Photo courtesy of CDC

New research suggests antithrombotic agents increase the risk of hematuria-related complications in older adults.

The study included more than 2.5 million Canadians over the age of 65.

The subjects had an increased risk of emergency department visits, hospitalizations, and urologic procedures to manage visible hematuria if they had received anticoagulants and/or antiplatelet agents.

Robert K. Nam, MD, of Sunnybrook Health Sciences Centre in Toronto, Ontario, Canada, and his colleagues reported these findings in JAMA.

The researchers examined rates of hematuria-related complications in 2,518,064 citizens of Ontario who were 66 and older between 2002 and 2014.

In all, 808,897 patients received at least 1 prescription for an antithrombotic agent over the study period. This included apixaban, dabigatran, rivaroxaban, warfarin, aspirin, and “other” antiplatelet agents.

At a median follow-up of 7.3 years, the incidence density rates (per 1000 person-years) of hematuria-related complications were 123.95 events among patients who were exposed to antithrombotic agents and 80.17 events among patients who were not (difference=43.8; 95% CI, 43.0-44.6; P<0.001; incidence rate ratio [IRR]=1.44; 95% CI, 1.42-1.46).

The incidence density rates of emergency department visits were 7.05 and 2.51, respectively (difference=4.5; 95% CI, 4.3-4.7; P<0.001; IRR=2.80; 95% CI, 2.74-2.86).

The incidence density rates of hospitalizations were 11.12 and 5.42, respectively (difference=5.7; 95% CI, 5.5-5.9; P<0.001; IRR=2.03; 95% CI, 2.00-2.06).

And the incidence density rates of urologic procedures were 105.78 and 72.24, respectively (difference=33.5; 95% CI, 32.8-34.3; P<0.001; IRR=1.37; 95% CI, 1.36-1.39).

The association between antithrombotic agents and hematuria-related complications was present for all the antithrombotic agents examined.

The researchers noted that this study had limitations. In particular, the cohort was restricted to patients age 66 and older because of funding eligibility for prescription medications in Ontario. Given the interaction between age and the association of antithrombotic therapies with hematuria-related complications, these results are not directly applicable to younger patients.

Photo courtesy of CDC

New research suggests antithrombotic agents increase the risk of hematuria-related complications in older adults.

The study included more than 2.5 million Canadians over the age of 65.

The subjects had an increased risk of emergency department visits, hospitalizations, and urologic procedures to manage visible hematuria if they had received anticoagulants and/or antiplatelet agents.

Robert K. Nam, MD, of Sunnybrook Health Sciences Centre in Toronto, Ontario, Canada, and his colleagues reported these findings in JAMA.

The researchers examined rates of hematuria-related complications in 2,518,064 citizens of Ontario who were 66 and older between 2002 and 2014.

In all, 808,897 patients received at least 1 prescription for an antithrombotic agent over the study period. This included apixaban, dabigatran, rivaroxaban, warfarin, aspirin, and “other” antiplatelet agents.

At a median follow-up of 7.3 years, the incidence density rates (per 1000 person-years) of hematuria-related complications were 123.95 events among patients who were exposed to antithrombotic agents and 80.17 events among patients who were not (difference=43.8; 95% CI, 43.0-44.6; P<0.001; incidence rate ratio [IRR]=1.44; 95% CI, 1.42-1.46).

The incidence density rates of emergency department visits were 7.05 and 2.51, respectively (difference=4.5; 95% CI, 4.3-4.7; P<0.001; IRR=2.80; 95% CI, 2.74-2.86).

The incidence density rates of hospitalizations were 11.12 and 5.42, respectively (difference=5.7; 95% CI, 5.5-5.9; P<0.001; IRR=2.03; 95% CI, 2.00-2.06).

And the incidence density rates of urologic procedures were 105.78 and 72.24, respectively (difference=33.5; 95% CI, 32.8-34.3; P<0.001; IRR=1.37; 95% CI, 1.36-1.39).

The association between antithrombotic agents and hematuria-related complications was present for all the antithrombotic agents examined.

The researchers noted that this study had limitations. In particular, the cohort was restricted to patients age 66 and older because of funding eligibility for prescription medications in Ontario. Given the interaction between age and the association of antithrombotic therapies with hematuria-related complications, these results are not directly applicable to younger patients.

Photo courtesy of CDC

New research suggests antithrombotic agents increase the risk of hematuria-related complications in older adults.

The study included more than 2.5 million Canadians over the age of 65.

The subjects had an increased risk of emergency department visits, hospitalizations, and urologic procedures to manage visible hematuria if they had received anticoagulants and/or antiplatelet agents.

Robert K. Nam, MD, of Sunnybrook Health Sciences Centre in Toronto, Ontario, Canada, and his colleagues reported these findings in JAMA.

The researchers examined rates of hematuria-related complications in 2,518,064 citizens of Ontario who were 66 and older between 2002 and 2014.

In all, 808,897 patients received at least 1 prescription for an antithrombotic agent over the study period. This included apixaban, dabigatran, rivaroxaban, warfarin, aspirin, and “other” antiplatelet agents.

At a median follow-up of 7.3 years, the incidence density rates (per 1000 person-years) of hematuria-related complications were 123.95 events among patients who were exposed to antithrombotic agents and 80.17 events among patients who were not (difference=43.8; 95% CI, 43.0-44.6; P<0.001; incidence rate ratio [IRR]=1.44; 95% CI, 1.42-1.46).

The incidence density rates of emergency department visits were 7.05 and 2.51, respectively (difference=4.5; 95% CI, 4.3-4.7; P<0.001; IRR=2.80; 95% CI, 2.74-2.86).

The incidence density rates of hospitalizations were 11.12 and 5.42, respectively (difference=5.7; 95% CI, 5.5-5.9; P<0.001; IRR=2.03; 95% CI, 2.00-2.06).

And the incidence density rates of urologic procedures were 105.78 and 72.24, respectively (difference=33.5; 95% CI, 32.8-34.3; P<0.001; IRR=1.37; 95% CI, 1.36-1.39).

The association between antithrombotic agents and hematuria-related complications was present for all the antithrombotic agents examined.

