UVA Study Shows Early Success In Treating Deadly Brain Tumors
New research from the University of Virginia Health System shows that, when combined, two emerging medical technologies hold significant promise for treating the most deadly and... devastating form of brain tumor, glioblastoma multiforme (GBM).
According to Jason Sheehan, M.D., a neurosurgeon and assistant professor of neurosurgery at the UVA School of Medicine, the use of controlled-released nanoparticles containing chemotherapeutic drugs and non-invasive ultrasound successfully helps to treat GBM tumors in mice.
Sheehan discussed the findings on May 4 during the annual meeting of the American Association of Neurological Surgeons (AANS). The association selected Sheehan for its 2009 Young Investigator Award in recognition of his outstanding potential as a researcher in the field of neuro-oncology.
During the study, Sheehan and his colleagues placed a cancer-killing drug inside nanoparticles affixed to microbubbles (which are the size of red blood cells) and injected the compound into the veins of immunocompromised mice. Carried by the bloodstream, the treatment travelled to the GBM tumor site. There, a 1 MHz dose of energy from the ultrasound equipment caused the microbubbles to burst and release the drug directly onto the cancer cells. Results show the treatment reduced tumor cell viability in a significant fashion and compared favorably with an anti-cancer drug, administered to the study's positive control group. The UVA study also showed ultrasound induced damage to the microvessels feeding the tumor.
"Many drugs that kill GBM cells in vitro prove ineffective in living organisms because they are not able to penetrate the blood brain barrier," noted Sheehan. "These new technologies are allowing us to overcome this challenging problem and deliver a highly targeted and sustained release of chemotherapy drugs. Although more research is needed, our findings indicate the technologies hold significant promise for patients with high grade gliomas and other malignant brain tumors."
Sheehan's research is on-going and is being performed in collaboration with his study co-authors, Caitlin Burke, BS, a graduate student in the UVA School of Engineering and Applied Science and Richard Price, PhD., a biomedical engineer in the UVA School of Medicine. Their research is funded by multi-year grants from the Hartwell Foundation.
"I'm honored to receive the 2009 AANS Young Investigator Award," Sheehan says.
Sponsored by the American Brain Tumor Association, the award is presented annually by the American Association of Neurological Surgeons to a young faculty member in neurosurgery.
Sheehan received his B.S., M.S., PhD, and M.D. from the University of Virginia. His B.S. is in Chemical Engineering with the highest honors awarded from the School of Engineering. He performed fellowships at Auckland University and the University of Pittsburgh. Sheehan won the University of Virginia Clinical Excellence Award in 2006.
Widely-published, Sheehan is author of more than 100 peer-reviewed papers as well as numerous invited manuscripts and a book. He reviews manuscripts for several medical journals and serves on a variety of professional committees. Sheehan's memberships include the American Association of Neurological Surgeons (AANS), the American College of Surgeons, Leksell Gamma Knife Society, Neurosurgical Society of the Virginias, AANS/CNS Tumor Section, and the American Society of Stereotactic and Functional Neurosurgeons.
Sheehan's laboratory team also pursues translational and basic science research in brain tumors.
Source: University of Virginia Health System
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According to Jason Sheehan, M.D., a neurosurgeon and assistant professor of neurosurgery at the UVA School of Medicine, the use of controlled-released nanoparticles containing chemotherapeutic drugs and non-invasive ultrasound successfully helps to treat GBM tumors in mice.
Sheehan discussed the findings on May 4 during the annual meeting of the American Association of Neurological Surgeons (AANS). The association selected Sheehan for its 2009 Young Investigator Award in recognition of his outstanding potential as a researcher in the field of neuro-oncology.
During the study, Sheehan and his colleagues placed a cancer-killing drug inside nanoparticles affixed to microbubbles (which are the size of red blood cells) and injected the compound into the veins of immunocompromised mice. Carried by the bloodstream, the treatment travelled to the GBM tumor site. There, a 1 MHz dose of energy from the ultrasound equipment caused the microbubbles to burst and release the drug directly onto the cancer cells. Results show the treatment reduced tumor cell viability in a significant fashion and compared favorably with an anti-cancer drug, administered to the study's positive control group. The UVA study also showed ultrasound induced damage to the microvessels feeding the tumor.
"Many drugs that kill GBM cells in vitro prove ineffective in living organisms because they are not able to penetrate the blood brain barrier," noted Sheehan. "These new technologies are allowing us to overcome this challenging problem and deliver a highly targeted and sustained release of chemotherapy drugs. Although more research is needed, our findings indicate the technologies hold significant promise for patients with high grade gliomas and other malignant brain tumors."
Sheehan's research is on-going and is being performed in collaboration with his study co-authors, Caitlin Burke, BS, a graduate student in the UVA School of Engineering and Applied Science and Richard Price, PhD., a biomedical engineer in the UVA School of Medicine. Their research is funded by multi-year grants from the Hartwell Foundation.
"I'm honored to receive the 2009 AANS Young Investigator Award," Sheehan says.
Sponsored by the American Brain Tumor Association, the award is presented annually by the American Association of Neurological Surgeons to a young faculty member in neurosurgery.
Sheehan received his B.S., M.S., PhD, and M.D. from the University of Virginia. His B.S. is in Chemical Engineering with the highest honors awarded from the School of Engineering. He performed fellowships at Auckland University and the University of Pittsburgh. Sheehan won the University of Virginia Clinical Excellence Award in 2006.
Widely-published, Sheehan is author of more than 100 peer-reviewed papers as well as numerous invited manuscripts and a book. He reviews manuscripts for several medical journals and serves on a variety of professional committees. Sheehan's memberships include the American Association of Neurological Surgeons (AANS), the American College of Surgeons, Leksell Gamma Knife Society, Neurosurgical Society of the Virginias, AANS/CNS Tumor Section, and the American Society of Stereotactic and Functional Neurosurgeons.
Sheehan's laboratory team also pursues translational and basic science research in brain tumors.
