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.

SAN DIEGO — “It’s very important that we know how to correctly diagnose this disease,” began nurse practitioner, Mary Lou Hayden, RN, MS, FNP-BC, AE-C, referring to the disease of asthma. She explained that correct diagnosis is important partly because the disease is so common, affecting 7.6% of adults and 8.4% of children in the United States, and partly because it is responsible for significant health care utilization, including 6.5% of office visits and 1.6 million emergency department visits.

Correctly and objectively diagnosing asthma is also important, Hayden continued in a presentation at the annual Cardiology, Allergy, and Respiratory Disease Summit, because, “We cannot simply rely upon patients’ reports of symptoms. Patients very frequently underreport their symptoms and don’t assume it’s asthma.” She says that while peak flow meters can be helpful, they are not diagnostic. “It’s important that we have objective measures . . . and the most important measure is spirometry.”

“You can buy a small office spirometer for as little as $1000,” Hayden continued at the conference, held by Global Academy for Medical Education, “and as a reimbursable procedure, it pays for itself in a short period of time.” “It actually becomes a revenue center for the practice,” she added.

She explained that she’s seen patients with supposed uncontrolled asthma referred to her practice who don’t, in fact, have asthma at all. “If the [referring] office had had a spirometer, they would have perhaps not needed to refer.”

So important is spirometry to the diagnosis and management of asthma that Hayden offers an annual pre-conference workshop on the test, so that “NPs and PAs can leave the conference having all the tools they need to optimize treatment.”

Selecting therapy
Hayden explained that because the US National Asthma Education and Prevention Program Expert Panel Report 3: Guidelines for the Diagnosis and Management of Asthma (https://www.nhlbi.nih.gov/files/docs/guidelines/asthgdln.pdf), commonly known as NAEPP or EPR-3, haven’t been updated since 2007, that it’s important to look to the Global Initiative for Asthma: Global Strategy for Asthma Management and Prevention (GINA) (https://ginasthma.org/2018-gina-report-global-strategy-for-asthma-management-and-prevention/), 2018, which is updated annually, for treatment guidance.

For example, personalized or precision medicine is now heavily influencing the field of asthma. Phenotypes, endotypes, and genotypes are helping to guide treatment of severe asthma with monoclonal antibodies and other therapeutic agents, remarked Hayden.

Continue to: Other aspects important to the selection...

Other aspects important to the selection of appropriate therapies include the severity of disease, the level of asthma control, patient preference, and practical issues such as is the patient able to use a particular device, is the patient likely to adhere to the dosing schedule, and, of course, cost. “Cost overlies everything,” said Hayden, “because if a patient can’t afford to buy [a drug], or their insurance doesn’t cover it, or their deductible is so high that it is unlikely that they are going to use it, then we need to think of an alternative that is on their formulary that they are more likely to use.”

At every visit . . .
“We need to measure for control at every visit,” Hayden emphasized, explaining that we assess control in terms of impairment and risk. Impairment includes aspects such as the number of times the patient has had symptoms or used their reliever medication in the past 2 weeks. It can also include results of lung function tests.

Risk includes questions about occurrence of exacerbations, use of systemic corticosteroids, any unscheduled or acute visits for asthma, significant deterioration in lung function, and adverse effects from the medications that have already been prescribed.

Another event that should occur at every visit is review of inhaler technique, said Hayden. She explained that there’s a wide variety of inhalers available that utilize different techniques. “With inhaled medicine, if you are not using the inhaler correctly, you are not going to get good drug deposition in the airways where its meant to be.”

Hayden summarized, “Even people with mild disease can have severe exacerbations following a viral cold or an unfortunate air pollutant exposure, so primary care [practices] need to feel comfortable managing mild to moderate asthma and need to know when to refer those who are not responding appropriately to recommended treatment plans.”

SAN DIEGO — “It’s very important that we know how to correctly diagnose this disease,” began nurse practitioner, Mary Lou Hayden, RN, MS, FNP-BC, AE-C, referring to the disease of asthma. She explained that correct diagnosis is important partly because the disease is so common, affecting 7.6% of adults and 8.4% of children in the United States, and partly because it is responsible for significant health care utilization, including 6.5% of office visits and 1.6 million emergency department visits.

Correctly and objectively diagnosing asthma is also important, Hayden continued in a presentation at the annual Cardiology, Allergy, and Respiratory Disease Summit, because, “We cannot simply rely upon patients’ reports of symptoms. Patients very frequently underreport their symptoms and don’t assume it’s asthma.” She says that while peak flow meters can be helpful, they are not diagnostic. “It’s important that we have objective measures . . . and the most important measure is spirometry.”

“You can buy a small office spirometer for as little as $1000,” Hayden continued at the conference, held by Global Academy for Medical Education, “and as a reimbursable procedure, it pays for itself in a short period of time.” “It actually becomes a revenue center for the practice,” she added.

She explained that she’s seen patients with supposed uncontrolled asthma referred to her practice who don’t, in fact, have asthma at all. “If the [referring] office had had a spirometer, they would have perhaps not needed to refer.”

So important is spirometry to the diagnosis and management of asthma that Hayden offers an annual pre-conference workshop on the test, so that “NPs and PAs can leave the conference having all the tools they need to optimize treatment.”

Selecting therapy
Hayden explained that because the US National Asthma Education and Prevention Program Expert Panel Report 3: Guidelines for the Diagnosis and Management of Asthma (https://www.nhlbi.nih.gov/files/docs/guidelines/asthgdln.pdf), commonly known as NAEPP or EPR-3, haven’t been updated since 2007, that it’s important to look to the Global Initiative for Asthma: Global Strategy for Asthma Management and Prevention (GINA) (https://ginasthma.org/2018-gina-report-global-strategy-for-asthma-management-and-prevention/), 2018, which is updated annually, for treatment guidance.

