Poster session at ASCO 2016
© ASCO/Zach Boyden-Holmes

CHICAGO—Investigators have found an increased risk in cancer incidence for patients with primary immunodeficiency diseases (PIDD), and in particular, a significant increase in lymphoma cases.

Investigators reviewed records of patients registered in the United States Immune Deficiency Network (USIDNET) and found they had a 42% increase in cancer incidence overall compared to the general population in the Surveillance, Epidemiology and End Results (SEER) database.

And lymphoma incidence was 10 times higher among men and 8 times higher among women in the USIDNET registry.

The USIDNET registry collects information, including clinical, laboratory, and outcome data, on patients affected by PIDD. Site-specific cancer incidence rates are included in the registry.

Investigators compared data from the 2 registries based on age and gender. They abstracted data on 3665 patients from the USIDNET Registry from 2003 to 2015 and generated site-specific incidence rates for them. They also generated age adjusted incidence rates using the SEER database for comparison.

The investigators observed a 1.34-fold excess relative risk of cancer (P<0.001) in patients with PIDD compared to the age-adjusted SEER population.

They also discovered that in men, the relative risk increased to 1.8-fold (P<0.001), while in women, the excess relative risk of cancer was not significant.

Men also had a statistically significant increase in skin cancer (4.45-fold excess relative risk, P<0.001) and thyroid cancer (4-fold excess relative risk, P=0.002).

Women had a statistically significant increase in skin (3.19-fold excess relative risk, P<0.001) and stomach cancer (3-fold excess relative risk, P=0.015).

And both men and women had a statistically significant increase in lymphoma, at a significance of P<0.001 for each gender.

“This study found that patients with primary immunodeficiency disorders have a modest increase in overall cancer incidence,” senior author, Brahm Segal, MD, of Roswell Park Cancer Institute in Buffalo, New York, said, “driven by specific primary immunodeficiency disorders predisposing to specific cancers, particularly lymphoma.”

The investigators did not observe an increased risk for the most common solid tumor cancers, including breast, lung, prostate, and colon.

The investigators believe the findings point to a “restricted role of the immune system in protecting from specific cancers and question the role of immunosurveillance in incident risk of common solid tumor cancers.”

They reported their findings at the 2016 ASCO Annual Meeting as abstract 1520.

Poster session at ASCO 2016
© ASCO/Zach Boyden-Holmes

CHICAGO—Investigators have found an increased risk in cancer incidence for patients with primary immunodeficiency diseases (PIDD), and in particular, a significant increase in lymphoma cases.

Investigators reviewed records of patients registered in the United States Immune Deficiency Network (USIDNET) and found they had a 42% increase in cancer incidence overall compared to the general population in the Surveillance, Epidemiology and End Results (SEER) database.

And lymphoma incidence was 10 times higher among men and 8 times higher among women in the USIDNET registry.

The USIDNET registry collects information, including clinical, laboratory, and outcome data, on patients affected by PIDD. Site-specific cancer incidence rates are included in the registry.

Investigators compared data from the 2 registries based on age and gender. They abstracted data on 3665 patients from the USIDNET Registry from 2003 to 2015 and generated site-specific incidence rates for them. They also generated age adjusted incidence rates using the SEER database for comparison.

The investigators observed a 1.34-fold excess relative risk of cancer (P<0.001) in patients with PIDD compared to the age-adjusted SEER population.

They also discovered that in men, the relative risk increased to 1.8-fold (P<0.001), while in women, the excess relative risk of cancer was not significant.

Men also had a statistically significant increase in skin cancer (4.45-fold excess relative risk, P<0.001) and thyroid cancer (4-fold excess relative risk, P=0.002).

Women had a statistically significant increase in skin (3.19-fold excess relative risk, P<0.001) and stomach cancer (3-fold excess relative risk, P=0.015).

And both men and women had a statistically significant increase in lymphoma, at a significance of P<0.001 for each gender.

“This study found that patients with primary immunodeficiency disorders have a modest increase in overall cancer incidence,” senior author, Brahm Segal, MD, of Roswell Park Cancer Institute in Buffalo, New York, said, “driven by specific primary immunodeficiency disorders predisposing to specific cancers, particularly lymphoma.”

The investigators did not observe an increased risk for the most common solid tumor cancers, including breast, lung, prostate, and colon.

The investigators believe the findings point to a “restricted role of the immune system in protecting from specific cancers and question the role of immunosurveillance in incident risk of common solid tumor cancers.”

They reported their findings at the 2016 ASCO Annual Meeting as abstract 1520.

Poster session at ASCO 2016
© ASCO/Zach Boyden-Holmes

CHICAGO—Investigators have found an increased risk in cancer incidence for patients with primary immunodeficiency diseases (PIDD), and in particular, a significant increase in lymphoma cases.

Investigators reviewed records of patients registered in the United States Immune Deficiency Network (USIDNET) and found they had a 42% increase in cancer incidence overall compared to the general population in the Surveillance, Epidemiology and End Results (SEER) database.

And lymphoma incidence was 10 times higher among men and 8 times higher among women in the USIDNET registry.

The USIDNET registry collects information, including clinical, laboratory, and outcome data, on patients affected by PIDD. Site-specific cancer incidence rates are included in the registry.

Investigators compared data from the 2 registries based on age and gender. They abstracted data on 3665 patients from the USIDNET Registry from 2003 to 2015 and generated site-specific incidence rates for them. They also generated age adjusted incidence rates using the SEER database for comparison.

The investigators observed a 1.34-fold excess relative risk of cancer (P<0.001) in patients with PIDD compared to the age-adjusted SEER population.

They also discovered that in men, the relative risk increased to 1.8-fold (P<0.001), while in women, the excess relative risk of cancer was not significant.

Men also had a statistically significant increase in skin cancer (4.45-fold excess relative risk, P<0.001) and thyroid cancer (4-fold excess relative risk, P=0.002).

Women had a statistically significant increase in skin (3.19-fold excess relative risk, P<0.001) and stomach cancer (3-fold excess relative risk, P=0.015).

And both men and women had a statistically significant increase in lymphoma, at a significance of P<0.001 for each gender.

“This study found that patients with primary immunodeficiency disorders have a modest increase in overall cancer incidence,” senior author, Brahm Segal, MD, of Roswell Park Cancer Institute in Buffalo, New York, said, “driven by specific primary immunodeficiency disorders predisposing to specific cancers, particularly lymphoma.”

The investigators did not observe an increased risk for the most common solid tumor cancers, including breast, lung, prostate, and colon.

The investigators believe the findings point to a “restricted role of the immune system in protecting from specific cancers and question the role of immunosurveillance in incident risk of common solid tumor cancers.”

They reported their findings at the 2016 ASCO Annual Meeting as abstract 1520.

LONDON – The option of treating axial spondyloarthritis with an interleukin-17 inhibitor has become an officially recommended option for the first time in a new update to management recommendations for this disease released by a task force assembled jointly by the Assessment of SpondyloArthritis International Society and the European League Against Rheumatism.

The update replaces recommendations last released by the two groups for managing patients with ankylosing spondylitis in 2010 (Ann Rheum Dis. 2011 June;70[6]:896-904), as well as the prior recommendations from the two organizations for using tumor necrosis factor (TNF) inhibitors on these patients (Ann Rheum Dis. 2011 June;70[6]:905-8). The new update also broadens the disease spectrum from ankylosing spondylitis to axial spondyloarthritis (SpA).

Mitchel L. Zoler/Frontline Medical News

The latest recommendations continue to place nonsteroidal anti-inflammatory drugs (NSAIDs) as first-line pharmacotherapy for patients with axial SpA to control pain and stiffness, and continue to place treatment with a biological disease modifying antirheumatic drug (DMARD) – identified in the recommendations as most typically a TNF inhibitor by current practice – as second-line treatment after NSAIDs. The recommendations specify that initiation of a biological DMARD should target patients who have both failed treatment with at least two different NSAIDs over the course of at least 4 weeks of treatment, and who have active disease documented by either of two standard measures of disease activity in patients with axial SpA: either a score of at least 2.1 on the ankylosing spondylitis disease activity score (ASDAS) or a score of at least 4 on the Bath ankylosing spondylitis disease activity index (BASDAI).

Incorporation of the ASDAS as a potential alternative to the BASDAI for assessing disease activity in these patients is another new feature of these recommendations, noted Dr. Désirée van der Heijde, convenor of the update task force, who presented the new recommendations at the European Congress of Rheumatology.

The new recommendations place use of an interleukin (IL)-17 inhibitor as a third-line management option, for patients who fail to adequately respond to a first TNF inhibitor, and they also say that an alternative to starting an IL-17 inhibitor at this stage of management is to instead try treatment with a second type of TNF inhibitor. The IL-17 inhibitor class includes secukinumab (Cosentyx), which received approval from the Food and Drug Administration for treating active ankylosing spondylitis in January 2016, and which also has approval for the same indication from the European Medicines Agency.

The updated recommendations leave unchanged from the prior version advice to use biological DMARDs only after failure of other treatments, as well as advocacy of nondrug therapy with regular exercise, smoking cessation, and physical therapy when appropriate as the very first therapeutic step to take, before even starting a NSAID regimen. For patients with axial SpA who have peripheral arthritis, the recommendations say that clinicians can consider treatment with a local injection of a glucocorticoid, and a treatment course with sulfasalazine. The recommendations do not endorse treatment with a conventional, synthetic DMARD for patients with purely axial disease, and they also recommend against long-term treatment with a systemic corticosteroid. The update calls analgesics contraindicated.

Another new feature of the updated recommendations is endorsement of treating axial SpA patients to a predefined treatment target, although the recommendations left the nature of that target undefined and is something for the treating clinician to discuss and tailor to each patient individually, said Dr. van der Heijde, professor of rheumatology at Leiden University Medical Center in The Netherlands. The update also introduces for the first time the recommendation to consider tapering down treatment with a biological DMARD for patients who achieve remission.

Dr. van der Heijde said that she has been a consultant to 17 drug companies.

[email protected]

On Twitter @mitchelzoler

LONDON – The option of treating axial spondyloarthritis with an interleukin-17 inhibitor has become an officially recommended option for the first time in a new update to management recommendations for this disease released by a task force assembled jointly by the Assessment of SpondyloArthritis International Society and the European League Against Rheumatism.

The update replaces recommendations last released by the two groups for managing patients with ankylosing spondylitis in 2010 (Ann Rheum Dis. 2011 June;70[6]:896-904), as well as the prior recommendations from the two organizations for using tumor necrosis factor (TNF) inhibitors on these patients (Ann Rheum Dis. 2011 June;70[6]:905-8). The new update also broadens the disease spectrum from ankylosing spondylitis to axial spondyloarthritis (SpA).

Mitchel L. Zoler/Frontline Medical News

The latest recommendations continue to place nonsteroidal anti-inflammatory drugs (NSAIDs) as first-line pharmacotherapy for patients with axial SpA to control pain and stiffness, and continue to place treatment with a biological disease modifying antirheumatic drug (DMARD) – identified in the recommendations as most typically a TNF inhibitor by current practice – as second-line treatment after NSAIDs. The recommendations specify that initiation of a biological DMARD should target patients who have both failed treatment with at least two different NSAIDs over the course of at least 4 weeks of treatment, and who have active disease documented by either of two standard measures of disease activity in patients with axial SpA: either a score of at least 2.1 on the ankylosing spondylitis disease activity score (ASDAS) or a score of at least 4 on the Bath ankylosing spondylitis disease activity index (BASDAI).

Incorporation of the ASDAS as a potential alternative to the BASDAI for assessing disease activity in these patients is another new feature of these recommendations, noted Dr. Désirée van der Heijde, convenor of the update task force, who presented the new recommendations at the European Congress of Rheumatology.

The new recommendations place use of an interleukin (IL)-17 inhibitor as a third-line management option, for patients who fail to adequately respond to a first TNF inhibitor, and they also say that an alternative to starting an IL-17 inhibitor at this stage of management is to instead try treatment with a second type of TNF inhibitor. The IL-17 inhibitor class includes secukinumab (Cosentyx), which received approval from the Food and Drug Administration for treating active ankylosing spondylitis in January 2016, and which also has approval for the same indication from the European Medicines Agency.

