The overall prevalence of chronic hepatitis C virus (HCV) in the United States was 1.19%, giving an estimate of 2,347,852 infected adults. Baby boomers had the highest prevalence at 2.23%, accounting for more than 74% of all chronic HCV cases, according to the results of a database analysis done by Kevin J. Moore, MD, of the University of Miami and his colleagues.

©vchal/Thinkstock

In the analysis, published in the Journal of Infection and Public Health, the researchers assessed data from National Health and Nutrition Examination Survey for the years 1999-2012. They separated three age categories: baby boomers (BB), younger than BB (YG), and older than BB (OG). BBs showed an HCV prevalence over four times higher than YG or OG. BBs also had more significant predictors of positive HCV status than YGs or OGs.

In addition to the overall difference in incidence of HCV infection in boomers and nonboomers, they found that significant predictors of chronic HCV positivity among BBs were being male or non-Hispanic black, having a positive blood transfusion history, being a current or former smoker, and living below the poverty line.

The most significant risk factor for HCV positivity differed across age groups – being a current smoker in YG and BB and being non-Hispanic black in OG, the researchers noted.

“These results show that HCV infection continues to be a significant public health issue and warrants further attention given the aging BB population. Future studies should seek to further identify age-specific risk factors for HCV infection to optimize HCV screening and prevention programs through public health interventions,” the researchers concluded.

The authors reported that they had no conflicts of interest.

mlesney@mdedge.com

SOURCE: Moore KJ et al. J Infect Public Health. 2019 Jan-Feb;12(1):32-6.

The overall prevalence of chronic hepatitis C virus (HCV) in the United States was 1.19%, giving an estimate of 2,347,852 infected adults. Baby boomers had the highest prevalence at 2.23%, accounting for more than 74% of all chronic HCV cases, according to the results of a database analysis done by Kevin J. Moore, MD, of the University of Miami and his colleagues.

©vchal/Thinkstock

In the analysis, published in the Journal of Infection and Public Health, the researchers assessed data from National Health and Nutrition Examination Survey for the years 1999-2012. They separated three age categories: baby boomers (BB), younger than BB (YG), and older than BB (OG). BBs showed an HCV prevalence over four times higher than YG or OG. BBs also had more significant predictors of positive HCV status than YGs or OGs.

In addition to the overall difference in incidence of HCV infection in boomers and nonboomers, they found that significant predictors of chronic HCV positivity among BBs were being male or non-Hispanic black, having a positive blood transfusion history, being a current or former smoker, and living below the poverty line.

The most significant risk factor for HCV positivity differed across age groups – being a current smoker in YG and BB and being non-Hispanic black in OG, the researchers noted.

“These results show that HCV infection continues to be a significant public health issue and warrants further attention given the aging BB population. Future studies should seek to further identify age-specific risk factors for HCV infection to optimize HCV screening and prevention programs through public health interventions,” the researchers concluded.

The authors reported that they had no conflicts of interest.

mlesney@mdedge.com

SOURCE: Moore KJ et al. J Infect Public Health. 2019 Jan-Feb;12(1):32-6.

The overall prevalence of chronic hepatitis C virus (HCV) in the United States was 1.19%, giving an estimate of 2,347,852 infected adults. Baby boomers had the highest prevalence at 2.23%, accounting for more than 74% of all chronic HCV cases, according to the results of a database analysis done by Kevin J. Moore, MD, of the University of Miami and his colleagues.

©vchal/Thinkstock

In the analysis, published in the Journal of Infection and Public Health, the researchers assessed data from National Health and Nutrition Examination Survey for the years 1999-2012. They separated three age categories: baby boomers (BB), younger than BB (YG), and older than BB (OG). BBs showed an HCV prevalence over four times higher than YG or OG. BBs also had more significant predictors of positive HCV status than YGs or OGs.

In addition to the overall difference in incidence of HCV infection in boomers and nonboomers, they found that significant predictors of chronic HCV positivity among BBs were being male or non-Hispanic black, having a positive blood transfusion history, being a current or former smoker, and living below the poverty line.

The most significant risk factor for HCV positivity differed across age groups – being a current smoker in YG and BB and being non-Hispanic black in OG, the researchers noted.

“These results show that HCV infection continues to be a significant public health issue and warrants further attention given the aging BB population. Future studies should seek to further identify age-specific risk factors for HCV infection to optimize HCV screening and prevention programs through public health interventions,” the researchers concluded.

The authors reported that they had no conflicts of interest.

mlesney@mdedge.com

SOURCE: Moore KJ et al. J Infect Public Health. 2019 Jan-Feb;12(1):32-6.

Myth: Getting a Tan Helps Improve Acne

Acne has a multifaceted impact on patients, and facial acne in particular can impair self-image, psychological well-being, and ability to develop relationships. Patients cope with the clinical presentation of the disease in various ways, such as wearing makeup to cover blemishes, changing their hair color or diet, or getting regular facials. A common misconception is that a tan will help resolve acne.

A 2014 study on the burden of adult female acne (N=208) found that 5.3% of patients go to tanning salons or lay out in the sun to cope with their acne and 17% use self-tanning products to make their acne less visible. Many patients (40%) also believed that sunscreen exacerbates acne. Furthermore, a study of adolescents in Stockholm reported that those with acne, eczema, or psoriasis used sunbeds more than others without skin diseases.

The risk of developing skin cancer from sun exposure or UV light has been well established, and there is no evidence that UV light helps improve acne. A 2015 review of the literature on tanning bed use and phototherapy associated with treatment of conditions such as acne reported that experimental trials have been conducted for various light source therapies (eg, blue light, red-blue light, photodynamic therapy); however, there is no direct evidence for UV light.

In fact, acne patients should be counseled on the importance of photoprotection. Many acne therapies leave patients predisposed to UV damage, and UV damage generates free radical formation, which has been implicated in acne flares.

Expert Commentary

Often I hear from patients they feel tanning helps improve their acne. I tell them there is no evidence this is at all true. Just like cream makeup can camouflage acne, so too can tanning. But, trying to hide your blemishes does not actually help nor treat them. And moreover, tanning is so dangerous for potential skin cancer later in life.

—Lawrence J. Green, MD (Washington, DC)

Myth: Getting a Tan Helps Improve Acne

Acne has a multifaceted impact on patients, and facial acne in particular can impair self-image, psychological well-being, and ability to develop relationships. Patients cope with the clinical presentation of the disease in various ways, such as wearing makeup to cover blemishes, changing their hair color or diet, or getting regular facials. A common misconception is that a tan will help resolve acne.