For example, personalized or precision medicine is now heavily influencing the field of asthma. Phenotypes, endotypes, and genotypes are helping to guide treatment of severe asthma with monoclonal antibodies and other therapeutic agents, remarked Hayden.

Continue to: Other aspects important to the selection...

Other aspects important to the selection of appropriate therapies include the severity of disease, the level of asthma control, patient preference, and practical issues such as is the patient able to use a particular device, is the patient likely to adhere to the dosing schedule, and, of course, cost. “Cost overlies everything,” said Hayden, “because if a patient can’t afford to buy [a drug], or their insurance doesn’t cover it, or their deductible is so high that it is unlikely that they are going to use it, then we need to think of an alternative that is on their formulary that they are more likely to use.”

At every visit . . .
“We need to measure for control at every visit,” Hayden emphasized, explaining that we assess control in terms of impairment and risk. Impairment includes aspects such as the number of times the patient has had symptoms or used their reliever medication in the past 2 weeks. It can also include results of lung function tests.

Risk includes questions about occurrence of exacerbations, use of systemic corticosteroids, any unscheduled or acute visits for asthma, significant deterioration in lung function, and adverse effects from the medications that have already been prescribed.

Another event that should occur at every visit is review of inhaler technique, said Hayden. She explained that there’s a wide variety of inhalers available that utilize different techniques. “With inhaled medicine, if you are not using the inhaler correctly, you are not going to get good drug deposition in the airways where its meant to be.”

Hayden summarized, “Even people with mild disease can have severe exacerbations following a viral cold or an unfortunate air pollutant exposure, so primary care [practices] need to feel comfortable managing mild to moderate asthma and need to know when to refer those who are not responding appropriately to recommended treatment plans.”

SAN DIEGO — “It’s very important that we know how to correctly diagnose this disease,” began nurse practitioner, Mary Lou Hayden, RN, MS, FNP-BC, AE-C, referring to the disease of asthma. She explained that correct diagnosis is important partly because the disease is so common, affecting 7.6% of adults and 8.4% of children in the United States, and partly because it is responsible for significant health care utilization, including 6.5% of office visits and 1.6 million emergency department visits.

Correctly and objectively diagnosing asthma is also important, Hayden continued in a presentation at the annual Cardiology, Allergy, and Respiratory Disease Summit, because, “We cannot simply rely upon patients’ reports of symptoms. Patients very frequently underreport their symptoms and don’t assume it’s asthma.” She says that while peak flow meters can be helpful, they are not diagnostic. “It’s important that we have objective measures . . . and the most important measure is spirometry.”

“You can buy a small office spirometer for as little as $1000,” Hayden continued at the conference, held by Global Academy for Medical Education, “and as a reimbursable procedure, it pays for itself in a short period of time.” “It actually becomes a revenue center for the practice,” she added.

She explained that she’s seen patients with supposed uncontrolled asthma referred to her practice who don’t, in fact, have asthma at all. “If the [referring] office had had a spirometer, they would have perhaps not needed to refer.”

So important is spirometry to the diagnosis and management of asthma that Hayden offers an annual pre-conference workshop on the test, so that “NPs and PAs can leave the conference having all the tools they need to optimize treatment.”

Selecting therapy
Hayden explained that because the US National Asthma Education and Prevention Program Expert Panel Report 3: Guidelines for the Diagnosis and Management of Asthma (https://www.nhlbi.nih.gov/files/docs/guidelines/asthgdln.pdf), commonly known as NAEPP or EPR-3, haven’t been updated since 2007, that it’s important to look to the Global Initiative for Asthma: Global Strategy for Asthma Management and Prevention (GINA) (https://ginasthma.org/2018-gina-report-global-strategy-for-asthma-management-and-prevention/), 2018, which is updated annually, for treatment guidance.

For example, personalized or precision medicine is now heavily influencing the field of asthma. Phenotypes, endotypes, and genotypes are helping to guide treatment of severe asthma with monoclonal antibodies and other therapeutic agents, remarked Hayden.

Continue to: Other aspects important to the selection...

Other aspects important to the selection of appropriate therapies include the severity of disease, the level of asthma control, patient preference, and practical issues such as is the patient able to use a particular device, is the patient likely to adhere to the dosing schedule, and, of course, cost. “Cost overlies everything,” said Hayden, “because if a patient can’t afford to buy [a drug], or their insurance doesn’t cover it, or their deductible is so high that it is unlikely that they are going to use it, then we need to think of an alternative that is on their formulary that they are more likely to use.”

At every visit . . .
“We need to measure for control at every visit,” Hayden emphasized, explaining that we assess control in terms of impairment and risk. Impairment includes aspects such as the number of times the patient has had symptoms or used their reliever medication in the past 2 weeks. It can also include results of lung function tests.

Risk includes questions about occurrence of exacerbations, use of systemic corticosteroids, any unscheduled or acute visits for asthma, significant deterioration in lung function, and adverse effects from the medications that have already been prescribed.

Another event that should occur at every visit is review of inhaler technique, said Hayden. She explained that there’s a wide variety of inhalers available that utilize different techniques. “With inhaled medicine, if you are not using the inhaler correctly, you are not going to get good drug deposition in the airways where its meant to be.”

Hayden summarized, “Even people with mild disease can have severe exacerbations following a viral cold or an unfortunate air pollutant exposure, so primary care [practices] need to feel comfortable managing mild to moderate asthma and need to know when to refer those who are not responding appropriately to recommended treatment plans.”

SEATTLE – Movement disorders should be a factor in screening children receiving pharmacotherapy, Jagan K. Chilakamarri, MD, said at the annual meeting of the American Academy of Child and Adolescent Psychiatry. 

