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Can’t Quite Put My Finger On It …
ANSWER
The correct answer is perform a shave biopsy (choice “c”). It is a bedrock principle in dermatology that there is no substitute for a correct diagnosis, because correct diagnosis dictates proper treatment. When practical, biopsy is an excellent way to establish the true nature of a lesion and rule out other possibilities; it cuts through all conjecture.
DISCUSSION
The report showed intraepidermal squamous cell carcinoma, also known as Bowen disease. In this case, overexposure to the sun was the probable cause; however, Bowen disease can also develop from non–UV-related triggers, including human papillomavirus, arsenic (usually in contaminated ground water), and radiation treatment.
The differential includes psoriasis (which waxes and wanes), fungal infection (unlikely to last 10 years with so little growth), and superficial basal cell carcinoma.
Treatment success can be achieved by electrodessication and curettage or by the application of 5-fluorouracil or imiquimod cream for a month or two. Rarely, Bowen lesions can become invasive and metastasize if left untreated.
This patient’s prognosis, however, is excellent—at least, as far as this lesion is concerned. His history of sun exposure and numerous skin cancers
ANSWER
The correct answer is perform a shave biopsy (choice “c”). It is a bedrock principle in dermatology that there is no substitute for a correct diagnosis, because correct diagnosis dictates proper treatment. When practical, biopsy is an excellent way to establish the true nature of a lesion and rule out other possibilities; it cuts through all conjecture.
DISCUSSION
The report showed intraepidermal squamous cell carcinoma, also known as Bowen disease. In this case, overexposure to the sun was the probable cause; however, Bowen disease can also develop from non–UV-related triggers, including human papillomavirus, arsenic (usually in contaminated ground water), and radiation treatment.
The differential includes psoriasis (which waxes and wanes), fungal infection (unlikely to last 10 years with so little growth), and superficial basal cell carcinoma.
Treatment success can be achieved by electrodessication and curettage or by the application of 5-fluorouracil or imiquimod cream for a month or two. Rarely, Bowen lesions can become invasive and metastasize if left untreated.
This patient’s prognosis, however, is excellent—at least, as far as this lesion is concerned. His history of sun exposure and numerous skin cancers
ANSWER
The correct answer is perform a shave biopsy (choice “c”). It is a bedrock principle in dermatology that there is no substitute for a correct diagnosis, because correct diagnosis dictates proper treatment. When practical, biopsy is an excellent way to establish the true nature of a lesion and rule out other possibilities; it cuts through all conjecture.
DISCUSSION
The report showed intraepidermal squamous cell carcinoma, also known as Bowen disease. In this case, overexposure to the sun was the probable cause; however, Bowen disease can also develop from non–UV-related triggers, including human papillomavirus, arsenic (usually in contaminated ground water), and radiation treatment.
The differential includes psoriasis (which waxes and wanes), fungal infection (unlikely to last 10 years with so little growth), and superficial basal cell carcinoma.
Treatment success can be achieved by electrodessication and curettage or by the application of 5-fluorouracil or imiquimod cream for a month or two. Rarely, Bowen lesions can become invasive and metastasize if left untreated.
This patient’s prognosis, however, is excellent—at least, as far as this lesion is concerned. His history of sun exposure and numerous skin cancers
For at least 10 years, a now 70-year-old man has had a lesion on his left third finger. It is asymptomatic but gradually growing larger. Various primary care providers have offered diagnoses, the most recent being “fungal infection,” but treatments including nystatin cream have had no good effect.
The oval, pink, scaly lesion is located on the medial aspect of the proximal phalanx of the patient’s left hand; it measures 2.3 cm with well-defined borders. It is barely palpable and is not at all tender. No nodes can be felt in the arm or axilla.
The patient is otherwise healthy and is not immunosuppressed. His skin elsewhere shows evidence of sun damage—including actinic keratosis, solar lentigines, and telangiectasias—and removal of several basal cell carcinomas from his face and arms. His elbows, knees, scalp, and nails are free of any notable skin changes.
Stroke Deaths: Reversing a Healthy Trend?
After decades of decline, progress has slowed in preventing stroke deaths, according to a CDC Vital Signs report. The report is a “wake-up call,” CDC Director Brenda Fitzgerald says.
About 3 in every 4 states showed stalled rates of decline between 2000 and 2015. In some states, the trend of declining stroke deaths has actually reversed. It is a “disturbing” finding, the researchers say—particularly because 80% of strokes are preventable.
Every 40 seconds, someone in the U.S. has a stroke. Each year, > 140,000 die. Blacks continue to be hardest hit by stroke but stroke deaths are on the rise among Hispanics (by 6% each year between 2013 and 2015) and people living in the South.
Death rates continued to drop steadily between the years 2000 and 2015 among adults aged ≥ 35 years. However, people are dying of stroke at younger ages. Over the past 15 years, stroke hospitalizations have increased among adults aged 18 to 54 years. But the researchers note that risk factors, such as high blood pressure, high cholesterol, obesity, and diabetes are also appearing in younger people. Moreover, those risk factors may not be recognized and treated in middle-aged adults aged 35 to 64 years.
The study categorizes stroke deaths in the U.S. from 2000 to 2015, by age, sex, race/ethnicity, and geographic area. It does not, however, address causes for the slowdown, although it cites other studies that point to obesity and diabetes as contributors. High blood pressure is the single “most important preventable and treatable risk factor for stroke,” the CDC says.
After decades of decline, progress has slowed in preventing stroke deaths, according to a CDC Vital Signs report. The report is a “wake-up call,” CDC Director Brenda Fitzgerald says.
About 3 in every 4 states showed stalled rates of decline between 2000 and 2015. In some states, the trend of declining stroke deaths has actually reversed. It is a “disturbing” finding, the researchers say—particularly because 80% of strokes are preventable.
Every 40 seconds, someone in the U.S. has a stroke. Each year, > 140,000 die. Blacks continue to be hardest hit by stroke but stroke deaths are on the rise among Hispanics (by 6% each year between 2013 and 2015) and people living in the South.
