of Biostatistics at the Medical University of South Carolina in Charleston. During the subsequent 69 days of treatment, the incidence of major ischemic events was approximately 1% in both arms of the study, showing that after three weeks, the incremental benefit of DAPT disappeared, said Dr. Elm.

Early Treatment

Another finding from the new analysis was that many major ischemic events, hence many of the events prevented by DAPT, occurred during the first two days following the index event. The POINT investigators were able to observe this finding because they enrolled patients and started treatment within 12 hours of the qualifying events.

“It is better to start treatment early,” said Dr. Elm. Major ischemic events continued to accumulate during Days 3 through 21, suggesting that patients could still benefit from DAPT if treatment did not start until 24 or 48 hours after the index event.

—Mitchel L. Zoler

Suggested Reading

Johnston SC, Easton JD, Farrant M, et al. Clopidogrel and aspirin in acute ischemic stroke and high-risk TIA. N Engl J Med. 2018;379(3):215-225.

Tsivgoulis G, Safouris A, Kim DE, Alexandrov AV. Recent advances in primary and secondary prevention of atherosclerotic stroke. J Stroke. 2018;20(2):145-166.

Wang Y, Wang Y, Zhao X, et al. Clopidogrel with aspirin in acute minor stroke or transient ischemic attack. N Engl J Med. 2013;369(1):11-19.

MONTREAL—The optimal length for dual antiplatelet therapy (DAPT) in patients with mild stroke or transient ischemic attack (TIA) is 21 days, according to a prespecified analysis of data from the Platelet-Oriented Inhibition in New TIA and Minor Ischemic Stroke (POINT) trial that was presented at the 11th World Stroke Congress. This duration of combined treatment maximizes protection against major ischemic events while minimizing the extra risk of a major hemorrhage, the researchers said.

Clopidogrel Plus Aspirin or Aspirin Alone

The POINT trial randomized 4,881 patients with a recent mild stroke or TIA and without atrial fibrillation to treatment with either clopidogrel plus aspirin or aspirin alone for 90 days. Compared with aspirin alone, DAPT decreased the incidence of a major ischemic event by 25% and more than doubled the rate of major hemorrhage.

The new prespecified analysis looked at outcomes on a weekly basis during 90 days of treatment. During the first 21 days, the rate of major hemorrhage events was 5.6% among those patients on aspirin alone and 3.6% among those on DAPT. Thus, DAPT was associated with a statistically significant 35% decrease in these adverse outcomes, said Jordan J. Elm, PhD, Associate Professor of Biostatistics at the Medical University of South Carolina in Charleston. During the subsequent 69 days of treatment, the incidence of major ischemic events was approximately 1% in both arms of the study, showing that after three weeks, the incremental benefit of DAPT disappeared, said Dr. Elm.

Early Treatment

Another finding from the new analysis was that many major ischemic events, hence many of the events prevented by DAPT, occurred during the first two days following the index event. The POINT investigators were able to observe this finding because they enrolled patients and started treatment within 12 hours of the qualifying events.

“It is better to start treatment early,” said Dr. Elm. Major ischemic events continued to accumulate during Days 3 through 21, suggesting that patients could still benefit from DAPT if treatment did not start until 24 or 48 hours after the index event.

—Mitchel L. Zoler

Suggested Reading

Johnston SC, Easton JD, Farrant M, et al. Clopidogrel and aspirin in acute ischemic stroke and high-risk TIA. N Engl J Med. 2018;379(3):215-225.

Tsivgoulis G, Safouris A, Kim DE, Alexandrov AV. Recent advances in primary and secondary prevention of atherosclerotic stroke. J Stroke. 2018;20(2):145-166.

Wang Y, Wang Y, Zhao X, et al. Clopidogrel with aspirin in acute minor stroke or transient ischemic attack. N Engl J Med. 2013;369(1):11-19.

MONTREAL—The optimal length for dual antiplatelet therapy (DAPT) in patients with mild stroke or transient ischemic attack (TIA) is 21 days, according to a prespecified analysis of data from the Platelet-Oriented Inhibition in New TIA and Minor Ischemic Stroke (POINT) trial that was presented at the 11th World Stroke Congress. This duration of combined treatment maximizes protection against major ischemic events while minimizing the extra risk of a major hemorrhage, the researchers said.

Clopidogrel Plus Aspirin or Aspirin Alone

The POINT trial randomized 4,881 patients with a recent mild stroke or TIA and without atrial fibrillation to treatment with either clopidogrel plus aspirin or aspirin alone for 90 days. Compared with aspirin alone, DAPT decreased the incidence of a major ischemic event by 25% and more than doubled the rate of major hemorrhage.

The new prespecified analysis looked at outcomes on a weekly basis during 90 days of treatment. During the first 21 days, the rate of major hemorrhage events was 5.6% among those patients on aspirin alone and 3.6% among those on DAPT. Thus, DAPT was associated with a statistically significant 35% decrease in these adverse outcomes, said Jordan J. Elm, PhD, Associate Professor of Biostatistics at the Medical University of South Carolina in Charleston. During the subsequent 69 days of treatment, the incidence of major ischemic events was approximately 1% in both arms of the study, showing that after three weeks, the incremental benefit of DAPT disappeared, said Dr. Elm.

Early Treatment

Another finding from the new analysis was that many major ischemic events, hence many of the events prevented by DAPT, occurred during the first two days following the index event. The POINT investigators were able to observe this finding because they enrolled patients and started treatment within 12 hours of the qualifying events.

“It is better to start treatment early,” said Dr. Elm. Major ischemic events continued to accumulate during Days 3 through 21, suggesting that patients could still benefit from DAPT if treatment did not start until 24 or 48 hours after the index event.

—Mitchel L. Zoler

Suggested Reading

Johnston SC, Easton JD, Farrant M, et al. Clopidogrel and aspirin in acute ischemic stroke and high-risk TIA. N Engl J Med. 2018;379(3):215-225.

Tsivgoulis G, Safouris A, Kim DE, Alexandrov AV. Recent advances in primary and secondary prevention of atherosclerotic stroke. J Stroke. 2018;20(2):145-166.

Wang Y, Wang Y, Zhao X, et al. Clopidogrel with aspirin in acute minor stroke or transient ischemic attack. N Engl J Med. 2013;369(1):11-19.

In 2015, 75% of U.S. hospitals with more than 50 beds had palliative care programs – a sharp increase from the 25% that had palliative care in 2000.

“The rapid adoption of this high-value program, which is voluntary and runs counter to the dominant culture in U.S. hospitals, was catalyzed by tens of millions of dollars in philanthropic support for innovation, dissemination, and professionalization in the palliative care field,” according to research published in Health Affairs.
 

Reference

Cassel JB et al. Palliative care leadership centers are key to the diffusion of palliative care innovation. Health Aff. 2018 Feb. doi: 10.1377/hlthaff.2017.1122.

In 2015, 75% of U.S. hospitals with more than 50 beds had palliative care programs – a sharp increase from the 25% that had palliative care in 2000.

“The rapid adoption of this high-value program, which is voluntary and runs counter to the dominant culture in U.S. hospitals, was catalyzed by tens of millions of dollars in philanthropic support for innovation, dissemination, and professionalization in the palliative care field,” according to research published in Health Affairs.
 

Reference

Cassel JB et al. Palliative care leadership centers are key to the diffusion of palliative care innovation. Health Aff. 2018 Feb. doi: 10.1377/hlthaff.2017.1122.

In 2015, 75% of U.S. hospitals with more than 50 beds had palliative care programs – a sharp increase from the 25% that had palliative care in 2000.

“The rapid adoption of this high-value program, which is voluntary and runs counter to the dominant culture in U.S. hospitals, was catalyzed by tens of millions of dollars in philanthropic support for innovation, dissemination, and professionalization in the palliative care field,” according to research published in Health Affairs.
 

Reference

Cassel JB et al. Palliative care leadership centers are key to the diffusion of palliative care innovation. Health Aff. 2018 Feb. doi: 10.1377/hlthaff.2017.1122.

ORLANDO – Many pediatricians have little support or guidance in how to address the unique issues that arise during care of transgender and gender-diverse children and adolescents, Colleen A. Kraft, MD, president of the American Academy of Pediatrics, said in an interview.