The researchers noted that this study had limitations. In particular, the cohort was restricted to patients age 66 and older because of funding eligibility for prescription medications in Ontario. Given the interaction between age and the association of antithrombotic therapies with hematuria-related complications, these results are not directly applicable to younger patients.

Study of AG-120 (Ivosidenib) vs. Placebo in Combination With Azacitidine in Patients With Previously Untreated Acute Myeloid Leukemia With an IDH1 Mutation (AGILE)

AG120-C-009 (NCT03173248) will evaluate the efficacy and safety of AG-120 (ivosidenib) plus azacitidine vs. placebo plus azacitidine in adult subjects with previously untreated IDH1m AML who are considered appropriate candidates for non-intensive therapy.

The primary endpoint of this global, phase 3, multicenter, double-blind, randomized, placebo-controlled clinical trial is overall survival. Key secondary efficacy endpoints are event-free survival, rate of complete remission, rate of complete remission with partial hematologic recovery, and overall response rate. Subjects will be randomized 1:1 to receive either oral AG-120 or matched placebo, both administered in combination with subcutaneous or intravenous azacitidine. An estimated 392 subjects will participate in the study, which is sponsored by Agios Pharmaceuticals. Estimated completion date is June 2022.

Study of AG-120 (Ivosidenib) vs. Placebo in Combination With Azacitidine in Patients With Previously Untreated Acute Myeloid Leukemia With an IDH1 Mutation (AGILE)

AG120-C-009 (NCT03173248) will evaluate the efficacy and safety of AG-120 (ivosidenib) plus azacitidine vs. placebo plus azacitidine in adult subjects with previously untreated IDH1m AML who are considered appropriate candidates for non-intensive therapy.

The primary endpoint of this global, phase 3, multicenter, double-blind, randomized, placebo-controlled clinical trial is overall survival. Key secondary efficacy endpoints are event-free survival, rate of complete remission, rate of complete remission with partial hematologic recovery, and overall response rate. Subjects will be randomized 1:1 to receive either oral AG-120 or matched placebo, both administered in combination with subcutaneous or intravenous azacitidine. An estimated 392 subjects will participate in the study, which is sponsored by Agios Pharmaceuticals. Estimated completion date is June 2022.

Study of AG-120 (Ivosidenib) vs. Placebo in Combination With Azacitidine in Patients With Previously Untreated Acute Myeloid Leukemia With an IDH1 Mutation (AGILE)

AG120-C-009 (NCT03173248) will evaluate the efficacy and safety of AG-120 (ivosidenib) plus azacitidine vs. placebo plus azacitidine in adult subjects with previously untreated IDH1m AML who are considered appropriate candidates for non-intensive therapy.

The primary endpoint of this global, phase 3, multicenter, double-blind, randomized, placebo-controlled clinical trial is overall survival. Key secondary efficacy endpoints are event-free survival, rate of complete remission, rate of complete remission with partial hematologic recovery, and overall response rate. Subjects will be randomized 1:1 to receive either oral AG-120 or matched placebo, both administered in combination with subcutaneous or intravenous azacitidine. An estimated 392 subjects will participate in the study, which is sponsored by Agios Pharmaceuticals. Estimated completion date is June 2022.

Nearly four out of five health care personnel in the United States received a flu vaccination during the 2016-2017 flu season, but a majority of those working in long-term care settings were not vaccinated, based on data from an Internet survey of more than 2,000 individuals that was conducted by the Centers for Disease Control and Prevention.

A total of 78.6% of the survey’s respondents said they’d been vaccinated during the 2016-2017 season. Vaccination coverage for health care personnel overall has remained in the 77%-79% range in recent years, but that represents an increase from 64% in 2010-2011.

“As in previous seasons, the highest coverage was among HCP whose workplace had vaccination requirements,” noted Carla L. Black, PhD, of the CDC, and colleagues (MMWR Morb Mortal Wkly Rep. 2017 Sep 29;66[38]:1009-15). The researchers reviewed data collected from an Internet panel survey of 2,438 health care personnel between March 28, 2017, and April 19, 2017.

Physicians boasted the highest vaccination coverage in 2016-2017 (96%), followed by pharmacists (94%), nurses (93%), nurse practitioners and physician assistants (92%), other clinical providers (80%), nonclinical health care providers (74%), and aides and assistants (69%).

Flu vaccination rates were highest among HCPs working in a hospital setting (92%); 94% of survey respondents in hospitals reported either having a vaccination requirement at work or being provided at least 1 day of on-site vaccination.

Vaccination rates were lowest among health care personnel in long-term care settings (68%), where only 26% reported a workplace vaccination requirement. However, vaccination rates in long-term care rose to 90% when employers required vaccination.

The report’s findings were limited by several factors, including the use of a volunteer sample, the reliance on self-reports, and the potential differences between Internet survey results and population-based estimates of flu vaccination.

However, “in the absence of vaccination requirements, the findings in this study support the recommendations found in the Guide to Community Preventive Services, which include active promotion of on-site vaccination at no cost or low cost to increase influenza vaccination coverage among HCPs,” the researchers said.

The researchers had no financial conflicts to disclose.

[email protected]

Nearly four out of five health care personnel in the United States received a flu vaccination during the 2016-2017 flu season, but a majority of those working in long-term care settings were not vaccinated, based on data from an Internet survey of more than 2,000 individuals that was conducted by the Centers for Disease Control and Prevention.

A total of 78.6% of the survey’s respondents said they’d been vaccinated during the 2016-2017 season. Vaccination coverage for health care personnel overall has remained in the 77%-79% range in recent years, but that represents an increase from 64% in 2010-2011.

“As in previous seasons, the highest coverage was among HCP whose workplace had vaccination requirements,” noted Carla L. Black, PhD, of the CDC, and colleagues (MMWR Morb Mortal Wkly Rep. 2017 Sep 29;66[38]:1009-15). The researchers reviewed data collected from an Internet panel survey of 2,438 health care personnel between March 28, 2017, and April 19, 2017.

Physicians boasted the highest vaccination coverage in 2016-2017 (96%), followed by pharmacists (94%), nurses (93%), nurse practitioners and physician assistants (92%), other clinical providers (80%), nonclinical health care providers (74%), and aides and assistants (69%).