Death rates continued to drop steadily between the years 2000 and 2015 among adults aged ≥ 35 years. However, people are dying of stroke at younger ages. Over the past 15 years, stroke hospitalizations have increased among adults aged 18 to 54 years. But the researchers note that risk factors, such as high blood pressure, high cholesterol, obesity, and diabetes are also appearing in younger people. Moreover, those risk factors may not be recognized and treated in middle-aged adults aged 35 to 64 years.
The study categorizes stroke deaths in the U.S. from 2000 to 2015, by age, sex, race/ethnicity, and geographic area. It does not, however, address causes for the slowdown, although it cites other studies that point to obesity and diabetes as contributors. High blood pressure is the single “most important preventable and treatable risk factor for stroke,” the CDC says.
After decades of decline, progress has slowed in preventing stroke deaths, according to a CDC Vital Signs report. The report is a “wake-up call,” CDC Director Brenda Fitzgerald says.
About 3 in every 4 states showed stalled rates of decline between 2000 and 2015. In some states, the trend of declining stroke deaths has actually reversed. It is a “disturbing” finding, the researchers say—particularly because 80% of strokes are preventable.
Every 40 seconds, someone in the U.S. has a stroke. Each year, > 140,000 die. Blacks continue to be hardest hit by stroke but stroke deaths are on the rise among Hispanics (by 6% each year between 2013 and 2015) and people living in the South.
Death rates continued to drop steadily between the years 2000 and 2015 among adults aged ≥ 35 years. However, people are dying of stroke at younger ages. Over the past 15 years, stroke hospitalizations have increased among adults aged 18 to 54 years. But the researchers note that risk factors, such as high blood pressure, high cholesterol, obesity, and diabetes are also appearing in younger people. Moreover, those risk factors may not be recognized and treated in middle-aged adults aged 35 to 64 years.
The study categorizes stroke deaths in the U.S. from 2000 to 2015, by age, sex, race/ethnicity, and geographic area. It does not, however, address causes for the slowdown, although it cites other studies that point to obesity and diabetes as contributors. High blood pressure is the single “most important preventable and treatable risk factor for stroke,” the CDC says.
Predicting neurotoxicity after CAR T-cell therapy
Researchers say they have identified potential biomarkers that may be used to help identify patients at an increased risk of neurotoxicity after chimeric antigen receptor (CAR) T-cell therapy.
The team also created an algorithm intended to identify patients whose symptoms were most likely to be life-threatening.
The researchers discovered the biomarkers and developed the algorithm based on data from a trial of JCAR014, an anti-CD19 CAR T-cell therapy, in patients with B-cell malignancies.
Cameron J. Turtle, MBBS, PhD, of Fred Hutchinson Cancer Research Center in Seattle, Washington, and his colleagues described this research in Cancer Discovery.
“It’s essential that we understand the potential side effects of CAR T therapies” Dr Turtle said. “While use of these cell therapies is likely to dramatically increase because they’ve been so effective in patients with resistant or refractory B-cell malignancies, there is still much to learn.”
Dr Turtle and his colleagues sought to provide a detailed clinical, radiological, and pathological characterization of neurotoxicity arising from anti-CD19 CAR T-cell therapy.
So the team analyzed data from a phase 1/2 trial of 133 adults with relapsed and/or refractory CD19+ B-cell acute lymphoblastic leukemia, non-Hodgkin lymphoma, or chronic lymphocytic leukemia.
The patients received lymphodepleting chemotherapy followed by an infusion of JCAR014.
Neurotoxicity
Within 28 days of treatment, 53 patients (40%) developed grade 1 or higher neurologic adverse events (AEs), 28 patients (21%) had grade 3 or higher neurotoxicity, and 4 patients (3%) developed fatal neurotoxicity.
Of the 53 patients with any neurologic AE, 48 (91%) also had cytokine release syndrome (CRS). All neurologic AEs in the 5 patients who did not have CRS were mild (grade 1) and transient.
Neurologic AEs included delirium with preserved alertness (66%), headache (55%), language disturbance (34%), decreased level of consciousness (25%), seizures (8%), and macroscopic intracranial hemorrhage (2%).
For most patients, neurotoxicity resolved by day 28 after CAR T-cell infusion. The exceptions were 1 patient in whom a grade 1 neurologic AE resolved 2 months after CAR T-cell infusion and the 4 patients who died of neurotoxicity.
The 4 neurotoxicity-related deaths were due to:
- Acute cerebral edema (n=2)
- Multifocal brainstem hemorrhage and edema associated with disseminated intravascular coagulation (n=1)
- Cortical laminar necrosis with a persistent minimally conscious state until death (n=1).
Potential biomarkers
In a univariate analysis, neurotoxicity was significantly more frequent in patients who:
- Had CRS (P<0.0001)
- Received a high CAR T-cell dose (P<0.0001)
- Had pre-existing neurologic comorbidities at baseline (P=0.0059).
In a multivariable analysis (which did not include CRS as a variable), patients had an increased risk of neurotoxicity if they:
- Had pre-existing neurologic comorbidities (P=0.0023)
- Received cyclophosphamide and fludarabine lymphodepletion (P=0.0259)
- Received a higher CAR T-cell dose (P=0.0009)
- Had a higher burden of malignant CD19+ B cells in the bone marrow (P=0.0165).
The researchers noted that patients who developed grade 3 or higher neurotoxicity had more severe CRS (P<0.0001).
“It appears that cytokine release syndrome is probably necessary for most cases of severe neurotoxicity, but, in terms of what triggers a person with cytokine release syndrome to get neurotoxicity, that’s something we need to investigate further,” said study author Kevin Hay, MD, of Fred Hutchinson Cancer Research Center.
Dr Hay and his colleagues also found that patients with severe neurotoxicity exhibited evidence of endothelial activation, which could contribute to manifestations such as capillary leak, disseminated intravascular coagulation, and disruption of the blood-brain barrier.
Algorithm
The researchers developed a predictive classification tree algorithm to identify patients who have an increased risk of severe neurotoxicity.
