Naseem S. Miller

Since Sept. 29, when a man in Texas tested positive for Ebola, federal and state officials have identified more than 100 people who may have come in direct or indirect contact with him. They are being monitored for fever, and four individuals are quarantined for 21 days in an apartment for a more controlled monitoring. None have symptoms so far.

“We remain confident that we can contain the spread of Ebola in the U.S.,” Dr. Thomas Frieden, director of the Centers for Disease Control and Prevention (CDC), said during a press briefing. “There could be additional cases, and if that occurs, there are systems in place to prevent the spread.”

The sick man, who has been identified in the media as Thomas Eric Duncan, first visited the emergency department at Texas Health Presbyterian Hospital in Dallas on Sept. 26, a week after he left Liberia. He was sent home, only to be brought back 2 days later by an ambulance. He is still in serious condition and remains the only case of Ebola to be diagnosed in the United States.

Texas officials said they are investigating why he was sent home at his first visit.

“The lesson from all of this for the hospitals across the nation is that they really have to take the travel history,” Dr. Frieden said. “Ask if they’ve been in these areas where there’s Ebola, and if so, they have to put Ebola on the differential diagnosis.” He stressed the importance of hospitals working and collaborating with public health officials.

“Any hospital in the country can safely take care of Ebola patients,” he said, as long as they have a room with its own bathroom. “But you need rigorous, meticulous training, and you need to make sure that the care is done well.”

There are currently 12 laboratories around the nation prepared to test for the Ebola virus, according to officials. As of Oct. 2, there have been 100 inquiries from hospitals in 34 states about the possibility of having a patient infected with Ebola. So far 15 cases have been tested for Ebola, and the only positive case so far is the man in Texas.

Staff trained by the CDC took the Texas patient’s temperature when he was boarding the plane in Liberia, which is the current protocol, and his temperature was 97.3° F, officials said. The status of his exposure in Liberia is now being investigated.

“The broader issue is, can we make the risk zero,” Dr. Frieden said. “And the bottom line, the plain truth, is that we can’t make the risk zero until the outbreak is controlled in West Africa.” Until then, officials will do what they can to minimize the risk of spread, he said. “It’s not impossible that we’ll have other individuals coming to the country that have Ebola.”

Based on the most recent data, there have been more than 6,500 cases of Ebola in West Africa, and more than 3,000 of those patients have died. Liberia has had the highest number of Ebola cases, followed by Sierra Leone, Guinea, and Nigeria. There has been one travel-reported case in Senegal.

Whether the affected countries should be isolated is a tough question, Dr. Frieden said, because isolating the countries will make it more difficult to deliver help, which in turn will enable the disease to spread more widely.

“The best way is not to seal off those countries, but to provide the services needed” and identify any [infected] individual who may be leaving those countries.

Ebola outbreaks have been recorded since 1976, but none has been as large as the current epidemic in West Africa, which was first identified on March 23 as an outbreak in Guinea.

In a study published in the New England Journal of Medicine on Sept. 23, the World Health Organization Ebola Response Team predicted that by Nov. 2, 2014, the cumulative reported numbers of confirmed and probable cases in the affected West African countries will exceed 20,000 in total.

“These data indicate that without drastic improvements in control measures, the numbers of cases of and deaths from [Ebola virus disease] are expected to continue increasing from hundreds to thousands per week in the coming months,” the team wrote.

Helpful links

Hospital checklist: http://www.cdc.gov/vhf/ebola/pdf/hospital-checklist-ebola-preparedness.pdf

Information for health care workers: http://www.cdc.gov/vhf/ebola/hcp/index.html

Latest outbreak information in West Africa:

http://www.cdc.gov/vhf/ebola/outbreaks/2014-west-africa/index.html

History of Ebola outbreaks: http://www.cdc.gov/vhf/ebola/outbreaks/history/distribution-map.html

[email protected]

On Twitter @naseemmiller

Since Sept. 29, when a man in Texas tested positive for Ebola, federal and state officials have identified more than 100 people who may have come in direct or indirect contact with him. They are being monitored for fever, and four individuals are quarantined for 21 days in an apartment for a more controlled monitoring. None have symptoms so far.

“We remain confident that we can contain the spread of Ebola in the U.S.,” Dr. Thomas Frieden, director of the Centers for Disease Control and Prevention (CDC), said during a press briefing. “There could be additional cases, and if that occurs, there are systems in place to prevent the spread.”

The sick man, who has been identified in the media as Thomas Eric Duncan, first visited the emergency department at Texas Health Presbyterian Hospital in Dallas on Sept. 26, a week after he left Liberia. He was sent home, only to be brought back 2 days later by an ambulance. He is still in serious condition and remains the only case of Ebola to be diagnosed in the United States.

Texas officials said they are investigating why he was sent home at his first visit.

“The lesson from all of this for the hospitals across the nation is that they really have to take the travel history,” Dr. Frieden said. “Ask if they’ve been in these areas where there’s Ebola, and if so, they have to put Ebola on the differential diagnosis.” He stressed the importance of hospitals working and collaborating with public health officials.

“Any hospital in the country can safely take care of Ebola patients,” he said, as long as they have a room with its own bathroom. “But you need rigorous, meticulous training, and you need to make sure that the care is done well.”

There are currently 12 laboratories around the nation prepared to test for the Ebola virus, according to officials. As of Oct. 2, there have been 100 inquiries from hospitals in 34 states about the possibility of having a patient infected with Ebola. So far 15 cases have been tested for Ebola, and the only positive case so far is the man in Texas.

Staff trained by the CDC took the Texas patient’s temperature when he was boarding the plane in Liberia, which is the current protocol, and his temperature was 97.3° F, officials said. The status of his exposure in Liberia is now being investigated.

“The broader issue is, can we make the risk zero,” Dr. Frieden said. “And the bottom line, the plain truth, is that we can’t make the risk zero until the outbreak is controlled in West Africa.” Until then, officials will do what they can to minimize the risk of spread, he said. “It’s not impossible that we’ll have other individuals coming to the country that have Ebola.”

Based on the most recent data, there have been more than 6,500 cases of Ebola in West Africa, and more than 3,000 of those patients have died. Liberia has had the highest number of Ebola cases, followed by Sierra Leone, Guinea, and Nigeria. There has been one travel-reported case in Senegal.

Whether the affected countries should be isolated is a tough question, Dr. Frieden said, because isolating the countries will make it more difficult to deliver help, which in turn will enable the disease to spread more widely.

“The best way is not to seal off those countries, but to provide the services needed” and identify any [infected] individual who may be leaving those countries.

Ebola outbreaks have been recorded since 1976, but none has been as large as the current epidemic in West Africa, which was first identified on March 23 as an outbreak in Guinea.

In a study published in the New England Journal of Medicine on Sept. 23, the World Health Organization Ebola Response Team predicted that by Nov. 2, 2014, the cumulative reported numbers of confirmed and probable cases in the affected West African countries will exceed 20,000 in total.

“These data indicate that without drastic improvements in control measures, the numbers of cases of and deaths from [Ebola virus disease] are expected to continue increasing from hundreds to thousands per week in the coming months,” the team wrote.

Helpful links

Hospital checklist: http://www.cdc.gov/vhf/ebola/pdf/hospital-checklist-ebola-preparedness.pdf

Information for health care workers: http://www.cdc.gov/vhf/ebola/hcp/index.html

Latest outbreak information in West Africa:

http://www.cdc.gov/vhf/ebola/outbreaks/2014-west-africa/index.html

History of Ebola outbreaks: http://www.cdc.gov/vhf/ebola/outbreaks/history/distribution-map.html

[email protected]

On Twitter @naseemmiller

Since Sept. 29, when a man in Texas tested positive for Ebola, federal and state officials have identified more than 100 people who may have come in direct or indirect contact with him. They are being monitored for fever, and four individuals are quarantined for 21 days in an apartment for a more controlled monitoring. None have symptoms so far.

“We remain confident that we can contain the spread of Ebola in the U.S.,” Dr. Thomas Frieden, director of the Centers for Disease Control and Prevention (CDC), said during a press briefing. “There could be additional cases, and if that occurs, there are systems in place to prevent the spread.”

The sick man, who has been identified in the media as Thomas Eric Duncan, first visited the emergency department at Texas Health Presbyterian Hospital in Dallas on Sept. 26, a week after he left Liberia. He was sent home, only to be brought back 2 days later by an ambulance. He is still in serious condition and remains the only case of Ebola to be diagnosed in the United States.

Texas officials said they are investigating why he was sent home at his first visit.

“The lesson from all of this for the hospitals across the nation is that they really have to take the travel history,” Dr. Frieden said. “Ask if they’ve been in these areas where there’s Ebola, and if so, they have to put Ebola on the differential diagnosis.” He stressed the importance of hospitals working and collaborating with public health officials.

“Any hospital in the country can safely take care of Ebola patients,” he said, as long as they have a room with its own bathroom. “But you need rigorous, meticulous training, and you need to make sure that the care is done well.”

There are currently 12 laboratories around the nation prepared to test for the Ebola virus, according to officials. As of Oct. 2, there have been 100 inquiries from hospitals in 34 states about the possibility of having a patient infected with Ebola. So far 15 cases have been tested for Ebola, and the only positive case so far is the man in Texas.

Staff trained by the CDC took the Texas patient’s temperature when he was boarding the plane in Liberia, which is the current protocol, and his temperature was 97.3° F, officials said. The status of his exposure in Liberia is now being investigated.

“The broader issue is, can we make the risk zero,” Dr. Frieden said. “And the bottom line, the plain truth, is that we can’t make the risk zero until the outbreak is controlled in West Africa.” Until then, officials will do what they can to minimize the risk of spread, he said. “It’s not impossible that we’ll have other individuals coming to the country that have Ebola.”

Based on the most recent data, there have been more than 6,500 cases of Ebola in West Africa, and more than 3,000 of those patients have died. Liberia has had the highest number of Ebola cases, followed by Sierra Leone, Guinea, and Nigeria. There has been one travel-reported case in Senegal.

Whether the affected countries should be isolated is a tough question, Dr. Frieden said, because isolating the countries will make it more difficult to deliver help, which in turn will enable the disease to spread more widely.

“The best way is not to seal off those countries, but to provide the services needed” and identify any [infected] individual who may be leaving those countries.

Ebola outbreaks have been recorded since 1976, but none has been as large as the current epidemic in West Africa, which was first identified on March 23 as an outbreak in Guinea.

In a study published in the New England Journal of Medicine on Sept. 23, the World Health Organization Ebola Response Team predicted that by Nov. 2, 2014, the cumulative reported numbers of confirmed and probable cases in the affected West African countries will exceed 20,000 in total.

“These data indicate that without drastic improvements in control measures, the numbers of cases of and deaths from [Ebola virus disease] are expected to continue increasing from hundreds to thousands per week in the coming months,” the team wrote.

Helpful links

Hospital checklist: http://www.cdc.gov/vhf/ebola/pdf/hospital-checklist-ebola-preparedness.pdf

Information for health care workers: http://www.cdc.gov/vhf/ebola/hcp/index.html

Latest outbreak information in West Africa:

http://www.cdc.gov/vhf/ebola/outbreaks/2014-west-africa/index.html

History of Ebola outbreaks: http://www.cdc.gov/vhf/ebola/outbreaks/history/distribution-map.html

[email protected]

On Twitter @naseemmiller

Acute onset of limb weakness and an MRI showing a spinal cord lesion largely restricted to the gray matter have been noted in several children who tested positive for enterovirus D68 infections, which have been spreading rapidly across the nation.

