User login
Breath test may detect esophagogastric cancer
A breath test that analyzes volatile organic compounds to detect esophagogastric cancer showed similar diagnostic accuracy to an existing test for endoscopy referral based on clinical parameters, based on a study in 335 patients – 163 with esophagogastric cancer and 172 controls.
The resulting test, which examined the concentrations of volatile organic compounds including butyric acid, hexanoic acid, butanal, and decanal, had a sensitivity of 80%, a specificity of 81%, and an area under the curve of 0.85. However, all of the patients had T3-stage esophagogastric cancer, so there is no indication about whether the breath test would be effective at picking up earlier T1-stage cancers, the authors wrote in the study, published online May 17 in JAMA Oncology.
By comparison, the clinical parameters test based on the NICE guidelines for endoscopy referral has a sensitivity of 59%, a specificity of 81% and an area under the curve of 0.72. These guidelines use age thresholds and symptom criteria such as dyspepsia, but the authors commented that there still remains a huge degree of variability in referral patterns for endoscopy.
“The breath test for esophagogastric cancer aims to provide clinicians with an objective assessment of need for endoscopic referral,” wrote Sheraz R. Markar, PhD, of the department of surgery & cancer at Imperial College London and his coauthors.
The authors said the diagnostic accuracy of the breath test also compared favorably with other cancer diagnostic technologies such as the fecal occult blood test – for which the sensitivity ranges from 30% to 70% – and the Cytosponge test for Barrett esophagus, which has a sensitivity of 73%.
Because all five volatile organic compounds showed an association with esophagogastric cancer, the authors suggested that there could be the possibility of calculating a more stratified risk of cancer for individual patients.
The study found no significant differences in the concentration of the five volatile organic compounds used in the test between patients with esophageal or those with gastric cancer.
The authors noted that with fecal occult blood testing and the Cytosponge test, multiple episodes of testing were known to increase the sensitivity, so this could be another area for future research in breath testing.
The breath test was seen as something that could be used in primary care to identify patients with nonspecific symptoms who should be referred for endoscopy.
“This view has been endorsed by our recent finding that the diagnostic model for OGC [oesophagogastric cancer] is different from that for colorectal cancer, providing the concept for a single breath test for multiple gastrointestinal cancers,” the authors wrote.
“If a clinician is presented with a patient with gastrointestinal symptoms that do not prompt referral based on NICE [National Institute for Health and Care Excellence] criteria, he/she would not need to watch and wait to see if symptoms worsen but could offer the exhaled breath test immediately.”
This approach could help avoid unnecessary endoscopies, which are expensive and have a low diagnostic yield. The breath test could also be administered by a nurse.
One author declared support from the National Institute of Health Research, and the study was supported by the National Institute for Health Research, the Rosetrees Trust and Stoneygate Trust. No conflicts of interest were declared.
SOURCE: Markar SR et al. JAMA Oncol. 2018 May 17. doi: 10.1001/jamaoncol.2018.0991.
A breath test that analyzes volatile organic compounds to detect esophagogastric cancer showed similar diagnostic accuracy to an existing test for endoscopy referral based on clinical parameters, based on a study in 335 patients – 163 with esophagogastric cancer and 172 controls.
The resulting test, which examined the concentrations of volatile organic compounds including butyric acid, hexanoic acid, butanal, and decanal, had a sensitivity of 80%, a specificity of 81%, and an area under the curve of 0.85. However, all of the patients had T3-stage esophagogastric cancer, so there is no indication about whether the breath test would be effective at picking up earlier T1-stage cancers, the authors wrote in the study, published online May 17 in JAMA Oncology.
By comparison, the clinical parameters test based on the NICE guidelines for endoscopy referral has a sensitivity of 59%, a specificity of 81% and an area under the curve of 0.72. These guidelines use age thresholds and symptom criteria such as dyspepsia, but the authors commented that there still remains a huge degree of variability in referral patterns for endoscopy.
“The breath test for esophagogastric cancer aims to provide clinicians with an objective assessment of need for endoscopic referral,” wrote Sheraz R. Markar, PhD, of the department of surgery & cancer at Imperial College London and his coauthors.
The authors said the diagnostic accuracy of the breath test also compared favorably with other cancer diagnostic technologies such as the fecal occult blood test – for which the sensitivity ranges from 30% to 70% – and the Cytosponge test for Barrett esophagus, which has a sensitivity of 73%.
Because all five volatile organic compounds showed an association with esophagogastric cancer, the authors suggested that there could be the possibility of calculating a more stratified risk of cancer for individual patients.
The study found no significant differences in the concentration of the five volatile organic compounds used in the test between patients with esophageal or those with gastric cancer.
The authors noted that with fecal occult blood testing and the Cytosponge test, multiple episodes of testing were known to increase the sensitivity, so this could be another area for future research in breath testing.
The breath test was seen as something that could be used in primary care to identify patients with nonspecific symptoms who should be referred for endoscopy.
“This view has been endorsed by our recent finding that the diagnostic model for OGC [oesophagogastric cancer] is different from that for colorectal cancer, providing the concept for a single breath test for multiple gastrointestinal cancers,” the authors wrote.
“If a clinician is presented with a patient with gastrointestinal symptoms that do not prompt referral based on NICE [National Institute for Health and Care Excellence] criteria, he/she would not need to watch and wait to see if symptoms worsen but could offer the exhaled breath test immediately.”
This approach could help avoid unnecessary endoscopies, which are expensive and have a low diagnostic yield. The breath test could also be administered by a nurse.
One author declared support from the National Institute of Health Research, and the study was supported by the National Institute for Health Research, the Rosetrees Trust and Stoneygate Trust. No conflicts of interest were declared.
SOURCE: Markar SR et al. JAMA Oncol. 2018 May 17. doi: 10.1001/jamaoncol.2018.0991.
A breath test that analyzes volatile organic compounds to detect esophagogastric cancer showed similar diagnostic accuracy to an existing test for endoscopy referral based on clinical parameters, based on a study in 335 patients – 163 with esophagogastric cancer and 172 controls.
The resulting test, which examined the concentrations of volatile organic compounds including butyric acid, hexanoic acid, butanal, and decanal, had a sensitivity of 80%, a specificity of 81%, and an area under the curve of 0.85. However, all of the patients had T3-stage esophagogastric cancer, so there is no indication about whether the breath test would be effective at picking up earlier T1-stage cancers, the authors wrote in the study, published online May 17 in JAMA Oncology.
By comparison, the clinical parameters test based on the NICE guidelines for endoscopy referral has a sensitivity of 59%, a specificity of 81% and an area under the curve of 0.72. These guidelines use age thresholds and symptom criteria such as dyspepsia, but the authors commented that there still remains a huge degree of variability in referral patterns for endoscopy.
“The breath test for esophagogastric cancer aims to provide clinicians with an objective assessment of need for endoscopic referral,” wrote Sheraz R. Markar, PhD, of the department of surgery & cancer at Imperial College London and his coauthors.
The authors said the diagnostic accuracy of the breath test also compared favorably with other cancer diagnostic technologies such as the fecal occult blood test – for which the sensitivity ranges from 30% to 70% – and the Cytosponge test for Barrett esophagus, which has a sensitivity of 73%.
Because all five volatile organic compounds showed an association with esophagogastric cancer, the authors suggested that there could be the possibility of calculating a more stratified risk of cancer for individual patients.
The study found no significant differences in the concentration of the five volatile organic compounds used in the test between patients with esophageal or those with gastric cancer.
The authors noted that with fecal occult blood testing and the Cytosponge test, multiple episodes of testing were known to increase the sensitivity, so this could be another area for future research in breath testing.
The breath test was seen as something that could be used in primary care to identify patients with nonspecific symptoms who should be referred for endoscopy.
“This view has been endorsed by our recent finding that the diagnostic model for OGC [oesophagogastric cancer] is different from that for colorectal cancer, providing the concept for a single breath test for multiple gastrointestinal cancers,” the authors wrote.
“If a clinician is presented with a patient with gastrointestinal symptoms that do not prompt referral based on NICE [National Institute for Health and Care Excellence] criteria, he/she would not need to watch and wait to see if symptoms worsen but could offer the exhaled breath test immediately.”
This approach could help avoid unnecessary endoscopies, which are expensive and have a low diagnostic yield. The breath test could also be administered by a nurse.
One author declared support from the National Institute of Health Research, and the study was supported by the National Institute for Health Research, the Rosetrees Trust and Stoneygate Trust. No conflicts of interest were declared.
SOURCE: Markar SR et al. JAMA Oncol. 2018 May 17. doi: 10.1001/jamaoncol.2018.0991.
FROM JAMA ONCOLOGY
Key clinical point: A breath test could help detect esophagogastric cancer.
Major finding:
Study details: Study in 163 with esophagogastric cancer and 172 controls.
Disclosures: One author declared support from the National Institute of Health Research, and the study was supported by the National Institute for Health Research, the Rosetrees Trust and Stoneygate Trust. No conflicts of interest were declared.
Source: Markar SR et al. JAMA Oncol. 2018 May 17. doi:10.1001/jamaoncol.2018.0991.
New regimens for youth with T-cell malignancies yield best outcomes yet
A set of novel chemotherapy regimens yield excellent outcomes—the best yet—among pediatric and young adult patients with T-cell malignancies, finds a phase 3 randomized controlled trial conducted by the Children’s Oncology Group (ALL0434).
“Despite very intense and complex chemotherapy, 20% of children and adolescents enrolled in Children’s Oncology Group T-cell leukemia trials between 2000 and 2005 did not survive. New drugs were needed to improve survival rates for T-cell malignancies,” lead study author Kimberly P. Dunsmore, MD, a professor at Virginia Tech, Roanoke, said in a press briefing leading up to the annual meeting of the American Society of Clinical Oncology.
The ALL0434 trial tested the addition of methotrexate (Trexall) and/or nelarabine (Arranon), a T cell–specific drug known to be efficacious in relapsed disease, to standard chemotherapy, with tailoring of the regimen to recurrence risk. Analyses were based on 1,545 patients with T-cell acute lymphoblastic leukemia (T-ALL) or T-cell lymphoblastic lymphoma (T-LL).
Results for all patients with T-ALL showed that, with addition of either or both drugs, more than 90% were alive at 4 years and more than 80% were leukemia free. Adding nelarabine to standard chemotherapy improved disease-free survival among the subset having intermediate- or high-risk disease, and the best outcomes were seen with addition of both nelarabine and an escalating dose of methotrexate.
Although patients with T-LL did not see benefit from addition of nelarabine, they still had an 85% rate of overall survival at 4 years.
“ALL0434 is the largest trial for children and young adults with T-cell malignancy ever conducted. It has the best-ever survival data,” Dr. Dunsmore commented.
