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Scientists create online database to aid CML research
A newly launched online database provides researchers with access to data on gene expression in chronic myeloid leukemia (CML).
The LEUKomics database includes datasets relating to clinical parameters in CML, normal and leukemic stem cells, CML disease stages, treatments for the disease, and mouse models of CML.
The database is free for researchers to use and share.
The scientists who developed the database hope it will increase our understanding of CML and lead to new treatments for the disease.
“LEUKomics is a very valuable resource and could help us to reveal new underlying mechanisms that drive CML,” said Jeff Evans, Director of the Institute of Cancer Sciences at the University of Glasgow in Scotland.
“It has the potential to transform CML research on a global level, as the findings can be downloaded and shared with other researchers across the world. We also hope it inspires new research ideas and ultimately fuels a global search into finding cures for CML.”
The LEUKomics database includes datasets with information on gene expression related to:
- Clinical parameters in CML, such as disease aggressiveness and response to treatment
- Stem and progenitor cells from CML patients and healthy individuals
- Chronic, accelerated, and blast phases of CML
- CML treatment (currently only tyrosine kinase inhibitors)
- Stem and progenitor cells from mouse models of CML.
The LEUKomics database was launched by scientists at the University of Glasgow and the University of Melbourne.
The website has been built as part of the stem cell database Stemformatics, with funding from the Scottish Cancer Foundation and Bloodwise.
“Thanks to research, most patients with CML will now live a normal life by taking a single pill,” said Alasdair Rankin, Director of Research at Bloodwise in London, England.
“But treatment is life-long, and not everyone can tolerate the side effects from their treatment or may not respond and see their CML return. There remains a need to develop a permanent cure for all people with this blood cancer. LEUKomics is a highly innovative way to speed up this search for a cure and should be a valuable asset for the global blood cancer research community. We look forward to seeing its impact in the months to come.”
The LEUKomics database can be accessed at: www.stemformatics.org/leukomics. 
A newly launched online database provides researchers with access to data on gene expression in chronic myeloid leukemia (CML).
The LEUKomics database includes datasets relating to clinical parameters in CML, normal and leukemic stem cells, CML disease stages, treatments for the disease, and mouse models of CML.
The database is free for researchers to use and share.
The scientists who developed the database hope it will increase our understanding of CML and lead to new treatments for the disease.
“LEUKomics is a very valuable resource and could help us to reveal new underlying mechanisms that drive CML,” said Jeff Evans, Director of the Institute of Cancer Sciences at the University of Glasgow in Scotland.
“It has the potential to transform CML research on a global level, as the findings can be downloaded and shared with other researchers across the world. We also hope it inspires new research ideas and ultimately fuels a global search into finding cures for CML.”
The LEUKomics database includes datasets with information on gene expression related to:
- Clinical parameters in CML, such as disease aggressiveness and response to treatment
- Stem and progenitor cells from CML patients and healthy individuals
- Chronic, accelerated, and blast phases of CML
- CML treatment (currently only tyrosine kinase inhibitors)
- Stem and progenitor cells from mouse models of CML.
The LEUKomics database was launched by scientists at the University of Glasgow and the University of Melbourne.
The website has been built as part of the stem cell database Stemformatics, with funding from the Scottish Cancer Foundation and Bloodwise.
“Thanks to research, most patients with CML will now live a normal life by taking a single pill,” said Alasdair Rankin, Director of Research at Bloodwise in London, England.
“But treatment is life-long, and not everyone can tolerate the side effects from their treatment or may not respond and see their CML return. There remains a need to develop a permanent cure for all people with this blood cancer. LEUKomics is a highly innovative way to speed up this search for a cure and should be a valuable asset for the global blood cancer research community. We look forward to seeing its impact in the months to come.”
The LEUKomics database can be accessed at: www.stemformatics.org/leukomics.
A newly launched online database provides researchers with access to data on gene expression in chronic myeloid leukemia (CML).
The LEUKomics database includes datasets relating to clinical parameters in CML, normal and leukemic stem cells, CML disease stages, treatments for the disease, and mouse models of CML.
The database is free for researchers to use and share.
The scientists who developed the database hope it will increase our understanding of CML and lead to new treatments for the disease.
“LEUKomics is a very valuable resource and could help us to reveal new underlying mechanisms that drive CML,” said Jeff Evans, Director of the Institute of Cancer Sciences at the University of Glasgow in Scotland.
“It has the potential to transform CML research on a global level, as the findings can be downloaded and shared with other researchers across the world. We also hope it inspires new research ideas and ultimately fuels a global search into finding cures for CML.”
The LEUKomics database includes datasets with information on gene expression related to:
- Clinical parameters in CML, such as disease aggressiveness and response to treatment
- Stem and progenitor cells from CML patients and healthy individuals
- Chronic, accelerated, and blast phases of CML
- CML treatment (currently only tyrosine kinase inhibitors)
- Stem and progenitor cells from mouse models of CML.
The LEUKomics database was launched by scientists at the University of Glasgow and the University of Melbourne.
The website has been built as part of the stem cell database Stemformatics, with funding from the Scottish Cancer Foundation and Bloodwise.
“Thanks to research, most patients with CML will now live a normal life by taking a single pill,” said Alasdair Rankin, Director of Research at Bloodwise in London, England.
“But treatment is life-long, and not everyone can tolerate the side effects from their treatment or may not respond and see their CML return. There remains a need to develop a permanent cure for all people with this blood cancer. LEUKomics is a highly innovative way to speed up this search for a cure and should be a valuable asset for the global blood cancer research community. We look forward to seeing its impact in the months to come.”
The LEUKomics database can be accessed at: www.stemformatics.org/leukomics.
England did not benefit from CDF, analysis suggests
The National Health Service’s (NHS) Cancer Drugs Fund (CDF) has not benefitted the people of England and may have been detrimental for English cancer patients, according to researchers.
The group analyzed 29 drugs that were approved for use through the CDF and found the fund did not “deliver meaningful value for patients or society” and may have resulted in patients suffering unnecessarily from adverse effects.
The CDF is money the English government sets aside to pay for cancer drugs that haven’t been approved by the National Institute for Health and Care Excellence (NICE), the health technology assessment body in the UK, and aren’t available within the NHS, the publicly funded national healthcare system for England.
The original CDF was closed in March 2016, but a new CDF was opened at the end of July 2016.
In a study published in Annals of Oncology, researchers looked at 29 drugs that had been approved for use through the CDF for 47 specific indications and were available in January 2015.
The team said only 18 of the indications (38%) were based on clinical trials that reported a statistically significant benefit in terms of patients’ overall survival. The median overall survival benefit was 3.2 months, ranging from 1.4 months to 15.7 months.
The researchers also considered other factors, such as quality of life and adverse effects, to measure the drugs’ value to patients. And the team found that most of the drugs failed to show any evidence of meaningful clinical benefit.
In fact, the researchers said the benefit to patients in real-world situations was probably less than the benefit observed in the clinical trials, since trial participants are carefully selected, have fewer comorbidities, and tend to be younger than patients not included in trials.
“From 2010 when it started to 2016 when it closed, the Cancer Drugs Fund cost the UK taxpayer a total of £1.27 billion, the equivalent of 1 year’s total spending on all cancer drugs in the NHS,” said study author Ajay Aggarwal, of the London School of Hygiene & Tropical Medicine in England.
“The majority of cancer medicines funded through the CDF were found wanting with respect to what patients, clinicians, and NICE would count as clinically meaningful benefit. In addition, no data on the outcome of patients who used drugs accessed through the fund were collected.”
The researchers said basic information on patients who accessed the fund—including date of treatment cessation, side effects, deaths after 30 days of treatment, and date of death or relapse—was supposed to have been collected by April 2012.
However, even after it became mandatory to collect these data in 2014, 93% of outcome data were incomplete for 2014-2015.
“We also lost a major opportunity to understand how these medicines work in the real world,” said study author Richard Sullivan, MD, PhD, of King’s College London in England.
The original CDF was closed in March 2016 because it had become financially unsustainable, but a new CDF was opened at the end of July 2016.
The new CDF provides managed access to new cancer drugs for a limited period in circumstances where the clinical and cost-effectiveness of the drug is deemed uncertain by NICE. The new CDF works in close collaboration with NICE, to which all newly licensed drugs will be referred for appraisal first.
“This addresses some of the problems with the old CDF; namely, the fund would no longer support the provision of drugs that have been appraised but not recommended by NICE,” Dr Sullivan said.
“It still provides funding for new drugs awaiting NICE appraisal that have potential benefit. However, the issue here is one of fairness: why should cancer medicines be treated in this way and not all medicines and, indeed, all technologies?”
The National Health Service’s (NHS) Cancer Drugs Fund (CDF) has not benefitted the people of England and may have been detrimental for English cancer patients, according to researchers.
The group analyzed 29 drugs that were approved for use through the CDF and found the fund did not “deliver meaningful value for patients or society” and may have resulted in patients suffering unnecessarily from adverse effects.
The CDF is money the English government sets aside to pay for cancer drugs that haven’t been approved by the National Institute for Health and Care Excellence (NICE), the health technology assessment body in the UK, and aren’t available within the NHS, the publicly funded national healthcare system for England.
The original CDF was closed in March 2016, but a new CDF was opened at the end of July 2016.
In a study published in Annals of Oncology, researchers looked at 29 drugs that had been approved for use through the CDF for 47 specific indications and were available in January 2015.
The team said only 18 of the indications (38%) were based on clinical trials that reported a statistically significant benefit in terms of patients’ overall survival. The median overall survival benefit was 3.2 months, ranging from 1.4 months to 15.7 months.
The researchers also considered other factors, such as quality of life and adverse effects, to measure the drugs’ value to patients. And the team found that most of the drugs failed to show any evidence of meaningful clinical benefit.
In fact, the researchers said the benefit to patients in real-world situations was probably less than the benefit observed in the clinical trials, since trial participants are carefully selected, have fewer comorbidities, and tend to be younger than patients not included in trials.
“From 2010 when it started to 2016 when it closed, the Cancer Drugs Fund cost the UK taxpayer a total of £1.27 billion, the equivalent of 1 year’s total spending on all cancer drugs in the NHS,” said study author Ajay Aggarwal, of the London School of Hygiene & Tropical Medicine in England.
