Treating Asymptomatic Bacteriuria Can Be Dangerous

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Treating Asymptomatic Bacteriuria Can Be Dangerous

Clinical question: Does treating asymptomatic bacteriuria (AB) cause harm in women?

Background: In women with recurrent UTIs, AB is often treated, increasing the risk of multi-drug-resistant bacteria. At the same time, little data exist on the relationship between AB treatment and risk of higher antibiotic resistance in women with recurrent UTIs.

Study design: Follow-up observational, analytical, longitudinal study on a previously randomized clinical trial (RCT).

Setting: Sexually transmitted disease (STD) center in Florence, Italy.

Synopsis: Using the patients from the authors’ previous RCT, the study followed 550 women with recurrent UTIs and AB for a mean of 38.8 months in parallel groups: One group had AB treated, and the other group did not. In the group of women treated with antibiotics, the recurrence rate was 69.6% versus 37.7% in the group not treated (P<0.001). In addition, E. coli isolates showed more resistance to amoxicillin/clavulanic acid (P=0.03), trimethoprim/sulfamethazole (P=0.01), and ciprofloxacin (P=0.03) in the group previously treated with antibiotics.

Given the observational design of the study, data must be interpreted with caution in determining a causal relationship. However, prior studies have shown this relationship, and current Infectious Diseases Society of America guidelines support neither screening nor treating AB.

Bottom line: In women with recurrent UTIs, previous treatment of AB is associated with higher rates of antibiotic-resistant bacteria, causing symptomatic UTIs.

Citation: Cai T, Nsei G, Mazzoli S, et al. Asymptomatic bacteriuria treatment is associated with a higher prevalence of antibiotic resistant strains in women with urinary tract infection. Clin Infect Dis. 2015;61(11):1655-1661.

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National Healthcare Spending Increased in 2014

Led by expansions under the Affordable Care Act, healthcare spending increased 5.3% from the previous year and now totals $3 trillion, which represents 17.5% of the gross domestic product.

Citation: Martin AB, Hartman M, Benson J, Catlin A. National health spending in 2014: faster growth drive by coverage expansion and prescription drug spending. Health Aff. 2016;35(1):150-160.

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Clinical question: Does treating asymptomatic bacteriuria (AB) cause harm in women?

Background: In women with recurrent UTIs, AB is often treated, increasing the risk of multi-drug-resistant bacteria. At the same time, little data exist on the relationship between AB treatment and risk of higher antibiotic resistance in women with recurrent UTIs.

Study design: Follow-up observational, analytical, longitudinal study on a previously randomized clinical trial (RCT).

Setting: Sexually transmitted disease (STD) center in Florence, Italy.

Synopsis: Using the patients from the authors’ previous RCT, the study followed 550 women with recurrent UTIs and AB for a mean of 38.8 months in parallel groups: One group had AB treated, and the other group did not. In the group of women treated with antibiotics, the recurrence rate was 69.6% versus 37.7% in the group not treated (P<0.001). In addition, E. coli isolates showed more resistance to amoxicillin/clavulanic acid (P=0.03), trimethoprim/sulfamethazole (P=0.01), and ciprofloxacin (P=0.03) in the group previously treated with antibiotics.

Given the observational design of the study, data must be interpreted with caution in determining a causal relationship. However, prior studies have shown this relationship, and current Infectious Diseases Society of America guidelines support neither screening nor treating AB.

Bottom line: In women with recurrent UTIs, previous treatment of AB is associated with higher rates of antibiotic-resistant bacteria, causing symptomatic UTIs.

Citation: Cai T, Nsei G, Mazzoli S, et al. Asymptomatic bacteriuria treatment is associated with a higher prevalence of antibiotic resistant strains in women with urinary tract infection. Clin Infect Dis. 2015;61(11):1655-1661.

Short Take

National Healthcare Spending Increased in 2014

Led by expansions under the Affordable Care Act, healthcare spending increased 5.3% from the previous year and now totals $3 trillion, which represents 17.5% of the gross domestic product.

Citation: Martin AB, Hartman M, Benson J, Catlin A. National health spending in 2014: faster growth drive by coverage expansion and prescription drug spending. Health Aff. 2016;35(1):150-160.

Clinical question: Does treating asymptomatic bacteriuria (AB) cause harm in women?

Background: In women with recurrent UTIs, AB is often treated, increasing the risk of multi-drug-resistant bacteria. At the same time, little data exist on the relationship between AB treatment and risk of higher antibiotic resistance in women with recurrent UTIs.

Study design: Follow-up observational, analytical, longitudinal study on a previously randomized clinical trial (RCT).

Setting: Sexually transmitted disease (STD) center in Florence, Italy.

Synopsis: Using the patients from the authors’ previous RCT, the study followed 550 women with recurrent UTIs and AB for a mean of 38.8 months in parallel groups: One group had AB treated, and the other group did not. In the group of women treated with antibiotics, the recurrence rate was 69.6% versus 37.7% in the group not treated (P<0.001). In addition, E. coli isolates showed more resistance to amoxicillin/clavulanic acid (P=0.03), trimethoprim/sulfamethazole (P=0.01), and ciprofloxacin (P=0.03) in the group previously treated with antibiotics.

Given the observational design of the study, data must be interpreted with caution in determining a causal relationship. However, prior studies have shown this relationship, and current Infectious Diseases Society of America guidelines support neither screening nor treating AB.

Bottom line: In women with recurrent UTIs, previous treatment of AB is associated with higher rates of antibiotic-resistant bacteria, causing symptomatic UTIs.

Citation: Cai T, Nsei G, Mazzoli S, et al. Asymptomatic bacteriuria treatment is associated with a higher prevalence of antibiotic resistant strains in women with urinary tract infection. Clin Infect Dis. 2015;61(11):1655-1661.

Short Take

National Healthcare Spending Increased in 2014

Led by expansions under the Affordable Care Act, healthcare spending increased 5.3% from the previous year and now totals $3 trillion, which represents 17.5% of the gross domestic product.

Citation: Martin AB, Hartman M, Benson J, Catlin A. National health spending in 2014: faster growth drive by coverage expansion and prescription drug spending. Health Aff. 2016;35(1):150-160.

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Targeted corticosteroids cut GVHD incidence

Effect on harder endpoints unknown
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Targeted corticosteroids cut GVHD incidence

Short-term low-dose corticosteroid prophylaxis reduces the incidence of graft-vs.-host disease in patients who undergo allogeneic haploidentical stem-cell transplantation to treat hematologic neoplasms, according to a report published online April 18 in the Journal of Clinical Oncology.