A 2014 study on the burden of adult female acne (N=208) found that 5.3% of patients go to tanning salons or lay out in the sun to cope with their acne and 17% use self-tanning products to make their acne less visible. Many patients (40%) also believed that sunscreen exacerbates acne. Furthermore, a study of adolescents in Stockholm reported that those with acne, eczema, or psoriasis used sunbeds more than others without skin diseases.

The risk of developing skin cancer from sun exposure or UV light has been well established, and there is no evidence that UV light helps improve acne. A 2015 review of the literature on tanning bed use and phototherapy associated with treatment of conditions such as acne reported that experimental trials have been conducted for various light source therapies (eg, blue light, red-blue light, photodynamic therapy); however, there is no direct evidence for UV light.

In fact, acne patients should be counseled on the importance of photoprotection. Many acne therapies leave patients predisposed to UV damage, and UV damage generates free radical formation, which has been implicated in acne flares.

Expert Commentary

Often I hear from patients they feel tanning helps improve their acne. I tell them there is no evidence this is at all true. Just like cream makeup can camouflage acne, so too can tanning. But, trying to hide your blemishes does not actually help nor treat them. And moreover, tanning is so dangerous for potential skin cancer later in life.

—Lawrence J. Green, MD (Washington, DC)

Myth: Getting a Tan Helps Improve Acne

Acne has a multifaceted impact on patients, and facial acne in particular can impair self-image, psychological well-being, and ability to develop relationships. Patients cope with the clinical presentation of the disease in various ways, such as wearing makeup to cover blemishes, changing their hair color or diet, or getting regular facials. A common misconception is that a tan will help resolve acne.

A 2014 study on the burden of adult female acne (N=208) found that 5.3% of patients go to tanning salons or lay out in the sun to cope with their acne and 17% use self-tanning products to make their acne less visible. Many patients (40%) also believed that sunscreen exacerbates acne. Furthermore, a study of adolescents in Stockholm reported that those with acne, eczema, or psoriasis used sunbeds more than others without skin diseases.

The risk of developing skin cancer from sun exposure or UV light has been well established, and there is no evidence that UV light helps improve acne. A 2015 review of the literature on tanning bed use and phototherapy associated with treatment of conditions such as acne reported that experimental trials have been conducted for various light source therapies (eg, blue light, red-blue light, photodynamic therapy); however, there is no direct evidence for UV light.

In fact, acne patients should be counseled on the importance of photoprotection. Many acne therapies leave patients predisposed to UV damage, and UV damage generates free radical formation, which has been implicated in acne flares.

Expert Commentary

Often I hear from patients they feel tanning helps improve their acne. I tell them there is no evidence this is at all true. Just like cream makeup can camouflage acne, so too can tanning. But, trying to hide your blemishes does not actually help nor treat them. And moreover, tanning is so dangerous for potential skin cancer later in life.

—Lawrence J. Green, MD (Washington, DC)

WAIKOLOA, HAWAII – Check for joint tenderness and swelling routinely in your psoriasis patients, to detect psoriatic joint disease at an early stage, advised Alan Menter, MD.

About a third of patients with psoriasis will go on to develop joint involvement, and about half of those will go on to develop permanent joint destruction “if left untreated,” he noted. But early joint involvement has to be caught first, and dermatologists aren’t doing a very good job at early detection, according to Dr. Menter, clinical professor of dermatology at the University of Texas, Dallas.

The consequences, including arthritis mutilans, can be devastating. “It’s vitally important for us to prevent any permanent joint disease by” picking it up early, he said. “Our job as dermatologists is to diagnose it early.”

It’s not hard to do, just a few extra questions and a few extra steps on the physical exam, which takes a minute or two during each visit with psoriasis patients, are needed, he said.

Dr. Menter reviewed questions to ask patients, and explained how to examine patients for joint involvement and alter treatment when it’s found, in an interview at the Hawaii Dermatology Seminar provided by Global Academy for Medical Education/Skin Disease Education Foundation.

SDEF/Global Academy for Medical Education and this news organization are owned by the same parent company.

aotto@mdedge.com

WAIKOLOA, HAWAII – Check for joint tenderness and swelling routinely in your psoriasis patients, to detect psoriatic joint disease at an early stage, advised Alan Menter, MD.

About a third of patients with psoriasis will go on to develop joint involvement, and about half of those will go on to develop permanent joint destruction “if left untreated,” he noted. But early joint involvement has to be caught first, and dermatologists aren’t doing a very good job at early detection, according to Dr. Menter, clinical professor of dermatology at the University of Texas, Dallas.

The consequences, including arthritis mutilans, can be devastating. “It’s vitally important for us to prevent any permanent joint disease by” picking it up early, he said. “Our job as dermatologists is to diagnose it early.”

It’s not hard to do, just a few extra questions and a few extra steps on the physical exam, which takes a minute or two during each visit with psoriasis patients, are needed, he said.

Dr. Menter reviewed questions to ask patients, and explained how to examine patients for joint involvement and alter treatment when it’s found, in an interview at the Hawaii Dermatology Seminar provided by Global Academy for Medical Education/Skin Disease Education Foundation.

SDEF/Global Academy for Medical Education and this news organization are owned by the same parent company.

aotto@mdedge.com

WAIKOLOA, HAWAII – Check for joint tenderness and swelling routinely in your psoriasis patients, to detect psoriatic joint disease at an early stage, advised Alan Menter, MD.

About a third of patients with psoriasis will go on to develop joint involvement, and about half of those will go on to develop permanent joint destruction “if left untreated,” he noted. But early joint involvement has to be caught first, and dermatologists aren’t doing a very good job at early detection, according to Dr. Menter, clinical professor of dermatology at the University of Texas, Dallas.

The consequences, including arthritis mutilans, can be devastating. “It’s vitally important for us to prevent any permanent joint disease by” picking it up early, he said. “Our job as dermatologists is to diagnose it early.”

It’s not hard to do, just a few extra questions and a few extra steps on the physical exam, which takes a minute or two during each visit with psoriasis patients, are needed, he said.

Dr. Menter reviewed questions to ask patients, and explained how to examine patients for joint involvement and alter treatment when it’s found, in an interview at the Hawaii Dermatology Seminar provided by Global Academy for Medical Education/Skin Disease Education Foundation.

SDEF/Global Academy for Medical Education and this news organization are owned by the same parent company.

aotto@mdedge.com

WAIKOLOA, HAWAII – The work up of a case of onychomycosis doesn’t end with the detection of fungal hyphae.

Trichophyton rubrum remains the most common cause of toenail fungus in the United States, but nondermatophyte molds – Scopulariopsis, Fusarium, and others – are on the rise, so it’s important to speciate, especially when patients have atypical presentations or fail to respond to the T. rubrum go-to treatment, terbinafine, according to Nathaniel Jellinek, MD, of the department of dermatology, Brown University, Providence, R.I.

