Many cancer patients who have heart attacks often are not treated with life saving aspirin given the belief in the medical community that they could experience lethal bleeding. Researchers at The University of Texas M. D. Anderson Cancer Center, however, say that notion is now proven wrong and that without aspirin, the majority of these patients will die.
Researchers say that their study, to be published in the February 1, 2007 issue of the journal Cancer and now available online, turns common medical assumptions upside down and will likely change medical practice for cancer patients. Because aspirin can thin blood and cancer patients experience low platelet counts and abnormal clotting, physicians view aspirin as a relative contraindication. Given that blood platelets are responsible for the clotting process, physicians do not eagerly prescribe aspirin as a standard treatment.
In this study, however, the investigators found that 9 of 10 cancer patients with thrombocytopenia (low platelet count) who were experiencing a heart attack and who did not receive aspirin died, whereas only one patient died in a group of 17 similar cancer patients who received aspirin. They also found aspirin helps cancer patients with normal platelet count survive heart attacks, just as it does for people without cancer.
"The notion that heart attacks in patients with low platelets should be treated with clot-dissolving aspirin defies logic, that is unless you suspect that the cancer is interfering with platelet function," says the study's senior investigator and author, Jean-Bernard Durand, M.D., assistant professor in the Department of Cardiology at M. D. Anderson Cancer Center.
"We believe tumors may be releasing chemicals that allow the cancer to form new blood supplies which makes blood more susceptible to forming clots." Durand, a heart failure specialist, says. "There appears to be a platelet paradox suggesting that cancer may affect the mechanism of the way that blood clots, and from this analysis, we have found that the single most important predictor of survival in these patients is whether or not they received aspirin." Durand says more research is needed to better understand this contraindication.
According to the World Health Organization there are approximately 10 million cancer patients worldwide, of which 1.5 million may develop blood clots during their cancer treatment and, as such, are at a much higher risk of dying from heart disease if not treated properly. "Now that we have this study, it would be a travesty if you survive treatment for cancer only to die of a heart attack soon thereafter," Durand says.
According to Durand, no guidelines currently exist for treatment of heart attacks in patients with cancer. He says that physicians are especially perplexed about what to do for cancer patients with thrombosis (blood clots), a condition that affects about 15 percent of all cancer patients and can be due to the use of chemotherapy or the presence of cancer.
Durand came to M. D. Anderson in 2000 to start the Cardiomyopathy Services, which is believed to be the only program in the world specifically designed to look at cardiovascular complications caused by chemotherapy treatment. He is also the co-founder of CONQUER (Cardiology Oncology International Quest to Educate and Research Heart Failure in Cancer), a newly created organization with goals of increasing the success of chemotherapy by reducing cardiovascular disease as a barrier and long term risk.
He and anesthesiologist Mona Sarkiss, M.D., Ph.D., made the observation that patients with thrombocytopenia who suffered a heart attack and were being treated in the intensive care unit at M. D. Anderson tended to die more often when they were not given aspirin. However, they noted that some of the patients given aspirin and/or beta-blockers had "great" clinical outcomes. "Because no practice guidelines exist, physicians were treating their patients with great variability and the disparity was obvious," Durand says.
Sarkiss, who is the study's lead author, Durand, and a team of researchers which included investigators from Baylor College of Medicine and Duke University Medical Center, conducted a retrospective analysis of cancer patients treated for heart attacks at M. D. Anderson Cancer Center in 2001. These 70 patients were divided into two groups based on their platelet counts, and data was collected on the use of aspirin, bleeding complications, and survival.
They found that heart attack patients with low platelets who did not receive aspirin had a seven-day survival rate of 6 percent, compared with 90 percent survival in those who received aspirin. Dr. Durand notes that there were no severe bleeding complications in patients who used aspirin. Conversely, patients with low platelet counts who formed a blood clot and were not exposed to aspirin died.
The beneficial effect of aspirin also was seen in patients with normal platelet counts. Seven-day survival was 88 percent in aspirin-treated patients as compared to 45 percent in patients who did not receive aspirin, the researchers found.
Durand observed that these deaths rates are abnormally high. "In the non-cancer patient with acute coronary syndrome anywhere in the United States, an expected seven-day mortality is less than 1 percent," he says.
There were parallel findings for those patients in either group who were treated with beta-blockers, which block the heart's use of adrenalin. The protective effect was not as strong as seen with aspirin, but was still life saving.
In those patients with a normal platelet count, 91 percent survived seven days when treated with beta-blockers, whereas 36 percent survived if they were not treated with the agent. In the thrombocytopenic group, 73 percent survived seven days when treated with beta-blockers, whereas only 13 percent survived if they were not treated.
###
Investigators working with Durand and Sarkiss were: Andrew Shaw, M.D., from Duke; Nasser Lakkis, M.D. from Baylor; and S. Wamique Yusuf, M.D., Carla Warneke, M.D., Gregory Botz, M.D., Cheryl Hirsch-Ginsburg, M.D., J. Chris Champion, M.D., Joseph Swafford, M.D., and Daniel Lenihan, M.D., from M. D. Anderson.
Contact: Laura Sussman
University of Texas M. D. Anderson Cancer Center
Showing posts with label Heart. Show all posts
Showing posts with label Heart. Show all posts
April 15, 2007
Stem Cell Trial With Potential To Repair Hearts Damaged By Severe Coronary Artery Disease
Rush University Medical Center is one of the first medical centers in the country, and currently the only site in Illinois, participating in a novel clinical trial to determine if a subject's own stem cells can treat a form of severe coronary artery disease.
The Autologous Cellular Therapy CD34-Chronic Myocardial Ischemia (ACT34-CMI) Trial is the first human, Phase II adult stem cell therapy study in the U.S. designed to investigate the efficacy, tolerability, and safety of blood-derived selected CD34+ stem cells to improve symptoms and clinical outcomes in subjects with chronic myocardial ischemia (CMI), a severe form of coronary artery disease.
"What we're hoping is that these stem cells will be able to stimulate the growth of new blood vessels to bring more blood and oxygen to the heart muscle, so that these patients will have a better quality of life and less chest pain," said Dr. Gary Schaer, director of the Rush Cardiac Catheterization Lab and study investigator.
Myocardial ischemia is a serious heart condition that involves narrowing of coronary arteries and results in limited blood flow to the heart. The disease affects hundreds of thousands of new people each year. A person who suffers from chronic myocardial ischemia continues to experience insufficient flow of oxygen-rich blood to the heart despite optimum medical intervention.
The study is a randomized, double-blind, placebo-controlled study that involves adult subjects with severe coronary artery disease who are currently on the maximum medical therapy and who are not suitable candidates for conventional procedures to improve blood flow to the heart such as angioplasty, stents, or coronary artery bypass surgery.
Rush is one of 15 to 20 research sites nationwide participating in the study, which is sponsored by the Cellular Therapies business unit of Baxter Healthcare Corporation. Baxter technology is used to select the subject's own CD34+ stem cells that are under investigation in this trial.
The baseline frequency and severity of anginal episodes are established as a first step for all study subjects. Next, all subjects receive a series of subcutaneous injections (needle shots, typically delivered under the skin in the arm, thigh or abdomen) of a commercially produced protein (granulocyte colony stimulating factor). The protein helps to release CD34+ stem cells (also known as endothelial progenitor cells) from a subject's bone marrow into the bloodstream.
Then, investigators use a cell separation system, similar to the automated systems that are used with people who donate specific blood components such as platelets or red blood cells, to collect from the subject's bloodstream, an enriched preparation of cells that contain CD34+ stem cells. When this process, known as apheresis, is complete, technologists further process the collected stem cells with Baxter's ISOLEX 300i Magnetic Cell Selection System, currently approved for use with cancer patients, to select the subject's CD34+ stem cells for use in this investigational therapy.