Flu vaccination rates were highest among HCPs working in a hospital setting (92%); 94% of survey respondents in hospitals reported either having a vaccination requirement at work or being provided at least 1 day of on-site vaccination.

Vaccination rates were lowest among health care personnel in long-term care settings (68%), where only 26% reported a workplace vaccination requirement. However, vaccination rates in long-term care rose to 90% when employers required vaccination.

The report’s findings were limited by several factors, including the use of a volunteer sample, the reliance on self-reports, and the potential differences between Internet survey results and population-based estimates of flu vaccination.

However, “in the absence of vaccination requirements, the findings in this study support the recommendations found in the Guide to Community Preventive Services, which include active promotion of on-site vaccination at no cost or low cost to increase influenza vaccination coverage among HCPs,” the researchers said.

The researchers had no financial conflicts to disclose.

[email protected]

Nearly four out of five health care personnel in the United States received a flu vaccination during the 2016-2017 flu season, but a majority of those working in long-term care settings were not vaccinated, based on data from an Internet survey of more than 2,000 individuals that was conducted by the Centers for Disease Control and Prevention.

A total of 78.6% of the survey’s respondents said they’d been vaccinated during the 2016-2017 season. Vaccination coverage for health care personnel overall has remained in the 77%-79% range in recent years, but that represents an increase from 64% in 2010-2011.

“As in previous seasons, the highest coverage was among HCP whose workplace had vaccination requirements,” noted Carla L. Black, PhD, of the CDC, and colleagues (MMWR Morb Mortal Wkly Rep. 2017 Sep 29;66[38]:1009-15). The researchers reviewed data collected from an Internet panel survey of 2,438 health care personnel between March 28, 2017, and April 19, 2017.

Physicians boasted the highest vaccination coverage in 2016-2017 (96%), followed by pharmacists (94%), nurses (93%), nurse practitioners and physician assistants (92%), other clinical providers (80%), nonclinical health care providers (74%), and aides and assistants (69%).

Flu vaccination rates were highest among HCPs working in a hospital setting (92%); 94% of survey respondents in hospitals reported either having a vaccination requirement at work or being provided at least 1 day of on-site vaccination.

Vaccination rates were lowest among health care personnel in long-term care settings (68%), where only 26% reported a workplace vaccination requirement. However, vaccination rates in long-term care rose to 90% when employers required vaccination.

The report’s findings were limited by several factors, including the use of a volunteer sample, the reliance on self-reports, and the potential differences between Internet survey results and population-based estimates of flu vaccination.

However, “in the absence of vaccination requirements, the findings in this study support the recommendations found in the Guide to Community Preventive Services, which include active promotion of on-site vaccination at no cost or low cost to increase influenza vaccination coverage among HCPs,” the researchers said.

The researchers had no financial conflicts to disclose.

[email protected]

BARCELONA – Women diagnosed with hyperlipidemia had a strikingly reduced risk of subsequently developing breast cancer in a big-data, case-control study, Paul R. Carter, MD, reported at the annual congress of the European Society of Cardiology.

Moreover, those baseline hyperlipidemic women who later got breast cancer had a 40% lower risk of all-cause mortality than did matched nonhyperlipidemic controls diagnosed with the malignancy during follow-up, according to Dr. Carter, a cardiology fellow at Cambridge (England) University.

The inference isn’t that hyperlipidemia somehow protects against the most common type of cancer in women. Indeed, preclinical evidence indicates high cholesterol drives several key steps in carcinogenesis. Rather, the strong implication is that the explanation for the observed preventive effect lies in the pleotropic effects of the statin therapy routinely prescribed in accordance with guidelines once women received the diagnosis of hyperlipidemia, he continued.

“The results of this study provide the strongest justification to date for a clinical trial evaluating the protective effect of statins in patients with breast cancer, and this is what we intend to do,” according to Dr. Carter.

He presented a retrospective longitudinal study of the Algorithm for Comorbidities, Associations, Length of Stay and Mortality database, comprising more than 1.2 million patients admitted for various reasons to selected hospitals in northern England during 2000-2014. This big-data study entailed recruitment of 16,043 women aged 40 years and older who were diagnosed with hyperlipidemia during their hospital stay along with an equal number of age-matched women with normal lipid levels. None of the participants had a breast cancer diagnosis at baseline.

[email protected]
 

BARCELONA – Women diagnosed with hyperlipidemia had a strikingly reduced risk of subsequently developing breast cancer in a big-data, case-control study, Paul R. Carter, MD, reported at the annual congress of the European Society of Cardiology.

Moreover, those baseline hyperlipidemic women who later got breast cancer had a 40% lower risk of all-cause mortality than did matched nonhyperlipidemic controls diagnosed with the malignancy during follow-up, according to Dr. Carter, a cardiology fellow at Cambridge (England) University.

The inference isn’t that hyperlipidemia somehow protects against the most common type of cancer in women. Indeed, preclinical evidence indicates high cholesterol drives several key steps in carcinogenesis. Rather, the strong implication is that the explanation for the observed preventive effect lies in the pleotropic effects of the statin therapy routinely prescribed in accordance with guidelines once women received the diagnosis of hyperlipidemia, he continued.

“The results of this study provide the strongest justification to date for a clinical trial evaluating the protective effect of statins in patients with breast cancer, and this is what we intend to do,” according to Dr. Carter.

He presented a retrospective longitudinal study of the Algorithm for Comorbidities, Associations, Length of Stay and Mortality database, comprising more than 1.2 million patients admitted for various reasons to selected hospitals in northern England during 2000-2014. This big-data study entailed recruitment of 16,043 women aged 40 years and older who were diagnosed with hyperlipidemia during their hospital stay along with an equal number of age-matched women with normal lipid levels. None of the participants had a breast cancer diagnosis at baseline.

[email protected]
 

BARCELONA – Women diagnosed with hyperlipidemia had a strikingly reduced risk of subsequently developing breast cancer in a big-data, case-control study, Paul R. Carter, MD, reported at the annual congress of the European Society of Cardiology.