“Our next steps will be to examine what implications and benefits may accrue when using nelarabine in protocols without cranial irradiation. This is to decrease long-term neurologic side effects, and we think it may be possible since nelarabine also reduces CNS relapses,” she said.
“This trial highlights how effective our pediatric and young adult oncologists are at accruing: This is a rare disease, and they were able to put more than 1,500 patients on trial with this rare disease over the course of time,” commented ASCO President Bruce E. Johnson, MD, FASCO.
The new combination regimens are noteworthy in that they improved survival by an absolute 10% without minimal increase in toxicity, he maintained.
“This is part of the paradigm where nelarabine had been approved [by the FDA] for relapsed or recurrent disease, and in this particular setting, it has been moved upfront, closer to the initial treatment, improving the outcomes for those patients,” elaborated Dr. Johnson, who is also a professor of medicine at the Dana-Farber Cancer Institute and a leader of the Dana-Farber/Harvard Cancer Center Lung Cancer Program, both in Boston.
Study details
The ALL0434 trial enrolled patients aged 1-30 years with newly diagnosed T-ALL or T-LL. After induction chemotherapy, all patients received standard chemotherapy, the Children’s Oncology Group augmented Berlin-Frankfurt-Munster regimen (N Engl J Med. 1998;338:1663-71), and depending on recurrence risk, cranial irradiation.
In addition to that regimen, they were randomly assigned to four arms, according to methotrexate dosing (high dose with leucovorin rescue in the inpatient setting vs. escalating dose in the outpatient setting) and nelarabine therapy (receipt vs. nonreceipt).
Among patients with T-ALL, those with low-risk disease were ineligible for nelarabine and did not receive cranial irradiation, whereas those with intermediate- and high-risk disease were randomized to all four arms, Dr. Dunsmore explained. In addition, those who did not achieve remission on induction chemotherapy were nonrandomly assigned to the high-dose methotrexate plus nelarabine arm.
Patients with T-LL were ineligible for high-dose methotrexate and were randomized to escalating-dose methotrexate with or without nelarabine.
Among all patients with T-ALL, the 4-year rate of overall survival was 90.2%, and the 4-year rate of disease-free survival was 84.1%, Dr. Dunsmore reported.
Disease-free survival was better with escalating-dose methotrexate than with high-dose methotrexate (89.8% vs. 78%).
Addition of nelarabine for patients with T-ALL having intermediate- or high-risk disease improved disease-free survival, from 83% without the drug to 88% with the drug (P = .0450), and reduced the rate of CNS relapse. Disease-free survival was highest, at 91%, among those who received both escalating-dose methotrexate and nelarabine.
Among the patients who did not achieve remission from induction chemotherapy, the 4-year rate of overall survival was 54%. “This is important because it’s more than double the past survival rates,” Dr. Dunsmore noted.
Patients with T-LL fared similarly well whether they received nelarabine or not; fully 85% overall were still alive at 4 years.
In terms of adverse effects of nelarabine therapy, the rate of peripheral neuropathy (motor or sensory), one of the more problematic adverse effects of the drug, was 8% in the trial population overall and did not exceed 9% in any treatment arm, she reported.
Dr. Dunsmore disclosed that an immediate family member is an employee of and has a leadership role with TypeZero Technologies; that she receives travel, accommodations, and/or expenses from Novo Nordisk; and that an immediate family member receives travel, accommodations, and/or expenses from Tandem Diabetes Care. The study received funding from the Cancer Therapy Evaluation Program within the National Cancer Institute/National Institutes of Health and received support from the St. Baldrick’s Foundation.
SOURCE: Dunsmore KP et al. ASCO 2018, Abstract 10500.
A set of novel chemotherapy regimens yield excellent outcomes—the best yet—among pediatric and young adult patients with T-cell malignancies, finds a phase 3 randomized controlled trial conducted by the Children’s Oncology Group (ALL0434).
“Despite very intense and complex chemotherapy, 20% of children and adolescents enrolled in Children’s Oncology Group T-cell leukemia trials between 2000 and 2005 did not survive. New drugs were needed to improve survival rates for T-cell malignancies,” lead study author Kimberly P. Dunsmore, MD, a professor at Virginia Tech, Roanoke, said in a press briefing leading up to the annual meeting of the American Society of Clinical Oncology.
The ALL0434 trial tested the addition of methotrexate (Trexall) and/or nelarabine (Arranon), a T cell–specific drug known to be efficacious in relapsed disease, to standard chemotherapy, with tailoring of the regimen to recurrence risk. Analyses were based on 1,545 patients with T-cell acute lymphoblastic leukemia (T-ALL) or T-cell lymphoblastic lymphoma (T-LL).
Results for all patients with T-ALL showed that, with addition of either or both drugs, more than 90% were alive at 4 years and more than 80% were leukemia free. Adding nelarabine to standard chemotherapy improved disease-free survival among the subset having intermediate- or high-risk disease, and the best outcomes were seen with addition of both nelarabine and an escalating dose of methotrexate.
Although patients with T-LL did not see benefit from addition of nelarabine, they still had an 85% rate of overall survival at 4 years.
“ALL0434 is the largest trial for children and young adults with T-cell malignancy ever conducted. It has the best-ever survival data,” Dr. Dunsmore commented.
“Our next steps will be to examine what implications and benefits may accrue when using nelarabine in protocols without cranial irradiation. This is to decrease long-term neurologic side effects, and we think it may be possible since nelarabine also reduces CNS relapses,” she said.
“This trial highlights how effective our pediatric and young adult oncologists are at accruing: This is a rare disease, and they were able to put more than 1,500 patients on trial with this rare disease over the course of time,” commented ASCO President Bruce E. Johnson, MD, FASCO.
The new combination regimens are noteworthy in that they improved survival by an absolute 10% without minimal increase in toxicity, he maintained.
“This is part of the paradigm where nelarabine had been approved [by the FDA] for relapsed or recurrent disease, and in this particular setting, it has been moved upfront, closer to the initial treatment, improving the outcomes for those patients,” elaborated Dr. Johnson, who is also a professor of medicine at the Dana-Farber Cancer Institute and a leader of the Dana-Farber/Harvard Cancer Center Lung Cancer Program, both in Boston.
Study details
The ALL0434 trial enrolled patients aged 1-30 years with newly diagnosed T-ALL or T-LL. After induction chemotherapy, all patients received standard chemotherapy, the Children’s Oncology Group augmented Berlin-Frankfurt-Munster regimen (N Engl J Med. 1998;338:1663-71), and depending on recurrence risk, cranial irradiation.
In addition to that regimen, they were randomly assigned to four arms, according to methotrexate dosing (high dose with leucovorin rescue in the inpatient setting vs. escalating dose in the outpatient setting) and nelarabine therapy (receipt vs. nonreceipt).
Among patients with T-ALL, those with low-risk disease were ineligible for nelarabine and did not receive cranial irradiation, whereas those with intermediate- and high-risk disease were randomized to all four arms, Dr. Dunsmore explained. In addition, those who did not achieve remission on induction chemotherapy were nonrandomly assigned to the high-dose methotrexate plus nelarabine arm.
Patients with T-LL were ineligible for high-dose methotrexate and were randomized to escalating-dose methotrexate with or without nelarabine.
Among all patients with T-ALL, the 4-year rate of overall survival was 90.2%, and the 4-year rate of disease-free survival was 84.1%, Dr. Dunsmore reported.
Disease-free survival was better with escalating-dose methotrexate than with high-dose methotrexate (89.8% vs. 78%).
Addition of nelarabine for patients with T-ALL having intermediate- or high-risk disease improved disease-free survival, from 83% without the drug to 88% with the drug (P = .0450), and reduced the rate of CNS relapse. Disease-free survival was highest, at 91%, among those who received both escalating-dose methotrexate and nelarabine.
Among the patients who did not achieve remission from induction chemotherapy, the 4-year rate of overall survival was 54%. “This is important because it’s more than double the past survival rates,” Dr. Dunsmore noted.
Patients with T-LL fared similarly well whether they received nelarabine or not; fully 85% overall were still alive at 4 years.
In terms of adverse effects of nelarabine therapy, the rate of peripheral neuropathy (motor or sensory), one of the more problematic adverse effects of the drug, was 8% in the trial population overall and did not exceed 9% in any treatment arm, she reported.
Dr. Dunsmore disclosed that an immediate family member is an employee of and has a leadership role with TypeZero Technologies; that she receives travel, accommodations, and/or expenses from Novo Nordisk; and that an immediate family member receives travel, accommodations, and/or expenses from Tandem Diabetes Care. The study received funding from the Cancer Therapy Evaluation Program within the National Cancer Institute/National Institutes of Health and received support from the St. Baldrick’s Foundation.
SOURCE: Dunsmore KP et al. ASCO 2018, Abstract 10500.
A set of novel chemotherapy regimens yield excellent outcomes—the best yet—among pediatric and young adult patients with T-cell malignancies, finds a phase 3 randomized controlled trial conducted by the Children’s Oncology Group (ALL0434).
“Despite very intense and complex chemotherapy, 20% of children and adolescents enrolled in Children’s Oncology Group T-cell leukemia trials between 2000 and 2005 did not survive. New drugs were needed to improve survival rates for T-cell malignancies,” lead study author Kimberly P. Dunsmore, MD, a professor at Virginia Tech, Roanoke, said in a press briefing leading up to the annual meeting of the American Society of Clinical Oncology.
The ALL0434 trial tested the addition of methotrexate (Trexall) and/or nelarabine (Arranon), a T cell–specific drug known to be efficacious in relapsed disease, to standard chemotherapy, with tailoring of the regimen to recurrence risk. Analyses were based on 1,545 patients with T-cell acute lymphoblastic leukemia (T-ALL) or T-cell lymphoblastic lymphoma (T-LL).
Results for all patients with T-ALL showed that, with addition of either or both drugs, more than 90% were alive at 4 years and more than 80% were leukemia free. Adding nelarabine to standard chemotherapy improved disease-free survival among the subset having intermediate- or high-risk disease, and the best outcomes were seen with addition of both nelarabine and an escalating dose of methotrexate.
Although patients with T-LL did not see benefit from addition of nelarabine, they still had an 85% rate of overall survival at 4 years.
“ALL0434 is the largest trial for children and young adults with T-cell malignancy ever conducted. It has the best-ever survival data,” Dr. Dunsmore commented.
“Our next steps will be to examine what implications and benefits may accrue when using nelarabine in protocols without cranial irradiation. This is to decrease long-term neurologic side effects, and we think it may be possible since nelarabine also reduces CNS relapses,” she said.
“This trial highlights how effective our pediatric and young adult oncologists are at accruing: This is a rare disease, and they were able to put more than 1,500 patients on trial with this rare disease over the course of time,” commented ASCO President Bruce E. Johnson, MD, FASCO.