Schaer then uses a catheter-based, non-surgical system to map the patient's heart three-dimensionally to identify the damaged areas into which the stem cells would be injected. "This targeted approach increases the treatment's effectiveness by delivering the stem cells exactly where they are needed." Schaer uses the Johnson & Johnson's NOGA XP Cardiac Navigation System to identify ischemic but viable regions of the heart as targets for cell delivery. The researchers then use a special investigational catheter that functions like a "global positioning system" to precisely deliver CD34+ cells, or placebo, into the areas of the heart that have been identified as having poor blood flow.
Subjects are randomly selected to receive either one of two dosing levels of CD34+ stem cells, or placebo. Rush researchers will conduct follow-up examinations for 12 months,
Researchers are encouraged by reports that the therapy appeared to be well-tolerated and no serious adverse events directly related to the stem cell therapy in an earlier study. According to preliminary, anecdotal patient reports, 16 of the 24 total Phase I study subjects reported feeling better with reductions in chest pain and improved exercise capacity during the early stage of the trial.
####
Coronary Artery Disease and Chronic Myocardial Ischemia
Coronary artery disease is the most common form of heart disease and is the leading cause of death in the United States. This condition occurs when the coronary arteries and the smaller vessels that supply oxygen-rich blood to the heart muscle become narrowed or blocke by plaque deposits and blood clots. Poor blood flow and blood clots "starve" and injure the heart muscle.
The American Heart Association estimates that every year, between 125,000 and 250,000 individuals with coronary artery disease develop chronic myocardial ischemia (CMI), one of the most severe forms of coronary artery disease, which can cause unstable angina, heart attacks and progressive heart failure when adequate blood flow is not restored. CMI develops when the coronary arteries become so diseased that they limit the flow of blood to the heart and send small blood clots downstream, blocking the small blood vessels in the heart. These blockages can result in a series of mini-heart attacks that, while they may be too small to notice at the time, in aggregate cause significant long-term damage to the heart muscle and disability to the patient. While cardiologists can restore blood flow in some cases, the heart muscle can be irreversibly damaged, leading to significant disability, progressive heart failure and often death.
What are stem cells?
Stem cells, which have the potential to develop into many different cell types in the body, act like a repair system for the body. They theoretically can divide without limit to replenish other cells as long as the person or animal is alive.
When a stem cell divides, each new cell has the potential either to remain a stem cell or become another type of cell with a more specialized function, such as a muscle cell, a red blood cell, or a brain cell.
Source: National Institutes of Health
To participate in the study
The trial is open to adult patients who have daily chest pain but are not suitable candidates for conventional procedures to improve blood flow to the heart, such as angioplasty, stents, or bypass surgery. Participants must be able to do a treadmill exercise test..
About the NOGA Navigation System
The NOGA system is the most advanced technology currently available on the market to create highly precise, 3-dimensional images of the heart. Based on these images, physicians are able to accurately identify tissue that could potentially benefit from a variety of targeted investigational therapies. Built on a proprietary magnetic reference system that operates like a global positioning system, the NOGA XP enables physicians to view the treatment area in a 3D reconstruction that represents real anatomy and provides accuracy of the site being mapped within 1 mm. These highly precise images assess heart tissue with pinpoint specificity, identifying areas for therapeutic targeting.
The innovative technology offers remarkably consistent and precise tissue characterization available, which has a significant importance for intramyocardial delivery of stem cells and genes in cardiac patients. Features such as reduced mapping time made possible by QWIKMAP Software and universal data portability that enable one to download the cardiac maps are vast improvements over existing technologies.
The NOGA XP Cardiac Navigation System is currently being used to map the heart in more than 17 ongoing clinical studies worldwide, investigating the use of adult stem cell and gene therapies to treat conditions such as congestive heart failure and chronic ischemia.
About Rush
Rush University Medical Center includes the 650-bed (staffed) hospital; the Johnston R. Bowman Health Center; and Rush University (Rush Medical College, College of Nursing, College of Health Sciences and the Graduate College).
Contact: Mary Ann Schultz
Rush University Medical Center
The Autologous Cellular Therapy CD34-Chronic Myocardial Ischemia (ACT34-CMI) Trial is the first human, Phase II adult stem cell therapy study in the U.S. designed to investigate the efficacy, tolerability, and safety of blood-derived selected CD34+ stem cells to improve symptoms and clinical outcomes in subjects with chronic myocardial ischemia (CMI), a severe form of coronary artery disease.
"What we're hoping is that these stem cells will be able to stimulate the growth of new blood vessels to bring more blood and oxygen to the heart muscle, so that these patients will have a better quality of life and less chest pain," said Dr. Gary Schaer, director of the Rush Cardiac Catheterization Lab and study investigator.
Myocardial ischemia is a serious heart condition that involves narrowing of coronary arteries and results in limited blood flow to the heart. The disease affects hundreds of thousands of new people each year. A person who suffers from chronic myocardial ischemia continues to experience insufficient flow of oxygen-rich blood to the heart despite optimum medical intervention.
The study is a randomized, double-blind, placebo-controlled study that involves adult subjects with severe coronary artery disease who are currently on the maximum medical therapy and who are not suitable candidates for conventional procedures to improve blood flow to the heart such as angioplasty, stents, or coronary artery bypass surgery.
Rush is one of 15 to 20 research sites nationwide participating in the study, which is sponsored by the Cellular Therapies business unit of Baxter Healthcare Corporation. Baxter technology is used to select the subject's own CD34+ stem cells that are under investigation in this trial.
The baseline frequency and severity of anginal episodes are established as a first step for all study subjects. Next, all subjects receive a series of subcutaneous injections (needle shots, typically delivered under the skin in the arm, thigh or abdomen) of a commercially produced protein (granulocyte colony stimulating factor). The protein helps to release CD34+ stem cells (also known as endothelial progenitor cells) from a subject's bone marrow into the bloodstream.
Then, investigators use a cell separation system, similar to the automated systems that are used with people who donate specific blood components such as platelets or red blood cells, to collect from the subject's bloodstream, an enriched preparation of cells that contain CD34+ stem cells. When this process, known as apheresis, is complete, technologists further process the collected stem cells with Baxter's ISOLEX 300i Magnetic Cell Selection System, currently approved for use with cancer patients, to select the subject's CD34+ stem cells for use in this investigational therapy.
Schaer then uses a catheter-based, non-surgical system to map the patient's heart three-dimensionally to identify the damaged areas into which the stem cells would be injected. "This targeted approach increases the treatment's effectiveness by delivering the stem cells exactly where they are needed." Schaer uses the Johnson & Johnson's NOGA XP Cardiac Navigation System to identify ischemic but viable regions of the heart as targets for cell delivery. The researchers then use a special investigational catheter that functions like a "global positioning system" to precisely deliver CD34+ cells, or placebo, into the areas of the heart that have been identified as having poor blood flow.
Subjects are randomly selected to receive either one of two dosing levels of CD34+ stem cells, or placebo. Rush researchers will conduct follow-up examinations for 12 months,
Researchers are encouraged by reports that the therapy appeared to be well-tolerated and no serious adverse events directly related to the stem cell therapy in an earlier study. According to preliminary, anecdotal patient reports, 16 of the 24 total Phase I study subjects reported feeling better with reductions in chest pain and improved exercise capacity during the early stage of the trial.
####
Coronary Artery Disease and Chronic Myocardial Ischemia
Coronary artery disease is the most common form of heart disease and is the leading cause of death in the United States. This condition occurs when the coronary arteries and the smaller vessels that supply oxygen-rich blood to the heart muscle become narrowed or blocke by plaque deposits and blood clots. Poor blood flow and blood clots "starve" and injure the heart muscle.
The American Heart Association estimates that every year, between 125,000 and 250,000 individuals with coronary artery disease develop chronic myocardial ischemia (CMI), one of the most severe forms of coronary artery disease, which can cause unstable angina, heart attacks and progressive heart failure when adequate blood flow is not restored. CMI develops when the coronary arteries become so diseased that they limit the flow of blood to the heart and send small blood clots downstream, blocking the small blood vessels in the heart. These blockages can result in a series of mini-heart attacks that, while they may be too small to notice at the time, in aggregate cause significant long-term damage to the heart muscle and disability to the patient. While cardiologists can restore blood flow in some cases, the heart muscle can be irreversibly damaged, leading to significant disability, progressive heart failure and often death.