Moreover, those baseline hyperlipidemic women who later got breast cancer had a 40% lower risk of all-cause mortality than did matched nonhyperlipidemic controls diagnosed with the malignancy during follow-up, according to Dr. Carter, a cardiology fellow at Cambridge (England) University.

The inference isn’t that hyperlipidemia somehow protects against the most common type of cancer in women. Indeed, preclinical evidence indicates high cholesterol drives several key steps in carcinogenesis. Rather, the strong implication is that the explanation for the observed preventive effect lies in the pleotropic effects of the statin therapy routinely prescribed in accordance with guidelines once women received the diagnosis of hyperlipidemia, he continued.

“The results of this study provide the strongest justification to date for a clinical trial evaluating the protective effect of statins in patients with breast cancer, and this is what we intend to do,” according to Dr. Carter.

He presented a retrospective longitudinal study of the Algorithm for Comorbidities, Associations, Length of Stay and Mortality database, comprising more than 1.2 million patients admitted for various reasons to selected hospitals in northern England during 2000-2014. This big-data study entailed recruitment of 16,043 women aged 40 years and older who were diagnosed with hyperlipidemia during their hospital stay along with an equal number of age-matched women with normal lipid levels. None of the participants had a breast cancer diagnosis at baseline.

[email protected]
 

Children with type 1 diabetes mellitus who use insulin pumps are at a lower risk for ketoacidosis and severe hypoglycemia, compared with those receiving insulin by injection, according to a population-based cohort study from the University of Ulm, Germany.

The study participants were all younger than 20 years of age and were divided into the following groups for data analysis: 1.5-5 years; 6-10 years; 11-15 years; or 16-19 years. The study evaluated both primary and secondary outcomes to analyze the effectiveness of insulin pumps vs. traditional insulin injections. The primary outcomes were the rates of ketoacidosis and hypoglycemia severe enough to require assistance from another person to administer intravenous carbohydrates or induce hypoglycemic coma. The secondary outcomes were serum levels of glycated hemoglobin (HbA_1c), daily insulin dose, prandial to total insulin ratio, frequency of self-monitoring blood glucose level, and body mass index, according to Beate Karges, MD, of the University of Aachen (Germany), Division of Endocrinology and Diabetes, and her colleagues.

After applying selection criteria, 30,579 patients treated for type 1 diabetes were selected for analysis. Of the 30,579, a 1 to 1 matched cohort of 19,628 patients, split into equal sized groups, was created for propensity score analysis to compare the effect of treatment between insulin pumps and injects. The matched cohort was also included in the entire cohort for another propensity score analysis. Of the entire 30,579 patients, 14,119 used pump therapy and 16,460 used traditional daily insulin injections.

In the matched cohort, event rates for both severe hypoglycemia and hypoglycemic coma were much lower with insulin pumps than with traditional insulin injections (9.55 vs. 13.97 per 100 patient-years and 2.30 vs. 2.96 per 100 patient-years, respectively). The pattern of pump therapy lowering rates of severe hypoglycemia and hypoglycemic coma was observed in entire cohort as well, according to the investigators (JAMA. 2017 Oct 10;318[14]:1358-66).

Courtesy Wikimedia Commons/Mbbradford/CC-by-3.0

[email protected]

Children with type 1 diabetes mellitus who use insulin pumps are at a lower risk for ketoacidosis and severe hypoglycemia, compared with those receiving insulin by injection, according to a population-based cohort study from the University of Ulm, Germany.

The study participants were all younger than 20 years of age and were divided into the following groups for data analysis: 1.5-5 years; 6-10 years; 11-15 years; or 16-19 years. The study evaluated both primary and secondary outcomes to analyze the effectiveness of insulin pumps vs. traditional insulin injections. The primary outcomes were the rates of ketoacidosis and hypoglycemia severe enough to require assistance from another person to administer intravenous carbohydrates or induce hypoglycemic coma. The secondary outcomes were serum levels of glycated hemoglobin (HbA_1c), daily insulin dose, prandial to total insulin ratio, frequency of self-monitoring blood glucose level, and body mass index, according to Beate Karges, MD, of the University of Aachen (Germany), Division of Endocrinology and Diabetes, and her colleagues.

After applying selection criteria, 30,579 patients treated for type 1 diabetes were selected for analysis. Of the 30,579, a 1 to 1 matched cohort of 19,628 patients, split into equal sized groups, was created for propensity score analysis to compare the effect of treatment between insulin pumps and injects. The matched cohort was also included in the entire cohort for another propensity score analysis. Of the entire 30,579 patients, 14,119 used pump therapy and 16,460 used traditional daily insulin injections.

In the matched cohort, event rates for both severe hypoglycemia and hypoglycemic coma were much lower with insulin pumps than with traditional insulin injections (9.55 vs. 13.97 per 100 patient-years and 2.30 vs. 2.96 per 100 patient-years, respectively). The pattern of pump therapy lowering rates of severe hypoglycemia and hypoglycemic coma was observed in entire cohort as well, according to the investigators (JAMA. 2017 Oct 10;318[14]:1358-66).

Courtesy Wikimedia Commons/Mbbradford/CC-by-3.0

[email protected]

Children with type 1 diabetes mellitus who use insulin pumps are at a lower risk for ketoacidosis and severe hypoglycemia, compared with those receiving insulin by injection, according to a population-based cohort study from the University of Ulm, Germany.

The study participants were all younger than 20 years of age and were divided into the following groups for data analysis: 1.5-5 years; 6-10 years; 11-15 years; or 16-19 years. The study evaluated both primary and secondary outcomes to analyze the effectiveness of insulin pumps vs. traditional insulin injections. The primary outcomes were the rates of ketoacidosis and hypoglycemia severe enough to require assistance from another person to administer intravenous carbohydrates or induce hypoglycemic coma. The secondary outcomes were serum levels of glycated hemoglobin (HbA_1c), daily insulin dose, prandial to total insulin ratio, frequency of self-monitoring blood glucose level, and body mass index, according to Beate Karges, MD, of the University of Aachen (Germany), Division of Endocrinology and Diabetes, and her colleagues.