The updated recommendations leave unchanged from the prior version advice to use biological DMARDs only after failure of other treatments, as well as advocacy of nondrug therapy with regular exercise, smoking cessation, and physical therapy when appropriate as the very first therapeutic step to take, before even starting a NSAID regimen. For patients with axial SpA who have peripheral arthritis, the recommendations say that clinicians can consider treatment with a local injection of a glucocorticoid, and a treatment course with sulfasalazine. The recommendations do not endorse treatment with a conventional, synthetic DMARD for patients with purely axial disease, and they also recommend against long-term treatment with a systemic corticosteroid. The update calls analgesics contraindicated.

Another new feature of the updated recommendations is endorsement of treating axial SpA patients to a predefined treatment target, although the recommendations left the nature of that target undefined and is something for the treating clinician to discuss and tailor to each patient individually, said Dr. van der Heijde, professor of rheumatology at Leiden University Medical Center in The Netherlands. The update also introduces for the first time the recommendation to consider tapering down treatment with a biological DMARD for patients who achieve remission.

Dr. van der Heijde said that she has been a consultant to 17 drug companies.

[email protected]

On Twitter @mitchelzoler

LONDON – The option of treating axial spondyloarthritis with an interleukin-17 inhibitor has become an officially recommended option for the first time in a new update to management recommendations for this disease released by a task force assembled jointly by the Assessment of SpondyloArthritis International Society and the European League Against Rheumatism.

The update replaces recommendations last released by the two groups for managing patients with ankylosing spondylitis in 2010 (Ann Rheum Dis. 2011 June;70[6]:896-904), as well as the prior recommendations from the two organizations for using tumor necrosis factor (TNF) inhibitors on these patients (Ann Rheum Dis. 2011 June;70[6]:905-8). The new update also broadens the disease spectrum from ankylosing spondylitis to axial spondyloarthritis (SpA).

Mitchel L. Zoler/Frontline Medical News

The latest recommendations continue to place nonsteroidal anti-inflammatory drugs (NSAIDs) as first-line pharmacotherapy for patients with axial SpA to control pain and stiffness, and continue to place treatment with a biological disease modifying antirheumatic drug (DMARD) – identified in the recommendations as most typically a TNF inhibitor by current practice – as second-line treatment after NSAIDs. The recommendations specify that initiation of a biological DMARD should target patients who have both failed treatment with at least two different NSAIDs over the course of at least 4 weeks of treatment, and who have active disease documented by either of two standard measures of disease activity in patients with axial SpA: either a score of at least 2.1 on the ankylosing spondylitis disease activity score (ASDAS) or a score of at least 4 on the Bath ankylosing spondylitis disease activity index (BASDAI).

Incorporation of the ASDAS as a potential alternative to the BASDAI for assessing disease activity in these patients is another new feature of these recommendations, noted Dr. Désirée van der Heijde, convenor of the update task force, who presented the new recommendations at the European Congress of Rheumatology.

The new recommendations place use of an interleukin (IL)-17 inhibitor as a third-line management option, for patients who fail to adequately respond to a first TNF inhibitor, and they also say that an alternative to starting an IL-17 inhibitor at this stage of management is to instead try treatment with a second type of TNF inhibitor. The IL-17 inhibitor class includes secukinumab (Cosentyx), which received approval from the Food and Drug Administration for treating active ankylosing spondylitis in January 2016, and which also has approval for the same indication from the European Medicines Agency.

The updated recommendations leave unchanged from the prior version advice to use biological DMARDs only after failure of other treatments, as well as advocacy of nondrug therapy with regular exercise, smoking cessation, and physical therapy when appropriate as the very first therapeutic step to take, before even starting a NSAID regimen. For patients with axial SpA who have peripheral arthritis, the recommendations say that clinicians can consider treatment with a local injection of a glucocorticoid, and a treatment course with sulfasalazine. The recommendations do not endorse treatment with a conventional, synthetic DMARD for patients with purely axial disease, and they also recommend against long-term treatment with a systemic corticosteroid. The update calls analgesics contraindicated.

Another new feature of the updated recommendations is endorsement of treating axial SpA patients to a predefined treatment target, although the recommendations left the nature of that target undefined and is something for the treating clinician to discuss and tailor to each patient individually, said Dr. van der Heijde, professor of rheumatology at Leiden University Medical Center in The Netherlands. The update also introduces for the first time the recommendation to consider tapering down treatment with a biological DMARD for patients who achieve remission.

Dr. van der Heijde said that she has been a consultant to 17 drug companies.

[email protected]

On Twitter @mitchelzoler

NEW ORLEANS – Patients with diabetes and peripheral neuropathy who used a smart watch and specially designed smart insoles equipped with an alert system minimized their reulceration risk, results from a proof-of-concept study demonstrated.

The findings suggest that mobile health “could be an effective method to educate patients to change their harmful activity behavior, could enhance adherence to regularly inspect their feet and seek for care in a timely manner, and ultimately may assist in prevention of recurrence of ulcers,” lead author Bijan Najafi, Ph.D., said in an interview in advance of the annual scientific sessions of the American Diabetes Association.

Dr. Najafi, professor of surgery at Baylor College of Medicine, Houston, said that in 2015, approximately one-third of all diabetes-related costs in the United States were spent on diabetic foot ulcers (DFUs). “Unfortunately, many DFUs end up in amputation, which could devastate patients and their families,” he said. “On the same note, persons within the lowest income brackets are estimated to have 38% higher amputation rate, compared with those in the highest income bracket. All these highlight an important gap in effective management of DFUs, in particular among poor working-class people.”

He also noted that DFU recurrence rates are 30%-40% in the first year, compared with 7.5% annual incidence for patients with peripheral neuropathy and no ulcer history. “The good news is that 75% of recurrent foot ulcers are preventable,” said Dr. Najafi, who is also director of clinical research in Baylor’s division of vascular surgery and endovascular therapy and director of the Interdisciplinary Consortium on Advanced Motion Performance. “An effective method is empowering patients to take care of their own health via regular self-inspection of their feet as well as providing timely and personalized foot care. The big challenge is adherence to prevention and regular foot inspection.”

In a study supported in part by Orpyx Medical Technologies, the investigators used a smart watch and smart insoles to enhance adherence to footwear and effective offloading by providing real-time feedback to 19 patients at high risk of DFUs about a harmful plantar pressure event. The patients wore the insole system for 3 months and were alerted through a smart watch if their plantar pressure exceeded 50 mm Hg over 95% of a moving 15-minute window. A successful response to an alert was recorded when offloading occurred within 20 minutes.

Dr. Najafi reported that by the third month, patients who received a higher number of alerts were more likely to use devices and technique to offload weight from their foot, compared with those who received a lower number of alerts (55% vs. 17%, respectively; P less than .01). In addition, patients whose wear time increased during the study tended to have more alerts, compared with other participants (a mean of .82 vs. .36 alerts per hour; P = .09). The best results occurred when patients received at least one alert every 2 hours. “We found that those who frequently received alerts about harmful plantar pressure events improved their adherence to the prescribed footwear and were more responsive to alerts,” he said. At the same time, those patients who received fewer alerts per day, “started to neglect alerts and adherence to footwear over time, despite having initially good adherence at the first month.”

Going forward, Dr. Najafi said, a key challenge is to continue engaging patients to use such technologies on a daily basis. “This could be addressable by providing frequent and comprehensive alerts which not only address harmful plantar pressure during walking but also any harmful foot-loading conditions, including prolonged harmful foot-loading pressure during standing as well as sitting,” he said.

In a video interview at the meeting, Dr. Najafi discussed the study and the challenges of encouraging treatment adherence.

Orpyx Medical Technologies provided partial funding support for the study. Dr. Najafi reported having no financial disclosures. The other authors of this study are Eyal Ron, Ana Enriquez, Ivan Marin, Jacqueline Lee-Eng, Javad Razjouyan, Ph.D., and Dr. David Armstrong. All subjects were recruited at the University of Arizona, College of Medicine, Tucson.

[email protected]

NEW ORLEANS – Patients with diabetes and peripheral neuropathy who used a smart watch and specially designed smart insoles equipped with an alert system minimized their reulceration risk, results from a proof-of-concept study demonstrated.

The findings suggest that mobile health “could be an effective method to educate patients to change their harmful activity behavior, could enhance adherence to regularly inspect their feet and seek for care in a timely manner, and ultimately may assist in prevention of recurrence of ulcers,” lead author Bijan Najafi, Ph.D., said in an interview in advance of the annual scientific sessions of the American Diabetes Association.

Dr. Najafi, professor of surgery at Baylor College of Medicine, Houston, said that in 2015, approximately one-third of all diabetes-related costs in the United States were spent on diabetic foot ulcers (DFUs). “Unfortunately, many DFUs end up in amputation, which could devastate patients and their families,” he said. “On the same note, persons within the lowest income brackets are estimated to have 38% higher amputation rate, compared with those in the highest income bracket. All these highlight an important gap in effective management of DFUs, in particular among poor working-class people.”

He also noted that DFU recurrence rates are 30%-40% in the first year, compared with 7.5% annual incidence for patients with peripheral neuropathy and no ulcer history. “The good news is that 75% of recurrent foot ulcers are preventable,” said Dr. Najafi, who is also director of clinical research in Baylor’s division of vascular surgery and endovascular therapy and director of the Interdisciplinary Consortium on Advanced Motion Performance. “An effective method is empowering patients to take care of their own health via regular self-inspection of their feet as well as providing timely and personalized foot care. The big challenge is adherence to prevention and regular foot inspection.”

In a study supported in part by Orpyx Medical Technologies, the investigators used a smart watch and smart insoles to enhance adherence to footwear and effective offloading by providing real-time feedback to 19 patients at high risk of DFUs about a harmful plantar pressure event. The patients wore the insole system for 3 months and were alerted through a smart watch if their plantar pressure exceeded 50 mm Hg over 95% of a moving 15-minute window. A successful response to an alert was recorded when offloading occurred within 20 minutes.

Dr. Najafi reported that by the third month, patients who received a higher number of alerts were more likely to use devices and technique to offload weight from their foot, compared with those who received a lower number of alerts (55% vs. 17%, respectively; P less than .01). In addition, patients whose wear time increased during the study tended to have more alerts, compared with other participants (a mean of .82 vs. .36 alerts per hour; P = .09). The best results occurred when patients received at least one alert every 2 hours. “We found that those who frequently received alerts about harmful plantar pressure events improved their adherence to the prescribed footwear and were more responsive to alerts,” he said. At the same time, those patients who received fewer alerts per day, “started to neglect alerts and adherence to footwear over time, despite having initially good adherence at the first month.”

Going forward, Dr. Najafi said, a key challenge is to continue engaging patients to use such technologies on a daily basis. “This could be addressable by providing frequent and comprehensive alerts which not only address harmful plantar pressure during walking but also any harmful foot-loading conditions, including prolonged harmful foot-loading pressure during standing as well as sitting,” he said.

In a video interview at the meeting, Dr. Najafi discussed the study and the challenges of encouraging treatment adherence.

Orpyx Medical Technologies provided partial funding support for the study. Dr. Najafi reported having no financial disclosures. The other authors of this study are Eyal Ron, Ana Enriquez, Ivan Marin, Jacqueline Lee-Eng, Javad Razjouyan, Ph.D., and Dr. David Armstrong. All subjects were recruited at the University of Arizona, College of Medicine, Tucson.

[email protected]

NEW ORLEANS – Patients with diabetes and peripheral neuropathy who used a smart watch and specially designed smart insoles equipped with an alert system minimized their reulceration risk, results from a proof-of-concept study demonstrated.

The findings suggest that mobile health “could be an effective method to educate patients to change their harmful activity behavior, could enhance adherence to regularly inspect their feet and seek for care in a timely manner, and ultimately may assist in prevention of recurrence of ulcers,” lead author Bijan Najafi, Ph.D., said in an interview in advance of the annual scientific sessions of the American Diabetes Association.