“I started seeing a very, very complex group of pediatric patients in my office,” said Dr. Chilakamarri, medical director at the Atlanta Psychiatric Institute, and codirector of the Movement Disorders Program at Emory University, Atlanta. “I decided I needed to coordinate with a neurologist and sort out what was happening.”

Dr. Chilakamarri suspects that the advent of new drug therapies and polytherapy is leading to a range of movement effects, especially in young patients prescribed multiple agents.

Many psychiatrists may not be comfortable with screening or diagnosing movement disorders, preferring instead to refer a patient to a neurologist. That’s understandable, but the neurologist may not have the psychotropic drug history in mind when assessing a patient. If a drug or drug combination is responsible for a movement disorder, it befits the psychiatrist to address it, he said.

“I want psychiatrists to be more familiar with how to do a basic movement disorder assessment, and how to understand these movements in the context of the patient, whether they’re drug induced or related to their own disorder, or something comorbid that we are not able to understand – how to measure them, how to understand them, and when to send them to the appropriate referral so that these patients are being well addressed. Some may not be addressed by a neurologist; maybe the patient should go to an endocrinologist because of a thyroid problem,” said Dr. Chilakamarri.

The best way to gain that understanding and familiarity, aside from reviewing the potential side effects of psychotropic medications, is to partner with a neurologist who can impart a better understanding of how movement disorders present.

“Whenever we see these odd or strange movements, we basically see if we can send the patient to a neurologist. I have no problem with that, but what I’m trying to say is, if we can be a little bit more aware, a little bit more understanding of these things, we can reduce some of those events,” said Dr. Chilakamarri.

He disclosed no conflicts of interest.

SOURCE: Commonly occurring movement disorders in children, AACAP 2018.

SEATTLE – Movement disorders should be a factor in screening children receiving pharmacotherapy, Jagan K. Chilakamarri, MD, said at the annual meeting of the American Academy of Child and Adolescent Psychiatry. 

“I started seeing a very, very complex group of pediatric patients in my office,” said Dr. Chilakamarri, medical director at the Atlanta Psychiatric Institute, and codirector of the Movement Disorders Program at Emory University, Atlanta. “I decided I needed to coordinate with a neurologist and sort out what was happening.”

Dr. Chilakamarri suspects that the advent of new drug therapies and polytherapy is leading to a range of movement effects, especially in young patients prescribed multiple agents.

Many psychiatrists may not be comfortable with screening or diagnosing movement disorders, preferring instead to refer a patient to a neurologist. That’s understandable, but the neurologist may not have the psychotropic drug history in mind when assessing a patient. If a drug or drug combination is responsible for a movement disorder, it befits the psychiatrist to address it, he said.

“I want psychiatrists to be more familiar with how to do a basic movement disorder assessment, and how to understand these movements in the context of the patient, whether they’re drug induced or related to their own disorder, or something comorbid that we are not able to understand – how to measure them, how to understand them, and when to send them to the appropriate referral so that these patients are being well addressed. Some may not be addressed by a neurologist; maybe the patient should go to an endocrinologist because of a thyroid problem,” said Dr. Chilakamarri.

The best way to gain that understanding and familiarity, aside from reviewing the potential side effects of psychotropic medications, is to partner with a neurologist who can impart a better understanding of how movement disorders present.

“Whenever we see these odd or strange movements, we basically see if we can send the patient to a neurologist. I have no problem with that, but what I’m trying to say is, if we can be a little bit more aware, a little bit more understanding of these things, we can reduce some of those events,” said Dr. Chilakamarri.

He disclosed no conflicts of interest.

SOURCE: Commonly occurring movement disorders in children, AACAP 2018.

SEATTLE – Movement disorders should be a factor in screening children receiving pharmacotherapy, Jagan K. Chilakamarri, MD, said at the annual meeting of the American Academy of Child and Adolescent Psychiatry. 

“I started seeing a very, very complex group of pediatric patients in my office,” said Dr. Chilakamarri, medical director at the Atlanta Psychiatric Institute, and codirector of the Movement Disorders Program at Emory University, Atlanta. “I decided I needed to coordinate with a neurologist and sort out what was happening.”

Dr. Chilakamarri suspects that the advent of new drug therapies and polytherapy is leading to a range of movement effects, especially in young patients prescribed multiple agents.

Many psychiatrists may not be comfortable with screening or diagnosing movement disorders, preferring instead to refer a patient to a neurologist. That’s understandable, but the neurologist may not have the psychotropic drug history in mind when assessing a patient. If a drug or drug combination is responsible for a movement disorder, it befits the psychiatrist to address it, he said.

“I want psychiatrists to be more familiar with how to do a basic movement disorder assessment, and how to understand these movements in the context of the patient, whether they’re drug induced or related to their own disorder, or something comorbid that we are not able to understand – how to measure them, how to understand them, and when to send them to the appropriate referral so that these patients are being well addressed. Some may not be addressed by a neurologist; maybe the patient should go to an endocrinologist because of a thyroid problem,” said Dr. Chilakamarri.

The best way to gain that understanding and familiarity, aside from reviewing the potential side effects of psychotropic medications, is to partner with a neurologist who can impart a better understanding of how movement disorders present.

“Whenever we see these odd or strange movements, we basically see if we can send the patient to a neurologist. I have no problem with that, but what I’m trying to say is, if we can be a little bit more aware, a little bit more understanding of these things, we can reduce some of those events,” said Dr. Chilakamarri.

He disclosed no conflicts of interest.

SOURCE: Commonly occurring movement disorders in children, AACAP 2018.

SAN DIEGO—The first practice changer is with the diagnosis of hypertension, began Leslie L. Davis, PhD, RN, ANP-BC, FAANP, FPCNA, FAHA. “The 2017 American Heart Association/American College of Cardiology guidelines¹ show us that Stage 1 hypertension is now 130 to 139 mm Hg systolic, and that has always been traditionally 140 mm Hg and above, so this dramatically changes how we diagnose and treat hypertension.”

