Statins for the Physically Fit: Do They Help or Hurt?

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Tue, 08/21/2018 - 16:15
Military health researchers studied active-duty military statin users and nonusers to determine the risk of cardiovascular adverse events based on treatment.

Statins may not be the best choice for physically active people, even short term. A study by researchers from VA North Texas Health Care System in Dallas, University of Texas in Austin, and Joint Base Antonio-Fort Sam in Houston, Texas, found higher risks of diabetes and diabetic complications—“without any of the hoped-for cardiovascular benefits.”

It is already established that statins can raise the risk of diabetes. But the military health researchers say there has been no primary prevention clinical trial to examine the overall adverse events (AEs) of statins in physically active people. In a previous study of TRICARE enrollees, the researchers found that short-term statin therapy was not associated with reduced cardiovascular morbidity but was associated with increased risk of AEs. To follow up on those findings, the researchers conducted another study to examine the short- and long-term AEs of statins in active-duty military—chosen precisely because of their physical fitness.

The study, which involved 837 statin users and 2,488 nonusers, covered 2001-2011. The researchers captured 3 intervals: short-term outcomes, 2006; intermediate outcomes, 2006-2009; and long-term outcomes, 2006-2011.

Statin users had nearly twice the risk of diabetes compared with nonusers: 12.5% vs 5.8%. They also had a higher incidence of diabetes with complications: 1.7% vs 0.7%. However, the overall incidence of major acute cardiovascular events was low: 2.58 events per 1,000 person-years in users, and 2.63 events in nonusers. That small number meant the researchers could not show beneficial cardiovascular effects due to statins.

Their findings help fill a gap in the literature, the researchers say, and highlight the possibility that some healthy and active individuals may be receiving statins unnecessarily, putting them at risk for AEs. Moreover, those risks persist long after statins are discontinued, the researchers note. Their study suggests that “we may need to adjust our approach and priorities to primary prevention.”

 

Source:
Mansi IA, English JL, Morris MJ, Zhang S, Mortensen EM, Halm EA. J Sci Med Sport. 2017;20(7):627-632.
doi: 10.1016/j.jsams.2016.12.075.

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Military health researchers studied active-duty military statin users and nonusers to determine the risk of cardiovascular adverse events based on treatment.
Military health researchers studied active-duty military statin users and nonusers to determine the risk of cardiovascular adverse events based on treatment.

Statins may not be the best choice for physically active people, even short term. A study by researchers from VA North Texas Health Care System in Dallas, University of Texas in Austin, and Joint Base Antonio-Fort Sam in Houston, Texas, found higher risks of diabetes and diabetic complications—“without any of the hoped-for cardiovascular benefits.”

It is already established that statins can raise the risk of diabetes. But the military health researchers say there has been no primary prevention clinical trial to examine the overall adverse events (AEs) of statins in physically active people. In a previous study of TRICARE enrollees, the researchers found that short-term statin therapy was not associated with reduced cardiovascular morbidity but was associated with increased risk of AEs. To follow up on those findings, the researchers conducted another study to examine the short- and long-term AEs of statins in active-duty military—chosen precisely because of their physical fitness.

The study, which involved 837 statin users and 2,488 nonusers, covered 2001-2011. The researchers captured 3 intervals: short-term outcomes, 2006; intermediate outcomes, 2006-2009; and long-term outcomes, 2006-2011.

Statin users had nearly twice the risk of diabetes compared with nonusers: 12.5% vs 5.8%. They also had a higher incidence of diabetes with complications: 1.7% vs 0.7%. However, the overall incidence of major acute cardiovascular events was low: 2.58 events per 1,000 person-years in users, and 2.63 events in nonusers. That small number meant the researchers could not show beneficial cardiovascular effects due to statins.

Their findings help fill a gap in the literature, the researchers say, and highlight the possibility that some healthy and active individuals may be receiving statins unnecessarily, putting them at risk for AEs. Moreover, those risks persist long after statins are discontinued, the researchers note. Their study suggests that “we may need to adjust our approach and priorities to primary prevention.”

 

Source:
Mansi IA, English JL, Morris MJ, Zhang S, Mortensen EM, Halm EA. J Sci Med Sport. 2017;20(7):627-632.
doi: 10.1016/j.jsams.2016.12.075.

Statins may not be the best choice for physically active people, even short term. A study by researchers from VA North Texas Health Care System in Dallas, University of Texas in Austin, and Joint Base Antonio-Fort Sam in Houston, Texas, found higher risks of diabetes and diabetic complications—“without any of the hoped-for cardiovascular benefits.”

It is already established that statins can raise the risk of diabetes. But the military health researchers say there has been no primary prevention clinical trial to examine the overall adverse events (AEs) of statins in physically active people. In a previous study of TRICARE enrollees, the researchers found that short-term statin therapy was not associated with reduced cardiovascular morbidity but was associated with increased risk of AEs. To follow up on those findings, the researchers conducted another study to examine the short- and long-term AEs of statins in active-duty military—chosen precisely because of their physical fitness.

The study, which involved 837 statin users and 2,488 nonusers, covered 2001-2011. The researchers captured 3 intervals: short-term outcomes, 2006; intermediate outcomes, 2006-2009; and long-term outcomes, 2006-2011.

Statin users had nearly twice the risk of diabetes compared with nonusers: 12.5% vs 5.8%. They also had a higher incidence of diabetes with complications: 1.7% vs 0.7%. However, the overall incidence of major acute cardiovascular events was low: 2.58 events per 1,000 person-years in users, and 2.63 events in nonusers. That small number meant the researchers could not show beneficial cardiovascular effects due to statins.

Their findings help fill a gap in the literature, the researchers say, and highlight the possibility that some healthy and active individuals may be receiving statins unnecessarily, putting them at risk for AEs. Moreover, those risks persist long after statins are discontinued, the researchers note. Their study suggests that “we may need to adjust our approach and priorities to primary prevention.”