What are stem cells?
Stem cells, which have the potential to develop into many different cell types in the body, act like a repair system for the body. They theoretically can divide without limit to replenish other cells as long as the person or animal is alive.
When a stem cell divides, each new cell has the potential either to remain a stem cell or become another type of cell with a more specialized function, such as a muscle cell, a red blood cell, or a brain cell.
Source: National Institutes of Health
To participate in the study
The trial is open to adult patients who have daily chest pain but are not suitable candidates for conventional procedures to improve blood flow to the heart, such as angioplasty, stents, or bypass surgery. Participants must be able to do a treadmill exercise test..
About the NOGA Navigation System
The NOGA system is the most advanced technology currently available on the market to create highly precise, 3-dimensional images of the heart. Based on these images, physicians are able to accurately identify tissue that could potentially benefit from a variety of targeted investigational therapies. Built on a proprietary magnetic reference system that operates like a global positioning system, the NOGA XP enables physicians to view the treatment area in a 3D reconstruction that represents real anatomy and provides accuracy of the site being mapped within 1 mm. These highly precise images assess heart tissue with pinpoint specificity, identifying areas for therapeutic targeting.
The innovative technology offers remarkably consistent and precise tissue characterization available, which has a significant importance for intramyocardial delivery of stem cells and genes in cardiac patients. Features such as reduced mapping time made possible by QWIKMAP Software and universal data portability that enable one to download the cardiac maps are vast improvements over existing technologies.
The NOGA XP Cardiac Navigation System is currently being used to map the heart in more than 17 ongoing clinical studies worldwide, investigating the use of adult stem cell and gene therapies to treat conditions such as congestive heart failure and chronic ischemia.
About Rush
Rush University Medical Center includes the 650-bed (staffed) hospital; the Johnston R. Bowman Health Center; and Rush University (Rush Medical College, College of Nursing, College of Health Sciences and the Graduate College).
Contact: Mary Ann Schultz
Rush University Medical Center
March 7, 2007
Aspirin Saves Lives Of Cancer Patients Suffering Heart Attacks, Despite Fears Of Bleeding
Many cancer patients who have heart attacks often are not treated with life saving aspirin given the belief in the medical community that they could experience lethal bleeding. Researchers at The University of Texas M. D. Anderson Cancer Center, however, say that notion is now proven wrong and that without aspirin, the majority of these patients will die.
Researchers say that their study, to be published in the February 1, 2007 issue of the journal Cancer and now available online, turns common medical assumptions upside down and will likely change medical practice for cancer patients. Because aspirin can thin blood and cancer patients experience low platelet counts and abnormal clotting, physicians view aspirin as a relative contraindication. Given that blood platelets are responsible for the clotting process, physicians do not eagerly prescribe aspirin as a standard treatment.
In this study, however, the investigators found that 9 of 10 cancer patients with thrombocytopenia (low platelet count) who were experiencing a heart attack and who did not receive aspirin died, whereas only one patient died in a group of 17 similar cancer patients who received aspirin. They also found aspirin helps cancer patients with normal platelet count survive heart attacks, just as it does for people without cancer.
"The notion that heart attacks in patients with low platelets should be treated with clot-dissolving aspirin defies logic, that is unless you suspect that the cancer is interfering with platelet function," says the study's senior investigator and author, Jean-Bernard Durand, M.D., assistant professor in the Department of Cardiology at M. D. Anderson Cancer Center.
"We believe tumors may be releasing chemicals that allow the cancer to form new blood supplies which makes blood more susceptible to forming clots." Durand, a heart failure specialist, says. "There appears to be a platelet paradox suggesting that cancer may affect the mechanism of the way that blood clots, and from this analysis, we have found that the single most important predictor of survival in these patients is whether or not they received aspirin." Durand says more research is needed to better understand this contraindication.
According to the World Health Organization there are approximately 10 million cancer patients worldwide, of which 1.5 million may develop blood clots during their cancer treatment and, as such, are at a much higher risk of dying from heart disease if not treated properly. "Now that we have this study, it would be a travesty if you survive treatment for cancer only to die of a heart attack soon thereafter," Durand says.
According to Durand, no guidelines currently exist for treatment of heart attacks in patients with cancer. He says that physicians are especially perplexed about what to do for cancer patients with thrombosis (blood clots), a condition that affects about 15 percent of all cancer patients and can be due to the use of chemotherapy or the presence of cancer.
Durand came to M. D. Anderson in 2000 to start the Cardiomyopathy Services, which is believed to be the only program in the world specifically designed to look at cardiovascular complications caused by chemotherapy treatment. He is also the co-founder of CONQUER (Cardiology Oncology International Quest to Educate and Research Heart Failure in Cancer), a newly created organization with goals of increasing the success of chemotherapy by reducing cardiovascular disease as a barrier and long term risk.
He and anesthesiologist Mona Sarkiss, M.D., Ph.D., made the observation that patients with thrombocytopenia who suffered a heart attack and were being treated in the intensive care unit at M. D. Anderson tended to die more often when they were not given aspirin. However, they noted that some of the patients given aspirin and/or beta-blockers had "great" clinical outcomes. "Because no practice guidelines exist, physicians were treating their patients with great variability and the disparity was obvious," Durand says.
Sarkiss, who is the study's lead author, Durand, and a team of researchers which included investigators from Baylor College of Medicine and Duke University Medical Center, conducted a retrospective analysis of cancer patients treated for heart attacks at M. D. Anderson Cancer Center in 2001. These 70 patients were divided into two groups based on their platelet counts, and data was collected on the use of aspirin, bleeding complications, and survival.
They found that heart attack patients with low platelets who did not receive aspirin had a seven-day survival rate of 6 percent, compared with 90 percent survival in those who received aspirin. Dr. Durand notes that there were no severe bleeding complications in patients who used aspirin. Conversely, patients with low platelet counts who formed a blood clot and were not exposed to aspirin died.
The beneficial effect of aspirin also was seen in patients with normal platelet counts. Seven-day survival was 88 percent in aspirin-treated patients as compared to 45 percent in patients who did not receive aspirin, the researchers found.
Durand observed that these deaths rates are abnormally high. "In the non-cancer patient with acute coronary syndrome anywhere in the United States, an expected seven-day mortality is less than 1 percent," he says.
There were parallel findings for those patients in either group who were treated with beta-blockers, which block the heart's use of adrenalin. The protective effect was not as strong as seen with aspirin, but was still life saving.
In those patients with a normal platelet count, 91 percent survived seven days when treated with beta-blockers, whereas 36 percent survived if they were not treated with the agent. In the thrombocytopenic group, 73 percent survived seven days when treated with beta-blockers, whereas only 13 percent survived if they were not treated.
###
Investigators working with Durand and Sarkiss were: Andrew Shaw, M.D., from Duke; Nasser Lakkis, M.D. from Baylor; and S. Wamique Yusuf, M.D., Carla Warneke, M.D., Gregory Botz, M.D., Cheryl Hirsch-Ginsburg, M.D., J. Chris Champion, M.D., Joseph Swafford, M.D., and Daniel Lenihan, M.D., from M. D. Anderson.
Contact: Laura Sussman
University of Texas M. D. Anderson Cancer Center
Researchers say that their study, to be published in the February 1, 2007 issue of the journal Cancer and now available online, turns common medical assumptions upside down and will likely change medical practice for cancer patients. Because aspirin can thin blood and cancer patients experience low platelet counts and abnormal clotting, physicians view aspirin as a relative contraindication. Given that blood platelets are responsible for the clotting process, physicians do not eagerly prescribe aspirin as a standard treatment.
In this study, however, the investigators found that 9 of 10 cancer patients with thrombocytopenia (low platelet count) who were experiencing a heart attack and who did not receive aspirin died, whereas only one patient died in a group of 17 similar cancer patients who received aspirin. They also found aspirin helps cancer patients with normal platelet count survive heart attacks, just as it does for people without cancer.