“That means that another 14% or so of Americans will now fall under the category of Stage 1 hypertension. It doesn’t mean that all of these people will be on medication; however, when we reclassify, that’s a big chunk of the population. We go from about 32% prevalence to about 46% of adults in the United States having hypertension,” Davis said during a presentation at the annual Cardiology, Allergy, and Respiratory Disease Summit.

According to the guidelines, normal blood pressure (BP) is now <120 mm Hg systolic and <80 mm Hg diastolic. Elevated BP is 120 to 129 mm Hg systolic and <80 mm Hg diastolic. And Stage 2 hypertension is ≥140 mm Hg systolic and ≥90 mm Hg diastolic.

“This means we need to be a little more vigilant about screening and about getting patients in the system a little sooner . . . and  potentially about making some critical lifestyle changes because we know that blood pressure over time in men and women will gradually go up,” Davis said at the conference, held by Global Academy for Medical Education. “Systolic and diastolic blood pressure increases every year of life on average, and by the fifth decade of life, diastolic will start going down, but systolic will continue to increase. If we can catch folks sooner, we can prevent the poor outcomes associated with having hypertension,” she stated.

Numbers matter
The new guidelines, Davis continued, mean that “more than ever, accuracy in blood pressure measurement really matters.” She said, "It’s essential to take accurate blood pressures,” and to pay attention to things like having patients in a sitting position, at rest, with both feet planted on a flat surface, with back supported, and with arm at heart level for at least 5 minutes when taking BP measurements; to remove constrictive clothing and not just push it up; to make sure the patient hasn’t used caffeine or tobacco for at least 30 minutes prior to the measurement; to use the correct size sphygmomanometer cuff; to have the patient not talk during the measurement; and to consider out-of-office BP measurements in the overall assessment.

"We might have been late in the game in my opinion in the United States of really pushing this issue of using blood pressures from other settings—not just using in-office blood pressure readings,” Davis said making the point that the European and Canadian guidelines incorporated BP readings from other settings in the recommendations for diagnosing hypertension about 5 years ago.

“We need more than just the blood pressure readings we’re getting in the office,” she said, to identify things like white coat hypertension and masked hypertension, which is the opposite of white coat hypertension, meaning a patient’s BP is within normal limits in the office or clinic, but elevated when he/she is away from a medical setting. 

Continue to: When to start meds

When to start meds
Another practice changer, according to Davis, is when to start medications based on the new guidelines. “We are now looking at 10-year atherosclerotic risk, and that hasn’t been part of the management guidelines in the past for hypertension.” Similarly, “Treatment goals now have lower targets,” she said.

She explained that for patients who require secondary prevention of recurrent CVD (or if they have clinical CVD), then 10-year risk is irrelevant, and practitioners should start medication when systolic blood pressure (SBP) is ≥130 mm Hg or diastolic blood pressure (DBP) is ≥80 mm Hg. If the patient requires primary prevention (ie, no history of CVD or additional markers of increased risk of CVD) and their atherosclerotic 10-year risk is ≥10%, then medication is also warranted when SPB is ≥130 mm Hg or DBP is ≥80 mm Hg. Davis explained, “Some people might say [10% is] not much of a risk, but that’s considered as high a risk as someone who’s had a heart attack or stroke.”

If a patient requires primary prevention (ie, no history of CVD) and they have a 10-year atherosclerotic risk <10%, then health care providers should start medication when the patient’s SBP is ≥140 mm Hg or DBP is ≥90 mm Hg. Yet, Davis added, as with any patient with any elevation of BP, these patients should adopt lifestyle changes to reduce their BP.

In the end, Davis reminded that these are simply evidence-based guidelines, and that practitioners still need to have discussions with patients about when to start pharmacotherapy.

Continue to: Follow-up and nonpharmacologic care

Follow-up and nonpharmacologic care
“If patients have low atherosclerotic risk and an SBP that is 120 to 129 mm Hg, you can repeat the BP measurement after up to 6 months of lifestyle changes,” said Davis. “These guidelines don’t add anything magical about lifestyle changes,” Davis explained. “It’s stuff we’ve known” and been doing for a long time, such as the DASH diet and weight loss, which “are as good as low-dose medication at reducing BP in many cases.”

She cautioned, however, that with patients who are Stage 1 and Stage 2, “Don’t wait too long to bring them back; bring them back within a month.” She said that most patients with Stage 1 hypertension are managed with a combination of lifestyle changes and a medication, while those with Stage 2 hypertension are often started on 2 medications at once, along with lifestyle changes.

Lastly, Davis explained that older adults are defined as those ≥65 years of age, and that this population can range widely from those who are ambulatory and well to those who have many comorbid conditions. As a result, practitioners really need to talk to these patients and perhaps their families to determine through shared decision-making what treatment is necessary.

SAN DIEGO—The first practice changer is with the diagnosis of hypertension, began Leslie L. Davis, PhD, RN, ANP-BC, FAANP, FPCNA, FAHA. “The 2017 American Heart Association/American College of Cardiology guidelines¹ show us that Stage 1 hypertension is now 130 to 139 mm Hg systolic, and that has always been traditionally 140 mm Hg and above, so this dramatically changes how we diagnose and treat hypertension.”

“That means that another 14% or so of Americans will now fall under the category of Stage 1 hypertension. It doesn’t mean that all of these people will be on medication; however, when we reclassify, that’s a big chunk of the population. We go from about 32% prevalence to about 46% of adults in the United States having hypertension,” Davis said during a presentation at the annual Cardiology, Allergy, and Respiratory Disease Summit.