 

Source:
Mansi IA, English JL, Morris MJ, Zhang S, Mortensen EM, Halm EA. J Sci Med Sport. 2017;20(7):627-632.
doi: 10.1016/j.jsams.2016.12.075.

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Getting a Better Picture of Skin Cancer

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Tue, 08/21/2018 - 16:16
Development of a new dermatologic device allows surgeons to assess skin cancers with greater ease and accuracy.

A handheld detector that offers noninvasive real-time imaging can help dermatologic surgeons get a better idea of skin cancer dimensions before committing to surgery, according to researchers from National Skin Centre and Singapore Bioimaging Consortium, both in Singapore, and Technical University of Munich and iThera Medical GmbH, both in Germany.

Current imaging technologies can lead to excessive or incomplete removal of the cancer, the researchers say. The multispectral optoacoustic tomography (MSOT) allows the user to differentiate tissue chromophores (the chromophore is the part of the molecule responsible for its color) and exogenous contrast agents based on their spectral signatures.

The researchers performed MSOT imaging with 2- and 3-dimensional handheld scanners on 21 patients with nonmelanoma skin cancers. All the skin lesions had recognizable images on MSOT with both detectors, visualizing the shape and thickness of the lesions. The 2D and 3D detectors also offered images with well-resolved tissue chromophores. But the volumetric probe gave more accurate tumor dimensions compared with those from histology analysis.

Aggressive types of skin cancers can involve deeper structures, such as predominant deep blood vessels, the researchers note—another reason the MSOT detector could be useful. In one case, the depth of the basal cell carcinoma, which included its underlying vasculature, reached beyond 3 mm, which might have gone undetected by other imaging modalities, they say.

The fact that the device is also noninvasive and offers real-time imaging, the researchers suggest, makes volumetric MSOT “an ideal modality for longitudinal monitoring of skin diseases and treatment responses.”

Source:

Attia ABE, Chuah SY, Razansky D, et al. Photoacoustics. 2017;7:20-26.
doi: 10.1016/j.pacs.2017.05.003.

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Development of a new dermatologic device allows surgeons to assess skin cancers with greater ease and accuracy.
Development of a new dermatologic device allows surgeons to assess skin cancers with greater ease and accuracy.

A handheld detector that offers noninvasive real-time imaging can help dermatologic surgeons get a better idea of skin cancer dimensions before committing to surgery, according to researchers from National Skin Centre and Singapore Bioimaging Consortium, both in Singapore, and Technical University of Munich and iThera Medical GmbH, both in Germany.

Current imaging technologies can lead to excessive or incomplete removal of the cancer, the researchers say. The multispectral optoacoustic tomography (MSOT) allows the user to differentiate tissue chromophores (the chromophore is the part of the molecule responsible for its color) and exogenous contrast agents based on their spectral signatures.

The researchers performed MSOT imaging with 2- and 3-dimensional handheld scanners on 21 patients with nonmelanoma skin cancers. All the skin lesions had recognizable images on MSOT with both detectors, visualizing the shape and thickness of the lesions. The 2D and 3D detectors also offered images with well-resolved tissue chromophores. But the volumetric probe gave more accurate tumor dimensions compared with those from histology analysis.

Aggressive types of skin cancers can involve deeper structures, such as predominant deep blood vessels, the researchers note—another reason the MSOT detector could be useful. In one case, the depth of the basal cell carcinoma, which included its underlying vasculature, reached beyond 3 mm, which might have gone undetected by other imaging modalities, they say.

The fact that the device is also noninvasive and offers real-time imaging, the researchers suggest, makes volumetric MSOT “an ideal modality for longitudinal monitoring of skin diseases and treatment responses.”

Source:

Attia ABE, Chuah SY, Razansky D, et al. Photoacoustics. 2017;7:20-26.
doi: 10.1016/j.pacs.2017.05.003.

A handheld detector that offers noninvasive real-time imaging can help dermatologic surgeons get a better idea of skin cancer dimensions before committing to surgery, according to researchers from National Skin Centre and Singapore Bioimaging Consortium, both in Singapore, and Technical University of Munich and iThera Medical GmbH, both in Germany.

Current imaging technologies can lead to excessive or incomplete removal of the cancer, the researchers say. The multispectral optoacoustic tomography (MSOT) allows the user to differentiate tissue chromophores (the chromophore is the part of the molecule responsible for its color) and exogenous contrast agents based on their spectral signatures.

The researchers performed MSOT imaging with 2- and 3-dimensional handheld scanners on 21 patients with nonmelanoma skin cancers. All the skin lesions had recognizable images on MSOT with both detectors, visualizing the shape and thickness of the lesions. The 2D and 3D detectors also offered images with well-resolved tissue chromophores. But the volumetric probe gave more accurate tumor dimensions compared with those from histology analysis.

Aggressive types of skin cancers can involve deeper structures, such as predominant deep blood vessels, the researchers note—another reason the MSOT detector could be useful. In one case, the depth of the basal cell carcinoma, which included its underlying vasculature, reached beyond 3 mm, which might have gone undetected by other imaging modalities, they say.

The fact that the device is also noninvasive and offers real-time imaging, the researchers suggest, makes volumetric MSOT “an ideal modality for longitudinal monitoring of skin diseases and treatment responses.”

Source:

Attia ABE, Chuah SY, Razansky D, et al. Photoacoustics. 2017;7:20-26.
doi: 10.1016/j.pacs.2017.05.003.

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FDA Approves First New ALS Drug in Years

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Wed, 03/27/2019 - 11:47
After its success in Japan, the new treatment for amyotrophic lateral sclerosis be used for U.S. patients to improve their quality of life.

A new treatment for amyotrophic lateral sclerosis (ALS), Radicava (edaravone), is on the way for U.S. patients.