The algorithm suggests patients who meet the following criteria in the first 36 hours after CAR T-cell infusion have a high risk of grade 4-5 neurotoxicity:
- Fever of 38.9°C or greater
- Serum levels of IL6 at 16 pg/mL or higher
- Serum levels of MCP1 at 1343.5 pg/mL or higher.
This algorithm predicted severe neurotoxicity with 100% sensitivity and 94% specificity. Eight patients were misclassified, 1 of whom did not subsequently develop grade 2-3 neurotoxicity and/or grade 2 or higher CRS.
Funding
This research was funded by Juno Therapeutics Inc. (the company developing JCAR014), the National Cancer Institute, Life Science Discovery Fund, the Bezos family, the University of British Columbia Clinical Investigator Program, and via institutional funds from Bloodworks Northwest.
Dr Turtle receives research funding from Juno Therapeutics, holds patents licensed by Juno, and has pending patent applications that could be licensed by nonprofit institutions and for-profit companies, including Juno.
The Fred Hutchinson Cancer Research Center has a financial interest in Juno and receives licensing and other payments from the company. 
Researchers say they have identified potential biomarkers that may be used to help identify patients at an increased risk of neurotoxicity after chimeric antigen receptor (CAR) T-cell therapy.
The team also created an algorithm intended to identify patients whose symptoms were most likely to be life-threatening.
The researchers discovered the biomarkers and developed the algorithm based on data from a trial of JCAR014, an anti-CD19 CAR T-cell therapy, in patients with B-cell malignancies.
Cameron J. Turtle, MBBS, PhD, of Fred Hutchinson Cancer Research Center in Seattle, Washington, and his colleagues described this research in Cancer Discovery.
“It’s essential that we understand the potential side effects of CAR T therapies” Dr Turtle said. “While use of these cell therapies is likely to dramatically increase because they’ve been so effective in patients with resistant or refractory B-cell malignancies, there is still much to learn.”
Dr Turtle and his colleagues sought to provide a detailed clinical, radiological, and pathological characterization of neurotoxicity arising from anti-CD19 CAR T-cell therapy.
So the team analyzed data from a phase 1/2 trial of 133 adults with relapsed and/or refractory CD19+ B-cell acute lymphoblastic leukemia, non-Hodgkin lymphoma, or chronic lymphocytic leukemia.
The patients received lymphodepleting chemotherapy followed by an infusion of JCAR014.
Neurotoxicity
Within 28 days of treatment, 53 patients (40%) developed grade 1 or higher neurologic adverse events (AEs), 28 patients (21%) had grade 3 or higher neurotoxicity, and 4 patients (3%) developed fatal neurotoxicity.
Of the 53 patients with any neurologic AE, 48 (91%) also had cytokine release syndrome (CRS). All neurologic AEs in the 5 patients who did not have CRS were mild (grade 1) and transient.
Neurologic AEs included delirium with preserved alertness (66%), headache (55%), language disturbance (34%), decreased level of consciousness (25%), seizures (8%), and macroscopic intracranial hemorrhage (2%).
For most patients, neurotoxicity resolved by day 28 after CAR T-cell infusion. The exceptions were 1 patient in whom a grade 1 neurologic AE resolved 2 months after CAR T-cell infusion and the 4 patients who died of neurotoxicity.
The 4 neurotoxicity-related deaths were due to:
- Acute cerebral edema (n=2)
- Multifocal brainstem hemorrhage and edema associated with disseminated intravascular coagulation (n=1)
- Cortical laminar necrosis with a persistent minimally conscious state until death (n=1).
Potential biomarkers
In a univariate analysis, neurotoxicity was significantly more frequent in patients who:
- Had CRS (P<0.0001)
- Received a high CAR T-cell dose (P<0.0001)
- Had pre-existing neurologic comorbidities at baseline (P=0.0059).
In a multivariable analysis (which did not include CRS as a variable), patients had an increased risk of neurotoxicity if they:
- Had pre-existing neurologic comorbidities (P=0.0023)
- Received cyclophosphamide and fludarabine lymphodepletion (P=0.0259)
- Received a higher CAR T-cell dose (P=0.0009)
- Had a higher burden of malignant CD19+ B cells in the bone marrow (P=0.0165).
The researchers noted that patients who developed grade 3 or higher neurotoxicity had more severe CRS (P<0.0001).
“It appears that cytokine release syndrome is probably necessary for most cases of severe neurotoxicity, but, in terms of what triggers a person with cytokine release syndrome to get neurotoxicity, that’s something we need to investigate further,” said study author Kevin Hay, MD, of Fred Hutchinson Cancer Research Center.
Dr Hay and his colleagues also found that patients with severe neurotoxicity exhibited evidence of endothelial activation, which could contribute to manifestations such as capillary leak, disseminated intravascular coagulation, and disruption of the blood-brain barrier.
Algorithm
The researchers developed a predictive classification tree algorithm to identify patients who have an increased risk of severe neurotoxicity.
The algorithm suggests patients who meet the following criteria in the first 36 hours after CAR T-cell infusion have a high risk of grade 4-5 neurotoxicity:
- Fever of 38.9°C or greater
- Serum levels of IL6 at 16 pg/mL or higher
- Serum levels of MCP1 at 1343.5 pg/mL or higher.
This algorithm predicted severe neurotoxicity with 100% sensitivity and 94% specificity. Eight patients were misclassified, 1 of whom did not subsequently develop grade 2-3 neurotoxicity and/or grade 2 or higher CRS.
Funding
This research was funded by Juno Therapeutics Inc. (the company developing JCAR014), the National Cancer Institute, Life Science Discovery Fund, the Bezos family, the University of British Columbia Clinical Investigator Program, and via institutional funds from Bloodworks Northwest.
Dr Turtle receives research funding from Juno Therapeutics, holds patents licensed by Juno, and has pending patent applications that could be licensed by nonprofit institutions and for-profit companies, including Juno.
The Fred Hutchinson Cancer Research Center has a financial interest in Juno and receives licensing and other payments from the company.
Researchers say they have identified potential biomarkers that may be used to help identify patients at an increased risk of neurotoxicity after chimeric antigen receptor (CAR) T-cell therapy.
The team also created an algorithm intended to identify patients whose symptoms were most likely to be life-threatening.