Dr. Najafi, professor of surgery at Baylor College of Medicine, Houston, said that in 2015, approximately one-third of all diabetes-related costs in the United States were spent on diabetic foot ulcers (DFUs). “Unfortunately, many DFUs end up in amputation, which could devastate patients and their families,” he said. “On the same note, persons within the lowest income brackets are estimated to have 38% higher amputation rate, compared with those in the highest income bracket. All these highlight an important gap in effective management of DFUs, in particular among poor working-class people.”

He also noted that DFU recurrence rates are 30%-40% in the first year, compared with 7.5% annual incidence for patients with peripheral neuropathy and no ulcer history. “The good news is that 75% of recurrent foot ulcers are preventable,” said Dr. Najafi, who is also director of clinical research in Baylor’s division of vascular surgery and endovascular therapy and director of the Interdisciplinary Consortium on Advanced Motion Performance. “An effective method is empowering patients to take care of their own health via regular self-inspection of their feet as well as providing timely and personalized foot care. The big challenge is adherence to prevention and regular foot inspection.”

In a study supported in part by Orpyx Medical Technologies, the investigators used a smart watch and smart insoles to enhance adherence to footwear and effective offloading by providing real-time feedback to 19 patients at high risk of DFUs about a harmful plantar pressure event. The patients wore the insole system for 3 months and were alerted through a smart watch if their plantar pressure exceeded 50 mm Hg over 95% of a moving 15-minute window. A successful response to an alert was recorded when offloading occurred within 20 minutes.

Dr. Najafi reported that by the third month, patients who received a higher number of alerts were more likely to use devices and technique to offload weight from their foot, compared with those who received a lower number of alerts (55% vs. 17%, respectively; P less than .01). In addition, patients whose wear time increased during the study tended to have more alerts, compared with other participants (a mean of .82 vs. .36 alerts per hour; P = .09). The best results occurred when patients received at least one alert every 2 hours. “We found that those who frequently received alerts about harmful plantar pressure events improved their adherence to the prescribed footwear and were more responsive to alerts,” he said. At the same time, those patients who received fewer alerts per day, “started to neglect alerts and adherence to footwear over time, despite having initially good adherence at the first month.”

Going forward, Dr. Najafi said, a key challenge is to continue engaging patients to use such technologies on a daily basis. “This could be addressable by providing frequent and comprehensive alerts which not only address harmful plantar pressure during walking but also any harmful foot-loading conditions, including prolonged harmful foot-loading pressure during standing as well as sitting,” he said.

In a video interview at the meeting, Dr. Najafi discussed the study and the challenges of encouraging treatment adherence.

Orpyx Medical Technologies provided partial funding support for the study. Dr. Najafi reported having no financial disclosures. The other authors of this study are Eyal Ron, Ana Enriquez, Ivan Marin, Jacqueline Lee-Eng, Javad Razjouyan, Ph.D., and Dr. David Armstrong. All subjects were recruited at the University of Arizona, College of Medicine, Tucson.

[email protected]

When patients say they had “a reaction” to some treatment, they often don’t mean what we would call allergy or even intolerance. This doesn’t make their reluctance – or refusal – to consider what we suggest any less insistent.

I’ve lost track, for insistence, of the number of patients who called 2 days after I prescribed clindamycin lotion to complain that it “dried me out completely.”

When a customer in a cosmetic store or pharmacy returns a skin care cream because of that kind of “reaction,” the store takes it back, no questions asked. This is not just good business practice; in that context, both the customer and the salesperson use the word “reaction” the way laymen do, not the way doctors do.

If you doubt a reaction is real and say so, however gently, the response you may get is, “That may be true, Doctor, but my body is sensitive. I get strange reactions.”

Like most everyone else in practice, I use negotiating tactics, such as: “Stop the cream for 3 days, then try it again, but just in one spot in front of your left ear.”

Some patients agree to try this. Mostly, nothing happens, they resume the medication, and life goes on. For fearful people, we have to use something else. Sometimes patients and I run through a succession of options, each of which produces an inscrutable “reaction.”

As the years pass, I’ve gotten better at gauging the range of true reactions to medications. At the same time, the list of perplexing things patients complain about gets longer all the time. Lately, there’s been a run of them:

• The woman who used low-strength tretinoin cream all of twice and stopped 2 weeks ago who insisted that “my face is still all dried out.” I assured her that 2 days of tretinoin cannot damage the skin forever, but she remains unconvinced.

• The man who says that putting tretinoin on his face “made me dry out all over.”

• The mother who said her daughter stopped my steroid cream because “every time we used it, her tongue broke out in blisters.”

•  The middle-aged woman who claimed, “I can’t take minocycline because it changed the color of my teeth and my eyes.”

• The young woman who puts clindamycin pads only on her right cheek, where she still has pimples, but not on the left, “because it makes the pimples go away on the cheek that has them, but on the other side it makes pimples come out.”

When I hear complaints like these, I just sigh and make a lateral move.

But sometimes I run out of lateral moves. The other month a woman told me that doxycycline made her “tired.” We tried minocycline, but that made her “irritable.” “My body is prone to strange reactions that no one else gets,” she explained. Then she asked for a third option.

“I honestly don’t know what to suggest,” I apologized. “Because your body reacts in ways that other people don’t, I can’t predict what some other treatment will do to you, even if it hasn’t done it to anyone else.”

She asked for her records, to get another opinion. I happily complied.

Speaking of weird “reactions,” there are of course the ones listed on e-scribing programs. Here are a couple:

• Hydrocortisone valerate has been associated with WARTS. (Capitalized)

• Hydrocortisone valerate has been associated with tinea cruris.

Make any sense to you? Me neither.

I end with a call I got the other day from a pharmacist. This concerned a patient for whom I had prescribed oral doxycycline and topical tretinoin. The message was, “Please call regarding drug interaction.”

When I got through, I politely asked the nature of this interaction. The pharmacist said she didn’t know exactly, but would look into it and fax me the details.

Half an hour later I got a sheet explaining the there is an increased risk of pseudotumor cerebri when patients take both oral tretinoin and oral tetracyclines.

That is correct: Not isotretinoin. Oral tretinoin. Used any oral tretinoin lately?

At any rate, the helpful pharmacist wrote at the bottom, “This interaction is flagged by several insurers for topical tretinoin too.”

Thank heavens for computer-generated warnings. Whatever would we do without them?

Besides, it’s nice to know that even after all these years, I can still react myself, with surprise.

Dr. Rockoff practices dermatology in Brookline, Mass. He is on the clinical faculty at Tufts University School of Medicine, Boston, and has taught senior medical students and other trainees for 30 years. Dr. Rockoff has contributed to the Under My Skin column in Dermatology News since January 2002. Write to him at [email protected].

When patients say they had “a reaction” to some treatment, they often don’t mean what we would call allergy or even intolerance. This doesn’t make their reluctance – or refusal – to consider what we suggest any less insistent.

I’ve lost track, for insistence, of the number of patients who called 2 days after I prescribed clindamycin lotion to complain that it “dried me out completely.”

When a customer in a cosmetic store or pharmacy returns a skin care cream because of that kind of “reaction,” the store takes it back, no questions asked. This is not just good business practice; in that context, both the customer and the salesperson use the word “reaction” the way laymen do, not the way doctors do.

If you doubt a reaction is real and say so, however gently, the response you may get is, “That may be true, Doctor, but my body is sensitive. I get strange reactions.”

Like most everyone else in practice, I use negotiating tactics, such as: “Stop the cream for 3 days, then try it again, but just in one spot in front of your left ear.”

Some patients agree to try this. Mostly, nothing happens, they resume the medication, and life goes on. For fearful people, we have to use something else. Sometimes patients and I run through a succession of options, each of which produces an inscrutable “reaction.”

As the years pass, I’ve gotten better at gauging the range of true reactions to medications. At the same time, the list of perplexing things patients complain about gets longer all the time. Lately, there’s been a run of them:

• The woman who used low-strength tretinoin cream all of twice and stopped 2 weeks ago who insisted that “my face is still all dried out.” I assured her that 2 days of tretinoin cannot damage the skin forever, but she remains unconvinced.

• The man who says that putting tretinoin on his face “made me dry out all over.”

• The mother who said her daughter stopped my steroid cream because “every time we used it, her tongue broke out in blisters.”

•  The middle-aged woman who claimed, “I can’t take minocycline because it changed the color of my teeth and my eyes.”

• The young woman who puts clindamycin pads only on her right cheek, where she still has pimples, but not on the left, “because it makes the pimples go away on the cheek that has them, but on the other side it makes pimples come out.”

When I hear complaints like these, I just sigh and make a lateral move.

But sometimes I run out of lateral moves. The other month a woman told me that doxycycline made her “tired.” We tried minocycline, but that made her “irritable.” “My body is prone to strange reactions that no one else gets,” she explained. Then she asked for a third option.

“I honestly don’t know what to suggest,” I apologized. “Because your body reacts in ways that other people don’t, I can’t predict what some other treatment will do to you, even if it hasn’t done it to anyone else.”

She asked for her records, to get another opinion. I happily complied.

Speaking of weird “reactions,” there are of course the ones listed on e-scribing programs. Here are a couple:

• Hydrocortisone valerate has been associated with WARTS. (Capitalized)

• Hydrocortisone valerate has been associated with tinea cruris.

Make any sense to you? Me neither.

I end with a call I got the other day from a pharmacist. This concerned a patient for whom I had prescribed oral doxycycline and topical tretinoin. The message was, “Please call regarding drug interaction.”

When I got through, I politely asked the nature of this interaction. The pharmacist said she didn’t know exactly, but would look into it and fax me the details.

Half an hour later I got a sheet explaining the there is an increased risk of pseudotumor cerebri when patients take both oral tretinoin and oral tetracyclines.

That is correct: Not isotretinoin. Oral tretinoin. Used any oral tretinoin lately?

At any rate, the helpful pharmacist wrote at the bottom, “This interaction is flagged by several insurers for topical tretinoin too.”

Thank heavens for computer-generated warnings. Whatever would we do without them?

Besides, it’s nice to know that even after all these years, I can still react myself, with surprise.

Dr. Rockoff practices dermatology in Brookline, Mass. He is on the clinical faculty at Tufts University School of Medicine, Boston, and has taught senior medical students and other trainees for 30 years. Dr. Rockoff has contributed to the Under My Skin column in Dermatology News since January 2002. Write to him at [email protected].

When patients say they had “a reaction” to some treatment, they often don’t mean what we would call allergy or even intolerance. This doesn’t make their reluctance – or refusal – to consider what we suggest any less insistent.

I’ve lost track, for insistence, of the number of patients who called 2 days after I prescribed clindamycin lotion to complain that it “dried me out completely.”

When a customer in a cosmetic store or pharmacy returns a skin care cream because of that kind of “reaction,” the store takes it back, no questions asked. This is not just good business practice; in that context, both the customer and the salesperson use the word “reaction” the way laymen do, not the way doctors do.

If you doubt a reaction is real and say so, however gently, the response you may get is, “That may be true, Doctor, but my body is sensitive. I get strange reactions.”

Like most everyone else in practice, I use negotiating tactics, such as: “Stop the cream for 3 days, then try it again, but just in one spot in front of your left ear.”

Some patients agree to try this. Mostly, nothing happens, they resume the medication, and life goes on. For fearful people, we have to use something else. Sometimes patients and I run through a succession of options, each of which produces an inscrutable “reaction.”

As the years pass, I’ve gotten better at gauging the range of true reactions to medications. At the same time, the list of perplexing things patients complain about gets longer all the time. Lately, there’s been a run of them:

• The woman who used low-strength tretinoin cream all of twice and stopped 2 weeks ago who insisted that “my face is still all dried out.” I assured her that 2 days of tretinoin cannot damage the skin forever, but she remains unconvinced.

• The man who says that putting tretinoin on his face “made me dry out all over.”

• The mother who said her daughter stopped my steroid cream because “every time we used it, her tongue broke out in blisters.”

•  The middle-aged woman who claimed, “I can’t take minocycline because it changed the color of my teeth and my eyes.”

• The young woman who puts clindamycin pads only on her right cheek, where she still has pimples, but not on the left, “because it makes the pimples go away on the cheek that has them, but on the other side it makes pimples come out.”

When I hear complaints like these, I just sigh and make a lateral move.