“After learning about the use of edaravone to treat ALS in Japan, we rapidly engaged with the drug developer about filing a marketing application in the United States,” said Eric Bastings, MD, deputy director of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research. “This is the first new treatment approved by the FDA for ALS in many years, and we are pleased that people with ALS will now have an additional option.”

In a 6-month trial, 137 patients were randomly assigned to edaravone or placebo. At week 24, those receiving edaravone had declined less on a clinical assessment of daily functioning.

Edaravon is given intravenously daily for 14 days to start, followed by 14 days drug free. Subsequent treatment cycles consist of dosing on 10 of 14 days, followed by 14 days drug free.

The most common adverse reactions are bruising and gait disturbance. Edaravon also contains sodium bisulfite, which can cause serious allergic reactions in patients with sulfite sensitivity.

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After its success in Japan, the new treatment for amyotrophic lateral sclerosis be used for U.S. patients to improve their quality of life.
After its success in Japan, the new treatment for amyotrophic lateral sclerosis be used for U.S. patients to improve their quality of life.

A new treatment for amyotrophic lateral sclerosis (ALS), Radicava (edaravone), is on the way for U.S. patients.

“After learning about the use of edaravone to treat ALS in Japan, we rapidly engaged with the drug developer about filing a marketing application in the United States,” said Eric Bastings, MD, deputy director of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research. “This is the first new treatment approved by the FDA for ALS in many years, and we are pleased that people with ALS will now have an additional option.”

In a 6-month trial, 137 patients were randomly assigned to edaravone or placebo. At week 24, those receiving edaravone had declined less on a clinical assessment of daily functioning.

Edaravon is given intravenously daily for 14 days to start, followed by 14 days drug free. Subsequent treatment cycles consist of dosing on 10 of 14 days, followed by 14 days drug free.

The most common adverse reactions are bruising and gait disturbance. Edaravon also contains sodium bisulfite, which can cause serious allergic reactions in patients with sulfite sensitivity.

A new treatment for amyotrophic lateral sclerosis (ALS), Radicava (edaravone), is on the way for U.S. patients.

“After learning about the use of edaravone to treat ALS in Japan, we rapidly engaged with the drug developer about filing a marketing application in the United States,” said Eric Bastings, MD, deputy director of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research. “This is the first new treatment approved by the FDA for ALS in many years, and we are pleased that people with ALS will now have an additional option.”

In a 6-month trial, 137 patients were randomly assigned to edaravone or placebo. At week 24, those receiving edaravone had declined less on a clinical assessment of daily functioning.

Edaravon is given intravenously daily for 14 days to start, followed by 14 days drug free. Subsequent treatment cycles consist of dosing on 10 of 14 days, followed by 14 days drug free.

The most common adverse reactions are bruising and gait disturbance. Edaravon also contains sodium bisulfite, which can cause serious allergic reactions in patients with sulfite sensitivity.

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An Action Plan for Better COPD Care

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Tue, 08/21/2018 - 16:17
National Heart, Lung, and Blood Institute aims to empower and equip the millions of people effected by chronic obstructive pulmonary disease with ways to reduce the burden.

A “detailed, patient-centered roadmap” for addressing the third leading cause of death in the U.S.—chronic obstructive pulmonary disease (COPD)—will provide a “cohesive tool” for health professionals, according to the National Heart, Lung, and Blood Institute (NHLBI). Together with federal and non-federal partners, NHLBI released the first-ever COPD National Action Plan in May at the American Thoracic Society International Conference in Washington, DC.

The plan was developed from comments shared at a “COPD Town Hall” by patients and their families, health care providers, academics, and industry representatives. It takes a unified approach identifying the specific work doctors, educators, researchers, federal agencies, patients, advocates, and the biomedical industry can do to make a difference, according to official at NHLBI.

An estimated 16 million Americans have COPD—and millions more may have it and not know. However COPD often is preventable and highly treatable, early diagnosis can lead to better outcomes. With that as the goal, the plan’s developers aim to:

  • Empower patients, families, and caregivers to recognize and reduce the burden of COPD
  • Equip health care professionals to provide comprehensive care to people with COPD
  • Collect, analyze, report, and disseminate COPD data
  • Increase and sustain COPD research
  • Turn COPD recommendations into research and public health care actions

Involving patients and families has been “invaluable,” said James Kiley, PhD, director of NHLBI’s division of Lung Diseases. “The different perspectives brought by those who live these issues every day contributed to making this a clear, coordinated way forward for all stakeholders.”

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National Heart, Lung, and Blood Institute aims to empower and equip the millions of people effected by chronic obstructive pulmonary disease with ways to reduce the burden.
National Heart, Lung, and Blood Institute aims to empower and equip the millions of people effected by chronic obstructive pulmonary disease with ways to reduce the burden.

A “detailed, patient-centered roadmap” for addressing the third leading cause of death in the U.S.—chronic obstructive pulmonary disease (COPD)—will provide a “cohesive tool” for health professionals, according to the National Heart, Lung, and Blood Institute (NHLBI). Together with federal and non-federal partners, NHLBI released the first-ever COPD National Action Plan in May at the American Thoracic Society International Conference in Washington, DC.

The plan was developed from comments shared at a “COPD Town Hall” by patients and their families, health care providers, academics, and industry representatives. It takes a unified approach identifying the specific work doctors, educators, researchers, federal agencies, patients, advocates, and the biomedical industry can do to make a difference, according to official at NHLBI.

An estimated 16 million Americans have COPD—and millions more may have it and not know. However COPD often is preventable and highly treatable, early diagnosis can lead to better outcomes. With that as the goal, the plan’s developers aim to:

  • Empower patients, families, and caregivers to recognize and reduce the burden of COPD
  • Equip health care professionals to provide comprehensive care to people with COPD
  • Collect, analyze, report, and disseminate COPD data
  • Increase and sustain COPD research
  • Turn COPD recommendations into research and public health care actions

Involving patients and families has been “invaluable,” said James Kiley, PhD, director of NHLBI’s division of Lung Diseases. “The different perspectives brought by those who live these issues every day contributed to making this a clear, coordinated way forward for all stakeholders.”