Source: University of Virginia Health System
New Therapy Improves Chances Of Living Disease-free With Difficult-to-treat Childhood Cancer
A phase III study has shown that adding an antibody-based therapy that harnesses the body's immune system resulted in a 20 percent increase in the number of children living disease-free for... at least two years with neuroblastoma. Neuroblastoma, a hard-to-treat cancer arising from nervous system cells, is responsible for 15 percent of cancer-related deaths in children. The researchers reported their findings - the first to show that immunotherapy could be effective against childhood cancer - online May 14, 2009 on the American Society of Clinical Oncology website in advance of presentation June 2.
"This establishes a new standard of care for a traditionally very difficult cancer in children," said lead author Alice Yu, MD, PhD, professor of pediatric hematology/oncology at the University of California, San Diego School of Medicine and the Moores UCSD Cancer Center. "High-risk neuroblastoma has always been a frustrating cancer to treat because, despite aggressive therapy, it has a high relapse rate."
The therapy targets a specific glycan (a complex sugar chain found on the surface of cells) on neuroblastoma cells called GD2, which inhibit the immune system from killing cancer cells. The antibody - ch14.18 - binds to this glycan, enabling various types of immune cells to attack the cancer.
Neuroblastoma - in which the cancer cells arise from nerve cells in the neck, chest, or abdomen - is the most common cancer diagnosed in the first year of life. Approximately 650 new cases of neuroblastoma are diagnosed in this country every year, and about 40 percent of patients have high-risk neuroblastoma. These high-risk patients are usually treated with surgery, intensive chemotherapy with stem cell rescue (in which patients' adult stem cells, removed before treatment, are returned after chemotherapy to restore the blood and immune system), and radiation therapy. Still, only 30 percent of patients survive.
Yu and her colleagues compared both the percentage of patients who were still alive without experiencing a recurrence after two years as well as overall survival in two groups of 113 patients each. Patients began the trial when they were newly diagnosed with high-risk neuroblastoma. After conventional treatment with surgery, chemotherapy, stem cell rescue and radiotherapy, one group was given the standard treatment (retinoic acid) plus immunotherapy (the antibody plus immune-boosting substances), while 113 similar patients received the standard treatment alone.
After two years, 66 percent of individuals in the immunotherapy group were living free of cancer compared to 46 percent in the standard treatment group. Overall survival improved significantly as well. The trial patient randomization was halted early because of the benefit seen, and all patients enrolled in the trial will receive immunotherapy plus standard treatment.
Yu noted that the two-year mark is especially important because past trials have shown that those neuroblastoma patients who live without disease for two years after a stem cell transplant will most likely be cured.
"This is the first time in many years that we have been able to improve the 'cure rate' for neuroblastoma patients," she said. "This new therapy can help us improve care and perhaps offer new hope to many patients and families."
Yu and her team conducted the early phase I and phase II trials at the General Clinical Research Center at UC San Diego Medical Center.
Other co-authors include Andrew Gilman, Carolinas Medical Centre; M. Fevzi Ozkaynak, New York Medical College; Susan Cohn, University of Chicago; John Maris, Children's Hospital of Philadelphia; Paul Sondel, University of Wisconsin; W. B. London, University of Florida; S. Kreissman, Duke University; H.X. Chen, National Cancer Institute; and K.K. Matthay, UCSD. Local patients were seen in San Diego at Rady Children's Hospital.
Source:
Steve Benowitz
University of California - San Diego
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"This establishes a new standard of care for a traditionally very difficult cancer in children," said lead author Alice Yu, MD, PhD, professor of pediatric hematology/oncology at the University of California, San Diego School of Medicine and the Moores UCSD Cancer Center. "High-risk neuroblastoma has always been a frustrating cancer to treat because, despite aggressive therapy, it has a high relapse rate."
The therapy targets a specific glycan (a complex sugar chain found on the surface of cells) on neuroblastoma cells called GD2, which inhibit the immune system from killing cancer cells. The antibody - ch14.18 - binds to this glycan, enabling various types of immune cells to attack the cancer.
Neuroblastoma - in which the cancer cells arise from nerve cells in the neck, chest, or abdomen - is the most common cancer diagnosed in the first year of life. Approximately 650 new cases of neuroblastoma are diagnosed in this country every year, and about 40 percent of patients have high-risk neuroblastoma. These high-risk patients are usually treated with surgery, intensive chemotherapy with stem cell rescue (in which patients' adult stem cells, removed before treatment, are returned after chemotherapy to restore the blood and immune system), and radiation therapy. Still, only 30 percent of patients survive.
Yu and her colleagues compared both the percentage of patients who were still alive without experiencing a recurrence after two years as well as overall survival in two groups of 113 patients each. Patients began the trial when they were newly diagnosed with high-risk neuroblastoma. After conventional treatment with surgery, chemotherapy, stem cell rescue and radiotherapy, one group was given the standard treatment (retinoic acid) plus immunotherapy (the antibody plus immune-boosting substances), while 113 similar patients received the standard treatment alone.
After two years, 66 percent of individuals in the immunotherapy group were living free of cancer compared to 46 percent in the standard treatment group. Overall survival improved significantly as well. The trial patient randomization was halted early because of the benefit seen, and all patients enrolled in the trial will receive immunotherapy plus standard treatment.
Yu noted that the two-year mark is especially important because past trials have shown that those neuroblastoma patients who live without disease for two years after a stem cell transplant will most likely be cured.
"This is the first time in many years that we have been able to improve the 'cure rate' for neuroblastoma patients," she said. "This new therapy can help us improve care and perhaps offer new hope to many patients and families."
Yu and her team conducted the early phase I and phase II trials at the General Clinical Research Center at UC San Diego Medical Center.
Other co-authors include Andrew Gilman, Carolinas Medical Centre; M. Fevzi Ozkaynak, New York Medical College; Susan Cohn, University of Chicago; John Maris, Children's Hospital of Philadelphia; Paul Sondel, University of Wisconsin; W. B. London, University of Florida; S. Kreissman, Duke University; H.X. Chen, National Cancer Institute; and K.K. Matthay, UCSD. Local patients were seen in San Diego at Rady Children's Hospital.
Source:
Steve Benowitz
University of California - San Diego
Physicians Offer Practical Tips On Preventing Strokes And Their Lasting Effects
It takes less than a minute for a stroke to change a person's life forever, but taking the time to make a few simple lifestyle adjustments and finding out how to recognize an attack when... it happens can save thousands of lives.