The AAP’s policy on caring and supporting these patients is evidence-based, and includes recommendations on providing appropriate health care services for transgender individuals, as well as respect and understanding for families. In the interview, Dr. Kraft, discussed the role pediatricians have in providing a safe and supportive environment for transgender and gender-diverse individuals and their families.

“[These children] need to be listened to, they need to be respected for who they are, and they need access to the appropriate health services,” Dr. Kraft said.

The AAP’s policy statement on ensuring care and support for transgender children and adolescents is available here.

Dr. Kraft reported no relevant conflicts of interest.

ORLANDO – Many pediatricians have little support or guidance in how to address the unique issues that arise during care of transgender and gender-diverse children and adolescents, Colleen A. Kraft, MD, president of the American Academy of Pediatrics, said in an interview.

The AAP’s policy on caring and supporting these patients is evidence-based, and includes recommendations on providing appropriate health care services for transgender individuals, as well as respect and understanding for families. In the interview, Dr. Kraft, discussed the role pediatricians have in providing a safe and supportive environment for transgender and gender-diverse individuals and their families.

“[These children] need to be listened to, they need to be respected for who they are, and they need access to the appropriate health services,” Dr. Kraft said.

The AAP’s policy statement on ensuring care and support for transgender children and adolescents is available here.

Dr. Kraft reported no relevant conflicts of interest.

ORLANDO – Many pediatricians have little support or guidance in how to address the unique issues that arise during care of transgender and gender-diverse children and adolescents, Colleen A. Kraft, MD, president of the American Academy of Pediatrics, said in an interview.

The AAP’s policy on caring and supporting these patients is evidence-based, and includes recommendations on providing appropriate health care services for transgender individuals, as well as respect and understanding for families. In the interview, Dr. Kraft, discussed the role pediatricians have in providing a safe and supportive environment for transgender and gender-diverse individuals and their families.

“[These children] need to be listened to, they need to be respected for who they are, and they need access to the appropriate health services,” Dr. Kraft said.

The AAP’s policy statement on ensuring care and support for transgender children and adolescents is available here.

Dr. Kraft reported no relevant conflicts of interest.

At the end of September, Amarin Corp. teased some early findings for Vascepa, its preventive medicine for people at risk of heart disease. The claim was astounding: a 25% relative risk reduction for deaths related to heart attacks, strokes, and other conditions. Headlines proclaimed a potential game changer in treating cardiovascular disease. And company shares quickly soared, from $3 a share to about $20.

Vascepa is Amarin’s only product. The company hopes to turn its pill made of purified fish oil into a cash cow, allowing it to staff up both in the United States and abroad so it can sell doctors and millions of consumers on its medical benefits. Although the product has been on the market for more than 5 years, its first TV ad campaign rolled out this summer in anticipation of the study findings.

Except there is one problem. The particulars of the scientific study on which this claim was based remain a mystery.

Amarin’s preliminary announcement came via a news release on Sept. 24. The company plans to release detailed findings in November at the national American Heart Association conference. Then early next year, it plans to seek Food and Drug Administration approval to use the drug as a preventive for a range of heart conditions, beyond its current role targeting high triglyceride levels.

In the interim, a battle is brewing among physicians, cardiovascular experts, and pharma watchers who say Vascepa brings to the foreground troubling trends in the marketing and advertising of new drugs. Companies sometimes promote new products, but withhold the detailed findings until much later. The consequences for both consumers and the health system are vast.

“Until all the data is available for review by the public and medical community, it’s really premature to see some of the cheerleading that’s being done,” said Eric Strong, MD, a hospitalist and clinical assistant professor at Stanford (Calif.) University. “It’s harder to change people’s minds once you have these rosy pictures.”

John Thero, Amarin’s CEO, argued that the imminent release of the drug’s complete picture should alleviate those concerns.

In unveiling topline findings in a news release, he said, the company’s playbook doesn’t diverge from that of other pharmaceutical makers and provides a necessary level of disclosure for shareholders.

But it’s the specifics in the data – for instance, which patients benefited, by how much, their absolute risk reduction and which precise conditions saw improvement – that illustrate whether a product is cost effective, said medical and drug experts.

That’s especially true in the case of Vascepa, whose manufacturer is working hard to convince people the product is clinically superior to ordinary fish oil supplements. Fish oil, which can retail for a few dollars a bottle, has long been promoted as a preventive for heart disease. But the substance has never held up in clinical trials as a way to systematically lower disease risk, said experts.

That’s where Amarin’s product is superior, Mr. Thero said.

The manufacturer has tried to limit competition by seeking to block other fish oil products, arguing to the U.S. International Trade Commission that omega-3 supplements aren’t equivalents, and calling on the FDA to block a chemical component of fish oil, known as EPA or eicosapentaenoic acid, and marketed by a number of supplement companies, from being sold as a dietary supplement. Amarin hasn’t yet prevailed.

Preston Mason, PhD, a biologist and faculty member in the division of cardiology at Brigham and Women’s Hospital, Boston, who consults for Amarin and has advocated on its behalf, argued that ordinary fish oil supplements carry risks because they are not regulated or approved by the FDA, which does oversee prescription drugs like Vascepa.

How Vascepa performs against regular fish oil remains unknown. Amarin’s trial compared the drug against a placebo, not over-the-counter supplements.

Vascepa itself isn’t new. It was approved in 2012 as a remedy for extremely high triglyceride levels, which can put patients at risk for pancreatic problems. But reducing that fat hadn’t been conclusively tied to, say, lowering the risk of heart attacks, or other major cardiac problems.

That link, ostensibly, is what Amarin is trying now to assert. And there’s plenty of money to be made if it succeeds.

As of last December, Vascepa retailed for about $280 for a month-long supply, a list price increase of 43% over 5 years, though the company says its net sale price has stayed the same. (That difference would come if Amarin increased the size of rebates, or discounts it provides, commensurate with price hikes.)

Now, citing the drug’s potentially increased value, Amarin has declined to say whether it will change the price again – though Mr. Thero said he sees greater profit potential if the company increases sales volume rather than price.

This gets at the crux of this debate. If a company makes available the technical details of a product, but only after hyping the findings, and if the details undercut some of that buzz – is it too late?

Khurram Nasir, MD, a cardiologist at Yale University in New Haven, Conn., acknowledged that it’s unclear how effective Vascepa really is, but maintained those ambiguities will be cleared up soon enough.

“As the findings reveal themselves, there will be a lot of discussion around cost effectiveness, and whether this is worth the spend,” Dr. Nasir said.

Dr. Mason, the Amarin scientist, said FDA scrutiny also can alleviate concerns about overhype.

But others worry the perception of Vascepa’s effectiveness is now set.

“People are weighing in with really strong language, without enough information,” said Lisa Schwartz, MD, MS, who codirects the Center for Medicine and Media at Dartmouth Institute in Hanover, N.H., and studies effective scientific communication.

That has both clinical and financial consequences, she added. Doctors are more likely to prescribe a product that’s been heavily promoted, even if subsequent discussion indicates the drug isn’t as powerful as initially implied. And manufacturers can cash in, whether through increased company stock market value or by charging higher list prices.

For Vascepa, the central question is which specific heart conditions saw risk reduction, she and others said. In its news release, Amarin noted a “composite outcome” – that is, the 25% relative improvement encompassed all conditions for which the researchers tested.

“People are saying, Wow, it reduced heart attack, stroke and blah, blah, blah – when it may just reduce the least important one,” said Steven Woloshin, MD, MS, who also codirects the Center for Medicine and Media at Dartmouth.

Another issue: The Vascepa trial focused on a specific population — patients with high triglyceride levels plus elevated risk of cardiovascular disease or diabetes who were already taking a daily statin. That means any proof of benefit is limited to that group.

Dr. Woloshin and Dr. Schwartz both suggested that nuance could get lost in translation. “It is this much narrower, high-risk population,” Dr. Schwartz said.

Dr. Woloshin added, “The fear is [the message] would generalize to anyone with high triglycerides.”

This concern is amplified by a 2016 court settlement in which the FDA permitted Amarin to market Vascepa to audiences for whom it hasn’t been specifically approved – so long as the company doesn’t say anything untrue about the drug.