“The majority of cancer medicines funded through the CDF were found wanting with respect to what patients, clinicians, and NICE would count as clinically meaningful benefit. In addition, no data on the outcome of patients who used drugs accessed through the fund were collected.”
The researchers said basic information on patients who accessed the fund—including date of treatment cessation, side effects, deaths after 30 days of treatment, and date of death or relapse—was supposed to have been collected by April 2012.
However, even after it became mandatory to collect these data in 2014, 93% of outcome data were incomplete for 2014-2015.
“We also lost a major opportunity to understand how these medicines work in the real world,” said study author Richard Sullivan, MD, PhD, of King’s College London in England.
The original CDF was closed in March 2016 because it had become financially unsustainable, but a new CDF was opened at the end of July 2016.
The new CDF provides managed access to new cancer drugs for a limited period in circumstances where the clinical and cost-effectiveness of the drug is deemed uncertain by NICE. The new CDF works in close collaboration with NICE, to which all newly licensed drugs will be referred for appraisal first.
“This addresses some of the problems with the old CDF; namely, the fund would no longer support the provision of drugs that have been appraised but not recommended by NICE,” Dr Sullivan said.
“It still provides funding for new drugs awaiting NICE appraisal that have potential benefit. However, the issue here is one of fairness: why should cancer medicines be treated in this way and not all medicines and, indeed, all technologies?”
The National Health Service’s (NHS) Cancer Drugs Fund (CDF) has not benefitted the people of England and may have been detrimental for English cancer patients, according to researchers.
The group analyzed 29 drugs that were approved for use through the CDF and found the fund did not “deliver meaningful value for patients or society” and may have resulted in patients suffering unnecessarily from adverse effects.
The CDF is money the English government sets aside to pay for cancer drugs that haven’t been approved by the National Institute for Health and Care Excellence (NICE), the health technology assessment body in the UK, and aren’t available within the NHS, the publicly funded national healthcare system for England.
The original CDF was closed in March 2016, but a new CDF was opened at the end of July 2016.
In a study published in Annals of Oncology, researchers looked at 29 drugs that had been approved for use through the CDF for 47 specific indications and were available in January 2015.
The team said only 18 of the indications (38%) were based on clinical trials that reported a statistically significant benefit in terms of patients’ overall survival. The median overall survival benefit was 3.2 months, ranging from 1.4 months to 15.7 months.
The researchers also considered other factors, such as quality of life and adverse effects, to measure the drugs’ value to patients. And the team found that most of the drugs failed to show any evidence of meaningful clinical benefit.
In fact, the researchers said the benefit to patients in real-world situations was probably less than the benefit observed in the clinical trials, since trial participants are carefully selected, have fewer comorbidities, and tend to be younger than patients not included in trials.
“From 2010 when it started to 2016 when it closed, the Cancer Drugs Fund cost the UK taxpayer a total of £1.27 billion, the equivalent of 1 year’s total spending on all cancer drugs in the NHS,” said study author Ajay Aggarwal, of the London School of Hygiene & Tropical Medicine in England.
“The majority of cancer medicines funded through the CDF were found wanting with respect to what patients, clinicians, and NICE would count as clinically meaningful benefit. In addition, no data on the outcome of patients who used drugs accessed through the fund were collected.”
The researchers said basic information on patients who accessed the fund—including date of treatment cessation, side effects, deaths after 30 days of treatment, and date of death or relapse—was supposed to have been collected by April 2012.
However, even after it became mandatory to collect these data in 2014, 93% of outcome data were incomplete for 2014-2015.
“We also lost a major opportunity to understand how these medicines work in the real world,” said study author Richard Sullivan, MD, PhD, of King’s College London in England.
The original CDF was closed in March 2016 because it had become financially unsustainable, but a new CDF was opened at the end of July 2016.
The new CDF provides managed access to new cancer drugs for a limited period in circumstances where the clinical and cost-effectiveness of the drug is deemed uncertain by NICE. The new CDF works in close collaboration with NICE, to which all newly licensed drugs will be referred for appraisal first.
“This addresses some of the problems with the old CDF; namely, the fund would no longer support the provision of drugs that have been appraised but not recommended by NICE,” Dr Sullivan said.
“It still provides funding for new drugs awaiting NICE appraisal that have potential benefit. However, the issue here is one of fairness: why should cancer medicines be treated in this way and not all medicines and, indeed, all technologies?”
EMA recommends orphan status for drug for DLBCL
The European Medicines Agency (EMA) has recommended that PQR309 receive orphan drug designation for the treatment of patients with diffuse large B-cell lymphoma (DLBCL).
PQR309, is an oral, brain-penetrant, dual inhibitor of the PI3K/mTOR pathway being developed by PIQUR Therapeutics AG.
PQR309 is currently being investigated in phase 1 and 2 studies in relapsed or refractory lymphoma (NCT02249429), relapsed or refractory primary central nervous system lymphoma (NCT02669511), and other malignancies.
Preclinical research of PQR309 in lymphomas was presented at the AACR Annual Meeting 2017 (abstract 2652).
Researchers tested the drug in 40 cell lines—27 DLBCL, 10 mantle cell lymphoma, and 3 splenic marginal zone lymphoma.
The researchers reported that PQR309 had “potent antiproliferative activity” in most of the cell lines.
The median IC50 was 166 nM in DLBCL cell lines, 235 nM in mantle cell lymphoma cell lines, and 214 nM in splenic marginal zone lymphoma cell lines.
In addition, PQR309 demonstrated similar activity in activated B-cell like DLBCL and germinal center B-cell like DLBCL.
About orphan designation
Orphan designation provides regulatory and financial incentives for companies to develop and market therapies that treat life-threatening or chronically debilitating conditions affecting no more than 5 in 10,000 people in the European Union, and where no satisfactory treatment is available.
Orphan designation provides a 10-year period of marketing exclusivity if the drug receives regulatory approval. The designation also provides incentives for companies seeking protocol assistance from the EMA during the product development phase and direct access to the centralized authorization procedure.
The EMA adopts an opinion on the granting of orphan drug designation, and that opinion is submitted to the European Commission for a final decision. The European Commission typically makes a decision within 30 days.
The European Medicines Agency (EMA) has recommended that PQR309 receive orphan drug designation for the treatment of patients with diffuse large B-cell lymphoma (DLBCL).
PQR309, is an oral, brain-penetrant, dual inhibitor of the PI3K/mTOR pathway being developed by PIQUR Therapeutics AG.
PQR309 is currently being investigated in phase 1 and 2 studies in relapsed or refractory lymphoma (NCT02249429), relapsed or refractory primary central nervous system lymphoma (NCT02669511), and other malignancies.
Preclinical research of PQR309 in lymphomas was presented at the AACR Annual Meeting 2017 (abstract 2652).
Researchers tested the drug in 40 cell lines—27 DLBCL, 10 mantle cell lymphoma, and 3 splenic marginal zone lymphoma.
The researchers reported that PQR309 had “potent antiproliferative activity” in most of the cell lines.
The median IC50 was 166 nM in DLBCL cell lines, 235 nM in mantle cell lymphoma cell lines, and 214 nM in splenic marginal zone lymphoma cell lines.
In addition, PQR309 demonstrated similar activity in activated B-cell like DLBCL and germinal center B-cell like DLBCL.
About orphan designation
Orphan designation provides regulatory and financial incentives for companies to develop and market therapies that treat life-threatening or chronically debilitating conditions affecting no more than 5 in 10,000 people in the European Union, and where no satisfactory treatment is available.
Orphan designation provides a 10-year period of marketing exclusivity if the drug receives regulatory approval. The designation also provides incentives for companies seeking protocol assistance from the EMA during the product development phase and direct access to the centralized authorization procedure.
The EMA adopts an opinion on the granting of orphan drug designation, and that opinion is submitted to the European Commission for a final decision. The European Commission typically makes a decision within 30 days.
The European Medicines Agency (EMA) has recommended that PQR309 receive orphan drug designation for the treatment of patients with diffuse large B-cell lymphoma (DLBCL).
PQR309, is an oral, brain-penetrant, dual inhibitor of the PI3K/mTOR pathway being developed by PIQUR Therapeutics AG.
PQR309 is currently being investigated in phase 1 and 2 studies in relapsed or refractory lymphoma (NCT02249429), relapsed or refractory primary central nervous system lymphoma (NCT02669511), and other malignancies.
Preclinical research of PQR309 in lymphomas was presented at the AACR Annual Meeting 2017 (abstract 2652).
Researchers tested the drug in 40 cell lines—27 DLBCL, 10 mantle cell lymphoma, and 3 splenic marginal zone lymphoma.
The researchers reported that PQR309 had “potent antiproliferative activity” in most of the cell lines.
The median IC50 was 166 nM in DLBCL cell lines, 235 nM in mantle cell lymphoma cell lines, and 214 nM in splenic marginal zone lymphoma cell lines.
In addition, PQR309 demonstrated similar activity in activated B-cell like DLBCL and germinal center B-cell like DLBCL.
About orphan designation
Orphan designation provides regulatory and financial incentives for companies to develop and market therapies that treat life-threatening or chronically debilitating conditions affecting no more than 5 in 10,000 people in the European Union, and where no satisfactory treatment is available.
Orphan designation provides a 10-year period of marketing exclusivity if the drug receives regulatory approval. The designation also provides incentives for companies seeking protocol assistance from the EMA during the product development phase and direct access to the centralized authorization procedure.
The EMA adopts an opinion on the granting of orphan drug designation, and that opinion is submitted to the European Commission for a final decision. The European Commission typically makes a decision within 30 days.
How choline increases the risk of thrombotic events
Past research indicated that choline, a nutrient found in animal products, is associated with a heightened risk of thrombosis.
Now, researchers have found evidence to suggest that consuming excess choline increases levels of the gut microbial metabolite trimethylamine N-oxide (TMAO), which increases platelet responsiveness, and this raises the risk of thrombotic events.
However, taking low-dose aspirin may reduce that risk.
“This is the first study in humans to directly demonstrate that dietary choline substantially elevates TMAO production by gut bacteria, impacting platelet function,” said Stanley Hazen, MD, PhD, of the Cleveland Clinic in Ohio.
“It provides direct evidence of a mechanistic link between TMAO levels and risk for blood clotting events like heart attack and stroke, the major culprit for the development of cardiovascular events.”
Dr Hazen and his colleagues reported these findings in Circulation.