A “detailed, patient-centered roadmap” for addressing the third leading cause of death in the U.S.—chronic obstructive pulmonary disease (COPD)—will provide a “cohesive tool” for health professionals, according to the National Heart, Lung, and Blood Institute (NHLBI). Together with federal and non-federal partners, NHLBI released the first-ever COPD National Action Plan in May at the American Thoracic Society International Conference in Washington, DC.

The plan was developed from comments shared at a “COPD Town Hall” by patients and their families, health care providers, academics, and industry representatives. It takes a unified approach identifying the specific work doctors, educators, researchers, federal agencies, patients, advocates, and the biomedical industry can do to make a difference, according to official at NHLBI.

An estimated 16 million Americans have COPD—and millions more may have it and not know. However COPD often is preventable and highly treatable, early diagnosis can lead to better outcomes. With that as the goal, the plan’s developers aim to:

  • Empower patients, families, and caregivers to recognize and reduce the burden of COPD
  • Equip health care professionals to provide comprehensive care to people with COPD
  • Collect, analyze, report, and disseminate COPD data
  • Increase and sustain COPD research
  • Turn COPD recommendations into research and public health care actions

Involving patients and families has been “invaluable,” said James Kiley, PhD, director of NHLBI’s division of Lung Diseases. “The different perspectives brought by those who live these issues every day contributed to making this a clear, coordinated way forward for all stakeholders.”

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Sick of Your Job—or Sick Because of Your Job?

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Tue, 08/21/2018 - 16:19
Analyzed data from a national health survey reveals work influences people’s health based on occupancy and workplace environment.

Does your work make you sick? If it does, do you have paid sick leave? A NIOSH study found that aspects of anoccupation influences people’s health in a multitude of ways, including work conditions, how the work is organized, job-related tasks, long work hours, and work-life balance. “Work is an important determinant of health,” the researchers conclude.

NIOSH researchers analyzed data from 10,767 adults in many occupations who participated in the 2010 National Health Interview Survey. People employed in business operations jobs, such as marketing and human resources, were 85% more likely to rate their health as fair or poor. Workers with no paid sick leave were 35% more likely to report fair or poor health. Workers who were worried about becoming unemployed were 43% more likely to report fair or poor health. Those who reported difficulty combining work and family were 23% more likely. Those who reported being bullied at work were 82% more likely.

“We believe this is the first study to show an association between business operations jobs and poor health,” said Sara Luckhaupt, MD, NIOSH medical officer and lead author of the study. “Knowing which aspects of a person’s job can lead to poor health can help public health and employee wellness professionals develop—ideally with worker input—tailored workplace interventions to advance worker well-being.”

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Analyzed data from a national health survey reveals work influences people’s health based on occupancy and workplace environment.
Analyzed data from a national health survey reveals work influences people’s health based on occupancy and workplace environment.

Does your work make you sick? If it does, do you have paid sick leave? A NIOSH study found that aspects of anoccupation influences people’s health in a multitude of ways, including work conditions, how the work is organized, job-related tasks, long work hours, and work-life balance. “Work is an important determinant of health,” the researchers conclude.

NIOSH researchers analyzed data from 10,767 adults in many occupations who participated in the 2010 National Health Interview Survey. People employed in business operations jobs, such as marketing and human resources, were 85% more likely to rate their health as fair or poor. Workers with no paid sick leave were 35% more likely to report fair or poor health. Workers who were worried about becoming unemployed were 43% more likely to report fair or poor health. Those who reported difficulty combining work and family were 23% more likely. Those who reported being bullied at work were 82% more likely.

“We believe this is the first study to show an association between business operations jobs and poor health,” said Sara Luckhaupt, MD, NIOSH medical officer and lead author of the study. “Knowing which aspects of a person’s job can lead to poor health can help public health and employee wellness professionals develop—ideally with worker input—tailored workplace interventions to advance worker well-being.”

Does your work make you sick? If it does, do you have paid sick leave? A NIOSH study found that aspects of anoccupation influences people’s health in a multitude of ways, including work conditions, how the work is organized, job-related tasks, long work hours, and work-life balance. “Work is an important determinant of health,” the researchers conclude.

NIOSH researchers analyzed data from 10,767 adults in many occupations who participated in the 2010 National Health Interview Survey. People employed in business operations jobs, such as marketing and human resources, were 85% more likely to rate their health as fair or poor. Workers with no paid sick leave were 35% more likely to report fair or poor health. Workers who were worried about becoming unemployed were 43% more likely to report fair or poor health. Those who reported difficulty combining work and family were 23% more likely. Those who reported being bullied at work were 82% more likely.

“We believe this is the first study to show an association between business operations jobs and poor health,” said Sara Luckhaupt, MD, NIOSH medical officer and lead author of the study. “Knowing which aspects of a person’s job can lead to poor health can help public health and employee wellness professionals develop—ideally with worker input—tailored workplace interventions to advance worker well-being.”

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A New ‘Triplet’ Treatment for Multiple Myeloma

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Tue, 08/21/2018 - 16:19
The researchers tested 3 doses of carfilzomib along with cyclophosphamide and dexamethasone.

Carfilzomib, a selective second-generation proteasome inhibitor, has performed well in clinical trials. So because other “triplets”—combinations of alkylator, proteasome inhibitor, and steroid—had shown “encouraging” response rates, researchers from the Center for Cancer and Blood Disorders in Bethesda, Maryland, and others, conducted a multicenter study to evaluate the safety and tolerability of twice-weekly carfilzomib combined with cyclophosphamide and dexamethasone (KCyd) for patients newly diagnosed with multiple myeloma (MM).