The researchers discovered the biomarkers and developed the algorithm based on data from a trial of JCAR014, an anti-CD19 CAR T-cell therapy, in patients with B-cell malignancies.
Cameron J. Turtle, MBBS, PhD, of Fred Hutchinson Cancer Research Center in Seattle, Washington, and his colleagues described this research in Cancer Discovery.
“It’s essential that we understand the potential side effects of CAR T therapies” Dr Turtle said. “While use of these cell therapies is likely to dramatically increase because they’ve been so effective in patients with resistant or refractory B-cell malignancies, there is still much to learn.”
Dr Turtle and his colleagues sought to provide a detailed clinical, radiological, and pathological characterization of neurotoxicity arising from anti-CD19 CAR T-cell therapy.
So the team analyzed data from a phase 1/2 trial of 133 adults with relapsed and/or refractory CD19+ B-cell acute lymphoblastic leukemia, non-Hodgkin lymphoma, or chronic lymphocytic leukemia.
The patients received lymphodepleting chemotherapy followed by an infusion of JCAR014.
Neurotoxicity
Within 28 days of treatment, 53 patients (40%) developed grade 1 or higher neurologic adverse events (AEs), 28 patients (21%) had grade 3 or higher neurotoxicity, and 4 patients (3%) developed fatal neurotoxicity.
Of the 53 patients with any neurologic AE, 48 (91%) also had cytokine release syndrome (CRS). All neurologic AEs in the 5 patients who did not have CRS were mild (grade 1) and transient.
Neurologic AEs included delirium with preserved alertness (66%), headache (55%), language disturbance (34%), decreased level of consciousness (25%), seizures (8%), and macroscopic intracranial hemorrhage (2%).
For most patients, neurotoxicity resolved by day 28 after CAR T-cell infusion. The exceptions were 1 patient in whom a grade 1 neurologic AE resolved 2 months after CAR T-cell infusion and the 4 patients who died of neurotoxicity.
The 4 neurotoxicity-related deaths were due to:
- Acute cerebral edema (n=2)
- Multifocal brainstem hemorrhage and edema associated with disseminated intravascular coagulation (n=1)
- Cortical laminar necrosis with a persistent minimally conscious state until death (n=1).
Potential biomarkers
In a univariate analysis, neurotoxicity was significantly more frequent in patients who:
- Had CRS (P<0.0001)
- Received a high CAR T-cell dose (P<0.0001)
- Had pre-existing neurologic comorbidities at baseline (P=0.0059).
In a multivariable analysis (which did not include CRS as a variable), patients had an increased risk of neurotoxicity if they:
- Had pre-existing neurologic comorbidities (P=0.0023)
- Received cyclophosphamide and fludarabine lymphodepletion (P=0.0259)
- Received a higher CAR T-cell dose (P=0.0009)
- Had a higher burden of malignant CD19+ B cells in the bone marrow (P=0.0165).
The researchers noted that patients who developed grade 3 or higher neurotoxicity had more severe CRS (P<0.0001).
“It appears that cytokine release syndrome is probably necessary for most cases of severe neurotoxicity, but, in terms of what triggers a person with cytokine release syndrome to get neurotoxicity, that’s something we need to investigate further,” said study author Kevin Hay, MD, of Fred Hutchinson Cancer Research Center.
Dr Hay and his colleagues also found that patients with severe neurotoxicity exhibited evidence of endothelial activation, which could contribute to manifestations such as capillary leak, disseminated intravascular coagulation, and disruption of the blood-brain barrier.
Algorithm
The researchers developed a predictive classification tree algorithm to identify patients who have an increased risk of severe neurotoxicity.
The algorithm suggests patients who meet the following criteria in the first 36 hours after CAR T-cell infusion have a high risk of grade 4-5 neurotoxicity:
- Fever of 38.9°C or greater
- Serum levels of IL6 at 16 pg/mL or higher
- Serum levels of MCP1 at 1343.5 pg/mL or higher.
This algorithm predicted severe neurotoxicity with 100% sensitivity and 94% specificity. Eight patients were misclassified, 1 of whom did not subsequently develop grade 2-3 neurotoxicity and/or grade 2 or higher CRS.
Funding
This research was funded by Juno Therapeutics Inc. (the company developing JCAR014), the National Cancer Institute, Life Science Discovery Fund, the Bezos family, the University of British Columbia Clinical Investigator Program, and via institutional funds from Bloodworks Northwest.
Dr Turtle receives research funding from Juno Therapeutics, holds patents licensed by Juno, and has pending patent applications that could be licensed by nonprofit institutions and for-profit companies, including Juno.
The Fred Hutchinson Cancer Research Center has a financial interest in Juno and receives licensing and other payments from the company.
FDA grants drug fast track designation for rel/ref AML
The US Food and Drug Administration (FDA) has granted fast track designation to gilteritinib for the treatment of adults with FLT3 mutation-positive relapsed or refractory acute myeloid leukemia (AML).
Gilteritinib is a compound that has demonstrated inhibitory activity against FLT3 internal tandem duplication (ITD) and FLT3 tyrosine kinase domain, 2 mutations that are seen in approximately one-third of patients with AML.
Gilteritinib has also demonstrated inhibition of AXL, which is reported to be associated with therapeutic resistance.
Astellas Pharma Inc. is currently investigating gilteritinib in phase 3 trials of AML patients.
Results from a phase 1/2 study of gilteritinib in AML were presented at the 2017 ASCO Annual Meeting.
The goal of the study was to determine the tolerability and antileukemic activity of once-daily gilteritinib in a FLT3-ITD-enriched, relapsed/refractory AML population.
Researchers said the drug exhibited potent FLT3 inhibition at doses greater than 80 mg/day. In patients who received such doses, the greatest overall response rate was 52%, and the longest median overall survival was 31 weeks.
The maximum tolerated dose of gilteritinib was 300 mg/day. Dose-limiting toxicities included diarrhea and liver function abnormalities.
About fast track designation
The FDA’s fast track program is designed to facilitate the development and expedite the review of products intended to treat or prevent serious or life-threatening conditions and address unmet medical need.