"It is the third leading cause of death in the United States and the leading cause of adult disabilities, but more than half of all strokes can be prevented," says Dr. Matthew Fink, chief of the Division of Stroke and Critical Care Neurology at NewYork-Presbyterian Hospital/Weill Cornell Medical Center.
These few lifestyle changes can greatly reduce anyone's chances of having a stroke:
- Reduce salt intake. High blood pressure is one of the leading causes of stroke. Cutting back on salt is one of the most significant steps to maintaining or lowering your blood pressure to a healthy level of 120/80 or below. Try flavoring your food with a variety of spices that may be healthier than salt.
- Eat a heart-healthy diet. Maintaining a healthy balance between your good cholesterol (HDL) and bad cholesterol (LDL) is the best way to prevent high cholesterol, heart disease and the increased risk of stroke. Your cholesterol level should remain at 200 mg/dl or below.
- Stop smoking. Smoking is not only bad for your lungs, it is bad for your brain, too. A smoker is at twice the risk of having a stroke because smoking damages blood vessels, raises blood pressure and speeds up the clogging of arteries.
- Exercise. If you are obese or overweight, your risk factors for high cholesterol, high blood pressure and diabetes increases and so does your risk for a stroke. Extra weight places an added strain on your entire circulatory system, but aerobic exercise can be a good way to lose those extra pounds and substantially improve your health.
However, there are certain populations that are still at higher risk of having a stroke even after making the proper lifestyle changes. These include adults 55 years of age or older, African-Americans and Hispanics, those with a family history of stroke, and people who have already had an attack or a transient ischemic attack (mini stroke). In addition, women are more likely to die from a stroke than men, although attacks are more common in men.
"When someone does have a stroke they may experience either slight or extremely noticeable physical changes. The most effective way to prevent the permanent damage associated with stroke is to recognize the signs of an attack and to seek medical attention immediately," says Dr. Randolph Marshall, director of the Stroke Division at NewYork-Presbyterian Hospital/Columbia University Medical Center.
The most common signs of a stroke are:
- Numbness. A sudden numbness or weakness in the face, arms or legs -- specifically on one side of the body.
- Trouble Speaking. A feeling of confusion and slurred speech or trouble speaking.
- Loss of Balance. Dizziness and trouble walking.
- Poor Eyesight. A loss of vision in one or both of the eyes.
- Headache. A sudden headache that occurs for no apparent reason.
"Eighty percent of all strokes are caused by a blood clot that blocks blood flow to the brain. Today there are many new drugs and techniques that when applied during the early onset of an attack can prevent, and in some cases reverse, the damage caused by these blockages," says Dr. Philip Stieg, chairman of the Department of Neurological Surgery and neurosurgeon-in-chief at NewYork-Presbyterian Hospital/Weill Cornell Medical Center.
Some of the most popular techniques include:
- Revascularization. Tiny micro catheters such as the Merci Retriever and the Penumbra System are inserted into the artery and used to remove the blockages and reopen the artery.
- Clot-Dissolving Drugs. Tissue Plasminogen Activator (t-PA) is a commonly used clot-dissolving drug that is injected into the artery and dissolves the clot, restoring blood flow to the brain. This procedure is most effective when used immediately following an attack.
Source
NewYork-Presbyterian Hospital
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"It is the third leading cause of death in the United States and the leading cause of adult disabilities, but more than half of all strokes can be prevented," says Dr. Matthew Fink, chief of the Division of Stroke and Critical Care Neurology at NewYork-Presbyterian Hospital/Weill Cornell Medical Center.
These few lifestyle changes can greatly reduce anyone's chances of having a stroke:
- Reduce salt intake. High blood pressure is one of the leading causes of stroke. Cutting back on salt is one of the most significant steps to maintaining or lowering your blood pressure to a healthy level of 120/80 or below. Try flavoring your food with a variety of spices that may be healthier than salt.
- Eat a heart-healthy diet. Maintaining a healthy balance between your good cholesterol (HDL) and bad cholesterol (LDL) is the best way to prevent high cholesterol, heart disease and the increased risk of stroke. Your cholesterol level should remain at 200 mg/dl or below.
- Stop smoking. Smoking is not only bad for your lungs, it is bad for your brain, too. A smoker is at twice the risk of having a stroke because smoking damages blood vessels, raises blood pressure and speeds up the clogging of arteries.
- Exercise. If you are obese or overweight, your risk factors for high cholesterol, high blood pressure and diabetes increases and so does your risk for a stroke. Extra weight places an added strain on your entire circulatory system, but aerobic exercise can be a good way to lose those extra pounds and substantially improve your health.
However, there are certain populations that are still at higher risk of having a stroke even after making the proper lifestyle changes. These include adults 55 years of age or older, African-Americans and Hispanics, those with a family history of stroke, and people who have already had an attack or a transient ischemic attack (mini stroke). In addition, women are more likely to die from a stroke than men, although attacks are more common in men.
"When someone does have a stroke they may experience either slight or extremely noticeable physical changes. The most effective way to prevent the permanent damage associated with stroke is to recognize the signs of an attack and to seek medical attention immediately," says Dr. Randolph Marshall, director of the Stroke Division at NewYork-Presbyterian Hospital/Columbia University Medical Center.
The most common signs of a stroke are:
- Numbness. A sudden numbness or weakness in the face, arms or legs -- specifically on one side of the body.
- Trouble Speaking. A feeling of confusion and slurred speech or trouble speaking.
- Loss of Balance. Dizziness and trouble walking.
- Poor Eyesight. A loss of vision in one or both of the eyes.
- Headache. A sudden headache that occurs for no apparent reason.
"Eighty percent of all strokes are caused by a blood clot that blocks blood flow to the brain. Today there are many new drugs and techniques that when applied during the early onset of an attack can prevent, and in some cases reverse, the damage caused by these blockages," says Dr. Philip Stieg, chairman of the Department of Neurological Surgery and neurosurgeon-in-chief at NewYork-Presbyterian Hospital/Weill Cornell Medical Center.
Some of the most popular techniques include:
- Revascularization. Tiny micro catheters such as the Merci Retriever and the Penumbra System are inserted into the artery and used to remove the blockages and reopen the artery.