Mr. Thero said Amarin’s marketing of Vascepa has stayed, and will remain, consistent with what is factual and relevant.

“We are proceeding consistently with what the FDA has guided,” he said.

But, some experts said, the 2016 settlement could unlock the door to wider marketing of Vascepa’s off-label use, implying the pill benefits more people than it actually does.

“They’ll take pains to show how different this is from everything out there ... and its results in these populations,” said Ameet Sarpatwari, MD, JD, an epidemiologist and lawyer at Harvard Medical School, Boston, who studies the pharmaceutical industry. “What they can’t do is say it will be beneficial to these other populations. But they can hint at that.”



Kaiser Health News is a nonprofit national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation that is not affiliated with Kaiser Permanente.

At the end of September, Amarin Corp. teased some early findings for Vascepa, its preventive medicine for people at risk of heart disease. The claim was astounding: a 25% relative risk reduction for deaths related to heart attacks, strokes, and other conditions. Headlines proclaimed a potential game changer in treating cardiovascular disease. And company shares quickly soared, from $3 a share to about $20.

Vascepa is Amarin’s only product. The company hopes to turn its pill made of purified fish oil into a cash cow, allowing it to staff up both in the United States and abroad so it can sell doctors and millions of consumers on its medical benefits. Although the product has been on the market for more than 5 years, its first TV ad campaign rolled out this summer in anticipation of the study findings.

Except there is one problem. The particulars of the scientific study on which this claim was based remain a mystery.

Amarin’s preliminary announcement came via a news release on Sept. 24. The company plans to release detailed findings in November at the national American Heart Association conference. Then early next year, it plans to seek Food and Drug Administration approval to use the drug as a preventive for a range of heart conditions, beyond its current role targeting high triglyceride levels.

In the interim, a battle is brewing among physicians, cardiovascular experts, and pharma watchers who say Vascepa brings to the foreground troubling trends in the marketing and advertising of new drugs. Companies sometimes promote new products, but withhold the detailed findings until much later. The consequences for both consumers and the health system are vast.

“Until all the data is available for review by the public and medical community, it’s really premature to see some of the cheerleading that’s being done,” said Eric Strong, MD, a hospitalist and clinical assistant professor at Stanford (Calif.) University. “It’s harder to change people’s minds once you have these rosy pictures.”

John Thero, Amarin’s CEO, argued that the imminent release of the drug’s complete picture should alleviate those concerns.

In unveiling topline findings in a news release, he said, the company’s playbook doesn’t diverge from that of other pharmaceutical makers and provides a necessary level of disclosure for shareholders.

But it’s the specifics in the data – for instance, which patients benefited, by how much, their absolute risk reduction and which precise conditions saw improvement – that illustrate whether a product is cost effective, said medical and drug experts.

That’s especially true in the case of Vascepa, whose manufacturer is working hard to convince people the product is clinically superior to ordinary fish oil supplements. Fish oil, which can retail for a few dollars a bottle, has long been promoted as a preventive for heart disease. But the substance has never held up in clinical trials as a way to systematically lower disease risk, said experts.

That’s where Amarin’s product is superior, Mr. Thero said.

The manufacturer has tried to limit competition by seeking to block other fish oil products, arguing to the U.S. International Trade Commission that omega-3 supplements aren’t equivalents, and calling on the FDA to block a chemical component of fish oil, known as EPA or eicosapentaenoic acid, and marketed by a number of supplement companies, from being sold as a dietary supplement. Amarin hasn’t yet prevailed.

Preston Mason, PhD, a biologist and faculty member in the division of cardiology at Brigham and Women’s Hospital, Boston, who consults for Amarin and has advocated on its behalf, argued that ordinary fish oil supplements carry risks because they are not regulated or approved by the FDA, which does oversee prescription drugs like Vascepa.

How Vascepa performs against regular fish oil remains unknown. Amarin’s trial compared the drug against a placebo, not over-the-counter supplements.

Vascepa itself isn’t new. It was approved in 2012 as a remedy for extremely high triglyceride levels, which can put patients at risk for pancreatic problems. But reducing that fat hadn’t been conclusively tied to, say, lowering the risk of heart attacks, or other major cardiac problems.

That link, ostensibly, is what Amarin is trying now to assert. And there’s plenty of money to be made if it succeeds.

As of last December, Vascepa retailed for about $280 for a month-long supply, a list price increase of 43% over 5 years, though the company says its net sale price has stayed the same. (That difference would come if Amarin increased the size of rebates, or discounts it provides, commensurate with price hikes.)

Now, citing the drug’s potentially increased value, Amarin has declined to say whether it will change the price again – though Mr. Thero said he sees greater profit potential if the company increases sales volume rather than price.

This gets at the crux of this debate. If a company makes available the technical details of a product, but only after hyping the findings, and if the details undercut some of that buzz – is it too late?

Khurram Nasir, MD, a cardiologist at Yale University in New Haven, Conn., acknowledged that it’s unclear how effective Vascepa really is, but maintained those ambiguities will be cleared up soon enough.

“As the findings reveal themselves, there will be a lot of discussion around cost effectiveness, and whether this is worth the spend,” Dr. Nasir said.

Dr. Mason, the Amarin scientist, said FDA scrutiny also can alleviate concerns about overhype.

But others worry the perception of Vascepa’s effectiveness is now set.

“People are weighing in with really strong language, without enough information,” said Lisa Schwartz, MD, MS, who codirects the Center for Medicine and Media at Dartmouth Institute in Hanover, N.H., and studies effective scientific communication.

That has both clinical and financial consequences, she added. Doctors are more likely to prescribe a product that’s been heavily promoted, even if subsequent discussion indicates the drug isn’t as powerful as initially implied. And manufacturers can cash in, whether through increased company stock market value or by charging higher list prices.

For Vascepa, the central question is which specific heart conditions saw risk reduction, she and others said. In its news release, Amarin noted a “composite outcome” – that is, the 25% relative improvement encompassed all conditions for which the researchers tested.

“People are saying, Wow, it reduced heart attack, stroke and blah, blah, blah – when it may just reduce the least important one,” said Steven Woloshin, MD, MS, who also codirects the Center for Medicine and Media at Dartmouth.

Another issue: The Vascepa trial focused on a specific population — patients with high triglyceride levels plus elevated risk of cardiovascular disease or diabetes who were already taking a daily statin. That means any proof of benefit is limited to that group.

Dr. Woloshin and Dr. Schwartz both suggested that nuance could get lost in translation. “It is this much narrower, high-risk population,” Dr. Schwartz said.

Dr. Woloshin added, “The fear is [the message] would generalize to anyone with high triglycerides.”

This concern is amplified by a 2016 court settlement in which the FDA permitted Amarin to market Vascepa to audiences for whom it hasn’t been specifically approved – so long as the company doesn’t say anything untrue about the drug.

Mr. Thero said Amarin’s marketing of Vascepa has stayed, and will remain, consistent with what is factual and relevant.

“We are proceeding consistently with what the FDA has guided,” he said.

But, some experts said, the 2016 settlement could unlock the door to wider marketing of Vascepa’s off-label use, implying the pill benefits more people than it actually does.

“They’ll take pains to show how different this is from everything out there ... and its results in these populations,” said Ameet Sarpatwari, MD, JD, an epidemiologist and lawyer at Harvard Medical School, Boston, who studies the pharmaceutical industry. “What they can’t do is say it will be beneficial to these other populations. But they can hint at that.”



Kaiser Health News is a nonprofit national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation that is not affiliated with Kaiser Permanente.

At the end of September, Amarin Corp. teased some early findings for Vascepa, its preventive medicine for people at risk of heart disease. The claim was astounding: a 25% relative risk reduction for deaths related to heart attacks, strokes, and other conditions. Headlines proclaimed a potential game changer in treating cardiovascular disease. And company shares quickly soared, from $3 a share to about $20.

Vascepa is Amarin’s only product. The company hopes to turn its pill made of purified fish oil into a cash cow, allowing it to staff up both in the United States and abroad so it can sell doctors and millions of consumers on its medical benefits. Although the product has been on the market for more than 5 years, its first TV ad campaign rolled out this summer in anticipation of the study findings.