Through the fast track program, a product may be eligible for priority review. In addition, the company developing the product may be allowed to submit sections of the new drug application or biologics license application on a rolling basis as data become available.
Fast track designation also provides the company with opportunities for more frequent meetings and written communications with the FDA.
About orphan designation
Gilteritinib also has orphan drug designation for the treatment of AML.
The FDA grants orphan designation to products intended to treat, diagnose, or prevent diseases/disorders that affect fewer than 200,000 people in the US.
The designation provides incentives for sponsors to develop products for rare diseases. This may include tax credits toward the cost of clinical trials, prescription drug user fee waivers, and 7 years of market exclusivity if the product is approved.
The US Food and Drug Administration (FDA) has granted fast track designation to gilteritinib for the treatment of adults with FLT3 mutation-positive relapsed or refractory acute myeloid leukemia (AML).
Gilteritinib is a compound that has demonstrated inhibitory activity against FLT3 internal tandem duplication (ITD) and FLT3 tyrosine kinase domain, 2 mutations that are seen in approximately one-third of patients with AML.
Gilteritinib has also demonstrated inhibition of AXL, which is reported to be associated with therapeutic resistance.
Astellas Pharma Inc. is currently investigating gilteritinib in phase 3 trials of AML patients.
Results from a phase 1/2 study of gilteritinib in AML were presented at the 2017 ASCO Annual Meeting.
The goal of the study was to determine the tolerability and antileukemic activity of once-daily gilteritinib in a FLT3-ITD-enriched, relapsed/refractory AML population.
Researchers said the drug exhibited potent FLT3 inhibition at doses greater than 80 mg/day. In patients who received such doses, the greatest overall response rate was 52%, and the longest median overall survival was 31 weeks.
The maximum tolerated dose of gilteritinib was 300 mg/day. Dose-limiting toxicities included diarrhea and liver function abnormalities.
About fast track designation
The FDA’s fast track program is designed to facilitate the development and expedite the review of products intended to treat or prevent serious or life-threatening conditions and address unmet medical need.
Through the fast track program, a product may be eligible for priority review. In addition, the company developing the product may be allowed to submit sections of the new drug application or biologics license application on a rolling basis as data become available.
Fast track designation also provides the company with opportunities for more frequent meetings and written communications with the FDA.
About orphan designation
Gilteritinib also has orphan drug designation for the treatment of AML.
The FDA grants orphan designation to products intended to treat, diagnose, or prevent diseases/disorders that affect fewer than 200,000 people in the US.
The designation provides incentives for sponsors to develop products for rare diseases. This may include tax credits toward the cost of clinical trials, prescription drug user fee waivers, and 7 years of market exclusivity if the product is approved.
The US Food and Drug Administration (FDA) has granted fast track designation to gilteritinib for the treatment of adults with FLT3 mutation-positive relapsed or refractory acute myeloid leukemia (AML).
Gilteritinib is a compound that has demonstrated inhibitory activity against FLT3 internal tandem duplication (ITD) and FLT3 tyrosine kinase domain, 2 mutations that are seen in approximately one-third of patients with AML.
Gilteritinib has also demonstrated inhibition of AXL, which is reported to be associated with therapeutic resistance.
Astellas Pharma Inc. is currently investigating gilteritinib in phase 3 trials of AML patients.
Results from a phase 1/2 study of gilteritinib in AML were presented at the 2017 ASCO Annual Meeting.
The goal of the study was to determine the tolerability and antileukemic activity of once-daily gilteritinib in a FLT3-ITD-enriched, relapsed/refractory AML population.
Researchers said the drug exhibited potent FLT3 inhibition at doses greater than 80 mg/day. In patients who received such doses, the greatest overall response rate was 52%, and the longest median overall survival was 31 weeks.
The maximum tolerated dose of gilteritinib was 300 mg/day. Dose-limiting toxicities included diarrhea and liver function abnormalities.
About fast track designation
The FDA’s fast track program is designed to facilitate the development and expedite the review of products intended to treat or prevent serious or life-threatening conditions and address unmet medical need.
Through the fast track program, a product may be eligible for priority review. In addition, the company developing the product may be allowed to submit sections of the new drug application or biologics license application on a rolling basis as data become available.
Fast track designation also provides the company with opportunities for more frequent meetings and written communications with the FDA.
About orphan designation
Gilteritinib also has orphan drug designation for the treatment of AML.
The FDA grants orphan designation to products intended to treat, diagnose, or prevent diseases/disorders that affect fewer than 200,000 people in the US.
The designation provides incentives for sponsors to develop products for rare diseases. This may include tax credits toward the cost of clinical trials, prescription drug user fee waivers, and 7 years of market exclusivity if the product is approved.
Antithrombotic agents linked to hematuria-related complications
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.
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.
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.
Clinical trials summary: AGILE
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.
Contact: Medical Affairs Agios Pharmaceuticals, Inc.; (844) 633-2332, e-mail: [email protected]
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.
Contact: Medical Affairs Agios Pharmaceuticals, Inc.; (844) 633-2332, e-mail: [email protected]
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.
Contact: Medical Affairs Agios Pharmaceuticals, Inc.; (844) 633-2332, e-mail: [email protected]
Nearly 80% of health care personnel stepped up for flu shots
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.
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.
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.
FROM MMWR
Key clinical point:
Major finding: Overall flu vaccination coverage among U.S. health care personnel was 78.6% in the 2016-2017 season
Data source: The data come from an Internet survey of 2,438 health care personnel.
Disclosures: The researchers had no financial conflicts to disclose.
Hyperlipidemia diagnosis protects against breast cancer
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.
The all-cause mortality rate in baseline hyperlipidemic women who later developed breast cancer was 27.4%, significantly lower than the 37.4% rate in normolipidemic women with breast cancer. This translated into an adjusted 40% relative risk reduction.
All-cause mortality occurred during follow-up in 13.7% of breast cancer–free women with baseline hyperlipidemia, compared with 23.6% of nonhyperlipidemic controls without breast cancer.