The new combination regimens are noteworthy in that they improved survival by an absolute 10% without minimal increase in toxicity, he maintained.
“This is part of the paradigm where nelarabine had been approved [by the FDA] for relapsed or recurrent disease, and in this particular setting, it has been moved upfront, closer to the initial treatment, improving the outcomes for those patients,” elaborated Dr. Johnson, who is also a professor of medicine at the Dana-Farber Cancer Institute and a leader of the Dana-Farber/Harvard Cancer Center Lung Cancer Program, both in Boston.
Study details
The ALL0434 trial enrolled patients aged 1-30 years with newly diagnosed T-ALL or T-LL. After induction chemotherapy, all patients received standard chemotherapy, the Children’s Oncology Group augmented Berlin-Frankfurt-Munster regimen (N Engl J Med. 1998;338:1663-71), and depending on recurrence risk, cranial irradiation.
In addition to that regimen, they were randomly assigned to four arms, according to methotrexate dosing (high dose with leucovorin rescue in the inpatient setting vs. escalating dose in the outpatient setting) and nelarabine therapy (receipt vs. nonreceipt).
Among patients with T-ALL, those with low-risk disease were ineligible for nelarabine and did not receive cranial irradiation, whereas those with intermediate- and high-risk disease were randomized to all four arms, Dr. Dunsmore explained. In addition, those who did not achieve remission on induction chemotherapy were nonrandomly assigned to the high-dose methotrexate plus nelarabine arm.
Patients with T-LL were ineligible for high-dose methotrexate and were randomized to escalating-dose methotrexate with or without nelarabine.
Among all patients with T-ALL, the 4-year rate of overall survival was 90.2%, and the 4-year rate of disease-free survival was 84.1%, Dr. Dunsmore reported.
Disease-free survival was better with escalating-dose methotrexate than with high-dose methotrexate (89.8% vs. 78%).
Addition of nelarabine for patients with T-ALL having intermediate- or high-risk disease improved disease-free survival, from 83% without the drug to 88% with the drug (P = .0450), and reduced the rate of CNS relapse. Disease-free survival was highest, at 91%, among those who received both escalating-dose methotrexate and nelarabine.
Among the patients who did not achieve remission from induction chemotherapy, the 4-year rate of overall survival was 54%. “This is important because it’s more than double the past survival rates,” Dr. Dunsmore noted.
Patients with T-LL fared similarly well whether they received nelarabine or not; fully 85% overall were still alive at 4 years.
In terms of adverse effects of nelarabine therapy, the rate of peripheral neuropathy (motor or sensory), one of the more problematic adverse effects of the drug, was 8% in the trial population overall and did not exceed 9% in any treatment arm, she reported.
Dr. Dunsmore disclosed that an immediate family member is an employee of and has a leadership role with TypeZero Technologies; that she receives travel, accommodations, and/or expenses from Novo Nordisk; and that an immediate family member receives travel, accommodations, and/or expenses from Tandem Diabetes Care. The study received funding from the Cancer Therapy Evaluation Program within the National Cancer Institute/National Institutes of Health and received support from the St. Baldrick’s Foundation.
SOURCE: Dunsmore KP et al. ASCO 2018, Abstract 10500.
REPORTING FROM ASCO 2018
Key clinical point:
Major finding: Patients with T-ALL had a 4-year rate of overall survival of 90.2% and disease-free survival of 84.1%; patients with T-LL had a 4-year rate of overall survival of 85%.
Study details: Phase 3 randomized controlled trial among 1,545 youth with T-ALL or T-LL testing various regimens of methotrexate and/or nelarabine with standard chemotherapy (ALL0434).
Disclosures: Dr. Dunsmore disclosed that an immediate family member is an employee of and has a leadership role with TypeZero; that she receives travel, accommodations, and/or expenses from Novo Nordisk; and that an immediate family member receives travel, accommodations, and/or expenses from Tandem Diabetes Care. The study received funding from the Cancer Therapy Evaluation Program within the National Cancer Institute/National Institutes of Health and received support from the St. Baldrick’s Foundation.
Source: Dunsmore KP et al. ASCO 2018, Abstract 10500.
VIDEO: Skin exam crucial in rheumatic diseases, expert says
SANDESTIN, FLA. – Even when you know a patient’s serology and hear their symptoms and think you have a bead on their rheumatic disease, you might not. It’s vital to check the skin in patients with rheumatic disease to be sure the right disease is being treated and that they don’t actually have a more severe condition that might progress suddenly if left unchecked, said Alisa Femia, MD, assistant professor of dermatology at the annual Congress of Clinical Rheumatology.
In a session filled with pearls for rheumatologists on what to look for on their patients’ skin to help guide diagnosis and treatment, she told the story of a woman whom a rheumatologist colleague had correctly diagnosed with dermatomyositis. She was started on prednisone and mycophenolate mofetil, but her skin disease did not clear.
After examining her skin, Dr. Femia became immediately concerned.
“Despite prednisone, despite mycophenolate, here not only does she have Gottron’s papules, but she has erosions within her Gottron’s papules,” Dr. Femia said. The woman also had erosions within papules on her palms.
These were telltale signs of MDA5-associated dermatomyositis, which studies have found to be linked with interstitial lung disease (J Am Acad Dermatol. 2011 Jul;65[1]:25-34). Under her care, these patients ideally undergo lung monitoring every 3 months, Dr. Femia said.
“That is a form of dermatomyositis that you cannot miss,” she said.
The effects of discoid lupus are another reason to take special care in skin examination. Once the disease, which involves a scaling of the skin, is obvious, there can be permanent aesthetic effects that could have been avoided with earlier detection and treatment, Dr. Femia said.
Clinicians should also be on the lookout for volume loss, or contour change, in discoid lupus patients, because that’s a sign of lupus panniculitis, which involves deeper lesions mainly to fatty areas such as the cheeks or thighs. The disease can progress fast, with sudden, massive loss of body volume, so therapy should be escalated quickly, she said.
“We want to treat these patients aggressively in order to avoid this.”
SOURCE: Femia A. CCR 2018.
SANDESTIN, FLA. – Even when you know a patient’s serology and hear their symptoms and think you have a bead on their rheumatic disease, you might not. It’s vital to check the skin in patients with rheumatic disease to be sure the right disease is being treated and that they don’t actually have a more severe condition that might progress suddenly if left unchecked, said Alisa Femia, MD, assistant professor of dermatology at the annual Congress of Clinical Rheumatology.
In a session filled with pearls for rheumatologists on what to look for on their patients’ skin to help guide diagnosis and treatment, she told the story of a woman whom a rheumatologist colleague had correctly diagnosed with dermatomyositis. She was started on prednisone and mycophenolate mofetil, but her skin disease did not clear.
After examining her skin, Dr. Femia became immediately concerned.
“Despite prednisone, despite mycophenolate, here not only does she have Gottron’s papules, but she has erosions within her Gottron’s papules,” Dr. Femia said. The woman also had erosions within papules on her palms.
These were telltale signs of MDA5-associated dermatomyositis, which studies have found to be linked with interstitial lung disease (J Am Acad Dermatol. 2011 Jul;65[1]:25-34). Under her care, these patients ideally undergo lung monitoring every 3 months, Dr. Femia said.
“That is a form of dermatomyositis that you cannot miss,” she said.
The effects of discoid lupus are another reason to take special care in skin examination. Once the disease, which involves a scaling of the skin, is obvious, there can be permanent aesthetic effects that could have been avoided with earlier detection and treatment, Dr. Femia said.
Clinicians should also be on the lookout for volume loss, or contour change, in discoid lupus patients, because that’s a sign of lupus panniculitis, which involves deeper lesions mainly to fatty areas such as the cheeks or thighs. The disease can progress fast, with sudden, massive loss of body volume, so therapy should be escalated quickly, she said.
“We want to treat these patients aggressively in order to avoid this.”
SOURCE: Femia A. CCR 2018.
SANDESTIN, FLA. – Even when you know a patient’s serology and hear their symptoms and think you have a bead on their rheumatic disease, you might not. It’s vital to check the skin in patients with rheumatic disease to be sure the right disease is being treated and that they don’t actually have a more severe condition that might progress suddenly if left unchecked, said Alisa Femia, MD, assistant professor of dermatology at the annual Congress of Clinical Rheumatology.
In a session filled with pearls for rheumatologists on what to look for on their patients’ skin to help guide diagnosis and treatment, she told the story of a woman whom a rheumatologist colleague had correctly diagnosed with dermatomyositis. She was started on prednisone and mycophenolate mofetil, but her skin disease did not clear.
After examining her skin, Dr. Femia became immediately concerned.
“Despite prednisone, despite mycophenolate, here not only does she have Gottron’s papules, but she has erosions within her Gottron’s papules,” Dr. Femia said. The woman also had erosions within papules on her palms.
These were telltale signs of MDA5-associated dermatomyositis, which studies have found to be linked with interstitial lung disease (J Am Acad Dermatol. 2011 Jul;65[1]:25-34). Under her care, these patients ideally undergo lung monitoring every 3 months, Dr. Femia said.
“That is a form of dermatomyositis that you cannot miss,” she said.
The effects of discoid lupus are another reason to take special care in skin examination. Once the disease, which involves a scaling of the skin, is obvious, there can be permanent aesthetic effects that could have been avoided with earlier detection and treatment, Dr. Femia said.
Clinicians should also be on the lookout for volume loss, or contour change, in discoid lupus patients, because that’s a sign of lupus panniculitis, which involves deeper lesions mainly to fatty areas such as the cheeks or thighs. The disease can progress fast, with sudden, massive loss of body volume, so therapy should be escalated quickly, she said.
“We want to treat these patients aggressively in order to avoid this.”
SOURCE: Femia A. CCR 2018.
EXPERT ANALYSIS AT CCR 18
VIDEO: Researchers seek end to early corticosteroid use in AAV
SANDESTIN, FLA. – Clinicians have long wanted to avoid using corticosteroids in the treatment of ANCA-associated vasculitis (AAV). They’re drawing closer to getting their wish, said Christian Pagnoux, MD, of the department of internal medicine at Mount Sinai Hospital in Toronto.
The drugs have been a cornerstone in the treatments of these diseases – including granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA) – for decades, but they come at the price of osteoporosis, cardiovascular comorbidities, diabetes, increased infection risk, and other problems.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
The emergence of newer therapies such as rituximab and complement C5a-blocker avacopan could mean less of a reliance on corticosteroids, Dr. Pagnoux said. The ongoing ADVOCATE trial is assessing the efficacy of avacopan with rituximab or cyclophosphamide, with or without a tapered dose of prednisone for the first 21 weeks.