- Clot-Dissolving Drugs. Tissue Plasminogen Activator (t-PA) is a commonly used clot-dissolving drug that is injected into the artery and dissolves the clot, restoring blood flow to the brain. This procedure is most effective when used immediately following an attack.
Source
NewYork-Presbyterian Hospital
Study Shows Relationship Between Atrial Fibrillation And Development Of Alzheimer's Disease
Researchers at Intermountain Medical Center in Salt Lake City believe that they have made a breakthrough connection between atrial fibrillation, a fairly common heart rhythm disorder, and... Alzheimer's disease, the leading form of dementia among Americans.
In a study presented May 15, at "Heart Rhythm 2009," the annual scientific sessions of the Heart Rhythm Society in Boston, researchers unveiled findings from the study of more than 37,000 patients that showed a strong relationship between atrial fibrillation and the development of Alzheimer's disease.
The study, which drew upon information from the Intermountain Heart Collaborative Study, a vast database from hundreds of thousands of patients treated at Intermountain Healthcare hospitals, found:
* Patients with atrial fibrillation were 44 percent more likely to develop dementia than patients without the heart disorder.
* Younger patients with atrial fibrillation were at higher risk of developing all types of dementia, particularly Alzheimer's. Atrial fibrillation patients under age 70 were 130 percent more likely to develop Alzheimer's.
* Patients who have both atrial fibrillation and dementia were 61 percent more likely to die during the study period than dementia patients without the rhythm problem.
* Younger atrial fibrillation patients with dementia may be at higher risk of death than older AF patients with dementia.
Intermountain Medical Center cardiologist T. Jared Bunch, M.D., the study's lead researcher, presented the findings at the scientific session.
"Previous studies have shown that patients with atrial fibrillation are at higher risk for some types of dementia, including vascular dementia. But to our knowledge, this is the first large-population study to clearly show that having atrial fibrillation puts patients at greater risk for developing Alzheimer's disease," said Dr. Bunch.
Alzheimer's is a devastating brain disease affecting approximately 5.3 million Americans. It is the most common form of dementia (a general term for life-altering loss of memory and other cognitive abilities), and accounts for 60-80 percent of all dementia cases. Today, it is the sixth leading cause of death in the United States.
Currently, the known risk factors for Alzheimer's are age, family history and genetics, though injury may also be linked with the disease. Heart health has long been suspected to play a role, but has not been linked. The Intermountain Medical Center study bolsters that connection.
"The study shows a connection between atrial fibrillation and all types of dementia," said Bunch. "The Alzheimer's findings - particularly the risk of death for younger patients - break new ground."
Atrial fibrillation is the most common heart rhythm problem, affecting about 2.2 million Americans. It occurs when the heart beats chaotically, leading blood to pool and possibly clot. If the clot leaves the heart, a stroke can result.
The Intermountain Medical Center study looked at five years of data for 37,025 patients. Of that group, 10,161 developed AF and 1,535 developed dementia during the study period.
The study authors say more research is needed to explore further the relationship between atrial fibrillation and the development of Alzheimer's disease.
"Now that we've established this link, our focus will be to see if early treatment of atrial fibrillation can prevent dementia or the development of Alzheimer's disease," says cardiologist John Day, M.D., director of heart rhythm services at Intermountain Medical Center and a co-author of the study.
Source:
Jess Gomez
Intermountain Medical Center
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In a study presented May 15, at "Heart Rhythm 2009," the annual scientific sessions of the Heart Rhythm Society in Boston, researchers unveiled findings from the study of more than 37,000 patients that showed a strong relationship between atrial fibrillation and the development of Alzheimer's disease.
The study, which drew upon information from the Intermountain Heart Collaborative Study, a vast database from hundreds of thousands of patients treated at Intermountain Healthcare hospitals, found:
* Patients with atrial fibrillation were 44 percent more likely to develop dementia than patients without the heart disorder.
* Younger patients with atrial fibrillation were at higher risk of developing all types of dementia, particularly Alzheimer's. Atrial fibrillation patients under age 70 were 130 percent more likely to develop Alzheimer's.
* Patients who have both atrial fibrillation and dementia were 61 percent more likely to die during the study period than dementia patients without the rhythm problem.
* Younger atrial fibrillation patients with dementia may be at higher risk of death than older AF patients with dementia.
Intermountain Medical Center cardiologist T. Jared Bunch, M.D., the study's lead researcher, presented the findings at the scientific session.
"Previous studies have shown that patients with atrial fibrillation are at higher risk for some types of dementia, including vascular dementia. But to our knowledge, this is the first large-population study to clearly show that having atrial fibrillation puts patients at greater risk for developing Alzheimer's disease," said Dr. Bunch.
Alzheimer's is a devastating brain disease affecting approximately 5.3 million Americans. It is the most common form of dementia (a general term for life-altering loss of memory and other cognitive abilities), and accounts for 60-80 percent of all dementia cases. Today, it is the sixth leading cause of death in the United States.
Currently, the known risk factors for Alzheimer's are age, family history and genetics, though injury may also be linked with the disease. Heart health has long been suspected to play a role, but has not been linked. The Intermountain Medical Center study bolsters that connection.
"The study shows a connection between atrial fibrillation and all types of dementia," said Bunch. "The Alzheimer's findings - particularly the risk of death for younger patients - break new ground."
Atrial fibrillation is the most common heart rhythm problem, affecting about 2.2 million Americans. It occurs when the heart beats chaotically, leading blood to pool and possibly clot. If the clot leaves the heart, a stroke can result.
The Intermountain Medical Center study looked at five years of data for 37,025 patients. Of that group, 10,161 developed AF and 1,535 developed dementia during the study period.
The study authors say more research is needed to explore further the relationship between atrial fibrillation and the development of Alzheimer's disease.
"Now that we've established this link, our focus will be to see if early treatment of atrial fibrillation can prevent dementia or the development of Alzheimer's disease," says cardiologist John Day, M.D., director of heart rhythm services at Intermountain Medical Center and a co-author of the study.
Source:
Jess Gomez
Intermountain Medical Center
Formulations Of Three Aspirin Types Compared By Study
For many years, it has been known that aspirin is beneficial to patients suffering heart attacks and near-heart attacks. But which of the many different types of.. aspirin is likely to help the most?