The key to selecting patients most likely to benefit from the corticosteroid therapy is to identify those at high risk for graft-vs.-host disease (GVHD) using two biomarkers: high levels of CD56bright natural killer cells in allogeneic grafts or high CD4:CD8 ratios in bone marrow grafts, according to Dr. Ying-Jun Chang of Peking University People’s Hospital, Beijing, and associates.

The investigators performed an open-label trial involving 228 patients aged 15-60 years treated at a single medical center during an 18-month period for acute myeloid leukemia, acute lymphoblastic leukemia, chronic myeloid leukemia, myelodysplastic syndrome, or other hematologic neoplasms. Using the two biomarkers, the patients were categorized as either high or low risk for developing GVHD. They were randomly assigned to three study groups: 72 high-risk patients who received short-term low-dose corticosteroids, 73 high-risk patients who received usual care, and 83 low-risk patients who received usual care.

The cumulative 100-day incidence of acute grade-II to grade-IV GVHD was significantly lower in the high-risk patients who received prophylaxis (21%) than in the high-risk patients who did not receive prophylaxis (48%). In fact, corticosteroids decreased the rate of GVHD so that it was comparable with that in the low-risk patients (26%), Dr. Chang and associates said (J Clin Oncol. 2016 Apr 18. doi: 10.1200/JCO.2015.63l.8817).

Moreover, in the high-risk patients the median interval until GVHD developed was 25 days for those who took corticosteroids, compared with only 15 days for those who did not. Median times to myeloid recovery and platelet recovery were significantly shorter for high-risk patients who received corticosteroids than for either of the other study groups. However, 3-year overall survival and leukemia-free survival were comparable among the three study groups.

The short-term low-dose regimen of corticosteroids did not raise the rate of adverse events, including infection, which suggests that it is preferable to standard corticosteroid regimens in this patient population. The incidences of cytomegalovirus or Epstein-Barr virus reactivation, post-transplantation lymphoproliferative disorder, hemorrhagic cystitis, bacteremia, and invasive fungal infections were comparable among the three study groups. Of note, the incidences of osteonecrosis of the femoral head and secondary hypertension were significantly lower among high-risk patients who received corticosteroid prophylaxis than among those who did not.

“These results provide the first test, to our knowledge, of a novel risk-stratification-directed prophylaxis strategy that effectively prevented acute GVHD among patients who were at high risk for GVHD, without unnecessarily exposing patients who were at low risk to excessive toxicity from additional immunosuppressive agents,” Dr. Chang and associates said.

References

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Despite the encouraging results of Chang et al, it would be premature to routinely use corticosteroid prophylaxis to prevent GVHD until further studies are completed.

This study wasn’t sufficiently powered to determine whether corticosteroids reduced treatment-specific mortality or improved overall survival. Future studies must examine these end points, as well as relapse rates, before this method of prophylaxis is widely adopted.

Dr. Edwin P. Alyea is at Dana-Farber Cancer Institute, Boston. He reported having no relevant financial disclosures. Dr. Alyea made these remarks in an editorial accompanying Dr. Chang’s report (J Clin Oncol. 2016 Apr 18. doi: 10.1200/JCO.2015.66.0902).

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Despite the encouraging results of Chang et al, it would be premature to routinely use corticosteroid prophylaxis to prevent GVHD until further studies are completed.

This study wasn’t sufficiently powered to determine whether corticosteroids reduced treatment-specific mortality or improved overall survival. Future studies must examine these end points, as well as relapse rates, before this method of prophylaxis is widely adopted.

Dr. Edwin P. Alyea is at Dana-Farber Cancer Institute, Boston. He reported having no relevant financial disclosures. Dr. Alyea made these remarks in an editorial accompanying Dr. Chang’s report (J Clin Oncol. 2016 Apr 18. doi: 10.1200/JCO.2015.66.0902).

Body

Despite the encouraging results of Chang et al, it would be premature to routinely use corticosteroid prophylaxis to prevent GVHD until further studies are completed.

This study wasn’t sufficiently powered to determine whether corticosteroids reduced treatment-specific mortality or improved overall survival. Future studies must examine these end points, as well as relapse rates, before this method of prophylaxis is widely adopted.

Dr. Edwin P. Alyea is at Dana-Farber Cancer Institute, Boston. He reported having no relevant financial disclosures. Dr. Alyea made these remarks in an editorial accompanying Dr. Chang’s report (J Clin Oncol. 2016 Apr 18. doi: 10.1200/JCO.2015.66.0902).

Title
Effect on harder endpoints unknown
Effect on harder endpoints unknown

Short-term low-dose corticosteroid prophylaxis reduces the incidence of graft-vs.-host disease in patients who undergo allogeneic haploidentical stem-cell transplantation to treat hematologic neoplasms, according to a report published online April 18 in the Journal of Clinical Oncology.

The key to selecting patients most likely to benefit from the corticosteroid therapy is to identify those at high risk for graft-vs.-host disease (GVHD) using two biomarkers: high levels of CD56bright natural killer cells in allogeneic grafts or high CD4:CD8 ratios in bone marrow grafts, according to Dr. Ying-Jun Chang of Peking University People’s Hospital, Beijing, and associates.

The investigators performed an open-label trial involving 228 patients aged 15-60 years treated at a single medical center during an 18-month period for acute myeloid leukemia, acute lymphoblastic leukemia, chronic myeloid leukemia, myelodysplastic syndrome, or other hematologic neoplasms. Using the two biomarkers, the patients were categorized as either high or low risk for developing GVHD. They were randomly assigned to three study groups: 72 high-risk patients who received short-term low-dose corticosteroids, 73 high-risk patients who received usual care, and 83 low-risk patients who received usual care.

The cumulative 100-day incidence of acute grade-II to grade-IV GVHD was significantly lower in the high-risk patients who received prophylaxis (21%) than in the high-risk patients who did not receive prophylaxis (48%). In fact, corticosteroids decreased the rate of GVHD so that it was comparable with that in the low-risk patients (26%), Dr. Chang and associates said (J Clin Oncol. 2016 Apr 18. doi: 10.1200/JCO.2015.63l.8817).

Moreover, in the high-risk patients the median interval until GVHD developed was 25 days for those who took corticosteroids, compared with only 15 days for those who did not. Median times to myeloid recovery and platelet recovery were significantly shorter for high-risk patients who received corticosteroids than for either of the other study groups. However, 3-year overall survival and leukemia-free survival were comparable among the three study groups.