According to the guidelines, normal blood pressure (BP) is now <120 mm Hg systolic and <80 mm Hg diastolic. Elevated BP is 120 to 129 mm Hg systolic and <80 mm Hg diastolic. And Stage 2 hypertension is ≥140 mm Hg systolic and ≥90 mm Hg diastolic.

“This means we need to be a little more vigilant about screening and about getting patients in the system a little sooner . . . and  potentially about making some critical lifestyle changes because we know that blood pressure over time in men and women will gradually go up,” Davis said at the conference, held by Global Academy for Medical Education. “Systolic and diastolic blood pressure increases every year of life on average, and by the fifth decade of life, diastolic will start going down, but systolic will continue to increase. If we can catch folks sooner, we can prevent the poor outcomes associated with having hypertension,” she stated.

Numbers matter
The new guidelines, Davis continued, mean that “more than ever, accuracy in blood pressure measurement really matters.” She said, "It’s essential to take accurate blood pressures,” and to pay attention to things like having patients in a sitting position, at rest, with both feet planted on a flat surface, with back supported, and with arm at heart level for at least 5 minutes when taking BP measurements; to remove constrictive clothing and not just push it up; to make sure the patient hasn’t used caffeine or tobacco for at least 30 minutes prior to the measurement; to use the correct size sphygmomanometer cuff; to have the patient not talk during the measurement; and to consider out-of-office BP measurements in the overall assessment.

"We might have been late in the game in my opinion in the United States of really pushing this issue of using blood pressures from other settings—not just using in-office blood pressure readings,” Davis said making the point that the European and Canadian guidelines incorporated BP readings from other settings in the recommendations for diagnosing hypertension about 5 years ago.

“We need more than just the blood pressure readings we’re getting in the office,” she said, to identify things like white coat hypertension and masked hypertension, which is the opposite of white coat hypertension, meaning a patient’s BP is within normal limits in the office or clinic, but elevated when he/she is away from a medical setting. 

Continue to: When to start meds

When to start meds
Another practice changer, according to Davis, is when to start medications based on the new guidelines. “We are now looking at 10-year atherosclerotic risk, and that hasn’t been part of the management guidelines in the past for hypertension.” Similarly, “Treatment goals now have lower targets,” she said.

She explained that for patients who require secondary prevention of recurrent CVD (or if they have clinical CVD), then 10-year risk is irrelevant, and practitioners should start medication when systolic blood pressure (SBP) is ≥130 mm Hg or diastolic blood pressure (DBP) is ≥80 mm Hg. If the patient requires primary prevention (ie, no history of CVD or additional markers of increased risk of CVD) and their atherosclerotic 10-year risk is ≥10%, then medication is also warranted when SPB is ≥130 mm Hg or DBP is ≥80 mm Hg. Davis explained, “Some people might say [10% is] not much of a risk, but that’s considered as high a risk as someone who’s had a heart attack or stroke.”

If a patient requires primary prevention (ie, no history of CVD) and they have a 10-year atherosclerotic risk <10%, then health care providers should start medication when the patient’s SBP is ≥140 mm Hg or DBP is ≥90 mm Hg. Yet, Davis added, as with any patient with any elevation of BP, these patients should adopt lifestyle changes to reduce their BP.

In the end, Davis reminded that these are simply evidence-based guidelines, and that practitioners still need to have discussions with patients about when to start pharmacotherapy.

Continue to: Follow-up and nonpharmacologic care

Follow-up and nonpharmacologic care
“If patients have low atherosclerotic risk and an SBP that is 120 to 129 mm Hg, you can repeat the BP measurement after up to 6 months of lifestyle changes,” said Davis. “These guidelines don’t add anything magical about lifestyle changes,” Davis explained. “It’s stuff we’ve known” and been doing for a long time, such as the DASH diet and weight loss, which “are as good as low-dose medication at reducing BP in many cases.”

She cautioned, however, that with patients who are Stage 1 and Stage 2, “Don’t wait too long to bring them back; bring them back within a month.” She said that most patients with Stage 1 hypertension are managed with a combination of lifestyle changes and a medication, while those with Stage 2 hypertension are often started on 2 medications at once, along with lifestyle changes.

Lastly, Davis explained that older adults are defined as those ≥65 years of age, and that this population can range widely from those who are ambulatory and well to those who have many comorbid conditions. As a result, practitioners really need to talk to these patients and perhaps their families to determine through shared decision-making what treatment is necessary.

SAN DIEGO—The first practice changer is with the diagnosis of hypertension, began Leslie L. Davis, PhD, RN, ANP-BC, FAANP, FPCNA, FAHA. “The 2017 American Heart Association/American College of Cardiology guidelines¹ show us that Stage 1 hypertension is now 130 to 139 mm Hg systolic, and that has always been traditionally 140 mm Hg and above, so this dramatically changes how we diagnose and treat hypertension.”

“That means that another 14% or so of Americans will now fall under the category of Stage 1 hypertension. It doesn’t mean that all of these people will be on medication; however, when we reclassify, that’s a big chunk of the population. We go from about 32% prevalence to about 46% of adults in the United States having hypertension,” Davis said during a presentation at the annual Cardiology, Allergy, and Respiratory Disease Summit.

According to the guidelines, normal blood pressure (BP) is now <120 mm Hg systolic and <80 mm Hg diastolic. Elevated BP is 120 to 129 mm Hg systolic and <80 mm Hg diastolic. And Stage 2 hypertension is ≥140 mm Hg systolic and ≥90 mm Hg diastolic.

“This means we need to be a little more vigilant about screening and about getting patients in the system a little sooner . . . and  potentially about making some critical lifestyle changes because we know that blood pressure over time in men and women will gradually go up,” Davis said at the conference, held by Global Academy for Medical Education. “Systolic and diastolic blood pressure increases every year of life on average, and by the fifth decade of life, diastolic will start going down, but systolic will continue to increase. If we can catch folks sooner, we can prevent the poor outcomes associated with having hypertension,” she stated.