Except there is one problem. The particulars of the scientific study on which this claim was based remain a mystery.

Amarin’s preliminary announcement came via a news release on Sept. 24. The company plans to release detailed findings in November at the national American Heart Association conference. Then early next year, it plans to seek Food and Drug Administration approval to use the drug as a preventive for a range of heart conditions, beyond its current role targeting high triglyceride levels.

In the interim, a battle is brewing among physicians, cardiovascular experts, and pharma watchers who say Vascepa brings to the foreground troubling trends in the marketing and advertising of new drugs. Companies sometimes promote new products, but withhold the detailed findings until much later. The consequences for both consumers and the health system are vast.

“Until all the data is available for review by the public and medical community, it’s really premature to see some of the cheerleading that’s being done,” said Eric Strong, MD, a hospitalist and clinical assistant professor at Stanford (Calif.) University. “It’s harder to change people’s minds once you have these rosy pictures.”

John Thero, Amarin’s CEO, argued that the imminent release of the drug’s complete picture should alleviate those concerns.

In unveiling topline findings in a news release, he said, the company’s playbook doesn’t diverge from that of other pharmaceutical makers and provides a necessary level of disclosure for shareholders.

But it’s the specifics in the data – for instance, which patients benefited, by how much, their absolute risk reduction and which precise conditions saw improvement – that illustrate whether a product is cost effective, said medical and drug experts.

That’s especially true in the case of Vascepa, whose manufacturer is working hard to convince people the product is clinically superior to ordinary fish oil supplements. Fish oil, which can retail for a few dollars a bottle, has long been promoted as a preventive for heart disease. But the substance has never held up in clinical trials as a way to systematically lower disease risk, said experts.

That’s where Amarin’s product is superior, Mr. Thero said.

The manufacturer has tried to limit competition by seeking to block other fish oil products, arguing to the U.S. International Trade Commission that omega-3 supplements aren’t equivalents, and calling on the FDA to block a chemical component of fish oil, known as EPA or eicosapentaenoic acid, and marketed by a number of supplement companies, from being sold as a dietary supplement. Amarin hasn’t yet prevailed.

Preston Mason, PhD, a biologist and faculty member in the division of cardiology at Brigham and Women’s Hospital, Boston, who consults for Amarin and has advocated on its behalf, argued that ordinary fish oil supplements carry risks because they are not regulated or approved by the FDA, which does oversee prescription drugs like Vascepa.

How Vascepa performs against regular fish oil remains unknown. Amarin’s trial compared the drug against a placebo, not over-the-counter supplements.

Vascepa itself isn’t new. It was approved in 2012 as a remedy for extremely high triglyceride levels, which can put patients at risk for pancreatic problems. But reducing that fat hadn’t been conclusively tied to, say, lowering the risk of heart attacks, or other major cardiac problems.

That link, ostensibly, is what Amarin is trying now to assert. And there’s plenty of money to be made if it succeeds.

As of last December, Vascepa retailed for about $280 for a month-long supply, a list price increase of 43% over 5 years, though the company says its net sale price has stayed the same. (That difference would come if Amarin increased the size of rebates, or discounts it provides, commensurate with price hikes.)

Now, citing the drug’s potentially increased value, Amarin has declined to say whether it will change the price again – though Mr. Thero said he sees greater profit potential if the company increases sales volume rather than price.

This gets at the crux of this debate. If a company makes available the technical details of a product, but only after hyping the findings, and if the details undercut some of that buzz – is it too late?

Khurram Nasir, MD, a cardiologist at Yale University in New Haven, Conn., acknowledged that it’s unclear how effective Vascepa really is, but maintained those ambiguities will be cleared up soon enough.

“As the findings reveal themselves, there will be a lot of discussion around cost effectiveness, and whether this is worth the spend,” Dr. Nasir said.

Dr. Mason, the Amarin scientist, said FDA scrutiny also can alleviate concerns about overhype.

But others worry the perception of Vascepa’s effectiveness is now set.

“People are weighing in with really strong language, without enough information,” said Lisa Schwartz, MD, MS, who codirects the Center for Medicine and Media at Dartmouth Institute in Hanover, N.H., and studies effective scientific communication.

That has both clinical and financial consequences, she added. Doctors are more likely to prescribe a product that’s been heavily promoted, even if subsequent discussion indicates the drug isn’t as powerful as initially implied. And manufacturers can cash in, whether through increased company stock market value or by charging higher list prices.

For Vascepa, the central question is which specific heart conditions saw risk reduction, she and others said. In its news release, Amarin noted a “composite outcome” – that is, the 25% relative improvement encompassed all conditions for which the researchers tested.

“People are saying, Wow, it reduced heart attack, stroke and blah, blah, blah – when it may just reduce the least important one,” said Steven Woloshin, MD, MS, who also codirects the Center for Medicine and Media at Dartmouth.

Another issue: The Vascepa trial focused on a specific population — patients with high triglyceride levels plus elevated risk of cardiovascular disease or diabetes who were already taking a daily statin. That means any proof of benefit is limited to that group.

Dr. Woloshin and Dr. Schwartz both suggested that nuance could get lost in translation. “It is this much narrower, high-risk population,” Dr. Schwartz said.

Dr. Woloshin added, “The fear is [the message] would generalize to anyone with high triglycerides.”

This concern is amplified by a 2016 court settlement in which the FDA permitted Amarin to market Vascepa to audiences for whom it hasn’t been specifically approved – so long as the company doesn’t say anything untrue about the drug.

Mr. Thero said Amarin’s marketing of Vascepa has stayed, and will remain, consistent with what is factual and relevant.

“We are proceeding consistently with what the FDA has guided,” he said.

But, some experts said, the 2016 settlement could unlock the door to wider marketing of Vascepa’s off-label use, implying the pill benefits more people than it actually does.

“They’ll take pains to show how different this is from everything out there ... and its results in these populations,” said Ameet Sarpatwari, MD, JD, an epidemiologist and lawyer at Harvard Medical School, Boston, who studies the pharmaceutical industry. “What they can’t do is say it will be beneficial to these other populations. But they can hint at that.”



Kaiser Health News is a nonprofit national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation that is not affiliated with Kaiser Permanente.

SAN DIEGO – Point-of-care ultrasound should be the go-to approach for the routine assessment of suspected shoulder dislocations in the ED, based on data from a prospective, multicenter study presented at the annual meeting of the American College of Emergency Physicians.

In the observational study, the average time needed to diagnose shoulder dislocation using ultrasound was 18 seconds, far faster than time from triage to x-ray, according to Michael Secko, MD, director of the emergency ultrasound division at Stony Brook University (NY).

The results from this study, called MUDDS (Musculoskeletal Ultrasound to Diagnose Dislocated Shoulders), support point-of-care ultrasound as a faster and more readily performed alternative to x-ray. Of the 46 adult patients enrolled so far in the ongoing study, ultrasound’s sensitivity has been 96% and its specificity 100% when validated by x-ray findings.

In the study, adults presenting to the ED are evaluated with point-of-care ultrasound from a posterior approach using either a curvilinear or linear transducer in the transverse plane. About half of the patients enrolled so far had injuries caused by falls, and many of the others had a shoulder complaint related to being pulled. Slightly more than one-third had a previous shoulder dislocation.

When evaluated with point-of-care ultrasound and x-ray, 23 of the 42 evaluable patients had a dislocation. The time from triage to ultrasound evaluation averaged 60 minutes, 40 minutes faster than the average of 100 minutes from triage to x-ray. Both tests were ordered at the same time.

Ultrasound performed less well for the diagnosis of a fracture, with a sensitivity of only 53%. Dr. Secko said the anterior approach would not be expected to provide a comprehensive assessment for fracture. He noted, for example, that there was no attempt in this study to evaluate patients for the presence of Bankart lesions. However, in those found to have a fracture on point-of-care ultrasound, the specificity of this imaging tool was 96%.

Ultimately, a major goal of this study was to determine whether a posterior point-of-care ultrasound could provide a quick answer to the question, “is it in or out?” Although patients are still being enrolled, Dr. Secko believed there is already good evidence that ultrasound is fast and effective for diagnosing dislocations.