The researchers tested 3 doses of carfilzomib: 36 mg/m2, 45 mg/m2, and 56 mg/m2. Of the 22 enrolled patients, 16 were treated with the maximum dose.

Fourteen patients completed all 8 cycles of treatment; 10 in the maximum-dose group completed all 8. At 56 mg/m2, the overall response rate was 87.5%. Among the 14 patients whose disease responded to therapy, the median time to response was 1 month.

Five patients discontinued treatment because of adverse effects (AEs), but the researchers found no dose-limiting toxicities at any of the dose levels. The most common AEs were nausea, diarrhea, and anemia.

The researchers concluded that based on previous research, KCyd with 36 mg/m2 is safe and effective in patients aged ≥ 65 years with newly diagnosed MM. However, their findings suggest that twice-weekly carfilzomib 56 mg/m2 in combination with cyclophosphamide and dexamethasone also is effective with “manageable toxicity.”

 

Source:
Boccia RV, Bessudo A, Agajanian R, et al. Clin Lymphoma Myeloma Leuk. In press.
doi: 10.1016/j.clml.2017.05.009.

 

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The researchers tested 3 doses of carfilzomib along with cyclophosphamide and dexamethasone.
The researchers tested 3 doses of carfilzomib along with cyclophosphamide and dexamethasone.

Carfilzomib, a selective second-generation proteasome inhibitor, has performed well in clinical trials. So because other “triplets”—combinations of alkylator, proteasome inhibitor, and steroid—had shown “encouraging” response rates, researchers from the Center for Cancer and Blood Disorders in Bethesda, Maryland, and others, conducted a multicenter study to evaluate the safety and tolerability of twice-weekly carfilzomib combined with cyclophosphamide and dexamethasone (KCyd) for patients newly diagnosed with multiple myeloma (MM).

The researchers tested 3 doses of carfilzomib: 36 mg/m2, 45 mg/m2, and 56 mg/m2. Of the 22 enrolled patients, 16 were treated with the maximum dose.

Fourteen patients completed all 8 cycles of treatment; 10 in the maximum-dose group completed all 8. At 56 mg/m2, the overall response rate was 87.5%. Among the 14 patients whose disease responded to therapy, the median time to response was 1 month.

Five patients discontinued treatment because of adverse effects (AEs), but the researchers found no dose-limiting toxicities at any of the dose levels. The most common AEs were nausea, diarrhea, and anemia.

The researchers concluded that based on previous research, KCyd with 36 mg/m2 is safe and effective in patients aged ≥ 65 years with newly diagnosed MM. However, their findings suggest that twice-weekly carfilzomib 56 mg/m2 in combination with cyclophosphamide and dexamethasone also is effective with “manageable toxicity.”

 

Source:
Boccia RV, Bessudo A, Agajanian R, et al. Clin Lymphoma Myeloma Leuk. In press.
doi: 10.1016/j.clml.2017.05.009.

 

Carfilzomib, a selective second-generation proteasome inhibitor, has performed well in clinical trials. So because other “triplets”—combinations of alkylator, proteasome inhibitor, and steroid—had shown “encouraging” response rates, researchers from the Center for Cancer and Blood Disorders in Bethesda, Maryland, and others, conducted a multicenter study to evaluate the safety and tolerability of twice-weekly carfilzomib combined with cyclophosphamide and dexamethasone (KCyd) for patients newly diagnosed with multiple myeloma (MM).

The researchers tested 3 doses of carfilzomib: 36 mg/m2, 45 mg/m2, and 56 mg/m2. Of the 22 enrolled patients, 16 were treated with the maximum dose.

Fourteen patients completed all 8 cycles of treatment; 10 in the maximum-dose group completed all 8. At 56 mg/m2, the overall response rate was 87.5%. Among the 14 patients whose disease responded to therapy, the median time to response was 1 month.

Five patients discontinued treatment because of adverse effects (AEs), but the researchers found no dose-limiting toxicities at any of the dose levels. The most common AEs were nausea, diarrhea, and anemia.

The researchers concluded that based on previous research, KCyd with 36 mg/m2 is safe and effective in patients aged ≥ 65 years with newly diagnosed MM. However, their findings suggest that twice-weekly carfilzomib 56 mg/m2 in combination with cyclophosphamide and dexamethasone also is effective with “manageable toxicity.”

 

Source:
Boccia RV, Bessudo A, Agajanian R, et al. Clin Lymphoma Myeloma Leuk. In press.
doi: 10.1016/j.clml.2017.05.009.

 

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Federal Health Care Data Trends 2017 Introduction

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Military service comes with many health care costs, both immediate and long term. These costs are incurred by active-duty and veteran patients, as well as the VA and DoD systems that have struggled to adequately meet their health care needs. The VA and DoD health care systems face a myriad of challenges in treating their diverse populations.

Identifying and responding to health care challenges requires reliable and detailed data. The 2017 Federal Health Care Data Trends was developed not only to report important data on the most significant health care challenges in federal medicine, but also to simplify and identify emergent trends.

The men and women who serve in the U.S. military are more likely to be diagnosed with posttraumatic stress disorder, diabetes mellitus, and chronic obstructive pulmonary disease. Agent Orange, burn pits, and other toxic exposures also increase their risk of developing multiple types of cancer, multiple sclerosis, asthma, and many other conditions. Veterans are likely to be older than nonveterans (the median age of male veterans is 64 years, compared with 41 years for nonveterans), and therefore at risk for age-related conditions.

Of the nearly 22 million veterans in the U.S., 8.9 million are enrolled in the VA, and just short of 6 million access health care services annually. Active-duty service members make up just 15% of the military health system, while the family members of active-duty service members, National Guard members, reservists, and retirees constitute more than half of the TRICARE population.