"The notion that heart attacks in patients with low platelets should be treated with clot-dissolving aspirin defies logic, that is unless you suspect that the cancer is interfering with platelet function," says the study's senior investigator and author, Jean-Bernard Durand, M.D., assistant professor in the Department of Cardiology at M. D. Anderson Cancer Center.
"We believe tumors may be releasing chemicals that allow the cancer to form new blood supplies which makes blood more susceptible to forming clots." Durand, a heart failure specialist, says. "There appears to be a platelet paradox suggesting that cancer may affect the mechanism of the way that blood clots, and from this analysis, we have found that the single most important predictor of survival in these patients is whether or not they received aspirin." Durand says more research is needed to better understand this contraindication.
According to the World Health Organization there are approximately 10 million cancer patients worldwide, of which 1.5 million may develop blood clots during their cancer treatment and, as such, are at a much higher risk of dying from heart disease if not treated properly. "Now that we have this study, it would be a travesty if you survive treatment for cancer only to die of a heart attack soon thereafter," Durand says.
According to Durand, no guidelines currently exist for treatment of heart attacks in patients with cancer. He says that physicians are especially perplexed about what to do for cancer patients with thrombosis (blood clots), a condition that affects about 15 percent of all cancer patients and can be due to the use of chemotherapy or the presence of cancer.
Durand came to M. D. Anderson in 2000 to start the Cardiomyopathy Services, which is believed to be the only program in the world specifically designed to look at cardiovascular complications caused by chemotherapy treatment. He is also the co-founder of CONQUER (Cardiology Oncology International Quest to Educate and Research Heart Failure in Cancer), a newly created organization with goals of increasing the success of chemotherapy by reducing cardiovascular disease as a barrier and long term risk.
He and anesthesiologist Mona Sarkiss, M.D., Ph.D., made the observation that patients with thrombocytopenia who suffered a heart attack and were being treated in the intensive care unit at M. D. Anderson tended to die more often when they were not given aspirin. However, they noted that some of the patients given aspirin and/or beta-blockers had "great" clinical outcomes. "Because no practice guidelines exist, physicians were treating their patients with great variability and the disparity was obvious," Durand says.
Sarkiss, who is the study's lead author, Durand, and a team of researchers which included investigators from Baylor College of Medicine and Duke University Medical Center, conducted a retrospective analysis of cancer patients treated for heart attacks at M. D. Anderson Cancer Center in 2001. These 70 patients were divided into two groups based on their platelet counts, and data was collected on the use of aspirin, bleeding complications, and survival.
They found that heart attack patients with low platelets who did not receive aspirin had a seven-day survival rate of 6 percent, compared with 90 percent survival in those who received aspirin. Dr. Durand notes that there were no severe bleeding complications in patients who used aspirin. Conversely, patients with low platelet counts who formed a blood clot and were not exposed to aspirin died.
The beneficial effect of aspirin also was seen in patients with normal platelet counts. Seven-day survival was 88 percent in aspirin-treated patients as compared to 45 percent in patients who did not receive aspirin, the researchers found.
Durand observed that these deaths rates are abnormally high. "In the non-cancer patient with acute coronary syndrome anywhere in the United States, an expected seven-day mortality is less than 1 percent," he says.
There were parallel findings for those patients in either group who were treated with beta-blockers, which block the heart's use of adrenalin. The protective effect was not as strong as seen with aspirin, but was still life saving.
In those patients with a normal platelet count, 91 percent survived seven days when treated with beta-blockers, whereas 36 percent survived if they were not treated with the agent. In the thrombocytopenic group, 73 percent survived seven days when treated with beta-blockers, whereas only 13 percent survived if they were not treated.
###
Investigators working with Durand and Sarkiss were: Andrew Shaw, M.D., from Duke; Nasser Lakkis, M.D. from Baylor; and S. Wamique Yusuf, M.D., Carla Warneke, M.D., Gregory Botz, M.D., Cheryl Hirsch-Ginsburg, M.D., J. Chris Champion, M.D., Joseph Swafford, M.D., and Daniel Lenihan, M.D., from M. D. Anderson.
Contact: Laura Sussman
University of Texas M. D. Anderson Cancer Center
March 5, 2007
Stem Cell Trial With Potential To Repair Hearts Damaged By Severe Coronary Artery Disease
Rush University Medical Center is one of the first medical centers in the country, and currently the only site in Illinois, participating in a novel clinical trial to determine if a subject's own stem cells can treat a form of severe coronary artery disease.
The Autologous Cellular Therapy CD34-Chronic Myocardial Ischemia (ACT34-CMI) Trial is the first human, Phase II adult stem cell therapy study in the U.S. designed to investigate the efficacy, tolerability, and safety of blood-derived selected CD34+ stem cells to improve symptoms and clinical outcomes in subjects with chronic myocardial ischemia (CMI), a severe form of coronary artery disease.
"What we're hoping is that these stem cells will be able to stimulate the growth of new blood vessels to bring more blood and oxygen to the heart muscle, so that these patients will have a better quality of life and less chest pain," said Dr. Gary Schaer, director of the Rush Cardiac Catheterization Lab and study investigator.
Myocardial ischemia is a serious heart condition that involves narrowing of coronary arteries and results in limited blood flow to the heart. The disease affects hundreds of thousands of new people each year. A person who suffers from chronic myocardial ischemia continues to experience insufficient flow of oxygen-rich blood to the heart despite optimum medical intervention.
The study is a randomized, double-blind, placebo-controlled study that involves adult subjects with severe coronary artery disease who are currently on the maximum medical therapy and who are not suitable candidates for conventional procedures to improve blood flow to the heart such as angioplasty, stents, or coronary artery bypass surgery.
Rush is one of 15 to 20 research sites nationwide participating in the study, which is sponsored by the Cellular Therapies business unit of Baxter Healthcare Corporation. Baxter technology is used to select the subject's own CD34+ stem cells that are under investigation in this trial.
The baseline frequency and severity of anginal episodes are established as a first step for all study subjects. Next, all subjects receive a series of subcutaneous injections (needle shots, typically delivered under the skin in the arm, thigh or abdomen) of a commercially produced protein (granulocyte colony stimulating factor). The protein helps to release CD34+ stem cells (also known as endothelial progenitor cells) from a subject's bone marrow into the bloodstream.
Then, investigators use a cell separation system, similar to the automated systems that are used with people who donate specific blood components such as platelets or red blood cells, to collect from the subject's bloodstream, an enriched preparation of cells that contain CD34+ stem cells. When this process, known as apheresis, is complete, technologists further process the collected stem cells with Baxter's ISOLEX 300i Magnetic Cell Selection System, currently approved for use with cancer patients, to select the subject's CD34+ stem cells for use in this investigational therapy.
Schaer then uses a catheter-based, non-surgical system to map the patient's heart three-dimensionally to identify the damaged areas into which the stem cells would be injected. "This targeted approach increases the treatment's effectiveness by delivering the stem cells exactly where they are needed." Schaer uses the Johnson & Johnson's NOGA XP Cardiac Navigation System to identify ischemic but viable regions of the heart as targets for cell delivery. The researchers then use a special investigational catheter that functions like a "global positioning system" to precisely deliver CD34+ cells, or placebo, into the areas of the heart that have been identified as having poor blood flow.
Subjects are randomly selected to receive either one of two dosing levels of CD34+ stem cells, or placebo. Rush researchers will conduct follow-up examinations for 12 months,
Researchers are encouraged by reports that the therapy appeared to be well-tolerated and no serious adverse events directly related to the stem cell therapy in an earlier study. According to preliminary, anecdotal patient reports, 16 of the 24 total Phase I study subjects reported feeling better with reductions in chest pain and improved exercise capacity during the early stage of the trial.