“Whether we can use a lighter, briefer, shorter corticosteroid regimen for induction is really a burning question,” Dr. Pagnoux said. Avacopan “may totally replace corticosteroids in the very near future,” he said.
Another trial taking an intense look at winnowing corticosteroids from GPA and MPA treatment is the eagerly awaited PEXIVAS trial, an international effort of 700 patients that is the largest ever in AAV, Dr. Pagnoux said.
The primary endpoint in the trial is assessing plasma exchange versus no plasma exchange, but the use of corticosteroids is being assessed as well.
“The PEXIVAS [trial] may give you some additional information,” Dr. Pagnoux said. “Patients were not only randomized to receive plasma exchange or no plasma exchange, but they were also randomized to receive the standard regimen of corticosteroids with a slow taper ... or a much faster regimen with a much faster tapering of the corticosteroids.” The fast taper involves a steep drop every week, so that, after just 1 month, doses have fallen from 60 mg to 10 mg.
Dr. Pagnoux said he can imagine the day when corticosteroids can be completely eliminated from induction treatment for GPA and MPA. But he added there are studies looking at the efficacy and safety of the drugs in maintenance treatment even once they’re eliminated from induction, but at far lower doses.
“The good news is that it would only be 5 mg per day, for example.”
SOURCE: Pagnoux C. CCR 2018.
SANDESTIN, FLA. – Clinicians have long wanted to avoid using corticosteroids in the treatment of ANCA-associated vasculitis (AAV). They’re drawing closer to getting their wish, said Christian Pagnoux, MD, of the department of internal medicine at Mount Sinai Hospital in Toronto.
The drugs have been a cornerstone in the treatments of these diseases – including granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA) – for decades, but they come at the price of osteoporosis, cardiovascular comorbidities, diabetes, increased infection risk, and other problems.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
The emergence of newer therapies such as rituximab and complement C5a-blocker avacopan could mean less of a reliance on corticosteroids, Dr. Pagnoux said. The ongoing ADVOCATE trial is assessing the efficacy of avacopan with rituximab or cyclophosphamide, with or without a tapered dose of prednisone for the first 21 weeks.
“Whether we can use a lighter, briefer, shorter corticosteroid regimen for induction is really a burning question,” Dr. Pagnoux said. Avacopan “may totally replace corticosteroids in the very near future,” he said.
Another trial taking an intense look at winnowing corticosteroids from GPA and MPA treatment is the eagerly awaited PEXIVAS trial, an international effort of 700 patients that is the largest ever in AAV, Dr. Pagnoux said.
The primary endpoint in the trial is assessing plasma exchange versus no plasma exchange, but the use of corticosteroids is being assessed as well.
“The PEXIVAS [trial] may give you some additional information,” Dr. Pagnoux said. “Patients were not only randomized to receive plasma exchange or no plasma exchange, but they were also randomized to receive the standard regimen of corticosteroids with a slow taper ... or a much faster regimen with a much faster tapering of the corticosteroids.” The fast taper involves a steep drop every week, so that, after just 1 month, doses have fallen from 60 mg to 10 mg.
Dr. Pagnoux said he can imagine the day when corticosteroids can be completely eliminated from induction treatment for GPA and MPA. But he added there are studies looking at the efficacy and safety of the drugs in maintenance treatment even once they’re eliminated from induction, but at far lower doses.
“The good news is that it would only be 5 mg per day, for example.”
SOURCE: Pagnoux C. CCR 2018.
SANDESTIN, FLA. – Clinicians have long wanted to avoid using corticosteroids in the treatment of ANCA-associated vasculitis (AAV). They’re drawing closer to getting their wish, said Christian Pagnoux, MD, of the department of internal medicine at Mount Sinai Hospital in Toronto.
The drugs have been a cornerstone in the treatments of these diseases – including granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA) – for decades, but they come at the price of osteoporosis, cardiovascular comorbidities, diabetes, increased infection risk, and other problems.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
The emergence of newer therapies such as rituximab and complement C5a-blocker avacopan could mean less of a reliance on corticosteroids, Dr. Pagnoux said. The ongoing ADVOCATE trial is assessing the efficacy of avacopan with rituximab or cyclophosphamide, with or without a tapered dose of prednisone for the first 21 weeks.
“Whether we can use a lighter, briefer, shorter corticosteroid regimen for induction is really a burning question,” Dr. Pagnoux said. Avacopan “may totally replace corticosteroids in the very near future,” he said.
Another trial taking an intense look at winnowing corticosteroids from GPA and MPA treatment is the eagerly awaited PEXIVAS trial, an international effort of 700 patients that is the largest ever in AAV, Dr. Pagnoux said.
The primary endpoint in the trial is assessing plasma exchange versus no plasma exchange, but the use of corticosteroids is being assessed as well.
“The PEXIVAS [trial] may give you some additional information,” Dr. Pagnoux said. “Patients were not only randomized to receive plasma exchange or no plasma exchange, but they were also randomized to receive the standard regimen of corticosteroids with a slow taper ... or a much faster regimen with a much faster tapering of the corticosteroids.” The fast taper involves a steep drop every week, so that, after just 1 month, doses have fallen from 60 mg to 10 mg.
Dr. Pagnoux said he can imagine the day when corticosteroids can be completely eliminated from induction treatment for GPA and MPA. But he added there are studies looking at the efficacy and safety of the drugs in maintenance treatment even once they’re eliminated from induction, but at far lower doses.
“The good news is that it would only be 5 mg per day, for example.”
SOURCE: Pagnoux C. CCR 2018.
EXPERT ANALYSIS AT CCR 18
Hematocrit improvement with SGLT2 inhibitor: Not just a diuretic effect?
BOSTON – The SGLT2 inhibitor dapagliflozin may increase red blood cell production by suppressing plasma levels of hepcidin, a proinflammatory inhibitor of iron transport, according to results of a randomized study.
This reduction in hepcidin provides a new mechanistic explanation for the improvement in hematocrit seen with SGLT2 inhibitor treatment and suggests a role for use of these drugs beyond their current indications, according to researcher Husam A. Ghanim, PhD, of the State University of New York at Buffalo.
To see whether there were other mechanisms involved beyond hemoconcentration caused by diuretic effects of the drugs, Dr. Ghanim and his colleagues investigated the possibility that dapagliflozin might suppress concentrations of hepcidin concentrations, thereby increasing erythropoiesis.
Their study included 22 patients with type 2 diabetes and normal renal function randomized to dapagliflozin 10 mg daily or placebo for 12 weeks.
They found that the plasma concentration of hepcidin fell significantly over that time period, from 265 to 215 ng/mL in dapagliflozin-treated patients. They also saw significant decreases in hemoglobin A1c, hemoglobin concentration, and hematocrit, as well as an increase in transferrin, the major transporter of iron in the circulation, over 12 weeks.
No such significant changes in those measures were seen in the placebo group, Dr. Ghanim said.
There was a modest but nonsignificant increase in erythropoietin concentrations in the dapagliflozin-treated group, according to the researcher.
Circulating ferritin also fell by about 40% over the course of the study. “Circulating ferritin doesn’t have a clear indication or implication on iron transport,” Dr. Ghanim said. “However, it gets secreted from macrophages and from the liver, and it gets used as a marker for inflammation, and it’s also used as a marker of liver function. So a reduction in ferritin levels may have some clinical implication to what’s going on in the liver.”
On the basis of these findings, it appears that SGLT2 inhibition might increase hematocrit via anti-inflammatory effects and increased erythropoiesis, Dr. Ghanim said.
The increase in oxygenated blood available to tissues might contribute to the beneficial effects of SGLT2 inhibitors on cardiovascular disease, he added.
Also, it’s possible that SGLT2 inhibitors could have a “major impact” on the liver since hepcidin and ferritin are secreted mainly by the liver: “This could also lead us to think that it is possible that we could use SGLT2 inhibitors in conditions of liver inflammation like nonalcoholic steatohepatitis and fatty liver disease,” Dr. Ghanim said in his presentation. “These are future ideas we could explore, based on our data.”
Dr. Ghanim had no disclosures to report.
SOURCE: Ghanim HA et al. AACE 2018, Abstract 228.
BOSTON – The SGLT2 inhibitor dapagliflozin may increase red blood cell production by suppressing plasma levels of hepcidin, a proinflammatory inhibitor of iron transport, according to results of a randomized study.
This reduction in hepcidin provides a new mechanistic explanation for the improvement in hematocrit seen with SGLT2 inhibitor treatment and suggests a role for use of these drugs beyond their current indications, according to researcher Husam A. Ghanim, PhD, of the State University of New York at Buffalo.
To see whether there were other mechanisms involved beyond hemoconcentration caused by diuretic effects of the drugs, Dr. Ghanim and his colleagues investigated the possibility that dapagliflozin might suppress concentrations of hepcidin concentrations, thereby increasing erythropoiesis.
Their study included 22 patients with type 2 diabetes and normal renal function randomized to dapagliflozin 10 mg daily or placebo for 12 weeks.
They found that the plasma concentration of hepcidin fell significantly over that time period, from 265 to 215 ng/mL in dapagliflozin-treated patients. They also saw significant decreases in hemoglobin A1c, hemoglobin concentration, and hematocrit, as well as an increase in transferrin, the major transporter of iron in the circulation, over 12 weeks.
No such significant changes in those measures were seen in the placebo group, Dr. Ghanim said.
There was a modest but nonsignificant increase in erythropoietin concentrations in the dapagliflozin-treated group, according to the researcher.
Circulating ferritin also fell by about 40% over the course of the study. “Circulating ferritin doesn’t have a clear indication or implication on iron transport,” Dr. Ghanim said. “However, it gets secreted from macrophages and from the liver, and it gets used as a marker for inflammation, and it’s also used as a marker of liver function. So a reduction in ferritin levels may have some clinical implication to what’s going on in the liver.”
On the basis of these findings, it appears that SGLT2 inhibition might increase hematocrit via anti-inflammatory effects and increased erythropoiesis, Dr. Ghanim said.
The increase in oxygenated blood available to tissues might contribute to the beneficial effects of SGLT2 inhibitors on cardiovascular disease, he added.
Also, it’s possible that SGLT2 inhibitors could have a “major impact” on the liver since hepcidin and ferritin are secreted mainly by the liver: “This could also lead us to think that it is possible that we could use SGLT2 inhibitors in conditions of liver inflammation like nonalcoholic steatohepatitis and fatty liver disease,” Dr. Ghanim said in his presentation. “These are future ideas we could explore, based on our data.”
Dr. Ghanim had no disclosures to report.
SOURCE: Ghanim HA et al. AACE 2018, Abstract 228.