In an analysis adjusted for age, ethnicity, and the top-10 causes of death in the U.K., women with baseline hyperlipidemia were 40% less likely to die during follow-up than were women without high cholesterol.
Dr. Carter reported having no financial conflicts of interest regarding his study, which was conducted free of commercial support.
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.
The all-cause mortality rate in baseline hyperlipidemic women who later developed breast cancer was 27.4%, significantly lower than the 37.4% rate in normolipidemic women with breast cancer. This translated into an adjusted 40% relative risk reduction.
All-cause mortality occurred during follow-up in 13.7% of breast cancer–free women with baseline hyperlipidemia, compared with 23.6% of nonhyperlipidemic controls without breast cancer.
In an analysis adjusted for age, ethnicity, and the top-10 causes of death in the U.K., women with baseline hyperlipidemia were 40% less likely to die during follow-up than were women without high cholesterol.
Dr. Carter reported having no financial conflicts of interest regarding his study, which was conducted free of commercial support.
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.
The all-cause mortality rate in baseline hyperlipidemic women who later developed breast cancer was 27.4%, significantly lower than the 37.4% rate in normolipidemic women with breast cancer. This translated into an adjusted 40% relative risk reduction.
All-cause mortality occurred during follow-up in 13.7% of breast cancer–free women with baseline hyperlipidemia, compared with 23.6% of nonhyperlipidemic controls without breast cancer.
In an analysis adjusted for age, ethnicity, and the top-10 causes of death in the U.K., women with baseline hyperlipidemia were 40% less likely to die during follow-up than were women without high cholesterol.
Dr. Carter reported having no financial conflicts of interest regarding his study, which was conducted free of commercial support.
AT THE ESC CONGRESS 2017
Key clinical point:
Major finding: The risk of subsequent development of breast cancer was one-third lower in women diagnosed with hyperlipidemia than in controls with normal lipid levels.
Data source: A retrospective longitudinal case-control study of 16,043 U.K. women aged 40 years or older when diagnosed with hyperlipidemia and an equal number of age-matched women with normal lipids.
Disclosures: The presenter reported having no financial conflicts of interest regarding his study, which was conducted free of commercial support.
Insulin pumps associated with lower risk of ketoacidosis and severe hypoglycemia in kids
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 (HbA1c), 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).
The secondary outcomes of the matched cohort did not share as consistent a pattern as the primary outcomes. HbA1c levels were lower in pump users (8.04% vs. 8.22%). Total daily insulin doses were lower in pump users, but the prandial to total insulin ratio was higher. Daily frequency of self-monitoring blood glucose level was also elevated in pump users.
“These findings provide evidence for improved clinical outcomes associated with insulin pump therapy, compared with injection therapy, in children, adolescents, and young adults with type 1 diabetes,” Dr. Karges and her colleagues wrote.
The study was funded by both the Competence Network Diabetes Mellitus and the German Center for Diabetes Research. Thomas Kapellen, MD, had received funding from the European Commission concerning closed-loop systems as well as speaking fees for pharmaceuticals companies including Abbott, Medtronic, and Novo Nordisk. No other authors reported financial conflicts.
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 (HbA1c), 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).
The secondary outcomes of the matched cohort did not share as consistent a pattern as the primary outcomes. HbA1c levels were lower in pump users (8.04% vs. 8.22%). Total daily insulin doses were lower in pump users, but the prandial to total insulin ratio was higher. Daily frequency of self-monitoring blood glucose level was also elevated in pump users.
“These findings provide evidence for improved clinical outcomes associated with insulin pump therapy, compared with injection therapy, in children, adolescents, and young adults with type 1 diabetes,” Dr. Karges and her colleagues wrote.
The study was funded by both the Competence Network Diabetes Mellitus and the German Center for Diabetes Research. Thomas Kapellen, MD, had received funding from the European Commission concerning closed-loop systems as well as speaking fees for pharmaceuticals companies including Abbott, Medtronic, and Novo Nordisk. No other authors reported financial conflicts.
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 (HbA1c), 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).
The secondary outcomes of the matched cohort did not share as consistent a pattern as the primary outcomes. HbA1c levels were lower in pump users (8.04% vs. 8.22%). Total daily insulin doses were lower in pump users, but the prandial to total insulin ratio was higher. Daily frequency of self-monitoring blood glucose level was also elevated in pump users.
“These findings provide evidence for improved clinical outcomes associated with insulin pump therapy, compared with injection therapy, in children, adolescents, and young adults with type 1 diabetes,” Dr. Karges and her colleagues wrote.
The study was funded by both the Competence Network Diabetes Mellitus and the German Center for Diabetes Research. Thomas Kapellen, MD, had received funding from the European Commission concerning closed-loop systems as well as speaking fees for pharmaceuticals companies including Abbott, Medtronic, and Novo Nordisk. No other authors reported financial conflicts.
FROM JAMA
Key clinical point:
Major finding: Patients using insulin pumps had lower rates of hypoglycemia (9.55 per 100 patient-years) and severe ketoacidosis (3.64 per 100 patient-years).
Data source: Population cohort study of 30,579 patients from the Diabetes Prospective Follow-up Initiative Database.
Disclosures: The study was funded by both the Competence Network Diabetes Mellitus and the German Center for Diabetes Research. Thomas Kapellen, MD, had received funding from the European Commission concerning closed-loop systems as well as speaking fees for pharmaceutical companies including Abbott, Medtronic, and Novo Nordisk. No other authors reported financial conflicts.
Revisions proposed for sexual behaviors in ICD-11
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.
This definition parallels the A criterion in the paraphilic definitions in the DSM-5, which identifies a pattern of “recurrent and intense sexual arousal” as well as the B criterion, which specifies that the person “has acted on these sexual urges with a nonconsenting person, or the sexual urges or fantasies cause clinically significant distress or impairment in social, occupational, or other important areas of functioning.”
The proposed revisions reflect a growing acceptance of the immense variation in human sexual behavior, and the depathologization of some of them, as long as they do not affect public health, said Dr. Krueger, a psychiatrist with expertise in forensic and sexual psychiatry.