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Military service comes with many health care costs, both immediate and long term. These costs are incurred by active-duty and veteran patients, as well as the VA and DoD systems that have struggled to adequately meet their health care needs. The VA and DoD health care systems face a myriad of challenges in treating their diverse populations.

Identifying and responding to health care challenges requires reliable and detailed data. The 2017 Federal Health Care Data Trends was developed not only to report important data on the most significant health care challenges in federal medicine, but also to simplify and identify emergent trends.

The men and women who serve in the U.S. military are more likely to be diagnosed with posttraumatic stress disorder, diabetes mellitus, and chronic obstructive pulmonary disease. Agent Orange, burn pits, and other toxic exposures also increase their risk of developing multiple types of cancer, multiple sclerosis, asthma, and many other conditions. Veterans are likely to be older than nonveterans (the median age of male veterans is 64 years, compared with 41 years for nonveterans), and therefore at risk for age-related conditions.

Of the nearly 22 million veterans in the U.S., 8.9 million are enrolled in the VA, and just short of 6 million access health care services annually. Active-duty service members make up just 15% of the military health system, while the family members of active-duty service members, National Guard members, reservists, and retirees constitute more than half of the TRICARE population.

Click here to continue reading.

Military service comes with many health care costs, both immediate and long term. These costs are incurred by active-duty and veteran patients, as well as the VA and DoD systems that have struggled to adequately meet their health care needs. The VA and DoD health care systems face a myriad of challenges in treating their diverse populations.

Identifying and responding to health care challenges requires reliable and detailed data. The 2017 Federal Health Care Data Trends was developed not only to report important data on the most significant health care challenges in federal medicine, but also to simplify and identify emergent trends.

The men and women who serve in the U.S. military are more likely to be diagnosed with posttraumatic stress disorder, diabetes mellitus, and chronic obstructive pulmonary disease. Agent Orange, burn pits, and other toxic exposures also increase their risk of developing multiple types of cancer, multiple sclerosis, asthma, and many other conditions. Veterans are likely to be older than nonveterans (the median age of male veterans is 64 years, compared with 41 years for nonveterans), and therefore at risk for age-related conditions.

Of the nearly 22 million veterans in the U.S., 8.9 million are enrolled in the VA, and just short of 6 million access health care services annually. Active-duty service members make up just 15% of the military health system, while the family members of active-duty service members, National Guard members, reservists, and retirees constitute more than half of the TRICARE population.

Click here to continue reading.

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The Drive to Reduce HCV Among Native Americans

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The IHS goal of screening 80,000 patients for HCV is possible through multiple programs and methods of participation within the Native community.

American Indians/Alaska Natives have the highest rate of new hepatitis C virus (HCV) infections of all ethnic groups, according to recent surveillance data from CDC.

The IHS has distributed updated guidelines on HCV prevention, testing, and treatment to IHS facilities. The guidelines are based on those of the National Viral Hepatitis Action Plan for 2017-2020, the U.S. Preventive Services Task Force, the CDC, and the American Association for the Study of Liver Diseases.

Tribal programs are an important element of the outreach. In 2015, for instance, the Cherokee Nation became the first tribe in the U.S. to launch an HCV Elimination Project, with the goal of screening 80,000 patients over the next 3 years. Last year, 23,000 patients were screened.

Other programs provide telehealth and teleconsultation services to treat patients on-site, rather than referring them to facilities far from their communities. A pharmacist-led treatment program, for example, in conjunction with a local physician and Project ECHO (Extension for Community Health Outcomes) and telehealth programs, has successfully cured > 10 patients on the Fort Peck reservation.

An estimated 20,000 to 40,000 IHS patients need HCV treatment. The IHS encourages anyone with HCV—even those who had unsuccessful treatment in the past—to seek care as soon as possible.

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The IHS goal of screening 80,000 patients for HCV is possible through multiple programs and methods of participation within the Native community.
The IHS goal of screening 80,000 patients for HCV is possible through multiple programs and methods of participation within the Native community.

American Indians/Alaska Natives have the highest rate of new hepatitis C virus (HCV) infections of all ethnic groups, according to recent surveillance data from CDC.

The IHS has distributed updated guidelines on HCV prevention, testing, and treatment to IHS facilities. The guidelines are based on those of the National Viral Hepatitis Action Plan for 2017-2020, the U.S. Preventive Services Task Force, the CDC, and the American Association for the Study of Liver Diseases.

Tribal programs are an important element of the outreach. In 2015, for instance, the Cherokee Nation became the first tribe in the U.S. to launch an HCV Elimination Project, with the goal of screening 80,000 patients over the next 3 years. Last year, 23,000 patients were screened.

Other programs provide telehealth and teleconsultation services to treat patients on-site, rather than referring them to facilities far from their communities. A pharmacist-led treatment program, for example, in conjunction with a local physician and Project ECHO (Extension for Community Health Outcomes) and telehealth programs, has successfully cured > 10 patients on the Fort Peck reservation.

An estimated 20,000 to 40,000 IHS patients need HCV treatment. The IHS encourages anyone with HCV—even those who had unsuccessful treatment in the past—to seek care as soon as possible.

American Indians/Alaska Natives have the highest rate of new hepatitis C virus (HCV) infections of all ethnic groups, according to recent surveillance data from CDC.

The IHS has distributed updated guidelines on HCV prevention, testing, and treatment to IHS facilities. The guidelines are based on those of the National Viral Hepatitis Action Plan for 2017-2020, the U.S. Preventive Services Task Force, the CDC, and the American Association for the Study of Liver Diseases.

Tribal programs are an important element of the outreach. In 2015, for instance, the Cherokee Nation became the first tribe in the U.S. to launch an HCV Elimination Project, with the goal of screening 80,000 patients over the next 3 years. Last year, 23,000 patients were screened.