But sometimes I run out of lateral moves. The other month a woman told me that doxycycline made her “tired.” We tried minocycline, but that made her “irritable.” “My body is prone to strange reactions that no one else gets,” she explained. Then she asked for a third option.

“I honestly don’t know what to suggest,” I apologized. “Because your body reacts in ways that other people don’t, I can’t predict what some other treatment will do to you, even if it hasn’t done it to anyone else.”

She asked for her records, to get another opinion. I happily complied.

Speaking of weird “reactions,” there are of course the ones listed on e-scribing programs. Here are a couple:

• Hydrocortisone valerate has been associated with WARTS. (Capitalized)

• Hydrocortisone valerate has been associated with tinea cruris.

Make any sense to you? Me neither.

I end with a call I got the other day from a pharmacist. This concerned a patient for whom I had prescribed oral doxycycline and topical tretinoin. The message was, “Please call regarding drug interaction.”

When I got through, I politely asked the nature of this interaction. The pharmacist said she didn’t know exactly, but would look into it and fax me the details.

Half an hour later I got a sheet explaining the there is an increased risk of pseudotumor cerebri when patients take both oral tretinoin and oral tetracyclines.

That is correct: Not isotretinoin. Oral tretinoin. Used any oral tretinoin lately?

At any rate, the helpful pharmacist wrote at the bottom, “This interaction is flagged by several insurers for topical tretinoin too.”

Thank heavens for computer-generated warnings. Whatever would we do without them?

Besides, it’s nice to know that even after all these years, I can still react myself, with surprise.

Dr. Rockoff practices dermatology in Brookline, Mass. He is on the clinical faculty at Tufts University School of Medicine, Boston, and has taught senior medical students and other trainees for 30 years. Dr. Rockoff has contributed to the Under My Skin column in Dermatology News since January 2002. Write to him at [email protected].

In May 2016, a 4-year-old managed to get into the gorilla enclosure at the Cincinnati Zoo. In a successful attempt to remove the child before he could be seriously injured, the zoo officials shot and killed the gorilla. While there has been some debate as to whether the situation warranted the use of deadly force, there is general agreement that we should value a human life over that of an animal.

However, the debate that continues to simmer focuses on whether the child’s parents share in any culpability for the event. I suspect we will never know enough of the details to make a judgment on this question. And faced with that uncertainty, what I am going to say in the next few paragraphs does not apply to the situation at the Cincinnati Zoo. I am using that event only as a place to start a discussion.

You and I have seen scores of children who, because of their immaturity and to a larger extent to their temperament, are adventuresome and resistant to attempts by those who would like to keep them safe. You could label them as risk takers, but I don’t think those children are perceptive enough to understand that what they are doing is risky.

You could call them accident prone, but this raises the question of how many events that end in injury or death are really accidental. Almost all of those tragedies aren’t intentional. But how many were preventable? Of course, that depends on how broadly you define preventable. How far back in the chain of events that preceded an incident are you willing to realistically assign causality or culpability?

For example, a mother is standing on the sidewalk of busy intersection with a traffic light, holding her 3-year-old’s hand. Her cell phone alerts her of a text, she drops his hand to check it, and in an instant he darts out into the travel lane to grab what turns out to be an empty candy wrapper and is struck by a car. Was this an accident?

I suspect that if we interviewed family friends, neighbors, and maybe even the child’s pediatrician, we would learn of several dozen examples of the child’s unusually impulsive behavior. We also might learn that he had been resistant to his mother’s attempts to set limits and modify his behavior. In other words, his past history suggests that he was an “accident” waiting to happen.

Who is culpable here? Should the driver have been more aware of the pedestrians who were waiting to cross and, seeing that one was a young child, realized that some little children are more impulsive than others and driven more prudently? Should the child’s mother have accepted the fact that while some 3-year-olds can be under “voice control,” her son was certainly not one of those and ignored her phone?

Should the child’s pediatrician, who was aware of his temperament and impulsivity, have spent more time with the family on how to manage his behavior? Dr. William J. Turtle published a book in the 1970s titled, “Dr. Turtle’s Babies,” in which among other sage advice, he suggests most if not all toddlers should be fitted with a harness until they can be trusted. While you and I may have trouble selling this concept to parents – particularly parents of post toddlers – a harness or wrist-restraining tether might have saved this 3-year-old’s life. Whether a child’s impulsivity is age appropriate or pathologic, we must include advice on its management in our anticipatory guidance. There are very few true accidents, many are incidents that were predictable – and to some extent – preventable.

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.”

In May 2016, a 4-year-old managed to get into the gorilla enclosure at the Cincinnati Zoo. In a successful attempt to remove the child before he could be seriously injured, the zoo officials shot and killed the gorilla. While there has been some debate as to whether the situation warranted the use of deadly force, there is general agreement that we should value a human life over that of an animal.

However, the debate that continues to simmer focuses on whether the child’s parents share in any culpability for the event. I suspect we will never know enough of the details to make a judgment on this question. And faced with that uncertainty, what I am going to say in the next few paragraphs does not apply to the situation at the Cincinnati Zoo. I am using that event only as a place to start a discussion.

You and I have seen scores of children who, because of their immaturity and to a larger extent to their temperament, are adventuresome and resistant to attempts by those who would like to keep them safe. You could label them as risk takers, but I don’t think those children are perceptive enough to understand that what they are doing is risky.

You could call them accident prone, but this raises the question of how many events that end in injury or death are really accidental. Almost all of those tragedies aren’t intentional. But how many were preventable? Of course, that depends on how broadly you define preventable. How far back in the chain of events that preceded an incident are you willing to realistically assign causality or culpability?

For example, a mother is standing on the sidewalk of busy intersection with a traffic light, holding her 3-year-old’s hand. Her cell phone alerts her of a text, she drops his hand to check it, and in an instant he darts out into the travel lane to grab what turns out to be an empty candy wrapper and is struck by a car. Was this an accident?

I suspect that if we interviewed family friends, neighbors, and maybe even the child’s pediatrician, we would learn of several dozen examples of the child’s unusually impulsive behavior. We also might learn that he had been resistant to his mother’s attempts to set limits and modify his behavior. In other words, his past history suggests that he was an “accident” waiting to happen.

Who is culpable here? Should the driver have been more aware of the pedestrians who were waiting to cross and, seeing that one was a young child, realized that some little children are more impulsive than others and driven more prudently? Should the child’s mother have accepted the fact that while some 3-year-olds can be under “voice control,” her son was certainly not one of those and ignored her phone?

Should the child’s pediatrician, who was aware of his temperament and impulsivity, have spent more time with the family on how to manage his behavior? Dr. William J. Turtle published a book in the 1970s titled, “Dr. Turtle’s Babies,” in which among other sage advice, he suggests most if not all toddlers should be fitted with a harness until they can be trusted. While you and I may have trouble selling this concept to parents – particularly parents of post toddlers – a harness or wrist-restraining tether might have saved this 3-year-old’s life. Whether a child’s impulsivity is age appropriate or pathologic, we must include advice on its management in our anticipatory guidance. There are very few true accidents, many are incidents that were predictable – and to some extent – preventable.

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.”

In May 2016, a 4-year-old managed to get into the gorilla enclosure at the Cincinnati Zoo. In a successful attempt to remove the child before he could be seriously injured, the zoo officials shot and killed the gorilla. While there has been some debate as to whether the situation warranted the use of deadly force, there is general agreement that we should value a human life over that of an animal.

However, the debate that continues to simmer focuses on whether the child’s parents share in any culpability for the event. I suspect we will never know enough of the details to make a judgment on this question. And faced with that uncertainty, what I am going to say in the next few paragraphs does not apply to the situation at the Cincinnati Zoo. I am using that event only as a place to start a discussion.

You and I have seen scores of children who, because of their immaturity and to a larger extent to their temperament, are adventuresome and resistant to attempts by those who would like to keep them safe. You could label them as risk takers, but I don’t think those children are perceptive enough to understand that what they are doing is risky.

You could call them accident prone, but this raises the question of how many events that end in injury or death are really accidental. Almost all of those tragedies aren’t intentional. But how many were preventable? Of course, that depends on how broadly you define preventable. How far back in the chain of events that preceded an incident are you willing to realistically assign causality or culpability?

For example, a mother is standing on the sidewalk of busy intersection with a traffic light, holding her 3-year-old’s hand. Her cell phone alerts her of a text, she drops his hand to check it, and in an instant he darts out into the travel lane to grab what turns out to be an empty candy wrapper and is struck by a car. Was this an accident?

I suspect that if we interviewed family friends, neighbors, and maybe even the child’s pediatrician, we would learn of several dozen examples of the child’s unusually impulsive behavior. We also might learn that he had been resistant to his mother’s attempts to set limits and modify his behavior. In other words, his past history suggests that he was an “accident” waiting to happen.

Who is culpable here? Should the driver have been more aware of the pedestrians who were waiting to cross and, seeing that one was a young child, realized that some little children are more impulsive than others and driven more prudently? Should the child’s mother have accepted the fact that while some 3-year-olds can be under “voice control,” her son was certainly not one of those and ignored her phone?

Should the child’s pediatrician, who was aware of his temperament and impulsivity, have spent more time with the family on how to manage his behavior? Dr. William J. Turtle published a book in the 1970s titled, “Dr. Turtle’s Babies,” in which among other sage advice, he suggests most if not all toddlers should be fitted with a harness until they can be trusted. While you and I may have trouble selling this concept to parents – particularly parents of post toddlers – a harness or wrist-restraining tether might have saved this 3-year-old’s life. Whether a child’s impulsivity is age appropriate or pathologic, we must include advice on its management in our anticipatory guidance. There are very few true accidents, many are incidents that were predictable – and to some extent – preventable.

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.”

Copenhagen – A real-life comparison of major bleeding risk with anticoagulants showed that in-hospital mortality was lower with novel oral agents than with vitamin K antagonists, but the risk varied by bleeding site.

Novel oral anticoagulants (NOACs) such as dabigatran (Pradaxa), rivaroxaban (Xarelto), and apixaban (Eliquis) were associated in randomized phase III clinical trials with lower incidences of major bleeding than vitamin K antagonists (VKA) such as warfarin, and the newer, heavily advertised agents are widely used in clinical practice, noted Dr. Laura Franco of the Stroke Unit at the University of Perugia, Italy.

“But there is [little] information about the management and outcomes of major bleeding with NOACs in real life,” she said at a briefing at the annual congress of the European Hematology Association.

Neil Osterweil/Frontline Medical News

To rectify this situation, Dr. Franco and her colleagues at nine Italian hospitals and the NOAC registry based in Dresden, Germany, looked at 30-day mortality and other outcomes among 874 consecutive patients admitted for a major bleeding episode from September 2013 through May 2016. In all, 220 of the patients were on NOACs, and 654 were on VKAs.

Intracranial bleeds occurred in 44% of all patients, but were significantly less common among patients on NOACs than on VKAs (22% vs, 52%, respectively, odds ratio 0.26, P less than .001), whereas gastrointestinal bleeds, which occurred in 30% of all patients, were more frequent with the newer oral agents than with the older VKAs (46% vs. 30%, OR 2.69, P less than .001).

Deaths within 30 days of emergency department admission were less frequent with NOACs (10% vs. 17%, hazard ratio 0.56, P = .012).

“But when we analyzed the subpopulation of patients with different sites of bleeding, we saw that among intracranial hemorrhage, the rate was equal among NOAC and VKAs patients, 25% in both groups,” Dr. Franco said.

Deaths from gastrointestinal bleeding were numerically lower among patients on NOACs (7% vs. 10%), but this difference was not statistically significant.

“The great advantages of the new oral anticoagulants are the reduced risk in intracranial hemorrhage, so we showed that the lower mortality is not due to an intrinsic capacity to reduce deaths by NOACs as compared to VKAs, but to a different pattern of bleeding sites,” Dr. Franco said.

The study funding source was not disclosed. Dr. Franco did not report relevant disclosures.

Copenhagen – A real-life comparison of major bleeding risk with anticoagulants showed that in-hospital mortality was lower with novel oral agents than with vitamin K antagonists, but the risk varied by bleeding site.