####
Coronary Artery Disease and Chronic Myocardial Ischemia
Coronary artery disease is the most common form of heart disease and is the leading cause of death in the United States. This condition occurs when the coronary arteries and the smaller vessels that supply oxygen-rich blood to the heart muscle become narrowed or blocke by plaque deposits and blood clots. Poor blood flow and blood clots "starve" and injure the heart muscle.
The American Heart Association estimates that every year, between 125,000 and 250,000 individuals with coronary artery disease develop chronic myocardial ischemia (CMI), one of the most severe forms of coronary artery disease, which can cause unstable angina, heart attacks and progressive heart failure when adequate blood flow is not restored. CMI develops when the coronary arteries become so diseased that they limit the flow of blood to the heart and send small blood clots downstream, blocking the small blood vessels in the heart. These blockages can result in a series of mini-heart attacks that, while they may be too small to notice at the time, in aggregate cause significant long-term damage to the heart muscle and disability to the patient. While cardiologists can restore blood flow in some cases, the heart muscle can be irreversibly damaged, leading to significant disability, progressive heart failure and often death.
What are stem cells?
Stem cells, which have the potential to develop into many different cell types in the body, act like a repair system for the body. They theoretically can divide without limit to replenish other cells as long as the person or animal is alive.
When a stem cell divides, each new cell has the potential either to remain a stem cell or become another type of cell with a more specialized function, such as a muscle cell, a red blood cell, or a brain cell.
Source: National Institutes of Health
To participate in the study
The trial is open to adult patients who have daily chest pain but are not suitable candidates for conventional procedures to improve blood flow to the heart, such as angioplasty, stents, or bypass surgery. Participants must be able to do a treadmill exercise test..
About the NOGA Navigation System
The NOGA system is the most advanced technology currently available on the market to create highly precise, 3-dimensional images of the heart. Based on these images, physicians are able to accurately identify tissue that could potentially benefit from a variety of targeted investigational therapies. Built on a proprietary magnetic reference system that operates like a global positioning system, the NOGA XP enables physicians to view the treatment area in a 3D reconstruction that represents real anatomy and provides accuracy of the site being mapped within 1 mm. These highly precise images assess heart tissue with pinpoint specificity, identifying areas for therapeutic targeting.
The innovative technology offers remarkably consistent and precise tissue characterization available, which has a significant importance for intramyocardial delivery of stem cells and genes in cardiac patients. Features such as reduced mapping time made possible by QWIKMAP Software and universal data portability that enable one to download the cardiac maps are vast improvements over existing technologies.
The NOGA XP Cardiac Navigation System is currently being used to map the heart in more than 17 ongoing clinical studies worldwide, investigating the use of adult stem cell and gene therapies to treat conditions such as congestive heart failure and chronic ischemia.
About Rush
Rush University Medical Center includes the 650-bed (staffed) hospital; the Johnston R. Bowman Health Center; and Rush University (Rush Medical College, College of Nursing, College of Health Sciences and the Graduate College).
Contact: Mary Ann Schultz
Rush University Medical Center
The Autologous Cellular Therapy CD34-Chronic Myocardial Ischemia (ACT34-CMI) Trial is the first human, Phase II adult stem cell therapy study in the U.S. designed to investigate the efficacy, tolerability, and safety of blood-derived selected CD34+ stem cells to improve symptoms and clinical outcomes in subjects with chronic myocardial ischemia (CMI), a severe form of coronary artery disease.
"What we're hoping is that these stem cells will be able to stimulate the growth of new blood vessels to bring more blood and oxygen to the heart muscle, so that these patients will have a better quality of life and less chest pain," said Dr. Gary Schaer, director of the Rush Cardiac Catheterization Lab and study investigator.
Myocardial ischemia is a serious heart condition that involves narrowing of coronary arteries and results in limited blood flow to the heart. The disease affects hundreds of thousands of new people each year. A person who suffers from chronic myocardial ischemia continues to experience insufficient flow of oxygen-rich blood to the heart despite optimum medical intervention.
The study is a randomized, double-blind, placebo-controlled study that involves adult subjects with severe coronary artery disease who are currently on the maximum medical therapy and who are not suitable candidates for conventional procedures to improve blood flow to the heart such as angioplasty, stents, or coronary artery bypass surgery.
Rush is one of 15 to 20 research sites nationwide participating in the study, which is sponsored by the Cellular Therapies business unit of Baxter Healthcare Corporation. Baxter technology is used to select the subject's own CD34+ stem cells that are under investigation in this trial.
The baseline frequency and severity of anginal episodes are established as a first step for all study subjects. Next, all subjects receive a series of subcutaneous injections (needle shots, typically delivered under the skin in the arm, thigh or abdomen) of a commercially produced protein (granulocyte colony stimulating factor). The protein helps to release CD34+ stem cells (also known as endothelial progenitor cells) from a subject's bone marrow into the bloodstream.
Then, investigators use a cell separation system, similar to the automated systems that are used with people who donate specific blood components such as platelets or red blood cells, to collect from the subject's bloodstream, an enriched preparation of cells that contain CD34+ stem cells. When this process, known as apheresis, is complete, technologists further process the collected stem cells with Baxter's ISOLEX 300i Magnetic Cell Selection System, currently approved for use with cancer patients, to select the subject's CD34+ stem cells for use in this investigational therapy.
Schaer then uses a catheter-based, non-surgical system to map the patient's heart three-dimensionally to identify the damaged areas into which the stem cells would be injected. "This targeted approach increases the treatment's effectiveness by delivering the stem cells exactly where they are needed." Schaer uses the Johnson & Johnson's NOGA XP Cardiac Navigation System to identify ischemic but viable regions of the heart as targets for cell delivery. The researchers then use a special investigational catheter that functions like a "global positioning system" to precisely deliver CD34+ cells, or placebo, into the areas of the heart that have been identified as having poor blood flow.
Subjects are randomly selected to receive either one of two dosing levels of CD34+ stem cells, or placebo. Rush researchers will conduct follow-up examinations for 12 months,
Researchers are encouraged by reports that the therapy appeared to be well-tolerated and no serious adverse events directly related to the stem cell therapy in an earlier study. According to preliminary, anecdotal patient reports, 16 of the 24 total Phase I study subjects reported feeling better with reductions in chest pain and improved exercise capacity during the early stage of the trial.
####
Coronary Artery Disease and Chronic Myocardial Ischemia
Coronary artery disease is the most common form of heart disease and is the leading cause of death in the United States. This condition occurs when the coronary arteries and the smaller vessels that supply oxygen-rich blood to the heart muscle become narrowed or blocke by plaque deposits and blood clots. Poor blood flow and blood clots "starve" and injure the heart muscle.
The American Heart Association estimates that every year, between 125,000 and 250,000 individuals with coronary artery disease develop chronic myocardial ischemia (CMI), one of the most severe forms of coronary artery disease, which can cause unstable angina, heart attacks and progressive heart failure when adequate blood flow is not restored. CMI develops when the coronary arteries become so diseased that they limit the flow of blood to the heart and send small blood clots downstream, blocking the small blood vessels in the heart. These blockages can result in a series of mini-heart attacks that, while they may be too small to notice at the time, in aggregate cause significant long-term damage to the heart muscle and disability to the patient. While cardiologists can restore blood flow in some cases, the heart muscle can be irreversibly damaged, leading to significant disability, progressive heart failure and often death.
What are stem cells?
Stem cells, which have the potential to develop into many different cell types in the body, act like a repair system for the body. They theoretically can divide without limit to replenish other cells as long as the person or animal is alive.
When a stem cell divides, each new cell has the potential either to remain a stem cell or become another type of cell with a more specialized function, such as a muscle cell, a red blood cell, or a brain cell.
Source: National Institutes of Health
To participate in the study
The trial is open to adult patients who have daily chest pain but are not suitable candidates for conventional procedures to improve blood flow to the heart, such as angioplasty, stents, or bypass surgery. Participants must be able to do a treadmill exercise test..
