среда, 22 июня 2011 г.

Improving Survival Rate In Patients With An Acute Coronary Syndrome

Today in most countries of the world almost 50 per cent of patients in hospital for a cardiac condition began their treatment as emergency cases: chest pain at home... a cardiac arrest in the street. Thus, according to Dr Peter Clemmensen, local chairman of this year's Acute Cardiac Care congress which opened in Copenhagen on 16 October, of the 22 million hospital admissions in Europe each year for acute cardiac events, more than 10 million of them would have begun as an emergency and without warning. "Early diagnosis is crucial in these cases for successful treatment and survival," he says, describing acute coronary care as "the most challenging field of cardiology".



Such events - evident as chest pain or at worst a cardiac arrest - are invariably the prelude to one of the most critical episodes of health care. Acute cardiac care, that first emergency phase in which the event is assessed and its cause treated, embraces a broad spectrum of diagnoses ranging from unstable angina to acute heart failure, from myocardial infarction to other life-threatening disorders of the heart.



Dealing with these cases - and importantly as quickly as possible - is the theme of Acute Cardiac Care 2010, this year's congress of the ESC's Working Group on Acute Cardiac Care, which is taking place in Copenhagen from 16 -19 October.



1. Diagnosis as early as possible



While there has been progress in improving overall mortality rates following acute myocardial infarction (AMI), survival rates when the arrest takes place outside hospital are poor - and no better than 5 per cent in some European countries. The key to improving survival rates are early and accurate diagnosis; once in hospital and undergoing acute cardiac care, patients have a much better chance of survival.



So, much depends on immediate intervention, which can be much more efficiently introduced if diagnosis can be made in the ambulance. "Two-thirds of European ambulances are now able to transmit digitalised ECG recordings," says Dr Clemmensen. "If we can reopen the occluded arteries - by angioplasty, surgery or thrombolysis - within the first hour, we can usually prevent damage to the heart muscle and improve the chance of survival. Timing is crucial, so we'll be considering at the congress how a more efficient paramedical service with telemonitoring ECG can shorten the time delay between the onset of symptoms and treatment."



2. The risk-benefit of early thrombolytic therapy



The latest ESC guidelines on the treatment of acute coronary syndromes emphasise the importance of therapies to prevent thrombosis and maximise the effect of other treatments (PCI, percutaneous coronary intervention with balloon angioplasty and stent, or coronary artery by-pass surgery). However, it is now clear that the administration of some of these antithrombotic treatments is also associated with a high risk of gastric bleeding. The guidelines state: "Since the vast majority of PCI procedures eventually conclude with stent implantation, every patient scheduled for PCI should be considered for pre-treatment with clopidogrel, regardless of whether stent implantation is intended or not." However, therapies like clopidogrel or prasugrel are also associated with a risk of (gastric) bleeding and a variation in response. "This is important," says Dr Clemmensen, "and the congress will consider the most effective dose and the most effective treatment for each individual patient. There's a delicate balance between beneficial effect and risk of bleeding." Finding a way to find this balance remains a major challenge in acute coronary care.
















3. Intensive care units



Surveys indicate that there is a shortage of intensive coronary care beds in European hospitals. One in 20 patients admitted to hospital with an acute coronary syndrome are in a state of "cardiogenic shock", a condition in which the heart fails to pump adequately and which is the leading cause of death for acute heart attack patients. Again, PCI is the standard treatment, but these patients, says Dr Clemmensen, are most efficiently treated in intensive care units. Several presentations at the congress will consider the most effective way of dealing with patients with cardiogenic shock and in less than ideal circumstances.



Acute Cardiac Care 2010 will present new data on the way acute cardiac patients are managed, particularly in accordance (or not) with the latest guidelines. There have been significant improvements in mortality rates in acute patients admitted to hospital. The challenge raised at this congress is how to improve survival rates in that short period of time between onset of symptoms and first medical contact.


вторник, 21 июня 2011 г.