Others have addressed this same question. Citing a meta-analysis published last year, Dr. Secko reported that all but one of four studies evaluating ultrasound for shoulder dislocations found a sensitivity and specificity of 100% (Gottlieb M et al. West J Emerg Med. 2017 Aug;18[5]:937-942).

Many centers have already switched to ultrasound for the evaluation of shoulder dislocations, according to Andrew S. Liteplo, MD, who moderated the ACEP session in which Dr. Secko presented his data. “If you are not already doing this for suspected shoulder dislocation, start right away because it is easy and awesome,” said Dr. Liteplo, who is chief of the division of ultrasound in emergency medicine at Massachusetts General Hospital, Boston. He also advised that ultrasound can also can be performed after reduction to confirm the efficacy of treatment.

Dr. Secko reported no financial relationships relevant to this study.
 

SAN DIEGO – Point-of-care ultrasound should be the go-to approach for the routine assessment of suspected shoulder dislocations in the ED, based on data from a prospective, multicenter study presented at the annual meeting of the American College of Emergency Physicians.

In the observational study, the average time needed to diagnose shoulder dislocation using ultrasound was 18 seconds, far faster than time from triage to x-ray, according to Michael Secko, MD, director of the emergency ultrasound division at Stony Brook University (NY).

The results from this study, called MUDDS (Musculoskeletal Ultrasound to Diagnose Dislocated Shoulders), support point-of-care ultrasound as a faster and more readily performed alternative to x-ray. Of the 46 adult patients enrolled so far in the ongoing study, ultrasound’s sensitivity has been 96% and its specificity 100% when validated by x-ray findings.

In the study, adults presenting to the ED are evaluated with point-of-care ultrasound from a posterior approach using either a curvilinear or linear transducer in the transverse plane. About half of the patients enrolled so far had injuries caused by falls, and many of the others had a shoulder complaint related to being pulled. Slightly more than one-third had a previous shoulder dislocation.

When evaluated with point-of-care ultrasound and x-ray, 23 of the 42 evaluable patients had a dislocation. The time from triage to ultrasound evaluation averaged 60 minutes, 40 minutes faster than the average of 100 minutes from triage to x-ray. Both tests were ordered at the same time.

Ultrasound performed less well for the diagnosis of a fracture, with a sensitivity of only 53%. Dr. Secko said the anterior approach would not be expected to provide a comprehensive assessment for fracture. He noted, for example, that there was no attempt in this study to evaluate patients for the presence of Bankart lesions. However, in those found to have a fracture on point-of-care ultrasound, the specificity of this imaging tool was 96%.

Ultimately, a major goal of this study was to determine whether a posterior point-of-care ultrasound could provide a quick answer to the question, “is it in or out?” Although patients are still being enrolled, Dr. Secko believed there is already good evidence that ultrasound is fast and effective for diagnosing dislocations.

Others have addressed this same question. Citing a meta-analysis published last year, Dr. Secko reported that all but one of four studies evaluating ultrasound for shoulder dislocations found a sensitivity and specificity of 100% (Gottlieb M et al. West J Emerg Med. 2017 Aug;18[5]:937-942).

Many centers have already switched to ultrasound for the evaluation of shoulder dislocations, according to Andrew S. Liteplo, MD, who moderated the ACEP session in which Dr. Secko presented his data. “If you are not already doing this for suspected shoulder dislocation, start right away because it is easy and awesome,” said Dr. Liteplo, who is chief of the division of ultrasound in emergency medicine at Massachusetts General Hospital, Boston. He also advised that ultrasound can also can be performed after reduction to confirm the efficacy of treatment.

Dr. Secko reported no financial relationships relevant to this study.
 

SAN DIEGO – Point-of-care ultrasound should be the go-to approach for the routine assessment of suspected shoulder dislocations in the ED, based on data from a prospective, multicenter study presented at the annual meeting of the American College of Emergency Physicians.

In the observational study, the average time needed to diagnose shoulder dislocation using ultrasound was 18 seconds, far faster than time from triage to x-ray, according to Michael Secko, MD, director of the emergency ultrasound division at Stony Brook University (NY).

The results from this study, called MUDDS (Musculoskeletal Ultrasound to Diagnose Dislocated Shoulders), support point-of-care ultrasound as a faster and more readily performed alternative to x-ray. Of the 46 adult patients enrolled so far in the ongoing study, ultrasound’s sensitivity has been 96% and its specificity 100% when validated by x-ray findings.

In the study, adults presenting to the ED are evaluated with point-of-care ultrasound from a posterior approach using either a curvilinear or linear transducer in the transverse plane. About half of the patients enrolled so far had injuries caused by falls, and many of the others had a shoulder complaint related to being pulled. Slightly more than one-third had a previous shoulder dislocation.

When evaluated with point-of-care ultrasound and x-ray, 23 of the 42 evaluable patients had a dislocation. The time from triage to ultrasound evaluation averaged 60 minutes, 40 minutes faster than the average of 100 minutes from triage to x-ray. Both tests were ordered at the same time.

Ultrasound performed less well for the diagnosis of a fracture, with a sensitivity of only 53%. Dr. Secko said the anterior approach would not be expected to provide a comprehensive assessment for fracture. He noted, for example, that there was no attempt in this study to evaluate patients for the presence of Bankart lesions. However, in those found to have a fracture on point-of-care ultrasound, the specificity of this imaging tool was 96%.

Ultimately, a major goal of this study was to determine whether a posterior point-of-care ultrasound could provide a quick answer to the question, “is it in or out?” Although patients are still being enrolled, Dr. Secko believed there is already good evidence that ultrasound is fast and effective for diagnosing dislocations.

Others have addressed this same question. Citing a meta-analysis published last year, Dr. Secko reported that all but one of four studies evaluating ultrasound for shoulder dislocations found a sensitivity and specificity of 100% (Gottlieb M et al. West J Emerg Med. 2017 Aug;18[5]:937-942).

Many centers have already switched to ultrasound for the evaluation of shoulder dislocations, according to Andrew S. Liteplo, MD, who moderated the ACEP session in which Dr. Secko presented his data. “If you are not already doing this for suspected shoulder dislocation, start right away because it is easy and awesome,” said Dr. Liteplo, who is chief of the division of ultrasound in emergency medicine at Massachusetts General Hospital, Boston. He also advised that ultrasound can also can be performed after reduction to confirm the efficacy of treatment.

Dr. Secko reported no financial relationships relevant to this study.
 

The Food and Drug Administration has granted accelerated approval to lorlatinib for patients with anaplastic lymphoma kinase (ALK)–positive metastatic non–small cell lung cancer (NSCLC) whose disease has progressed on crizotinib and at least one other ALK inhibitor for metastatic disease or whose disease has progressed on alectinib or ceritinib as the first ALK inhibitor therapy for metastatic disease.

Approval of the next-generation ALK inhibitor was based on an overall response rate of 48% – with 4% complete and 44% partial – in a subgroup of 215 patients with ALK-positive metastatic NSCLC enrolled in a nonrandomized, phase 2 trial, the FDA said in a press announcement. All patients had been previously treated with one or more ALK kinase inhibitors.

The median response duration was 12.5 months (95% confidence interval, 8.4-23.7) and the intracranial overall response rate in 89 patients with measurable lesions in the CNS was 60% (95% CI, 49-70) with 21% complete and 38% partial responses.

Common adverse reactions in patients receiving lorlatinib were edema, peripheral neuropathy, cognitive effects, dyspnea, fatigue, weight gain, arthralgia, mood effects, and diarrhea. The most common laboratory abnormalities were hypercholesterolemia and hypertriglyceridemia, the FDA said.

The recommended dose of lorlatinib, to be marketed as Lorbrena by Pfizer, is 100 mg orally once daily.

The Food and Drug Administration has granted accelerated approval to lorlatinib for patients with anaplastic lymphoma kinase (ALK)–positive metastatic non–small cell lung cancer (NSCLC) whose disease has progressed on crizotinib and at least one other ALK inhibitor for metastatic disease or whose disease has progressed on alectinib or ceritinib as the first ALK inhibitor therapy for metastatic disease.

Approval of the next-generation ALK inhibitor was based on an overall response rate of 48% – with 4% complete and 44% partial – in a subgroup of 215 patients with ALK-positive metastatic NSCLC enrolled in a nonrandomized, phase 2 trial, the FDA said in a press announcement. All patients had been previously treated with one or more ALK kinase inhibitors.