The short-term low-dose regimen of corticosteroids did not raise the rate of adverse events, including infection, which suggests that it is preferable to standard corticosteroid regimens in this patient population. The incidences of cytomegalovirus or Epstein-Barr virus reactivation, post-transplantation lymphoproliferative disorder, hemorrhagic cystitis, bacteremia, and invasive fungal infections were comparable among the three study groups. Of note, the incidences of osteonecrosis of the femoral head and secondary hypertension were significantly lower among high-risk patients who received corticosteroid prophylaxis than among those who did not.

“These results provide the first test, to our knowledge, of a novel risk-stratification-directed prophylaxis strategy that effectively prevented acute GVHD among patients who were at high risk for GVHD, without unnecessarily exposing patients who were at low risk to excessive toxicity from additional immunosuppressive agents,” Dr. Chang and associates said.

Short-term low-dose corticosteroid prophylaxis reduces the incidence of graft-vs.-host disease in patients who undergo allogeneic haploidentical stem-cell transplantation to treat hematologic neoplasms, according to a report published online April 18 in the Journal of Clinical Oncology.

The key to selecting patients most likely to benefit from the corticosteroid therapy is to identify those at high risk for graft-vs.-host disease (GVHD) using two biomarkers: high levels of CD56bright natural killer cells in allogeneic grafts or high CD4:CD8 ratios in bone marrow grafts, according to Dr. Ying-Jun Chang of Peking University People’s Hospital, Beijing, and associates.

The investigators performed an open-label trial involving 228 patients aged 15-60 years treated at a single medical center during an 18-month period for acute myeloid leukemia, acute lymphoblastic leukemia, chronic myeloid leukemia, myelodysplastic syndrome, or other hematologic neoplasms. Using the two biomarkers, the patients were categorized as either high or low risk for developing GVHD. They were randomly assigned to three study groups: 72 high-risk patients who received short-term low-dose corticosteroids, 73 high-risk patients who received usual care, and 83 low-risk patients who received usual care.

The cumulative 100-day incidence of acute grade-II to grade-IV GVHD was significantly lower in the high-risk patients who received prophylaxis (21%) than in the high-risk patients who did not receive prophylaxis (48%). In fact, corticosteroids decreased the rate of GVHD so that it was comparable with that in the low-risk patients (26%), Dr. Chang and associates said (J Clin Oncol. 2016 Apr 18. doi: 10.1200/JCO.2015.63l.8817).

Moreover, in the high-risk patients the median interval until GVHD developed was 25 days for those who took corticosteroids, compared with only 15 days for those who did not. Median times to myeloid recovery and platelet recovery were significantly shorter for high-risk patients who received corticosteroids than for either of the other study groups. However, 3-year overall survival and leukemia-free survival were comparable among the three study groups.

The short-term low-dose regimen of corticosteroids did not raise the rate of adverse events, including infection, which suggests that it is preferable to standard corticosteroid regimens in this patient population. The incidences of cytomegalovirus or Epstein-Barr virus reactivation, post-transplantation lymphoproliferative disorder, hemorrhagic cystitis, bacteremia, and invasive fungal infections were comparable among the three study groups. Of note, the incidences of osteonecrosis of the femoral head and secondary hypertension were significantly lower among high-risk patients who received corticosteroid prophylaxis than among those who did not.

“These results provide the first test, to our knowledge, of a novel risk-stratification-directed prophylaxis strategy that effectively prevented acute GVHD among patients who were at high risk for GVHD, without unnecessarily exposing patients who were at low risk to excessive toxicity from additional immunosuppressive agents,” Dr. Chang and associates said.

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Targeted corticosteroids cut GVHD incidence
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FROM THE JOURNAL OF CLINICAL ONCOLOGY

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Key clinical point: Short-term low-dose corticosteroid prophylaxis reduces the incidence of the GVHD in patients who undergo haploidentical stem-cell transplantation to treat hematologic neoplasms.

Major finding: The 100-day incidence of acute GVHD was significantly lower in the high-risk patients who received corticosteroid prophylaxis (21%) than in the high-risk patients who did not (48%).

Data source: An open-label randomized controlled trial involving 228 Chinese patients who underwent stem-cell transplantation.

Disclosures: This study was supported by the Beijing Committee of Science and Technology, the National High Technology Research and Development Program of China, and the National Natural Science Foundation of China. Dr. Chang and associates reported having no relevant financial disclosures.

Donor EBV status affects recipient graft-vs-host disease risk

Control EBV to prevent, treat GVHD?
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Donor EBV status affects recipient graft-vs-host disease risk

In allogeneic hematopoietic stem-cell transplantation, the donor’s status regarding Epstein-Barr virus affects the recipient’s risk of developing graft-vs-host disease – a “completely new and striking” finding, according to a report published online April 18 in the Journal of Clinical Oncology.

Approximately 80% of the general population has been infected with EBV and carries persistent virus in memory B cells. When viral material is transmitted to stem-cell recipients, it is known to cause posttransplantation lymphoproliferative disorder. Until now, however, no data were available to examine EBV serology’s effect on other posttransplantation outcomes, said Dr. Jan Styczynski of the department of pediatric hematology and oncology at Nicolaus Copernicus University, Bydgoszcz, Poland, and his associates.

They analyzed information in the European Society of Blood and Marrow Transplantation database for 11,364 patients with acute lymphoblastic leukemia or acute myeloblastic leukemia who underwent stem-cell transplantation between 1997 and 2012 and who were followed for approximately 5 years. Most of the donors (82%) were seropositive for EBV. Acute graft-vs-host disease (GVHD) developed in 32% and chronic GVHD developed in 40% of these stem cell–transplant recipients.

The incidence of chronic GVHD was significantly higher when the donor was EBV-seropositive (41%) than when the donor was EBV-seronegative (31%). Similarly, the incidence of acute GVHD was significantly higher when the donor was EBV-seropositive (32% vs 30%), but the magnitude of the difference between the two groups was smaller. The risk for GVHD increased even though patients receiving transplants from EBV-seropositive donors underwent more intensive GVHD prophylaxis than did those who had seronegative donors, the investigators said (J Clin Oncol. 2016 Apr 18. doi: 10.1200/JCO.2015.64.2405).

In contrast, the transplant recipients’ EBV status did not affect their risk of developing GVHD.

“Despite the effect of donor EBV serostatus on GVHD, we did not observe a corresponding GVHD-related death rate, and as a result, there was no effect on overall survival, relapse-free survival, relapse incidence, and nonrelapse mortality. However, it should be kept in mind that many other pre- and posttransplantation factors play a role in contributing to final transplantation outcomes,” Dr. Styczynski and his associates noted.

The current recommendation to monitor transplantation recipients for EBV and to give them “preemptive” rituximab to stave off the development of posttransplantation lymphoproliferative disorder might prove useful in also preventing GVHD, they added.