Novel oral anticoagulants (NOACs) such as dabigatran (Pradaxa), rivaroxaban (Xarelto), and apixaban (Eliquis) were associated in randomized phase III clinical trials with lower incidences of major bleeding than vitamin K antagonists (VKA) such as warfarin, and the newer, heavily advertised agents are widely used in clinical practice, noted Dr. Laura Franco of the Stroke Unit at the University of Perugia, Italy.

“But there is [little] information about the management and outcomes of major bleeding with NOACs in real life,” she said at a briefing at the annual congress of the European Hematology Association.

Neil Osterweil/Frontline Medical News

To rectify this situation, Dr. Franco and her colleagues at nine Italian hospitals and the NOAC registry based in Dresden, Germany, looked at 30-day mortality and other outcomes among 874 consecutive patients admitted for a major bleeding episode from September 2013 through May 2016. In all, 220 of the patients were on NOACs, and 654 were on VKAs.

Intracranial bleeds occurred in 44% of all patients, but were significantly less common among patients on NOACs than on VKAs (22% vs, 52%, respectively, odds ratio 0.26, P less than .001), whereas gastrointestinal bleeds, which occurred in 30% of all patients, were more frequent with the newer oral agents than with the older VKAs (46% vs. 30%, OR 2.69, P less than .001).

Deaths within 30 days of emergency department admission were less frequent with NOACs (10% vs. 17%, hazard ratio 0.56, P = .012).

“But when we analyzed the subpopulation of patients with different sites of bleeding, we saw that among intracranial hemorrhage, the rate was equal among NOAC and VKAs patients, 25% in both groups,” Dr. Franco said.

Deaths from gastrointestinal bleeding were numerically lower among patients on NOACs (7% vs. 10%), but this difference was not statistically significant.

“The great advantages of the new oral anticoagulants are the reduced risk in intracranial hemorrhage, so we showed that the lower mortality is not due to an intrinsic capacity to reduce deaths by NOACs as compared to VKAs, but to a different pattern of bleeding sites,” Dr. Franco said.

The study funding source was not disclosed. Dr. Franco did not report relevant disclosures.

Copenhagen – A real-life comparison of major bleeding risk with anticoagulants showed that in-hospital mortality was lower with novel oral agents than with vitamin K antagonists, but the risk varied by bleeding site.

Novel oral anticoagulants (NOACs) such as dabigatran (Pradaxa), rivaroxaban (Xarelto), and apixaban (Eliquis) were associated in randomized phase III clinical trials with lower incidences of major bleeding than vitamin K antagonists (VKA) such as warfarin, and the newer, heavily advertised agents are widely used in clinical practice, noted Dr. Laura Franco of the Stroke Unit at the University of Perugia, Italy.

“But there is [little] information about the management and outcomes of major bleeding with NOACs in real life,” she said at a briefing at the annual congress of the European Hematology Association.

Neil Osterweil/Frontline Medical News

To rectify this situation, Dr. Franco and her colleagues at nine Italian hospitals and the NOAC registry based in Dresden, Germany, looked at 30-day mortality and other outcomes among 874 consecutive patients admitted for a major bleeding episode from September 2013 through May 2016. In all, 220 of the patients were on NOACs, and 654 were on VKAs.

Intracranial bleeds occurred in 44% of all patients, but were significantly less common among patients on NOACs than on VKAs (22% vs, 52%, respectively, odds ratio 0.26, P less than .001), whereas gastrointestinal bleeds, which occurred in 30% of all patients, were more frequent with the newer oral agents than with the older VKAs (46% vs. 30%, OR 2.69, P less than .001).

Deaths within 30 days of emergency department admission were less frequent with NOACs (10% vs. 17%, hazard ratio 0.56, P = .012).

“But when we analyzed the subpopulation of patients with different sites of bleeding, we saw that among intracranial hemorrhage, the rate was equal among NOAC and VKAs patients, 25% in both groups,” Dr. Franco said.

Deaths from gastrointestinal bleeding were numerically lower among patients on NOACs (7% vs. 10%), but this difference was not statistically significant.

“The great advantages of the new oral anticoagulants are the reduced risk in intracranial hemorrhage, so we showed that the lower mortality is not due to an intrinsic capacity to reduce deaths by NOACs as compared to VKAs, but to a different pattern of bleeding sites,” Dr. Franco said.

The study funding source was not disclosed. Dr. Franco did not report relevant disclosures.

Recent marijuana use may have an effect similar to recent tobacco use with regard to decreased production of exhaled nitric oxide (eNO), but a very different effect on forced vital capacity (FVC), according to the results of a study published in Chest.

Dr. Stefania I. Papatheodorou from the Cyprus International Institute for Environmental and Public Health, Limassol, Cyprus, in association with the Harvard T. H. Chan School of Public Health, and her colleagues conducted a retrospective analysis of National Health and Nutrition Examination Survey (NHANES) data collected from 10,327 people aged 18-59 years between 2007 to 2012. Respondents completed a questionnaire on illicit drug use and were given a physical examination. Outcomes of interest for this study were eNO levels and pulmonary function measurements including the forced expiratory volume in 1 second (FEV₁), FVC, the FEV1/FVC ratio, and the average forced expiratory flow during the mid (25%-75%) portion of the FVC (FEF_25%-75%) (Chest. 2016 Jan 16. doi: 10.1016/j.chest.2015.12.033).

©KatarzynaBialasiewicz/thinkstockphotos.com

The population available for analysis included 4,797 people who reported never having used marijuana, and 4,084 who reported past use. The recent users were divided into two groups; 555 and 891 respondents who reported using marijuana 5-30 days and 0-4 days before their examinations, respectively. The study results from age-adjusted analyses standardized to the 2000 U.S. Census population indicated that both past and current users had significantly lower eNO levels (in parts per billion) than those that had never used (all P less than .001). The same analysis demonstrated that FEV₁, FVC, and FEV₁/FVC ratios were all higher in current and past users than in never users (all P less than .001).

Using a multivariable model adjusted for age, sex, race/ethnicity, height, education level, income, marital status, asthma, tobacco use in pack-years, smoking category, and body mass index, both the 0-4 day users and the 5-30 day users showed significantly decreased eNO levels, compared with never users (-7%, 95% confidence interval -12% to -2%, P = .03; -13%, CI -18% to -8%, P less than .001, respectively). Additionally, recent users in the 0-4 day group had significantly higher FEV₁ measures than never users (89 mL, CI 29-150, P = 0.005), as well as lower FEV₁/FVC ratios (-.02, CI –.03 to –.01, P = .003).

Regarding the broader implications of their study findings, Dr. Papatheodorou and colleagues stated, “Given that nitric oxide plays a role in inflammatory and immune defense pathways in the respiratory system and is a mediator of vasodilation in the pulmonary and systemic vasculature, it would be useful to further explore the associations between marijuana use and vascular and pulmonary function in randomized trials.”

Dr. Mary B. Rice received funding from the Institute for Environmental Sciences. The other authors reported no conflicts of interest.

Recent marijuana use may have an effect similar to recent tobacco use with regard to decreased production of exhaled nitric oxide (eNO), but a very different effect on forced vital capacity (FVC), according to the results of a study published in Chest.

Dr. Stefania I. Papatheodorou from the Cyprus International Institute for Environmental and Public Health, Limassol, Cyprus, in association with the Harvard T. H. Chan School of Public Health, and her colleagues conducted a retrospective analysis of National Health and Nutrition Examination Survey (NHANES) data collected from 10,327 people aged 18-59 years between 2007 to 2012. Respondents completed a questionnaire on illicit drug use and were given a physical examination. Outcomes of interest for this study were eNO levels and pulmonary function measurements including the forced expiratory volume in 1 second (FEV₁), FVC, the FEV1/FVC ratio, and the average forced expiratory flow during the mid (25%-75%) portion of the FVC (FEF_25%-75%) (Chest. 2016 Jan 16. doi: 10.1016/j.chest.2015.12.033).

©KatarzynaBialasiewicz/thinkstockphotos.com

The population available for analysis included 4,797 people who reported never having used marijuana, and 4,084 who reported past use. The recent users were divided into two groups; 555 and 891 respondents who reported using marijuana 5-30 days and 0-4 days before their examinations, respectively. The study results from age-adjusted analyses standardized to the 2000 U.S. Census population indicated that both past and current users had significantly lower eNO levels (in parts per billion) than those that had never used (all P less than .001). The same analysis demonstrated that FEV₁, FVC, and FEV₁/FVC ratios were all higher in current and past users than in never users (all P less than .001).

Using a multivariable model adjusted for age, sex, race/ethnicity, height, education level, income, marital status, asthma, tobacco use in pack-years, smoking category, and body mass index, both the 0-4 day users and the 5-30 day users showed significantly decreased eNO levels, compared with never users (-7%, 95% confidence interval -12% to -2%, P = .03; -13%, CI -18% to -8%, P less than .001, respectively). Additionally, recent users in the 0-4 day group had significantly higher FEV₁ measures than never users (89 mL, CI 29-150, P = 0.005), as well as lower FEV₁/FVC ratios (-.02, CI –.03 to –.01, P = .003).

Regarding the broader implications of their study findings, Dr. Papatheodorou and colleagues stated, “Given that nitric oxide plays a role in inflammatory and immune defense pathways in the respiratory system and is a mediator of vasodilation in the pulmonary and systemic vasculature, it would be useful to further explore the associations between marijuana use and vascular and pulmonary function in randomized trials.”

Dr. Mary B. Rice received funding from the Institute for Environmental Sciences. The other authors reported no conflicts of interest.

Recent marijuana use may have an effect similar to recent tobacco use with regard to decreased production of exhaled nitric oxide (eNO), but a very different effect on forced vital capacity (FVC), according to the results of a study published in Chest.

Dr. Stefania I. Papatheodorou from the Cyprus International Institute for Environmental and Public Health, Limassol, Cyprus, in association with the Harvard T. H. Chan School of Public Health, and her colleagues conducted a retrospective analysis of National Health and Nutrition Examination Survey (NHANES) data collected from 10,327 people aged 18-59 years between 2007 to 2012. Respondents completed a questionnaire on illicit drug use and were given a physical examination. Outcomes of interest for this study were eNO levels and pulmonary function measurements including the forced expiratory volume in 1 second (FEV₁), FVC, the FEV1/FVC ratio, and the average forced expiratory flow during the mid (25%-75%) portion of the FVC (FEF_25%-75%) (Chest. 2016 Jan 16. doi: 10.1016/j.chest.2015.12.033).

©KatarzynaBialasiewicz/thinkstockphotos.com

The population available for analysis included 4,797 people who reported never having used marijuana, and 4,084 who reported past use. The recent users were divided into two groups; 555 and 891 respondents who reported using marijuana 5-30 days and 0-4 days before their examinations, respectively. The study results from age-adjusted analyses standardized to the 2000 U.S. Census population indicated that both past and current users had significantly lower eNO levels (in parts per billion) than those that had never used (all P less than .001). The same analysis demonstrated that FEV₁, FVC, and FEV₁/FVC ratios were all higher in current and past users than in never users (all P less than .001).

Using a multivariable model adjusted for age, sex, race/ethnicity, height, education level, income, marital status, asthma, tobacco use in pack-years, smoking category, and body mass index, both the 0-4 day users and the 5-30 day users showed significantly decreased eNO levels, compared with never users (-7%, 95% confidence interval -12% to -2%, P = .03; -13%, CI -18% to -8%, P less than .001, respectively). Additionally, recent users in the 0-4 day group had significantly higher FEV₁ measures than never users (89 mL, CI 29-150, P = 0.005), as well as lower FEV₁/FVC ratios (-.02, CI –.03 to –.01, P = .003).

Regarding the broader implications of their study findings, Dr. Papatheodorou and colleagues stated, “Given that nitric oxide plays a role in inflammatory and immune defense pathways in the respiratory system and is a mediator of vasodilation in the pulmonary and systemic vasculature, it would be useful to further explore the associations between marijuana use and vascular and pulmonary function in randomized trials.”

Dr. Mary B. Rice received funding from the Institute for Environmental Sciences. The other authors reported no conflicts of interest.