Federal health officials are urging that cases be reported to state and local health departments. The Centers for Disease Control and Prevention issued the alert on Sept. 26th in response to an ongoing investigation in Colorado involving a cluster of nine children who have been hospitalized with acute neurologic illness. A 10th case was added to the cluster on Monday, Sept. 29, according to the Colorado Department of Public Health & Environment.

Four of the children have tested positive for the virus and test results are pending in two other cases. Most cases had a febrile respiratory illness in the 2 weeks before they developed neurologic symptoms.

EV-D68, which has been historically rare, is a non–polio enterovirus causing mild to severe respiratory illness. Since initial reports in mid-August, more than 440 cases of EV-D68 have been confirmed in 40 states and the District of Columbia. The numbers are likely to increase as states process the backlog of specimens, according to the CDC. “As the scale of this year’s EV-D68 outbreak is much larger in comparison to the past, we will likely see rare complications of this infection, such as paralysis,” Dr. Jana Shaw, an infectious disease specialist at Upstate Golisano Children’s Hospital in Syracuse, N.Y., wrote in an e-mail. “In our experience, many patients with respiratory illness had uneventful hospitalizations and completely recovered. Hence, the frequency of paralysis with EV-D68 remains to be seen.”

The Colorado pediatric cases were identified between Aug. 9 and Sept. 17 this year among children aged 1-18 years old, with a median age of 10 years. All were hospitalized. Eight of the nine children are up to date with their polio vaccinations.

Most patients presented with acute focal limb weakness and their MRIs showed nonenhancing lesions that were largely restricted to the gray matter and spanned more than the level of the spinal cord in most cases. Some patients also had acute cranial nerve dysfunction with correlating nonenhancing brainstem lesions on MRI. There were no cases of altered mental status or seizure, nor any cortical, subcortical, basal ganglia, or thalamic lesions on MRI, according to the CDC report.

CDC is prioritizing testing of specimens from children with severe respiratory illness, according to its website.

Nearly half of the specimens tested for EV-D68 at the CDC have tested positive and about one-third have tested positive for an enterovirus or rhinovirus other than EV-D68, according to the agency.

“Not much is known about the spectrum and the severity of the disease [EV-D68] can cause,” Dr. Shaw said. “Recent reports of polio-like illness among children alert us to include EV-D68 virus in a differential diagnosis when evaluating a pediatric patient with acute focal limb weakness and prior respiratory illness. The current nationwide outbreak of EV-D68 gives us an opportunity to learn more about this virus, its epidemiology, and the etiology of recent polio-like illness reported in Colorado.”

In a recent commentary in JAMA Pediatrics, Dr. Shaw wrote that “rapid detection and media collaboration are crucial in limiting the effect of an outbreak in a community.”

[email protected]

On Twitter @naseemmiller

Acute onset of limb weakness and an MRI showing a spinal cord lesion largely restricted to the gray matter have been noted in several children who tested positive for enterovirus D68 infections, which have been spreading rapidly across the nation.

Federal health officials are urging that cases be reported to state and local health departments. The Centers for Disease Control and Prevention issued the alert on Sept. 26th in response to an ongoing investigation in Colorado involving a cluster of nine children who have been hospitalized with acute neurologic illness. A 10th case was added to the cluster on Monday, Sept. 29, according to the Colorado Department of Public Health & Environment.

Four of the children have tested positive for the virus and test results are pending in two other cases. Most cases had a febrile respiratory illness in the 2 weeks before they developed neurologic symptoms.

EV-D68, which has been historically rare, is a non–polio enterovirus causing mild to severe respiratory illness. Since initial reports in mid-August, more than 440 cases of EV-D68 have been confirmed in 40 states and the District of Columbia. The numbers are likely to increase as states process the backlog of specimens, according to the CDC. “As the scale of this year’s EV-D68 outbreak is much larger in comparison to the past, we will likely see rare complications of this infection, such as paralysis,” Dr. Jana Shaw, an infectious disease specialist at Upstate Golisano Children’s Hospital in Syracuse, N.Y., wrote in an e-mail. “In our experience, many patients with respiratory illness had uneventful hospitalizations and completely recovered. Hence, the frequency of paralysis with EV-D68 remains to be seen.”

The Colorado pediatric cases were identified between Aug. 9 and Sept. 17 this year among children aged 1-18 years old, with a median age of 10 years. All were hospitalized. Eight of the nine children are up to date with their polio vaccinations.

Most patients presented with acute focal limb weakness and their MRIs showed nonenhancing lesions that were largely restricted to the gray matter and spanned more than the level of the spinal cord in most cases. Some patients also had acute cranial nerve dysfunction with correlating nonenhancing brainstem lesions on MRI. There were no cases of altered mental status or seizure, nor any cortical, subcortical, basal ganglia, or thalamic lesions on MRI, according to the CDC report.

CDC is prioritizing testing of specimens from children with severe respiratory illness, according to its website.

Nearly half of the specimens tested for EV-D68 at the CDC have tested positive and about one-third have tested positive for an enterovirus or rhinovirus other than EV-D68, according to the agency.

“Not much is known about the spectrum and the severity of the disease [EV-D68] can cause,” Dr. Shaw said. “Recent reports of polio-like illness among children alert us to include EV-D68 virus in a differential diagnosis when evaluating a pediatric patient with acute focal limb weakness and prior respiratory illness. The current nationwide outbreak of EV-D68 gives us an opportunity to learn more about this virus, its epidemiology, and the etiology of recent polio-like illness reported in Colorado.”

In a recent commentary in JAMA Pediatrics, Dr. Shaw wrote that “rapid detection and media collaboration are crucial in limiting the effect of an outbreak in a community.”

[email protected]

On Twitter @naseemmiller

Acute onset of limb weakness and an MRI showing a spinal cord lesion largely restricted to the gray matter have been noted in several children who tested positive for enterovirus D68 infections, which have been spreading rapidly across the nation.

Federal health officials are urging that cases be reported to state and local health departments. The Centers for Disease Control and Prevention issued the alert on Sept. 26th in response to an ongoing investigation in Colorado involving a cluster of nine children who have been hospitalized with acute neurologic illness. A 10th case was added to the cluster on Monday, Sept. 29, according to the Colorado Department of Public Health & Environment.

Four of the children have tested positive for the virus and test results are pending in two other cases. Most cases had a febrile respiratory illness in the 2 weeks before they developed neurologic symptoms.

EV-D68, which has been historically rare, is a non–polio enterovirus causing mild to severe respiratory illness. Since initial reports in mid-August, more than 440 cases of EV-D68 have been confirmed in 40 states and the District of Columbia. The numbers are likely to increase as states process the backlog of specimens, according to the CDC. “As the scale of this year’s EV-D68 outbreak is much larger in comparison to the past, we will likely see rare complications of this infection, such as paralysis,” Dr. Jana Shaw, an infectious disease specialist at Upstate Golisano Children’s Hospital in Syracuse, N.Y., wrote in an e-mail. “In our experience, many patients with respiratory illness had uneventful hospitalizations and completely recovered. Hence, the frequency of paralysis with EV-D68 remains to be seen.”

The Colorado pediatric cases were identified between Aug. 9 and Sept. 17 this year among children aged 1-18 years old, with a median age of 10 years. All were hospitalized. Eight of the nine children are up to date with their polio vaccinations.

Most patients presented with acute focal limb weakness and their MRIs showed nonenhancing lesions that were largely restricted to the gray matter and spanned more than the level of the spinal cord in most cases. Some patients also had acute cranial nerve dysfunction with correlating nonenhancing brainstem lesions on MRI. There were no cases of altered mental status or seizure, nor any cortical, subcortical, basal ganglia, or thalamic lesions on MRI, according to the CDC report.

CDC is prioritizing testing of specimens from children with severe respiratory illness, according to its website.

Nearly half of the specimens tested for EV-D68 at the CDC have tested positive and about one-third have tested positive for an enterovirus or rhinovirus other than EV-D68, according to the agency.

“Not much is known about the spectrum and the severity of the disease [EV-D68] can cause,” Dr. Shaw said. “Recent reports of polio-like illness among children alert us to include EV-D68 virus in a differential diagnosis when evaluating a pediatric patient with acute focal limb weakness and prior respiratory illness. The current nationwide outbreak of EV-D68 gives us an opportunity to learn more about this virus, its epidemiology, and the etiology of recent polio-like illness reported in Colorado.”

In a recent commentary in JAMA Pediatrics, Dr. Shaw wrote that “rapid detection and media collaboration are crucial in limiting the effect of an outbreak in a community.”

[email protected]

On Twitter @naseemmiller

BARCELONA – The transfemoral approach to aortic valve replacement is associated with lower risk of death, stroke, and bleeding, compared with the more invasive transapical approach, according to a meta-analysis of more than a dozen studies.

After adjustment for baseline characteristics, Italian researchers found that, compared with patients who underwent transapical transcatheter aortic valve replacement (TAVR), the transfemoral group was nearly 20% less likely to die within 30 days and during the first year after the procedure. The transfemoral group also was significantly less likely to have periprocedural bleeding or stroke.

Although the findings should be viewed as hypothesis generating, they suggest that “transapical access should be reserved as a last option in TAVR patients. This choice may guarantee less mortality, less stroke, and less bleeding in this frail and elderly population,” Dr. Federico Conrotto said at the annual congress of the European Society of Cardiology.

Although the transfemoral approach for aortic valve replacement is completely percutaneous, the transapical approach is more invasive and involves the direct puncture of the left ventricle. Also, the transapical approach is mostly reserved for patients in whom femoral vessels are unapproachable. These patients also turn out to be sicker, hence making it difficult to compare the two approaches, and there are no randomized trials comparing the two, said Dr. Conrotto of Città della Salute e della Scienza Hospital in Turin, Italy.

In the absence of randomized trials, Dr. Conrotto and his colleagues selected 13 studies that reported the adjustments for clinical baseline characteristics and reported the baseline, periprocedural, and midterm (median, 365 days) outcomes for patients who underwent transfemoral and transapical TAVR.

Their primary endpoint was all-cause mortality at 1-year follow-up. The secondary endpoint was 30-day mortality and in-hospital complications, including bleeding and stroke.

In total, the studies included 10,468 patients who underwent TAVR between 2005 and 2012. The patients’ median age was 82 years and half were men: one-fourth had diabetes, 18% had renal dysfunction, 61% had coronary artery disease, and the average ejection fraction was 50%. Almost 70% of the TAVR procedures were performed transfemorally.

Results showed that patients who underwent the transfemoral approach were 15% less likely to die at 365 days following TAVR and 20% less likely to die at 30 days, compared with those who underwent the transapical approach, Dr. Conrotto said. Both differences were statistically significant.

Those who underwent the transfemoral approach were almost 30% less likely to have periprocedural bleeding and 10% less likely to have a periprocedural stroke. Again, both differences were statistically significant, he noted.

“Not only does the transfemoral approach lead to longer life, but it’s safer,” said Dr. Conrotto.

But Dr. Michael A. Borger, director of the cardiovascular institute at Columbia University Medical Center, New York, had his reservations about drawing any practice-changing conclusion from the study. In many centers, the transfemoral approach is the preferred method, so naturally only sicker patients undergo transapical TAVR, “and those patients are going to have worse outcomes. So no matter how much they try with statistics, they will not be able to account for that selection bias. And really, the only way to know is with a randomized trial, but there’s no desire within the cardiology community for a randomized trial,” he said, citing the current widespread preference for the transfemoral approach.