About the NOGA Navigation System
The NOGA system is the most advanced technology currently available on the market to create highly precise, 3-dimensional images of the heart. Based on these images, physicians are able to accurately identify tissue that could potentially benefit from a variety of targeted investigational therapies. Built on a proprietary magnetic reference system that operates like a global positioning system, the NOGA XP enables physicians to view the treatment area in a 3D reconstruction that represents real anatomy and provides accuracy of the site being mapped within 1 mm. These highly precise images assess heart tissue with pinpoint specificity, identifying areas for therapeutic targeting.
The innovative technology offers remarkably consistent and precise tissue characterization available, which has a significant importance for intramyocardial delivery of stem cells and genes in cardiac patients. Features such as reduced mapping time made possible by QWIKMAP Software and universal data portability that enable one to download the cardiac maps are vast improvements over existing technologies.
The NOGA XP Cardiac Navigation System is currently being used to map the heart in more than 17 ongoing clinical studies worldwide, investigating the use of adult stem cell and gene therapies to treat conditions such as congestive heart failure and chronic ischemia.
About Rush
Rush University Medical Center includes the 650-bed (staffed) hospital; the Johnston R. Bowman Health Center; and Rush University (Rush Medical College, College of Nursing, College of Health Sciences and the Graduate College).
Contact: Mary Ann Schultz
Rush University Medical Center
March 4, 2007
Steroids Cause The Same Tissue Changes As Tendon Injury
Patients who get a steroid injection in their shoulder for rotator cuff pain relief or improved shoulder function should not return to their regular activities or start physical therapy for a few weeks, a Loyola University Health System study shows.
"Steroid injection temporarily produces a molecular response in the tissue that is similar to that of a tendon injury, possibly making it more vulnerable to damage during this time," said senior study investigator Dr. John Callaci, assistant professor, department of orthopedic surgery and rehabilitation, Loyola University Chicago Stritch School of Medicine, Maywood, Ill.
"This is especially important because steroids often give patients rapid pain relief," said Callaci. "If a patient returns to rigorous activities right after a steroid injection, the weakened tissue may not be able to sustain itself."
He cautioned that these findings should not preclude people from having a steroid injection or physicians from administering steroids. "The study gives us a better understanding of what is happening on the molecular level," he said.
Loyola presented the findings here today at the 53rd annual meeting of the Orthopaedic Research Society.
"We found that steroid injections cause a tendon to behave in a way where it thinks it has been acutely injured," noted Callaci. "Steroids rapidly provide anti-inflammatory and pain relief. That is why steroids are so popular, but physical therapy also can produce some of the same effects. It just takes longer."
For the study, Callaci and colleagues examined the global gene expression profiles in rotator cuff tendons following injury or exposure to corticosteroid. The researchers used gene array analysis of the complete rat genome to characterize the molecular response of rat rotator cuff tendon tissue to injury, injection of corticosteroids, and the presence of both injury and corticosteroid.
Results of the study shows that 2,000 genes were changed by injury; 1,000 genes were changed by steroids. A significant number, 750, of the changed genes overlapped between the two groups.
"Not only did gene expression overlap but so did some biological pathways," said Callaci. "Acute injury of the rat rotator cuff tendon significantly modulated the expression of genes in 26 different biological pathways and steroids affected 13 pathways. Twelve of the 13 overlap with the injured pathways.
"The implication of an overlapping pathway is that you have pathways that are modulated after an injury suggesting the tendon is doing things to try to heal itself," said Callaci. "That might suggest there might be a temporary period of vulnerability or weakness in a tendon. It thinks it is being injured and it produces things that normally it produces after injury, which might cause some temporary instability."
Loyola currently is conducting a biomechanical study to determine if the steroids change strength, stress, strain or elasticity of tendons. "We are investigating the biological basis of how tendons heal and how steroids may modulate that healing," said Callaci.
"We want to see if there are actual differences in biomechanical properties right after steroid injection," he said. "If you have a tendon injury already and you're given steroids, how is that modulating the healing response? Do you get more scar formation or do other things change? These are the questions we are researching now."
Co-authors of the study with Callaci are principal investigator Dr. Anthony S. Wei, who did his research at Loyola and now is at Washington University Medical Center in St. Louis; Dr. Benjamin Sears, Loyola resident, Dr. Dainius Juknelis, research associate, Dr. Frederick Wezeman, professor of orthopaedic surgery and rehabilitation, Loyola University Chicago Stritch School of Medicine, director, musculoskeletal biology research laboratory, Loyola University Health System, and associate dean, Loyola University Chicago Graduate School at Loyola University Medical Center, Maywood, Ill.; and Dr. Pietro Tonino, associate professor of orthopaedic surgery, department of orthopaedic surgery and rehabilitation, Loyola University Chicago Stritch School of Medicine and chief of sports medicine.
For more information on Loyola University Health System, log onto http://www.loyolamedicine.org
Funding for the study was provided by a gift from Mr. and Mrs. Charles R Walgreen III and a research grant from the Mid America Orthopaedic Association.
The 53rd Annual Meeting of the Orthopaedic Research Society at the San Diego Convention Center, 111 W. Harbor Drive, San Diego, runs through February 14, 2007.
Loyola University Health System, a wholly owned subsidiary of Loyola University Chicago (LUC), includes the private teaching hospital at Loyola University Medical Center (LUMC), 14 specialty and primary care centers in the western and southwestern suburbs, the Loyola Ambulatory Surgery Center at Oakbrook and the Loyola Oakbrook Terrace Imaging Center; and serves as co-owner-operator of RML Specialty Hospital, a long-term acute hospital specializing in ventilation weaning and other medically complex patients in suburban Hinsdale, Ill. Loyola is nationally recognized for its specialty care and groundbreaking research in cancer, neurological disorders, neonatology and the treatment of heart disease. The 61-acre medical center campus in Maywood, Ill., includes the 523-licensed bed Loyola University Hospital with a Level I trauma center, the region's largest burn unit, one of the Midwest's most comprehensive organ transplant programs, the Russo Surgical Pavilion and the Ronald McDonald® Children's Hospital of LUMC. Also on campus are Loyola's Center for Heart & Vascular Medicine, the Cardinal Bernardin Cancer Center, Loyola Outpatient Center and LUC Stritch School of Medicine. The medical school includes the Cardiovascular Institute, Oncology Institute, Burn & Shock Trauma Institute, Neuroscience Institute and the Neiswanger Institute for Bioethics and Health Policy.
Loyola University Health System
2160 S. First Ave.
Maywood, IL 60153
United States
http://www.luhs.org
"Steroid injection temporarily produces a molecular response in the tissue that is similar to that of a tendon injury, possibly making it more vulnerable to damage during this time," said senior study investigator Dr. John Callaci, assistant professor, department of orthopedic surgery and rehabilitation, Loyola University Chicago Stritch School of Medicine, Maywood, Ill.
"This is especially important because steroids often give patients rapid pain relief," said Callaci. "If a patient returns to rigorous activities right after a steroid injection, the weakened tissue may not be able to sustain itself."
He cautioned that these findings should not preclude people from having a steroid injection or physicians from administering steroids. "The study gives us a better understanding of what is happening on the molecular level," he said.
Loyola presented the findings here today at the 53rd annual meeting of the Orthopaedic Research Society.
"We found that steroid injections cause a tendon to behave in a way where it thinks it has been acutely injured," noted Callaci. "Steroids rapidly provide anti-inflammatory and pain relief. That is why steroids are so popular, but physical therapy also can produce some of the same effects. It just takes longer."
For the study, Callaci and colleagues examined the global gene expression profiles in rotator cuff tendons following injury or exposure to corticosteroid. The researchers used gene array analysis of the complete rat genome to characterize the molecular response of rat rotator cuff tendon tissue to injury, injection of corticosteroids, and the presence of both injury and corticosteroid.
Results of the study shows that 2,000 genes were changed by injury; 1,000 genes were changed by steroids. A significant number, 750, of the changed genes overlapped between the two groups.