“In a general sense, this is analogous to the situation that we faced with alcohol and drug users in the early 20th century, when the main treatment was incarceration. In the 1940s and 50s, if you admitted an alcoholic to the hospital for delirium tremens, you could risk losing your admitting privileges. This is similar to where we are now with the paraphilic disorders,” he said, with most of them still considered potentially criminal.
That paraphilic disorders will remain at all in ICD-11 is something of a compromise.
“At first, we considered outright deletion of this section. Many psychiatrists have suggested we have no business with these disorders, since paraphilias are largely dealt with in the legal system. Some feel that psychiatrists should not be involved with them at all. But there has been a lot of discussion about the public health impact of these behaviors. For example, about 50% of men incarcerated for crimes against children meet the diagnostic criteria for pedophilia, and about 10% of crimes that result in incarceration in the U.S. are sexual crimes. There is also forensic usage of these diagnoses in many countries in Europe, and in Great Britain, the U.S., and Canada, so we felt that it’s important to maintain them” as diagnosable disorders. Keeping official diagnostic codes alive also helps encourage research into epidemiology and potential treatments, he added.
The committee’s first recommendation is to change the name of the chapter from “Disorders of Sexual Preference” to “Paraphilic Disorders.”
“This better represents the content of the section, which involves atypical sexual interests,” Dr. Krueger said. “The word ‘disorders’ was added to clarify that these atypical interests have to be pathological. That is, they must result in action against a nonconsenting individual, or cause severe distress or significant risk of injury or death to the patient.”
This emphasis on a pathological aspect to the diagnoses leads directly to the elimination of the fetishism, transvestitism, and sadomasochism categories, which are considered largely benign. “These have no public health importance, generally no association with distress or functional impairment, and including them can result in stigmatization with no discernible health benefit,” Dr. Krueger said. “If you’re a sadomasochist and not bothered by it, and engage alone or with a consenting person, it’s not a problem. Why should these categories be retained if they are not associated with distress or dysfunction? If they are not, then clearly they are not disorders.”
The remaining diagnoses were not as cut-and-dried, he said. Voyeurism, exhibitionism, pedophilia, and frotteurism clearly can affect others who are either unwilling or unable to consent because of age or other circumstances – for example, children, unaware targets, and animals. These behaviors also present with different intensities, from solitary imaginings to well planned and executed acts.
Sadomasochism did retain an altered diagnostic code as a new entity: coercive sexual sadism disorder. While many practice sadomasochism with a willing partner and are not disturbed by it, the committee acknowledged that crimes of sexual sadism are a serious threat to public health and should be recognized as such.
The committee also added two general categories to cover unnamed paraphilias, of which there are many.
“Other paraphilic disorder involving nonconsenting individuals” may be used for a behavior in which the focus of arousal is unwilling or unable to consent, but not specified. Zoophilia would fall into this category, as would other potentially criminal acts. “We can capture a huge variety of paraphilic behaviors under this rubric,” Dr. Krueger said.
During discussion, some clinicians expressed concern that, in its effort to depathologize solitary behavior, the proposal shortchanges patients who suffer deeply from their sexual behaviors. An example, one British psychiatrist said, is the person who is distressed because he can’t experience sexual enjoyment without a particular object or behavior. The final diagnostic category, “Other paraphilic disorder involving solitary behavior or consenting individuals,” will serve that person’s needs, Dr. Krueger said.
“This is an attempt to address the concern if a behavior markedly distresses a person, outside of the rather normal fear of social rejection, or if the behavior poses a serious risk, such as asphyxiophilia.”
The draft proposal was published earlier this year in Archives of Sexual Behavior (2017 Jul;46[5]:1529-45).
Dr. Krueger had no financial disclosures.
[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.
This definition parallels the A criterion in the paraphilic definitions in the DSM-5, which identifies a pattern of “recurrent and intense sexual arousal” as well as the B criterion, which specifies that the person “has acted on these sexual urges with a nonconsenting person, or the sexual urges or fantasies cause clinically significant distress or impairment in social, occupational, or other important areas of functioning.”
The proposed revisions reflect a growing acceptance of the immense variation in human sexual behavior, and the depathologization of some of them, as long as they do not affect public health, said Dr. Krueger, a psychiatrist with expertise in forensic and sexual psychiatry.
“In a general sense, this is analogous to the situation that we faced with alcohol and drug users in the early 20th century, when the main treatment was incarceration. In the 1940s and 50s, if you admitted an alcoholic to the hospital for delirium tremens, you could risk losing your admitting privileges. This is similar to where we are now with the paraphilic disorders,” he said, with most of them still considered potentially criminal.
That paraphilic disorders will remain at all in ICD-11 is something of a compromise.
“At first, we considered outright deletion of this section. Many psychiatrists have suggested we have no business with these disorders, since paraphilias are largely dealt with in the legal system. Some feel that psychiatrists should not be involved with them at all. But there has been a lot of discussion about the public health impact of these behaviors. For example, about 50% of men incarcerated for crimes against children meet the diagnostic criteria for pedophilia, and about 10% of crimes that result in incarceration in the U.S. are sexual crimes. There is also forensic usage of these diagnoses in many countries in Europe, and in Great Britain, the U.S., and Canada, so we felt that it’s important to maintain them” as diagnosable disorders. Keeping official diagnostic codes alive also helps encourage research into epidemiology and potential treatments, he added.
The committee’s first recommendation is to change the name of the chapter from “Disorders of Sexual Preference” to “Paraphilic Disorders.”
“This better represents the content of the section, which involves atypical sexual interests,” Dr. Krueger said. “The word ‘disorders’ was added to clarify that these atypical interests have to be pathological. That is, they must result in action against a nonconsenting individual, or cause severe distress or significant risk of injury or death to the patient.”
This emphasis on a pathological aspect to the diagnoses leads directly to the elimination of the fetishism, transvestitism, and sadomasochism categories, which are considered largely benign. “These have no public health importance, generally no association with distress or functional impairment, and including them can result in stigmatization with no discernible health benefit,” Dr. Krueger said. “If you’re a sadomasochist and not bothered by it, and engage alone or with a consenting person, it’s not a problem. Why should these categories be retained if they are not associated with distress or dysfunction? If they are not, then clearly they are not disorders.”