Numbers matter
The new guidelines, Davis continued, mean that “more than ever, accuracy in blood pressure measurement really matters.” She said, "It’s essential to take accurate blood pressures,” and to pay attention to things like having patients in a sitting position, at rest, with both feet planted on a flat surface, with back supported, and with arm at heart level for at least 5 minutes when taking BP measurements; to remove constrictive clothing and not just push it up; to make sure the patient hasn’t used caffeine or tobacco for at least 30 minutes prior to the measurement; to use the correct size sphygmomanometer cuff; to have the patient not talk during the measurement; and to consider out-of-office BP measurements in the overall assessment.

"We might have been late in the game in my opinion in the United States of really pushing this issue of using blood pressures from other settings—not just using in-office blood pressure readings,” Davis said making the point that the European and Canadian guidelines incorporated BP readings from other settings in the recommendations for diagnosing hypertension about 5 years ago.

“We need more than just the blood pressure readings we’re getting in the office,” she said, to identify things like white coat hypertension and masked hypertension, which is the opposite of white coat hypertension, meaning a patient’s BP is within normal limits in the office or clinic, but elevated when he/she is away from a medical setting. 

Continue to: When to start meds

When to start meds
Another practice changer, according to Davis, is when to start medications based on the new guidelines. “We are now looking at 10-year atherosclerotic risk, and that hasn’t been part of the management guidelines in the past for hypertension.” Similarly, “Treatment goals now have lower targets,” she said.

She explained that for patients who require secondary prevention of recurrent CVD (or if they have clinical CVD), then 10-year risk is irrelevant, and practitioners should start medication when systolic blood pressure (SBP) is ≥130 mm Hg or diastolic blood pressure (DBP) is ≥80 mm Hg. If the patient requires primary prevention (ie, no history of CVD or additional markers of increased risk of CVD) and their atherosclerotic 10-year risk is ≥10%, then medication is also warranted when SPB is ≥130 mm Hg or DBP is ≥80 mm Hg. Davis explained, “Some people might say [10% is] not much of a risk, but that’s considered as high a risk as someone who’s had a heart attack or stroke.”

If a patient requires primary prevention (ie, no history of CVD) and they have a 10-year atherosclerotic risk <10%, then health care providers should start medication when the patient’s SBP is ≥140 mm Hg or DBP is ≥90 mm Hg. Yet, Davis added, as with any patient with any elevation of BP, these patients should adopt lifestyle changes to reduce their BP.

In the end, Davis reminded that these are simply evidence-based guidelines, and that practitioners still need to have discussions with patients about when to start pharmacotherapy.

Continue to: Follow-up and nonpharmacologic care

Follow-up and nonpharmacologic care
“If patients have low atherosclerotic risk and an SBP that is 120 to 129 mm Hg, you can repeat the BP measurement after up to 6 months of lifestyle changes,” said Davis. “These guidelines don’t add anything magical about lifestyle changes,” Davis explained. “It’s stuff we’ve known” and been doing for a long time, such as the DASH diet and weight loss, which “are as good as low-dose medication at reducing BP in many cases.”

She cautioned, however, that with patients who are Stage 1 and Stage 2, “Don’t wait too long to bring them back; bring them back within a month.” She said that most patients with Stage 1 hypertension are managed with a combination of lifestyle changes and a medication, while those with Stage 2 hypertension are often started on 2 medications at once, along with lifestyle changes.

Lastly, Davis explained that older adults are defined as those ≥65 years of age, and that this population can range widely from those who are ambulatory and well to those who have many comorbid conditions. As a result, practitioners really need to talk to these patients and perhaps their families to determine through shared decision-making what treatment is necessary.

SAN DIEGO – Symptoms alone are usually not sufficient for either patients or staff to determine whether an ED visit is warranted, based on an analysis of a national health care database presented at the annual meeting of the American College of Emergency Physicians and later published in JAMA Network Open.

The findings have important policy implications, as a large health care insurer recently rolled out a program to deny coverage for ED visits that conclude with a nonemergent diagnosis.

“Nonemergent diagnoses correlate poorly with visit severity and the need for multiple diagnostic tests and hospital care,” Shih-Chuan Chou, MD, of Brigham and Women’s Hospital in Boston, said at the meeting. “Nearly 9 out of 10 ED patients will present with some sort of symptoms that may potentially lead to a nonemergent diagnosis.”

Anthem initiated the decision to deny coverage for nonemergent conditions in 2017. Anthem’s policy is active in six states: Georgia, Indiana, Kentucky, Missouri, New Hampshire, and Ohio. ACEP and the Medical Association of Georgia have filed a federal lawsuit asserting that Anthem Blue Cross/Blue Shield of Georgia is violating the prudent layperson standard, which is a federal law requiring insurance companies to cover the costs of emergency care based on a patient’s symptoms – not their final diagnosis.

In the study reported by Dr. Chou, the impact of the change in reimbursement was applied to ED visit data from the National Hospital Ambulatory Medical Care Survey (NHAMCS-ED).

Of the 29.6 million adult ED visits by commercially insured patients in the NHAMCS-ED database over the study period, 15.7%, or approximately 4.6 million visits, would have been denied reimbursement based on the new Anthem policy. Of these, 24.5% of the visits were initially triaged by the ED staff as urgent or emergent. Another 26% of the visits resulted in two or more diagnostic tests, suggesting that ED staff were concerned that the underlying disease was potentially serious.

From another perspective, 87.9% of patients with a diagnosis that met criteria for reimbursement had symptoms similar to those of patients who would have been denied reimbursement. In other words, according to Dr. Chou, neither patients nor ED staff would likely be able to distinguish on the basis of symptoms alone which patients would ultimately be diagnosed with a disease that was or was not eligible for reimbursement.