Standard in-office potassium hydroxide (KOH) testing can’t distinguish one species of fungus from another, nor can pathology with Gomori methenamine silver (GMS) or Periodic acid-Schiff (PAS) staining. Both culture and polymerase chain reaction (PCR), however, do.

Since few hospitals are equipped to run those tests, Dr. Jellinek uses the Case Western Center for Medical Mycology, in Cleveland, for testing.

In an interview at the Hawaii Dermatology Seminar provided by the Global Academy for Medical Education/Skin Disease Education Foundation, Dr. Jellinek explained how to speciate, and the importance of doing so.

He also shared his tips on getting good nail clippings and good scrapings for debris for testing, and explained when KOH testing is enough – and when to opt for more advanced diagnostic methods, including PCR, which he said trumps all previous methods.

Terbinafine is still the best option for T. rubrum, but new topicals are better for nondermatophyte molds. There’s also a clever new dosing regimen for terbinafine, one that should put patients at ease about liver toxicity and other concerns. “If you tell them they’re getting 1 month off in the middle, it seems to go over a little easier,” Dr. Jellinek said.

SDEF/Global Academy for Medical Education and this news organization are owned by the same parent company.
 

aotto@mdedge.com

WAIKOLOA, HAWAII – The work up of a case of onychomycosis doesn’t end with the detection of fungal hyphae.

Trichophyton rubrum remains the most common cause of toenail fungus in the United States, but nondermatophyte molds – Scopulariopsis, Fusarium, and others – are on the rise, so it’s important to speciate, especially when patients have atypical presentations or fail to respond to the T. rubrum go-to treatment, terbinafine, according to Nathaniel Jellinek, MD, of the department of dermatology, Brown University, Providence, R.I.

Standard in-office potassium hydroxide (KOH) testing can’t distinguish one species of fungus from another, nor can pathology with Gomori methenamine silver (GMS) or Periodic acid-Schiff (PAS) staining. Both culture and polymerase chain reaction (PCR), however, do.

Since few hospitals are equipped to run those tests, Dr. Jellinek uses the Case Western Center for Medical Mycology, in Cleveland, for testing.

In an interview at the Hawaii Dermatology Seminar provided by the Global Academy for Medical Education/Skin Disease Education Foundation, Dr. Jellinek explained how to speciate, and the importance of doing so.

He also shared his tips on getting good nail clippings and good scrapings for debris for testing, and explained when KOH testing is enough – and when to opt for more advanced diagnostic methods, including PCR, which he said trumps all previous methods.

Terbinafine is still the best option for T. rubrum, but new topicals are better for nondermatophyte molds. There’s also a clever new dosing regimen for terbinafine, one that should put patients at ease about liver toxicity and other concerns. “If you tell them they’re getting 1 month off in the middle, it seems to go over a little easier,” Dr. Jellinek said.

SDEF/Global Academy for Medical Education and this news organization are owned by the same parent company.
 

aotto@mdedge.com

WAIKOLOA, HAWAII – The work up of a case of onychomycosis doesn’t end with the detection of fungal hyphae.

Trichophyton rubrum remains the most common cause of toenail fungus in the United States, but nondermatophyte molds – Scopulariopsis, Fusarium, and others – are on the rise, so it’s important to speciate, especially when patients have atypical presentations or fail to respond to the T. rubrum go-to treatment, terbinafine, according to Nathaniel Jellinek, MD, of the department of dermatology, Brown University, Providence, R.I.

Standard in-office potassium hydroxide (KOH) testing can’t distinguish one species of fungus from another, nor can pathology with Gomori methenamine silver (GMS) or Periodic acid-Schiff (PAS) staining. Both culture and polymerase chain reaction (PCR), however, do.

Since few hospitals are equipped to run those tests, Dr. Jellinek uses the Case Western Center for Medical Mycology, in Cleveland, for testing.

In an interview at the Hawaii Dermatology Seminar provided by the Global Academy for Medical Education/Skin Disease Education Foundation, Dr. Jellinek explained how to speciate, and the importance of doing so.

He also shared his tips on getting good nail clippings and good scrapings for debris for testing, and explained when KOH testing is enough – and when to opt for more advanced diagnostic methods, including PCR, which he said trumps all previous methods.

Terbinafine is still the best option for T. rubrum, but new topicals are better for nondermatophyte molds. There’s also a clever new dosing regimen for terbinafine, one that should put patients at ease about liver toxicity and other concerns. “If you tell them they’re getting 1 month off in the middle, it seems to go over a little easier,” Dr. Jellinek said.

SDEF/Global Academy for Medical Education and this news organization are owned by the same parent company.
 

aotto@mdedge.com

When a patient told Richard Balon, MD, that he could no longer afford to spend $300 a month on a tricyclic, Dr. Balon could not believe that the price was so high. “This is clearly unsustainable,” said Dr. Balon, professor of psychiatry and anesthesiology, and associate chair of education at Wayne State University in Detroit. In this Masterclass episode of the Psychcast from the 2018 AACP Encore meeting in Las Vegas, he lectures on the increase in the price of generic and brand name medications in the United States.

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When a patient told Richard Balon, MD, that he could no longer afford to spend $300 a month on a tricyclic, Dr. Balon could not believe that the price was so high. “This is clearly unsustainable,” said Dr. Balon, professor of psychiatry and anesthesiology, and associate chair of education at Wayne State University in Detroit. In this Masterclass episode of the Psychcast from the 2018 AACP Encore meeting in Las Vegas, he lectures on the increase in the price of generic and brand name medications in the United States.

Amazon

Apple Podcasts

Google Podcasts

Spotify


 

When a patient told Richard Balon, MD, that he could no longer afford to spend $300 a month on a tricyclic, Dr. Balon could not believe that the price was so high. “This is clearly unsustainable,” said Dr. Balon, professor of psychiatry and anesthesiology, and associate chair of education at Wayne State University in Detroit. In this Masterclass episode of the Psychcast from the 2018 AACP Encore meeting in Las Vegas, he lectures on the increase in the price of generic and brand name medications in the United States.

Amazon

Apple Podcasts

Google Podcasts

Spotify


 

SAN DIEGO – One year after implementation, a pulmonary embolism response team (PERT) is making a significant difference in care of patients with submassive pulmonary embolism and evidence of right ventricular (RV) dysfunction at the Christiana Medical Center in Delaware. An analysis of data collected showed reductions in ICU stays, early death, and overall hospital length of stay.

Andrei Malov/Thinkstock

Such patients pose a challenge to clinicians because some will go on to develop more serious pulmonary embolism (PE), yet aggressive treatment options carry their own risk. Existing guidelines, such as those by the European Society of Cardiology, recommend conservative treatment of these patients, with more aggressive measures if conditions don’t quickly improve.