The remaining diagnoses were not as cut-and-dried, he said. Voyeurism, exhibitionism, pedophilia, and frotteurism clearly can affect others who are either unwilling or unable to consent because of age or other circumstances – for example, children, unaware targets, and animals. These behaviors also present with different intensities, from solitary imaginings to well planned and executed acts.
Sadomasochism did retain an altered diagnostic code as a new entity: coercive sexual sadism disorder. While many practice sadomasochism with a willing partner and are not disturbed by it, the committee acknowledged that crimes of sexual sadism are a serious threat to public health and should be recognized as such.
The committee also added two general categories to cover unnamed paraphilias, of which there are many.
“Other paraphilic disorder involving nonconsenting individuals” may be used for a behavior in which the focus of arousal is unwilling or unable to consent, but not specified. Zoophilia would fall into this category, as would other potentially criminal acts. “We can capture a huge variety of paraphilic behaviors under this rubric,” Dr. Krueger said.
During discussion, some clinicians expressed concern that, in its effort to depathologize solitary behavior, the proposal shortchanges patients who suffer deeply from their sexual behaviors. An example, one British psychiatrist said, is the person who is distressed because he can’t experience sexual enjoyment without a particular object or behavior. The final diagnostic category, “Other paraphilic disorder involving solitary behavior or consenting individuals,” will serve that person’s needs, Dr. Krueger said.
“This is an attempt to address the concern if a behavior markedly distresses a person, outside of the rather normal fear of social rejection, or if the behavior poses a serious risk, such as asphyxiophilia.”
The draft proposal was published earlier this year in Archives of Sexual Behavior (2017 Jul;46[5]:1529-45).
Dr. Krueger had no financial disclosures.
[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.
This definition parallels the A criterion in the paraphilic definitions in the DSM-5, which identifies a pattern of “recurrent and intense sexual arousal” as well as the B criterion, which specifies that the person “has acted on these sexual urges with a nonconsenting person, or the sexual urges or fantasies cause clinically significant distress or impairment in social, occupational, or other important areas of functioning.”
The proposed revisions reflect a growing acceptance of the immense variation in human sexual behavior, and the depathologization of some of them, as long as they do not affect public health, said Dr. Krueger, a psychiatrist with expertise in forensic and sexual psychiatry.
“In a general sense, this is analogous to the situation that we faced with alcohol and drug users in the early 20th century, when the main treatment was incarceration. In the 1940s and 50s, if you admitted an alcoholic to the hospital for delirium tremens, you could risk losing your admitting privileges. This is similar to where we are now with the paraphilic disorders,” he said, with most of them still considered potentially criminal.
That paraphilic disorders will remain at all in ICD-11 is something of a compromise.
“At first, we considered outright deletion of this section. Many psychiatrists have suggested we have no business with these disorders, since paraphilias are largely dealt with in the legal system. Some feel that psychiatrists should not be involved with them at all. But there has been a lot of discussion about the public health impact of these behaviors. For example, about 50% of men incarcerated for crimes against children meet the diagnostic criteria for pedophilia, and about 10% of crimes that result in incarceration in the U.S. are sexual crimes. There is also forensic usage of these diagnoses in many countries in Europe, and in Great Britain, the U.S., and Canada, so we felt that it’s important to maintain them” as diagnosable disorders. Keeping official diagnostic codes alive also helps encourage research into epidemiology and potential treatments, he added.
The committee’s first recommendation is to change the name of the chapter from “Disorders of Sexual Preference” to “Paraphilic Disorders.”
“This better represents the content of the section, which involves atypical sexual interests,” Dr. Krueger said. “The word ‘disorders’ was added to clarify that these atypical interests have to be pathological. That is, they must result in action against a nonconsenting individual, or cause severe distress or significant risk of injury or death to the patient.”
This emphasis on a pathological aspect to the diagnoses leads directly to the elimination of the fetishism, transvestitism, and sadomasochism categories, which are considered largely benign. “These have no public health importance, generally no association with distress or functional impairment, and including them can result in stigmatization with no discernible health benefit,” Dr. Krueger said. “If you’re a sadomasochist and not bothered by it, and engage alone or with a consenting person, it’s not a problem. Why should these categories be retained if they are not associated with distress or dysfunction? If they are not, then clearly they are not disorders.”
The remaining diagnoses were not as cut-and-dried, he said. Voyeurism, exhibitionism, pedophilia, and frotteurism clearly can affect others who are either unwilling or unable to consent because of age or other circumstances – for example, children, unaware targets, and animals. These behaviors also present with different intensities, from solitary imaginings to well planned and executed acts.
Sadomasochism did retain an altered diagnostic code as a new entity: coercive sexual sadism disorder. While many practice sadomasochism with a willing partner and are not disturbed by it, the committee acknowledged that crimes of sexual sadism are a serious threat to public health and should be recognized as such.
The committee also added two general categories to cover unnamed paraphilias, of which there are many.
“Other paraphilic disorder involving nonconsenting individuals” may be used for a behavior in which the focus of arousal is unwilling or unable to consent, but not specified. Zoophilia would fall into this category, as would other potentially criminal acts. “We can capture a huge variety of paraphilic behaviors under this rubric,” Dr. Krueger said.
During discussion, some clinicians expressed concern that, in its effort to depathologize solitary behavior, the proposal shortchanges patients who suffer deeply from their sexual behaviors. An example, one British psychiatrist said, is the person who is distressed because he can’t experience sexual enjoyment without a particular object or behavior. The final diagnostic category, “Other paraphilic disorder involving solitary behavior or consenting individuals,” will serve that person’s needs, Dr. Krueger said.
“This is an attempt to address the concern if a behavior markedly distresses a person, outside of the rather normal fear of social rejection, or if the behavior poses a serious risk, such as asphyxiophilia.”
The draft proposal was published earlier this year in Archives of Sexual Behavior (2017 Jul;46[5]:1529-45).
Dr. Krueger had no financial disclosures.
[email protected]
On Twitter @Alz_Gal
AT WPA 2017