“If commercial insurers begin adopting similar policies and retrospectively deny coverage for ED visits using discharge diagnoses, patients will be forced to weigh the odds of foregoing potentially necessary care against the risk of facing a significant financial burden if they guessed wrong,” Dr. Chou said.

Such policies are “likely to disproportionally impact low income populations,” he added, noting that many patient advocacy groups, as well as the American Medical Association, have expressed opposition to Anthem’s approach.

New strategies are needed to reduce reliance on ED visits for acute but nonemergent diseases, Dr. Chou said, but the data argue against denial of reimbursement as a method consistent with delivery of good health care.

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

SOURCE: Chou S-C et al. JAMA Netw Open. 2018 Oct 19. doi: 10.1001/jamanetworkopen.2018.3731.

SAN DIEGO – Symptoms alone are usually not sufficient for either patients or staff to determine whether an ED visit is warranted, based on an analysis of a national health care database presented at the annual meeting of the American College of Emergency Physicians and later published in JAMA Network Open.

The findings have important policy implications, as a large health care insurer recently rolled out a program to deny coverage for ED visits that conclude with a nonemergent diagnosis.

“Nonemergent diagnoses correlate poorly with visit severity and the need for multiple diagnostic tests and hospital care,” Shih-Chuan Chou, MD, of Brigham and Women’s Hospital in Boston, said at the meeting. “Nearly 9 out of 10 ED patients will present with some sort of symptoms that may potentially lead to a nonemergent diagnosis.”

Anthem initiated the decision to deny coverage for nonemergent conditions in 2017. Anthem’s policy is active in six states: Georgia, Indiana, Kentucky, Missouri, New Hampshire, and Ohio. ACEP and the Medical Association of Georgia have filed a federal lawsuit asserting that Anthem Blue Cross/Blue Shield of Georgia is violating the prudent layperson standard, which is a federal law requiring insurance companies to cover the costs of emergency care based on a patient’s symptoms – not their final diagnosis.

In the study reported by Dr. Chou, the impact of the change in reimbursement was applied to ED visit data from the National Hospital Ambulatory Medical Care Survey (NHAMCS-ED).

Of the 29.6 million adult ED visits by commercially insured patients in the NHAMCS-ED database over the study period, 15.7%, or approximately 4.6 million visits, would have been denied reimbursement based on the new Anthem policy. Of these, 24.5% of the visits were initially triaged by the ED staff as urgent or emergent. Another 26% of the visits resulted in two or more diagnostic tests, suggesting that ED staff were concerned that the underlying disease was potentially serious.

From another perspective, 87.9% of patients with a diagnosis that met criteria for reimbursement had symptoms similar to those of patients who would have been denied reimbursement. In other words, according to Dr. Chou, neither patients nor ED staff would likely be able to distinguish on the basis of symptoms alone which patients would ultimately be diagnosed with a disease that was or was not eligible for reimbursement.

“If commercial insurers begin adopting similar policies and retrospectively deny coverage for ED visits using discharge diagnoses, patients will be forced to weigh the odds of foregoing potentially necessary care against the risk of facing a significant financial burden if they guessed wrong,” Dr. Chou said.

Such policies are “likely to disproportionally impact low income populations,” he added, noting that many patient advocacy groups, as well as the American Medical Association, have expressed opposition to Anthem’s approach.

New strategies are needed to reduce reliance on ED visits for acute but nonemergent diseases, Dr. Chou said, but the data argue against denial of reimbursement as a method consistent with delivery of good health care.

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

SOURCE: Chou S-C et al. JAMA Netw Open. 2018 Oct 19. doi: 10.1001/jamanetworkopen.2018.3731.

SAN DIEGO – Symptoms alone are usually not sufficient for either patients or staff to determine whether an ED visit is warranted, based on an analysis of a national health care database presented at the annual meeting of the American College of Emergency Physicians and later published in JAMA Network Open.

The findings have important policy implications, as a large health care insurer recently rolled out a program to deny coverage for ED visits that conclude with a nonemergent diagnosis.

“Nonemergent diagnoses correlate poorly with visit severity and the need for multiple diagnostic tests and hospital care,” Shih-Chuan Chou, MD, of Brigham and Women’s Hospital in Boston, said at the meeting. “Nearly 9 out of 10 ED patients will present with some sort of symptoms that may potentially lead to a nonemergent diagnosis.”

Anthem initiated the decision to deny coverage for nonemergent conditions in 2017. Anthem’s policy is active in six states: Georgia, Indiana, Kentucky, Missouri, New Hampshire, and Ohio. ACEP and the Medical Association of Georgia have filed a federal lawsuit asserting that Anthem Blue Cross/Blue Shield of Georgia is violating the prudent layperson standard, which is a federal law requiring insurance companies to cover the costs of emergency care based on a patient’s symptoms – not their final diagnosis.

In the study reported by Dr. Chou, the impact of the change in reimbursement was applied to ED visit data from the National Hospital Ambulatory Medical Care Survey (NHAMCS-ED).

Of the 29.6 million adult ED visits by commercially insured patients in the NHAMCS-ED database over the study period, 15.7%, or approximately 4.6 million visits, would have been denied reimbursement based on the new Anthem policy. Of these, 24.5% of the visits were initially triaged by the ED staff as urgent or emergent. Another 26% of the visits resulted in two or more diagnostic tests, suggesting that ED staff were concerned that the underlying disease was potentially serious.

From another perspective, 87.9% of patients with a diagnosis that met criteria for reimbursement had symptoms similar to those of patients who would have been denied reimbursement. In other words, according to Dr. Chou, neither patients nor ED staff would likely be able to distinguish on the basis of symptoms alone which patients would ultimately be diagnosed with a disease that was or was not eligible for reimbursement.