"Not only did gene expression overlap but so did some biological pathways," said Callaci. "Acute injury of the rat rotator cuff tendon significantly modulated the expression of genes in 26 different biological pathways and steroids affected 13 pathways. Twelve of the 13 overlap with the injured pathways.
"The implication of an overlapping pathway is that you have pathways that are modulated after an injury suggesting the tendon is doing things to try to heal itself," said Callaci. "That might suggest there might be a temporary period of vulnerability or weakness in a tendon. It thinks it is being injured and it produces things that normally it produces after injury, which might cause some temporary instability."
Loyola currently is conducting a biomechanical study to determine if the steroids change strength, stress, strain or elasticity of tendons. "We are investigating the biological basis of how tendons heal and how steroids may modulate that healing," said Callaci.
"We want to see if there are actual differences in biomechanical properties right after steroid injection," he said. "If you have a tendon injury already and you're given steroids, how is that modulating the healing response? Do you get more scar formation or do other things change? These are the questions we are researching now."
Co-authors of the study with Callaci are principal investigator Dr. Anthony S. Wei, who did his research at Loyola and now is at Washington University Medical Center in St. Louis; Dr. Benjamin Sears, Loyola resident, Dr. Dainius Juknelis, research associate, Dr. Frederick Wezeman, professor of orthopaedic surgery and rehabilitation, Loyola University Chicago Stritch School of Medicine, director, musculoskeletal biology research laboratory, Loyola University Health System, and associate dean, Loyola University Chicago Graduate School at Loyola University Medical Center, Maywood, Ill.; and Dr. Pietro Tonino, associate professor of orthopaedic surgery, department of orthopaedic surgery and rehabilitation, Loyola University Chicago Stritch School of Medicine and chief of sports medicine.
For more information on Loyola University Health System, log onto http://www.loyolamedicine.org
Funding for the study was provided by a gift from Mr. and Mrs. Charles R Walgreen III and a research grant from the Mid America Orthopaedic Association.
The 53rd Annual Meeting of the Orthopaedic Research Society at the San Diego Convention Center, 111 W. Harbor Drive, San Diego, runs through February 14, 2007.
Loyola University Health System, a wholly owned subsidiary of Loyola University Chicago (LUC), includes the private teaching hospital at Loyola University Medical Center (LUMC), 14 specialty and primary care centers in the western and southwestern suburbs, the Loyola Ambulatory Surgery Center at Oakbrook and the Loyola Oakbrook Terrace Imaging Center; and serves as co-owner-operator of RML Specialty Hospital, a long-term acute hospital specializing in ventilation weaning and other medically complex patients in suburban Hinsdale, Ill. Loyola is nationally recognized for its specialty care and groundbreaking research in cancer, neurological disorders, neonatology and the treatment of heart disease. The 61-acre medical center campus in Maywood, Ill., includes the 523-licensed bed Loyola University Hospital with a Level I trauma center, the region's largest burn unit, one of the Midwest's most comprehensive organ transplant programs, the Russo Surgical Pavilion and the Ronald McDonald® Children's Hospital of LUMC. Also on campus are Loyola's Center for Heart & Vascular Medicine, the Cardinal Bernardin Cancer Center, Loyola Outpatient Center and LUC Stritch School of Medicine. The medical school includes the Cardiovascular Institute, Oncology Institute, Burn & Shock Trauma Institute, Neuroscience Institute and the Neiswanger Institute for Bioethics and Health Policy.
Loyola University Health System
2160 S. First Ave.
Maywood, IL 60153
United States
http://www.luhs.org
High Blood Pressure Linked To Painkillers
American researchers have shown that men who use painkillers frequently risk higher blood pressure compared to those that do not.
The study is published in the journal Archives of Internal Medicine.
The team that did the research is from Brigham and Women's Hospital, Harvard Medical School and Harvard School of Public Health, Boston.
The researchers recruited 16,031 male health professionals of average age 65 with no history of high blood pressure (hypertension) and followed them over a four year period.
They measured their use of painkillers, or analgesics, by taking detailed information at the start and two years into the study.
The analgesics they studied were acetaminophen (paracetomol); nonsteroidal anti-inflammatories (NSAIDs) such as ibuprofen, and aspirin (which is also a type of NSAID). These are known as non-narcotic analgesics, the most commonly used drugs in the US.
At the end of the 4 year period they identified that 1,968 of the men (12 per cent) had developed hypertension and then they worked out the relative risk of hypertension in relation to analgesic use using regression-based statistical tests.
The relative risk for men who took NSAIDs 6 to 7 days a week was 38 per cent - they were 38 per cent more likely to develop high blood pressure than the men who took no painkillers at all. The relative risk of developing hypertension in the men who took acetaminophen (paracetomol) was 34 per cent and aspirin 26 per cent.
The results were very similar when number of pills per week was used as a frequency measure instead of days per week.
They concluded that the use of non-narcotic analgesics such as ibuprofen, aspirin and acetaminophen (paracetomol) is independently associated with a moderate increase in blood pressure. This finding has important implications for public health since this kind of medication is in widespread use throughout America.
High blood pressure is associated with increased risk of heart attack, heart failure, stroke, arterial aneurysm and kidney failure. The American Heart Association calls it the "silent killer".
72 million Americans aged 20 and over have high blood pressure (about one in three adults), and over 50,000 of them are killed by it every year. Most people with high blood pressure are unaware of their condition.
Acetaminophen (or paracetomol) is commonly known as Tylenol and Panadol and is available over the counter. It has analgesic (painkilling) and antipyretic (fever reducing) effects but is not effective as an anti-inflammatory. One little known fact is that it is highly toxic to cats.
NSAIDs such as ibuprofen and aspirin are also available over the counter and are effective as painkillers, fever reducers and anti-inflammatories.
There are hundreds of different NSAIDs, with broadly similar properties, the main differences being in the way they are taken, tolerance by patients, and how long they last in the body before being eliminated.
According to the Mayo Clinic, your blood pressure is normal if it's below 120 over 80 but they say that many studies suggest that 115 over 75 is a better standard.
The researchers were keen to point out that this research was not about the risk of painkillers to people who are taking them under doctor's advice to reduce the risk of stroke and heart attack. For instance aspirin is often used in this way. If you are such a patient you should continue to follow your doctor's advice, they said.
"Frequency of Analgesic Use and Risk of Hypertension Among Men."
John P. Forman, Eric B. Rimm, Gary C. Curhan.
Arch Intern Med. 2007;167:394-399.
Vol. 167 No. 4, February 26, 2007
Click here for Abstract.
Click here for the American Heart Association.
Written by: Catharine Paddock
Writer: Medical News Today
American Heart Association's Scientific Statement Supports Physical Therapy To Relieve Pain In Patients At Risk Of Heart Disease
In a scientific statement by the American Heart Association (AHA), doctors are cautioned to change their approach to prescribing pain relievers for patients at risk of heart disease and to begin with physical therapy and other non-pharmacological treatments.
According to AHA's scientific statement: "Use of Nonsteroidal Antiinflammatory Drugs. An Update for Clinicians." that appeared in the February 27 issue of "Circulation," non-pharmacological approaches such as physical therapy should be considered for initial treatment for musculoskeletal symptoms that result from tendonitis/bursitis, degenerative joint problems (osteoarthritis), and inflammatory joint problems (rheumatoid arthritis).
"We advise physicians to start with non-pharmacological treatments such as physical therapy and exercise, weight loss to reduce stress on joints, and heat or cold therapy," said Elliott M Antman, MD, FAHA, lead author of the AHA scientific statement.
"Clearly consumers need to know that physical therapy is an effective non- pharmacological approach to relieving pain," said APTA President R Scott Ward, PT, PhD. "Physical therapists diagnose and treat individuals who have medical problems or other health-related conditions that limit their abilities to move and perform functional activities in their daily lives. A person coming to a physical therapist will receive a complete musculoskeletal examination and an individualized treatment program to reduce pain and improve function."