BOSTON – The SGLT2 inhibitor dapagliflozin may increase red blood cell production by suppressing plasma levels of hepcidin, a proinflammatory inhibitor of iron transport, according to results of a randomized study.
This reduction in hepcidin provides a new mechanistic explanation for the improvement in hematocrit seen with SGLT2 inhibitor treatment and suggests a role for use of these drugs beyond their current indications, according to researcher Husam A. Ghanim, PhD, of the State University of New York at Buffalo.
To see whether there were other mechanisms involved beyond hemoconcentration caused by diuretic effects of the drugs, Dr. Ghanim and his colleagues investigated the possibility that dapagliflozin might suppress concentrations of hepcidin concentrations, thereby increasing erythropoiesis.
Their study included 22 patients with type 2 diabetes and normal renal function randomized to dapagliflozin 10 mg daily or placebo for 12 weeks.
They found that the plasma concentration of hepcidin fell significantly over that time period, from 265 to 215 ng/mL in dapagliflozin-treated patients. They also saw significant decreases in hemoglobin A1c, hemoglobin concentration, and hematocrit, as well as an increase in transferrin, the major transporter of iron in the circulation, over 12 weeks.
No such significant changes in those measures were seen in the placebo group, Dr. Ghanim said.
There was a modest but nonsignificant increase in erythropoietin concentrations in the dapagliflozin-treated group, according to the researcher.
Circulating ferritin also fell by about 40% over the course of the study. “Circulating ferritin doesn’t have a clear indication or implication on iron transport,” Dr. Ghanim said. “However, it gets secreted from macrophages and from the liver, and it gets used as a marker for inflammation, and it’s also used as a marker of liver function. So a reduction in ferritin levels may have some clinical implication to what’s going on in the liver.”
On the basis of these findings, it appears that SGLT2 inhibition might increase hematocrit via anti-inflammatory effects and increased erythropoiesis, Dr. Ghanim said.
The increase in oxygenated blood available to tissues might contribute to the beneficial effects of SGLT2 inhibitors on cardiovascular disease, he added.
Also, it’s possible that SGLT2 inhibitors could have a “major impact” on the liver since hepcidin and ferritin are secreted mainly by the liver: “This could also lead us to think that it is possible that we could use SGLT2 inhibitors in conditions of liver inflammation like nonalcoholic steatohepatitis and fatty liver disease,” Dr. Ghanim said in his presentation. “These are future ideas we could explore, based on our data.”
Dr. Ghanim had no disclosures to report.
SOURCE: Ghanim HA et al. AACE 2018, Abstract 228.
REPORTING FROM AACE 2018
Key clinical point: The SGLT2 inhibitor dapagliflozin suppressed hepcidin, a proinflammatory inhibitor of iron transport.
Major finding: Hepcidin plasma concentration fell from 265 to 215 ng/mL (P < 0.05) in dapagliflozin-treated patients.
Study details: A study of 22 patients with type 2 diabetes randomized to either dapagliflozin 10 mg daily or placebo for 12 weeks.
Disclosures: Dr. Ghanim had no disclosures related to the presentation.
Source: Ghanim HA et al. AACE 2018, Abstract 228.
Cannabidiol gel for osteoarthritis knee pain gives lukewarm results
LIVERPOOL, ENGLAND – There was no significant reduction in pain from knee osteoarthritis (OA) with the use of investigational cannabidiol (CBD) gel ZYN002 in a phase 2a trial presented at the World Congress on Osteoarthritis.
The mean reductions in baseline knee pain scores from study entry to a 12-week assessment were –2.4 for placebo and –2.6 (P = .5) and –2.8 (P = .25), respectively, for a 250-mg and a 500-mg formulation of the gel.
While there was a trend for benefit, it was “neither statistically or clinically significant,” reported David Hunter, MBBS, PhD.
However, he observed that a significantly (P = .016) greater number of patients who received the 250-mg dose (52.7%) were “composite responders,” compared with patients who received placebo (34.1%). A composite response was defined as at least a 30% reduction in pain, and a 20% decrease in WOMAC physical function subscale score at the last observation.
Although the percentage of composite responders was also higher than placebo with the 500-mg dose, the difference wasn’t significant (45.1% vs. 34.1%; P = .0169).
Post-hoc analyses also suggested that perhaps some patients may benefit more than others, reported Dr. Hunter, professor of medicine at the University of Sydney and the Royal North Shore Hospital, Sydney.
For example, patients with baseline pain scores or 7 or more had greater mean reduction in pain at 12 weeks with both doses of the gel combined than placebo at week 4 (–2.2 vs. –1.6; P = .029), although the difference was not significant at week 8 (–3.0 vs. –2.2; P = .05) or 12 (–3.3 vs. –2.5; P = .086).
Women also exhibited a greater placebo response than did men, and “patients with less variability in baseline pain scores may have had greater separation between placebo and the treatment,” Dr. Hunter said. Indeed, 50%-52% of patients with less than 33% variation in baseline scores had a composite response to the gel, versus 27% for the placebo arm.
Evidence from preclinical models suggest that cannabinoids have antinociceptive and antihyperalgesic effects, Dr. Hunter explained at the congress, sponsored by the Osteoarthritis Research Society International. CBD has also been shown to have broad anti-inflammatory effects, and it may even promote osteoclast cell function and decrease bone resorption.
ZYN002 is a synthetic CBD formulated for transdermal delivery using a patented method to enhance its permeation through the skin. According to the manufacturer, Zynerba, it was developed for neuropsychiatric disorders, including fragile X syndrome, adult refractory epilepsy, and developmental and epileptic encephalopathies.
The primary aim of the phase 2 trial reported by Dr. Hunter was to assess ZYN002’s efficacy in managing osteoarthritis knee pain. Secondary objectives were to assess the gel’s safety and tolerability.
The STOP 1 (Synthetic Transdermal Cannabidiol for the Treatment of Knee Pain Due to Osteoarthritis) trial was a double-blind, placebo-controlled trial. For inclusion in the study, patients had to be between age 40 and 75 years and have had knee pain for at least 12 months because of primary OA, based on clinical and x-ray data as per American College of Rheumatology criteria. Anyone with a history of fibromyalgia or epilepsy was excluded.
A total of 320 patients with painful knee OA, with a mean age of 62 years, were randomized and underwent a 1-week washout period in which all their analgesic medications being used for osteoarthritis knee pain, except acetaminophen, were stopped. That was followed by a 7- to 10-day period when baseline daily worst pain levels were captured using a 0-10 numeric rating scale. Patients then underwent 12 weeks of treatment with either a high (500 mg) or a low (250 mg) dose of the gel, or placebo, given in twice-daily doses.
Just over a third (34%) of patients in the placebo arm discontinued the study, compared with 22% and 24% of those in the high- and low-dose gel arms. The main reason for discontinuation was withdrawn consent because of lack of efficacy in the placebo arm, with 8%, 8%, and 4% of patients, respectively, discontinuing because of adverse effects.
“Treatment-emergent adverse effects were roughly equally distributed across the three groups,” Dr. Hunter reported. The adverse events of more interest, he noted, were application site dryness, reaction, or pain. There was “a slight predisposition” to each of these in the 250-mg gel arm (5%, 3%, and 3% of patients affected) versus the 500-mg gel (3%, 0%, and 0%) and placebo (1%, 1%, 0%) arms.
SOURCE: Hunter D et al. Osteoarthritis Cartilage 2018:26(1):S26. Abstract 30.
LIVERPOOL, ENGLAND – There was no significant reduction in pain from knee osteoarthritis (OA) with the use of investigational cannabidiol (CBD) gel ZYN002 in a phase 2a trial presented at the World Congress on Osteoarthritis.
The mean reductions in baseline knee pain scores from study entry to a 12-week assessment were –2.4 for placebo and –2.6 (P = .5) and –2.8 (P = .25), respectively, for a 250-mg and a 500-mg formulation of the gel.
While there was a trend for benefit, it was “neither statistically or clinically significant,” reported David Hunter, MBBS, PhD.
However, he observed that a significantly (P = .016) greater number of patients who received the 250-mg dose (52.7%) were “composite responders,” compared with patients who received placebo (34.1%). A composite response was defined as at least a 30% reduction in pain, and a 20% decrease in WOMAC physical function subscale score at the last observation.
Although the percentage of composite responders was also higher than placebo with the 500-mg dose, the difference wasn’t significant (45.1% vs. 34.1%; P = .0169).
Post-hoc analyses also suggested that perhaps some patients may benefit more than others, reported Dr. Hunter, professor of medicine at the University of Sydney and the Royal North Shore Hospital, Sydney.
For example, patients with baseline pain scores or 7 or more had greater mean reduction in pain at 12 weeks with both doses of the gel combined than placebo at week 4 (–2.2 vs. –1.6; P = .029), although the difference was not significant at week 8 (–3.0 vs. –2.2; P = .05) or 12 (–3.3 vs. –2.5; P = .086).
Women also exhibited a greater placebo response than did men, and “patients with less variability in baseline pain scores may have had greater separation between placebo and the treatment,” Dr. Hunter said. Indeed, 50%-52% of patients with less than 33% variation in baseline scores had a composite response to the gel, versus 27% for the placebo arm.
Evidence from preclinical models suggest that cannabinoids have antinociceptive and antihyperalgesic effects, Dr. Hunter explained at the congress, sponsored by the Osteoarthritis Research Society International. CBD has also been shown to have broad anti-inflammatory effects, and it may even promote osteoclast cell function and decrease bone resorption.
ZYN002 is a synthetic CBD formulated for transdermal delivery using a patented method to enhance its permeation through the skin. According to the manufacturer, Zynerba, it was developed for neuropsychiatric disorders, including fragile X syndrome, adult refractory epilepsy, and developmental and epileptic encephalopathies.
The primary aim of the phase 2 trial reported by Dr. Hunter was to assess ZYN002’s efficacy in managing osteoarthritis knee pain. Secondary objectives were to assess the gel’s safety and tolerability.
The STOP 1 (Synthetic Transdermal Cannabidiol for the Treatment of Knee Pain Due to Osteoarthritis) trial was a double-blind, placebo-controlled trial. For inclusion in the study, patients had to be between age 40 and 75 years and have had knee pain for at least 12 months because of primary OA, based on clinical and x-ray data as per American College of Rheumatology criteria. Anyone with a history of fibromyalgia or epilepsy was excluded.
A total of 320 patients with painful knee OA, with a mean age of 62 years, were randomized and underwent a 1-week washout period in which all their analgesic medications being used for osteoarthritis knee pain, except acetaminophen, were stopped. That was followed by a 7- to 10-day period when baseline daily worst pain levels were captured using a 0-10 numeric rating scale. Patients then underwent 12 weeks of treatment with either a high (500 mg) or a low (250 mg) dose of the gel, or placebo, given in twice-daily doses.