After applying selection criteria, 30,579 patients treated for type 1 diabetes were selected for analysis. Of the 30,579, a 1 to 1 matched cohort of 19,628 patients, split into equal sized groups, was created for propensity score analysis to compare the effect of treatment between insulin pumps and injects. The matched cohort was also included in the entire cohort for another propensity score analysis. Of the entire 30,579 patients, 14,119 used pump therapy and 16,460 used traditional daily insulin injections.

In the matched cohort, event rates for both severe hypoglycemia and hypoglycemic coma were much lower with insulin pumps than with traditional insulin injections (9.55 vs. 13.97 per 100 patient-years and 2.30 vs. 2.96 per 100 patient-years, respectively). The pattern of pump therapy lowering rates of severe hypoglycemia and hypoglycemic coma was observed in entire cohort as well, according to the investigators (JAMA. 2017 Oct 10;318[14]:1358-66).

Courtesy Wikimedia Commons/Mbbradford/CC-by-3.0

[email protected]

BERLIN – A move to depathologize paraphilias that do not adversely affect self or others is at the heart of changes suggested for the eleventh revision of the International Classification of Diseases and Related Health Problems.

The upcoming version of the World Health Organization document, slated for release in 2018, would reduce the number of named F65 classifications from nine to five, Richard B. Krueger, MD, said at the meeting of the World Psychiatric Association.

Three behaviors now included – fetishism, fetishistic transvestitism, and sadomasochism – would be dropped altogether, said Dr. Krueger of Columbia University, New York. Others would be streamlined into four more general diagnostic groupings (exhibitionism, voyeurism, pedophilia, and coercive sexual sadism disorderA fifth diagnosis, frotteuristic disorder, would be added in light of its fairly common presentation in clinical practice. Two new general categories would address unspecified behaviors that potentially are criminal, or which cause distress or danger to the individual who performs them, Dr. Krueger said.

The proposed changes would bring the document more in line with the DSM-5, said Dr. Krueger, who also leads the Working Group on the Classification of Sexual Disorders and Sexual Health. WHO charged the committee with reviewing the evidence and making recommendations for categories related to sexuality that are contained in the chapter of Mental and Behavioral Disorders in ICD-10.

[email protected]

On Twitter @Alz_Gal

BERLIN – A move to depathologize paraphilias that do not adversely affect self or others is at the heart of changes suggested for the eleventh revision of the International Classification of Diseases and Related Health Problems.

The upcoming version of the World Health Organization document, slated for release in 2018, would reduce the number of named F65 classifications from nine to five, Richard B. Krueger, MD, said at the meeting of the World Psychiatric Association.

Three behaviors now included – fetishism, fetishistic transvestitism, and sadomasochism – would be dropped altogether, said Dr. Krueger of Columbia University, New York. Others would be streamlined into four more general diagnostic groupings (exhibitionism, voyeurism, pedophilia, and coercive sexual sadism disorderA fifth diagnosis, frotteuristic disorder, would be added in light of its fairly common presentation in clinical practice. Two new general categories would address unspecified behaviors that potentially are criminal, or which cause distress or danger to the individual who performs them, Dr. Krueger said.

The proposed changes would bring the document more in line with the DSM-5, said Dr. Krueger, who also leads the Working Group on the Classification of Sexual Disorders and Sexual Health. WHO charged the committee with reviewing the evidence and making recommendations for categories related to sexuality that are contained in the chapter of Mental and Behavioral Disorders in ICD-10.

[email protected]

On Twitter @Alz_Gal

BERLIN – A move to depathologize paraphilias that do not adversely affect self or others is at the heart of changes suggested for the eleventh revision of the International Classification of Diseases and Related Health Problems.

The upcoming version of the World Health Organization document, slated for release in 2018, would reduce the number of named F65 classifications from nine to five, Richard B. Krueger, MD, said at the meeting of the World Psychiatric Association.

Three behaviors now included – fetishism, fetishistic transvestitism, and sadomasochism – would be dropped altogether, said Dr. Krueger of Columbia University, New York. Others would be streamlined into four more general diagnostic groupings (exhibitionism, voyeurism, pedophilia, and coercive sexual sadism disorderA fifth diagnosis, frotteuristic disorder, would be added in light of its fairly common presentation in clinical practice. Two new general categories would address unspecified behaviors that potentially are criminal, or which cause distress or danger to the individual who performs them, Dr. Krueger said.

The proposed changes would bring the document more in line with the DSM-5, said Dr. Krueger, who also leads the Working Group on the Classification of Sexual Disorders and Sexual Health. WHO charged the committee with reviewing the evidence and making recommendations for categories related to sexuality that are contained in the chapter of Mental and Behavioral Disorders in ICD-10.

[email protected]

On Twitter @Alz_Gal

Transgender men and women are at high risk for HIV infection. In a recent analysis of more than 9 million CDC-funded HIV test results, transgender women had the highest percentage of confirmed positive results (2.7%) of any gender category. But this group also tends to have too-low testing numbers. In a CDC study, only 36% of transgender women and 32% of transgender men reported being tested; only 10% of both groups had been tested in the past year. By comparison, gay and bisexual men reported getting tested at roughly twice the rates (61.8% ever and 21.6% past year).

Black transgender women and men had twice the prevalence of ever testing compared with their white counterparts (63%-67% vs 31%-33%). Transgender women who had been diagnosed with a depressive disorder had the highest prevalence of getting tested for HIV (69%).

Transgender persons face “unique barriers to testing,” the CDC researchers say, such as the HIV stigma within the transgender community, gender identity stigma in health care settings, and socioeconomic marginalization. The CDC is working on “innovative approaches” to delivering HIV testing and other prevention and support services to transgender persons who are at risk for or have newly diagnosed HIV.

Transgender men and women are at high risk for HIV infection. In a recent analysis of more than 9 million CDC-funded HIV test results, transgender women had the highest percentage of confirmed positive results (2.7%) of any gender category. But this group also tends to have too-low testing numbers. In a CDC study, only 36% of transgender women and 32% of transgender men reported being tested; only 10% of both groups had been tested in the past year. By comparison, gay and bisexual men reported getting tested at roughly twice the rates (61.8% ever and 21.6% past year).