A group of researchers led by Dr. Sean Nordt from the University of California, San Diego gave three different types of aspirin to a group of volunteer research subjects: regular aspirin swallowed whole, regular aspirin chewed and swallowed, and chewable aspirin chewed and swallowed. Blood levels of aspirin were then measured, to see which route led to the highest aspirin levels in the body.
The chewable aspirin consistently showed greater and more rapid absorption than the regular aspirin, whether swallowed whole or chewed. This seemingly quite simple finding could lead to improvements in the care of heart attack patients.
The presentation, entitled "Comparison Of Three Aspirin Formulations" was given by Dr. Sean Nordt in the Cardiovascular forum at the 2009 SAEM Annual Meeting at the Sheraton New Orleans on May 15. Abstracts are published in Vol. 16, No. 4, Supplement 1, April 2009 of Academic Emergency Medicine, the official journal of the Society for Academic Emergency Medicine.
Source:
Sean Wagner
Wiley-Blackwell
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A group of researchers led by Dr. Sean Nordt from the University of California, San Diego gave three different types of aspirin to a group of volunteer research subjects: regular aspirin swallowed whole, regular aspirin chewed and swallowed, and chewable aspirin chewed and swallowed. Blood levels of aspirin were then measured, to see which route led to the highest aspirin levels in the body.
The chewable aspirin consistently showed greater and more rapid absorption than the regular aspirin, whether swallowed whole or chewed. This seemingly quite simple finding could lead to improvements in the care of heart attack patients.
The presentation, entitled "Comparison Of Three Aspirin Formulations" was given by Dr. Sean Nordt in the Cardiovascular forum at the 2009 SAEM Annual Meeting at the Sheraton New Orleans on May 15. Abstracts are published in Vol. 16, No. 4, Supplement 1, April 2009 of Academic Emergency Medicine, the official journal of the Society for Academic Emergency Medicine.
Source:
Sean Wagner
Wiley-Blackwell
Heating Heart With Catheter Better Than Drugs For Common Heart Rhythm Disorder
Treating a common heart rhythm disorder by burning heart tissue with a catheter works dramatically better than drug treatments, a major international study has found.
One year after undergoing a treatment called catheter ablation, 63 percent of patients with an irregular heartbeat called atrial fibrillation were free of any recurrent atrial arrhythmias or symptoms. By comparison, only 17 percent of those treated with drugs were arrhythmia-free. Results were so convincing the trial was halted early.
The ablation group also scored significantly higher on a quality-of-life scale.
The study included 167 patients at 19 centers, including 15 centers in the United States. Lead researcher Dr. David Wilber presented results at Heart Rhythm 2009, the Society's 30th Annual Scientific Sessions. Wilber is director of the Cardiovascular Institute at Loyola University Stritch School of Medicine in Maywood, Il.
Atrial fibrillation, often called A-Fib, is the most common form of irregular heartbeat. Electrical signals, which regulate the heartbeat, become erratic. Instead of beating regularly, the upper chambers of the heart quiver. Not all the blood gets pumped out, so clots can form. Atrial fibrillation can lead to strokes and heart failure.
A-Fib patient Robin Drabant, 35, of Hanover Park, Il., said the condition once "made me feel like I was 90 years old with a failing heart." She was on a maximum dose of an A-Fib medication, which caused fatigue. Despite the drug, she still had episodes almost every day, lasting from 10 seconds to an hour or longer. "I would lose my breath and could feel my heart racing and fluttering," she said.
Wilber performed a catheter ablation on Drabant in May, 2008, and she no longer has A-Fib episodes. "I had great results," she said.
A-Fib symptoms include heart palpitations, dizziness, fatigue, shortness of breath and fainting. "A lot of people are disabled," Wilber said. "They have no energy. They can't work. They have a very poor quality of life."
More than 2 million Americans have atrial fibrillation, and there are about 160,000 new cases each year. The number is increasing, due in part to the aging population and the obesity epidemic.
Drugs such as beta blockers and calcium channel blockers can slow the heart rate during an A-Fib episode. Other drugs such as flecainide and propafenone can help maintain a normal rhythm. When drugs don't work or produce unacceptable side effects, alternative treatments include a pacemaker, surgery and catheter ablation.
In the ablation procedure, an electrophysiologist destroys small areas of heart tissue that are responsible for the erratic electrical signals. A catheter (thin flexible tube) is guided through blood vessels to the heart. The tip of the catheter delivers radiofrequency energy that heats and destroys tissue. Possible adverse effects include irritation of the lining of the heart, fluid in the lungs or around the heart, bleeding, clots and stroke.
In the study, 106 patients with frequent episodes of atrial fibrillation were randomly assigned to undergo ablation and 61 similar patients were randomly assigned to receive drug therapy. All patients had experienced at least three episodes of atrial fibrillation during the previous six months and had failed at least one attempt to control the rhythm with drugs.
The study was funded by Biosense Webster, which makes the ThermoCool catheter used in the trial. Wilber is a consultant to the company.
The study was the largest to date to compare ablation to drug therapy for atrial fibrillation. Earlier studies involved single centers and smaller sample sizes, Wilber said. An additional study called CABANA is designed to determine whether ablation patients live longer than patients receiving medication. Researchers will follow about 3,000 patients for three years.
Heart Rhythm 2009 May 13-16 at the Boston Exhibition and Convention Center.
Source:
Jim Ritter
Loyola University Health System
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One year after undergoing a treatment called catheter ablation, 63 percent of patients with an irregular heartbeat called atrial fibrillation were free of any recurrent atrial arrhythmias or symptoms. By comparison, only 17 percent of those treated with drugs were arrhythmia-free. Results were so convincing the trial was halted early.
The ablation group also scored significantly higher on a quality-of-life scale.
The study included 167 patients at 19 centers, including 15 centers in the United States. Lead researcher Dr. David Wilber presented results at Heart Rhythm 2009, the Society's 30th Annual Scientific Sessions. Wilber is director of the Cardiovascular Institute at Loyola University Stritch School of Medicine in Maywood, Il.
Atrial fibrillation, often called A-Fib, is the most common form of irregular heartbeat. Electrical signals, which regulate the heartbeat, become erratic. Instead of beating regularly, the upper chambers of the heart quiver. Not all the blood gets pumped out, so clots can form. Atrial fibrillation can lead to strokes and heart failure.