References

Body

The findings of Dr. Styczynski and his associates raise the possibility that we may be able to prevent or treat GVHD in transplant recipients by controlling EBV infection.

Selecting only EBV-negative donors would be one way to accomplish this, but that would be impractical given the high seroprevalence of EBV in the general population. Depleting memory B cells, the reservoir of EBV infection, using monoclonal antibodies may prove helpful, and these agents might provide additional therapeutic effects. And novel antivirals such as retroviral integrase inhibitors may be more specific at targeting EBV than acyclovir and related agents, which have limited activity against latently infected B cells. These novel drugs, however, are not without risks and adverse effects.

A promising alternative might be to boost immunity to EBV using vaccination or adoptive transfer of ex vivo expanded EBV-specific cytotoxic T cells.

Dr. Katayoun Rezvani and Dr. Richard E. Champlin are with the University of Texas MD Andersen Cancer Center, Houston. Their financial disclosures are available at www.jco.org. They made these remarks in an editorial accompanying Dr. Styczynski’s report (J Clin Oncol. 2016 Apr 18. doi: 10.1200/JCO.2016.66.6099).

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The findings of Dr. Styczynski and his associates raise the possibility that we may be able to prevent or treat GVHD in transplant recipients by controlling EBV infection.

Selecting only EBV-negative donors would be one way to accomplish this, but that would be impractical given the high seroprevalence of EBV in the general population. Depleting memory B cells, the reservoir of EBV infection, using monoclonal antibodies may prove helpful, and these agents might provide additional therapeutic effects. And novel antivirals such as retroviral integrase inhibitors may be more specific at targeting EBV than acyclovir and related agents, which have limited activity against latently infected B cells. These novel drugs, however, are not without risks and adverse effects.

A promising alternative might be to boost immunity to EBV using vaccination or adoptive transfer of ex vivo expanded EBV-specific cytotoxic T cells.

Dr. Katayoun Rezvani and Dr. Richard E. Champlin are with the University of Texas MD Andersen Cancer Center, Houston. Their financial disclosures are available at www.jco.org. They made these remarks in an editorial accompanying Dr. Styczynski’s report (J Clin Oncol. 2016 Apr 18. doi: 10.1200/JCO.2016.66.6099).

Body

The findings of Dr. Styczynski and his associates raise the possibility that we may be able to prevent or treat GVHD in transplant recipients by controlling EBV infection.

Selecting only EBV-negative donors would be one way to accomplish this, but that would be impractical given the high seroprevalence of EBV in the general population. Depleting memory B cells, the reservoir of EBV infection, using monoclonal antibodies may prove helpful, and these agents might provide additional therapeutic effects. And novel antivirals such as retroviral integrase inhibitors may be more specific at targeting EBV than acyclovir and related agents, which have limited activity against latently infected B cells. These novel drugs, however, are not without risks and adverse effects.

A promising alternative might be to boost immunity to EBV using vaccination or adoptive transfer of ex vivo expanded EBV-specific cytotoxic T cells.

Dr. Katayoun Rezvani and Dr. Richard E. Champlin are with the University of Texas MD Andersen Cancer Center, Houston. Their financial disclosures are available at www.jco.org. They made these remarks in an editorial accompanying Dr. Styczynski’s report (J Clin Oncol. 2016 Apr 18. doi: 10.1200/JCO.2016.66.6099).

Title
Control EBV to prevent, treat GVHD?
Control EBV to prevent, treat GVHD?

In allogeneic hematopoietic stem-cell transplantation, the donor’s status regarding Epstein-Barr virus affects the recipient’s risk of developing graft-vs-host disease – a “completely new and striking” finding, according to a report published online April 18 in the Journal of Clinical Oncology.

Approximately 80% of the general population has been infected with EBV and carries persistent virus in memory B cells. When viral material is transmitted to stem-cell recipients, it is known to cause posttransplantation lymphoproliferative disorder. Until now, however, no data were available to examine EBV serology’s effect on other posttransplantation outcomes, said Dr. Jan Styczynski of the department of pediatric hematology and oncology at Nicolaus Copernicus University, Bydgoszcz, Poland, and his associates.

They analyzed information in the European Society of Blood and Marrow Transplantation database for 11,364 patients with acute lymphoblastic leukemia or acute myeloblastic leukemia who underwent stem-cell transplantation between 1997 and 2012 and who were followed for approximately 5 years. Most of the donors (82%) were seropositive for EBV. Acute graft-vs-host disease (GVHD) developed in 32% and chronic GVHD developed in 40% of these stem cell–transplant recipients.

The incidence of chronic GVHD was significantly higher when the donor was EBV-seropositive (41%) than when the donor was EBV-seronegative (31%). Similarly, the incidence of acute GVHD was significantly higher when the donor was EBV-seropositive (32% vs 30%), but the magnitude of the difference between the two groups was smaller. The risk for GVHD increased even though patients receiving transplants from EBV-seropositive donors underwent more intensive GVHD prophylaxis than did those who had seronegative donors, the investigators said (J Clin Oncol. 2016 Apr 18. doi: 10.1200/JCO.2015.64.2405).

In contrast, the transplant recipients’ EBV status did not affect their risk of developing GVHD.

“Despite the effect of donor EBV serostatus on GVHD, we did not observe a corresponding GVHD-related death rate, and as a result, there was no effect on overall survival, relapse-free survival, relapse incidence, and nonrelapse mortality. However, it should be kept in mind that many other pre- and posttransplantation factors play a role in contributing to final transplantation outcomes,” Dr. Styczynski and his associates noted.

The current recommendation to monitor transplantation recipients for EBV and to give them “preemptive” rituximab to stave off the development of posttransplantation lymphoproliferative disorder might prove useful in also preventing GVHD, they added.

In allogeneic hematopoietic stem-cell transplantation, the donor’s status regarding Epstein-Barr virus affects the recipient’s risk of developing graft-vs-host disease – a “completely new and striking” finding, according to a report published online April 18 in the Journal of Clinical Oncology.

Approximately 80% of the general population has been infected with EBV and carries persistent virus in memory B cells. When viral material is transmitted to stem-cell recipients, it is known to cause posttransplantation lymphoproliferative disorder. Until now, however, no data were available to examine EBV serology’s effect on other posttransplantation outcomes, said Dr. Jan Styczynski of the department of pediatric hematology and oncology at Nicolaus Copernicus University, Bydgoszcz, Poland, and his associates.

They analyzed information in the European Society of Blood and Marrow Transplantation database for 11,364 patients with acute lymphoblastic leukemia or acute myeloblastic leukemia who underwent stem-cell transplantation between 1997 and 2012 and who were followed for approximately 5 years. Most of the donors (82%) were seropositive for EBV. Acute graft-vs-host disease (GVHD) developed in 32% and chronic GVHD developed in 40% of these stem cell–transplant recipients.