Dr. Conrotto and Dr. Borger had no disclosures.

[email protected]

On Twitter @naseemmiller

BARCELONA – The transfemoral approach to aortic valve replacement is associated with lower risk of death, stroke, and bleeding, compared with the more invasive transapical approach, according to a meta-analysis of more than a dozen studies.

After adjustment for baseline characteristics, Italian researchers found that, compared with patients who underwent transapical transcatheter aortic valve replacement (TAVR), the transfemoral group was nearly 20% less likely to die within 30 days and during the first year after the procedure. The transfemoral group also was significantly less likely to have periprocedural bleeding or stroke.

Although the findings should be viewed as hypothesis generating, they suggest that “transapical access should be reserved as a last option in TAVR patients. This choice may guarantee less mortality, less stroke, and less bleeding in this frail and elderly population,” Dr. Federico Conrotto said at the annual congress of the European Society of Cardiology.

Although the transfemoral approach for aortic valve replacement is completely percutaneous, the transapical approach is more invasive and involves the direct puncture of the left ventricle. Also, the transapical approach is mostly reserved for patients in whom femoral vessels are unapproachable. These patients also turn out to be sicker, hence making it difficult to compare the two approaches, and there are no randomized trials comparing the two, said Dr. Conrotto of Città della Salute e della Scienza Hospital in Turin, Italy.

In the absence of randomized trials, Dr. Conrotto and his colleagues selected 13 studies that reported the adjustments for clinical baseline characteristics and reported the baseline, periprocedural, and midterm (median, 365 days) outcomes for patients who underwent transfemoral and transapical TAVR.

Their primary endpoint was all-cause mortality at 1-year follow-up. The secondary endpoint was 30-day mortality and in-hospital complications, including bleeding and stroke.

In total, the studies included 10,468 patients who underwent TAVR between 2005 and 2012. The patients’ median age was 82 years and half were men: one-fourth had diabetes, 18% had renal dysfunction, 61% had coronary artery disease, and the average ejection fraction was 50%. Almost 70% of the TAVR procedures were performed transfemorally.

Results showed that patients who underwent the transfemoral approach were 15% less likely to die at 365 days following TAVR and 20% less likely to die at 30 days, compared with those who underwent the transapical approach, Dr. Conrotto said. Both differences were statistically significant.

Those who underwent the transfemoral approach were almost 30% less likely to have periprocedural bleeding and 10% less likely to have a periprocedural stroke. Again, both differences were statistically significant, he noted.

“Not only does the transfemoral approach lead to longer life, but it’s safer,” said Dr. Conrotto.

But Dr. Michael A. Borger, director of the cardiovascular institute at Columbia University Medical Center, New York, had his reservations about drawing any practice-changing conclusion from the study. In many centers, the transfemoral approach is the preferred method, so naturally only sicker patients undergo transapical TAVR, “and those patients are going to have worse outcomes. So no matter how much they try with statistics, they will not be able to account for that selection bias. And really, the only way to know is with a randomized trial, but there’s no desire within the cardiology community for a randomized trial,” he said, citing the current widespread preference for the transfemoral approach.

Dr. Conrotto and Dr. Borger had no disclosures.

[email protected]

On Twitter @naseemmiller

BARCELONA – The transfemoral approach to aortic valve replacement is associated with lower risk of death, stroke, and bleeding, compared with the more invasive transapical approach, according to a meta-analysis of more than a dozen studies.

After adjustment for baseline characteristics, Italian researchers found that, compared with patients who underwent transapical transcatheter aortic valve replacement (TAVR), the transfemoral group was nearly 20% less likely to die within 30 days and during the first year after the procedure. The transfemoral group also was significantly less likely to have periprocedural bleeding or stroke.

Although the findings should be viewed as hypothesis generating, they suggest that “transapical access should be reserved as a last option in TAVR patients. This choice may guarantee less mortality, less stroke, and less bleeding in this frail and elderly population,” Dr. Federico Conrotto said at the annual congress of the European Society of Cardiology.

Although the transfemoral approach for aortic valve replacement is completely percutaneous, the transapical approach is more invasive and involves the direct puncture of the left ventricle. Also, the transapical approach is mostly reserved for patients in whom femoral vessels are unapproachable. These patients also turn out to be sicker, hence making it difficult to compare the two approaches, and there are no randomized trials comparing the two, said Dr. Conrotto of Città della Salute e della Scienza Hospital in Turin, Italy.

In the absence of randomized trials, Dr. Conrotto and his colleagues selected 13 studies that reported the adjustments for clinical baseline characteristics and reported the baseline, periprocedural, and midterm (median, 365 days) outcomes for patients who underwent transfemoral and transapical TAVR.

Their primary endpoint was all-cause mortality at 1-year follow-up. The secondary endpoint was 30-day mortality and in-hospital complications, including bleeding and stroke.

In total, the studies included 10,468 patients who underwent TAVR between 2005 and 2012. The patients’ median age was 82 years and half were men: one-fourth had diabetes, 18% had renal dysfunction, 61% had coronary artery disease, and the average ejection fraction was 50%. Almost 70% of the TAVR procedures were performed transfemorally.

Results showed that patients who underwent the transfemoral approach were 15% less likely to die at 365 days following TAVR and 20% less likely to die at 30 days, compared with those who underwent the transapical approach, Dr. Conrotto said. Both differences were statistically significant.

Those who underwent the transfemoral approach were almost 30% less likely to have periprocedural bleeding and 10% less likely to have a periprocedural stroke. Again, both differences were statistically significant, he noted.

“Not only does the transfemoral approach lead to longer life, but it’s safer,” said Dr. Conrotto.

But Dr. Michael A. Borger, director of the cardiovascular institute at Columbia University Medical Center, New York, had his reservations about drawing any practice-changing conclusion from the study. In many centers, the transfemoral approach is the preferred method, so naturally only sicker patients undergo transapical TAVR, “and those patients are going to have worse outcomes. So no matter how much they try with statistics, they will not be able to account for that selection bias. And really, the only way to know is with a randomized trial, but there’s no desire within the cardiology community for a randomized trial,” he said, citing the current widespread preference for the transfemoral approach.

Dr. Conrotto and Dr. Borger had no disclosures.

[email protected]

On Twitter @naseemmiller

BARCELONA – An analysis of FRANCE 2 registry showed that local anesthesia during the transfemoral aortic valve replacement procedure is a safe and effective option, compared with general anesthesia.

The study was performed based on data from 2010 and 2011, and at the annual congress of the European Society of Cardiology, Dr. Romain Chopard of the University Hospital of Besançon, Paris, and his coinvestigators reported that the practice is rather common – even routine in some centers – today.

But, performing TAVR under local anesthesia is not common practice in the United States, said Dr. Deepak L. Bhatt, executive director of interventional cardiovascular programs at Brigham and Women’s Hospital and professor of medicine at Harvard Medical School, both in Boston.

In a video, Dr. Bhatt shares his thoughts on performing local anesthesia and why it hasn’t taken hold in the United States. He also shares his advice with physicians who perform the TAVR procedure.

[email protected]

On Twitter @naseemmiller

BARCELONA – An analysis of FRANCE 2 registry showed that local anesthesia during the transfemoral aortic valve replacement procedure is a safe and effective option, compared with general anesthesia.

The study was performed based on data from 2010 and 2011, and at the annual congress of the European Society of Cardiology, Dr. Romain Chopard of the University Hospital of Besançon, Paris, and his coinvestigators reported that the practice is rather common – even routine in some centers – today.

But, performing TAVR under local anesthesia is not common practice in the United States, said Dr. Deepak L. Bhatt, executive director of interventional cardiovascular programs at Brigham and Women’s Hospital and professor of medicine at Harvard Medical School, both in Boston.

In a video, Dr. Bhatt shares his thoughts on performing local anesthesia and why it hasn’t taken hold in the United States. He also shares his advice with physicians who perform the TAVR procedure.

[email protected]

On Twitter @naseemmiller

BARCELONA – An analysis of FRANCE 2 registry showed that local anesthesia during the transfemoral aortic valve replacement procedure is a safe and effective option, compared with general anesthesia.

The study was performed based on data from 2010 and 2011, and at the annual congress of the European Society of Cardiology, Dr. Romain Chopard of the University Hospital of Besançon, Paris, and his coinvestigators reported that the practice is rather common – even routine in some centers – today.

But, performing TAVR under local anesthesia is not common practice in the United States, said Dr. Deepak L. Bhatt, executive director of interventional cardiovascular programs at Brigham and Women’s Hospital and professor of medicine at Harvard Medical School, both in Boston.

In a video, Dr. Bhatt shares his thoughts on performing local anesthesia and why it hasn’t taken hold in the United States. He also shares his advice with physicians who perform the TAVR procedure.

[email protected]

On Twitter @naseemmiller

BARCELONA – The transcatheter aortic valve replacement technology is changing rapidly, especially in Europe where the regulatory process is different and more types of valves are on the market.

One of the current focus areas in the development of TAVR devices is making retrievable and repositionable valves to improve the implantation process and patient outcomes. Late last year, Lotus Valve System reported favorable results for its valve in the REPRISE II study. 

At the annual congress of the European Society of Cardiology, Dr. Stylianos A. Pyxaras presented another study showing that the repositionable Direct Flow Medical valve in elderly high-risk patients with severe aortic stenosis compared well in safety and efficacy with the results of the DISCOVER trial. 

Dr. Deepak L. Bhatt, executive director of Interventional Cardiovascular Programs and professor of medicine at Harvard Medical School in Boston, shared his opinion about the findings and the future implications on practice. He was not involved in any of the mentioned studies. 

[email protected]

Twitter: @naseemmiller

BARCELONA – The transcatheter aortic valve replacement technology is changing rapidly, especially in Europe where the regulatory process is different and more types of valves are on the market.

One of the current focus areas in the development of TAVR devices is making retrievable and repositionable valves to improve the implantation process and patient outcomes. Late last year, Lotus Valve System reported favorable results for its valve in the REPRISE II study. 

At the annual congress of the European Society of Cardiology, Dr. Stylianos A. Pyxaras presented another study showing that the repositionable Direct Flow Medical valve in elderly high-risk patients with severe aortic stenosis compared well in safety and efficacy with the results of the DISCOVER trial. 

Dr. Deepak L. Bhatt, executive director of Interventional Cardiovascular Programs and professor of medicine at Harvard Medical School in Boston, shared his opinion about the findings and the future implications on practice. He was not involved in any of the mentioned studies. 

[email protected]

Twitter: @naseemmiller

BARCELONA – The transcatheter aortic valve replacement technology is changing rapidly, especially in Europe where the regulatory process is different and more types of valves are on the market.

One of the current focus areas in the development of TAVR devices is making retrievable and repositionable valves to improve the implantation process and patient outcomes. Late last year, Lotus Valve System reported favorable results for its valve in the REPRISE II study. 

At the annual congress of the European Society of Cardiology, Dr. Stylianos A. Pyxaras presented another study showing that the repositionable Direct Flow Medical valve in elderly high-risk patients with severe aortic stenosis compared well in safety and efficacy with the results of the DISCOVER trial. 

Dr. Deepak L. Bhatt, executive director of Interventional Cardiovascular Programs and professor of medicine at Harvard Medical School in Boston, shared his opinion about the findings and the future implications on practice. He was not involved in any of the mentioned studies. 