A-Fib patient Robin Drabant, 35, of Hanover Park, Il., said the condition once "made me feel like I was 90 years old with a failing heart." She was on a maximum dose of an A-Fib medication, which caused fatigue. Despite the drug, she still had episodes almost every day, lasting from 10 seconds to an hour or longer. "I would lose my breath and could feel my heart racing and fluttering," she said.
Wilber performed a catheter ablation on Drabant in May, 2008, and she no longer has A-Fib episodes. "I had great results," she said.
A-Fib symptoms include heart palpitations, dizziness, fatigue, shortness of breath and fainting. "A lot of people are disabled," Wilber said. "They have no energy. They can't work. They have a very poor quality of life."
More than 2 million Americans have atrial fibrillation, and there are about 160,000 new cases each year. The number is increasing, due in part to the aging population and the obesity epidemic.
Drugs such as beta blockers and calcium channel blockers can slow the heart rate during an A-Fib episode. Other drugs such as flecainide and propafenone can help maintain a normal rhythm. When drugs don't work or produce unacceptable side effects, alternative treatments include a pacemaker, surgery and catheter ablation.
In the ablation procedure, an electrophysiologist destroys small areas of heart tissue that are responsible for the erratic electrical signals. A catheter (thin flexible tube) is guided through blood vessels to the heart. The tip of the catheter delivers radiofrequency energy that heats and destroys tissue. Possible adverse effects include irritation of the lining of the heart, fluid in the lungs or around the heart, bleeding, clots and stroke.
In the study, 106 patients with frequent episodes of atrial fibrillation were randomly assigned to undergo ablation and 61 similar patients were randomly assigned to receive drug therapy. All patients had experienced at least three episodes of atrial fibrillation during the previous six months and had failed at least one attempt to control the rhythm with drugs.
The study was funded by Biosense Webster, which makes the ThermoCool catheter used in the trial. Wilber is a consultant to the company.
The study was the largest to date to compare ablation to drug therapy for atrial fibrillation. Earlier studies involved single centers and smaller sample sizes, Wilber said. An additional study called CABANA is designed to determine whether ablation patients live longer than patients receiving medication. Researchers will follow about 3,000 patients for three years.
Heart Rhythm 2009 May 13-16 at the Boston Exhibition and Convention Center.
Source:
Jim Ritter
Loyola University Health System
PLC Medical Systems To Demonstrate RenalGuard(R) At EuroPCR 2009
PLC Systems Inc. (OTC Bulletin Board: PLCSF), a company focused on innovative cardiac and vascular medical device-based technologies, announced that it will demonstrate its RenalGuard System(TM) at EuroPCR, the annual meeting of... the European Association of Percutaneous Cardiovascular Interventions (EAPCI), May 19-22, 2009, in Barcelona, Spain. More than 11,000 clinicians and professionals are expected to attend this event.
In addition, RenalGuard(R) will be included as part of a live case transmission from Hospital Clinico San Carlos, Madrid, Spain during the meeting. The interventional cardiologists involved in the case plan to demonstrate how RenalGuard is used to help prevent Contrast-Induced Nephropathy (CIN) in a patient with impaired renal function undergoing a Percutaneous Coronary Intervention (PCI).
"Following the spirit of EuroPCR, our commitment during these live cases is to provide valuable clinical education to EuroPCR attendees," stated Dr. Javier Escaned, Consultant Interventional Cardiologist, Hospital Clinico. "I consider that creating awareness of the problem of CIN and disseminating new information on how to prevent it are very important."
Mark R. Tauscher, president and chief executive officer of PLC Systems, said, "We are very pleased to be presenting RenalGuard to this important audience, and especially pleased that Dr. Escaned will be demonstrating a live case illustrating how RenalGuard works and how it may benefit patients. CIN is a significant and growing concern worldwide, and we are very encouraged by the prospect that RenalGuard could remedy it."
Currently, RenalGuard is the subject of an investigator-sponsored trial to study its efficacy in mitigating against CIN at the University of Milan-Centro Cardiologico Monzino (CCM). The trial is designed to provide an assessment of the potential benefits of induced diuresis with matched hydration therapy compared to standard overnight hydration, a prevalent method of treatment in the EU, in the prevention of CIN in patients undergoing cardiac catheterization procedures and percutaneous coronary interventions with baseline impairment in renal function. The CIN-prevention therapy of induced diuresis and matched hydration therapy will be provided using RenalGuard.
PLC received the CE Mark Certificate for the RenalGuard System in December 2007, and concluded its pilot safety trial in the U.S. late in 2007. The company has received full approval from the FDA to commence a U.S. pivotal trial to study the effectiveness of RenalGuard in the prevention of CIN. In March 2008, PLC signed its first international distribution agreement for RenalGuard with Artech s.r.l., Cavezzo, Italy for distribution of its RenalGuard System into Italy, and in May 2009, PLC announced its second European distributor, IZASA Distribuciones Tecnicas S.A., headquartered in Barcelona, Spain, for the distribution of RenalGuard in Spain.
About PLC Systems Inc.
PLC Systems Inc. is a medical technology company specializing in innovative technologies for the cardiac and vascular markets. Headquartered in Franklin, Massachusetts, PLC pioneered the CO2 Heart Laser System, which cardiac surgeons use to perform CO2 transmyocardial revascularization (TMR) to alleviate symptoms of severe angina. PLC's newest product, RenalGuard, is approved for sale in the EU as a general fluid balancing device.
This press release contains "forward-looking" statements. For this purpose, any statements contained in this press release that relate to prospective events or developments are deemed to be forward-looking statements. Words such as "believes," "anticipates," "plans," "expects," "will" and similar expressions are intended to identify forward-looking statements. Our statements of our objectives are also forward-looking statements. While we may elect to update forward-looking statements in the future, we specifically disclaim any obligation to do so, even if our estimates change, and you should not rely on these forward-looking statements as representing our views as of any date subsequent to the date of this press release. Actual results could differ materially from those indicated by such forward-looking statements as a result of a variety of important factors, including that we may not receive necessary regulatory approvals to market our RenalGuard product or that such approvals may be withdrawn, we may be unable to raise sufficient funds in the future to implement our business plan and/or commence our planned U.S. clinical trial for RenalGuard, the current clinical trial in Italy and the planned future U.S. clinical trial for RenalGuard as a safe and effective prevention device for contrast induced nephropathy may not be completed in a timely fashion, if at all, or, if these clinical trials are completed, they may not produce clinically significant or meaningful results, the RenalGuard product may not be commercially accepted, operational changes, competitive developments may affect the market for our products, regulatory approval requirements may affect the market for our products, and additional risk factors described in the "Forward Looking Statements" section of our Annual Report on Form 10-K for the year ended December 31, 2008, and our other SEC reports.