For this study, the team tested the effects of oral choline supplements in healthy vegans/vegetarians (n=8) and omnivores (n=10). The subjects received choline bitartrate at 500 mg twice daily (about 450 mg total choline per day) for 2 months.
Both omnivores and vegans/vegetarians had at least a 10-fold increase in plasma levels of TMAO at 1 month and 2 months after starting choline supplementation, as well as an increase in platelet responsiveness.
In fact, the researchers observed a dose-dependent association between plasma TMAO levels and platelet function.
The team then set out to determine whether platelet hyper-responsiveness associated with choline supplementation and elevated TMAO would occur in the presence of aspirin.
For this, the researchers evaluated the 10 omnivores after a choline-free washout period of at least 1 month.
The subjects had their platelet function tested at baseline and after taking low-dose aspirin daily (81 mg each evening) for at least a month.
The subjects were then followed for another 2 months while continuing to take aspirin and a daily supplement of choline.
The researchers found that elevated TMAO levels and enhanced susceptibility for platelet activation still occurred, but the TMAO levels were attenuated by aspirin.
These findings suggest that a low dose of aspirin may partially counter the pro-thrombotic effects of a high TMAO plasma level associated with a diet rich in choline, and a high TMAO level can partially overcome the beneficial antiplatelet effects of taking low-dose aspirin.
“Further research is necessary to confirm these findings, but these studies suggest patients without known cardiovascular disease but with elevated TMAO levels may benefit from aspirin and diet modification in preventing blood clotting, which can lead to heart attack and stroke,” Dr Hazen said.
“They also suggest that a high TMAO level in a patient with known cardiovascular disease should be considered for more aggressive antiplatelet therapy.”
Past research indicated that choline, a nutrient found in animal products, is associated with a heightened risk of thrombosis.
Now, researchers have found evidence to suggest that consuming excess choline increases levels of the gut microbial metabolite trimethylamine N-oxide (TMAO), which increases platelet responsiveness, and this raises the risk of thrombotic events.
However, taking low-dose aspirin may reduce that risk.
“This is the first study in humans to directly demonstrate that dietary choline substantially elevates TMAO production by gut bacteria, impacting platelet function,” said Stanley Hazen, MD, PhD, of the Cleveland Clinic in Ohio.
“It provides direct evidence of a mechanistic link between TMAO levels and risk for blood clotting events like heart attack and stroke, the major culprit for the development of cardiovascular events.”
Dr Hazen and his colleagues reported these findings in Circulation.
For this study, the team tested the effects of oral choline supplements in healthy vegans/vegetarians (n=8) and omnivores (n=10). The subjects received choline bitartrate at 500 mg twice daily (about 450 mg total choline per day) for 2 months.
Both omnivores and vegans/vegetarians had at least a 10-fold increase in plasma levels of TMAO at 1 month and 2 months after starting choline supplementation, as well as an increase in platelet responsiveness.
In fact, the researchers observed a dose-dependent association between plasma TMAO levels and platelet function.
The team then set out to determine whether platelet hyper-responsiveness associated with choline supplementation and elevated TMAO would occur in the presence of aspirin.
For this, the researchers evaluated the 10 omnivores after a choline-free washout period of at least 1 month.
The subjects had their platelet function tested at baseline and after taking low-dose aspirin daily (81 mg each evening) for at least a month.
The subjects were then followed for another 2 months while continuing to take aspirin and a daily supplement of choline.
The researchers found that elevated TMAO levels and enhanced susceptibility for platelet activation still occurred, but the TMAO levels were attenuated by aspirin.
These findings suggest that a low dose of aspirin may partially counter the pro-thrombotic effects of a high TMAO plasma level associated with a diet rich in choline, and a high TMAO level can partially overcome the beneficial antiplatelet effects of taking low-dose aspirin.
“Further research is necessary to confirm these findings, but these studies suggest patients without known cardiovascular disease but with elevated TMAO levels may benefit from aspirin and diet modification in preventing blood clotting, which can lead to heart attack and stroke,” Dr Hazen said.
“They also suggest that a high TMAO level in a patient with known cardiovascular disease should be considered for more aggressive antiplatelet therapy.”
Past research indicated that choline, a nutrient found in animal products, is associated with a heightened risk of thrombosis.
Now, researchers have found evidence to suggest that consuming excess choline increases levels of the gut microbial metabolite trimethylamine N-oxide (TMAO), which increases platelet responsiveness, and this raises the risk of thrombotic events.
However, taking low-dose aspirin may reduce that risk.
“This is the first study in humans to directly demonstrate that dietary choline substantially elevates TMAO production by gut bacteria, impacting platelet function,” said Stanley Hazen, MD, PhD, of the Cleveland Clinic in Ohio.
“It provides direct evidence of a mechanistic link between TMAO levels and risk for blood clotting events like heart attack and stroke, the major culprit for the development of cardiovascular events.”
Dr Hazen and his colleagues reported these findings in Circulation.
For this study, the team tested the effects of oral choline supplements in healthy vegans/vegetarians (n=8) and omnivores (n=10). The subjects received choline bitartrate at 500 mg twice daily (about 450 mg total choline per day) for 2 months.
Both omnivores and vegans/vegetarians had at least a 10-fold increase in plasma levels of TMAO at 1 month and 2 months after starting choline supplementation, as well as an increase in platelet responsiveness.
In fact, the researchers observed a dose-dependent association between plasma TMAO levels and platelet function.
The team then set out to determine whether platelet hyper-responsiveness associated with choline supplementation and elevated TMAO would occur in the presence of aspirin.
For this, the researchers evaluated the 10 omnivores after a choline-free washout period of at least 1 month.
The subjects had their platelet function tested at baseline and after taking low-dose aspirin daily (81 mg each evening) for at least a month.
The subjects were then followed for another 2 months while continuing to take aspirin and a daily supplement of choline.
The researchers found that elevated TMAO levels and enhanced susceptibility for platelet activation still occurred, but the TMAO levels were attenuated by aspirin.
These findings suggest that a low dose of aspirin may partially counter the pro-thrombotic effects of a high TMAO plasma level associated with a diet rich in choline, and a high TMAO level can partially overcome the beneficial antiplatelet effects of taking low-dose aspirin.
“Further research is necessary to confirm these findings, but these studies suggest patients without known cardiovascular disease but with elevated TMAO levels may benefit from aspirin and diet modification in preventing blood clotting, which can lead to heart attack and stroke,” Dr Hazen said.
“They also suggest that a high TMAO level in a patient with known cardiovascular disease should be considered for more aggressive antiplatelet therapy.”
Decision pathway for periprocedural management of anticoagulation in patients with nonvalvular atrial fibrillation
Clinical question: This work group synthesized available data to address whether and when anticoagulant therapy should be interrupted, whether and how anticoagulant bridging with a parenteral agent should be performed, and when and how anticoagulant therapy should be restarted for those who require temporary interruption.
Background: Atrial fibrillation is the most common sustained arrhythmia worldwide. Antithrombotic therapy, with a strong preference to oral anticoagulant (vitamin K antagonists [VKA] or Direct oral anticoagulant [DOAC]) over antiplatelet, is recommended for patients with high thrombotic risk. Temporary interruption is frequently necessary to mitigate bleed risk with surgical or invasive procedures. Although several factors go into the decision to interrupt anticoagulation, practice varies widely.
Study design: Data review and commentary.
Setting: Veterans’ Affairs Hospitals.
For the assessment of patient-related bleed risk, consider the HAS-BLED (Hypertension, Abnormal Renal and Liver Function, Stroke–Bleeding, Labile INRs, Elderly, Drugs or Alcohol) score: bleeding in the preceding 3 months, bleeding with a similar procedure or prior bridging, abnormalities of platelet function, concomitant use of antiplatelet therapy, and/or supratherapeutic international normalized ratio.
Vitamin K Antagonists:
- Do not interrupt for no clinically important or low bleed risk AND absence of patient-related bleed risk factor(s).
- Interrupt for procedures with intermediate or high bleed risk OR procedures with uncertain bleed risk and the presence of patient-related bleed risk factor(s).
- Consider interruption for procedure with no clinically important or low bleed risk AND the presence of patient-related bleed risk factor(s) OR procedures with uncertain bleed risk AND the absence of patient-related bleed risk factor(s).
Direct Oral Anticoagulants:
Can interrupt therapy for all bleed risks; duration based on creatinine clearance.
A procedure performed at the trough level may allow reinitiation the evening of or the day after the procedure with 1 or fewer dose(s) missed.
Bottom line: VKAs should be held based on surgical and patient bleed risk factors. Guidelines provide tools to calculate and consider. DOACs can always be held, preferably at trough times to minimize interruptions and for durations based on creatinine clearance.
Citation: Doherty JU, Gluckman TJ, Hucker WJ, et al. “2017 ACC Expert consensus decision pathway for periprocedural management of anticoagulation in patients with nonvalvular atrial fibrillation.” J Am Coll Cardiol. 2017 Feb 21;69(7):871-98.
Dr. White is an instructor in the Division of Hospital Medicine, Loyola University Chicago.
Clinical question: This work group synthesized available data to address whether and when anticoagulant therapy should be interrupted, whether and how anticoagulant bridging with a parenteral agent should be performed, and when and how anticoagulant therapy should be restarted for those who require temporary interruption.
Background: Atrial fibrillation is the most common sustained arrhythmia worldwide. Antithrombotic therapy, with a strong preference to oral anticoagulant (vitamin K antagonists [VKA] or Direct oral anticoagulant [DOAC]) over antiplatelet, is recommended for patients with high thrombotic risk. Temporary interruption is frequently necessary to mitigate bleed risk with surgical or invasive procedures. Although several factors go into the decision to interrupt anticoagulation, practice varies widely.
Study design: Data review and commentary.
Setting: Veterans’ Affairs Hospitals.
For the assessment of patient-related bleed risk, consider the HAS-BLED (Hypertension, Abnormal Renal and Liver Function, Stroke–Bleeding, Labile INRs, Elderly, Drugs or Alcohol) score: bleeding in the preceding 3 months, bleeding with a similar procedure or prior bridging, abnormalities of platelet function, concomitant use of antiplatelet therapy, and/or supratherapeutic international normalized ratio.
Vitamin K Antagonists:
- Do not interrupt for no clinically important or low bleed risk AND absence of patient-related bleed risk factor(s).
- Interrupt for procedures with intermediate or high bleed risk OR procedures with uncertain bleed risk and the presence of patient-related bleed risk factor(s).