[email protected]

Twitter: @naseemmiller

BARCELONA— Risk calculators are usually confined to certain populations, but the recently updated ACC/AHA calculator might be effective beyond the United States borders in a Southern European population.

Researchers from Portugal compared the ACC/AHA risk calculator to the European Systematic COronary Risk Evaluation (SCORE) in a patient population that was treated with lipid-lowering drugs. They found that the ACC/AHA calculator’s cut-off point at 7.5% was "extremely effective in discriminating high-risk subject," said Dr. Manuel Oliveira-Santos of Coimbra (Portugal) University, who presented the findings at the annual congress of the European Society of Cardiology.

They also found that that the two scoring systems were strongly correlated and well calibrated. Both calculators overestimated the cardiovascular (CV) risk, "which confirms the previous findings and shows that the calculator works, since many patients in the study were treated with statins," said Dr. Kim A. Williams Sr., president-elect of the American College of Cardiology, who was not involved in the study.

One of the main differences between the two calculators is that the ACC/AHA risk calculator predicts atherosclerotic cardiovascular disease (ASCVD) events, while SCORE estimates the individual risk of fatal noncoronary atherosclerotic and coronary heart disease only, said Dr. Oliveira-Santos.

The study's primary endpoint was acute myocardial infarction, stroke and CV death at 10 years, and the aim was to find out if the ASCVD could be a meaningful tool for this particular patient population in Portugal, said Dr. Oliveira-Santos.

The team retrospectively calculated the two scores for 446 CV-naive patients who were treated at a lipidology clinic between 1994 and 2007. Patients were divided to four groups according to the ASCVD (cut points at 5%, 7.5%, and 10%) and the SCORE system (cut points at 1%, 5%, and 10%).

The mean age of the population was 49 years; more than half were men; 21% were smokers, 25% had type 2 diabetes. More than half were on antihypertensive drug therapy and 72% were receiving statin treatment.

Researchers were able to follow up 85% of the patients at 10 years. Of those, 3.4% had an acute MI, 2.4% had a stroke, and 1.5% died of a cardiovascular event.

The median calculated CV death risk based on SCORE was 0.95%, and the median CV risk calculated by ASCVD was 8.5%. The observed event rate based on the SCORE definition was 1%, compared to 6% based on the ASCVD definition.

When ASCVD was applied to the study cohort, the majority of the patients fell at the very low (less than 5%) or very high (10% or higher) risk categories. About 20% of the patients were at medium risk categories.

Patients who fell in the low and very low risk categories – in other words, they had a CV risk of less than 7.5% – had – no actual cardiovascular events. In the 10% or higher risk group, the predicted event rate was nearly twice the observed rate.

The overestimation, especially in the low risk category (5% to 7.5%) could lead to unnecessary statin therapy and may raise some safety concerns, but the overestimation in the high-risk category is not problematic, Dr. Oliveira-Santos said.

Meanwhile, the group at medium-high risk (from 7.5% to less than 10%) had a slightly higher rate of actual CV events than that estimated using the calculator. "We don’t see that as a cause for concern since those are high risk patients in whom statin therapy is indicated. The statin-treated patients in our study are the majority," he said.

When the SCORE calculator was applied to the cohort, the CV death risk was overestimated in all groups. The majority of the patients fell in the very-low- or low-risk categories, and there were no CV deaths in the very-low-risk category, which included 51% of the patient population.

Researchers conducted further analysis and found that the SCORE and ASCVD systems were positively correlated and they both had "good and similar discriminative power," in addition to good calibration, Dr. Oliveira-Santos reported.

Dr. Williams said that the correlation of the two systems is good news. "There’s always going to be interest in how well an American score will predict the risk in a European population. And the fact that there’s good correlation is reassuring.

"And the most important thing is whether or not an individual practitioner in another country should feel comfortable using this calculator, and that’s why we need more of this kind of study — to find out if they need to build another application or whether they can use what we’ve already created," said Dr. Williams, professor and chief of cardiology at Rush University in Chicago.

Dr. Oliveira-Santos and Dr. Williams had no relevant financial disclosures.

[email protected]

Twitter: @naseemmiller

BARCELONA— Risk calculators are usually confined to certain populations, but the recently updated ACC/AHA calculator might be effective beyond the United States borders in a Southern European population.

Researchers from Portugal compared the ACC/AHA risk calculator to the European Systematic COronary Risk Evaluation (SCORE) in a patient population that was treated with lipid-lowering drugs. They found that the ACC/AHA calculator’s cut-off point at 7.5% was "extremely effective in discriminating high-risk subject," said Dr. Manuel Oliveira-Santos of Coimbra (Portugal) University, who presented the findings at the annual congress of the European Society of Cardiology.

They also found that that the two scoring systems were strongly correlated and well calibrated. Both calculators overestimated the cardiovascular (CV) risk, "which confirms the previous findings and shows that the calculator works, since many patients in the study were treated with statins," said Dr. Kim A. Williams Sr., president-elect of the American College of Cardiology, who was not involved in the study.

One of the main differences between the two calculators is that the ACC/AHA risk calculator predicts atherosclerotic cardiovascular disease (ASCVD) events, while SCORE estimates the individual risk of fatal noncoronary atherosclerotic and coronary heart disease only, said Dr. Oliveira-Santos.

The study's primary endpoint was acute myocardial infarction, stroke and CV death at 10 years, and the aim was to find out if the ASCVD could be a meaningful tool for this particular patient population in Portugal, said Dr. Oliveira-Santos.

The team retrospectively calculated the two scores for 446 CV-naive patients who were treated at a lipidology clinic between 1994 and 2007. Patients were divided to four groups according to the ASCVD (cut points at 5%, 7.5%, and 10%) and the SCORE system (cut points at 1%, 5%, and 10%).

The mean age of the population was 49 years; more than half were men; 21% were smokers, 25% had type 2 diabetes. More than half were on antihypertensive drug therapy and 72% were receiving statin treatment.

Researchers were able to follow up 85% of the patients at 10 years. Of those, 3.4% had an acute MI, 2.4% had a stroke, and 1.5% died of a cardiovascular event.

The median calculated CV death risk based on SCORE was 0.95%, and the median CV risk calculated by ASCVD was 8.5%. The observed event rate based on the SCORE definition was 1%, compared to 6% based on the ASCVD definition.

When ASCVD was applied to the study cohort, the majority of the patients fell at the very low (less than 5%) or very high (10% or higher) risk categories. About 20% of the patients were at medium risk categories.

Patients who fell in the low and very low risk categories – in other words, they had a CV risk of less than 7.5% – had – no actual cardiovascular events. In the 10% or higher risk group, the predicted event rate was nearly twice the observed rate.

The overestimation, especially in the low risk category (5% to 7.5%) could lead to unnecessary statin therapy and may raise some safety concerns, but the overestimation in the high-risk category is not problematic, Dr. Oliveira-Santos said.

Meanwhile, the group at medium-high risk (from 7.5% to less than 10%) had a slightly higher rate of actual CV events than that estimated using the calculator. "We don’t see that as a cause for concern since those are high risk patients in whom statin therapy is indicated. The statin-treated patients in our study are the majority," he said.

When the SCORE calculator was applied to the cohort, the CV death risk was overestimated in all groups. The majority of the patients fell in the very-low- or low-risk categories, and there were no CV deaths in the very-low-risk category, which included 51% of the patient population.

Researchers conducted further analysis and found that the SCORE and ASCVD systems were positively correlated and they both had "good and similar discriminative power," in addition to good calibration, Dr. Oliveira-Santos reported.

Dr. Williams said that the correlation of the two systems is good news. "There’s always going to be interest in how well an American score will predict the risk in a European population. And the fact that there’s good correlation is reassuring.

"And the most important thing is whether or not an individual practitioner in another country should feel comfortable using this calculator, and that’s why we need more of this kind of study — to find out if they need to build another application or whether they can use what we’ve already created," said Dr. Williams, professor and chief of cardiology at Rush University in Chicago.

Dr. Oliveira-Santos and Dr. Williams had no relevant financial disclosures.

[email protected]

Twitter: @naseemmiller

BARCELONA— Risk calculators are usually confined to certain populations, but the recently updated ACC/AHA calculator might be effective beyond the United States borders in a Southern European population.

Researchers from Portugal compared the ACC/AHA risk calculator to the European Systematic COronary Risk Evaluation (SCORE) in a patient population that was treated with lipid-lowering drugs. They found that the ACC/AHA calculator’s cut-off point at 7.5% was "extremely effective in discriminating high-risk subject," said Dr. Manuel Oliveira-Santos of Coimbra (Portugal) University, who presented the findings at the annual congress of the European Society of Cardiology.

They also found that that the two scoring systems were strongly correlated and well calibrated. Both calculators overestimated the cardiovascular (CV) risk, "which confirms the previous findings and shows that the calculator works, since many patients in the study were treated with statins," said Dr. Kim A. Williams Sr., president-elect of the American College of Cardiology, who was not involved in the study.

One of the main differences between the two calculators is that the ACC/AHA risk calculator predicts atherosclerotic cardiovascular disease (ASCVD) events, while SCORE estimates the individual risk of fatal noncoronary atherosclerotic and coronary heart disease only, said Dr. Oliveira-Santos.

The study's primary endpoint was acute myocardial infarction, stroke and CV death at 10 years, and the aim was to find out if the ASCVD could be a meaningful tool for this particular patient population in Portugal, said Dr. Oliveira-Santos.

The team retrospectively calculated the two scores for 446 CV-naive patients who were treated at a lipidology clinic between 1994 and 2007. Patients were divided to four groups according to the ASCVD (cut points at 5%, 7.5%, and 10%) and the SCORE system (cut points at 1%, 5%, and 10%).

The mean age of the population was 49 years; more than half were men; 21% were smokers, 25% had type 2 diabetes. More than half were on antihypertensive drug therapy and 72% were receiving statin treatment.

Researchers were able to follow up 85% of the patients at 10 years. Of those, 3.4% had an acute MI, 2.4% had a stroke, and 1.5% died of a cardiovascular event.

The median calculated CV death risk based on SCORE was 0.95%, and the median CV risk calculated by ASCVD was 8.5%. The observed event rate based on the SCORE definition was 1%, compared to 6% based on the ASCVD definition.

When ASCVD was applied to the study cohort, the majority of the patients fell at the very low (less than 5%) or very high (10% or higher) risk categories. About 20% of the patients were at medium risk categories.

Patients who fell in the low and very low risk categories – in other words, they had a CV risk of less than 7.5% – had – no actual cardiovascular events. In the 10% or higher risk group, the predicted event rate was nearly twice the observed rate.

The overestimation, especially in the low risk category (5% to 7.5%) could lead to unnecessary statin therapy and may raise some safety concerns, but the overestimation in the high-risk category is not problematic, Dr. Oliveira-Santos said.

Meanwhile, the group at medium-high risk (from 7.5% to less than 10%) had a slightly higher rate of actual CV events than that estimated using the calculator. "We don’t see that as a cause for concern since those are high risk patients in whom statin therapy is indicated. The statin-treated patients in our study are the majority," he said.

When the SCORE calculator was applied to the cohort, the CV death risk was overestimated in all groups. The majority of the patients fell in the very-low- or low-risk categories, and there were no CV deaths in the very-low-risk category, which included 51% of the patient population.

Researchers conducted further analysis and found that the SCORE and ASCVD systems were positively correlated and they both had "good and similar discriminative power," in addition to good calibration, Dr. Oliveira-Santos reported.