PLC Systems, PLC Medical Systems, PLC and CO2 Heart Laser, RenalGuard and RenalGuard System are trademarks of PLC Systems Inc.
Source: PLC Systems Inc
Read More..
In addition, RenalGuard(R) will be included as part of a live case transmission from Hospital Clinico San Carlos, Madrid, Spain during the meeting. The interventional cardiologists involved in the case plan to demonstrate how RenalGuard is used to help prevent Contrast-Induced Nephropathy (CIN) in a patient with impaired renal function undergoing a Percutaneous Coronary Intervention (PCI).
"Following the spirit of EuroPCR, our commitment during these live cases is to provide valuable clinical education to EuroPCR attendees," stated Dr. Javier Escaned, Consultant Interventional Cardiologist, Hospital Clinico. "I consider that creating awareness of the problem of CIN and disseminating new information on how to prevent it are very important."
Mark R. Tauscher, president and chief executive officer of PLC Systems, said, "We are very pleased to be presenting RenalGuard to this important audience, and especially pleased that Dr. Escaned will be demonstrating a live case illustrating how RenalGuard works and how it may benefit patients. CIN is a significant and growing concern worldwide, and we are very encouraged by the prospect that RenalGuard could remedy it."
Currently, RenalGuard is the subject of an investigator-sponsored trial to study its efficacy in mitigating against CIN at the University of Milan-Centro Cardiologico Monzino (CCM). The trial is designed to provide an assessment of the potential benefits of induced diuresis with matched hydration therapy compared to standard overnight hydration, a prevalent method of treatment in the EU, in the prevention of CIN in patients undergoing cardiac catheterization procedures and percutaneous coronary interventions with baseline impairment in renal function. The CIN-prevention therapy of induced diuresis and matched hydration therapy will be provided using RenalGuard.
PLC received the CE Mark Certificate for the RenalGuard System in December 2007, and concluded its pilot safety trial in the U.S. late in 2007. The company has received full approval from the FDA to commence a U.S. pivotal trial to study the effectiveness of RenalGuard in the prevention of CIN. In March 2008, PLC signed its first international distribution agreement for RenalGuard with Artech s.r.l., Cavezzo, Italy for distribution of its RenalGuard System into Italy, and in May 2009, PLC announced its second European distributor, IZASA Distribuciones Tecnicas S.A., headquartered in Barcelona, Spain, for the distribution of RenalGuard in Spain.
About PLC Systems Inc.
PLC Systems Inc. is a medical technology company specializing in innovative technologies for the cardiac and vascular markets. Headquartered in Franklin, Massachusetts, PLC pioneered the CO2 Heart Laser System, which cardiac surgeons use to perform CO2 transmyocardial revascularization (TMR) to alleviate symptoms of severe angina. PLC's newest product, RenalGuard, is approved for sale in the EU as a general fluid balancing device.
This press release contains "forward-looking" statements. For this purpose, any statements contained in this press release that relate to prospective events or developments are deemed to be forward-looking statements. Words such as "believes," "anticipates," "plans," "expects," "will" and similar expressions are intended to identify forward-looking statements. Our statements of our objectives are also forward-looking statements. While we may elect to update forward-looking statements in the future, we specifically disclaim any obligation to do so, even if our estimates change, and you should not rely on these forward-looking statements as representing our views as of any date subsequent to the date of this press release. Actual results could differ materially from those indicated by such forward-looking statements as a result of a variety of important factors, including that we may not receive necessary regulatory approvals to market our RenalGuard product or that such approvals may be withdrawn, we may be unable to raise sufficient funds in the future to implement our business plan and/or commence our planned U.S. clinical trial for RenalGuard, the current clinical trial in Italy and the planned future U.S. clinical trial for RenalGuard as a safe and effective prevention device for contrast induced nephropathy may not be completed in a timely fashion, if at all, or, if these clinical trials are completed, they may not produce clinically significant or meaningful results, the RenalGuard product may not be commercially accepted, operational changes, competitive developments may affect the market for our products, regulatory approval requirements may affect the market for our products, and additional risk factors described in the "Forward Looking Statements" section of our Annual Report on Form 10-K for the year ended December 31, 2008, and our other SEC reports.
PLC Systems, PLC Medical Systems, PLC and CO2 Heart Laser, RenalGuard and RenalGuard System are trademarks of PLC Systems Inc.
Source: PLC Systems Inc
FDA Tells Cheerios Cereal Makers Their Health Claims Contain "Serious Violations"
The US Food and Drug Administration has written a warning letter to General Mills, the makers of the popular breakfast cereal Cheerios, explaining that they have reviewed the labelling of the product and found it contains "serious violations" of federal regulations.
The details of the FDA findings are in a letter dated May 5th, from W Charles Becoat, FDA Director for the Minneapolis District, to... Ken Powell, Chairman and CEO of Minneapolis-based General Mills, who make Cheerios.
According to the FDA, General Mills is breaking federal regulations on two counts: they are marketing Cheerios like an "unapproved new drug" and misbranding the product by making "unauthorized health claims".
The FDA letter to the food company states:
"FDA's review found serious violations of the Federal Food, Drug, and Cosmetic Act (the Act) and the applicable regulations in Title 21, Code of Federal Regulations (21 CFR)."
The FDA said that the Cheerios product label promotes it like a drug intended for use in the "prevention, mitigation, and treatment of disease". The letter drew particular attention to phrases that say the product lowers cholesterol by "4 per cent in 6 weeks", that it can also reduce bad cholesterol by 4 per cent, and that it is "clinical proven" to lower cholesterol.
The letter does not address the veracity of the claims, it addresses the point that by making such claims then the product is really a drug and should go through the proper channels for obtaining drug approval.