However, about 12% of patients on conservative therapy die, or about 100,000 per year. Those patients who go on to have bad outcomes “are obviously intermediate high risk or high risk. This is the patient population that we’re interested in [addressing through PERT]. These aren’t really sick patients. The blood pressure is normal, but they have the risk based on comorbidities or the clot burden to do poorly over the next day or two,” said Michael Benninghoff, DO, section chief of medical critical care and director of respiratory therapy at Christiana Medical Center, Wilmington, Del. Dr. Benninghoff presented the study at the Critical Care Congress sponsored by the Society of Critical Care Medicine.

The PERT concept was developed by physicians at Massachusetts General Hospital. It establishes clinical criteria that, if met, prompt a PERT alert, which in turn triggers a meeting between the initiating provider, a pulmonary intensivist, and a vascular and interventional radiology physician within 15 minutes to review the case and make rapid clinical decisions.

A PERT alert requires either a CT diagnosis of PE or a VQ scan showing a high probability of PE, combined with one of three additional criteria: elevated B-type (brain) natriuretic peptide (BNP) and troponin; echocardiographic evidence of right ventricular dysfunction; or clinical instability as indicated by heart rate over 110 beats per minute, systolic blood pressure below 100 mm Hg, or oxygen saturation lower than 90%.

The PERT program caught Dr. Benninghoff’s attention because of institutional experience with patients deteriorating on conservative treatment, but also because the treatment of submassive PE with RV dysfunction is quite scattered. “We were seeing really conservative to really aggressive treatment. I don’t think we’ve had the data to support treating a patient whose blood pressure is normal but they have signs of right ventricular dysfunction, whether it’s echocardiographic, radiographic, or laboratory evidence of myocardial necrosis. I don’t think we have a group conscience as providers as far as how aggressive to be with those patients,” said Dr. Benninghoff.

To examine the efficacy of the PERT program after 1 year, Dr. Benninghoff’s team reviewed all PE cases from 2016 (pre-PERT, n = 717) and 2017 (post-PERT, n = 752). The mortality index declined 30%, from 1.13 to 0.79, while the percentage of early death declined 52%, from 2.51 to 1.20. The mean number of ICU days fell from 5.01 to 4.40.

When the team restricted the analysis to PE lysis patients (n = 27 in 2016; n = 33 in 2017), the mean length of ICU stay dropped from 66.1 hours to 58.8 hours, and fewer patients were transferred from a lower level of care to the ICU (6 vs. 3).

“We think we have shown that just by talking in real time, forcing physicians to communicate – it certainly doesn’t hurt, that it probably helps with ICU utilization and perhaps even mortality,” said Dr. Benninghoff. 

The results are far from definitive, and much more work needs to be done to determine how best to manage patients with submassive PEs and RV dysfunction. Dr. Benninghoff doesn’t have the answers, but he’s hopeful that the PERT program can eventually provide some. “Probably the most important thing is we’re giving back to the medical community by enrolling in the consortium, putting our data in the hands of the Boston research institute, and seeing what comes of it. Hopefully in 5 years we will have a standard of care based on the work we’re doing now,” he said.

The study was funded internally. Dr. Benninghoff declared no conflicts of interest.

SOURCE: Benninghoff M. Critical Care Congress 2019, Abstract 490.

SAN DIEGO – One year after implementation, a pulmonary embolism response team (PERT) is making a significant difference in care of patients with submassive pulmonary embolism and evidence of right ventricular (RV) dysfunction at the Christiana Medical Center in Delaware. An analysis of data collected showed reductions in ICU stays, early death, and overall hospital length of stay.

Andrei Malov/Thinkstock

Such patients pose a challenge to clinicians because some will go on to develop more serious pulmonary embolism (PE), yet aggressive treatment options carry their own risk. Existing guidelines, such as those by the European Society of Cardiology, recommend conservative treatment of these patients, with more aggressive measures if conditions don’t quickly improve.

However, about 12% of patients on conservative therapy die, or about 100,000 per year. Those patients who go on to have bad outcomes “are obviously intermediate high risk or high risk. This is the patient population that we’re interested in [addressing through PERT]. These aren’t really sick patients. The blood pressure is normal, but they have the risk based on comorbidities or the clot burden to do poorly over the next day or two,” said Michael Benninghoff, DO, section chief of medical critical care and director of respiratory therapy at Christiana Medical Center, Wilmington, Del. Dr. Benninghoff presented the study at the Critical Care Congress sponsored by the Society of Critical Care Medicine.

The PERT concept was developed by physicians at Massachusetts General Hospital. It establishes clinical criteria that, if met, prompt a PERT alert, which in turn triggers a meeting between the initiating provider, a pulmonary intensivist, and a vascular and interventional radiology physician within 15 minutes to review the case and make rapid clinical decisions.

A PERT alert requires either a CT diagnosis of PE or a VQ scan showing a high probability of PE, combined with one of three additional criteria: elevated B-type (brain) natriuretic peptide (BNP) and troponin; echocardiographic evidence of right ventricular dysfunction; or clinical instability as indicated by heart rate over 110 beats per minute, systolic blood pressure below 100 mm Hg, or oxygen saturation lower than 90%.

The PERT program caught Dr. Benninghoff’s attention because of institutional experience with patients deteriorating on conservative treatment, but also because the treatment of submassive PE with RV dysfunction is quite scattered. “We were seeing really conservative to really aggressive treatment. I don’t think we’ve had the data to support treating a patient whose blood pressure is normal but they have signs of right ventricular dysfunction, whether it’s echocardiographic, radiographic, or laboratory evidence of myocardial necrosis. I don’t think we have a group conscience as providers as far as how aggressive to be with those patients,” said Dr. Benninghoff.

To examine the efficacy of the PERT program after 1 year, Dr. Benninghoff’s team reviewed all PE cases from 2016 (pre-PERT, n = 717) and 2017 (post-PERT, n = 752). The mortality index declined 30%, from 1.13 to 0.79, while the percentage of early death declined 52%, from 2.51 to 1.20. The mean number of ICU days fell from 5.01 to 4.40.

When the team restricted the analysis to PE lysis patients (n = 27 in 2016; n = 33 in 2017), the mean length of ICU stay dropped from 66.1 hours to 58.8 hours, and fewer patients were transferred from a lower level of care to the ICU (6 vs. 3).

“We think we have shown that just by talking in real time, forcing physicians to communicate – it certainly doesn’t hurt, that it probably helps with ICU utilization and perhaps even mortality,” said Dr. Benninghoff. 