Dr. Williams said that the correlation of the two systems is good news. "There’s always going to be interest in how well an American score will predict the risk in a European population. And the fact that there’s good correlation is reassuring.

"And the most important thing is whether or not an individual practitioner in another country should feel comfortable using this calculator, and that’s why we need more of this kind of study — to find out if they need to build another application or whether they can use what we’ve already created," said Dr. Williams, professor and chief of cardiology at Rush University in Chicago.

Dr. Oliveira-Santos and Dr. Williams had no relevant financial disclosures.

[email protected]

Twitter: @naseemmiller

LAS VEGAS – In patients with type 1 diabetes, adding a 1.8-mg daily dose of liraglutide to insulin significantly reduced hemoglobin A_1c, mean blood glucose, body weight, carbohydrate intake, and C-reactive protein, in a randomized study.

The 72-patient study also showed that adding liraglutide (Victoza) significantly improved quality of life and reduced systolic blood pressure in the groups that were receiving higher doses of the medicine.

Naseem Miller/Frontline Medical News

"Our findings have significant implications for the future treatment of type 1 diabetes," said Dr. Nitesh Kuhadiya of the State University of New York at Buffalo, who presented the findings at the annual meeting of the American Association of Clinical Endocrinologists. "Long term studies are needed to establish the durability of the effects."

In previous small, nonrandomized studies of patients with type 1 diabetes, liraglutide improved glycemic control and led to weight loss (Eur. J. Endocrinol. 2011;165:77-84; Endocr. Pract. 2013;19:963-7). They then decided to conduct a randomized controlled trial, which is the first of its kind, said Dr. Kuhadiya, who compared type 1 diabetes to a "wild horse that’s extremely difficult to tame and kicks you 10 times a day."

For the study, researchers randomized 72 patients to four groups to receive 0.6, 1.2, or 1.8 mg of liraglutide or a placebo daily for 12 weeks. One patient dropped out of placebo group, as well as five from the 1.2-mg and three from the 1.8-mg group.

The groups’ baseline characteristics were similar. All patients had type 1 diabetes for at least 1 year, were on insulin therapy, and had no detectable C-peptide in plasma. The mean age was 44 years, mean body weight was 83 kg, mean body mass index was 29 kg/m², mean HbA_1c was 7.5, and mean interval since diabetes diagnosis was 20 years. Nearly all (96%) patients were white and 56% were women.

There was a significant drop of nearly 10 mg/dL in average glucose in the 1.2- and 1.8-mg groups. The HbA_1c, also dropped in those two groups, although it was significant in only the 1.2-mg group, by about 0.8%. The drop was 0.4% in 1.8-mg group, 0.2% in the 0.6-mg group, and 0.3% in the placebo subjects.

There were also significant changes in the percent time spent in different glycemic thresholds for the 1.8-mg group. 

Patients on 1.2 mg and 1.8 mg of liraglutide spent about 3%-5% more time in the 70- to 160-mg/dL zone, respectively, although only those on 1.8 mg reached statistical significance. 

Again, the 1.2- and 1.8-mg groups spent less time in hyperglycemia, defined as 160-240 mg/dL, Dr. Kuhadiya said. No significant changes were observed in the other two groups. 

A similar trend was seen for severe hyperglycemia (250 mg/dL). 

There was, however, some additional hypoglycemia in the study in the range of 55 to 70 mg/dL, Dr. Kuhadiya reported. The 1.2- and 1.8-mg groups spent significantly more time (nearly 1%) in that range, but there was no incidence of hypoglycemia in the placebo and 0.6-mg groups. The results were similar for the less than 50 mg/dL range. However, there was no incidence of hypoglycemia requiring hospitalization or medical attention, Dr. Kuhadiya said. 

All three groups receiving liraglutide showed significant weight loss: nearly 5 kg in the 1.2- and 1.8-mg groups, and 3 kg in the 0.6-mg group, over a period of 12 weeks. 

The carbohydrate intake for the 1.2- and 1.8-mg groups also dropped significantly. 

Dr. Kuhadiya said that the findings also show that all changes are independent of each other. 

All groups showed a fall in C-reactive protein, which is a marker for cardiovascular risk, although only the 1.8-mg groups showed a statistical significance. "And this is important because most patients with type 1 diabetes have metabolic syndrome, and to be able to demonstrate all these changes and an additional fall in CRP means further protection from cardiovascular risk," Dr. Kuhadiya said.

The study was funded by Novo Nordisk. Dr. Kuhadiya had no relevant disclosures.

[email protected]

On Twitter @naseemmiller

LAS VEGAS – In patients with type 1 diabetes, adding a 1.8-mg daily dose of liraglutide to insulin significantly reduced hemoglobin A_1c, mean blood glucose, body weight, carbohydrate intake, and C-reactive protein, in a randomized study.

The 72-patient study also showed that adding liraglutide (Victoza) significantly improved quality of life and reduced systolic blood pressure in the groups that were receiving higher doses of the medicine.

Naseem Miller/Frontline Medical News

"Our findings have significant implications for the future treatment of type 1 diabetes," said Dr. Nitesh Kuhadiya of the State University of New York at Buffalo, who presented the findings at the annual meeting of the American Association of Clinical Endocrinologists. "Long term studies are needed to establish the durability of the effects."

In previous small, nonrandomized studies of patients with type 1 diabetes, liraglutide improved glycemic control and led to weight loss (Eur. J. Endocrinol. 2011;165:77-84; Endocr. Pract. 2013;19:963-7). They then decided to conduct a randomized controlled trial, which is the first of its kind, said Dr. Kuhadiya, who compared type 1 diabetes to a "wild horse that’s extremely difficult to tame and kicks you 10 times a day."

For the study, researchers randomized 72 patients to four groups to receive 0.6, 1.2, or 1.8 mg of liraglutide or a placebo daily for 12 weeks. One patient dropped out of placebo group, as well as five from the 1.2-mg and three from the 1.8-mg group.

The groups’ baseline characteristics were similar. All patients had type 1 diabetes for at least 1 year, were on insulin therapy, and had no detectable C-peptide in plasma. The mean age was 44 years, mean body weight was 83 kg, mean body mass index was 29 kg/m², mean HbA_1c was 7.5, and mean interval since diabetes diagnosis was 20 years. Nearly all (96%) patients were white and 56% were women.

There was a significant drop of nearly 10 mg/dL in average glucose in the 1.2- and 1.8-mg groups. The HbA_1c, also dropped in those two groups, although it was significant in only the 1.2-mg group, by about 0.8%. The drop was 0.4% in 1.8-mg group, 0.2% in the 0.6-mg group, and 0.3% in the placebo subjects.

There were also significant changes in the percent time spent in different glycemic thresholds for the 1.8-mg group. 

Patients on 1.2 mg and 1.8 mg of liraglutide spent about 3%-5% more time in the 70- to 160-mg/dL zone, respectively, although only those on 1.8 mg reached statistical significance. 

Again, the 1.2- and 1.8-mg groups spent less time in hyperglycemia, defined as 160-240 mg/dL, Dr. Kuhadiya said. No significant changes were observed in the other two groups. 

A similar trend was seen for severe hyperglycemia (250 mg/dL). 

There was, however, some additional hypoglycemia in the study in the range of 55 to 70 mg/dL, Dr. Kuhadiya reported. The 1.2- and 1.8-mg groups spent significantly more time (nearly 1%) in that range, but there was no incidence of hypoglycemia in the placebo and 0.6-mg groups. The results were similar for the less than 50 mg/dL range. However, there was no incidence of hypoglycemia requiring hospitalization or medical attention, Dr. Kuhadiya said. 

All three groups receiving liraglutide showed significant weight loss: nearly 5 kg in the 1.2- and 1.8-mg groups, and 3 kg in the 0.6-mg group, over a period of 12 weeks. 

The carbohydrate intake for the 1.2- and 1.8-mg groups also dropped significantly. 

Dr. Kuhadiya said that the findings also show that all changes are independent of each other. 

All groups showed a fall in C-reactive protein, which is a marker for cardiovascular risk, although only the 1.8-mg groups showed a statistical significance. "And this is important because most patients with type 1 diabetes have metabolic syndrome, and to be able to demonstrate all these changes and an additional fall in CRP means further protection from cardiovascular risk," Dr. Kuhadiya said.

The study was funded by Novo Nordisk. Dr. Kuhadiya had no relevant disclosures.

[email protected]

On Twitter @naseemmiller

LAS VEGAS – In patients with type 1 diabetes, adding a 1.8-mg daily dose of liraglutide to insulin significantly reduced hemoglobin A_1c, mean blood glucose, body weight, carbohydrate intake, and C-reactive protein, in a randomized study.

The 72-patient study also showed that adding liraglutide (Victoza) significantly improved quality of life and reduced systolic blood pressure in the groups that were receiving higher doses of the medicine.

Naseem Miller/Frontline Medical News

"Our findings have significant implications for the future treatment of type 1 diabetes," said Dr. Nitesh Kuhadiya of the State University of New York at Buffalo, who presented the findings at the annual meeting of the American Association of Clinical Endocrinologists. "Long term studies are needed to establish the durability of the effects."

In previous small, nonrandomized studies of patients with type 1 diabetes, liraglutide improved glycemic control and led to weight loss (Eur. J. Endocrinol. 2011;165:77-84; Endocr. Pract. 2013;19:963-7). They then decided to conduct a randomized controlled trial, which is the first of its kind, said Dr. Kuhadiya, who compared type 1 diabetes to a "wild horse that’s extremely difficult to tame and kicks you 10 times a day."

For the study, researchers randomized 72 patients to four groups to receive 0.6, 1.2, or 1.8 mg of liraglutide or a placebo daily for 12 weeks. One patient dropped out of placebo group, as well as five from the 1.2-mg and three from the 1.8-mg group.

The groups’ baseline characteristics were similar. All patients had type 1 diabetes for at least 1 year, were on insulin therapy, and had no detectable C-peptide in plasma. The mean age was 44 years, mean body weight was 83 kg, mean body mass index was 29 kg/m², mean HbA_1c was 7.5, and mean interval since diabetes diagnosis was 20 years. Nearly all (96%) patients were white and 56% were women.

There was a significant drop of nearly 10 mg/dL in average glucose in the 1.2- and 1.8-mg groups. The HbA_1c, also dropped in those two groups, although it was significant in only the 1.2-mg group, by about 0.8%. The drop was 0.4% in 1.8-mg group, 0.2% in the 0.6-mg group, and 0.3% in the placebo subjects.

There were also significant changes in the percent time spent in different glycemic thresholds for the 1.8-mg group. 

Patients on 1.2 mg and 1.8 mg of liraglutide spent about 3%-5% more time in the 70- to 160-mg/dL zone, respectively, although only those on 1.8 mg reached statistical significance. 

Again, the 1.2- and 1.8-mg groups spent less time in hyperglycemia, defined as 160-240 mg/dL, Dr. Kuhadiya said. No significant changes were observed in the other two groups. 

A similar trend was seen for severe hyperglycemia (250 mg/dL). 

There was, however, some additional hypoglycemia in the study in the range of 55 to 70 mg/dL, Dr. Kuhadiya reported. The 1.2- and 1.8-mg groups spent significantly more time (nearly 1%) in that range, but there was no incidence of hypoglycemia in the placebo and 0.6-mg groups. The results were similar for the less than 50 mg/dL range. However, there was no incidence of hypoglycemia requiring hospitalization or medical attention, Dr. Kuhadiya said. 