The 2015-2016 flu season was less severe than the last three seasons, with a lower hospitalization rate and fewer pediatric deaths.

Cases of influenza appeared later in the season than typically seen, and activity didn’t peak until March, Stacy L. Davlin, Ph.D., wrote in the June 10 issue of the Morbidity and Mortality Weekly Report (MMWR 2016;22:567-75)

“During the most recent 18 influenza seasons, only two other seasons have peaked in March (2011-2012 and 2005-2006),” wrote Dr. Davlin, an epidemiologist at the Centers for Disease Control and Prevention, Atlanta. This serves as a reminder that influenza can and does occur outside the traditionally expected season, and that clinicians shouldn’t discount the possibility of flu when a patient presents with typical symptoms.

Cynthia Goldsmith/CDC photo #10073

“Although summer influenza activity in the United States typically is low, influenza cases and outbreaks have occurred during summer months, and clinicians should remain vigilant in considering influenza in the differential diagnosis of summer respiratory illnesses,” Dr. Davlin said.

The most common influenza virus of the last season was A(H1N1), which accounted for about half of cases in those aged 5-24 years, and about 70% of cases in those younger than 5 years and those 65 years and older.

Three novel viruses were seen as well: variants of A(H1N1), A(H1N2), and A(H3N2). The A(H1N1) variant occurred in a Minnesota resident who lived and worked in an area of swine farming, but who denied direct contact with pigs. The A(H3N2) variant occurred in a New Jersey resident who reported visiting a farm shortly before symptom onset. There was no evidence of human-to-human transmission. Both recovered fully without hospitalization. The A(H1N2) variant occurred in a Minnesota resident who was hospitalized but who recovered. This person was not interviewed so no possible source of infection was identified.

The CDC tested 2,408 viral specimens for susceptibility to antiviral medications. Among the 2,193 A(H1N1) specimens, less than 1% were resistant to oseltamivir and peramivir. All were susceptible to zanamivir. However, the testing found persistent high levels of resistance to amantadine and rimantadine in the A viruses. Amantadine is not effective on the B strains at all. Therefore, CDC does not recommend the use of amantadine as an anti-influenza medication.

Reports of influenza first exceeded the 2.1% baseline level in the week ending Dec. 26, 2015, according to the U.S. Outpatient Influenza-Like Illness Surveillance Network (ILINet). They remained elevated for the next 17 weeks, with a peak of 3.6% of all outpatient visits in the week ending March 12. From October 2015-April 2016, the overall hospitalization rate for influenza-like illness was 31 per 100,000. This was highest in those aged 65 years and older (85/100,000), and lowest in those aged 5-17 years (10/100,000). About 92% of adults hospitalized for flu-like illness had at least one underlying medical comorbidity, including obesity (42%), cardiovascular disease (40%), and metabolic disorders (38%). Almost half of children (48%) also had medical comorbidities, including asthma or other reactive airway disease (22%) and neurologic disorders (18%).

CDC’s National Center for Health Statistics Mortality Surveillance System found that the percentage of deaths attributed to pneumonia and influenza peaked at 8% during the week ending March 19. This is slightly lower than the death rate seen in the last 5 years, which ranged from 9% in 2011-2012 to 11% in 2012-2013.

Of this season’s deaths, 74 occurred in children. The mean and median ages of these patients were 7 years and 6 years, respectively; the range was 2 months-16 years. This total was lower than that recorded in any of the past three influenza seasons: 171 pediatric deaths in 2012-2013, 111 in 2013-2014, and 148 in 2014-2015.

Dr. Davlin also announced the Food and Drug Administration’s recommendations for composition of the 2016-2017 influenza vaccine.

Trivalent vaccines should contain an A/California/7/2009 (H1N1) pdm09-like virus, an A/Hong Kong/4801/2014 (H3N2)-like virus, and a B/Brisbane/60/2008-like virus (B/Victoria lineage). Quadrivalent vaccines, which have two influenza B viruses, should include the viruses recommended for the trivalent vaccines, as well as a B/Phuket/3073/2013-like virus (B/Yamagata lineage).

“The vaccine viruses recommended for inclusion in the 2016-2017 Northern Hemisphere influenza vaccines are the same vaccine viruses that were chosen for inclusion in 2016 Southern Hemisphere seasonal influenza vaccines,” Dr. Davlin noted. “These vaccine recommendations were based on a number of factors, including global influenza virologic and epidemiologic surveillance, genetic and antigenic characterization, antiviral susceptibility, and the availability of candidate vaccine viruses for production.”

As a CDC employee, Dr. Davlin had no financial disclosures.

[email protected]

On Twitter @Alz_Gal

The 2015-2016 flu season was less severe than the last three seasons, with a lower hospitalization rate and fewer pediatric deaths.

Cases of influenza appeared later in the season than typically seen, and activity didn’t peak until March, Stacy L. Davlin, Ph.D., wrote in the June 10 issue of the Morbidity and Mortality Weekly Report (MMWR 2016;22:567-75)

“During the most recent 18 influenza seasons, only two other seasons have peaked in March (2011-2012 and 2005-2006),” wrote Dr. Davlin, an epidemiologist at the Centers for Disease Control and Prevention, Atlanta. This serves as a reminder that influenza can and does occur outside the traditionally expected season, and that clinicians shouldn’t discount the possibility of flu when a patient presents with typical symptoms.

Cynthia Goldsmith/CDC photo #10073

“Although summer influenza activity in the United States typically is low, influenza cases and outbreaks have occurred during summer months, and clinicians should remain vigilant in considering influenza in the differential diagnosis of summer respiratory illnesses,” Dr. Davlin said.

The most common influenza virus of the last season was A(H1N1), which accounted for about half of cases in those aged 5-24 years, and about 70% of cases in those younger than 5 years and those 65 years and older.

Three novel viruses were seen as well: variants of A(H1N1), A(H1N2), and A(H3N2). The A(H1N1) variant occurred in a Minnesota resident who lived and worked in an area of swine farming, but who denied direct contact with pigs. The A(H3N2) variant occurred in a New Jersey resident who reported visiting a farm shortly before symptom onset. There was no evidence of human-to-human transmission. Both recovered fully without hospitalization. The A(H1N2) variant occurred in a Minnesota resident who was hospitalized but who recovered. This person was not interviewed so no possible source of infection was identified.

The CDC tested 2,408 viral specimens for susceptibility to antiviral medications. Among the 2,193 A(H1N1) specimens, less than 1% were resistant to oseltamivir and peramivir. All were susceptible to zanamivir. However, the testing found persistent high levels of resistance to amantadine and rimantadine in the A viruses. Amantadine is not effective on the B strains at all. Therefore, CDC does not recommend the use of amantadine as an anti-influenza medication.

Reports of influenza first exceeded the 2.1% baseline level in the week ending Dec. 26, 2015, according to the U.S. Outpatient Influenza-Like Illness Surveillance Network (ILINet). They remained elevated for the next 17 weeks, with a peak of 3.6% of all outpatient visits in the week ending March 12. From October 2015-April 2016, the overall hospitalization rate for influenza-like illness was 31 per 100,000. This was highest in those aged 65 years and older (85/100,000), and lowest in those aged 5-17 years (10/100,000). About 92% of adults hospitalized for flu-like illness had at least one underlying medical comorbidity, including obesity (42%), cardiovascular disease (40%), and metabolic disorders (38%). Almost half of children (48%) also had medical comorbidities, including asthma or other reactive airway disease (22%) and neurologic disorders (18%).

CDC’s National Center for Health Statistics Mortality Surveillance System found that the percentage of deaths attributed to pneumonia and influenza peaked at 8% during the week ending March 19. This is slightly lower than the death rate seen in the last 5 years, which ranged from 9% in 2011-2012 to 11% in 2012-2013.

Of this season’s deaths, 74 occurred in children. The mean and median ages of these patients were 7 years and 6 years, respectively; the range was 2 months-16 years. This total was lower than that recorded in any of the past three influenza seasons: 171 pediatric deaths in 2012-2013, 111 in 2013-2014, and 148 in 2014-2015.

Dr. Davlin also announced the Food and Drug Administration’s recommendations for composition of the 2016-2017 influenza vaccine.

Trivalent vaccines should contain an A/California/7/2009 (H1N1) pdm09-like virus, an A/Hong Kong/4801/2014 (H3N2)-like virus, and a B/Brisbane/60/2008-like virus (B/Victoria lineage). Quadrivalent vaccines, which have two influenza B viruses, should include the viruses recommended for the trivalent vaccines, as well as a B/Phuket/3073/2013-like virus (B/Yamagata lineage).

“The vaccine viruses recommended for inclusion in the 2016-2017 Northern Hemisphere influenza vaccines are the same vaccine viruses that were chosen for inclusion in 2016 Southern Hemisphere seasonal influenza vaccines,” Dr. Davlin noted. “These vaccine recommendations were based on a number of factors, including global influenza virologic and epidemiologic surveillance, genetic and antigenic characterization, antiviral susceptibility, and the availability of candidate vaccine viruses for production.”

As a CDC employee, Dr. Davlin had no financial disclosures.

[email protected]

On Twitter @Alz_Gal

The 2015-2016 flu season was less severe than the last three seasons, with a lower hospitalization rate and fewer pediatric deaths.

Cases of influenza appeared later in the season than typically seen, and activity didn’t peak until March, Stacy L. Davlin, Ph.D., wrote in the June 10 issue of the Morbidity and Mortality Weekly Report (MMWR 2016;22:567-75)

“During the most recent 18 influenza seasons, only two other seasons have peaked in March (2011-2012 and 2005-2006),” wrote Dr. Davlin, an epidemiologist at the Centers for Disease Control and Prevention, Atlanta. This serves as a reminder that influenza can and does occur outside the traditionally expected season, and that clinicians shouldn’t discount the possibility of flu when a patient presents with typical symptoms.

Cynthia Goldsmith/CDC photo #10073

“Although summer influenza activity in the United States typically is low, influenza cases and outbreaks have occurred during summer months, and clinicians should remain vigilant in considering influenza in the differential diagnosis of summer respiratory illnesses,” Dr. Davlin said.

The most common influenza virus of the last season was A(H1N1), which accounted for about half of cases in those aged 5-24 years, and about 70% of cases in those younger than 5 years and those 65 years and older.

Three novel viruses were seen as well: variants of A(H1N1), A(H1N2), and A(H3N2). The A(H1N1) variant occurred in a Minnesota resident who lived and worked in an area of swine farming, but who denied direct contact with pigs. The A(H3N2) variant occurred in a New Jersey resident who reported visiting a farm shortly before symptom onset. There was no evidence of human-to-human transmission. Both recovered fully without hospitalization. The A(H1N2) variant occurred in a Minnesota resident who was hospitalized but who recovered. This person was not interviewed so no possible source of infection was identified.

The CDC tested 2,408 viral specimens for susceptibility to antiviral medications. Among the 2,193 A(H1N1) specimens, less than 1% were resistant to oseltamivir and peramivir. All were susceptible to zanamivir. However, the testing found persistent high levels of resistance to amantadine and rimantadine in the A viruses. Amantadine is not effective on the B strains at all. Therefore, CDC does not recommend the use of amantadine as an anti-influenza medication.

Reports of influenza first exceeded the 2.1% baseline level in the week ending Dec. 26, 2015, according to the U.S. Outpatient Influenza-Like Illness Surveillance Network (ILINet). They remained elevated for the next 17 weeks, with a peak of 3.6% of all outpatient visits in the week ending March 12. From October 2015-April 2016, the overall hospitalization rate for influenza-like illness was 31 per 100,000. This was highest in those aged 65 years and older (85/100,000), and lowest in those aged 5-17 years (10/100,000). About 92% of adults hospitalized for flu-like illness had at least one underlying medical comorbidity, including obesity (42%), cardiovascular disease (40%), and metabolic disorders (38%). Almost half of children (48%) also had medical comorbidities, including asthma or other reactive airway disease (22%) and neurologic disorders (18%).

CDC’s National Center for Health Statistics Mortality Surveillance System found that the percentage of deaths attributed to pneumonia and influenza peaked at 8% during the week ending March 19. This is slightly lower than the death rate seen in the last 5 years, which ranged from 9% in 2011-2012 to 11% in 2012-2013.