The incidence of chronic GVHD was significantly higher when the donor was EBV-seropositive (41%) than when the donor was EBV-seronegative (31%). Similarly, the incidence of acute GVHD was significantly higher when the donor was EBV-seropositive (32% vs 30%), but the magnitude of the difference between the two groups was smaller. The risk for GVHD increased even though patients receiving transplants from EBV-seropositive donors underwent more intensive GVHD prophylaxis than did those who had seronegative donors, the investigators said (J Clin Oncol. 2016 Apr 18. doi: 10.1200/JCO.2015.64.2405).

In contrast, the transplant recipients’ EBV status did not affect their risk of developing GVHD.

“Despite the effect of donor EBV serostatus on GVHD, we did not observe a corresponding GVHD-related death rate, and as a result, there was no effect on overall survival, relapse-free survival, relapse incidence, and nonrelapse mortality. However, it should be kept in mind that many other pre- and posttransplantation factors play a role in contributing to final transplantation outcomes,” Dr. Styczynski and his associates noted.

The current recommendation to monitor transplantation recipients for EBV and to give them “preemptive” rituximab to stave off the development of posttransplantation lymphoproliferative disorder might prove useful in also preventing GVHD, they added.

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Donor EBV status affects recipient graft-vs-host disease risk
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Key clinical point: In allogeneic hematopoietic stem-cell transplantation, the donor’s EBV status affects the recipient’s risk of developing GVHD.

Major finding: Chronic GVHD was significantly more likely to develop when the donor was EBV-seropositive (41%) than EBV-seronegative (31%).

Data source: A retrospective analysis of data regarding 11,364 European patients with acute leukemia who underwent stem-cell transplantation and were followed for 5 years.

Disclosures: No study sponsor was identified. Dr. Styczynski reported having no relevant financial disclosures; his associates reported ties to numerous industry sources.

Targeting T and B Cells as a Therapeutic Approach for Multiple Sclerosis

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Targeting T and B Cells as a Therapeutic Approach for Multiple Sclerosis

Immunotherapies that target abnormally activated T and B cells may represent a unique combination and promising DMT strategy for patients with RRMS and have the greatest potential for long-term success. Targeting T cells in MS may help attenuate initiation and maintenance of inflammatory attacks by reducing the production of pro-inflammatory cytokines, recruitment of innate immune cells, stimulation of antibody production, and direct attack of myelin. Targeting B cells in MS may attenuate secretion of autoantibodies and pro-inflammatory cytokines, as well as presentation of self-antigen to T cells.

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Immunotherapies that target abnormally activated T and B cells may represent a unique combination and promising DMT strategy for patients with RRMS and have the greatest potential for long-term success. Targeting T cells in MS may help attenuate initiation and maintenance of inflammatory attacks by reducing the production of pro-inflammatory cytokines, recruitment of innate immune cells, stimulation of antibody production, and direct attack of myelin. Targeting B cells in MS may attenuate secretion of autoantibodies and pro-inflammatory cytokines, as well as presentation of self-antigen to T cells.

Click here to read the digital edition.

Immunotherapies that target abnormally activated T and B cells may represent a unique combination and promising DMT strategy for patients with RRMS and have the greatest potential for long-term success. Targeting T cells in MS may help attenuate initiation and maintenance of inflammatory attacks by reducing the production of pro-inflammatory cytokines, recruitment of innate immune cells, stimulation of antibody production, and direct attack of myelin. Targeting B cells in MS may attenuate secretion of autoantibodies and pro-inflammatory cytokines, as well as presentation of self-antigen to T cells.

Click here to read the digital edition.

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U.S. flu activity down again, except in New Jersey

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Overall activity of influenza-like illness (ILI) in the United States continued to fall, but New Jersey took a turn for the worse during the week ending April 9, 2016, according to the Centers for Disease Control and Prevention.

New Jersey’s ILI activity level went from 8 the previous week to 10 on the CDC’s 1-10 scale. For the week ending April 9, it was the only U.S. state in the “high” range, with Hawaii the next highest at level 6 – the only state in the “moderate” range, the CDC reported.

Nationwide, the proportion of outpatient visits for ILI was 2.1%, which is at the national baseline of 2.1% and down from 2.5% the week before. That number has now dropped for 4 consecutive weeks since hitting a season high of 3.7% for the week ending March 12. The CDC also reported a cumulative rate of 26.6 influenza-associated hospitalizations per 100,000 population.

Ten flu-related pediatric deaths were reported during the week, of which only one occurred during the week. A total of 50 flu-related pediatric deaths have been reported during the 2015-2016 season, the CDC said. The overall proportion of deaths attributed to pneumonia and influenza was below the system-specific threshold in the National Center for Health Statistics Mortality Surveillance System, but above the system-specific threshold in the 122 Cities Mortality Reporting System.

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Overall activity of influenza-like illness (ILI) in the United States continued to fall, but New Jersey took a turn for the worse during the week ending April 9, 2016, according to the Centers for Disease Control and Prevention.

New Jersey’s ILI activity level went from 8 the previous week to 10 on the CDC’s 1-10 scale. For the week ending April 9, it was the only U.S. state in the “high” range, with Hawaii the next highest at level 6 – the only state in the “moderate” range, the CDC reported.

Nationwide, the proportion of outpatient visits for ILI was 2.1%, which is at the national baseline of 2.1% and down from 2.5% the week before. That number has now dropped for 4 consecutive weeks since hitting a season high of 3.7% for the week ending March 12. The CDC also reported a cumulative rate of 26.6 influenza-associated hospitalizations per 100,000 population.

Ten flu-related pediatric deaths were reported during the week, of which only one occurred during the week. A total of 50 flu-related pediatric deaths have been reported during the 2015-2016 season, the CDC said. The overall proportion of deaths attributed to pneumonia and influenza was below the system-specific threshold in the National Center for Health Statistics Mortality Surveillance System, but above the system-specific threshold in the 122 Cities Mortality Reporting System.

[email protected]

Overall activity of influenza-like illness (ILI) in the United States continued to fall, but New Jersey took a turn for the worse during the week ending April 9, 2016, according to the Centers for Disease Control and Prevention.

New Jersey’s ILI activity level went from 8 the previous week to 10 on the CDC’s 1-10 scale. For the week ending April 9, it was the only U.S. state in the “high” range, with Hawaii the next highest at level 6 – the only state in the “moderate” range, the CDC reported.