All three groups receiving liraglutide showed significant weight loss: nearly 5 kg in the 1.2- and 1.8-mg groups, and 3 kg in the 0.6-mg group, over a period of 12 weeks. 

The carbohydrate intake for the 1.2- and 1.8-mg groups also dropped significantly. 

Dr. Kuhadiya said that the findings also show that all changes are independent of each other. 

All groups showed a fall in C-reactive protein, which is a marker for cardiovascular risk, although only the 1.8-mg groups showed a statistical significance. "And this is important because most patients with type 1 diabetes have metabolic syndrome, and to be able to demonstrate all these changes and an additional fall in CRP means further protection from cardiovascular risk," Dr. Kuhadiya said.

The study was funded by Novo Nordisk. Dr. Kuhadiya had no relevant disclosures.

[email protected]

On Twitter @naseemmiller

ORLANDO – Here’s something to consider when prescribing insulin therapy for patients with type 2 diabetes: psychological insulin resistance.

After conducting a dozen focus groups at the University of Pittsburgh Diabetes Institute, researchers found that the condition is alive and well among patients with type 2 diabetes, mostly because of misunderstanding and lack of information about available injection tools.

Credit: © BakiBG / ThinkStockPhotos.com

But the condition has a simple cure: Either take the time to educate the patient about insulin therapy and various injection options or refer the patient to a diabetes educator.

"We need to recognize how to effectively educate patients," said Robert Powell at the annual meeting of the American Association of Diabetes Educators. "Demonstrate. Talk about side effects and dosing. Ask patients their concerns and provide them with options. Always seek out that teachable moment."

Patients’ resistance arises from negative beliefs about diabetes and insulin therapy, fear of injection, or fear of "what others may think of them if they see them injecting themselves," said Mr. Powell, diabetes educator and program manager at the University of Pittsburgh Diabetes Institute. Sometimes, patients think that insulin therapy is a sign that they’ve failed in managing their diabetes, he said.

A recent study found that "The acceptance of insulin is very low in type 2 diabetes patients. The option to inhale insulin increases the acceptability for some but not the majority of patients," the authors wrote. (Diabetes Technol. Ther. 2013;15:703-11).

Physicians, too, are sometimes reluctant to prescribe insulin, "because they know their patients have PIR [psychological insulin resistance], and this leads to clinical inertia," said Mr. Powell.

PIR is complex and multifaceted, according to a 2009 review published in the journal Quality of Life Research (2009;18:23-32).

PIR "plays an important, although often ignored, role in diabetes management," the authors wrote. "By tailoring treatments to patients’ PIR, clinicians may be better able to help their patients begin insulin treatment sooner and improve compliance, thus facilitating target glycemic control."

To further explore the patients’ perceptions and reactions to insulin therapy delivery modes, Mr. Powell and his colleagues conducted 12 patient focus groups – 100 patients in total. Six focus groups included patients who were insulin naive, and the other six had patients who had been taking insulin. The sessions were led by trained moderators and certified diabetes educators.

Patients were in their 50s, nearly half were white, and they had had diabetes for an average of 12-15 years.

Results showed that the majority of participants saw insulin therapy as negative and a sign of failure. They questioned the long-term prognosis and cited side effects and contraindications for insulin therapy.

Patients made comments such as "I think the drug itself is like cancer. You know, the chemotherapy kills, and I think the insulin does more harm than good," or "I feel like I was kind of a failure in doing my part and taking care of myself."

When patients were presented with various injection options, they requested more information, but cost was the main barrier to device selection and acceptance of insulin therapy, Mr. Powell reported.

Many preferred pens over vials and smaller needles over larger ones. Some patients said, "Why didn’t my doctor give me those needles [pointing to smaller ones]. I would prefer the smaller needle."

Many patients said that they weren’t shown insulin supplies and devices that are currently available. They weren’t shown how, when, and where to inject. Some said they were referred to the pharmacy for that information. Some said "Someone in the medical field needs to show me the correct way."

On the other hand, a patient who received proper instructions said, "I was lucky. My doctor sent me to an educator. They actually sat down and would not leave until I learned ... I also got information on insulin and injecting."

When the providers were interviewed for the study, they reported that patients had fear of needles; many said that they didn’t know about various needle options, and some cited lack of time to provide patients with appropriate diabetes education.

"Onsite training is something we have to make sure happens. To do so, we need to convince providers to refer patients to diabetes educators," said Mr. Powell. To reduce PIR, "we need provider-to-provider interaction," he said, encouraging diabetes educators to reach out to providers and ask for referrals.

"It’s our job to take the initiative to bridge the gap in diabetes education," he said.

Mr. Powell had no financial disclosures.

[email protected]

On Twitter @naseemmiller

ORLANDO – Here’s something to consider when prescribing insulin therapy for patients with type 2 diabetes: psychological insulin resistance.

After conducting a dozen focus groups at the University of Pittsburgh Diabetes Institute, researchers found that the condition is alive and well among patients with type 2 diabetes, mostly because of misunderstanding and lack of information about available injection tools.

Credit: © BakiBG / ThinkStockPhotos.com

But the condition has a simple cure: Either take the time to educate the patient about insulin therapy and various injection options or refer the patient to a diabetes educator.

"We need to recognize how to effectively educate patients," said Robert Powell at the annual meeting of the American Association of Diabetes Educators. "Demonstrate. Talk about side effects and dosing. Ask patients their concerns and provide them with options. Always seek out that teachable moment."

Patients’ resistance arises from negative beliefs about diabetes and insulin therapy, fear of injection, or fear of "what others may think of them if they see them injecting themselves," said Mr. Powell, diabetes educator and program manager at the University of Pittsburgh Diabetes Institute. Sometimes, patients think that insulin therapy is a sign that they’ve failed in managing their diabetes, he said.

A recent study found that "The acceptance of insulin is very low in type 2 diabetes patients. The option to inhale insulin increases the acceptability for some but not the majority of patients," the authors wrote. (Diabetes Technol. Ther. 2013;15:703-11).

Physicians, too, are sometimes reluctant to prescribe insulin, "because they know their patients have PIR [psychological insulin resistance], and this leads to clinical inertia," said Mr. Powell.

PIR is complex and multifaceted, according to a 2009 review published in the journal Quality of Life Research (2009;18:23-32).

PIR "plays an important, although often ignored, role in diabetes management," the authors wrote. "By tailoring treatments to patients’ PIR, clinicians may be better able to help their patients begin insulin treatment sooner and improve compliance, thus facilitating target glycemic control."

To further explore the patients’ perceptions and reactions to insulin therapy delivery modes, Mr. Powell and his colleagues conducted 12 patient focus groups – 100 patients in total. Six focus groups included patients who were insulin naive, and the other six had patients who had been taking insulin. The sessions were led by trained moderators and certified diabetes educators.

Patients were in their 50s, nearly half were white, and they had had diabetes for an average of 12-15 years.

Results showed that the majority of participants saw insulin therapy as negative and a sign of failure. They questioned the long-term prognosis and cited side effects and contraindications for insulin therapy.

Patients made comments such as "I think the drug itself is like cancer. You know, the chemotherapy kills, and I think the insulin does more harm than good," or "I feel like I was kind of a failure in doing my part and taking care of myself."

When patients were presented with various injection options, they requested more information, but cost was the main barrier to device selection and acceptance of insulin therapy, Mr. Powell reported.

Many preferred pens over vials and smaller needles over larger ones. Some patients said, "Why didn’t my doctor give me those needles [pointing to smaller ones]. I would prefer the smaller needle."

Many patients said that they weren’t shown insulin supplies and devices that are currently available. They weren’t shown how, when, and where to inject. Some said they were referred to the pharmacy for that information. Some said "Someone in the medical field needs to show me the correct way."

On the other hand, a patient who received proper instructions said, "I was lucky. My doctor sent me to an educator. They actually sat down and would not leave until I learned ... I also got information on insulin and injecting."

When the providers were interviewed for the study, they reported that patients had fear of needles; many said that they didn’t know about various needle options, and some cited lack of time to provide patients with appropriate diabetes education.

"Onsite training is something we have to make sure happens. To do so, we need to convince providers to refer patients to diabetes educators," said Mr. Powell. To reduce PIR, "we need provider-to-provider interaction," he said, encouraging diabetes educators to reach out to providers and ask for referrals.

"It’s our job to take the initiative to bridge the gap in diabetes education," he said.

Mr. Powell had no financial disclosures.

[email protected]

On Twitter @naseemmiller

ORLANDO – Here’s something to consider when prescribing insulin therapy for patients with type 2 diabetes: psychological insulin resistance.

After conducting a dozen focus groups at the University of Pittsburgh Diabetes Institute, researchers found that the condition is alive and well among patients with type 2 diabetes, mostly because of misunderstanding and lack of information about available injection tools.

Credit: © BakiBG / ThinkStockPhotos.com

But the condition has a simple cure: Either take the time to educate the patient about insulin therapy and various injection options or refer the patient to a diabetes educator.

"We need to recognize how to effectively educate patients," said Robert Powell at the annual meeting of the American Association of Diabetes Educators. "Demonstrate. Talk about side effects and dosing. Ask patients their concerns and provide them with options. Always seek out that teachable moment."

Patients’ resistance arises from negative beliefs about diabetes and insulin therapy, fear of injection, or fear of "what others may think of them if they see them injecting themselves," said Mr. Powell, diabetes educator and program manager at the University of Pittsburgh Diabetes Institute. Sometimes, patients think that insulin therapy is a sign that they’ve failed in managing their diabetes, he said.

A recent study found that "The acceptance of insulin is very low in type 2 diabetes patients. The option to inhale insulin increases the acceptability for some but not the majority of patients," the authors wrote. (Diabetes Technol. Ther. 2013;15:703-11).

Physicians, too, are sometimes reluctant to prescribe insulin, "because they know their patients have PIR [psychological insulin resistance], and this leads to clinical inertia," said Mr. Powell.

PIR is complex and multifaceted, according to a 2009 review published in the journal Quality of Life Research (2009;18:23-32).

PIR "plays an important, although often ignored, role in diabetes management," the authors wrote. "By tailoring treatments to patients’ PIR, clinicians may be better able to help their patients begin insulin treatment sooner and improve compliance, thus facilitating target glycemic control."

To further explore the patients’ perceptions and reactions to insulin therapy delivery modes, Mr. Powell and his colleagues conducted 12 patient focus groups – 100 patients in total. Six focus groups included patients who were insulin naive, and the other six had patients who had been taking insulin. The sessions were led by trained moderators and certified diabetes educators.

Patients were in their 50s, nearly half were white, and they had had diabetes for an average of 12-15 years.

Results showed that the majority of participants saw insulin therapy as negative and a sign of failure. They questioned the long-term prognosis and cited side effects and contraindications for insulin therapy.

Patients made comments such as "I think the drug itself is like cancer. You know, the chemotherapy kills, and I think the insulin does more harm than good," or "I feel like I was kind of a failure in doing my part and taking care of myself."

When patients were presented with various injection options, they requested more information, but cost was the main barrier to device selection and acceptance of insulin therapy, Mr. Powell reported.

Many preferred pens over vials and smaller needles over larger ones. Some patients said, "Why didn’t my doctor give me those needles [pointing to smaller ones]. I would prefer the smaller needle."