Black transgender women and men had twice the prevalence of ever testing compared with their white counterparts (63%-67% vs 31%-33%). Transgender women who had been diagnosed with a depressive disorder had the highest prevalence of getting tested for HIV (69%).

Transgender persons face “unique barriers to testing,” the CDC researchers say, such as the HIV stigma within the transgender community, gender identity stigma in health care settings, and socioeconomic marginalization. The CDC is working on “innovative approaches” to delivering HIV testing and other prevention and support services to transgender persons who are at risk for or have newly diagnosed HIV.

Transgender men and women are at high risk for HIV infection. In a recent analysis of more than 9 million CDC-funded HIV test results, transgender women had the highest percentage of confirmed positive results (2.7%) of any gender category. But this group also tends to have too-low testing numbers. In a CDC study, only 36% of transgender women and 32% of transgender men reported being tested; only 10% of both groups had been tested in the past year. By comparison, gay and bisexual men reported getting tested at roughly twice the rates (61.8% ever and 21.6% past year).

Black transgender women and men had twice the prevalence of ever testing compared with their white counterparts (63%-67% vs 31%-33%). Transgender women who had been diagnosed with a depressive disorder had the highest prevalence of getting tested for HIV (69%).

Transgender persons face “unique barriers to testing,” the CDC researchers say, such as the HIV stigma within the transgender community, gender identity stigma in health care settings, and socioeconomic marginalization. The CDC is working on “innovative approaches” to delivering HIV testing and other prevention and support services to transgender persons who are at risk for or have newly diagnosed HIV.

Image by Joshua Stokes

Researchers have reported successful inhibition of the phosphatase SHIP1, which may be an effective approach for treating T-cell lymphoma.

The team found that intermittent treatment with a SHIP1 inhibitor prevented the immune exhaustion observed with SHIP1 deletion.

Intermittent SHIP1 inhibition enhanced the antitumor activity of natural killer (NK) cells and T cells in a mouse model of T-cell lymphoma.

The treatment also appeared to have a direct chemotherapeutic effect and induced immunological memory against lymphoma cells.

Matthew Gumbleton, MD, of SUNY Upstate Medical University in Syracuse, New York, and his colleagues reported these results in Science Signaling.

The researchers noted that previous efforts to inhibit SHIP1 have yielded disappointing results. Mice engineered to lack the SHIP1 gene had poorly responsive immune systems, potentially because overactivated cells became exhausted.

Dr Gumbleton and his colleagues found they could overcome this problem by administering a SHIP1 inhibitor—3-a-aminocholestane (3AC)—in a pulsed regimen of 2 consecutive treatment days per week.

The team tested this regimen in mouse models of colorectal cancer and T-cell lymphoma (RMA-Rae1).

In the lymphoma model, intermittent 3AC treatment increased the responsiveness of T cells and NK cells.

The treatment significantly increased the number of NK cells at the tumor site and the terminal maturation of the peripheral NK-cell compartment.

3AC also enhanced FasL-Fas–mediated killing of lymphoma cells. (NK cells induce apoptosis of target cells via Fas-FasL signaling.)

However, 3AC treatment reduced lymphoma burden in NK-cell-deficient mice as well. Therefore, the researchers believe 3AC may have a direct chemotherapeutic effect.

The team also found that intermittent 3AC treatment increased survival in lymphoma-bearing mice.

Treated mice had significantly longer survival than control mice. And some of the treated mice had long-term survival with no evidence of tumor burden, which suggests the treatment could be curative.

Additional experiments revealed that both NK cells and T cells were required to induce long-term survival in the lymphoma-bearing mice.

Finally, the researchers found evidence to suggest that 3AC treatment triggered “immunological memory capable of sustained and protective antitumor response that prevents relapse.”

The team infused hematolymphoid cells from either a naïve donor mouse or a lymphoma-challenged, 3AC-treated, long-term-surviving donor mouse into naïve host mice. The host mice were then challenged with RMA-Rae1 cells but didn’t receive 3AC.

Mice that received cells from the 3AC-treated donors had significantly better survival than mice that received cells from naive donors.

Based on these results, the researchers concluded that intermittent SHIP1 inhibition may be effective for treating and preventing relapse of T-cell lymphoma and other cancers.

Image by Joshua Stokes

Researchers have reported successful inhibition of the phosphatase SHIP1, which may be an effective approach for treating T-cell lymphoma.

The team found that intermittent treatment with a SHIP1 inhibitor prevented the immune exhaustion observed with SHIP1 deletion.

Intermittent SHIP1 inhibition enhanced the antitumor activity of natural killer (NK) cells and T cells in a mouse model of T-cell lymphoma.

The treatment also appeared to have a direct chemotherapeutic effect and induced immunological memory against lymphoma cells.

Matthew Gumbleton, MD, of SUNY Upstate Medical University in Syracuse, New York, and his colleagues reported these results in Science Signaling.

The researchers noted that previous efforts to inhibit SHIP1 have yielded disappointing results. Mice engineered to lack the SHIP1 gene had poorly responsive immune systems, potentially because overactivated cells became exhausted.

Dr Gumbleton and his colleagues found they could overcome this problem by administering a SHIP1 inhibitor—3-a-aminocholestane (3AC)—in a pulsed regimen of 2 consecutive treatment days per week.

The team tested this regimen in mouse models of colorectal cancer and T-cell lymphoma (RMA-Rae1).

In the lymphoma model, intermittent 3AC treatment increased the responsiveness of T cells and NK cells.

The treatment significantly increased the number of NK cells at the tumor site and the terminal maturation of the peripheral NK-cell compartment.

3AC also enhanced FasL-Fas–mediated killing of lymphoma cells. (NK cells induce apoptosis of target cells via Fas-FasL signaling.)

However, 3AC treatment reduced lymphoma burden in NK-cell-deficient mice as well. Therefore, the researchers believe 3AC may have a direct chemotherapeutic effect.

The team also found that intermittent 3AC treatment increased survival in lymphoma-bearing mice.

Treated mice had significantly longer survival than control mice. And some of the treated mice had long-term survival with no evidence of tumor burden, which suggests the treatment could be curative.