Nationwide, the proportion of outpatient visits for ILI was 2.1%, which is at the national baseline of 2.1% and down from 2.5% the week before. That number has now dropped for 4 consecutive weeks since hitting a season high of 3.7% for the week ending March 12. The CDC also reported a cumulative rate of 26.6 influenza-associated hospitalizations per 100,000 population.

Ten flu-related pediatric deaths were reported during the week, of which only one occurred during the week. A total of 50 flu-related pediatric deaths have been reported during the 2015-2016 season, the CDC said. The overall proportion of deaths attributed to pneumonia and influenza was below the system-specific threshold in the National Center for Health Statistics Mortality Surveillance System, but above the system-specific threshold in the 122 Cities Mortality Reporting System.

[email protected]

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Pregnancy Considerations for Women With Epilepsy—The WEPOD Study

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VANCOUVER—Women with epilepsy seeking pregnancy had comparable likelihood of achieving pregnancy, time to achieve pregnancy, and pregnancy outcomes, compared with a group of healthy peers, according to study findings presented at the 68th Annual Meeting of the American Academy of Neurology. "These findings should reassure women with epilepsy and clinicians when counseling women with epilepsy who are planning pregnancy," said Page B. Pennell, MD, Associate Professor of Neurology at Brigham and Women's Hospital and Harvard Medical School in Boston, and her research colleagues.

Page B. Pennell, MD, Associate Professor of Neurology at Brigham and Women's Hospital and Harvard Medical School in Boston, and her research colleagues.

Page B. Pennell, MD

Previous studies suggested that women with epilepsy have lower fertility compared with healthy controls. Dr. Pennell and colleagues sought to compare time to pregnancy and outcomes (eg, live birth, miscarriage) among women with epilepsy and healthy controls. The Women with Epilepsy: Pregnancy Outcomes and Deliveries (WEPOD) study was a multicenter, prospective, observational study of women with epilepsy and healthy controls.

Dr. Pennell and colleagues enrolled and prospectively followed women with epilepsy and healthy controls, ages 18 to 41, seeking pregnancy within six months of discontinuing contraception. The customized WEPOD electronicdiary captured medication use, seizures, sexual activity, and menstrual bleeding. Pregnancy tests were performed if there was no menses by cycle day 35. Outcomes included proportions of women who achieved pregnancy and time to pregnancy from cessation of birth control. The researchers used a proportional hazard model to evaluate the association between time to pregnancy and certain baseline characteristics.

Enrolled in the study were 88 women with epilepsy and 109 healthy controls with similar demographic characteristics. Among women with epilepsy, 61.4% achieved pregnancy versus 60.6% for healthy controls. Median time to pregnancy was six months in women with epilepsy, compared with nine months for healthy controls. Time to pregnancy was no different across the two groups after controlling for age, BMI, parity, and race. Race and parity were significantly associated with time to pregnancy.

Of the pregnancies that occurred, a similar proportion resulted in miscarriage (12.9% among women with epilepsy and 19.7% among controls), live birth (80.0% among women with epilepsy and 80.3% controls) or other outcome (5.0% versus 0.0%).

The WEPOD study was supported by the Epilepsy Foundation.

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VANCOUVER—Women with epilepsy seeking pregnancy had comparable likelihood of achieving pregnancy, time to achieve pregnancy, and pregnancy outcomes, compared with a group of healthy peers, according to study findings presented at the 68th Annual Meeting of the American Academy of Neurology. "These findings should reassure women with epilepsy and clinicians when counseling women with epilepsy who are planning pregnancy," said Page B. Pennell, MD, Associate Professor of Neurology at Brigham and Women's Hospital and Harvard Medical School in Boston, and her research colleagues.

Page B. Pennell, MD, Associate Professor of Neurology at Brigham and Women's Hospital and Harvard Medical School in Boston, and her research colleagues.

Page B. Pennell, MD

Previous studies suggested that women with epilepsy have lower fertility compared with healthy controls. Dr. Pennell and colleagues sought to compare time to pregnancy and outcomes (eg, live birth, miscarriage) among women with epilepsy and healthy controls. The Women with Epilepsy: Pregnancy Outcomes and Deliveries (WEPOD) study was a multicenter, prospective, observational study of women with epilepsy and healthy controls.

Dr. Pennell and colleagues enrolled and prospectively followed women with epilepsy and healthy controls, ages 18 to 41, seeking pregnancy within six months of discontinuing contraception. The customized WEPOD electronicdiary captured medication use, seizures, sexual activity, and menstrual bleeding. Pregnancy tests were performed if there was no menses by cycle day 35. Outcomes included proportions of women who achieved pregnancy and time to pregnancy from cessation of birth control. The researchers used a proportional hazard model to evaluate the association between time to pregnancy and certain baseline characteristics.

Enrolled in the study were 88 women with epilepsy and 109 healthy controls with similar demographic characteristics. Among women with epilepsy, 61.4% achieved pregnancy versus 60.6% for healthy controls. Median time to pregnancy was six months in women with epilepsy, compared with nine months for healthy controls. Time to pregnancy was no different across the two groups after controlling for age, BMI, parity, and race. Race and parity were significantly associated with time to pregnancy.

Of the pregnancies that occurred, a similar proportion resulted in miscarriage (12.9% among women with epilepsy and 19.7% among controls), live birth (80.0% among women with epilepsy and 80.3% controls) or other outcome (5.0% versus 0.0%).

The WEPOD study was supported by the Epilepsy Foundation.

VANCOUVER—Women with epilepsy seeking pregnancy had comparable likelihood of achieving pregnancy, time to achieve pregnancy, and pregnancy outcomes, compared with a group of healthy peers, according to study findings presented at the 68th Annual Meeting of the American Academy of Neurology. "These findings should reassure women with epilepsy and clinicians when counseling women with epilepsy who are planning pregnancy," said Page B. Pennell, MD, Associate Professor of Neurology at Brigham and Women's Hospital and Harvard Medical School in Boston, and her research colleagues.

Page B. Pennell, MD, Associate Professor of Neurology at Brigham and Women's Hospital and Harvard Medical School in Boston, and her research colleagues.

Page B. Pennell, MD

Previous studies suggested that women with epilepsy have lower fertility compared with healthy controls. Dr. Pennell and colleagues sought to compare time to pregnancy and outcomes (eg, live birth, miscarriage) among women with epilepsy and healthy controls. The Women with Epilepsy: Pregnancy Outcomes and Deliveries (WEPOD) study was a multicenter, prospective, observational study of women with epilepsy and healthy controls.