Of this season’s deaths, 74 occurred in children. The mean and median ages of these patients were 7 years and 6 years, respectively; the range was 2 months-16 years. This total was lower than that recorded in any of the past three influenza seasons: 171 pediatric deaths in 2012-2013, 111 in 2013-2014, and 148 in 2014-2015.

Dr. Davlin also announced the Food and Drug Administration’s recommendations for composition of the 2016-2017 influenza vaccine.

Trivalent vaccines should contain an A/California/7/2009 (H1N1) pdm09-like virus, an A/Hong Kong/4801/2014 (H3N2)-like virus, and a B/Brisbane/60/2008-like virus (B/Victoria lineage). Quadrivalent vaccines, which have two influenza B viruses, should include the viruses recommended for the trivalent vaccines, as well as a B/Phuket/3073/2013-like virus (B/Yamagata lineage).

“The vaccine viruses recommended for inclusion in the 2016-2017 Northern Hemisphere influenza vaccines are the same vaccine viruses that were chosen for inclusion in 2016 Southern Hemisphere seasonal influenza vaccines,” Dr. Davlin noted. “These vaccine recommendations were based on a number of factors, including global influenza virologic and epidemiologic surveillance, genetic and antigenic characterization, antiviral susceptibility, and the availability of candidate vaccine viruses for production.”

As a CDC employee, Dr. Davlin had no financial disclosures.

[email protected]

On Twitter @Alz_Gal

The 2015-2016 flu season was less severe than the last three seasons, with a lower hospitalization rate and fewer pediatric deaths.

Cases of influenza appeared later in the season that typically seen, and activity didn’t peak until March, Stacy L. Davlin, Ph.D., wrote in the June 10 issue of the Morbidity and Mortality report (MMWR 2016; 22:567-75)

“During the most recent 18 influenza seasons, only two other seasons have peaked in March (2011-2012 and 2005-2006),” wrote Dr. Davlin, an epidemiologist at the Centers for Disease Control and Prevention, Atlanta. This serves as a reminder that influenza can and does occur outside the traditionally expected season, and that clinicians shouldn’t discount the possibility of flu when a patient presents with typical symptoms.

Cynthia Goldsmith/CDC photo #10073

“Although summer influenza activity in the United States typically is low, influenza cases and outbreaks have occurred during summer months, and clinicians should remain vigilant in considering influenza in the differential diagnosis of summer respiratory illnesses,” Dr. Davlin said.

The most common influenza virus of the last season was A(H1N1), which accounted for about half of cases in those aged 5-24 years, and about 70% of cases in those younger than 5 years and those 65 years and older.

Three novel viruses were seen as well: variants of A(H1N1), A(H1N2), and A(H3N2). The A(H1N1) variant occurred in a Minnesota resident who lived and worked in an area of swine farming, but who denied direct contact with pigs. The A(H3N2) variant occurred in a New Jersey resident who reported visiting a farm shortly before symptom onset. There was no evidence of human-to-human transmission. Both recovered fully without hospitalization. The A(H1N2) variant occurred in a Minnesota resident who was hospitalized but who recovered. This person was not interviewed so no possible source of infection was identified.

The CDC tested 2,408 viral specimens for susceptibility to antiviral medications. Among the 2,193 A(H1N1) specimens, less than 1% were resistant to oseltamivir and peramivir. All were susceptible to zanamivir. However, the testing found persistent high levels of resistant to amantadine and rimantadine in the A viruses. Amantadine is not effective on the B strains at all. Therefore, CDC does not recommend the use of amantadine as an anti-influenza medication.

Reports of influenza first exceeded the 2.1% baseline level in the week ending Dec. 26, 2015, according to the U.S. Outpatient Influenza-Like Illness Surveillance Network (ILINet). They remained elevated for the next 17 weeks, with a peak of 3.6% of all outpatient visits in the week ending March 12. From October 2015-April 2016, the overall hospitalization rate for influenza-like illness was 31 per 100,000. This was highest in those aged 65 years and older (85/100,000), and lowest in those aged 5-17 years (10/100,000). About 92% of adults hospitalized for flu-like illness had at least one underlying medical comorbidity, including obesity (42%), cardiovascular disease (40%), and metabolic disorders (38%). Almost half of children (48%) also had medical comorbidities, including asthma or other reactive airway disease (22%) and neurologic disorders (18%).

CDC’s National Center for Health Statistics Mortality Surveillance System found that the percentage of deaths attributed to pneumonia and influenza peaked at 8% during the week ending March 19. This is slightly lower than the death rate seen in the last 5 years, which ranged from 9% in 2011-2012 to 11% in 2012-2013.

Of this season’s deaths, 74 occurred in children. The mean and median ages of these patients were 7 years and 6 years, respectively; the range was 2 months-16 years. This total was lower than that recorded in any of the past three influenza seasons: 171 pediatric deaths in 2012-2013, 111 in 2013-2014, and 148 in 2014-2015.

Dr. Davlin also announced the Food and Drug Administration’s recommendations for composition of the 2016-2017 influenza vaccine.

Trivalent vaccines should contain an A/California/7/2009 (H1N1) pdm09-like virus, an A/Hong Kong/4801/2014 (H3N2)-like virus, and a B/Brisbane/60/2008-like virus (B/Victoria lineage). Quadrivalent vaccines, which have two influenza B viruses, should include the viruses recommended for the trivalent vaccines, as well as a B/Phuket/3073/2013-like virus (B/Yamagata lineage).

“The vaccine viruses recommended for inclusion in the 2016-2017 Northern Hemisphere influenza vaccines are the same vaccine viruses that were chosen for inclusion in 2016 Southern Hemisphere seasonal influenza vaccines,” Dr. Davlin noted. “These vaccine recommendations were based on a number of factors, including global influenza virologic and epidemiologic surveillance, genetic and antigenic characterization, antiviral susceptibility, and the availability of candidate vaccine viruses for production.”

As a CDC employee, Dr. Davlin had no financial disclosures.

[email protected]

On Twitter @Alz_Gal

The 2015-2016 flu season was less severe than the last three seasons, with a lower hospitalization rate and fewer pediatric deaths.

Cases of influenza appeared later in the season that typically seen, and activity didn’t peak until March, Stacy L. Davlin, Ph.D., wrote in the June 10 issue of the Morbidity and Mortality report (MMWR 2016; 22:567-75)

“During the most recent 18 influenza seasons, only two other seasons have peaked in March (2011-2012 and 2005-2006),” wrote Dr. Davlin, an epidemiologist at the Centers for Disease Control and Prevention, Atlanta. This serves as a reminder that influenza can and does occur outside the traditionally expected season, and that clinicians shouldn’t discount the possibility of flu when a patient presents with typical symptoms.

Cynthia Goldsmith/CDC photo #10073

“Although summer influenza activity in the United States typically is low, influenza cases and outbreaks have occurred during summer months, and clinicians should remain vigilant in considering influenza in the differential diagnosis of summer respiratory illnesses,” Dr. Davlin said.

The most common influenza virus of the last season was A(H1N1), which accounted for about half of cases in those aged 5-24 years, and about 70% of cases in those younger than 5 years and those 65 years and older.

Three novel viruses were seen as well: variants of A(H1N1), A(H1N2), and A(H3N2). The A(H1N1) variant occurred in a Minnesota resident who lived and worked in an area of swine farming, but who denied direct contact with pigs. The A(H3N2) variant occurred in a New Jersey resident who reported visiting a farm shortly before symptom onset. There was no evidence of human-to-human transmission. Both recovered fully without hospitalization. The A(H1N2) variant occurred in a Minnesota resident who was hospitalized but who recovered. This person was not interviewed so no possible source of infection was identified.

The CDC tested 2,408 viral specimens for susceptibility to antiviral medications. Among the 2,193 A(H1N1) specimens, less than 1% were resistant to oseltamivir and peramivir. All were susceptible to zanamivir. However, the testing found persistent high levels of resistant to amantadine and rimantadine in the A viruses. Amantadine is not effective on the B strains at all. Therefore, CDC does not recommend the use of amantadine as an anti-influenza medication.

Reports of influenza first exceeded the 2.1% baseline level in the week ending Dec. 26, 2015, according to the U.S. Outpatient Influenza-Like Illness Surveillance Network (ILINet). They remained elevated for the next 17 weeks, with a peak of 3.6% of all outpatient visits in the week ending March 12. From October 2015-April 2016, the overall hospitalization rate for influenza-like illness was 31 per 100,000. This was highest in those aged 65 years and older (85/100,000), and lowest in those aged 5-17 years (10/100,000). About 92% of adults hospitalized for flu-like illness had at least one underlying medical comorbidity, including obesity (42%), cardiovascular disease (40%), and metabolic disorders (38%). Almost half of children (48%) also had medical comorbidities, including asthma or other reactive airway disease (22%) and neurologic disorders (18%).

CDC’s National Center for Health Statistics Mortality Surveillance System found that the percentage of deaths attributed to pneumonia and influenza peaked at 8% during the week ending March 19. This is slightly lower than the death rate seen in the last 5 years, which ranged from 9% in 2011-2012 to 11% in 2012-2013.

Of this season’s deaths, 74 occurred in children. The mean and median ages of these patients were 7 years and 6 years, respectively; the range was 2 months-16 years. This total was lower than that recorded in any of the past three influenza seasons: 171 pediatric deaths in 2012-2013, 111 in 2013-2014, and 148 in 2014-2015.

Dr. Davlin also announced the Food and Drug Administration’s recommendations for composition of the 2016-2017 influenza vaccine.

Trivalent vaccines should contain an A/California/7/2009 (H1N1) pdm09-like virus, an A/Hong Kong/4801/2014 (H3N2)-like virus, and a B/Brisbane/60/2008-like virus (B/Victoria lineage). Quadrivalent vaccines, which have two influenza B viruses, should include the viruses recommended for the trivalent vaccines, as well as a B/Phuket/3073/2013-like virus (B/Yamagata lineage).

“The vaccine viruses recommended for inclusion in the 2016-2017 Northern Hemisphere influenza vaccines are the same vaccine viruses that were chosen for inclusion in 2016 Southern Hemisphere seasonal influenza vaccines,” Dr. Davlin noted. “These vaccine recommendations were based on a number of factors, including global influenza virologic and epidemiologic surveillance, genetic and antigenic characterization, antiviral susceptibility, and the availability of candidate vaccine viruses for production.”

As a CDC employee, Dr. Davlin had no financial disclosures.

[email protected]

On Twitter @Alz_Gal

The 2015-2016 flu season was less severe than the last three seasons, with a lower hospitalization rate and fewer pediatric deaths.

Cases of influenza appeared later in the season that typically seen, and activity didn’t peak until March, Stacy L. Davlin, Ph.D., wrote in the June 10 issue of the Morbidity and Mortality report (MMWR 2016; 22:567-75)

“During the most recent 18 influenza seasons, only two other seasons have peaked in March (2011-2012 and 2005-2006),” wrote Dr. Davlin, an epidemiologist at the Centers for Disease Control and Prevention, Atlanta. This serves as a reminder that influenza can and does occur outside the traditionally expected season, and that clinicians shouldn’t discount the possibility of flu when a patient presents with typical symptoms.

Cynthia Goldsmith/CDC photo #10073

“Although summer influenza activity in the United States typically is low, influenza cases and outbreaks have occurred during summer months, and clinicians should remain vigilant in considering influenza in the differential diagnosis of summer respiratory illnesses,” Dr. Davlin said.

The most common influenza virus of the last season was A(H1N1), which accounted for about half of cases in those aged 5-24 years, and about 70% of cases in those younger than 5 years and those 65 years and older.

Three novel viruses were seen as well: variants of A(H1N1), A(H1N2), and A(H3N2). The A(H1N1) variant occurred in a Minnesota resident who lived and worked in an area of swine farming, but who denied direct contact with pigs. The A(H3N2) variant occurred in a New Jersey resident who reported visiting a farm shortly before symptom onset. There was no evidence of human-to-human transmission. Both recovered fully without hospitalization. The A(H1N2) variant occurred in a Minnesota resident who was hospitalized but who recovered. This person was not interviewed so no possible source of infection was identified.