Additional experiments revealed that both NK cells and T cells were required to induce long-term survival in the lymphoma-bearing mice.

Finally, the researchers found evidence to suggest that 3AC treatment triggered “immunological memory capable of sustained and protective antitumor response that prevents relapse.”

The team infused hematolymphoid cells from either a naïve donor mouse or a lymphoma-challenged, 3AC-treated, long-term-surviving donor mouse into naïve host mice. The host mice were then challenged with RMA-Rae1 cells but didn’t receive 3AC.

Mice that received cells from the 3AC-treated donors had significantly better survival than mice that received cells from naive donors.

Based on these results, the researchers concluded that intermittent SHIP1 inhibition may be effective for treating and preventing relapse of T-cell lymphoma and other cancers.

Image by Joshua Stokes

Researchers have reported successful inhibition of the phosphatase SHIP1, which may be an effective approach for treating T-cell lymphoma.

The team found that intermittent treatment with a SHIP1 inhibitor prevented the immune exhaustion observed with SHIP1 deletion.

Intermittent SHIP1 inhibition enhanced the antitumor activity of natural killer (NK) cells and T cells in a mouse model of T-cell lymphoma.

The treatment also appeared to have a direct chemotherapeutic effect and induced immunological memory against lymphoma cells.

Matthew Gumbleton, MD, of SUNY Upstate Medical University in Syracuse, New York, and his colleagues reported these results in Science Signaling.

The researchers noted that previous efforts to inhibit SHIP1 have yielded disappointing results. Mice engineered to lack the SHIP1 gene had poorly responsive immune systems, potentially because overactivated cells became exhausted.

Dr Gumbleton and his colleagues found they could overcome this problem by administering a SHIP1 inhibitor—3-a-aminocholestane (3AC)—in a pulsed regimen of 2 consecutive treatment days per week.

The team tested this regimen in mouse models of colorectal cancer and T-cell lymphoma (RMA-Rae1).

In the lymphoma model, intermittent 3AC treatment increased the responsiveness of T cells and NK cells.

The treatment significantly increased the number of NK cells at the tumor site and the terminal maturation of the peripheral NK-cell compartment.

3AC also enhanced FasL-Fas–mediated killing of lymphoma cells. (NK cells induce apoptosis of target cells via Fas-FasL signaling.)

However, 3AC treatment reduced lymphoma burden in NK-cell-deficient mice as well. Therefore, the researchers believe 3AC may have a direct chemotherapeutic effect.

The team also found that intermittent 3AC treatment increased survival in lymphoma-bearing mice.

Treated mice had significantly longer survival than control mice. And some of the treated mice had long-term survival with no evidence of tumor burden, which suggests the treatment could be curative.

Additional experiments revealed that both NK cells and T cells were required to induce long-term survival in the lymphoma-bearing mice.

Finally, the researchers found evidence to suggest that 3AC treatment triggered “immunological memory capable of sustained and protective antitumor response that prevents relapse.”

The team infused hematolymphoid cells from either a naïve donor mouse or a lymphoma-challenged, 3AC-treated, long-term-surviving donor mouse into naïve host mice. The host mice were then challenged with RMA-Rae1 cells but didn’t receive 3AC.

Mice that received cells from the 3AC-treated donors had significantly better survival than mice that received cells from naive donors.

Based on these results, the researchers concluded that intermittent SHIP1 inhibition may be effective for treating and preventing relapse of T-cell lymphoma and other cancers.

Photo by Esther Dyson

The US Food and Drug Administration (FDA) has placed a full clinical hold on a phase 1/2 trial of SEL24, a dual PIM/FLT3 kinase inhibitor, in patients with relapsed/refractory acute myeloid leukemia (AML).

The hold is due to a fatal cerebral adverse event that is considered possibly related to SEL24.

The clinical hold means no new patients will be enrolled in the trial and enrolled patients will not receive SEL24 until the hold is lifted.

Selvita S.A., the company developing SEL24, received a clinical hold letter from the FDA on October 6 and said it plans to work with the agency to have the hold lifted.

As part of this process, Selvita will provide the FDA with additional data and analysis on patients treated with SEL24 as well as a proposed protocol amendment.

The trial began in the first quarter of 2017. The study is designed to determine the maximum tolerated dose and recommended dose of SEL24 in patients with relapsed and refractory AML. The study began with a 25 mg daily dose, which was then escalated following cohort reviews.

One AML patient started treatment with a 150 mg dose of SEL24 as the third patient in this dose cohort and received 4 doses of the drug. This patient developed a life-threatening, grade 4 venous thrombus in the brain with subsequent intracerebral hemorrhage, which required hospitalization.

The patient died in hospice 4 days later due to the cerebral event. The patient’s death was subsequently evaluated as possibly related to SEL24.

A safety report and a review of data by the trial’s data monitoring committee were submitted to the FDA. The agency then placed a clinical hold on the trial and requested more safety data on patients who have received SEL24, as well as specific protocol changes and additional guidance to the study staff.

Selvita said it plans to comply with the requests and provide additional information to the agency and clinical trial centers, in collaboration with the Menarini Group, its global development partner for SEL24.

The FDA has 30 days from the receipt of Selvita’s response to let the company know whether the clinical hold is lifted.

Photo by Esther Dyson

The US Food and Drug Administration (FDA) has placed a full clinical hold on a phase 1/2 trial of SEL24, a dual PIM/FLT3 kinase inhibitor, in patients with relapsed/refractory acute myeloid leukemia (AML).

The hold is due to a fatal cerebral adverse event that is considered possibly related to SEL24.

The clinical hold means no new patients will be enrolled in the trial and enrolled patients will not receive SEL24 until the hold is lifted.

Selvita S.A., the company developing SEL24, received a clinical hold letter from the FDA on October 6 and said it plans to work with the agency to have the hold lifted.

As part of this process, Selvita will provide the FDA with additional data and analysis on patients treated with SEL24 as well as a proposed protocol amendment.

The trial began in the first quarter of 2017. The study is designed to determine the maximum tolerated dose and recommended dose of SEL24 in patients with relapsed and refractory AML. The study began with a 25 mg daily dose, which was then escalated following cohort reviews.