Dr. Pennell and colleagues enrolled and prospectively followed women with epilepsy and healthy controls, ages 18 to 41, seeking pregnancy within six months of discontinuing contraception. The customized WEPOD electronicdiary captured medication use, seizures, sexual activity, and menstrual bleeding. Pregnancy tests were performed if there was no menses by cycle day 35. Outcomes included proportions of women who achieved pregnancy and time to pregnancy from cessation of birth control. The researchers used a proportional hazard model to evaluate the association between time to pregnancy and certain baseline characteristics.

Enrolled in the study were 88 women with epilepsy and 109 healthy controls with similar demographic characteristics. Among women with epilepsy, 61.4% achieved pregnancy versus 60.6% for healthy controls. Median time to pregnancy was six months in women with epilepsy, compared with nine months for healthy controls. Time to pregnancy was no different across the two groups after controlling for age, BMI, parity, and race. Race and parity were significantly associated with time to pregnancy.

Of the pregnancies that occurred, a similar proportion resulted in miscarriage (12.9% among women with epilepsy and 19.7% among controls), live birth (80.0% among women with epilepsy and 80.3% controls) or other outcome (5.0% versus 0.0%).

The WEPOD study was supported by the Epilepsy Foundation.

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VRIC is Just Around the Corner

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The Vascular Research Initiatives Conference - VRIC - is less than three weeks away. The one-day conference, on May 4 in Nashville, focuses on translational research. This year’s theme is “Outside In: Paradigm Shifts in Vascular Disease.”

VRIC takes place the day before the American Heart Association’s Arteriosclerosis, Thrombosis and Vascular Biology (ATVB) Scientific Sessions, and at the same venue in Nashville. VRIC is considered a key event for meeting and reconnecting with vascular research collaborators.

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The Vascular Research Initiatives Conference - VRIC - is less than three weeks away. The one-day conference, on May 4 in Nashville, focuses on translational research. This year’s theme is “Outside In: Paradigm Shifts in Vascular Disease.”

VRIC takes place the day before the American Heart Association’s Arteriosclerosis, Thrombosis and Vascular Biology (ATVB) Scientific Sessions, and at the same venue in Nashville. VRIC is considered a key event for meeting and reconnecting with vascular research collaborators.

The Vascular Research Initiatives Conference - VRIC - is less than three weeks away. The one-day conference, on May 4 in Nashville, focuses on translational research. This year’s theme is “Outside In: Paradigm Shifts in Vascular Disease.”

VRIC takes place the day before the American Heart Association’s Arteriosclerosis, Thrombosis and Vascular Biology (ATVB) Scientific Sessions, and at the same venue in Nashville. VRIC is considered a key event for meeting and reconnecting with vascular research collaborators.

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PCORI to Fund Pragmatic Trials and Studies

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The Patient-Centered Outcomes Research Institute (PCORI) has announced new funding for pragmatic clinical trials, large simple trials or large-scale observational studies that compare the relative effectiveness of two or more alternatives for improving patient-centered outcomes.

Up to $1 million in direct costs for each study will be available through the initiative, “Pragmatic Clinical Studies to Evaluate Patient-Centered Outcomes.”

PCORI has a list of priority topics, though any study that addresses critical choices faced by patients, caregivers, clinicians and/or delivery systems will be considered.

Deadline for letters of intent is May 4. Application deadline is Aug. 8, and awards will be announced in January 2017.

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The Patient-Centered Outcomes Research Institute (PCORI) has announced new funding for pragmatic clinical trials, large simple trials or large-scale observational studies that compare the relative effectiveness of two or more alternatives for improving patient-centered outcomes.

Up to $1 million in direct costs for each study will be available through the initiative, “Pragmatic Clinical Studies to Evaluate Patient-Centered Outcomes.”

PCORI has a list of priority topics, though any study that addresses critical choices faced by patients, caregivers, clinicians and/or delivery systems will be considered.

Deadline for letters of intent is May 4. Application deadline is Aug. 8, and awards will be announced in January 2017.

The Patient-Centered Outcomes Research Institute (PCORI) has announced new funding for pragmatic clinical trials, large simple trials or large-scale observational studies that compare the relative effectiveness of two or more alternatives for improving patient-centered outcomes.

Up to $1 million in direct costs for each study will be available through the initiative, “Pragmatic Clinical Studies to Evaluate Patient-Centered Outcomes.”

PCORI has a list of priority topics, though any study that addresses critical choices faced by patients, caregivers, clinicians and/or delivery systems will be considered.

Deadline for letters of intent is May 4. Application deadline is Aug. 8, and awards will be announced in January 2017.

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Register for VAM Hands-On Workshops

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SVS members have plenty of chances to learn by doing at hands-on workshops at the Vascular Annual Meeting. Twelve topics will be offered in four separate 90-minute sessions on Wednesday, June 8.

The workshops are $100 each (preregistration is required) and are not included in the VAM registration fee. Simply add the desired workshops when registering. Already registered? Just return to the registration page and add the workshops separately. The workshops are not eligible for CME credit.

Visit the VAM website for more information.

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SVS members have plenty of chances to learn by doing at hands-on workshops at the Vascular Annual Meeting. Twelve topics will be offered in four separate 90-minute sessions on Wednesday, June 8.

The workshops are $100 each (preregistration is required) and are not included in the VAM registration fee. Simply add the desired workshops when registering. Already registered? Just return to the registration page and add the workshops separately. The workshops are not eligible for CME credit.

Visit the VAM website for more information.

SVS members have plenty of chances to learn by doing at hands-on workshops at the Vascular Annual Meeting. Twelve topics will be offered in four separate 90-minute sessions on Wednesday, June 8.

The workshops are $100 each (preregistration is required) and are not included in the VAM registration fee. Simply add the desired workshops when registering. Already registered? Just return to the registration page and add the workshops separately. The workshops are not eligible for CME credit.

Visit the VAM website for more information.

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Edoxban has Advantages over Warfarin for Patients with Venous Thromboembolism

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NEW YORK (Reuters Health) - Edoxaban (Savaysa, Daiichi-Sankyo) shows advantages over warfarin in long-term treatment of patients with venous thromboembolism (VTE), according to a post-hoc analysis of multinational trial data.

As Dr. Gary Raskob told Reuters Health by email, "Our results indicate that once-daily edoxaban provides an effective

and more convenient alternative to warfarin, with lower major bleeding risk, for patients who require extended treatment

beyond three months to prevent recurrent venous thromboembolism."

In a March 22 online paper in the Lancet Haematology, Dr.Raskob, of the University of Oklahoma, Oklahoma City, and colleagues note that guidelines recommend anticoagulant treatment for at least three months. However, "The risk of recurrence is substantial for patients with unprovoked venous thromboembolism or continuing risk factors and many of these

patients need extended anticoagulation therapy beyond three months."