The results are far from definitive, and much more work needs to be done to determine how best to manage patients with submassive PEs and RV dysfunction. Dr. Benninghoff doesn’t have the answers, but he’s hopeful that the PERT program can eventually provide some. “Probably the most important thing is we’re giving back to the medical community by enrolling in the consortium, putting our data in the hands of the Boston research institute, and seeing what comes of it. Hopefully in 5 years we will have a standard of care based on the work we’re doing now,” he said.

The study was funded internally. Dr. Benninghoff declared no conflicts of interest.

SOURCE: Benninghoff M. Critical Care Congress 2019, Abstract 490.

SAN DIEGO – One year after implementation, a pulmonary embolism response team (PERT) is making a significant difference in care of patients with submassive pulmonary embolism and evidence of right ventricular (RV) dysfunction at the Christiana Medical Center in Delaware. An analysis of data collected showed reductions in ICU stays, early death, and overall hospital length of stay.

Andrei Malov/Thinkstock

Such patients pose a challenge to clinicians because some will go on to develop more serious pulmonary embolism (PE), yet aggressive treatment options carry their own risk. Existing guidelines, such as those by the European Society of Cardiology, recommend conservative treatment of these patients, with more aggressive measures if conditions don’t quickly improve.

However, about 12% of patients on conservative therapy die, or about 100,000 per year. Those patients who go on to have bad outcomes “are obviously intermediate high risk or high risk. This is the patient population that we’re interested in [addressing through PERT]. These aren’t really sick patients. The blood pressure is normal, but they have the risk based on comorbidities or the clot burden to do poorly over the next day or two,” said Michael Benninghoff, DO, section chief of medical critical care and director of respiratory therapy at Christiana Medical Center, Wilmington, Del. Dr. Benninghoff presented the study at the Critical Care Congress sponsored by the Society of Critical Care Medicine.

The PERT concept was developed by physicians at Massachusetts General Hospital. It establishes clinical criteria that, if met, prompt a PERT alert, which in turn triggers a meeting between the initiating provider, a pulmonary intensivist, and a vascular and interventional radiology physician within 15 minutes to review the case and make rapid clinical decisions.

A PERT alert requires either a CT diagnosis of PE or a VQ scan showing a high probability of PE, combined with one of three additional criteria: elevated B-type (brain) natriuretic peptide (BNP) and troponin; echocardiographic evidence of right ventricular dysfunction; or clinical instability as indicated by heart rate over 110 beats per minute, systolic blood pressure below 100 mm Hg, or oxygen saturation lower than 90%.

The PERT program caught Dr. Benninghoff’s attention because of institutional experience with patients deteriorating on conservative treatment, but also because the treatment of submassive PE with RV dysfunction is quite scattered. “We were seeing really conservative to really aggressive treatment. I don’t think we’ve had the data to support treating a patient whose blood pressure is normal but they have signs of right ventricular dysfunction, whether it’s echocardiographic, radiographic, or laboratory evidence of myocardial necrosis. I don’t think we have a group conscience as providers as far as how aggressive to be with those patients,” said Dr. Benninghoff.

To examine the efficacy of the PERT program after 1 year, Dr. Benninghoff’s team reviewed all PE cases from 2016 (pre-PERT, n = 717) and 2017 (post-PERT, n = 752). The mortality index declined 30%, from 1.13 to 0.79, while the percentage of early death declined 52%, from 2.51 to 1.20. The mean number of ICU days fell from 5.01 to 4.40.

When the team restricted the analysis to PE lysis patients (n = 27 in 2016; n = 33 in 2017), the mean length of ICU stay dropped from 66.1 hours to 58.8 hours, and fewer patients were transferred from a lower level of care to the ICU (6 vs. 3).

“We think we have shown that just by talking in real time, forcing physicians to communicate – it certainly doesn’t hurt, that it probably helps with ICU utilization and perhaps even mortality,” said Dr. Benninghoff. 

The results are far from definitive, and much more work needs to be done to determine how best to manage patients with submassive PEs and RV dysfunction. Dr. Benninghoff doesn’t have the answers, but he’s hopeful that the PERT program can eventually provide some. “Probably the most important thing is we’re giving back to the medical community by enrolling in the consortium, putting our data in the hands of the Boston research institute, and seeing what comes of it. Hopefully in 5 years we will have a standard of care based on the work we’re doing now,” he said.

The study was funded internally. Dr. Benninghoff declared no conflicts of interest.

SOURCE: Benninghoff M. Critical Care Congress 2019, Abstract 490.

Patients with diabetic foot ulcers have a high incidence of associated chronic vascular disease, including kidney disease, retinopathy, and peripheral artery disease (PAD). In addition, there was statistically significant association between both diabetic retinopathy and diabetic kidney disease and PAD, according to a study reported by Magdy H. Megallaa, MD, and colleagues at Alexandria (Egypt) University.

Rebecca L. Slebodnik/MDedge News

Their cross-sectional study, published in Diabetes & Metabolic Syndrome: Clinical Research and Reviews, comprised 180 type 2 diabetic patients (aged 30-70 years) with diabetic foot ulcers (DFUs) who attended an outpatient clinic between July and December 2017.

The prevalence of diabetic kidney disease and diabetic retinopathy was 86.1% and 90.0%, respectively, with 86.7% of patients having neuropathic DFUs, 11.1% having ischemic DFUs, and 2.2% having neuroischemic DFUs. The prevalence of peripheral neuropathy and PAD was 82% and 20%, respectively.

Using albuminuria as a measure of diabetic kidney disease, the researchers found that 86.1% of the patients had albuminuria and that there was a statistically significant association between albuminuria and the patient’s vibration reception threshold (VPT), a measure of diabetic neuropathy (P less than .001), and the ankle brachial index (ABI), a measure of PAD (P less than .031).

In addition, there was a statistically significant association between diabetic retinopathy and VPT (P less than .008) and between diabetic retinopathy and ABI (P less than .001).

“Albuminuria, diabetic retinopathy and peripheral neuropathy are very common among those patients and strongly associated with risk factors of diabetic foot ulceration,” the researchers concluded.

They reported that they had no conflicts.

mlesney@mdedge.com

SOURCE: Megallaa MH et al. Diabetes Metab Syndr. 2019 Mar-Apr;13(2):1287-92.

Patients with diabetic foot ulcers have a high incidence of associated chronic vascular disease, including kidney disease, retinopathy, and peripheral artery disease (PAD). In addition, there was statistically significant association between both diabetic retinopathy and diabetic kidney disease and PAD, according to a study reported by Magdy H. Megallaa, MD, and colleagues at Alexandria (Egypt) University.