The median response duration was 12.5 months (95% confidence interval, 8.4-23.7) and the intracranial overall response rate in 89 patients with measurable lesions in the CNS was 60% (95% CI, 49-70) with 21% complete and 38% partial responses.

Common adverse reactions in patients receiving lorlatinib were edema, peripheral neuropathy, cognitive effects, dyspnea, fatigue, weight gain, arthralgia, mood effects, and diarrhea. The most common laboratory abnormalities were hypercholesterolemia and hypertriglyceridemia, the FDA said.

The recommended dose of lorlatinib, to be marketed as Lorbrena by Pfizer, is 100 mg orally once daily.

The Food and Drug Administration has granted accelerated approval to lorlatinib for patients with anaplastic lymphoma kinase (ALK)–positive metastatic non–small cell lung cancer (NSCLC) whose disease has progressed on crizotinib and at least one other ALK inhibitor for metastatic disease or whose disease has progressed on alectinib or ceritinib as the first ALK inhibitor therapy for metastatic disease.

Approval of the next-generation ALK inhibitor was based on an overall response rate of 48% – with 4% complete and 44% partial – in a subgroup of 215 patients with ALK-positive metastatic NSCLC enrolled in a nonrandomized, phase 2 trial, the FDA said in a press announcement. All patients had been previously treated with one or more ALK kinase inhibitors.

The median response duration was 12.5 months (95% confidence interval, 8.4-23.7) and the intracranial overall response rate in 89 patients with measurable lesions in the CNS was 60% (95% CI, 49-70) with 21% complete and 38% partial responses.

Common adverse reactions in patients receiving lorlatinib were edema, peripheral neuropathy, cognitive effects, dyspnea, fatigue, weight gain, arthralgia, mood effects, and diarrhea. The most common laboratory abnormalities were hypercholesterolemia and hypertriglyceridemia, the FDA said.

The recommended dose of lorlatinib, to be marketed as Lorbrena by Pfizer, is 100 mg orally once daily.

SAN DIEGO—The first challenge with patients who potentially have coronary artery disease (CAD) is to “appropriately risk stratify them,” began physician assistant Daniel Thomas Thibodeau, MHP, PA-C, DFAAPA, in a presentation at the annual Cardiology, Allergy, and Respiratory Disease Summit.

He emphasized the importance of relying on tried and true guidelines, such as those that have been published by the American Heart Association/American College of Cardiology, to determine a patient’s risk. He explained that providers need to consider patient age; family history; whether the patient has comorbidities such as hypertension, diabetes mellitus, dyslipidemia, or obesity; whether the patient smokes; and race/ethnicity. “A 65-year-old black male who has hypertension, diabetes, a family history of CAD, and who is a pack-a-day smoker has a high-risk profile for heart disease,” Thibodeau illustrated.

“Then you place that [risk profile] in the context of why the patient is sitting in front of you,” Thibodeau continued at the conference, held by Global Academy for Medical Education. Does the patient have an acute, chronic, or subacute condition? Is the patient presenting with a cardiac complaint of chest pain or pressure?

Match the test to the patient
Then perhaps the biggest challenge, Thibodeau continued, is determining which stress test to order. To choose from the vast array of stress tests available, providers must consider, “What’s the likelihood of getting a positive test? That’s what you’re looking for. You’re looking for disease. What test do I want to order to provoke this patient enough to show that he/she has disease?” Thibodeau explained.

To narrow the testing options, Thibodeau said you begin by answering some basic questions. For example, can the patient exercise? If the patient is young and has some symptoms but her risk is low, then a simple treadmill test will probably suffice. If the patient is older with some orthopedic issues and can’t walk well, then a pharmacologic stress test will probably be necessary, Thibodeau explained. “Or perhaps you have a patient who cannot exercise and has severe chronic obstructive pulmonary disease and you require a dobutamine stress echocardiography to look at cardiac function and areas of wall motion abnormalities.”  

Thibodeau remarked of his situation, “PAs do all the stress tests in the hospital, and oftentimes you’re sent an order [for a test] that the patient simply can’t do,” underscoring the need to order a test that is appropriate for the patient’s abilities.

Continue to: With treatment don't forget the fundamentals

With treatment don’t forget the fundamentals
Thibodeau said that we need to take “a global approach to treatment” that generally includes daily aspirin, beta blockers, control of hypertension, antiplatelet therapy (or dual antiplatelet therapy when appropriate), and control of dyslipidemia and other comorbidities.

“As much as we advance in the treatment of patients with CAD, it still comes down to fundamentals,” Thibodeau remarked. “We’re making better stents that are smaller and more flexible. We have less bleeding complications [as a result of newer agents], but at the end of the day, it still comes down to educating patients and making sure the patient is adhering to prescribed therapy,” said Thibodeau.

He said that unintentional (eg, forgetting, shift work/work restrictions, confusion, lack of knowledge) and intentional (eg, fear of adverse effects or dependency, mistrust, lack of belief in benefits) obstacles to effective treatment are for the most part “tangible things that we as practitioners can do a better job at by just taking a little bit more time with patients. Talking about expectations and giving them a little bit more of a knowledge base about their disease can go miles when it comes to therapy,” Thibodeau explained.

Of course, with all the newer antiplatelet therapies that are available, providers need to keep up with bleeding profiles, what to do if patients bleed, and when patients should come off agents for procedures. Some of the newer agents are cost-prohibitive, Thibodeau added. But even for those, he explained, there are often assistance programs available for patients so that they can at least get a 90-day supply to, for example, protect a recently placed stent.

“When it comes to stenting patients, all you’re trying to do is protect that stent for the first 90 days so epithelialization can occur to cover the stent and keep the patency going. Once you’re past 90 days, you’re feeling a little bit more at ease,” Thibodeau said.

“But sometimes patients come off the drug a little too early and you really worry about new in-stent stenosis or thrombosis because of adherence problems. So, it’s really a matter of sitting down and educating patients about why those medications are important. And making sure that you keep communicating with them,” Thibodeau continued.

Thibodeau explained that providers also need to speak with patients about the adverse effects they may expect or may be experiencing. “For example, some patients who take ticagrelor experience shortness of breath or cough that usually subsides after a week. So, you have to explain to patients, ‘I know you’re feeling this way, but it will go away, and the benefits very much outweigh the risks.’”

“It’s surprising how as much as stuff changes, so little changes when it comes to all the reasons why we still have trouble. It’s because of simple things—adherence, education, cost. It’s all the same fundamental problems that we’ve experienced for decades. It’s that simple,” Thibodeau concluded.

SAN DIEGO—The first challenge with patients who potentially have coronary artery disease (CAD) is to “appropriately risk stratify them,” began physician assistant Daniel Thomas Thibodeau, MHP, PA-C, DFAAPA, in a presentation at the annual Cardiology, Allergy, and Respiratory Disease Summit.

He emphasized the importance of relying on tried and true guidelines, such as those that have been published by the American Heart Association/American College of Cardiology, to determine a patient’s risk. He explained that providers need to consider patient age; family history; whether the patient has comorbidities such as hypertension, diabetes mellitus, dyslipidemia, or obesity; whether the patient smokes; and race/ethnicity. “A 65-year-old black male who has hypertension, diabetes, a family history of CAD, and who is a pack-a-day smoker has a high-risk profile for heart disease,” Thibodeau illustrated.

“Then you place that [risk profile] in the context of why the patient is sitting in front of you,” Thibodeau continued at the conference, held by Global Academy for Medical Education. Does the patient have an acute, chronic, or subacute condition? Is the patient presenting with a cardiac complaint of chest pain or pressure?

Match the test to the patient
Then perhaps the biggest challenge, Thibodeau continued, is determining which stress test to order. To choose from the vast array of stress tests available, providers must consider, “What’s the likelihood of getting a positive test? That’s what you’re looking for. You’re looking for disease. What test do I want to order to provoke this patient enough to show that he/she has disease?” Thibodeau explained.