The CDC tested 2,408 viral specimens for susceptibility to antiviral medications. Among the 2,193 A(H1N1) specimens, less than 1% were resistant to oseltamivir and peramivir. All were susceptible to zanamivir. However, the testing found persistent high levels of resistant to amantadine and rimantadine in the A viruses. Amantadine is not effective on the B strains at all. Therefore, CDC does not recommend the use of amantadine as an anti-influenza medication.

Reports of influenza first exceeded the 2.1% baseline level in the week ending Dec. 26, 2015, according to the U.S. Outpatient Influenza-Like Illness Surveillance Network (ILINet). They remained elevated for the next 17 weeks, with a peak of 3.6% of all outpatient visits in the week ending March 12. From October 2015-April 2016, the overall hospitalization rate for influenza-like illness was 31 per 100,000. This was highest in those aged 65 years and older (85/100,000), and lowest in those aged 5-17 years (10/100,000). About 92% of adults hospitalized for flu-like illness had at least one underlying medical comorbidity, including obesity (42%), cardiovascular disease (40%), and metabolic disorders (38%). Almost half of children (48%) also had medical comorbidities, including asthma or other reactive airway disease (22%) and neurologic disorders (18%).

CDC’s National Center for Health Statistics Mortality Surveillance System found that the percentage of deaths attributed to pneumonia and influenza peaked at 8% during the week ending March 19. This is slightly lower than the death rate seen in the last 5 years, which ranged from 9% in 2011-2012 to 11% in 2012-2013.

Of this season’s deaths, 74 occurred in children. The mean and median ages of these patients were 7 years and 6 years, respectively; the range was 2 months-16 years. This total was lower than that recorded in any of the past three influenza seasons: 171 pediatric deaths in 2012-2013, 111 in 2013-2014, and 148 in 2014-2015.

Dr. Davlin also announced the Food and Drug Administration’s recommendations for composition of the 2016-2017 influenza vaccine.

Trivalent vaccines should contain an A/California/7/2009 (H1N1) pdm09-like virus, an A/Hong Kong/4801/2014 (H3N2)-like virus, and a B/Brisbane/60/2008-like virus (B/Victoria lineage). Quadrivalent vaccines, which have two influenza B viruses, should include the viruses recommended for the trivalent vaccines, as well as a B/Phuket/3073/2013-like virus (B/Yamagata lineage).

“The vaccine viruses recommended for inclusion in the 2016-2017 Northern Hemisphere influenza vaccines are the same vaccine viruses that were chosen for inclusion in 2016 Southern Hemisphere seasonal influenza vaccines,” Dr. Davlin noted. “These vaccine recommendations were based on a number of factors, including global influenza virologic and epidemiologic surveillance, genetic and antigenic characterization, antiviral susceptibility, and the availability of candidate vaccine viruses for production.”

As a CDC employee, Dr. Davlin had no financial disclosures.

[email protected]

On Twitter @Alz_Gal

Copenhagen – Investigators in Italy have found that a recently identified form of inherited thrombocytopenia related to mutations in the gene ETV6 (ETV6-RT) appears to be largely asymptomatic, but puts patients at significantly increased risk for hematologic malignancies, particularly childhood B-cell acute lymphoblastic leukemia (ALL).

“When we are talking about ETV6-related thrombocytopenia patients, we must pay more attention to this hidden but very dangerous risk of developing blood cancer – so that we can define prognosis and plan a personalized follow-up – [rather] than to bleeding complications, which are rare and usually do not affect the quality of life,” said Dr. Federica Melazzini from the University of Pavia, Italy.

Neil Osterweil/Frontline Medical News

At a briefing at the annual congress of the European Hematology Association, Dr. Melazzini described a prospective study of the clinical and laboratory features of the newly identified disorder, with a focus on its association with hematologic cancers.

They enrolled 130 unrelated consecutive patients with inherited thrombocytopenias (IT) who did not have definitive diagnoses because they did exhibit criteria for any of the known forms of IT.

The investigators used whole exome sequencing or Sanger sequencing to look for mutations in ETV6, and when a mutation was identified, all available relatives of the affected participant (proband) also were evaluated. The authors also included data on five patients from two families known to have ETV6-RT from previous studies.

The participants were evaluated with complete blood counts, platelet sizing, flow cytometry studies of platelet membrane glycoproteins, as well as platelet aggregation, activation, adhesion and spreading. Other evaluations included differentiation of human megakaryocytes, morphological analysis of megakaryocytes, megakaryocytes flow cytometry, and evaluation of pro-platelet formation by megakaryocytes differentiated in vitro.

The investigators identified a total of 20 patients from 7 families bearing 5 different mutations in ETV6. Although these patients had only mild thrombocytopenias and a low bleeding tendency, 4 of the 20 had childhood ALL, supporting the association between ETV6 mutations and early leukemic transformation.

This translated into an incidence rate for hematologic malignancies of nearly 1 in 100 persons per year, compared with 1 in 10,000 per year in the general population, Dr. Melazzini said.

The investigators also noted that one patient developed Janus kinase 2 (JAK2)-positive polycythemia vera at age 37 years, “suggesting that this disease should be added to the list of malignancies to which the ETV6-RT predisposes.”

Dr. Melazzini said that clinicians should suspect ETV6-RT when a patient presents with an autosomal inherited thrombocytopenia without platelet macrocytosis, and should confirm the diagnosis with genetic analysis.

Patients also should be followed with whole blood cell counts and peripheral blood smear evaluations every 6-12 months, she recommended.

Dr Anton Hagenbeek, professor of hematology at the University of Amsterdam, who moderated the briefing but was not involved in the study, asked how clinicians should communicate the increased risk of hematologic malignancies to the patients.

Dr. Melazzini replied that patients need counseling about the risks of developing ALL or of passing on the trait if they plan to have children. Additionally, if patients develop ALL, the family should be cautioned against using a related donor for any allogeneic stem cell transplants, she said.

The study funding source was not disclosed. Dr. Melazzini and Dr. Hagenbeek reported no relevant disclosures.

Copenhagen – Investigators in Italy have found that a recently identified form of inherited thrombocytopenia related to mutations in the gene ETV6 (ETV6-RT) appears to be largely asymptomatic, but puts patients at significantly increased risk for hematologic malignancies, particularly childhood B-cell acute lymphoblastic leukemia (ALL).

“When we are talking about ETV6-related thrombocytopenia patients, we must pay more attention to this hidden but very dangerous risk of developing blood cancer – so that we can define prognosis and plan a personalized follow-up – [rather] than to bleeding complications, which are rare and usually do not affect the quality of life,” said Dr. Federica Melazzini from the University of Pavia, Italy.

Neil Osterweil/Frontline Medical News

At a briefing at the annual congress of the European Hematology Association, Dr. Melazzini described a prospective study of the clinical and laboratory features of the newly identified disorder, with a focus on its association with hematologic cancers.

They enrolled 130 unrelated consecutive patients with inherited thrombocytopenias (IT) who did not have definitive diagnoses because they did exhibit criteria for any of the known forms of IT.

The investigators used whole exome sequencing or Sanger sequencing to look for mutations in ETV6, and when a mutation was identified, all available relatives of the affected participant (proband) also were evaluated. The authors also included data on five patients from two families known to have ETV6-RT from previous studies.

The participants were evaluated with complete blood counts, platelet sizing, flow cytometry studies of platelet membrane glycoproteins, as well as platelet aggregation, activation, adhesion and spreading. Other evaluations included differentiation of human megakaryocytes, morphological analysis of megakaryocytes, megakaryocytes flow cytometry, and evaluation of pro-platelet formation by megakaryocytes differentiated in vitro.

The investigators identified a total of 20 patients from 7 families bearing 5 different mutations in ETV6. Although these patients had only mild thrombocytopenias and a low bleeding tendency, 4 of the 20 had childhood ALL, supporting the association between ETV6 mutations and early leukemic transformation.

This translated into an incidence rate for hematologic malignancies of nearly 1 in 100 persons per year, compared with 1 in 10,000 per year in the general population, Dr. Melazzini said.

The investigators also noted that one patient developed Janus kinase 2 (JAK2)-positive polycythemia vera at age 37 years, “suggesting that this disease should be added to the list of malignancies to which the ETV6-RT predisposes.”

Dr. Melazzini said that clinicians should suspect ETV6-RT when a patient presents with an autosomal inherited thrombocytopenia without platelet macrocytosis, and should confirm the diagnosis with genetic analysis.

Patients also should be followed with whole blood cell counts and peripheral blood smear evaluations every 6-12 months, she recommended.

Dr Anton Hagenbeek, professor of hematology at the University of Amsterdam, who moderated the briefing but was not involved in the study, asked how clinicians should communicate the increased risk of hematologic malignancies to the patients.

Dr. Melazzini replied that patients need counseling about the risks of developing ALL or of passing on the trait if they plan to have children. Additionally, if patients develop ALL, the family should be cautioned against using a related donor for any allogeneic stem cell transplants, she said.

The study funding source was not disclosed. Dr. Melazzini and Dr. Hagenbeek reported no relevant disclosures.

Copenhagen – Investigators in Italy have found that a recently identified form of inherited thrombocytopenia related to mutations in the gene ETV6 (ETV6-RT) appears to be largely asymptomatic, but puts patients at significantly increased risk for hematologic malignancies, particularly childhood B-cell acute lymphoblastic leukemia (ALL).

“When we are talking about ETV6-related thrombocytopenia patients, we must pay more attention to this hidden but very dangerous risk of developing blood cancer – so that we can define prognosis and plan a personalized follow-up – [rather] than to bleeding complications, which are rare and usually do not affect the quality of life,” said Dr. Federica Melazzini from the University of Pavia, Italy.

Neil Osterweil/Frontline Medical News

At a briefing at the annual congress of the European Hematology Association, Dr. Melazzini described a prospective study of the clinical and laboratory features of the newly identified disorder, with a focus on its association with hematologic cancers.

They enrolled 130 unrelated consecutive patients with inherited thrombocytopenias (IT) who did not have definitive diagnoses because they did exhibit criteria for any of the known forms of IT.

The investigators used whole exome sequencing or Sanger sequencing to look for mutations in ETV6, and when a mutation was identified, all available relatives of the affected participant (proband) also were evaluated. The authors also included data on five patients from two families known to have ETV6-RT from previous studies.

The participants were evaluated with complete blood counts, platelet sizing, flow cytometry studies of platelet membrane glycoproteins, as well as platelet aggregation, activation, adhesion and spreading. Other evaluations included differentiation of human megakaryocytes, morphological analysis of megakaryocytes, megakaryocytes flow cytometry, and evaluation of pro-platelet formation by megakaryocytes differentiated in vitro.

The investigators identified a total of 20 patients from 7 families bearing 5 different mutations in ETV6. Although these patients had only mild thrombocytopenias and a low bleeding tendency, 4 of the 20 had childhood ALL, supporting the association between ETV6 mutations and early leukemic transformation.

This translated into an incidence rate for hematologic malignancies of nearly 1 in 100 persons per year, compared with 1 in 10,000 per year in the general population, Dr. Melazzini said.

The investigators also noted that one patient developed Janus kinase 2 (JAK2)-positive polycythemia vera at age 37 years, “suggesting that this disease should be added to the list of malignancies to which the ETV6-RT predisposes.”

Dr. Melazzini said that clinicians should suspect ETV6-RT when a patient presents with an autosomal inherited thrombocytopenia without platelet macrocytosis, and should confirm the diagnosis with genetic analysis.

Patients also should be followed with whole blood cell counts and peripheral blood smear evaluations every 6-12 months, she recommended.

Dr Anton Hagenbeek, professor of hematology at the University of Amsterdam, who moderated the briefing but was not involved in the study, asked how clinicians should communicate the increased risk of hematologic malignancies to the patients.

Dr. Melazzini replied that patients need counseling about the risks of developing ALL or of passing on the trait if they plan to have children. Additionally, if patients develop ALL, the family should be cautioned against using a related donor for any allogeneic stem cell transplants, she said.

The study funding source was not disclosed. Dr. Melazzini and Dr. Hagenbeek reported no relevant disclosures.