Rebecca L. Slebodnik/MDedge News

Their cross-sectional study, published in Diabetes & Metabolic Syndrome: Clinical Research and Reviews, comprised 180 type 2 diabetic patients (aged 30-70 years) with diabetic foot ulcers (DFUs) who attended an outpatient clinic between July and December 2017.

The prevalence of diabetic kidney disease and diabetic retinopathy was 86.1% and 90.0%, respectively, with 86.7% of patients having neuropathic DFUs, 11.1% having ischemic DFUs, and 2.2% having neuroischemic DFUs. The prevalence of peripheral neuropathy and PAD was 82% and 20%, respectively.

Using albuminuria as a measure of diabetic kidney disease, the researchers found that 86.1% of the patients had albuminuria and that there was a statistically significant association between albuminuria and the patient’s vibration reception threshold (VPT), a measure of diabetic neuropathy (P less than .001), and the ankle brachial index (ABI), a measure of PAD (P less than .031).

In addition, there was a statistically significant association between diabetic retinopathy and VPT (P less than .008) and between diabetic retinopathy and ABI (P less than .001).

“Albuminuria, diabetic retinopathy and peripheral neuropathy are very common among those patients and strongly associated with risk factors of diabetic foot ulceration,” the researchers concluded.

They reported that they had no conflicts.

mlesney@mdedge.com

SOURCE: Megallaa MH et al. Diabetes Metab Syndr. 2019 Mar-Apr;13(2):1287-92.

Patients with diabetic foot ulcers have a high incidence of associated chronic vascular disease, including kidney disease, retinopathy, and peripheral artery disease (PAD). In addition, there was statistically significant association between both diabetic retinopathy and diabetic kidney disease and PAD, according to a study reported by Magdy H. Megallaa, MD, and colleagues at Alexandria (Egypt) University.

Rebecca L. Slebodnik/MDedge News

Their cross-sectional study, published in Diabetes & Metabolic Syndrome: Clinical Research and Reviews, comprised 180 type 2 diabetic patients (aged 30-70 years) with diabetic foot ulcers (DFUs) who attended an outpatient clinic between July and December 2017.

The prevalence of diabetic kidney disease and diabetic retinopathy was 86.1% and 90.0%, respectively, with 86.7% of patients having neuropathic DFUs, 11.1% having ischemic DFUs, and 2.2% having neuroischemic DFUs. The prevalence of peripheral neuropathy and PAD was 82% and 20%, respectively.

Using albuminuria as a measure of diabetic kidney disease, the researchers found that 86.1% of the patients had albuminuria and that there was a statistically significant association between albuminuria and the patient’s vibration reception threshold (VPT), a measure of diabetic neuropathy (P less than .001), and the ankle brachial index (ABI), a measure of PAD (P less than .031).

In addition, there was a statistically significant association between diabetic retinopathy and VPT (P less than .008) and between diabetic retinopathy and ABI (P less than .001).

“Albuminuria, diabetic retinopathy and peripheral neuropathy are very common among those patients and strongly associated with risk factors of diabetic foot ulceration,” the researchers concluded.

They reported that they had no conflicts.

mlesney@mdedge.com

SOURCE: Megallaa MH et al. Diabetes Metab Syndr. 2019 Mar-Apr;13(2):1287-92.

WASHINGTON – As the rising cost of prescription drugs continues to garner heightened scrutiny from the federal government, one thing is missing from the conversation that would make any solution more effective, according to American Medical Association President Barbara L. McAneny, MD.

“We would like to see transparency from end to end in this pipeline because that is the way we will have the ability to look for savings,” she said in an interview at a national advocacy conference sponsored by the American Medical Association.

“I think we don’t have the information we need to make rational decisions,” she said. “I think the first thing we need to do is to understand the entire pipeline from the basic research that results in a drug’s clinical trials that results in a new drug to the pharmacy benefit managers and all of the ways that they have increased the cost of the drugs all the way to when the patient actually gets it.”

In particular, Dr. McAneny targeted the need for transparency in the role and financial impact pharmacy benefit managers have on the cost of prescription drugs.

“We were told at our state advocacy conference, which we held in January, by an expert who studied pharmacy benefit managers, that 42% of the cost of any drug is attributable to the profits of pharmacy benefit managers,” she said. “To me, that makes me wonder what value do they add that is worth 42% of these exorbitant costs and if they are not adding value, why do we have them in this process?”

She also called on the pharmaceutical manufacturers to be more forthcoming with their financial information regarding marketing and advertising, but she stressed that it needs to be done in a way that does not hinder future development of life-saving therapies.

“We do not want to stifle innovation.” Dr. McAneny said. “As a cancer doctor, I have seen diseases that I used to treat with morphine and sympathy now be diseases that I can treat, where I can restore people to good quality of life and buy them additional years of life because of these drugs. They are amazing and I don’t want to do without them and I want more of them. ... We want to support that research. That is probably worth a lot of the price tag. But how much of that goes to direct-to-consumer advertising? How much of that is the advertising budget? Where can we cut some of this out of the system so that we get the innovation, but we get innovation that all of our patients can afford?”

Another issue that is looming for physicians is a payment rate freeze from 2020-2025 under the Merit-based Incentive Payment System (MIPS) track of the Quality Payment Program, which was created under the Medicare Access and CHIP Reauthorization Act (MACRA).

“A 5-year freeze when my expenses do not freeze is a terrifying thing and could be a practice-ending expense for a lot of practices,” Dr. McAneny warned. “I will point out that independent practices, if they sell to a hospital, the cost of care immediately doubles. The amount that is paid for it, not the cost of delivering it. So that is not a great solution. But we also have this increasing practice expense and a flat rate is not going to help practices survive. So I am very concerned.”

Related to the QPP, Dr. McAneny also wants to see the Centers for Medicare & Medicaid Services do more with physician-developed alternative payment models. The Physician-Focused Payment Model Technical Advisory Committee (PTAC) continues to review and evaluate submissions, but to date, the CMS has yet to implement any of the committee’s recommendations.

“I read all of the PTAC submissions that went to CMS. Some of them I thought were a little on the weak side, but there are a lot of them that I thought were really good ideas. I do not know why CMS did not approve them and fund them and let them be tried,” she said, although she did offer an opinion on why the agency has yet to act on any of them.

“I read their paper saying why they didn’t approve [the recommended physician-developed alternative payment models]. It seemed to me they are waiting for one silver bullet that will fix all of health care. I don’t think a silver bullet is going to fix health care. It’s not an issue. It’s a complicated set of issues. You will not have a quick fix.”

gtwachtman@mdedge.com

WASHINGTON – As the rising cost of prescription drugs continues to garner heightened scrutiny from the federal government, one thing is missing from the conversation that would make any solution more effective, according to American Medical Association President Barbara L. McAneny, MD.