- Consider interruption for procedure with no clinically important or low bleed risk AND the presence of patient-related bleed risk factor(s) OR procedures with uncertain bleed risk AND the absence of patient-related bleed risk factor(s).
Direct Oral Anticoagulants:
Can interrupt therapy for all bleed risks; duration based on creatinine clearance.
A procedure performed at the trough level may allow reinitiation the evening of or the day after the procedure with 1 or fewer dose(s) missed.
Bottom line: VKAs should be held based on surgical and patient bleed risk factors. Guidelines provide tools to calculate and consider. DOACs can always be held, preferably at trough times to minimize interruptions and for durations based on creatinine clearance.
Citation: Doherty JU, Gluckman TJ, Hucker WJ, et al. “2017 ACC Expert consensus decision pathway for periprocedural management of anticoagulation in patients with nonvalvular atrial fibrillation.” J Am Coll Cardiol. 2017 Feb 21;69(7):871-98.
Dr. White is an instructor in the Division of Hospital Medicine, Loyola University Chicago.
Clinical question: This work group synthesized available data to address whether and when anticoagulant therapy should be interrupted, whether and how anticoagulant bridging with a parenteral agent should be performed, and when and how anticoagulant therapy should be restarted for those who require temporary interruption.
Background: Atrial fibrillation is the most common sustained arrhythmia worldwide. Antithrombotic therapy, with a strong preference to oral anticoagulant (vitamin K antagonists [VKA] or Direct oral anticoagulant [DOAC]) over antiplatelet, is recommended for patients with high thrombotic risk. Temporary interruption is frequently necessary to mitigate bleed risk with surgical or invasive procedures. Although several factors go into the decision to interrupt anticoagulation, practice varies widely.
Study design: Data review and commentary.
Setting: Veterans’ Affairs Hospitals.
For the assessment of patient-related bleed risk, consider the HAS-BLED (Hypertension, Abnormal Renal and Liver Function, Stroke–Bleeding, Labile INRs, Elderly, Drugs or Alcohol) score: bleeding in the preceding 3 months, bleeding with a similar procedure or prior bridging, abnormalities of platelet function, concomitant use of antiplatelet therapy, and/or supratherapeutic international normalized ratio.
Vitamin K Antagonists:
- Do not interrupt for no clinically important or low bleed risk AND absence of patient-related bleed risk factor(s).
- Interrupt for procedures with intermediate or high bleed risk OR procedures with uncertain bleed risk and the presence of patient-related bleed risk factor(s).
- Consider interruption for procedure with no clinically important or low bleed risk AND the presence of patient-related bleed risk factor(s) OR procedures with uncertain bleed risk AND the absence of patient-related bleed risk factor(s).
Direct Oral Anticoagulants:
Can interrupt therapy for all bleed risks; duration based on creatinine clearance.
A procedure performed at the trough level may allow reinitiation the evening of or the day after the procedure with 1 or fewer dose(s) missed.
Bottom line: VKAs should be held based on surgical and patient bleed risk factors. Guidelines provide tools to calculate and consider. DOACs can always be held, preferably at trough times to minimize interruptions and for durations based on creatinine clearance.
Citation: Doherty JU, Gluckman TJ, Hucker WJ, et al. “2017 ACC Expert consensus decision pathway for periprocedural management of anticoagulation in patients with nonvalvular atrial fibrillation.” J Am Coll Cardiol. 2017 Feb 21;69(7):871-98.
Dr. White is an instructor in the Division of Hospital Medicine, Loyola University Chicago.
HM17 satellite symposia schedule, information
Patient Care Transitions in COPD: Improving Collaboration Between Inpatient and Outpatient Providers to Reduce Readmissions
Monday, May 1
5–7 p.m., Mandalay Bay J
Dinner at 5 p.m.
Overview: The faculty panel will be composed of leading experts representing hospital medicine and pulmonary specialties. For detailed faculty information please visit www.practitionersedge.com/shmcopd.
Integrity Continuing Education Inc. is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians. Integrity Continuing Education designates this live activity for a maximum of 1.5 AMA PRA Category 1 Credits™. Register: www.practitionersedge.com/shmcopd.
Alcoholic Hepatitis: Advances in Therapeutic Management
Monday, May 1
5:30–7:30 p.m., Jasmine CDGH
Dinner at 5:30 p.m.
Overview: Because alcohol potentiates the fibrosis- and cancer-inducing actions of the hepatitis virus, people with heavy alcohol intake are particularly vulnerable to hepatitis infection and are most in need of treatment. In this activity, we will discuss advances in acute and long-term management of alcoholic hepatitis and liver function. Specifically, we will aim to review guideline-based screening and diagnostic considerations for alcoholic hepatitis; assess standards of care for management of acute alcoholic hepatitis, including lifestyle-, pharmacologic-, and device-related methods; and evaluate investigational methods of treatment with respect to efficacy, safety, and long-term management.
Presenters: Ram Mohan Subramanian, MD, associate professor of medicine and surgery, medical director of liver transplant, Emory University, Atlanta; Julie Thompson, MD, MPH, assistant professor of medicine, division of gastroenterology, hepatology, and nutrition, University of Minnesota, Minneapolis.
This activity has been approved for AMA PRA Category 1 Credit(s)™. Full accreditation information available: www.akhcme.com/SHM. This activity is supported by an educational grant from Vital Therapies, Inc. Register: https://akhinc.formstack.com/forms/shm.
A Physician’s Keys to Locking Out Lawsuits and Reducing Taxes
Tuesday, May 2
Noon–1 p.m., Oceanside G
Overview: This course educates on the dangers of lawsuits in the healthcare community. Focused primarily toward physicians and how they should be structured to protect themselves.
Presenter: Art McOmber business owner, retired FBI Agent.
Sponsored by Legally Mine.
A Master Class in Understanding & Applying Updated Treatment Guidelines and Scientific Advances to Reduce Mortality and Hospitalizations in Chronic Heart Failure Patients
Tuesday, May 2
7:30–9:30 p.m., Breakers ABGH
Dinner at 7 p.m.
Presenters: Alpesh Amin, MD, MBA, MACP, SFHM, University of California Irvine, California; Mark H. Drazner, MD, MSc, University of Texas Southwestern Medical Center, Dallas.
This CME activity is jointly provided by Medical Learning Institute and PVI, PeerView Institute for Medical Education. This activity is accredited by the ACCME to provide continuing medical education for physicians.
The Medical Learning Institute designates this live activity for a maximum of 2.0 AMA PRA Category 1 Credits™. This activity is supported by educational grants from Novartis Pharmaceuticals Corporation and ZS Pharma, a member of the AstraZeneca Group. Register: www.peerviewpress.com/CHF2017.
Assessing VTE Risk in Medically Ill Patients: The Critical Role of the Hospitalist
Tuesday, May 2
7:30–9:30 p.m., Jasmine CDGH
Dinner at 7 p.m.
Presenters: Ebrahim Barkoudah, MD, MPH, instructor in medicine, associate director, global clinical scholars research training program, office of global education, Harvard Medical School, associate director, hospital medicine unit, department of medicine, Brigham and Women’s Hospital (BWH), Boston; Elaine M. Hylek, MD, MPH, professor of medicine, Boston University School of Medicine, director, thrombosis and anticoagulation service, Boston Medical Center; Aaron P. Kithcart, MD, PhD, vascular medicine fellow, BWH; John Fanikos, RPh, MBA, assistant professor of clinical pharmacy practice at Northeastern University, Massachusetts College of Pharmacy, director of pharmacy business and financial services, BWH; Arman Qamar, MD, vascular medicine and cardiology fellow, BWH.
This activity is held in conjunction with the North American Thrombosis Forum and with HM17.
Medscape LLC is accredited by the American Nurses Credentialing Center (ANCC), the Accreditation Council for Pharmacy Education (ACPE), and the Accreditation Council for Continuing Medical Education (ACCME), to provide continuing education for the health care team. Medscape LLC designates this live activity for a maximum of 2.0 AMA PRA Category 1 Credit(s)™. Physicians should claim only the credit commensurate with the extent of their participation in the activity. This activity is supported by an independent educational grant from Portola Pharmaceuticals. Register: www.medscape.org/townhall/vte-risk.
Understanding and Managing Hyponatremia: Key Information for Today’s Hospitalist
Wednesday, May 3
7:30 - 9:30 p.m., Jasmine CDGH
Dinner at 7:30 p.m.
Presenters: Jeffrey S. Shapiro, MD, regional medical director and hospitalist, Southern California Hospitalist Network, Anaheim; Alpesh N. Amin, MD, MBA, MACP, SFHM, FACC, Thomas and Mary Cesario chair, Department of Medicine, professor of medicine, business, public health, nursing science, and biomedical engineering, executive director, hospitalist program, University of California, Irvine; Mohammed S. Ahmed, DO, CSH, FASN, associate professor, Department of Internal Medicine, Midwestern University, Chicago College of Osteopathic Medicine
Sponsored by Otsuka Pharmaceuticals.
Patient Care Transitions in COPD: Improving Collaboration Between Inpatient and Outpatient Providers to Reduce Readmissions
Monday, May 1
5–7 p.m., Mandalay Bay J
Dinner at 5 p.m.
Overview: The faculty panel will be composed of leading experts representing hospital medicine and pulmonary specialties. For detailed faculty information please visit www.practitionersedge.com/shmcopd.
Integrity Continuing Education Inc. is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians. Integrity Continuing Education designates this live activity for a maximum of 1.5 AMA PRA Category 1 Credits™. Register: www.practitionersedge.com/shmcopd.
Alcoholic Hepatitis: Advances in Therapeutic Management
Monday, May 1
5:30–7:30 p.m., Jasmine CDGH
Dinner at 5:30 p.m.
Overview: Because alcohol potentiates the fibrosis- and cancer-inducing actions of the hepatitis virus, people with heavy alcohol intake are particularly vulnerable to hepatitis infection and are most in need of treatment. In this activity, we will discuss advances in acute and long-term management of alcoholic hepatitis and liver function. Specifically, we will aim to review guideline-based screening and diagnostic considerations for alcoholic hepatitis; assess standards of care for management of acute alcoholic hepatitis, including lifestyle-, pharmacologic-, and device-related methods; and evaluate investigational methods of treatment with respect to efficacy, safety, and long-term management.