For example, as the letter explains, the claims indicate that Cheerios is:
"Intended for use in lowering cholesterol, and therefore in preventing, mitigating, and treating the disease hypercholesterolemia."
And by claiming that the product lowers total and bad cholesterol, then it is also claiming to treat heart disease, for which total and bad (LDL) cholesterol are known risk factors. This is what puts the product in the "new drug" category, and the letter quotes several sections of "the Act" to support their case.
The FDA said another reason that the product is considered to be a "new drug" was because under another section of "the Act", it is "not generally recognized as safe and effective for use in preventing or treating hypercholesterolemia or coronary heart disease".
The letter acknowledged that General Mills had observed regulations correctly in respect of a health claim associating "soluble fiber from whole grain oats with a reduced risk of coronary heart disease", but the two claims about lowering cholesterol are not part of that, and goes into great detail about the positioning on the packet label and how the words are shown to make its case.
The FDA said that even if the cholesterol-lowering claim could be argued to be part of an otherwise permissible claim, the wording disqualifies it from use in the soluble fiber health claim.
On the issue of misbranding, the FDA said that Cheerios bears "unauthorized health claims in its labeling" and cites text on the company's website, which under the Act is considered to be part of the product labelling, as being faulty in this respect. The text says "heart-healthy diets rich in whole grain foods, can reduce the risk of heart disease."
According to the FDA, the claim does not meet the requirements of the Act which requires such assertions to state that "diets low in saturated fat and cholesterol and high in fiber-containing fruit, vegetable, and grain products may reduce the risk of heart disease". The Cheerios labelling neither mentions fruits, vegetables and fiber, nor the need for the diet to be low in saturated fat and cholesterol.
Thus the label does not have enough information to "enable the public to understand the significance of the claim in the context of the total daily diet," said the FDA letter.
The letter also refers to another labelling claim about reduction in cancer risk.
The FDA said the claim, which includes the statement "regular consumption of whole grains as part of, a low-fat diet reduces the risk for some cancers, especially cancers of the stomach and colon", fails to meet the authorized format because, for example, like the other claim, it does not mention fruits and vegetables and fiber content and again denies the public the chance to see the overall context of the healthy diet.
The agency also takes issue with the added phrase "especially cancers of the stomach and colon" which goes beyond what an authorized claim is allowed to say. As the FDA letter explains:
"The claim authorized through the notification procedure does not emphasize the relationship between whole grain foods and stomach and colon cancer as compared to other cancers."
General Mills has 15 days to reply with an explanation of how they intend to "correct the violations" and to ensure that "similar violations do not occur".
Read More..
The details of the FDA findings are in a letter dated May 5th, from W Charles Becoat, FDA Director for the Minneapolis District, to... Ken Powell, Chairman and CEO of Minneapolis-based General Mills, who make Cheerios.
According to the FDA, General Mills is breaking federal regulations on two counts: they are marketing Cheerios like an "unapproved new drug" and misbranding the product by making "unauthorized health claims".
The FDA letter to the food company states:
"FDA's review found serious violations of the Federal Food, Drug, and Cosmetic Act (the Act) and the applicable regulations in Title 21, Code of Federal Regulations (21 CFR)."
The FDA said that the Cheerios product label promotes it like a drug intended for use in the "prevention, mitigation, and treatment of disease". The letter drew particular attention to phrases that say the product lowers cholesterol by "4 per cent in 6 weeks", that it can also reduce bad cholesterol by 4 per cent, and that it is "clinical proven" to lower cholesterol.
The letter does not address the veracity of the claims, it addresses the point that by making such claims then the product is really a drug and should go through the proper channels for obtaining drug approval.
For example, as the letter explains, the claims indicate that Cheerios is:
"Intended for use in lowering cholesterol, and therefore in preventing, mitigating, and treating the disease hypercholesterolemia."
And by claiming that the product lowers total and bad cholesterol, then it is also claiming to treat heart disease, for which total and bad (LDL) cholesterol are known risk factors. This is what puts the product in the "new drug" category, and the letter quotes several sections of "the Act" to support their case.
The FDA said another reason that the product is considered to be a "new drug" was because under another section of "the Act", it is "not generally recognized as safe and effective for use in preventing or treating hypercholesterolemia or coronary heart disease".
The letter acknowledged that General Mills had observed regulations correctly in respect of a health claim associating "soluble fiber from whole grain oats with a reduced risk of coronary heart disease", but the two claims about lowering cholesterol are not part of that, and goes into great detail about the positioning on the packet label and how the words are shown to make its case.
The FDA said that even if the cholesterol-lowering claim could be argued to be part of an otherwise permissible claim, the wording disqualifies it from use in the soluble fiber health claim.
On the issue of misbranding, the FDA said that Cheerios bears "unauthorized health claims in its labeling" and cites text on the company's website, which under the Act is considered to be part of the product labelling, as being faulty in this respect. The text says "heart-healthy diets rich in whole grain foods, can reduce the risk of heart disease."
According to the FDA, the claim does not meet the requirements of the Act which requires such assertions to state that "diets low in saturated fat and cholesterol and high in fiber-containing fruit, vegetable, and grain products may reduce the risk of heart disease". The Cheerios labelling neither mentions fruits, vegetables and fiber, nor the need for the diet to be low in saturated fat and cholesterol.
Thus the label does not have enough information to "enable the public to understand the significance of the claim in the context of the total daily diet," said the FDA letter.
The letter also refers to another labelling claim about reduction in cancer risk.
The FDA said the claim, which includes the statement "regular consumption of whole grains as part of, a low-fat diet reduces the risk for some cancers, especially cancers of the stomach and colon", fails to meet the authorized format because, for example, like the other claim, it does not mention fruits and vegetables and fiber content and again denies the public the chance to see the overall context of the healthy diet.
The agency also takes issue with the added phrase "especially cancers of the stomach and colon" which goes beyond what an authorized claim is allowed to say. As the FDA letter explains:
"The claim authorized through the notification procedure does not emphasize the relationship between whole grain foods and stomach and colon cancer as compared to other cancers."
General Mills has 15 days to reply with an explanation of how they intend to "correct the violations" and to ensure that "similar violations do not occur".
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