“We would like to see transparency from end to end in this pipeline because that is the way we will have the ability to look for savings,” she said in an interview at a national advocacy conference sponsored by the American Medical Association.

“I think we don’t have the information we need to make rational decisions,” she said. “I think the first thing we need to do is to understand the entire pipeline from the basic research that results in a drug’s clinical trials that results in a new drug to the pharmacy benefit managers and all of the ways that they have increased the cost of the drugs all the way to when the patient actually gets it.”

In particular, Dr. McAneny targeted the need for transparency in the role and financial impact pharmacy benefit managers have on the cost of prescription drugs.

“We were told at our state advocacy conference, which we held in January, by an expert who studied pharmacy benefit managers, that 42% of the cost of any drug is attributable to the profits of pharmacy benefit managers,” she said. “To me, that makes me wonder what value do they add that is worth 42% of these exorbitant costs and if they are not adding value, why do we have them in this process?”

She also called on the pharmaceutical manufacturers to be more forthcoming with their financial information regarding marketing and advertising, but she stressed that it needs to be done in a way that does not hinder future development of life-saving therapies.

“We do not want to stifle innovation.” Dr. McAneny said. “As a cancer doctor, I have seen diseases that I used to treat with morphine and sympathy now be diseases that I can treat, where I can restore people to good quality of life and buy them additional years of life because of these drugs. They are amazing and I don’t want to do without them and I want more of them. ... We want to support that research. That is probably worth a lot of the price tag. But how much of that goes to direct-to-consumer advertising? How much of that is the advertising budget? Where can we cut some of this out of the system so that we get the innovation, but we get innovation that all of our patients can afford?”

Another issue that is looming for physicians is a payment rate freeze from 2020-2025 under the Merit-based Incentive Payment System (MIPS) track of the Quality Payment Program, which was created under the Medicare Access and CHIP Reauthorization Act (MACRA).

“A 5-year freeze when my expenses do not freeze is a terrifying thing and could be a practice-ending expense for a lot of practices,” Dr. McAneny warned. “I will point out that independent practices, if they sell to a hospital, the cost of care immediately doubles. The amount that is paid for it, not the cost of delivering it. So that is not a great solution. But we also have this increasing practice expense and a flat rate is not going to help practices survive. So I am very concerned.”

Related to the QPP, Dr. McAneny also wants to see the Centers for Medicare & Medicaid Services do more with physician-developed alternative payment models. The Physician-Focused Payment Model Technical Advisory Committee (PTAC) continues to review and evaluate submissions, but to date, the CMS has yet to implement any of the committee’s recommendations.

“I read all of the PTAC submissions that went to CMS. Some of them I thought were a little on the weak side, but there are a lot of them that I thought were really good ideas. I do not know why CMS did not approve them and fund them and let them be tried,” she said, although she did offer an opinion on why the agency has yet to act on any of them.

“I read their paper saying why they didn’t approve [the recommended physician-developed alternative payment models]. It seemed to me they are waiting for one silver bullet that will fix all of health care. I don’t think a silver bullet is going to fix health care. It’s not an issue. It’s a complicated set of issues. You will not have a quick fix.”

gtwachtman@mdedge.com

WASHINGTON – As the rising cost of prescription drugs continues to garner heightened scrutiny from the federal government, one thing is missing from the conversation that would make any solution more effective, according to American Medical Association President Barbara L. McAneny, MD.

“We would like to see transparency from end to end in this pipeline because that is the way we will have the ability to look for savings,” she said in an interview at a national advocacy conference sponsored by the American Medical Association.

“I think we don’t have the information we need to make rational decisions,” she said. “I think the first thing we need to do is to understand the entire pipeline from the basic research that results in a drug’s clinical trials that results in a new drug to the pharmacy benefit managers and all of the ways that they have increased the cost of the drugs all the way to when the patient actually gets it.”

In particular, Dr. McAneny targeted the need for transparency in the role and financial impact pharmacy benefit managers have on the cost of prescription drugs.

“We were told at our state advocacy conference, which we held in January, by an expert who studied pharmacy benefit managers, that 42% of the cost of any drug is attributable to the profits of pharmacy benefit managers,” she said. “To me, that makes me wonder what value do they add that is worth 42% of these exorbitant costs and if they are not adding value, why do we have them in this process?”

She also called on the pharmaceutical manufacturers to be more forthcoming with their financial information regarding marketing and advertising, but she stressed that it needs to be done in a way that does not hinder future development of life-saving therapies.

“We do not want to stifle innovation.” Dr. McAneny said. “As a cancer doctor, I have seen diseases that I used to treat with morphine and sympathy now be diseases that I can treat, where I can restore people to good quality of life and buy them additional years of life because of these drugs. They are amazing and I don’t want to do without them and I want more of them. ... We want to support that research. That is probably worth a lot of the price tag. But how much of that goes to direct-to-consumer advertising? How much of that is the advertising budget? Where can we cut some of this out of the system so that we get the innovation, but we get innovation that all of our patients can afford?”

Another issue that is looming for physicians is a payment rate freeze from 2020-2025 under the Merit-based Incentive Payment System (MIPS) track of the Quality Payment Program, which was created under the Medicare Access and CHIP Reauthorization Act (MACRA).

“A 5-year freeze when my expenses do not freeze is a terrifying thing and could be a practice-ending expense for a lot of practices,” Dr. McAneny warned. “I will point out that independent practices, if they sell to a hospital, the cost of care immediately doubles. The amount that is paid for it, not the cost of delivering it. So that is not a great solution. But we also have this increasing practice expense and a flat rate is not going to help practices survive. So I am very concerned.”

Related to the QPP, Dr. McAneny also wants to see the Centers for Medicare & Medicaid Services do more with physician-developed alternative payment models. The Physician-Focused Payment Model Technical Advisory Committee (PTAC) continues to review and evaluate submissions, but to date, the CMS has yet to implement any of the committee’s recommendations.

“I read all of the PTAC submissions that went to CMS. Some of them I thought were a little on the weak side, but there are a lot of them that I thought were really good ideas. I do not know why CMS did not approve them and fund them and let them be tried,” she said, although she did offer an opinion on why the agency has yet to act on any of them.

“I read their paper saying why they didn’t approve [the recommended physician-developed alternative payment models]. It seemed to me they are waiting for one silver bullet that will fix all of health care. I don’t think a silver bullet is going to fix health care. It’s not an issue. It’s a complicated set of issues. You will not have a quick fix.”

gtwachtman@mdedge.com

Patients with peripheral artery disease (PAD) were also more likely to have left ventricular diastolic dysfunction, according to a study published in the Journal of Cardiology.