To narrow the testing options, Thibodeau said you begin by answering some basic questions. For example, can the patient exercise? If the patient is young and has some symptoms but her risk is low, then a simple treadmill test will probably suffice. If the patient is older with some orthopedic issues and can’t walk well, then a pharmacologic stress test will probably be necessary, Thibodeau explained. “Or perhaps you have a patient who cannot exercise and has severe chronic obstructive pulmonary disease and you require a dobutamine stress echocardiography to look at cardiac function and areas of wall motion abnormalities.”  

Thibodeau remarked of his situation, “PAs do all the stress tests in the hospital, and oftentimes you’re sent an order [for a test] that the patient simply can’t do,” underscoring the need to order a test that is appropriate for the patient’s abilities.

Continue to: With treatment don't forget the fundamentals

With treatment don’t forget the fundamentals
Thibodeau said that we need to take “a global approach to treatment” that generally includes daily aspirin, beta blockers, control of hypertension, antiplatelet therapy (or dual antiplatelet therapy when appropriate), and control of dyslipidemia and other comorbidities.

“As much as we advance in the treatment of patients with CAD, it still comes down to fundamentals,” Thibodeau remarked. “We’re making better stents that are smaller and more flexible. We have less bleeding complications [as a result of newer agents], but at the end of the day, it still comes down to educating patients and making sure the patient is adhering to prescribed therapy,” said Thibodeau.

He said that unintentional (eg, forgetting, shift work/work restrictions, confusion, lack of knowledge) and intentional (eg, fear of adverse effects or dependency, mistrust, lack of belief in benefits) obstacles to effective treatment are for the most part “tangible things that we as practitioners can do a better job at by just taking a little bit more time with patients. Talking about expectations and giving them a little bit more of a knowledge base about their disease can go miles when it comes to therapy,” Thibodeau explained.

Of course, with all the newer antiplatelet therapies that are available, providers need to keep up with bleeding profiles, what to do if patients bleed, and when patients should come off agents for procedures. Some of the newer agents are cost-prohibitive, Thibodeau added. But even for those, he explained, there are often assistance programs available for patients so that they can at least get a 90-day supply to, for example, protect a recently placed stent.

“When it comes to stenting patients, all you’re trying to do is protect that stent for the first 90 days so epithelialization can occur to cover the stent and keep the patency going. Once you’re past 90 days, you’re feeling a little bit more at ease,” Thibodeau said.

“But sometimes patients come off the drug a little too early and you really worry about new in-stent stenosis or thrombosis because of adherence problems. So, it’s really a matter of sitting down and educating patients about why those medications are important. And making sure that you keep communicating with them,” Thibodeau continued.

Thibodeau explained that providers also need to speak with patients about the adverse effects they may expect or may be experiencing. “For example, some patients who take ticagrelor experience shortness of breath or cough that usually subsides after a week. So, you have to explain to patients, ‘I know you’re feeling this way, but it will go away, and the benefits very much outweigh the risks.’”

“It’s surprising how as much as stuff changes, so little changes when it comes to all the reasons why we still have trouble. It’s because of simple things—adherence, education, cost. It’s all the same fundamental problems that we’ve experienced for decades. It’s that simple,” Thibodeau concluded.

SAN DIEGO—The first challenge with patients who potentially have coronary artery disease (CAD) is to “appropriately risk stratify them,” began physician assistant Daniel Thomas Thibodeau, MHP, PA-C, DFAAPA, in a presentation at the annual Cardiology, Allergy, and Respiratory Disease Summit.

He emphasized the importance of relying on tried and true guidelines, such as those that have been published by the American Heart Association/American College of Cardiology, to determine a patient’s risk. He explained that providers need to consider patient age; family history; whether the patient has comorbidities such as hypertension, diabetes mellitus, dyslipidemia, or obesity; whether the patient smokes; and race/ethnicity. “A 65-year-old black male who has hypertension, diabetes, a family history of CAD, and who is a pack-a-day smoker has a high-risk profile for heart disease,” Thibodeau illustrated.

“Then you place that [risk profile] in the context of why the patient is sitting in front of you,” Thibodeau continued at the conference, held by Global Academy for Medical Education. Does the patient have an acute, chronic, or subacute condition? Is the patient presenting with a cardiac complaint of chest pain or pressure?

Match the test to the patient
Then perhaps the biggest challenge, Thibodeau continued, is determining which stress test to order. To choose from the vast array of stress tests available, providers must consider, “What’s the likelihood of getting a positive test? That’s what you’re looking for. You’re looking for disease. What test do I want to order to provoke this patient enough to show that he/she has disease?” Thibodeau explained.

To narrow the testing options, Thibodeau said you begin by answering some basic questions. For example, can the patient exercise? If the patient is young and has some symptoms but her risk is low, then a simple treadmill test will probably suffice. If the patient is older with some orthopedic issues and can’t walk well, then a pharmacologic stress test will probably be necessary, Thibodeau explained. “Or perhaps you have a patient who cannot exercise and has severe chronic obstructive pulmonary disease and you require a dobutamine stress echocardiography to look at cardiac function and areas of wall motion abnormalities.”  

Thibodeau remarked of his situation, “PAs do all the stress tests in the hospital, and oftentimes you’re sent an order [for a test] that the patient simply can’t do,” underscoring the need to order a test that is appropriate for the patient’s abilities.

Continue to: With treatment don't forget the fundamentals

With treatment don’t forget the fundamentals
Thibodeau said that we need to take “a global approach to treatment” that generally includes daily aspirin, beta blockers, control of hypertension, antiplatelet therapy (or dual antiplatelet therapy when appropriate), and control of dyslipidemia and other comorbidities.

“As much as we advance in the treatment of patients with CAD, it still comes down to fundamentals,” Thibodeau remarked. “We’re making better stents that are smaller and more flexible. We have less bleeding complications [as a result of newer agents], but at the end of the day, it still comes down to educating patients and making sure the patient is adhering to prescribed therapy,” said Thibodeau.

He said that unintentional (eg, forgetting, shift work/work restrictions, confusion, lack of knowledge) and intentional (eg, fear of adverse effects or dependency, mistrust, lack of belief in benefits) obstacles to effective treatment are for the most part “tangible things that we as practitioners can do a better job at by just taking a little bit more time with patients. Talking about expectations and giving them a little bit more of a knowledge base about their disease can go miles when it comes to therapy,” Thibodeau explained.

Of course, with all the newer antiplatelet therapies that are available, providers need to keep up with bleeding profiles, what to do if patients bleed, and when patients should come off agents for procedures. Some of the newer agents are cost-prohibitive, Thibodeau added. But even for those, he explained, there are often assistance programs available for patients so that they can at least get a 90-day supply to, for example, protect a recently placed stent.

“When it comes to stenting patients, all you’re trying to do is protect that stent for the first 90 days so epithelialization can occur to cover the stent and keep the patency going. Once you’re past 90 days, you’re feeling a little bit more at ease,” Thibodeau said.

“But sometimes patients come off the drug a little too early and you really worry about new in-stent stenosis or thrombosis because of adherence problems. So, it’s really a matter of sitting down and educating patients about why those medications are important. And making sure that you keep communicating with them,” Thibodeau continued.

Thibodeau explained that providers also need to speak with patients about the adverse effects they may expect or may be experiencing. “For example, some patients who take ticagrelor experience shortness of breath or cough that usually subsides after a week. So, you have to explain to patients, ‘I know you’re feeling this way, but it will go away, and the benefits very much outweigh the risks.’”

“It’s surprising how as much as stuff changes, so little changes when it comes to all the reasons why we still have trouble. It’s because of simple things—adherence, education, cost. It’s all the same fundamental problems that we’ve experienced for decades. It’s that simple,” Thibodeau concluded.

SAN DIEGO—One of the most significant challenges related to the treatment of chronic obstructive pulmonary disease (COPD), according to physician assistant Gabriel Ortiz, MPAS, PA-C, DFAAPA, is getting health care providers to use spirometry. “Spirometry is essential to establish the diagnosis,” Ortiz explained in a presentation at the annual Cardiology, Allergy, and Respiratory Disease Summit. Yet many providers, he continued, just assume they are dealing with COPD. “The only way to differentiate between COPD and asthma is with spirometry.”