Just over a third (34%) of patients in the placebo arm discontinued the study, compared with 22% and 24% of those in the high- and low-dose gel arms. The main reason for discontinuation was withdrawn consent because of lack of efficacy in the placebo arm, with 8%, 8%, and 4% of patients, respectively, discontinuing because of adverse effects.
“Treatment-emergent adverse effects were roughly equally distributed across the three groups,” Dr. Hunter reported. The adverse events of more interest, he noted, were application site dryness, reaction, or pain. There was “a slight predisposition” to each of these in the 250-mg gel arm (5%, 3%, and 3% of patients affected) versus the 500-mg gel (3%, 0%, and 0%) and placebo (1%, 1%, 0%) arms.
SOURCE: Hunter D et al. Osteoarthritis Cartilage 2018:26(1):S26. Abstract 30.
LIVERPOOL, ENGLAND – There was no significant reduction in pain from knee osteoarthritis (OA) with the use of investigational cannabidiol (CBD) gel ZYN002 in a phase 2a trial presented at the World Congress on Osteoarthritis.
The mean reductions in baseline knee pain scores from study entry to a 12-week assessment were –2.4 for placebo and –2.6 (P = .5) and –2.8 (P = .25), respectively, for a 250-mg and a 500-mg formulation of the gel.
While there was a trend for benefit, it was “neither statistically or clinically significant,” reported David Hunter, MBBS, PhD.
However, he observed that a significantly (P = .016) greater number of patients who received the 250-mg dose (52.7%) were “composite responders,” compared with patients who received placebo (34.1%). A composite response was defined as at least a 30% reduction in pain, and a 20% decrease in WOMAC physical function subscale score at the last observation.
Although the percentage of composite responders was also higher than placebo with the 500-mg dose, the difference wasn’t significant (45.1% vs. 34.1%; P = .0169).
Post-hoc analyses also suggested that perhaps some patients may benefit more than others, reported Dr. Hunter, professor of medicine at the University of Sydney and the Royal North Shore Hospital, Sydney.
For example, patients with baseline pain scores or 7 or more had greater mean reduction in pain at 12 weeks with both doses of the gel combined than placebo at week 4 (–2.2 vs. –1.6; P = .029), although the difference was not significant at week 8 (–3.0 vs. –2.2; P = .05) or 12 (–3.3 vs. –2.5; P = .086).
Women also exhibited a greater placebo response than did men, and “patients with less variability in baseline pain scores may have had greater separation between placebo and the treatment,” Dr. Hunter said. Indeed, 50%-52% of patients with less than 33% variation in baseline scores had a composite response to the gel, versus 27% for the placebo arm.
Evidence from preclinical models suggest that cannabinoids have antinociceptive and antihyperalgesic effects, Dr. Hunter explained at the congress, sponsored by the Osteoarthritis Research Society International. CBD has also been shown to have broad anti-inflammatory effects, and it may even promote osteoclast cell function and decrease bone resorption.
ZYN002 is a synthetic CBD formulated for transdermal delivery using a patented method to enhance its permeation through the skin. According to the manufacturer, Zynerba, it was developed for neuropsychiatric disorders, including fragile X syndrome, adult refractory epilepsy, and developmental and epileptic encephalopathies.
The primary aim of the phase 2 trial reported by Dr. Hunter was to assess ZYN002’s efficacy in managing osteoarthritis knee pain. Secondary objectives were to assess the gel’s safety and tolerability.
The STOP 1 (Synthetic Transdermal Cannabidiol for the Treatment of Knee Pain Due to Osteoarthritis) trial was a double-blind, placebo-controlled trial. For inclusion in the study, patients had to be between age 40 and 75 years and have had knee pain for at least 12 months because of primary OA, based on clinical and x-ray data as per American College of Rheumatology criteria. Anyone with a history of fibromyalgia or epilepsy was excluded.
A total of 320 patients with painful knee OA, with a mean age of 62 years, were randomized and underwent a 1-week washout period in which all their analgesic medications being used for osteoarthritis knee pain, except acetaminophen, were stopped. That was followed by a 7- to 10-day period when baseline daily worst pain levels were captured using a 0-10 numeric rating scale. Patients then underwent 12 weeks of treatment with either a high (500 mg) or a low (250 mg) dose of the gel, or placebo, given in twice-daily doses.
Just over a third (34%) of patients in the placebo arm discontinued the study, compared with 22% and 24% of those in the high- and low-dose gel arms. The main reason for discontinuation was withdrawn consent because of lack of efficacy in the placebo arm, with 8%, 8%, and 4% of patients, respectively, discontinuing because of adverse effects.
“Treatment-emergent adverse effects were roughly equally distributed across the three groups,” Dr. Hunter reported. The adverse events of more interest, he noted, were application site dryness, reaction, or pain. There was “a slight predisposition” to each of these in the 250-mg gel arm (5%, 3%, and 3% of patients affected) versus the 500-mg gel (3%, 0%, and 0%) and placebo (1%, 1%, 0%) arms.
SOURCE: Hunter D et al. Osteoarthritis Cartilage 2018:26(1):S26. Abstract 30.
REPORTING FROM OARSI 2018
Key clinical point:
Major finding: Mean knee pain scores at 12 weeks fell by –2.4 for placebo, and –2.6 (P = .5) and –2.8 (P = .25) for a 250-mg and a 500-mg formulation of the gel.
Study details: A 12-week, randomized, double-blind, placebo-controlled, phase 2, multidose study involving 320 patients with osteoarthritis knee pain for at least 12 months.
Disclosures: Dr. Hunter has consulted for Flexion, Merck Serono, TissueGene, and Zynerba, and has received royalties from DJO for a patellofemoral brace.
Source: Hunter D et al. Osteoarthritis Cartilage 2018:26(1):S26. Abstract 30.
VIDEO: Real-world findings on hybrid closed-loop insulin system
BOSTON – Real-world experience with the Medtronic MiniMed 670G, a hybrid closed-loop insulin delivery system, showed the device was associated with improved average glucose readings and more time in euglycemia in 26 patients with type 1 diabetes.
The findings go beyond the safety data from the clinical trial of the MiniMed 670G system, Kathryn Weaver, MD, of the University of Washington, Seattle, and her colleagues reported in a poster presented at the annual meeting of the American Association of Clinical Endocrinologists.
The clinical trial included a 2-week run-in period during which the system was used in manual mode before it was switched to automated mode. Mean sensor glucose readings for participants went from 150.2 mg/dL during run-in to 150.8 mg/dL at the end of 3 months, which was not a statistically significant difference (JAMA. 2016;316[13]:1407-8).
In the real-world study, average sensor glucose readings dropped from a mean 169.46 mg/dL at baseline to 157.08 mg/dL at the end of the 3-month study period (P = .05). Also, the time spent with blood glucose levels greater than 180 mg/dL fell from 26.5% to 20% (P = .007), while the amount of time with glucose readings between 70 and 180 mg/dL increased from 61.7% to 71.1% (P = .02). Periods of hypoglycemia and severe hypoglycemia were already low at baseline and did not change, Dr. Weaver said.
“It is important to note that the initial pivotal trial was a study designed to evaluate safety not a study designed to evaluate effectiveness. And the [trial] group did demonstrate safety; they had a very significant reduction in the amount of hypoglycemia” with the pump, said Dr. Weaver. “We did not show a significant reduction in hypoglycemia in our [real-world] group, likely because we had a very low rate of hypoglycemia going into the study.”
Two of the study coauthors are employees of Medtronic, which manufactures the MiniMed 670G insulin pump/continuous glucose monitor. Medtronic did not provide funding support for the study or provide the closed-loop systems, and Dr. Weaver reported that she had no relevant financial disclosures.
SOURCE: Weaver K et al. AACE 2018, Abstract 210.
BOSTON – Real-world experience with the Medtronic MiniMed 670G, a hybrid closed-loop insulin delivery system, showed the device was associated with improved average glucose readings and more time in euglycemia in 26 patients with type 1 diabetes.
The findings go beyond the safety data from the clinical trial of the MiniMed 670G system, Kathryn Weaver, MD, of the University of Washington, Seattle, and her colleagues reported in a poster presented at the annual meeting of the American Association of Clinical Endocrinologists.
The clinical trial included a 2-week run-in period during which the system was used in manual mode before it was switched to automated mode. Mean sensor glucose readings for participants went from 150.2 mg/dL during run-in to 150.8 mg/dL at the end of 3 months, which was not a statistically significant difference (JAMA. 2016;316[13]:1407-8).
In the real-world study, average sensor glucose readings dropped from a mean 169.46 mg/dL at baseline to 157.08 mg/dL at the end of the 3-month study period (P = .05). Also, the time spent with blood glucose levels greater than 180 mg/dL fell from 26.5% to 20% (P = .007), while the amount of time with glucose readings between 70 and 180 mg/dL increased from 61.7% to 71.1% (P = .02). Periods of hypoglycemia and severe hypoglycemia were already low at baseline and did not change, Dr. Weaver said.
“It is important to note that the initial pivotal trial was a study designed to evaluate safety not a study designed to evaluate effectiveness. And the [trial] group did demonstrate safety; they had a very significant reduction in the amount of hypoglycemia” with the pump, said Dr. Weaver. “We did not show a significant reduction in hypoglycemia in our [real-world] group, likely because we had a very low rate of hypoglycemia going into the study.”
Two of the study coauthors are employees of Medtronic, which manufactures the MiniMed 670G insulin pump/continuous glucose monitor. Medtronic did not provide funding support for the study or provide the closed-loop systems, and Dr. Weaver reported that she had no relevant financial disclosures.
SOURCE: Weaver K et al. AACE 2018, Abstract 210.
BOSTON – Real-world experience with the Medtronic MiniMed 670G, a hybrid closed-loop insulin delivery system, showed the device was associated with improved average glucose readings and more time in euglycemia in 26 patients with type 1 diabetes.
The findings go beyond the safety data from the clinical trial of the MiniMed 670G system, Kathryn Weaver, MD, of the University of Washington, Seattle, and her colleagues reported in a poster presented at the annual meeting of the American Association of Clinical Endocrinologists.
The clinical trial included a 2-week run-in period during which the system was used in manual mode before it was switched to automated mode. Mean sensor glucose readings for participants went from 150.2 mg/dL during run-in to 150.8 mg/dL at the end of 3 months, which was not a statistically significant difference (JAMA. 2016;316[13]:1407-8).
In the real-world study, average sensor glucose readings dropped from a mean 169.46 mg/dL at baseline to 157.08 mg/dL at the end of the 3-month study period (P = .05). Also, the time spent with blood glucose levels greater than 180 mg/dL fell from 26.5% to 20% (P = .007), while the amount of time with glucose readings between 70 and 180 mg/dL increased from 61.7% to 71.1% (P = .02). Periods of hypoglycemia and severe hypoglycemia were already low at baseline and did not change, Dr. Weaver said.