One AML patient started treatment with a 150 mg dose of SEL24 as the third patient in this dose cohort and received 4 doses of the drug. This patient developed a life-threatening, grade 4 venous thrombus in the brain with subsequent intracerebral hemorrhage, which required hospitalization.

The patient died in hospice 4 days later due to the cerebral event. The patient’s death was subsequently evaluated as possibly related to SEL24.

A safety report and a review of data by the trial’s data monitoring committee were submitted to the FDA. The agency then placed a clinical hold on the trial and requested more safety data on patients who have received SEL24, as well as specific protocol changes and additional guidance to the study staff.

Selvita said it plans to comply with the requests and provide additional information to the agency and clinical trial centers, in collaboration with the Menarini Group, its global development partner for SEL24.

The FDA has 30 days from the receipt of Selvita’s response to let the company know whether the clinical hold is lifted.

Photo by Esther Dyson

The US Food and Drug Administration (FDA) has placed a full clinical hold on a phase 1/2 trial of SEL24, a dual PIM/FLT3 kinase inhibitor, in patients with relapsed/refractory acute myeloid leukemia (AML).

The hold is due to a fatal cerebral adverse event that is considered possibly related to SEL24.

The clinical hold means no new patients will be enrolled in the trial and enrolled patients will not receive SEL24 until the hold is lifted.

Selvita S.A., the company developing SEL24, received a clinical hold letter from the FDA on October 6 and said it plans to work with the agency to have the hold lifted.

As part of this process, Selvita will provide the FDA with additional data and analysis on patients treated with SEL24 as well as a proposed protocol amendment.

The trial began in the first quarter of 2017. The study is designed to determine the maximum tolerated dose and recommended dose of SEL24 in patients with relapsed and refractory AML. The study began with a 25 mg daily dose, which was then escalated following cohort reviews.

One AML patient started treatment with a 150 mg dose of SEL24 as the third patient in this dose cohort and received 4 doses of the drug. This patient developed a life-threatening, grade 4 venous thrombus in the brain with subsequent intracerebral hemorrhage, which required hospitalization.

The patient died in hospice 4 days later due to the cerebral event. The patient’s death was subsequently evaluated as possibly related to SEL24.

A safety report and a review of data by the trial’s data monitoring committee were submitted to the FDA. The agency then placed a clinical hold on the trial and requested more safety data on patients who have received SEL24, as well as specific protocol changes and additional guidance to the study staff.

Selvita said it plans to comply with the requests and provide additional information to the agency and clinical trial centers, in collaboration with the Menarini Group, its global development partner for SEL24.

The FDA has 30 days from the receipt of Selvita’s response to let the company know whether the clinical hold is lifted.

Photo by Rhoda Baer

The US Food and Drug Administration (FDA) has issued a complete response letter saying the agency cannot approve MYL-1401H, a proposed biosimilar of pegfilgrastim (Neulasta).

Biocon and Mylan are seeking approval of MYL-1401H to reduce the duration of neutropenia and the incidence of febrile neutropenia in adults receiving chemotherapy to treat non-myeloid malignancies.

Biocon and Mylan filed the biologics license application for MYL-1401H in February.

The FDA had planned to issue a decision on the application by October 9.

Biocon and Mylan said the FDA’s complete response letter relates to a pending update to the application. The update involves chemistry manufacturing and control data from facility requalification activities after recent plant modifications.

The complete response letter did not raise any questions on the biosimilarity of MYL-1401H, pharmacokinetic/pharmacodynamic data, clinical data, or immunogenicity. (Results of a phase 3 study presented at ESMO 2016 Congress suggested MYL-1401H is equivalent to Neulasta.)

Biocon and Mylan said they do not expect the complete response letter for MYL-1401H to impact the commercial launch timing of the drug in the US. The companies said they are committed to working with the FDA to resolve the issues outlined in the letter.

Photo by Rhoda Baer

The US Food and Drug Administration (FDA) has issued a complete response letter saying the agency cannot approve MYL-1401H, a proposed biosimilar of pegfilgrastim (Neulasta).

Biocon and Mylan are seeking approval of MYL-1401H to reduce the duration of neutropenia and the incidence of febrile neutropenia in adults receiving chemotherapy to treat non-myeloid malignancies.

Biocon and Mylan filed the biologics license application for MYL-1401H in February.

The FDA had planned to issue a decision on the application by October 9.

Biocon and Mylan said the FDA’s complete response letter relates to a pending update to the application. The update involves chemistry manufacturing and control data from facility requalification activities after recent plant modifications.

The complete response letter did not raise any questions on the biosimilarity of MYL-1401H, pharmacokinetic/pharmacodynamic data, clinical data, or immunogenicity. (Results of a phase 3 study presented at ESMO 2016 Congress suggested MYL-1401H is equivalent to Neulasta.)

Biocon and Mylan said they do not expect the complete response letter for MYL-1401H to impact the commercial launch timing of the drug in the US. The companies said they are committed to working with the FDA to resolve the issues outlined in the letter.

Photo by Rhoda Baer

The US Food and Drug Administration (FDA) has issued a complete response letter saying the agency cannot approve MYL-1401H, a proposed biosimilar of pegfilgrastim (Neulasta).

Biocon and Mylan are seeking approval of MYL-1401H to reduce the duration of neutropenia and the incidence of febrile neutropenia in adults receiving chemotherapy to treat non-myeloid malignancies.

Biocon and Mylan filed the biologics license application for MYL-1401H in February.

The FDA had planned to issue a decision on the application by October 9.

Biocon and Mylan said the FDA’s complete response letter relates to a pending update to the application. The update involves chemistry manufacturing and control data from facility requalification activities after recent plant modifications.

The complete response letter did not raise any questions on the biosimilarity of MYL-1401H, pharmacokinetic/pharmacodynamic data, clinical data, or immunogenicity. (Results of a phase 3 study presented at ESMO 2016 Congress suggested MYL-1401H is equivalent to Neulasta.)

Biocon and Mylan said they do not expect the complete response letter for MYL-1401H to impact the commercial launch timing of the drug in the US. The companies said they are committed to working with the FDA to resolve the issues outlined in the letter.