Other programs provide telehealth and teleconsultation services to treat patients on-site, rather than referring them to facilities far from their communities. A pharmacist-led treatment program, for example, in conjunction with a local physician and Project ECHO (Extension for Community Health Outcomes) and telehealth programs, has successfully cured > 10 patients on the Fort Peck reservation.

An estimated 20,000 to 40,000 IHS patients need HCV treatment. The IHS encourages anyone with HCV—even those who had unsuccessful treatment in the past—to seek care as soon as possible.

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Stopping Prediabetes Before It Becomes Diabetes

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A new prediabetes awareness program aims to assess and reverse type 2 diabetes risk factors among Native Americans.

In the Navajo area, 1 in 5 Native Americans has diabetes, and about 75,000 have prediabetes. That is the impetus for IHS’s new campaign, launched at the Northern Navajo Medical Center, to raise awareness and knowledge of prediabetes—and to let people know it can be reversed.

The “Do I Have Prediabetes?” campaign by the Shiprock Health Promotion Program is intended to help people assess their risk and reverse prediabetes before their blood sugar level is high enough to be type 2 diabetes. The program builds on the groundwork of a 2016 CDC national prediabetes awareness campaign. Materials include posters, an infographic that depicts the risk factors, roadside billboards, and a video for waiting rooms.

The IHS has already made progress against at least 1 diabetes-related issue: kidney failure. Through the Special Diabetes Program for Indians, innovative evidence-based interventions helped reduce kidney failure from diabetes among Native American adults by 54% between 1996 and 2013. Kidney failure from diabetes in Native Americans was the highest of any ethnic group but now has dropped the fastest.  The Shiprock program will continue through early 2018.

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A new prediabetes awareness program aims to assess and reverse type 2 diabetes risk factors among Native Americans.
A new prediabetes awareness program aims to assess and reverse type 2 diabetes risk factors among Native Americans.

In the Navajo area, 1 in 5 Native Americans has diabetes, and about 75,000 have prediabetes. That is the impetus for IHS’s new campaign, launched at the Northern Navajo Medical Center, to raise awareness and knowledge of prediabetes—and to let people know it can be reversed.

The “Do I Have Prediabetes?” campaign by the Shiprock Health Promotion Program is intended to help people assess their risk and reverse prediabetes before their blood sugar level is high enough to be type 2 diabetes. The program builds on the groundwork of a 2016 CDC national prediabetes awareness campaign. Materials include posters, an infographic that depicts the risk factors, roadside billboards, and a video for waiting rooms.

The IHS has already made progress against at least 1 diabetes-related issue: kidney failure. Through the Special Diabetes Program for Indians, innovative evidence-based interventions helped reduce kidney failure from diabetes among Native American adults by 54% between 1996 and 2013. Kidney failure from diabetes in Native Americans was the highest of any ethnic group but now has dropped the fastest.  The Shiprock program will continue through early 2018.

In the Navajo area, 1 in 5 Native Americans has diabetes, and about 75,000 have prediabetes. That is the impetus for IHS’s new campaign, launched at the Northern Navajo Medical Center, to raise awareness and knowledge of prediabetes—and to let people know it can be reversed.

The “Do I Have Prediabetes?” campaign by the Shiprock Health Promotion Program is intended to help people assess their risk and reverse prediabetes before their blood sugar level is high enough to be type 2 diabetes. The program builds on the groundwork of a 2016 CDC national prediabetes awareness campaign. Materials include posters, an infographic that depicts the risk factors, roadside billboards, and a video for waiting rooms.

The IHS has already made progress against at least 1 diabetes-related issue: kidney failure. Through the Special Diabetes Program for Indians, innovative evidence-based interventions helped reduce kidney failure from diabetes among Native American adults by 54% between 1996 and 2013. Kidney failure from diabetes in Native Americans was the highest of any ethnic group but now has dropped the fastest.  The Shiprock program will continue through early 2018.

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How Well Does Metabolic Syndrome Predict Prognosis of STEMI?

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Researchers analyzed the ability of predicting a prognosis of acute ST-elevation myocardial infarction based on the patient’s metabolic syndrome.

Metabolic syndrome (MetS) is common among patients with coronary artery disease (CAD) and highly prevalent in those with acute ST-elevation myocardial infarction (STEMI). But are all elements of MetS equally good predictors of clinical severity and prognosis?

To find out, researchers from Sestre Milosrdnice University Hospital Center in Zagreb, Croatia, prospectively analyzed data of 250 patients with acute STEMI who were treated with primary percutaneous coronary intervention. Metabolic syndrome was defined according to the revised National Cholesterol Education Program-Adult Treatment Panel III and the International Diabetes Federation.

Patients with and without MetS were analyzed according to obesity indexes: body mass index (BMI); central-body adiposity index (BAI); conicity index (Cindex); visceral adiposity index (VAI); waist circumference (WC); waist-to-hip ratio (WHR); and waist-to-height ratio (WHtR).

During hospitalization, 19 patients died; 231 were included in the 12-month follow-up.

Patients with acute STEMI had high rates of central obesity, increased VAI, WHtR, and very high BAI, dyslipidemia, and hypertension. However, they had lower rates of overall obesity and hyperglycemia.

The researchers found MetS and several obesity indexes were superior to overall obesity BMI in predicting acute STEMI severity: clinical presentation, in-hospital complications, and severity of CAD. Waist circumference and MetS had no influence on prognosis. Moreover, MetS and obesity indexes had no influence on prognosis of major adverse cardiovascular events (MACE).

The researchers also found Cindex > 1.25/1.18, very high BAI, and WHtR ≥ 63/58 increased the risk of total in-hospital complications, dyspnea, and heart failure, respectively. The number of significantly stenosed coronary arteries increased the risk of total MACE. Waist-to-hip ratio independently increased the risk of significant stenosis of the coronary segment 1 and proximal/middle coronary artery (CA) segments.