“It is important to note that the initial pivotal trial was a study designed to evaluate safety not a study designed to evaluate effectiveness. And the [trial] group did demonstrate safety; they had a very significant reduction in the amount of hypoglycemia” with the pump, said Dr. Weaver. “We did not show a significant reduction in hypoglycemia in our [real-world] group, likely because we had a very low rate of hypoglycemia going into the study.”
Two of the study coauthors are employees of Medtronic, which manufactures the MiniMed 670G insulin pump/continuous glucose monitor. Medtronic did not provide funding support for the study or provide the closed-loop systems, and Dr. Weaver reported that she had no relevant financial disclosures.
SOURCE: Weaver K et al. AACE 2018, Abstract 210.
REPORTING FROM AACE 2018
Vestibular/oculomotor component of concussion warrants more attention
NEW ORLEANS – Vestibular and oculomotor impairment is increasingly recognized as a common, underappreciated, and yet treatable aspect of sports concussions, Gary W. Dorshimer, MD, said at the annual meeting of the American College of Physicians.
A major advance in the diagnosis and treatment of this form of impairment has been achieved by researchers at the University of Pittsburgh Medical Center sports medicine concussion program.
“The Pitt group has come up with a nice exam to assess this part of the concussion injury, which doesn’t affect your memory, it doesn’t affect your cognition, it affects what I’ve found to be the thing that takes the longest to get better: the oculomotor/vestibular mechanism,” explained Dr. Dorshimer, chief of general internal medicine at Penn Medicine, Philadelphia, and team physician for the Philadelphia Flyers professional ice hockey team.
The exam, which the Pitt group has described in full detail (Am J Sports Med. 2014;42(10):2479-86), is known as the Vestibular/Ocular Motor Screening assessment, or VOMS. The tool has filled an unmet need in sports medicine, he said. It takes only a few minutes for a physician to perform. The rating scale assesses visual motion sensitivity, smooth eye pursuits, horizontal and vertical saccades, the vestibular ocular reflex, and convergence. Positive findings warrant specialized referral for targeted rehabilitation using visual-ocular and vestibular therapies.
The symptoms of sports concussion–related oculomotor/vestibular impairment may include nausea, vertigo, dizziness, blurred or double vision, difficulty tracking a moving target, and discomfort in busy environments. These symptoms often translate to difficulty reading and academic problems, which historically often were misinterpreted as cognitive impairments.
It’s estimated that oculomotor/vestibular impairment occurs in roughly 60% of sports concussions. These vestibular and/or vision symptoms are associated with protracted recovery. And preliminary evidence demonstrates that targeted physical therapies are effective in speeding recovery.
“It’s so important to be able to find this [impairment] because it’s something you can do something about. We find that when these things are off and people work on them, they get better. That’s why so many people in the field are now saying that if a patient works hard, does the rehabilitation, the majority of them are going to get better. And they won’t get better unless they press forward,” the internist said.
The VOMS screen is simple to perform. It entails tasks such as convergence testing, in which the physician moves a finger or pen steadily closer to the patient’s face; if the patient reports that the single object has turned into two at a distance of more than 6 cm, that’s a positive result indicative of convergence insufficiency.
In another task, the physician hold his two index fingers apart and has the patients move their eyes from finger to finger while holding their heads still.
“I’m not that interested in whether they’re catching the tips of fingers, I’m interested in if they can go fast, and can they go faster if I challenge them, or do they stop doing it? When people with ocular vestibular dysfunction start doing this task, they’re going to slow down. They can’t keep it up because it’s so unpleasant. It really bothers them a lot,” Dr. Dorshimer observed.
In his experience, another key element in a smooth and successful recovery from sports concussions, in addition to getting skilled help for vestibular/oculomotor impairment, if present, is to encourage a positive attitude.
“If you think you’re going to get CTE [chronic traumatic encephalopathy] when you get older because you got waffled a bit in sport, that’s just such a negative attitude. I mean, you can’t lie to them: We don’t know. But I take care of a ton of retired athletes who don’t have CTE. Maybe they’re going to have some tangles in their brains, but they don’t have it clinically. So you want them to keep a positive attitude,” he emphasized.
“CTE was around when your parents and grandparents were jocks. They went out on the playground and pummeled each other every day after school. There are probably all kinds of factors involved in CTE: the number of concussions, hereditary factors, alcohol, drugs. No one really knows yet,” he said.
Dr. Dorshimer reported having no financial conflicts regarding his presentation on the athlete as patient.
NEW ORLEANS – Vestibular and oculomotor impairment is increasingly recognized as a common, underappreciated, and yet treatable aspect of sports concussions, Gary W. Dorshimer, MD, said at the annual meeting of the American College of Physicians.
A major advance in the diagnosis and treatment of this form of impairment has been achieved by researchers at the University of Pittsburgh Medical Center sports medicine concussion program.
“The Pitt group has come up with a nice exam to assess this part of the concussion injury, which doesn’t affect your memory, it doesn’t affect your cognition, it affects what I’ve found to be the thing that takes the longest to get better: the oculomotor/vestibular mechanism,” explained Dr. Dorshimer, chief of general internal medicine at Penn Medicine, Philadelphia, and team physician for the Philadelphia Flyers professional ice hockey team.
The exam, which the Pitt group has described in full detail (Am J Sports Med. 2014;42(10):2479-86), is known as the Vestibular/Ocular Motor Screening assessment, or VOMS. The tool has filled an unmet need in sports medicine, he said. It takes only a few minutes for a physician to perform. The rating scale assesses visual motion sensitivity, smooth eye pursuits, horizontal and vertical saccades, the vestibular ocular reflex, and convergence. Positive findings warrant specialized referral for targeted rehabilitation using visual-ocular and vestibular therapies.
The symptoms of sports concussion–related oculomotor/vestibular impairment may include nausea, vertigo, dizziness, blurred or double vision, difficulty tracking a moving target, and discomfort in busy environments. These symptoms often translate to difficulty reading and academic problems, which historically often were misinterpreted as cognitive impairments.
It’s estimated that oculomotor/vestibular impairment occurs in roughly 60% of sports concussions. These vestibular and/or vision symptoms are associated with protracted recovery. And preliminary evidence demonstrates that targeted physical therapies are effective in speeding recovery.
“It’s so important to be able to find this [impairment] because it’s something you can do something about. We find that when these things are off and people work on them, they get better. That’s why so many people in the field are now saying that if a patient works hard, does the rehabilitation, the majority of them are going to get better. And they won’t get better unless they press forward,” the internist said.
The VOMS screen is simple to perform. It entails tasks such as convergence testing, in which the physician moves a finger or pen steadily closer to the patient’s face; if the patient reports that the single object has turned into two at a distance of more than 6 cm, that’s a positive result indicative of convergence insufficiency.
In another task, the physician hold his two index fingers apart and has the patients move their eyes from finger to finger while holding their heads still.
“I’m not that interested in whether they’re catching the tips of fingers, I’m interested in if they can go fast, and can they go faster if I challenge them, or do they stop doing it? When people with ocular vestibular dysfunction start doing this task, they’re going to slow down. They can’t keep it up because it’s so unpleasant. It really bothers them a lot,” Dr. Dorshimer observed.
In his experience, another key element in a smooth and successful recovery from sports concussions, in addition to getting skilled help for vestibular/oculomotor impairment, if present, is to encourage a positive attitude.
“If you think you’re going to get CTE [chronic traumatic encephalopathy] when you get older because you got waffled a bit in sport, that’s just such a negative attitude. I mean, you can’t lie to them: We don’t know. But I take care of a ton of retired athletes who don’t have CTE. Maybe they’re going to have some tangles in their brains, but they don’t have it clinically. So you want them to keep a positive attitude,” he emphasized.
“CTE was around when your parents and grandparents were jocks. They went out on the playground and pummeled each other every day after school. There are probably all kinds of factors involved in CTE: the number of concussions, hereditary factors, alcohol, drugs. No one really knows yet,” he said.
Dr. Dorshimer reported having no financial conflicts regarding his presentation on the athlete as patient.
NEW ORLEANS – Vestibular and oculomotor impairment is increasingly recognized as a common, underappreciated, and yet treatable aspect of sports concussions, Gary W. Dorshimer, MD, said at the annual meeting of the American College of Physicians.
A major advance in the diagnosis and treatment of this form of impairment has been achieved by researchers at the University of Pittsburgh Medical Center sports medicine concussion program.
“The Pitt group has come up with a nice exam to assess this part of the concussion injury, which doesn’t affect your memory, it doesn’t affect your cognition, it affects what I’ve found to be the thing that takes the longest to get better: the oculomotor/vestibular mechanism,” explained Dr. Dorshimer, chief of general internal medicine at Penn Medicine, Philadelphia, and team physician for the Philadelphia Flyers professional ice hockey team.
The exam, which the Pitt group has described in full detail (Am J Sports Med. 2014;42(10):2479-86), is known as the Vestibular/Ocular Motor Screening assessment, or VOMS. The tool has filled an unmet need in sports medicine, he said. It takes only a few minutes for a physician to perform. The rating scale assesses visual motion sensitivity, smooth eye pursuits, horizontal and vertical saccades, the vestibular ocular reflex, and convergence. Positive findings warrant specialized referral for targeted rehabilitation using visual-ocular and vestibular therapies.
The symptoms of sports concussion–related oculomotor/vestibular impairment may include nausea, vertigo, dizziness, blurred or double vision, difficulty tracking a moving target, and discomfort in busy environments. These symptoms often translate to difficulty reading and academic problems, which historically often were misinterpreted as cognitive impairments.
It’s estimated that oculomotor/vestibular impairment occurs in roughly 60% of sports concussions. These vestibular and/or vision symptoms are associated with protracted recovery. And preliminary evidence demonstrates that targeted physical therapies are effective in speeding recovery.
“It’s so important to be able to find this [impairment] because it’s something you can do something about. We find that when these things are off and people work on them, they get better. That’s why so many people in the field are now saying that if a patient works hard, does the rehabilitation, the majority of them are going to get better. And they won’t get better unless they press forward,” the internist said.
The VOMS screen is simple to perform. It entails tasks such as convergence testing, in which the physician moves a finger or pen steadily closer to the patient’s face; if the patient reports that the single object has turned into two at a distance of more than 6 cm, that’s a positive result indicative of convergence insufficiency.
In another task, the physician hold his two index fingers apart and has the patients move their eyes from finger to finger while holding their heads still.