The study enrolled 1,121 patients with preserved left ventricular (LV) systolic function. The mean age was 68 years and 56% of patients were men. A total of 200 patients (17.8%) had PAD; 33.0% of these had no symptoms, 54.5% had intermittent symptoms, and 12.5% had critical ischemia, according to Koji Yanaka, MD, and colleagues at the Hyogo College of Medicine, Nishinomiya, Japan.

Multivariate logistic regression analysis showed that PAD was an independent predictor of LV diastolic dysfunction (adjusted odds ratio, 1.77; P = .01).

“The prevalence of LV diastolic dysfunction was higher in patients with PAD than those without PAD. These findings suggest that patients with PAD should be evaluated not only for LV systolic but also diastolic function in echocardiography,” the researchers concluded.

The authors reported that they had no disclosures.

mlesney@mdedge.com

SOURCE: Yanaka K et al. J Cardiol. 2019 Feb 18. doi: 10.1016/j.jjcc.2019.01.011.

Patients with peripheral artery disease (PAD) were also more likely to have left ventricular diastolic dysfunction, according to a study published in the Journal of Cardiology.

The study enrolled 1,121 patients with preserved left ventricular (LV) systolic function. The mean age was 68 years and 56% of patients were men. A total of 200 patients (17.8%) had PAD; 33.0% of these had no symptoms, 54.5% had intermittent symptoms, and 12.5% had critical ischemia, according to Koji Yanaka, MD, and colleagues at the Hyogo College of Medicine, Nishinomiya, Japan.

Multivariate logistic regression analysis showed that PAD was an independent predictor of LV diastolic dysfunction (adjusted odds ratio, 1.77; P = .01).

“The prevalence of LV diastolic dysfunction was higher in patients with PAD than those without PAD. These findings suggest that patients with PAD should be evaluated not only for LV systolic but also diastolic function in echocardiography,” the researchers concluded.

The authors reported that they had no disclosures.

mlesney@mdedge.com

SOURCE: Yanaka K et al. J Cardiol. 2019 Feb 18. doi: 10.1016/j.jjcc.2019.01.011.

Patients with peripheral artery disease (PAD) were also more likely to have left ventricular diastolic dysfunction, according to a study published in the Journal of Cardiology.

The study enrolled 1,121 patients with preserved left ventricular (LV) systolic function. The mean age was 68 years and 56% of patients were men. A total of 200 patients (17.8%) had PAD; 33.0% of these had no symptoms, 54.5% had intermittent symptoms, and 12.5% had critical ischemia, according to Koji Yanaka, MD, and colleagues at the Hyogo College of Medicine, Nishinomiya, Japan.

Multivariate logistic regression analysis showed that PAD was an independent predictor of LV diastolic dysfunction (adjusted odds ratio, 1.77; P = .01).

“The prevalence of LV diastolic dysfunction was higher in patients with PAD than those without PAD. These findings suggest that patients with PAD should be evaluated not only for LV systolic but also diastolic function in echocardiography,” the researchers concluded.

The authors reported that they had no disclosures.

mlesney@mdedge.com

SOURCE: Yanaka K et al. J Cardiol. 2019 Feb 18. doi: 10.1016/j.jjcc.2019.01.011.

The Food and Drug Administration has approved turoctocog alfa pegol (N8-GP, Esperoct), a glycopegylated recombinant factor VIII product, to treat hemophilia A.

The agency approved turoctocog alfa pegol for use as routine prophylaxis to reduce the frequency of bleeding episodes, for on-demand treatment and control of bleeding episodes, and for perioperative management of bleeding in adults and children with hemophilia A.

Turoctocog alfa pegol will not be available in the United States before 2020, according to Novo Nordisk. The company cannot yet launch the product because of third-party intellectual property agreements.

The FDA’s approval of turoctocog alfa pegol was supported by results from the pathfinder 2 (NCT01480180), pathfinder 3 (NCT01489111), and pathfinder 5 (NCT01731600) trials.

The trials included children, adolescents, and adults with previously treated, severe hemophilia A and no history of inhibitors. Turoctocog alfa pegol was considered effective and well tolerated in these trials.

Pooled results from pathfinder 2 and pathfinder 5 were presented at the 2018 annual meeting of the American Society of Hematology (Blood. 2018:132:1177).

Results from pathfinder 3 were previously published in Haemophilia (2017. Sep;23[5]:689-96).

jensmith@mdedge.com

The Food and Drug Administration has approved turoctocog alfa pegol (N8-GP, Esperoct), a glycopegylated recombinant factor VIII product, to treat hemophilia A.

The agency approved turoctocog alfa pegol for use as routine prophylaxis to reduce the frequency of bleeding episodes, for on-demand treatment and control of bleeding episodes, and for perioperative management of bleeding in adults and children with hemophilia A.

Turoctocog alfa pegol will not be available in the United States before 2020, according to Novo Nordisk. The company cannot yet launch the product because of third-party intellectual property agreements.

The FDA’s approval of turoctocog alfa pegol was supported by results from the pathfinder 2 (NCT01480180), pathfinder 3 (NCT01489111), and pathfinder 5 (NCT01731600) trials.

The trials included children, adolescents, and adults with previously treated, severe hemophilia A and no history of inhibitors. Turoctocog alfa pegol was considered effective and well tolerated in these trials.

Pooled results from pathfinder 2 and pathfinder 5 were presented at the 2018 annual meeting of the American Society of Hematology (Blood. 2018:132:1177).

Results from pathfinder 3 were previously published in Haemophilia (2017. Sep;23[5]:689-96).

jensmith@mdedge.com

The Food and Drug Administration has approved turoctocog alfa pegol (N8-GP, Esperoct), a glycopegylated recombinant factor VIII product, to treat hemophilia A.

The agency approved turoctocog alfa pegol for use as routine prophylaxis to reduce the frequency of bleeding episodes, for on-demand treatment and control of bleeding episodes, and for perioperative management of bleeding in adults and children with hemophilia A.

Turoctocog alfa pegol will not be available in the United States before 2020, according to Novo Nordisk. The company cannot yet launch the product because of third-party intellectual property agreements.

The FDA’s approval of turoctocog alfa pegol was supported by results from the pathfinder 2 (NCT01480180), pathfinder 3 (NCT01489111), and pathfinder 5 (NCT01731600) trials.

The trials included children, adolescents, and adults with previously treated, severe hemophilia A and no history of inhibitors. Turoctocog alfa pegol was considered effective and well tolerated in these trials.

Pooled results from pathfinder 2 and pathfinder 5 were presented at the 2018 annual meeting of the American Society of Hematology (Blood. 2018:132:1177).

Results from pathfinder 3 were previously published in Haemophilia (2017. Sep;23[5]:689-96).

jensmith@mdedge.com