Many patients said that they weren’t shown insulin supplies and devices that are currently available. They weren’t shown how, when, and where to inject. Some said they were referred to the pharmacy for that information. Some said "Someone in the medical field needs to show me the correct way."

On the other hand, a patient who received proper instructions said, "I was lucky. My doctor sent me to an educator. They actually sat down and would not leave until I learned ... I also got information on insulin and injecting."

When the providers were interviewed for the study, they reported that patients had fear of needles; many said that they didn’t know about various needle options, and some cited lack of time to provide patients with appropriate diabetes education.

"Onsite training is something we have to make sure happens. To do so, we need to convince providers to refer patients to diabetes educators," said Mr. Powell. To reduce PIR, "we need provider-to-provider interaction," he said, encouraging diabetes educators to reach out to providers and ask for referrals.

"It’s our job to take the initiative to bridge the gap in diabetes education," he said.

Mr. Powell had no financial disclosures.

[email protected]

On Twitter @naseemmiller

The inactivated poliovirus vaccine and the live-attenuated oral poliovirus vaccine were discovered and developed separately by two men who never quite got along. And for years, the scientific community debated about which vaccine to use.

Now, decades later, a study shows that the two vaccines complement each other well, and the combination could be the key to worldwide eradication of polio in the near future.

Courtesy Wikimedia Commons/Shobhit Gosain/Creative Commons License

The study, conducted in India, shows that in children who had a history of receiving multiple doses of oral poliovirus vaccine (OPV), one injection of inactivated poliovirus vaccine (IPV), boosted intestinal immunity and reduced excretion of the virus by as much as 75%.

The findings also provide support for use of IPV (or OPV) for boosting intestinal immunity for travelers to and from polio-infected countries, according to the investigators Hamid Jafari, M.D., and associates.

"More than 25 years after the World Health Assembly resolution to eradicate polio myelitis, the answer to the vaccine controversy is apparent," they wrote in Science (2014;345:922-5). "Both vaccines, IPV and OPV, should be used."

Polio is currently endemic in only three countries: Afghanistan, Nigeria, and Pakistan. Since 1988 when the Global Polio Eradication Initiative was launched, the incidence of polio cases has decreased by 99%, according to the World Health Organization (WHO).

"But 99% is not enough in eradication," Dr. Jafari, WHO’s director of polio eradication and research, said at a teleconference. "Our aim is 100%. IPV can help us achieve that 1%."

Studies have shown that administration of IPV after OPV closes the humoral immunity gaps, the investigators wrote, but its effect on intestinal mucosal immunity is less well known.

With the help of WHO officers and field workers, Dr. Jafari and colleagues enrolled roughly 1,000 children from the Moradabad district in Uttar Pradash State in India.

The region was also the main limitation of the study, the authors noted, because the immunogenicity of OPV is low there, and "extrapolation or generalization of these findings to other areas of India or elsewhere must be done with caution," they wrote.

Enrolled children were 6-11 months old, 5 years old, and 10 years old. All children had received several doses of OPV prior to enrollment.

The participants were randomized to receive IPV, bivalent OPV (bOPV, containing poliovirus type 1 and type 3), or no vaccine. After 4 weeks, they all received bOPV, and their poliovirus excretion was measured on days 3, 7, and 14.

When comparing the IPV group with the control group, the poliovirus type 1 excretion decreased by 39% in children aged 6-11 months, by 62% in 5-year-olds, and by 74% in 10-year-olds. For poliovirus type 3, the decreases were 71%, 53%, and 76%, respectively.

bOPV significantly decreased excretion of poliovirus type 1 by 52% and type 3 by 41% in only 10-year-olds.

Also, the 10-year-olds had the highest degree of waning intestinal mucosal immunity, the study showed.

Meanwhile, the effect of IPV in inducing humoral immune response was significantly greater than bOPV.

Four weeks after vaccination, the IPV-induced humoral immune response to poliovirus type 1 was 83% in 6- to 11-month-olds, 98% in 5-year-olds, and 96% in 10-year-olds. That’s compared to 2.9%, 3.1%, and 0%, respectively, in the control group. bOPV also induced a humoral immune response, although milder: 14%, 13%, and 42%, respectively among the age groups. Similar results were observed for poliovirus type 3, the authors reported.

OPV has been used as the primary vaccine to eradicate polio, mainly because it’s cheap, easy to administer, and induces mucosal immunity. But the immunity wanes within 6 months, and several doses of the vaccine are required, which could prove challenging, particularly in conflict zone and hard-to-reach areas.

Meanwhile, IPV is more expensive – around $1 per dose, compared with 15 cents for OPV. Also, its administration could prove challenging because it has to be injected. But WHO officials said that the existing budget and vaccination programs that are already in place should help with successful introduction of IPV in targeted areas.

WHO recommended in 2012 that all countries introduce at least one dose of IPV in their routine immunization program, mainly to reduce the risks associated with the withdrawal of the poliovirus type 2 component of OPV. Poliovirus type 2 was last reported in 1999.

"IPV is the best way to rapidly boost immunity," Dr. Roland Sutter, one of the study’s authors and WHO’s coordinator of research and product development, polio, said at the teleconference.

The findings provide a critical piece of knowledge and can prevent epidemics and international spread of the disease and help "secure a lasting polio-free world," he said.

The study was funded by the Rotary International Polio Plus Program. There were no financial disclosures by the authors.

[email protected]

On Twitter @naseemmiller

The inactivated poliovirus vaccine and the live-attenuated oral poliovirus vaccine were discovered and developed separately by two men who never quite got along. And for years, the scientific community debated about which vaccine to use.

Now, decades later, a study shows that the two vaccines complement each other well, and the combination could be the key to worldwide eradication of polio in the near future.

Courtesy Wikimedia Commons/Shobhit Gosain/Creative Commons License

The study, conducted in India, shows that in children who had a history of receiving multiple doses of oral poliovirus vaccine (OPV), one injection of inactivated poliovirus vaccine (IPV), boosted intestinal immunity and reduced excretion of the virus by as much as 75%.

The findings also provide support for use of IPV (or OPV) for boosting intestinal immunity for travelers to and from polio-infected countries, according to the investigators Hamid Jafari, M.D., and associates.

"More than 25 years after the World Health Assembly resolution to eradicate polio myelitis, the answer to the vaccine controversy is apparent," they wrote in Science (2014;345:922-5). "Both vaccines, IPV and OPV, should be used."

Polio is currently endemic in only three countries: Afghanistan, Nigeria, and Pakistan. Since 1988 when the Global Polio Eradication Initiative was launched, the incidence of polio cases has decreased by 99%, according to the World Health Organization (WHO).

"But 99% is not enough in eradication," Dr. Jafari, WHO’s director of polio eradication and research, said at a teleconference. "Our aim is 100%. IPV can help us achieve that 1%."

Studies have shown that administration of IPV after OPV closes the humoral immunity gaps, the investigators wrote, but its effect on intestinal mucosal immunity is less well known.

With the help of WHO officers and field workers, Dr. Jafari and colleagues enrolled roughly 1,000 children from the Moradabad district in Uttar Pradash State in India.

The region was also the main limitation of the study, the authors noted, because the immunogenicity of OPV is low there, and "extrapolation or generalization of these findings to other areas of India or elsewhere must be done with caution," they wrote.

Enrolled children were 6-11 months old, 5 years old, and 10 years old. All children had received several doses of OPV prior to enrollment.

The participants were randomized to receive IPV, bivalent OPV (bOPV, containing poliovirus type 1 and type 3), or no vaccine. After 4 weeks, they all received bOPV, and their poliovirus excretion was measured on days 3, 7, and 14.

When comparing the IPV group with the control group, the poliovirus type 1 excretion decreased by 39% in children aged 6-11 months, by 62% in 5-year-olds, and by 74% in 10-year-olds. For poliovirus type 3, the decreases were 71%, 53%, and 76%, respectively.

bOPV significantly decreased excretion of poliovirus type 1 by 52% and type 3 by 41% in only 10-year-olds.

Also, the 10-year-olds had the highest degree of waning intestinal mucosal immunity, the study showed.

Meanwhile, the effect of IPV in inducing humoral immune response was significantly greater than bOPV.

Four weeks after vaccination, the IPV-induced humoral immune response to poliovirus type 1 was 83% in 6- to 11-month-olds, 98% in 5-year-olds, and 96% in 10-year-olds. That’s compared to 2.9%, 3.1%, and 0%, respectively, in the control group. bOPV also induced a humoral immune response, although milder: 14%, 13%, and 42%, respectively among the age groups. Similar results were observed for poliovirus type 3, the authors reported.

OPV has been used as the primary vaccine to eradicate polio, mainly because it’s cheap, easy to administer, and induces mucosal immunity. But the immunity wanes within 6 months, and several doses of the vaccine are required, which could prove challenging, particularly in conflict zone and hard-to-reach areas.

Meanwhile, IPV is more expensive – around $1 per dose, compared with 15 cents for OPV. Also, its administration could prove challenging because it has to be injected. But WHO officials said that the existing budget and vaccination programs that are already in place should help with successful introduction of IPV in targeted areas.

WHO recommended in 2012 that all countries introduce at least one dose of IPV in their routine immunization program, mainly to reduce the risks associated with the withdrawal of the poliovirus type 2 component of OPV. Poliovirus type 2 was last reported in 1999.

"IPV is the best way to rapidly boost immunity," Dr. Roland Sutter, one of the study’s authors and WHO’s coordinator of research and product development, polio, said at the teleconference.

The findings provide a critical piece of knowledge and can prevent epidemics and international spread of the disease and help "secure a lasting polio-free world," he said.

The study was funded by the Rotary International Polio Plus Program. There were no financial disclosures by the authors.

[email protected]

On Twitter @naseemmiller

The inactivated poliovirus vaccine and the live-attenuated oral poliovirus vaccine were discovered and developed separately by two men who never quite got along. And for years, the scientific community debated about which vaccine to use.

Now, decades later, a study shows that the two vaccines complement each other well, and the combination could be the key to worldwide eradication of polio in the near future.

Courtesy Wikimedia Commons/Shobhit Gosain/Creative Commons License

The study, conducted in India, shows that in children who had a history of receiving multiple doses of oral poliovirus vaccine (OPV), one injection of inactivated poliovirus vaccine (IPV), boosted intestinal immunity and reduced excretion of the virus by as much as 75%.

The findings also provide support for use of IPV (or OPV) for boosting intestinal immunity for travelers to and from polio-infected countries, according to the investigators Hamid Jafari, M.D., and associates.

"More than 25 years after the World Health Assembly resolution to eradicate polio myelitis, the answer to the vaccine controversy is apparent," they wrote in Science (2014;345:922-5). "Both vaccines, IPV and OPV, should be used."

Polio is currently endemic in only three countries: Afghanistan, Nigeria, and Pakistan. Since 1988 when the Global Polio Eradication Initiative was launched, the incidence of polio cases has decreased by 99%, according to the World Health Organization (WHO).

"But 99% is not enough in eradication," Dr. Jafari, WHO’s director of polio eradication and research, said at a teleconference. "Our aim is 100%. IPV can help us achieve that 1%."

Studies have shown that administration of IPV after OPV closes the humoral immunity gaps, the investigators wrote, but its effect on intestinal mucosal immunity is less well known.

With the help of WHO officers and field workers, Dr. Jafari and colleagues enrolled roughly 1,000 children from the Moradabad district in Uttar Pradash State in India.