He believes that many health care providers avoid the diagnostic either because they perceive it as being too difficult and/or time-consuming to master or too expensive. But Ortiz insists it is not difficult and that it is “a billable, reimbursable medical expense.” “If providers used it for all of their patients with asthma, COPD, and cough, wheezing, and shortness of breath, the machine would probably be paid for in about 3 months,” he remarked.

Ortiz reported at the conference, held by Global Academy for Medical Education, that COPD, currently the 4th leading cause of death in the world, is projected to be the 3rd leading cause by 2020. Its burden is significant. Limited inspiratory capacity that worsens with activity and that increases the work of breathing significantly impacts quality of life. In fact, reports indicate that 25% to 60% of patients experience depression, Ortiz said.

A most important risk factor
Past or present cigarette smoking remains one of the most important risk factors for COPD, and cessation has the greatest capacity to influence the natural history of the disease, Ortiz said. In fact, Ortiz remarked, “Getting smokers to quit is probably the other biggest challenge with this disease.” He explains that while patients must have the desire to quit and make the decision to do so on their own, “We can provide the option and the information they need.” Ortiz likes to discuss with patients a plan for quitting and agree on a quit date. He says patients will often agree to something like, “I’d like to start reducing right after Thanksgiving,” or “I’d like to be smoke-free by summer.” If effective resources and time are dedicated to smoking cessation, Ortiz reported, long-term quit success rates of up to 25% can be achieved.

Continue to: Treatment changes

Treatment changes
The Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2018 report (https://goldcopd.org/wp-content/uploads/2017/11/GOLD-2018-v6.0-FINAL-revised-20-Nov_WMS.pdf) brings with it a new treatment recommendation, Ortiz said. “We used to recommend, and many providers still do, starting with a long-acting beta-agonist bronchodilator (LABA) and then adding an inhaled corticosteroid, much like we do in asthma,” Ortiz explained. But patients who require more than just a LABA should be given a long-acting muscarinic receptor antagonist (LAMA). “That’s the preferred treatment,” Ortiz said. An inhaled corticosteroid would then be added as a 3rd agent, if necessary. “So, the order of therapy is now to start with a bronchodilator (either a LABA or LAMA), then add an agent from whichever of these 2 classes was not already started, and then add a corticosteroid,” Ortiz summarized.

Ortiz said that one of the most significant changes in the treatment of COPD is the recent availability of a therapy that combines an inhaled corticosteroid, a LAMA, and a LABA in one inhaler for once-daily dosing.

SAN DIEGO—One of the most significant challenges related to the treatment of chronic obstructive pulmonary disease (COPD), according to physician assistant Gabriel Ortiz, MPAS, PA-C, DFAAPA, is getting health care providers to use spirometry. “Spirometry is essential to establish the diagnosis,” Ortiz explained in a presentation at the annual Cardiology, Allergy, and Respiratory Disease Summit. Yet many providers, he continued, just assume they are dealing with COPD. “The only way to differentiate between COPD and asthma is with spirometry.”

He believes that many health care providers avoid the diagnostic either because they perceive it as being too difficult and/or time-consuming to master or too expensive. But Ortiz insists it is not difficult and that it is “a billable, reimbursable medical expense.” “If providers used it for all of their patients with asthma, COPD, and cough, wheezing, and shortness of breath, the machine would probably be paid for in about 3 months,” he remarked.

Ortiz reported at the conference, held by Global Academy for Medical Education, that COPD, currently the 4th leading cause of death in the world, is projected to be the 3rd leading cause by 2020. Its burden is significant. Limited inspiratory capacity that worsens with activity and that increases the work of breathing significantly impacts quality of life. In fact, reports indicate that 25% to 60% of patients experience depression, Ortiz said.

A most important risk factor
Past or present cigarette smoking remains one of the most important risk factors for COPD, and cessation has the greatest capacity to influence the natural history of the disease, Ortiz said. In fact, Ortiz remarked, “Getting smokers to quit is probably the other biggest challenge with this disease.” He explains that while patients must have the desire to quit and make the decision to do so on their own, “We can provide the option and the information they need.” Ortiz likes to discuss with patients a plan for quitting and agree on a quit date. He says patients will often agree to something like, “I’d like to start reducing right after Thanksgiving,” or “I’d like to be smoke-free by summer.” If effective resources and time are dedicated to smoking cessation, Ortiz reported, long-term quit success rates of up to 25% can be achieved.

Continue to: Treatment changes

Treatment changes
The Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2018 report (https://goldcopd.org/wp-content/uploads/2017/11/GOLD-2018-v6.0-FINAL-revised-20-Nov_WMS.pdf) brings with it a new treatment recommendation, Ortiz said. “We used to recommend, and many providers still do, starting with a long-acting beta-agonist bronchodilator (LABA) and then adding an inhaled corticosteroid, much like we do in asthma,” Ortiz explained. But patients who require more than just a LABA should be given a long-acting muscarinic receptor antagonist (LAMA). “That’s the preferred treatment,” Ortiz said. An inhaled corticosteroid would then be added as a 3rd agent, if necessary. “So, the order of therapy is now to start with a bronchodilator (either a LABA or LAMA), then add an agent from whichever of these 2 classes was not already started, and then add a corticosteroid,” Ortiz summarized.

Ortiz said that one of the most significant changes in the treatment of COPD is the recent availability of a therapy that combines an inhaled corticosteroid, a LAMA, and a LABA in one inhaler for once-daily dosing.

SAN DIEGO—One of the most significant challenges related to the treatment of chronic obstructive pulmonary disease (COPD), according to physician assistant Gabriel Ortiz, MPAS, PA-C, DFAAPA, is getting health care providers to use spirometry. “Spirometry is essential to establish the diagnosis,” Ortiz explained in a presentation at the annual Cardiology, Allergy, and Respiratory Disease Summit. Yet many providers, he continued, just assume they are dealing with COPD. “The only way to differentiate between COPD and asthma is with spirometry.”

He believes that many health care providers avoid the diagnostic either because they perceive it as being too difficult and/or time-consuming to master or too expensive. But Ortiz insists it is not difficult and that it is “a billable, reimbursable medical expense.” “If providers used it for all of their patients with asthma, COPD, and cough, wheezing, and shortness of breath, the machine would probably be paid for in about 3 months,” he remarked.

Ortiz reported at the conference, held by Global Academy for Medical Education, that COPD, currently the 4th leading cause of death in the world, is projected to be the 3rd leading cause by 2020. Its burden is significant. Limited inspiratory capacity that worsens with activity and that increases the work of breathing significantly impacts quality of life. In fact, reports indicate that 25% to 60% of patients experience depression, Ortiz said.

A most important risk factor
Past or present cigarette smoking remains one of the most important risk factors for COPD, and cessation has the greatest capacity to influence the natural history of the disease, Ortiz said. In fact, Ortiz remarked, “Getting smokers to quit is probably the other biggest challenge with this disease.” He explains that while patients must have the desire to quit and make the decision to do so on their own, “We can provide the option and the information they need.” Ortiz likes to discuss with patients a plan for quitting and agree on a quit date. He says patients will often agree to something like, “I’d like to start reducing right after Thanksgiving,” or “I’d like to be smoke-free by summer.” If effective resources and time are dedicated to smoking cessation, Ortiz reported, long-term quit success rates of up to 25% can be achieved.

Continue to: Treatment changes

Treatment changes
The Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2018 report (https://goldcopd.org/wp-content/uploads/2017/11/GOLD-2018-v6.0-FINAL-revised-20-Nov_WMS.pdf) brings with it a new treatment recommendation, Ortiz said. “We used to recommend, and many providers still do, starting with a long-acting beta-agonist bronchodilator (LABA) and then adding an inhaled corticosteroid, much like we do in asthma,” Ortiz explained. But patients who require more than just a LABA should be given a long-acting muscarinic receptor antagonist (LAMA). “That’s the preferred treatment,” Ortiz said. An inhaled corticosteroid would then be added as a 3rd agent, if necessary. “So, the order of therapy is now to start with a bronchodilator (either a LABA or LAMA), then add an agent from whichever of these 2 classes was not already started, and then add a corticosteroid,” Ortiz summarized.

Ortiz said that one of the most significant changes in the treatment of COPD is the recent availability of a therapy that combines an inhaled corticosteroid, a LAMA, and a LABA in one inhaler for once-daily dosing.