There are many types of pain and inflammation that can be reduced by a physical therapist's intervention. For example, chronic pain in the back, shoulder, or knee, or pain associated with certain degenerative diseases such as osteoarthritis, can be reduced with the appropriate combination of medication and exercise. "The physical therapist, in collaboration with the patient and the patient's physician, can help the patient manage his or her health over the long term," explained Ward.
"Physical therapists, who treat nearly 1 million people every day, also work with individuals to prevent the loss of mobility before it occurs by developing fitness- and wellness-oriented programs for healthier and more active lifestyles," Ward said.
Physical therapists (PTs) are health care professionals who diagnose and treat individuals of all ages, from newborns to the elderly, who have medical problems or other health-related conditions that limit their abilities to move and perform functional activities in their daily lives. PTs examine each individual and develop a plan of care using treatment techniques to promote the ability to move, reduce pain, restore function, and prevent disability.
The American Physical Therapy Association (http://www.apta.org) is a national organization representing nearly 70,000 physical therapists, physical therapist assistants, and students nationwide. Its goal is to foster advancements in physical therapist education, practice, and research. Consumers can access "Find a PT" to find a physical therapist in their area, as well as physical therapy news and information at http://www.apta.org/consumer.
American Physical Therapy Association
http://www.apta.org
According to AHA's scientific statement: "Use of Nonsteroidal Antiinflammatory Drugs. An Update for Clinicians." that appeared in the February 27 issue of "Circulation," non-pharmacological approaches such as physical therapy should be considered for initial treatment for musculoskeletal symptoms that result from tendonitis/bursitis, degenerative joint problems (osteoarthritis), and inflammatory joint problems (rheumatoid arthritis).
"We advise physicians to start with non-pharmacological treatments such as physical therapy and exercise, weight loss to reduce stress on joints, and heat or cold therapy," said Elliott M Antman, MD, FAHA, lead author of the AHA scientific statement.
"Clearly consumers need to know that physical therapy is an effective non- pharmacological approach to relieving pain," said APTA President R Scott Ward, PT, PhD. "Physical therapists diagnose and treat individuals who have medical problems or other health-related conditions that limit their abilities to move and perform functional activities in their daily lives. A person coming to a physical therapist will receive a complete musculoskeletal examination and an individualized treatment program to reduce pain and improve function."
There are many types of pain and inflammation that can be reduced by a physical therapist's intervention. For example, chronic pain in the back, shoulder, or knee, or pain associated with certain degenerative diseases such as osteoarthritis, can be reduced with the appropriate combination of medication and exercise. "The physical therapist, in collaboration with the patient and the patient's physician, can help the patient manage his or her health over the long term," explained Ward.
"Physical therapists, who treat nearly 1 million people every day, also work with individuals to prevent the loss of mobility before it occurs by developing fitness- and wellness-oriented programs for healthier and more active lifestyles," Ward said.
Physical therapists (PTs) are health care professionals who diagnose and treat individuals of all ages, from newborns to the elderly, who have medical problems or other health-related conditions that limit their abilities to move and perform functional activities in their daily lives. PTs examine each individual and develop a plan of care using treatment techniques to promote the ability to move, reduce pain, restore function, and prevent disability.
The American Physical Therapy Association (http://www.apta.org) is a national organization representing nearly 70,000 physical therapists, physical therapist assistants, and students nationwide. Its goal is to foster advancements in physical therapist education, practice, and research. Consumers can access "Find a PT" to find a physical therapist in their area, as well as physical therapy news and information at http://www.apta.org/consumer.
American Physical Therapy Association
http://www.apta.org
Increased Risk Of Blood Pressure In Men And Use Of Common Pain Relievers Linked
Men who regularly take commonly available and widely used pain relievers may have an increased risk of high blood pressure compared with those who do not use these medications, according to a report in the Archives of Internal Medicine, one of the JAMA/Archives journals.
Acetaminophen, ibuprofen and aspirin are among the most commonly used drugs in the United States, according to background information in the article. Two large studies have recently suggested that pain-relieving medications (analgesics) may be associated with an increased risk of hypertension (high blood pressure) in women. However, the association has not been extensively studied in men.
John P. Forman, M.Sc., M.D., of Brigham and Women's Hospital and Harvard Medical School, Boston, and colleagues followed a total of 16,031 male health professionals (average age 64.6 years) who did not have a history of high blood pressure. The men were asked in 2000 and again in 2002 about whether and how often they used three types of pain relievers: acetaminophen, non-steroidal anti-inflammatory drugs (NSAIDs, which include ibuprofen and naproxen) and aspirin. They were also asked to report if their physician had diagnosed them with hypertension.
Over four years of follow-up, 1,968 men developed hypertension. Compared with men who did not take analgesics, those who took acetaminophen six or seven days a week had a 34 percent higher risk of hypertension. Those who took NSAIDs six or seven days a week had a 38 percent higher risk and those who took aspirin six or seven days a week had a 26 percent higher risk. The researchers also looked at the total number of pain-relieving pills men took each week, regardless of type. Compared with men who took no pills, those who took 15 or more pills each week had a 48 percent higher risk of hypertension.
All three types of analgesics may inhibit the effects of chemicals that relax the blood vessels, decreasing blood pressure, the authors suggest. Acetaminophen also may impair cell functioning through high levels of oxygen (oxidative stress) or reduce the proper functioning of blood vessel lining.
"These data add further support to the hypothesis that non-narcotic analgesics independently elevate the risk of hypertension," the authors write. "Given their common consumption and the high prevalence of hypertension, our results may have substantial public health implications and suggest that these agents be used with greater caution. The contribution of non-narcotic analgesics to the hypertension disease burden merits further study."
###
(Arch Intern Med. 2007;167:394-399.)
This study was supported by a scientist development grant from the American Heart Association and by grants from the National Institutes of Health. Please see the article for additional information, including other authors, author contributions and affiliations, financial disclosures, funding and support, etc.
Contact: Lori J. Shanks
JAMA and Archives Journals
Acetaminophen, ibuprofen and aspirin are among the most commonly used drugs in the United States, according to background information in the article. Two large studies have recently suggested that pain-relieving medications (analgesics) may be associated with an increased risk of hypertension (high blood pressure) in women. However, the association has not been extensively studied in men.
John P. Forman, M.Sc., M.D., of Brigham and Women's Hospital and Harvard Medical School, Boston, and colleagues followed a total of 16,031 male health professionals (average age 64.6 years) who did not have a history of high blood pressure. The men were asked in 2000 and again in 2002 about whether and how often they used three types of pain relievers: acetaminophen, non-steroidal anti-inflammatory drugs (NSAIDs, which include ibuprofen and naproxen) and aspirin. They were also asked to report if their physician had diagnosed them with hypertension.
Over four years of follow-up, 1,968 men developed hypertension. Compared with men who did not take analgesics, those who took acetaminophen six or seven days a week had a 34 percent higher risk of hypertension. Those who took NSAIDs six or seven days a week had a 38 percent higher risk and those who took aspirin six or seven days a week had a 26 percent higher risk. The researchers also looked at the total number of pain-relieving pills men took each week, regardless of type. Compared with men who took no pills, those who took 15 or more pills each week had a 48 percent higher risk of hypertension.
All three types of analgesics may inhibit the effects of chemicals that relax the blood vessels, decreasing blood pressure, the authors suggest. Acetaminophen also may impair cell functioning through high levels of oxygen (oxidative stress) or reduce the proper functioning of blood vessel lining.
"These data add further support to the hypothesis that non-narcotic analgesics independently elevate the risk of hypertension," the authors write. "Given their common consumption and the high prevalence of hypertension, our results may have substantial public health implications and suggest that these agents be used with greater caution. The contribution of non-narcotic analgesics to the hypertension disease burden merits further study."
###
(Arch Intern Med. 2007;167:394-399.)
This study was supported by a scientist development grant from the American Heart Association and by grants from the National Institutes of Health. Please see the article for additional information, including other authors, author contributions and affiliations, financial disclosures, funding and support, etc.
Contact: Lori J. Shanks
JAMA and Archives Journals
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