In a previous study, the researchers had found that MetS patients had longer hospitalization and severe CAD. However, although MetS increased the risk of > 1 significantly stenosed CAs and total in-hospital complications, none of the MetS components per se significantly influenced clinical severity or prognosis; except hyperglycemia, which increased the risk of heart failure. The researchers found that was still true in this study, but Cindex was a stronger predictor of total in-hospital complications. The researchers concluded that VAI is more reliable than WC for predicting clinical severity of acute STEMI.

Source:

Jelavic MM, Barbic Z, Pintaric H. Arch Med Sci. 2017;13(4):795-806.

doi: https://doi.org/10.5114/aoms.2016.59703.

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Researchers analyzed the ability of predicting a prognosis of acute ST-elevation myocardial infarction based on the patient’s metabolic syndrome.
Researchers analyzed the ability of predicting a prognosis of acute ST-elevation myocardial infarction based on the patient’s metabolic syndrome.

Metabolic syndrome (MetS) is common among patients with coronary artery disease (CAD) and highly prevalent in those with acute ST-elevation myocardial infarction (STEMI). But are all elements of MetS equally good predictors of clinical severity and prognosis?

To find out, researchers from Sestre Milosrdnice University Hospital Center in Zagreb, Croatia, prospectively analyzed data of 250 patients with acute STEMI who were treated with primary percutaneous coronary intervention. Metabolic syndrome was defined according to the revised National Cholesterol Education Program-Adult Treatment Panel III and the International Diabetes Federation.

Patients with and without MetS were analyzed according to obesity indexes: body mass index (BMI); central-body adiposity index (BAI); conicity index (Cindex); visceral adiposity index (VAI); waist circumference (WC); waist-to-hip ratio (WHR); and waist-to-height ratio (WHtR).

During hospitalization, 19 patients died; 231 were included in the 12-month follow-up.

Patients with acute STEMI had high rates of central obesity, increased VAI, WHtR, and very high BAI, dyslipidemia, and hypertension. However, they had lower rates of overall obesity and hyperglycemia.

The researchers found MetS and several obesity indexes were superior to overall obesity BMI in predicting acute STEMI severity: clinical presentation, in-hospital complications, and severity of CAD. Waist circumference and MetS had no influence on prognosis. Moreover, MetS and obesity indexes had no influence on prognosis of major adverse cardiovascular events (MACE).

The researchers also found Cindex > 1.25/1.18, very high BAI, and WHtR ≥ 63/58 increased the risk of total in-hospital complications, dyspnea, and heart failure, respectively. The number of significantly stenosed coronary arteries increased the risk of total MACE. Waist-to-hip ratio independently increased the risk of significant stenosis of the coronary segment 1 and proximal/middle coronary artery (CA) segments.

In a previous study, the researchers had found that MetS patients had longer hospitalization and severe CAD. However, although MetS increased the risk of > 1 significantly stenosed CAs and total in-hospital complications, none of the MetS components per se significantly influenced clinical severity or prognosis; except hyperglycemia, which increased the risk of heart failure. The researchers found that was still true in this study, but Cindex was a stronger predictor of total in-hospital complications. The researchers concluded that VAI is more reliable than WC for predicting clinical severity of acute STEMI.

Source:

Jelavic MM, Barbic Z, Pintaric H. Arch Med Sci. 2017;13(4):795-806.

doi: https://doi.org/10.5114/aoms.2016.59703.

Metabolic syndrome (MetS) is common among patients with coronary artery disease (CAD) and highly prevalent in those with acute ST-elevation myocardial infarction (STEMI). But are all elements of MetS equally good predictors of clinical severity and prognosis?

To find out, researchers from Sestre Milosrdnice University Hospital Center in Zagreb, Croatia, prospectively analyzed data of 250 patients with acute STEMI who were treated with primary percutaneous coronary intervention. Metabolic syndrome was defined according to the revised National Cholesterol Education Program-Adult Treatment Panel III and the International Diabetes Federation.

Patients with and without MetS were analyzed according to obesity indexes: body mass index (BMI); central-body adiposity index (BAI); conicity index (Cindex); visceral adiposity index (VAI); waist circumference (WC); waist-to-hip ratio (WHR); and waist-to-height ratio (WHtR).

During hospitalization, 19 patients died; 231 were included in the 12-month follow-up.

Patients with acute STEMI had high rates of central obesity, increased VAI, WHtR, and very high BAI, dyslipidemia, and hypertension. However, they had lower rates of overall obesity and hyperglycemia.

The researchers found MetS and several obesity indexes were superior to overall obesity BMI in predicting acute STEMI severity: clinical presentation, in-hospital complications, and severity of CAD. Waist circumference and MetS had no influence on prognosis. Moreover, MetS and obesity indexes had no influence on prognosis of major adverse cardiovascular events (MACE).

The researchers also found Cindex > 1.25/1.18, very high BAI, and WHtR ≥ 63/58 increased the risk of total in-hospital complications, dyspnea, and heart failure, respectively. The number of significantly stenosed coronary arteries increased the risk of total MACE. Waist-to-hip ratio independently increased the risk of significant stenosis of the coronary segment 1 and proximal/middle coronary artery (CA) segments.

In a previous study, the researchers had found that MetS patients had longer hospitalization and severe CAD. However, although MetS increased the risk of > 1 significantly stenosed CAs and total in-hospital complications, none of the MetS components per se significantly influenced clinical severity or prognosis; except hyperglycemia, which increased the risk of heart failure. The researchers found that was still true in this study, but Cindex was a stronger predictor of total in-hospital complications. The researchers concluded that VAI is more reliable than WC for predicting clinical severity of acute STEMI.

Source:

Jelavic MM, Barbic Z, Pintaric H. Arch Med Sci. 2017;13(4):795-806.

doi: https://doi.org/10.5114/aoms.2016.59703.

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