Presenters: Ram Mohan Subramanian, MD, associate professor of medicine and surgery, medical director of liver transplant, Emory University, Atlanta; Julie Thompson, MD, MPH, assistant professor of medicine, division of gastroenterology, hepatology, and nutrition, University of Minnesota, Minneapolis.
This activity has been approved for AMA PRA Category 1 Credit(s)™. Full accreditation information available: www.akhcme.com/SHM. This activity is supported by an educational grant from Vital Therapies, Inc. Register: https://akhinc.formstack.com/forms/shm.
A Physician’s Keys to Locking Out Lawsuits and Reducing Taxes
Tuesday, May 2
Noon–1 p.m., Oceanside G
Overview: This course educates on the dangers of lawsuits in the healthcare community. Focused primarily toward physicians and how they should be structured to protect themselves.
Presenter: Art McOmber business owner, retired FBI Agent.
Sponsored by Legally Mine.
A Master Class in Understanding & Applying Updated Treatment Guidelines and Scientific Advances to Reduce Mortality and Hospitalizations in Chronic Heart Failure Patients
Tuesday, May 2
7:30–9:30 p.m., Breakers ABGH
Dinner at 7 p.m.
Presenters: Alpesh Amin, MD, MBA, MACP, SFHM, University of California Irvine, California; Mark H. Drazner, MD, MSc, University of Texas Southwestern Medical Center, Dallas.
This CME activity is jointly provided by Medical Learning Institute and PVI, PeerView Institute for Medical Education. This activity is accredited by the ACCME to provide continuing medical education for physicians.
The Medical Learning Institute designates this live activity for a maximum of 2.0 AMA PRA Category 1 Credits™. This activity is supported by educational grants from Novartis Pharmaceuticals Corporation and ZS Pharma, a member of the AstraZeneca Group. Register: www.peerviewpress.com/CHF2017.
Assessing VTE Risk in Medically Ill Patients: The Critical Role of the Hospitalist
Tuesday, May 2
7:30–9:30 p.m., Jasmine CDGH
Dinner at 7 p.m.
Presenters: Ebrahim Barkoudah, MD, MPH, instructor in medicine, associate director, global clinical scholars research training program, office of global education, Harvard Medical School, associate director, hospital medicine unit, department of medicine, Brigham and Women’s Hospital (BWH), Boston; Elaine M. Hylek, MD, MPH, professor of medicine, Boston University School of Medicine, director, thrombosis and anticoagulation service, Boston Medical Center; Aaron P. Kithcart, MD, PhD, vascular medicine fellow, BWH; John Fanikos, RPh, MBA, assistant professor of clinical pharmacy practice at Northeastern University, Massachusetts College of Pharmacy, director of pharmacy business and financial services, BWH; Arman Qamar, MD, vascular medicine and cardiology fellow, BWH.
This activity is held in conjunction with the North American Thrombosis Forum and with HM17.
Medscape LLC is accredited by the American Nurses Credentialing Center (ANCC), the Accreditation Council for Pharmacy Education (ACPE), and the Accreditation Council for Continuing Medical Education (ACCME), to provide continuing education for the health care team. Medscape LLC designates this live activity for a maximum of 2.0 AMA PRA Category 1 Credit(s)™. Physicians should claim only the credit commensurate with the extent of their participation in the activity. This activity is supported by an independent educational grant from Portola Pharmaceuticals. Register: www.medscape.org/townhall/vte-risk.
Understanding and Managing Hyponatremia: Key Information for Today’s Hospitalist
Wednesday, May 3
7:30 - 9:30 p.m., Jasmine CDGH
Dinner at 7:30 p.m.
Presenters: Jeffrey S. Shapiro, MD, regional medical director and hospitalist, Southern California Hospitalist Network, Anaheim; Alpesh N. Amin, MD, MBA, MACP, SFHM, FACC, Thomas and Mary Cesario chair, Department of Medicine, professor of medicine, business, public health, nursing science, and biomedical engineering, executive director, hospitalist program, University of California, Irvine; Mohammed S. Ahmed, DO, CSH, FASN, associate professor, Department of Internal Medicine, Midwestern University, Chicago College of Osteopathic Medicine
Sponsored by Otsuka Pharmaceuticals.
Patient Care Transitions in COPD: Improving Collaboration Between Inpatient and Outpatient Providers to Reduce Readmissions
Monday, May 1
5–7 p.m., Mandalay Bay J
Dinner at 5 p.m.
Overview: The faculty panel will be composed of leading experts representing hospital medicine and pulmonary specialties. For detailed faculty information please visit www.practitionersedge.com/shmcopd.
Integrity Continuing Education Inc. is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians. Integrity Continuing Education designates this live activity for a maximum of 1.5 AMA PRA Category 1 Credits™. Register: www.practitionersedge.com/shmcopd.
Alcoholic Hepatitis: Advances in Therapeutic Management
Monday, May 1
5:30–7:30 p.m., Jasmine CDGH
Dinner at 5:30 p.m.
Overview: Because alcohol potentiates the fibrosis- and cancer-inducing actions of the hepatitis virus, people with heavy alcohol intake are particularly vulnerable to hepatitis infection and are most in need of treatment. In this activity, we will discuss advances in acute and long-term management of alcoholic hepatitis and liver function. Specifically, we will aim to review guideline-based screening and diagnostic considerations for alcoholic hepatitis; assess standards of care for management of acute alcoholic hepatitis, including lifestyle-, pharmacologic-, and device-related methods; and evaluate investigational methods of treatment with respect to efficacy, safety, and long-term management.
Presenters: Ram Mohan Subramanian, MD, associate professor of medicine and surgery, medical director of liver transplant, Emory University, Atlanta; Julie Thompson, MD, MPH, assistant professor of medicine, division of gastroenterology, hepatology, and nutrition, University of Minnesota, Minneapolis.
This activity has been approved for AMA PRA Category 1 Credit(s)™. Full accreditation information available: www.akhcme.com/SHM. This activity is supported by an educational grant from Vital Therapies, Inc. Register: https://akhinc.formstack.com/forms/shm.
A Physician’s Keys to Locking Out Lawsuits and Reducing Taxes
Tuesday, May 2
Noon–1 p.m., Oceanside G
Overview: This course educates on the dangers of lawsuits in the healthcare community. Focused primarily toward physicians and how they should be structured to protect themselves.
Presenter: Art McOmber business owner, retired FBI Agent.
Sponsored by Legally Mine.
A Master Class in Understanding & Applying Updated Treatment Guidelines and Scientific Advances to Reduce Mortality and Hospitalizations in Chronic Heart Failure Patients
Tuesday, May 2
7:30–9:30 p.m., Breakers ABGH
Dinner at 7 p.m.
Presenters: Alpesh Amin, MD, MBA, MACP, SFHM, University of California Irvine, California; Mark H. Drazner, MD, MSc, University of Texas Southwestern Medical Center, Dallas.
This CME activity is jointly provided by Medical Learning Institute and PVI, PeerView Institute for Medical Education. This activity is accredited by the ACCME to provide continuing medical education for physicians.
The Medical Learning Institute designates this live activity for a maximum of 2.0 AMA PRA Category 1 Credits™. This activity is supported by educational grants from Novartis Pharmaceuticals Corporation and ZS Pharma, a member of the AstraZeneca Group. Register: www.peerviewpress.com/CHF2017.
Assessing VTE Risk in Medically Ill Patients: The Critical Role of the Hospitalist
Tuesday, May 2
7:30–9:30 p.m., Jasmine CDGH
Dinner at 7 p.m.
Presenters: Ebrahim Barkoudah, MD, MPH, instructor in medicine, associate director, global clinical scholars research training program, office of global education, Harvard Medical School, associate director, hospital medicine unit, department of medicine, Brigham and Women’s Hospital (BWH), Boston; Elaine M. Hylek, MD, MPH, professor of medicine, Boston University School of Medicine, director, thrombosis and anticoagulation service, Boston Medical Center; Aaron P. Kithcart, MD, PhD, vascular medicine fellow, BWH; John Fanikos, RPh, MBA, assistant professor of clinical pharmacy practice at Northeastern University, Massachusetts College of Pharmacy, director of pharmacy business and financial services, BWH; Arman Qamar, MD, vascular medicine and cardiology fellow, BWH.
This activity is held in conjunction with the North American Thrombosis Forum and with HM17.
Medscape LLC is accredited by the American Nurses Credentialing Center (ANCC), the Accreditation Council for Pharmacy Education (ACPE), and the Accreditation Council for Continuing Medical Education (ACCME), to provide continuing education for the health care team. Medscape LLC designates this live activity for a maximum of 2.0 AMA PRA Category 1 Credit(s)™. Physicians should claim only the credit commensurate with the extent of their participation in the activity. This activity is supported by an independent educational grant from Portola Pharmaceuticals. Register: www.medscape.org/townhall/vte-risk.
Understanding and Managing Hyponatremia: Key Information for Today’s Hospitalist
Wednesday, May 3
7:30 - 9:30 p.m., Jasmine CDGH
Dinner at 7:30 p.m.
Presenters: Jeffrey S. Shapiro, MD, regional medical director and hospitalist, Southern California Hospitalist Network, Anaheim; Alpesh N. Amin, MD, MBA, MACP, SFHM, FACC, Thomas and Mary Cesario chair, Department of Medicine, professor of medicine, business, public health, nursing science, and biomedical engineering, executive director, hospitalist program, University of California, Irvine; Mohammed S. Ahmed, DO, CSH, FASN, associate professor, Department of Internal Medicine, Midwestern University, Chicago College of Osteopathic Medicine
Sponsored by Otsuka Pharmaceuticals.
Multimodal breast cancer treatment linked with greater risk of lymphedema
Chemotherapy, radiation, and higher body mass index are strongly associated with increased risk of lymphedema in breast cancer patients who have undergone sentinel node biopsy or axillary lymph node dissection, according to analysis of data from the Rochester Epidemiology Project.
Judy C. Boughey, MD, professor of surgery and vice chair of research at the Mayo Clinic, Rochester, Minn., and her associates performed a chart review of 1,794 patients diagnosed with a first breast cancer in Olmsted County, Minn., between 1990 and 2010. Patients’ median age at diagnosis was 60 years. About half (48%) were diagnosed at stage I, while 17% were diagnosed at Stage 0, 29% at Stage II, and 6% at Stage III.