“If commercial insurers begin adopting similar policies and retrospectively deny coverage for ED visits using discharge diagnoses, patients will be forced to weigh the odds of foregoing potentially necessary care against the risk of facing a significant financial burden if they guessed wrong,” Dr. Chou said.

Such policies are “likely to disproportionally impact low income populations,” he added, noting that many patient advocacy groups, as well as the American Medical Association, have expressed opposition to Anthem’s approach.

New strategies are needed to reduce reliance on ED visits for acute but nonemergent diseases, Dr. Chou said, but the data argue against denial of reimbursement as a method consistent with delivery of good health care.

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

SOURCE: Chou S-C et al. JAMA Netw Open. 2018 Oct 19. doi: 10.1001/jamanetworkopen.2018.3731.

BOSTON – For women undergoing nipple-sparing mastectomy, advanced age and neoadjuvant chemotherapy are not associated with increased postoperative complications, results of recent studies suggest.

Andrew D. Bowser/MDedge News

The procedure was “surgically safe” in older patients, with complication rates comparable to those seen in younger patients, Solange E. Cox, MD, of MedStar Georgetown University Hospital, Washington, said in a presentation of one those two retrospective analyses at the annual clinical congress of the American College of Surgeons.

“From this, we think that eligible older patients should be offered a nipple-sparing mastectomy as a surgical option for breast cancer, and age alone should not be used as criteria to exclude these patients from the option,” she said.

The second retrospective study showed that patients undergoing neoadjuvant chemotherapy had a rate of surgical complications and unintended reoperations comparable to what was seen in women undergoing primary surgery.

“Our big-picture takeaway from this study is that receipt of neoadjuvant chemotherapy is not a contraindication for nipple-sparing mastectomy,” said investigator Alex J. Bartholomew, MS, also of Medstar Georgetown University Hospital.

Mr. Bartholomew’s conclusion was based on an analysis of the nipple-sparing mastectomy registry of the American Society of Breast Surgeons that included a total of 3,125 breasts. Neoadjuvant chemotherapy was used in 528, or 16.9%, while primary surgery was performed in 2,597, or 83.1%.

The overall rate of complications was 11%, with nonsignificant differences between the neoadjuvant chemotherapy and primary surgery groups at 12.7% and 10.7%, respectively.

Andrew D. Bowser/MDedge News

SOURCES: Cox S et al. SF310 abstract; Bartholomew AJ et al. SF310 abstract ACS Clinical Congress 2018

BOSTON – For women undergoing nipple-sparing mastectomy, advanced age and neoadjuvant chemotherapy are not associated with increased postoperative complications, results of recent studies suggest.

Andrew D. Bowser/MDedge News

The procedure was “surgically safe” in older patients, with complication rates comparable to those seen in younger patients, Solange E. Cox, MD, of MedStar Georgetown University Hospital, Washington, said in a presentation of one those two retrospective analyses at the annual clinical congress of the American College of Surgeons.

“From this, we think that eligible older patients should be offered a nipple-sparing mastectomy as a surgical option for breast cancer, and age alone should not be used as criteria to exclude these patients from the option,” she said.

The second retrospective study showed that patients undergoing neoadjuvant chemotherapy had a rate of surgical complications and unintended reoperations comparable to what was seen in women undergoing primary surgery.

“Our big-picture takeaway from this study is that receipt of neoadjuvant chemotherapy is not a contraindication for nipple-sparing mastectomy,” said investigator Alex J. Bartholomew, MS, also of Medstar Georgetown University Hospital.

Mr. Bartholomew’s conclusion was based on an analysis of the nipple-sparing mastectomy registry of the American Society of Breast Surgeons that included a total of 3,125 breasts. Neoadjuvant chemotherapy was used in 528, or 16.9%, while primary surgery was performed in 2,597, or 83.1%.

The overall rate of complications was 11%, with nonsignificant differences between the neoadjuvant chemotherapy and primary surgery groups at 12.7% and 10.7%, respectively.

Andrew D. Bowser/MDedge News

SOURCES: Cox S et al. SF310 abstract; Bartholomew AJ et al. SF310 abstract ACS Clinical Congress 2018

BOSTON – For women undergoing nipple-sparing mastectomy, advanced age and neoadjuvant chemotherapy are not associated with increased postoperative complications, results of recent studies suggest.

Andrew D. Bowser/MDedge News

The procedure was “surgically safe” in older patients, with complication rates comparable to those seen in younger patients, Solange E. Cox, MD, of MedStar Georgetown University Hospital, Washington, said in a presentation of one those two retrospective analyses at the annual clinical congress of the American College of Surgeons.

“From this, we think that eligible older patients should be offered a nipple-sparing mastectomy as a surgical option for breast cancer, and age alone should not be used as criteria to exclude these patients from the option,” she said.

The second retrospective study showed that patients undergoing neoadjuvant chemotherapy had a rate of surgical complications and unintended reoperations comparable to what was seen in women undergoing primary surgery.

“Our big-picture takeaway from this study is that receipt of neoadjuvant chemotherapy is not a contraindication for nipple-sparing mastectomy,” said investigator Alex J. Bartholomew, MS, also of Medstar Georgetown University Hospital.

Mr. Bartholomew’s conclusion was based on an analysis of the nipple-sparing mastectomy registry of the American Society of Breast Surgeons that included a total of 3,125 breasts. Neoadjuvant chemotherapy was used in 528, or 16.9%, while primary surgery was performed in 2,597, or 83.1%.

The overall rate of complications was 11%, with nonsignificant differences between the neoadjuvant chemotherapy and primary surgery groups at 12.7% and 10.7%, respectively.

Andrew D. Bowser/MDedge News

SOURCES: Cox S et al. SF310 abstract; Bartholomew AJ et al. SF310 abstract ACS Clinical Congress 2018