“I’m not that interested in whether they’re catching the tips of fingers, I’m interested in if they can go fast, and can they go faster if I challenge them, or do they stop doing it? When people with ocular vestibular dysfunction start doing this task, they’re going to slow down. They can’t keep it up because it’s so unpleasant. It really bothers them a lot,” Dr. Dorshimer observed.
In his experience, another key element in a smooth and successful recovery from sports concussions, in addition to getting skilled help for vestibular/oculomotor impairment, if present, is to encourage a positive attitude.
“If you think you’re going to get CTE [chronic traumatic encephalopathy] when you get older because you got waffled a bit in sport, that’s just such a negative attitude. I mean, you can’t lie to them: We don’t know. But I take care of a ton of retired athletes who don’t have CTE. Maybe they’re going to have some tangles in their brains, but they don’t have it clinically. So you want them to keep a positive attitude,” he emphasized.
“CTE was around when your parents and grandparents were jocks. They went out on the playground and pummeled each other every day after school. There are probably all kinds of factors involved in CTE: the number of concussions, hereditary factors, alcohol, drugs. No one really knows yet,” he said.
Dr. Dorshimer reported having no financial conflicts regarding his presentation on the athlete as patient.
REPORTING FROM ACP INTERNAL MEDICINE
HBV birth dose predicts vaccine adherence
TORONTO – Infants who do not receive the hepatitis B vaccine birth dose are less likely to be up-to-date recipients of recommended vaccines by 19 months, based on results from a retrospective study of more than 9,000 infants.
“As pediatricians, we should be mindful of that when we are meeting families after the birth hospitalization and start a conversation at that point around vaccines,” one of the study authors, Annika M. Hofstetter, MD, PhD, said in an interview at the Pediatric Academic Societies meeting.
Of the 9,080 infants, 51% were male, 49% were non-Hispanic white, 56% were covered by public health insurance, and 47% stayed in the hospital for 48 hours or longer. The researchers reported that 76% infants received the HBV during the birth hospitalization, and 54% of subjects completed the seven-vaccine series by age 19 months. They also found that (P less than .001). Infants who received the HBV birth dose were 2.9 times more likely to complete the seven-vaccine series by age 19 months, compared with those who did not receive the HBV birth dose.
“Parents are making their first vaccine decision during that birth hospitalization,” said Dr. Hofstetter, who also conducts immunization research studies at Seattle Children’s Research Institute. “It’s unclear what underlies this decision, such as specific parent concerns or the way in which we as providers in the hospital are communicating vaccine information to the families. It’s telling, and it will be interesting to further explore the factors that are determining whether a family gets the vaccine during the birth hospitalization or not, and how we as a pediatric community can start having effective vaccine conversations earlier.”
She acknowledged certain limitations of the study, including the potential for misclassification errors in vaccine reporting systems and the fact that no data were available on parental attitudes about vaccination. The researchers reported having no financial disclosures.
TORONTO – Infants who do not receive the hepatitis B vaccine birth dose are less likely to be up-to-date recipients of recommended vaccines by 19 months, based on results from a retrospective study of more than 9,000 infants.
“As pediatricians, we should be mindful of that when we are meeting families after the birth hospitalization and start a conversation at that point around vaccines,” one of the study authors, Annika M. Hofstetter, MD, PhD, said in an interview at the Pediatric Academic Societies meeting.
Of the 9,080 infants, 51% were male, 49% were non-Hispanic white, 56% were covered by public health insurance, and 47% stayed in the hospital for 48 hours or longer. The researchers reported that 76% infants received the HBV during the birth hospitalization, and 54% of subjects completed the seven-vaccine series by age 19 months. They also found that (P less than .001). Infants who received the HBV birth dose were 2.9 times more likely to complete the seven-vaccine series by age 19 months, compared with those who did not receive the HBV birth dose.
“Parents are making their first vaccine decision during that birth hospitalization,” said Dr. Hofstetter, who also conducts immunization research studies at Seattle Children’s Research Institute. “It’s unclear what underlies this decision, such as specific parent concerns or the way in which we as providers in the hospital are communicating vaccine information to the families. It’s telling, and it will be interesting to further explore the factors that are determining whether a family gets the vaccine during the birth hospitalization or not, and how we as a pediatric community can start having effective vaccine conversations earlier.”
She acknowledged certain limitations of the study, including the potential for misclassification errors in vaccine reporting systems and the fact that no data were available on parental attitudes about vaccination. The researchers reported having no financial disclosures.
TORONTO – Infants who do not receive the hepatitis B vaccine birth dose are less likely to be up-to-date recipients of recommended vaccines by 19 months, based on results from a retrospective study of more than 9,000 infants.
“As pediatricians, we should be mindful of that when we are meeting families after the birth hospitalization and start a conversation at that point around vaccines,” one of the study authors, Annika M. Hofstetter, MD, PhD, said in an interview at the Pediatric Academic Societies meeting.
Of the 9,080 infants, 51% were male, 49% were non-Hispanic white, 56% were covered by public health insurance, and 47% stayed in the hospital for 48 hours or longer. The researchers reported that 76% infants received the HBV during the birth hospitalization, and 54% of subjects completed the seven-vaccine series by age 19 months. They also found that (P less than .001). Infants who received the HBV birth dose were 2.9 times more likely to complete the seven-vaccine series by age 19 months, compared with those who did not receive the HBV birth dose.
“Parents are making their first vaccine decision during that birth hospitalization,” said Dr. Hofstetter, who also conducts immunization research studies at Seattle Children’s Research Institute. “It’s unclear what underlies this decision, such as specific parent concerns or the way in which we as providers in the hospital are communicating vaccine information to the families. It’s telling, and it will be interesting to further explore the factors that are determining whether a family gets the vaccine during the birth hospitalization or not, and how we as a pediatric community can start having effective vaccine conversations earlier.”
She acknowledged certain limitations of the study, including the potential for misclassification errors in vaccine reporting systems and the fact that no data were available on parental attitudes about vaccination. The researchers reported having no financial disclosures.
AT PAS 2018
Key clinical point: Likelihood of completing the 7-vaccine series at 19 months was higher among infants who received the HBV birth dose.
Major finding: Infants who received the HBV birth dose were 2.9 times more likely to complete the 7-vaccine series by age 19 months, compared with those who did not receive the HBV birth dose.
Study details: A retrospective review of 9,080 infants born weighing at least 2,000 grams who received hospitalization care between January 1, 2008 and December 31, 2013.
Disclosures: The researchers reported having no financial disclosures.
Behavioral sleep intervention linked to sleep improvement in infants
(BSI) in a real-world setting, Sarah M. Honaker, PhD, of Indiana University, Indianapolis, and her associates, reported in the Journal of Pediatrics.
In a study of 652 parents who participated, parents started BSI when their infants were as young as less than 1 month of age and as late as 18 months of age. Most parents started BSI at 3-5 months.
Crying generally was greatest the first night, occurring in 45% of cases when all BSI approaches were considered. It lasted a mean 43 minutes, which dropped significantly after 1 week to a mean 9 minutes (P less than .001). Crying was considered most intense (on a 1-5 scale) on the initial night of BSI, a mean 4.42, and this “was equally true for all of the BSI approaches,” Dr. Honaker and her colleagues wrote.
In most cases, the parents’ first attempt at BSI worked (83%). Success varied by BSI approach, with the highest first attempt success rate in the unmodified extinction group (90%), followed by parental presence without support (83%), modified extinction (81%), and parental presence with support (65%). Eventually, 27% of parents were successful with a different approach than the one with which they started. Most commonly, they changed from modified extinction to unmodified extinction (66% of those who changed approaches).
“The majority of parents report successfully implementing BSI at a variety of ages across infancy, primarily using extinction-based approaches,” the researchers concluded. “Few significant differences were found between approaches, suggesting that health providers should offer parents options for BSI implementation.”
SOURCE: Honaker SM et al., J Pediatr. 2018. doi: 10.1016/j.jpeds.2018.04.009.
(BSI) in a real-world setting, Sarah M. Honaker, PhD, of Indiana University, Indianapolis, and her associates, reported in the Journal of Pediatrics.
In a study of 652 parents who participated, parents started BSI when their infants were as young as less than 1 month of age and as late as 18 months of age. Most parents started BSI at 3-5 months.
Crying generally was greatest the first night, occurring in 45% of cases when all BSI approaches were considered. It lasted a mean 43 minutes, which dropped significantly after 1 week to a mean 9 minutes (P less than .001). Crying was considered most intense (on a 1-5 scale) on the initial night of BSI, a mean 4.42, and this “was equally true for all of the BSI approaches,” Dr. Honaker and her colleagues wrote.
In most cases, the parents’ first attempt at BSI worked (83%). Success varied by BSI approach, with the highest first attempt success rate in the unmodified extinction group (90%), followed by parental presence without support (83%), modified extinction (81%), and parental presence with support (65%). Eventually, 27% of parents were successful with a different approach than the one with which they started. Most commonly, they changed from modified extinction to unmodified extinction (66% of those who changed approaches).
“The majority of parents report successfully implementing BSI at a variety of ages across infancy, primarily using extinction-based approaches,” the researchers concluded. “Few significant differences were found between approaches, suggesting that health providers should offer parents options for BSI implementation.”
SOURCE: Honaker SM et al., J Pediatr. 2018. doi: 10.1016/j.jpeds.2018.04.009.
(BSI) in a real-world setting, Sarah M. Honaker, PhD, of Indiana University, Indianapolis, and her associates, reported in the Journal of Pediatrics.
In a study of 652 parents who participated, parents started BSI when their infants were as young as less than 1 month of age and as late as 18 months of age. Most parents started BSI at 3-5 months.
Crying generally was greatest the first night, occurring in 45% of cases when all BSI approaches were considered. It lasted a mean 43 minutes, which dropped significantly after 1 week to a mean 9 minutes (P less than .001). Crying was considered most intense (on a 1-5 scale) on the initial night of BSI, a mean 4.42, and this “was equally true for all of the BSI approaches,” Dr. Honaker and her colleagues wrote.
In most cases, the parents’ first attempt at BSI worked (83%). Success varied by BSI approach, with the highest first attempt success rate in the unmodified extinction group (90%), followed by parental presence without support (83%), modified extinction (81%), and parental presence with support (65%). Eventually, 27% of parents were successful with a different approach than the one with which they started. Most commonly, they changed from modified extinction to unmodified extinction (66% of those who changed approaches).
“The majority of parents report successfully implementing BSI at a variety of ages across infancy, primarily using extinction-based approaches,” the researchers concluded. “Few significant differences were found between approaches, suggesting that health providers should offer parents options for BSI implementation.”
SOURCE: Honaker SM et al., J Pediatr. 2018. doi: 10.1016/j.jpeds.2018.04.009.
FROM THE JOURNAL OF PEDIATRICS