At a median of 10 years of follow-up, 209 patients had been diagnosed with breast cancer–related lymphedema, with most diagnoses occurring within 5 years of surgery. No cases of lymphedema were found in patients who did not have axillary surgery.
There was no significant difference in the rate of lymphedema based on type of breast cancer surgery (mastectomy vs. lumpectomy with breast-conserving surgery); however, lymphedema occurred significantly more frequently in patients who received ALND as compared to those who received SLN (15.9% vs. 5.3%). Lymphedema rates did not differ based on type of axillary surgery (3.5% for ALND and 4.1% for SLN) in a subset of 453 patients who did not receive radiation or chemotherapy.
Almost a third (31.3%) of patients who had nodal radiation, with or without breast or chest wall radiation, developed lymphedema by 5 years, as compared with 5.9% of patients who did not receive radiation (P less than .001). Similarly, patients who received chemotherapy were significantly more likely to develop lymphedema. At 5 years, lymphedema was present in 27.2% of patients who received anthracylcline/cyclophosphamide (AC) with a taxane agent, 29.7% of those who received a taxane agent without AC , and 6.0% of those who did not get chemotherapy (P less than .001).
Five-year incidence of lymphedema also increased significantly with body mass index, occurring in 17.1% of patients with a BMI greater than 35 kg/m2, 13% of those with a BMI between 30-34.99, and 14.4% of those with a BMI between 25-29.99, as compared with 8% of those with a BMI below 25.
On univariate analysis, increased stage was associated with risk of lymphedema, Dr. Boughey said. However, on multivariate analysis, stage was no longer associated with risk of lymphedema and “the dominate factors were BMI, type of axillary surgery, use of radiation therapy and particularly nodal radiation, and the use of chemotherapy.”
The highest rate of lymphedema was seen in a patients with the most advanced disease who had ALND with nodal radiation and AC with a taxane agent, she said.
“We think this is primarily due to the modalities of treatment rather that the pure phenomenon of stage,” Dr. Boughey added. “This study can help identify patients at a higher risk of lymphedema so that we can individualize the surveillance of these patients to allow them to have earlier identification and earlier treatment of lymphedema.”
[email protected]
On Twitter @denisefulton
Chemotherapy, radiation, and higher body mass index are strongly associated with increased risk of lymphedema in breast cancer patients who have undergone sentinel node biopsy or axillary lymph node dissection, according to analysis of data from the Rochester Epidemiology Project.
Judy C. Boughey, MD, professor of surgery and vice chair of research at the Mayo Clinic, Rochester, Minn., and her associates performed a chart review of 1,794 patients diagnosed with a first breast cancer in Olmsted County, Minn., between 1990 and 2010. Patients’ median age at diagnosis was 60 years. About half (48%) were diagnosed at stage I, while 17% were diagnosed at Stage 0, 29% at Stage II, and 6% at Stage III.
At a median of 10 years of follow-up, 209 patients had been diagnosed with breast cancer–related lymphedema, with most diagnoses occurring within 5 years of surgery. No cases of lymphedema were found in patients who did not have axillary surgery.
There was no significant difference in the rate of lymphedema based on type of breast cancer surgery (mastectomy vs. lumpectomy with breast-conserving surgery); however, lymphedema occurred significantly more frequently in patients who received ALND as compared to those who received SLN (15.9% vs. 5.3%). Lymphedema rates did not differ based on type of axillary surgery (3.5% for ALND and 4.1% for SLN) in a subset of 453 patients who did not receive radiation or chemotherapy.
Almost a third (31.3%) of patients who had nodal radiation, with or without breast or chest wall radiation, developed lymphedema by 5 years, as compared with 5.9% of patients who did not receive radiation (P less than .001). Similarly, patients who received chemotherapy were significantly more likely to develop lymphedema. At 5 years, lymphedema was present in 27.2% of patients who received anthracylcline/cyclophosphamide (AC) with a taxane agent, 29.7% of those who received a taxane agent without AC , and 6.0% of those who did not get chemotherapy (P less than .001).
Five-year incidence of lymphedema also increased significantly with body mass index, occurring in 17.1% of patients with a BMI greater than 35 kg/m2, 13% of those with a BMI between 30-34.99, and 14.4% of those with a BMI between 25-29.99, as compared with 8% of those with a BMI below 25.
On univariate analysis, increased stage was associated with risk of lymphedema, Dr. Boughey said. However, on multivariate analysis, stage was no longer associated with risk of lymphedema and “the dominate factors were BMI, type of axillary surgery, use of radiation therapy and particularly nodal radiation, and the use of chemotherapy.”
The highest rate of lymphedema was seen in a patients with the most advanced disease who had ALND with nodal radiation and AC with a taxane agent, she said.
“We think this is primarily due to the modalities of treatment rather that the pure phenomenon of stage,” Dr. Boughey added. “This study can help identify patients at a higher risk of lymphedema so that we can individualize the surveillance of these patients to allow them to have earlier identification and earlier treatment of lymphedema.”
[email protected]
On Twitter @denisefulton
Chemotherapy, radiation, and higher body mass index are strongly associated with increased risk of lymphedema in breast cancer patients who have undergone sentinel node biopsy or axillary lymph node dissection, according to analysis of data from the Rochester Epidemiology Project.
Judy C. Boughey, MD, professor of surgery and vice chair of research at the Mayo Clinic, Rochester, Minn., and her associates performed a chart review of 1,794 patients diagnosed with a first breast cancer in Olmsted County, Minn., between 1990 and 2010. Patients’ median age at diagnosis was 60 years. About half (48%) were diagnosed at stage I, while 17% were diagnosed at Stage 0, 29% at Stage II, and 6% at Stage III.
At a median of 10 years of follow-up, 209 patients had been diagnosed with breast cancer–related lymphedema, with most diagnoses occurring within 5 years of surgery. No cases of lymphedema were found in patients who did not have axillary surgery.
There was no significant difference in the rate of lymphedema based on type of breast cancer surgery (mastectomy vs. lumpectomy with breast-conserving surgery); however, lymphedema occurred significantly more frequently in patients who received ALND as compared to those who received SLN (15.9% vs. 5.3%). Lymphedema rates did not differ based on type of axillary surgery (3.5% for ALND and 4.1% for SLN) in a subset of 453 patients who did not receive radiation or chemotherapy.
Almost a third (31.3%) of patients who had nodal radiation, with or without breast or chest wall radiation, developed lymphedema by 5 years, as compared with 5.9% of patients who did not receive radiation (P less than .001). Similarly, patients who received chemotherapy were significantly more likely to develop lymphedema. At 5 years, lymphedema was present in 27.2% of patients who received anthracylcline/cyclophosphamide (AC) with a taxane agent, 29.7% of those who received a taxane agent without AC , and 6.0% of those who did not get chemotherapy (P less than .001).
Five-year incidence of lymphedema also increased significantly with body mass index, occurring in 17.1% of patients with a BMI greater than 35 kg/m2, 13% of those with a BMI between 30-34.99, and 14.4% of those with a BMI between 25-29.99, as compared with 8% of those with a BMI below 25.
On univariate analysis, increased stage was associated with risk of lymphedema, Dr. Boughey said. However, on multivariate analysis, stage was no longer associated with risk of lymphedema and “the dominate factors were BMI, type of axillary surgery, use of radiation therapy and particularly nodal radiation, and the use of chemotherapy.”
The highest rate of lymphedema was seen in a patients with the most advanced disease who had ALND with nodal radiation and AC with a taxane agent, she said.
“We think this is primarily due to the modalities of treatment rather that the pure phenomenon of stage,” Dr. Boughey added. “This study can help identify patients at a higher risk of lymphedema so that we can individualize the surveillance of these patients to allow them to have earlier identification and earlier treatment of lymphedema.”
[email protected]
On Twitter @denisefulton
FROM ASBS 2017
Key clinical point:
Major finding: More than 30% of patients receiving nodal radiation developed lymphedema vs. 5.9% of those who did not. Similarly, lymphedema developed in just under 30% of patients who received a taxane vs. 6.9% of those who did not.
Data source: Analysis of all 1,794 cases of first breast cancers diagnosed in Olmsted County, Minn., 1990-2010.
Disclosures: The Rochester Epidemiology Project receives federal funding from agencies of the Health & Human Services Department. Dr. Boughey reported no relevant financial conflicts of interest.
Risk of recurrence outweighs risk of contralateral breast cancer for DCIS patients
LAS VEGAS – The risk of ipsilateral breast tumor recurrence was greater than the risk of contralateral breast cancer at both 5 and 10 years following diagnosis of ductal carcinoma in situ (DCIS), investigators report at a press conference in advance of the annual meeting of the American Society of Breast Surgeons.
“A rapidly growing number of women are choosing double mastectomies for DCIS, perhaps because they misperceive their risk of future cancer. Our research provides important data for treatment decision-making,” said Megan Miller, MD, of Memorial Sloan Kettering Cancer Center. “It suggests patients and their doctors should focus on risk factors and appropriate therapy for the diseased breast, not the opposite breast, and that ipsilateral DCIS should not prompt a bilateral mastectomy.”
The investigators also found that CBC did not correlate with age, family history, and initial DCIS characteristics, though these factors did correlate with the risk of IBTR.
Dr. Miller and her colleagues found radiation had no impact on risk of CBC (4.9% vs. 6.3%; P = .1), though it significantly reduced the risk for IBTR (10.3% vs. 19.3%; P less than .0001).
More research is needed on risk factors for patients with a preinvasive condition, Dr. Miller said.
“Most studies examining the benefits of bilateral mastectomy focus on invasive cancer,” she said. “This study is unique in providing hard data for women with preinvasive disease. For these patients, examining risk factors for recurrence and the benefits of radiation and endocrine therapy to treat the existing cancer are important.”
[email protected]
On Twitter @eaztweets
LAS VEGAS – The risk of ipsilateral breast tumor recurrence was greater than the risk of contralateral breast cancer at both 5 and 10 years following diagnosis of ductal carcinoma in situ (DCIS), investigators report at a press conference in advance of the annual meeting of the American Society of Breast Surgeons.
“A rapidly growing number of women are choosing double mastectomies for DCIS, perhaps because they misperceive their risk of future cancer. Our research provides important data for treatment decision-making,” said Megan Miller, MD, of Memorial Sloan Kettering Cancer Center. “It suggests patients and their doctors should focus on risk factors and appropriate therapy for the diseased breast, not the opposite breast, and that ipsilateral DCIS should not prompt a bilateral mastectomy.”