The region was also the main limitation of the study, the authors noted, because the immunogenicity of OPV is low there, and "extrapolation or generalization of these findings to other areas of India or elsewhere must be done with caution," they wrote.

Enrolled children were 6-11 months old, 5 years old, and 10 years old. All children had received several doses of OPV prior to enrollment.

The participants were randomized to receive IPV, bivalent OPV (bOPV, containing poliovirus type 1 and type 3), or no vaccine. After 4 weeks, they all received bOPV, and their poliovirus excretion was measured on days 3, 7, and 14.

When comparing the IPV group with the control group, the poliovirus type 1 excretion decreased by 39% in children aged 6-11 months, by 62% in 5-year-olds, and by 74% in 10-year-olds. For poliovirus type 3, the decreases were 71%, 53%, and 76%, respectively.

bOPV significantly decreased excretion of poliovirus type 1 by 52% and type 3 by 41% in only 10-year-olds.

Also, the 10-year-olds had the highest degree of waning intestinal mucosal immunity, the study showed.

Meanwhile, the effect of IPV in inducing humoral immune response was significantly greater than bOPV.

Four weeks after vaccination, the IPV-induced humoral immune response to poliovirus type 1 was 83% in 6- to 11-month-olds, 98% in 5-year-olds, and 96% in 10-year-olds. That’s compared to 2.9%, 3.1%, and 0%, respectively, in the control group. bOPV also induced a humoral immune response, although milder: 14%, 13%, and 42%, respectively among the age groups. Similar results were observed for poliovirus type 3, the authors reported.

OPV has been used as the primary vaccine to eradicate polio, mainly because it’s cheap, easy to administer, and induces mucosal immunity. But the immunity wanes within 6 months, and several doses of the vaccine are required, which could prove challenging, particularly in conflict zone and hard-to-reach areas.

Meanwhile, IPV is more expensive – around $1 per dose, compared with 15 cents for OPV. Also, its administration could prove challenging because it has to be injected. But WHO officials said that the existing budget and vaccination programs that are already in place should help with successful introduction of IPV in targeted areas.

WHO recommended in 2012 that all countries introduce at least one dose of IPV in their routine immunization program, mainly to reduce the risks associated with the withdrawal of the poliovirus type 2 component of OPV. Poliovirus type 2 was last reported in 1999.

"IPV is the best way to rapidly boost immunity," Dr. Roland Sutter, one of the study’s authors and WHO’s coordinator of research and product development, polio, said at the teleconference.

The findings provide a critical piece of knowledge and can prevent epidemics and international spread of the disease and help "secure a lasting polio-free world," he said.

The study was funded by the Rotary International Polio Plus Program. There were no financial disclosures by the authors.

[email protected]

On Twitter @naseemmiller

ORLANDO – Asking just a few questions about mental health from patients with type 2 diabetes helped identify underlying depression, and a consequent referral to a behavioral coach improved the patients’ mental health status and diabetes self-management skills, according to a pilot study in rural North Carolina.

The patients who had depression received three coaching sessions with a social worker over a 3- to 6-month period, and their hemoglobin A_1c dropped by 1%, while their depression scores were cut in half. "We also may have prevented 11 suicides," said Melissa Herman, who presented the poster at the American Academy of Diabetes Educators.

The findings could also mean that behavioral coaching may "improve diabetes self-management among those who do not present with depressive symptoms ... as an array of other tangible and intangible barriers may impede the patient’s ability to proper self-management," Ms. Herman and her colleagues wrote in their study.

The mental health aspect of diabetes care can go unnoticed and untreated if providers don’t open the conversation because of a lack of training, comfort, or resources. This could especially affect patients in rural areas where access to care is limited and many are uninsured and underinsured.

The FirstHealth Diabetes Self-Management Program began screening all patients for depression and anxiety in three rural counties in North Carolina where more than 60% of the population is below the poverty level, and the diabetes prevalence is 16%, compared with 9% statewide, Ms. Herman said. In addition, roughly 30% of patients with diabetes have depression.

"We realized that there really were no resources for patients who had underlying depression or other mental health issues," said Ms. Herman, a registered dietitian and certified diabetes educator who is the director of the diabetes program at FirstHealth of Carolinas.

"Folks were not asking or screening these individuals about depression, and we really felt like the depression interfered with their ability to take care of their diabetes, because the lack of jobs, lack of access to care, medication, and social issues trumped the diabetes care."

Five diabetes educators were trained to screen every patient for depression and anxiety with a Patient Health Questionnaire–2 tool or – PHQ-2. The tool was built into the electronic medical record.

Out of 2,233 patients screened from June 2011 to July 2013, a total of 222 were referred for behavioral health coaching with a social worker, and 181 kept their initial appointment. Those patients were further assessed with the PHQ-9, a more advanced questionnaire, and saw their coach an average of three times over a 3-month period.

Researchers found that in roughly 60% of the patients, the PHQ-9 scores improved by average of 50%, hinting at improvement in depressive symptoms.

Also, more than half of the patients had a 1% drop in the HbA_1c levels, from an average of 8.9% to an average of 7.8%.

The behavioral health coaches also negotiated 11 life contracts, which were used when there was a suspicion of self-harm. Those patients were also referred to psychiatric services.

Another important factor in success of the program was having a mental health coach who had a background in social work, health education, and diabetes knowledge. "This proved key to linking the behavior change to the influence of disease management," Ms. Herman and her colleagues wrote in their poster.

The team continues the program, even though the grant that initially funded the project has ended, "because it’s been phenomenal," said Ms. Herman. "It’s not time intensive, it’s just a matter of telling people that it’s okay to vent, and then give them some coping skills."

Ms. Herman had no disclosures.

[email protected]

On Twitter @naseemmiller

ORLANDO – Asking just a few questions about mental health from patients with type 2 diabetes helped identify underlying depression, and a consequent referral to a behavioral coach improved the patients’ mental health status and diabetes self-management skills, according to a pilot study in rural North Carolina.

The patients who had depression received three coaching sessions with a social worker over a 3- to 6-month period, and their hemoglobin A_1c dropped by 1%, while their depression scores were cut in half. "We also may have prevented 11 suicides," said Melissa Herman, who presented the poster at the American Academy of Diabetes Educators.

The findings could also mean that behavioral coaching may "improve diabetes self-management among those who do not present with depressive symptoms ... as an array of other tangible and intangible barriers may impede the patient’s ability to proper self-management," Ms. Herman and her colleagues wrote in their study.

The mental health aspect of diabetes care can go unnoticed and untreated if providers don’t open the conversation because of a lack of training, comfort, or resources. This could especially affect patients in rural areas where access to care is limited and many are uninsured and underinsured.

The FirstHealth Diabetes Self-Management Program began screening all patients for depression and anxiety in three rural counties in North Carolina where more than 60% of the population is below the poverty level, and the diabetes prevalence is 16%, compared with 9% statewide, Ms. Herman said. In addition, roughly 30% of patients with diabetes have depression.

"We realized that there really were no resources for patients who had underlying depression or other mental health issues," said Ms. Herman, a registered dietitian and certified diabetes educator who is the director of the diabetes program at FirstHealth of Carolinas.

"Folks were not asking or screening these individuals about depression, and we really felt like the depression interfered with their ability to take care of their diabetes, because the lack of jobs, lack of access to care, medication, and social issues trumped the diabetes care."

Five diabetes educators were trained to screen every patient for depression and anxiety with a Patient Health Questionnaire–2 tool or – PHQ-2. The tool was built into the electronic medical record.

Out of 2,233 patients screened from June 2011 to July 2013, a total of 222 were referred for behavioral health coaching with a social worker, and 181 kept their initial appointment. Those patients were further assessed with the PHQ-9, a more advanced questionnaire, and saw their coach an average of three times over a 3-month period.

Researchers found that in roughly 60% of the patients, the PHQ-9 scores improved by average of 50%, hinting at improvement in depressive symptoms.

Also, more than half of the patients had a 1% drop in the HbA_1c levels, from an average of 8.9% to an average of 7.8%.

The behavioral health coaches also negotiated 11 life contracts, which were used when there was a suspicion of self-harm. Those patients were also referred to psychiatric services.

Another important factor in success of the program was having a mental health coach who had a background in social work, health education, and diabetes knowledge. "This proved key to linking the behavior change to the influence of disease management," Ms. Herman and her colleagues wrote in their poster.

The team continues the program, even though the grant that initially funded the project has ended, "because it’s been phenomenal," said Ms. Herman. "It’s not time intensive, it’s just a matter of telling people that it’s okay to vent, and then give them some coping skills."

Ms. Herman had no disclosures.

[email protected]

On Twitter @naseemmiller

ORLANDO – Asking just a few questions about mental health from patients with type 2 diabetes helped identify underlying depression, and a consequent referral to a behavioral coach improved the patients’ mental health status and diabetes self-management skills, according to a pilot study in rural North Carolina.

The patients who had depression received three coaching sessions with a social worker over a 3- to 6-month period, and their hemoglobin A_1c dropped by 1%, while their depression scores were cut in half. "We also may have prevented 11 suicides," said Melissa Herman, who presented the poster at the American Academy of Diabetes Educators.

The findings could also mean that behavioral coaching may "improve diabetes self-management among those who do not present with depressive symptoms ... as an array of other tangible and intangible barriers may impede the patient’s ability to proper self-management," Ms. Herman and her colleagues wrote in their study.

The mental health aspect of diabetes care can go unnoticed and untreated if providers don’t open the conversation because of a lack of training, comfort, or resources. This could especially affect patients in rural areas where access to care is limited and many are uninsured and underinsured.

The FirstHealth Diabetes Self-Management Program began screening all patients for depression and anxiety in three rural counties in North Carolina where more than 60% of the population is below the poverty level, and the diabetes prevalence is 16%, compared with 9% statewide, Ms. Herman said. In addition, roughly 30% of patients with diabetes have depression.

"We realized that there really were no resources for patients who had underlying depression or other mental health issues," said Ms. Herman, a registered dietitian and certified diabetes educator who is the director of the diabetes program at FirstHealth of Carolinas.

"Folks were not asking or screening these individuals about depression, and we really felt like the depression interfered with their ability to take care of their diabetes, because the lack of jobs, lack of access to care, medication, and social issues trumped the diabetes care."

Five diabetes educators were trained to screen every patient for depression and anxiety with a Patient Health Questionnaire–2 tool or – PHQ-2. The tool was built into the electronic medical record.

Out of 2,233 patients screened from June 2011 to July 2013, a total of 222 were referred for behavioral health coaching with a social worker, and 181 kept their initial appointment. Those patients were further assessed with the PHQ-9, a more advanced questionnaire, and saw their coach an average of three times over a 3-month period.

Researchers found that in roughly 60% of the patients, the PHQ-9 scores improved by average of 50%, hinting at improvement in depressive symptoms.

Also, more than half of the patients had a 1% drop in the HbA_1c levels, from an average of 8.9% to an average of 7.8%.

The behavioral health coaches also negotiated 11 life contracts, which were used when there was a suspicion of self-harm. Those patients were also referred to psychiatric services.

Another important factor in success of the program was having a mental health coach who had a background in social work, health education, and diabetes knowledge. "This proved key to linking the behavior change to the influence of disease management," Ms. Herman and her colleagues wrote in their poster.

The team continues the program, even though the grant that initially funded the project has ended, "because it’s been phenomenal," said Ms. Herman. "It’s not time intensive, it’s just a matter of telling people that it’s okay to vent, and then give them some coping skills."

Ms. Herman had no disclosures.

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