To shed more light on longer term effects, the team examined outcome after three to 12 months in 3,633 patients treated with heparin and edoxaban and 3,594 treated with heparin and warfarin who took part in a randomized, double-blind trial. Median treatment duration was close to 9 months.

At three months, recurrent VTE was seen in 1.1% of the edoxaban group and 1.2% of the warfarin patients. At three to six months, the corresponding proportions were 0.7% and 0.5%. At more than six but less than 12 months, they were 0.2% and 0.8%.

Among other findings was that the cumulative incidence of major bleeding was 0.3% in the edoxaban-treated group and 0.7%

in the warfarin-treated patients. Intention-to-treat analysis gave similar results to these per-protocol findings.

Use of edoxaban, Dr. Raskob concluded, "may enable more patients to stay on extended anticoagulant treatment and help reduce the burden from recurrent venous thromboembolism."

Commenting on the findings by email, Dr. Jerrold H. Levy, coauthor of an accompanying editorial, told Reuters Health, "This post-hoc analysis reports that edoxaban is an alternative to warfarin for extended use in the secondary prevention of venous thromboembolism."

Dr. Levy, of Duke University Hospital, Durham, North Carolina, concluded, "The only other study where a direct oral anticoagulant was compared with warfarin for extended use in this setting was the RE-MEDY trial that compared dabigatran with warfarin in patients for six to 36 months and found dabigatran was similar to warfarin for efficacy with a lower incidence of clinically relevant major bleeding."

This study was funded by Daiichi-Sankyo.  Dr. Raskob received fees from the company during the study. Other coauthors

also have ties to the company and a number are employees of Daiichi-Sankyo.

 

 

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NEW YORK (Reuters Health) - Edoxaban (Savaysa, Daiichi-Sankyo) shows advantages over warfarin in long-term treatment of patients with venous thromboembolism (VTE), according to a post-hoc analysis of multinational trial data.

As Dr. Gary Raskob told Reuters Health by email, "Our results indicate that once-daily edoxaban provides an effective

and more convenient alternative to warfarin, with lower major bleeding risk, for patients who require extended treatment

beyond three months to prevent recurrent venous thromboembolism."

In a March 22 online paper in the Lancet Haematology, Dr.Raskob, of the University of Oklahoma, Oklahoma City, and colleagues note that guidelines recommend anticoagulant treatment for at least three months. However, "The risk of recurrence is substantial for patients with unprovoked venous thromboembolism or continuing risk factors and many of these

patients need extended anticoagulation therapy beyond three months."

To shed more light on longer term effects, the team examined outcome after three to 12 months in 3,633 patients treated with heparin and edoxaban and 3,594 treated with heparin and warfarin who took part in a randomized, double-blind trial. Median treatment duration was close to 9 months.

At three months, recurrent VTE was seen in 1.1% of the edoxaban group and 1.2% of the warfarin patients. At three to six months, the corresponding proportions were 0.7% and 0.5%. At more than six but less than 12 months, they were 0.2% and 0.8%.

Among other findings was that the cumulative incidence of major bleeding was 0.3% in the edoxaban-treated group and 0.7%

in the warfarin-treated patients. Intention-to-treat analysis gave similar results to these per-protocol findings.

Use of edoxaban, Dr. Raskob concluded, "may enable more patients to stay on extended anticoagulant treatment and help reduce the burden from recurrent venous thromboembolism."

Commenting on the findings by email, Dr. Jerrold H. Levy, coauthor of an accompanying editorial, told Reuters Health, "This post-hoc analysis reports that edoxaban is an alternative to warfarin for extended use in the secondary prevention of venous thromboembolism."

Dr. Levy, of Duke University Hospital, Durham, North Carolina, concluded, "The only other study where a direct oral anticoagulant was compared with warfarin for extended use in this setting was the RE-MEDY trial that compared dabigatran with warfarin in patients for six to 36 months and found dabigatran was similar to warfarin for efficacy with a lower incidence of clinically relevant major bleeding."

This study was funded by Daiichi-Sankyo.  Dr. Raskob received fees from the company during the study. Other coauthors

also have ties to the company and a number are employees of Daiichi-Sankyo.

 

 

NEW YORK (Reuters Health) - Edoxaban (Savaysa, Daiichi-Sankyo) shows advantages over warfarin in long-term treatment of patients with venous thromboembolism (VTE), according to a post-hoc analysis of multinational trial data.

As Dr. Gary Raskob told Reuters Health by email, "Our results indicate that once-daily edoxaban provides an effective

and more convenient alternative to warfarin, with lower major bleeding risk, for patients who require extended treatment

beyond three months to prevent recurrent venous thromboembolism."

In a March 22 online paper in the Lancet Haematology, Dr.Raskob, of the University of Oklahoma, Oklahoma City, and colleagues note that guidelines recommend anticoagulant treatment for at least three months. However, "The risk of recurrence is substantial for patients with unprovoked venous thromboembolism or continuing risk factors and many of these

patients need extended anticoagulation therapy beyond three months."

To shed more light on longer term effects, the team examined outcome after three to 12 months in 3,633 patients treated with heparin and edoxaban and 3,594 treated with heparin and warfarin who took part in a randomized, double-blind trial. Median treatment duration was close to 9 months.

At three months, recurrent VTE was seen in 1.1% of the edoxaban group and 1.2% of the warfarin patients. At three to six months, the corresponding proportions were 0.7% and 0.5%. At more than six but less than 12 months, they were 0.2% and 0.8%.

Among other findings was that the cumulative incidence of major bleeding was 0.3% in the edoxaban-treated group and 0.7%

in the warfarin-treated patients. Intention-to-treat analysis gave similar results to these per-protocol findings.

Use of edoxaban, Dr. Raskob concluded, "may enable more patients to stay on extended anticoagulant treatment and help reduce the burden from recurrent venous thromboembolism."

Commenting on the findings by email, Dr. Jerrold H. Levy, coauthor of an accompanying editorial, told Reuters Health, "This post-hoc analysis reports that edoxaban is an alternative to warfarin for extended use in the secondary prevention of venous thromboembolism."

Dr. Levy, of Duke University Hospital, Durham, North Carolina, concluded, "The only other study where a direct oral anticoagulant was compared with warfarin for extended use in this setting was the RE-MEDY trial that compared dabigatran with warfarin in patients for six to 36 months and found dabigatran was similar to warfarin for efficacy with a lower incidence of clinically relevant major bleeding."

This study was funded by Daiichi-Sankyo.  Dr. Raskob received fees from the company during the study. Other coauthors

also have ties to the company and a number are employees of Daiichi-Sankyo.

 

 

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