The investigators also found that CBC did not correlate with age, family history, and initial DCIS characteristics, though these factors did correlate with the risk of IBTR.
Dr. Miller and her colleagues found radiation had no impact on risk of CBC (4.9% vs. 6.3%; P = .1), though it significantly reduced the risk for IBTR (10.3% vs. 19.3%; P less than .0001).
More research is needed on risk factors for patients with a preinvasive condition, Dr. Miller said.
“Most studies examining the benefits of bilateral mastectomy focus on invasive cancer,” she said. “This study is unique in providing hard data for women with preinvasive disease. For these patients, examining risk factors for recurrence and the benefits of radiation and endocrine therapy to treat the existing cancer are important.”
[email protected]
On Twitter @eaztweets
LAS VEGAS – The risk of ipsilateral breast tumor recurrence was greater than the risk of contralateral breast cancer at both 5 and 10 years following diagnosis of ductal carcinoma in situ (DCIS), investigators report at a press conference in advance of the annual meeting of the American Society of Breast Surgeons.
“A rapidly growing number of women are choosing double mastectomies for DCIS, perhaps because they misperceive their risk of future cancer. Our research provides important data for treatment decision-making,” said Megan Miller, MD, of Memorial Sloan Kettering Cancer Center. “It suggests patients and their doctors should focus on risk factors and appropriate therapy for the diseased breast, not the opposite breast, and that ipsilateral DCIS should not prompt a bilateral mastectomy.”
The investigators also found that CBC did not correlate with age, family history, and initial DCIS characteristics, though these factors did correlate with the risk of IBTR.
Dr. Miller and her colleagues found radiation had no impact on risk of CBC (4.9% vs. 6.3%; P = .1), though it significantly reduced the risk for IBTR (10.3% vs. 19.3%; P less than .0001).
More research is needed on risk factors for patients with a preinvasive condition, Dr. Miller said.
“Most studies examining the benefits of bilateral mastectomy focus on invasive cancer,” she said. “This study is unique in providing hard data for women with preinvasive disease. For these patients, examining risk factors for recurrence and the benefits of radiation and endocrine therapy to treat the existing cancer are important.”
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On Twitter @eaztweets
FROM ASBS 2017
Key clinical point:
Major finding: Among 2,759 patients, incidence rate of contralateral breast cancer was 2.8% and 5.6% over 5 and 10 years, respectively, while risk of ipsilateral breast tumor recurrence was 7.8% and 14.3% over 5 and 10 years, respectively.
Data source: Study of 2,759 DCIS patients who underwent breast conserving surgery between 1978-2011, who were followed for a median of 6.8 years.
Disclosures: The investigators reported no relevant disclosures.
The EHR Report: Communication, social media, and legal vulnerability
Social media is now a part of everyday life. From Twitter, with its 140 character limit, to Facebook to Linkedin, there is a world of possibilities for communicating with friends, family, colleagues, and others online. Communication is good, but electronic media is a minefield for medical professionals who do not think carefully before they post.
The stories in the news about health care professionals who have posted obviously inflammatory material online, perhaps in a fit of rage, and have had their careers impacted or ended are just the tip of the iceberg. HIPAA violations have received a good deal of attention, with a well-known example being the doctor who was accused of posting a selfie with Joan Rivers, who was unconscious on the operating table. These examples, however, represent obvious violations of HIPAA and are infractions that most physicians would readily identify. Other examples may not be as obvious.
We know of one case where a nurse on the staff of a physicians’ office posted on Facebook that work was grueling that day because he felt under the weather with suspected flu. This may seem, at first, to be an innocuous communication. And that’s all it was, until, the son of an immunosuppressed man who had an appointment at that doctor’s office was flabbergasted to hear from a mutual friend that one of the nurses in the office was at work despite having the flu. He demanded to speak with the office manager and made sure that his father was not seen by that nurse. It may seem like an unlikely coincidence, but, in medical-legal circles, unlikely events occur all the time.
Many people who use social media will check in or post when they are out with friends or colleagues blowing off steam. For example, you might post something on social media about a holiday party you are attending. But, consider what happens if, at work the next day, something goes wrong, your care is called into question, and a lawsuit ensues. Your post may be innocent, but it now falls into the hands of the patient’s attorney. When you are having your deposition taken, the lawyer pulls your social media post out of a stack of papers and grills you about where you were, what you were doing, how late you stayed out, whether you were drinking, how much, and so on. Maybe you explain to him that you were only at the holiday party for an hour and did not have a single drink. That attorney, however, is not required to take your word for it and can ask you who you were with. All of a sudden, your friends and colleagues are being served with subpoenas for their depositions and being examined about what you did that night. Possibly, the lawyer is sending a subpoena for your credit card receipt and the restaurant’s billing records to determine what you ordered that night.
You should never rely on the false assumption that even “private” messages sent directly to other people will truly remain private. One of us was recently involved in a case where this worked to our advantage. A 30-year-old woman claimed that her family doctor never recommended that she see a gastroenterologist. A friend of the patient testified in a deposition that the two of them had discussed her medical care in private messages on Facebook. After the court ordered that the patient turn over her private Facebook messages, we learned that she told her friend that the doctor had indeed made the recommendation for her to see that specialist.
This cautionary tale doesn’t just apply to social media. Keep in mind that, if you are involved in litigation, attorneys can subpoena the records from your cellular phone provider. All cell phone text message are archived by the cellular provider and can be retrieved under subpoena. You may innocently be blowing off steam to a spouse or friend about a difficult patient or bad outcome but later have those text messages used against you in litigation.
The various social media platforms can be great tools for all kinds of professionals to share interesting information and further their professional development. However, everybody, especially the medical professional, needs to think before they post or send a message. We must also remember that, once information is out in cyberspace, it remains there and can never be truly erased. In other words, you can never unring the proverbial bell. It is important to think about the potential impact of that communication before posting and electronically communicating. Only communicate something that you would be comfortable defending in court.
Dr. Skolnik is professor of family and community medicine at Jefferson Medical College, Philadelphia, and associate director of the family medicine residency program at Abington (Pa.) Jefferson Health. Mr. Shear is an associate attorney in the health care department at Marshall Dennehey Warner Coleman & Goggin in Pittsburgh. He represents physicians, medical professionals, and hospitals in medical malpractice actions.
Social media is now a part of everyday life. From Twitter, with its 140 character limit, to Facebook to Linkedin, there is a world of possibilities for communicating with friends, family, colleagues, and others online. Communication is good, but electronic media is a minefield for medical professionals who do not think carefully before they post.
The stories in the news about health care professionals who have posted obviously inflammatory material online, perhaps in a fit of rage, and have had their careers impacted or ended are just the tip of the iceberg. HIPAA violations have received a good deal of attention, with a well-known example being the doctor who was accused of posting a selfie with Joan Rivers, who was unconscious on the operating table. These examples, however, represent obvious violations of HIPAA and are infractions that most physicians would readily identify. Other examples may not be as obvious.
We know of one case where a nurse on the staff of a physicians’ office posted on Facebook that work was grueling that day because he felt under the weather with suspected flu. This may seem, at first, to be an innocuous communication. And that’s all it was, until, the son of an immunosuppressed man who had an appointment at that doctor’s office was flabbergasted to hear from a mutual friend that one of the nurses in the office was at work despite having the flu. He demanded to speak with the office manager and made sure that his father was not seen by that nurse. It may seem like an unlikely coincidence, but, in medical-legal circles, unlikely events occur all the time.
Many people who use social media will check in or post when they are out with friends or colleagues blowing off steam. For example, you might post something on social media about a holiday party you are attending. But, consider what happens if, at work the next day, something goes wrong, your care is called into question, and a lawsuit ensues. Your post may be innocent, but it now falls into the hands of the patient’s attorney. When you are having your deposition taken, the lawyer pulls your social media post out of a stack of papers and grills you about where you were, what you were doing, how late you stayed out, whether you were drinking, how much, and so on. Maybe you explain to him that you were only at the holiday party for an hour and did not have a single drink. That attorney, however, is not required to take your word for it and can ask you who you were with. All of a sudden, your friends and colleagues are being served with subpoenas for their depositions and being examined about what you did that night. Possibly, the lawyer is sending a subpoena for your credit card receipt and the restaurant’s billing records to determine what you ordered that night.
You should never rely on the false assumption that even “private” messages sent directly to other people will truly remain private. One of us was recently involved in a case where this worked to our advantage. A 30-year-old woman claimed that her family doctor never recommended that she see a gastroenterologist. A friend of the patient testified in a deposition that the two of them had discussed her medical care in private messages on Facebook. After the court ordered that the patient turn over her private Facebook messages, we learned that she told her friend that the doctor had indeed made the recommendation for her to see that specialist.
This cautionary tale doesn’t just apply to social media. Keep in mind that, if you are involved in litigation, attorneys can subpoena the records from your cellular phone provider. All cell phone text message are archived by the cellular provider and can be retrieved under subpoena. You may innocently be blowing off steam to a spouse or friend about a difficult patient or bad outcome but later have those text messages used against you in litigation.
The various social media platforms can be great tools for all kinds of professionals to share interesting information and further their professional development. However, everybody, especially the medical professional, needs to think before they post or send a message. We must also remember that, once information is out in cyberspace, it remains there and can never be truly erased. In other words, you can never unring the proverbial bell. It is important to think about the potential impact of that communication before posting and electronically communicating. Only communicate something that you would be comfortable defending in court.
Dr. Skolnik is professor of family and community medicine at Jefferson Medical College, Philadelphia, and associate director of the family medicine residency program at Abington (Pa.) Jefferson Health. Mr. Shear is an associate attorney in the health care department at Marshall Dennehey Warner Coleman & Goggin in Pittsburgh. He represents physicians, medical professionals, and hospitals in medical malpractice actions.
Social media is now a part of everyday life. From Twitter, with its 140 character limit, to Facebook to Linkedin, there is a world of possibilities for communicating with friends, family, colleagues, and others online. Communication is good, but electronic media is a minefield for medical professionals who do not think carefully before they post.
The stories in the news about health care professionals who have posted obviously inflammatory material online, perhaps in a fit of rage, and have had their careers impacted or ended are just the tip of the iceberg. HIPAA violations have received a good deal of attention, with a well-known example being the doctor who was accused of posting a selfie with Joan Rivers, who was unconscious on the operating table. These examples, however, represent obvious violations of HIPAA and are infractions that most physicians would readily identify. Other examples may not be as obvious.
We know of one case where a nurse on the staff of a physicians’ office posted on Facebook that work was grueling that day because he felt under the weather with suspected flu. This may seem, at first, to be an innocuous communication. And that’s all it was, until, the son of an immunosuppressed man who had an appointment at that doctor’s office was flabbergasted to hear from a mutual friend that one of the nurses in the office was at work despite having the flu. He demanded to speak with the office manager and made sure that his father was not seen by that nurse. It may seem like an unlikely coincidence, but, in medical-legal circles, unlikely events occur all the time.
Many people who use social media will check in or post when they are out with friends or colleagues blowing off steam. For example, you might post something on social media about a holiday party you are attending. But, consider what happens if, at work the next day, something goes wrong, your care is called into question, and a lawsuit ensues. Your post may be innocent, but it now falls into the hands of the patient’s attorney. When you are having your deposition taken, the lawyer pulls your social media post out of a stack of papers and grills you about where you were, what you were doing, how late you stayed out, whether you were drinking, how much, and so on. Maybe you explain to him that you were only at the holiday party for an hour and did not have a single drink. That attorney, however, is not required to take your word for it and can ask you who you were with. All of a sudden, your friends and colleagues are being served with subpoenas for their depositions and being examined about what you did that night. Possibly, the lawyer is sending a subpoena for your credit card receipt and the restaurant’s billing records to determine what you ordered that night.
You should never rely on the false assumption that even “private” messages sent directly to other people will truly remain private. One of us was recently involved in a case where this worked to our advantage. A 30-year-old woman claimed that her family doctor never recommended that she see a gastroenterologist. A friend of the patient testified in a deposition that the two of them had discussed her medical care in private messages on Facebook. After the court ordered that the patient turn over her private Facebook messages, we learned that she told her friend that the doctor had indeed made the recommendation for her to see that specialist.
This cautionary tale doesn’t just apply to social media. Keep in mind that, if you are involved in litigation, attorneys can subpoena the records from your cellular phone provider. All cell phone text message are archived by the cellular provider and can be retrieved under subpoena. You may innocently be blowing off steam to a spouse or friend about a difficult patient or bad outcome but later have those text messages used against you in litigation.
The various social media platforms can be great tools for all kinds of professionals to share interesting information and further their professional development. However, everybody, especially the medical professional, needs to think before they post or send a message. We must also remember that, once information is out in cyberspace, it remains there and can never be truly erased. In other words, you can never unring the proverbial bell. It is important to think about the potential impact of that communication before posting and electronically communicating. Only communicate something that you would be comfortable defending in court.
Dr. Skolnik is professor of family and community medicine at Jefferson Medical College, Philadelphia, and associate director of the family medicine residency program at Abington (Pa.) Jefferson Health. Mr. Shear is an associate attorney in the health care department at Marshall Dennehey Warner Coleman & Goggin in Pittsburgh. He represents physicians, medical professionals, and hospitals in medical malpractice actions.
Small study: Vitamin D repletion may decrease insulin resistance
WASHINGTON – Normalizing vitamin D levels correlated with lower insulin resistance and decreased adipose fibrosis in obese patients, according to a study presented at the Eastern regional meeting of the American Federation for Medical Research.
Approximately 86 million U.S. patients have prediabetes, according to Diabetes Report Card 2014, the most recent estimates from the Centers for Disease Control and Prevention. Vitamin D therapy may be able to help lower that number and prevent diabetes in some patients, Jee Young You, MD, a research fellow at Albert Einstein College of Medicine, New York, said at the meeting.
“When there’s increased adiposity, there is reduction of the blood flow which will further lead to inflammation, macrophage infiltration, and fibrosis, which all together leads to insulin resistance,” Dr. You said. “It is shown that there are vitamin D receptors present on adipocytes, so we hypothesize repleting vitamin D will help in reducing this inflammation.”
In a double blind study, Dr. You and her colleagues randomized 11 obese patients, with an average body mass index of 34 kg/m2, insulin resistance, and vitamin D deficiency to vitamin D repletion therapy. Eight similar patients served as controls. The average age was 43 years.
Patients in the test group were placed on a step schedule for vitamin D supplementation. For 3 months, they received 40,000 IU of vitamin D3 weekly in an effort to reach a target 25-hydroxyvitamin D level of greater than 30 ng/ml. Patients then received another 3 months of the same supplementation with an aim to reach a target level of greater than 50 ng/ml.
“We wanted to see if there was a dose dependent effect for vitamin D in patients,” Dr. You said.
Endogenous glucose production decreased by 24% (P = .04) after normalization of vitamin D levels. Patients who received placebo saw an increase in endogenous glucose, pointing to lower hepatic insulin sensitivity, Dr. You said.
When the vitamin D receptors are activated, they inhibit the profibrotic pathways like TGFb-1, Dr. You explained, decreasing fibrosis.
The researchers also found a decrease in profibrotic gene expression in TGFb-1, HiF-1, MMP7, and Collagen I, V, and VI.
However, while testing for reduction in profibrotic gene expression in whole fat, the investigators found that there was no additional improvement after the first round of vitamin D therapy, leading them to assert that raising vitamin D levels above the normal range does not give any additional benefit.
[email protected]
On Twitter @eaztweets
WASHINGTON – Normalizing vitamin D levels correlated with lower insulin resistance and decreased adipose fibrosis in obese patients, according to a study presented at the Eastern regional meeting of the American Federation for Medical Research.
Approximately 86 million U.S. patients have prediabetes, according to Diabetes Report Card 2014, the most recent estimates from the Centers for Disease Control and Prevention. Vitamin D therapy may be able to help lower that number and prevent diabetes in some patients, Jee Young You, MD, a research fellow at Albert Einstein College of Medicine, New York, said at the meeting.
“When there’s increased adiposity, there is reduction of the blood flow which will further lead to inflammation, macrophage infiltration, and fibrosis, which all together leads to insulin resistance,” Dr. You said. “It is shown that there are vitamin D receptors present on adipocytes, so we hypothesize repleting vitamin D will help in reducing this inflammation.”
In a double blind study, Dr. You and her colleagues randomized 11 obese patients, with an average body mass index of 34 kg/m2, insulin resistance, and vitamin D deficiency to vitamin D repletion therapy. Eight similar patients served as controls. The average age was 43 years.
Patients in the test group were placed on a step schedule for vitamin D supplementation. For 3 months, they received 40,000 IU of vitamin D3 weekly in an effort to reach a target 25-hydroxyvitamin D level of greater than 30 ng/ml. Patients then received another 3 months of the same supplementation with an aim to reach a target level of greater than 50 ng/ml.
“We wanted to see if there was a dose dependent effect for vitamin D in patients,” Dr. You said.
Endogenous glucose production decreased by 24% (P = .04) after normalization of vitamin D levels. Patients who received placebo saw an increase in endogenous glucose, pointing to lower hepatic insulin sensitivity, Dr. You said.
When the vitamin D receptors are activated, they inhibit the profibrotic pathways like TGFb-1, Dr. You explained, decreasing fibrosis.
The researchers also found a decrease in profibrotic gene expression in TGFb-1, HiF-1, MMP7, and Collagen I, V, and VI.
However, while testing for reduction in profibrotic gene expression in whole fat, the investigators found that there was no additional improvement after the first round of vitamin D therapy, leading them to assert that raising vitamin D levels above the normal range does not give any additional benefit.
[email protected]
On Twitter @eaztweets
WASHINGTON – Normalizing vitamin D levels correlated with lower insulin resistance and decreased adipose fibrosis in obese patients, according to a study presented at the Eastern regional meeting of the American Federation for Medical Research.
Approximately 86 million U.S. patients have prediabetes, according to Diabetes Report Card 2014, the most recent estimates from the Centers for Disease Control and Prevention. Vitamin D therapy may be able to help lower that number and prevent diabetes in some patients, Jee Young You, MD, a research fellow at Albert Einstein College of Medicine, New York, said at the meeting.
“When there’s increased adiposity, there is reduction of the blood flow which will further lead to inflammation, macrophage infiltration, and fibrosis, which all together leads to insulin resistance,” Dr. You said. “It is shown that there are vitamin D receptors present on adipocytes, so we hypothesize repleting vitamin D will help in reducing this inflammation.”
In a double blind study, Dr. You and her colleagues randomized 11 obese patients, with an average body mass index of 34 kg/m2, insulin resistance, and vitamin D deficiency to vitamin D repletion therapy. Eight similar patients served as controls. The average age was 43 years.
Patients in the test group were placed on a step schedule for vitamin D supplementation. For 3 months, they received 40,000 IU of vitamin D3 weekly in an effort to reach a target 25-hydroxyvitamin D level of greater than 30 ng/ml. Patients then received another 3 months of the same supplementation with an aim to reach a target level of greater than 50 ng/ml.
“We wanted to see if there was a dose dependent effect for vitamin D in patients,” Dr. You said.
Endogenous glucose production decreased by 24% (P = .04) after normalization of vitamin D levels. Patients who received placebo saw an increase in endogenous glucose, pointing to lower hepatic insulin sensitivity, Dr. You said.
When the vitamin D receptors are activated, they inhibit the profibrotic pathways like TGFb-1, Dr. You explained, decreasing fibrosis.
The researchers also found a decrease in profibrotic gene expression in TGFb-1, HiF-1, MMP7, and Collagen I, V, and VI.
However, while testing for reduction in profibrotic gene expression in whole fat, the investigators found that there was no additional improvement after the first round of vitamin D therapy, leading them to assert that raising vitamin D levels above the normal range does not give any additional benefit.
[email protected]
On Twitter @eaztweets
AT THE AFMR EASTERN REGIONAL MEETING
Key clinical point:
Major finding: Of the 19 patients studied, expression of profibrotic genes TGFb-1, HiF-1, MMP7, and Collagen I, V, and VI in those given vitamin D therapy decreased 0.81, 0.72, 0.62,. 0.56, 0.56, and 0.43 times, respectively (P less than .05).
Data source: Randomized, double blind, placebo-controlled study of 19 obese, insulin resistant, vitamin D deficient patients.
Disclosures: The investigators reported no relevant conflicts of interest.