Manufacturer Removes Remaining Stocks Of Trasylol

Background: On Nov. 5, 2007, the U.S. Food and Drug Administration announced that Bayer Pharmaceuticals Corp. agreed to an FDA-requested marketing suspension of Trasylol, a drug used to control bleeding during heart surgery. At that time, preliminary results from a Canadian study suggested an increased risk for death compared to two other drugs used to control bleeding.


Bayer HealthCare Pharmaceuticals Inc. has notified the FDA that the company will begin removing the remaining Trasylol stock from the U.S. market, most of which is in warehouses and hospital or physician's stock. The FDA will work with Bayer to ensure a smooth and complete process.


Under a limited use agreement, access to Trasylol is limited to investigational use of the drug according to the procedures described in a special treatment protocol. The protocol allows treatment for certain patients who are at increased risk of blood loss and transfusions during coronary artery bypass graft surgery and who have no acceptable alternative therapy. Physicians using Trasylol in this situation must also verify that the benefits of the drug clearly outweigh the risks for their patients.


FDA limits access to certain drugs to patients with serious or immediately life-threatening disease or conditions who lack other therapeutic options and may benefit from such therapies. This type of access requires the submission of a protocol, which is reviewed and approved by the agency. Bayer has agreed to provide Trasylol through this mechanism for the limited use described above.


Trasylol is an antifibrinolytic drug approved to reduce blood loss during surgery and the need for blood transfusion in certain patient undergoing cardiopulmonary bypass in the course of coronary artery bypass graft surgery. Antifibrinolyitc drugs help slow the breakdown of blood clots and subsequent excessive bleeding.


Results from a randomized Canadian study that prompted last November's marketing suspension of Trasylol are expected to be published this week. The data contained in this article suggest that Trasylol appears to increase the risk for death compared to two other antifibrinolytic drugs used in the study.


The findings from this randomized study are similar to those from an observational study that was discussed at a September 2007 FDA advisory committee meeting. Based upon the data available at the time, the advisory committee recommended continued marketing of Trasylol. However, FDA requested the marketing suspension in the interest of patient safety based on the serious nature of the outcomes suggested in the preliminary data. The committee also advised that a large, randomized clinical study was needed to further assess Trasylol's safety compared to other drugs. This recently published Canadian study helps address this need for additional information.


The FDA has not yet received full study data from the study's researchers at the Ottawa Health Research Institute but supports Bayer's decision to completely remove Trasylol from regular use in the U.S. market. FDA is also reviewing the available Canadian study data to reassess the currently active special treatment protocol that provides access to Trasylol.















FDA oversight requires comprehensive and thorough studies of a drug not only during the pre-market review phase but throughout the drug's life cycle. As studies and data on Trasylol emerged over the years, FDA actions included labeling changes, safety communications to physicians and other health care professionals, public discussion and review of study data at two Advisory Committee meetings, as well as close scrutiny of the ongoing studies.


The agency will consider a variety of study designs to support the review process for future antifibrinolytics, and will incorporate into these considerations information from the recently published Canadian study. FDA will continue to publicly disseminate safety information.


Additional Information


Feb. 8, 2006-FDA Press Release on Public Health Advisory for Trasylol

Sep. 29, 2006-FDA Statement Regarding New Trasylol Data

Dec. 15, 2006-FDA Press Release Announcing Trasylol Label Changes

Oct. 25, 2007-FDA Early Communication on Trasylol Safety

Nov. 5, 2007-FDA Press Release Announcing Marketing Suspension of Trasylol

Treatment Use of an Investigational New Dug-21 Code of Federal Regulations

fda

понедельник, 20 июня 2011 г.

New Analysis Showed That High Dose Lipitor Can Reduce The Risk Of Cardiovascular Events In Bypass Surgery Patients

Pfizer Inc announced that Lipitor® (atorvastatin calcium) 80 mg significantly reduced the risk of major cardiovascular events, including heart attack and stroke, by 27 percent in patients with heart disease who had previous coronary bypass surgery compared with patients taking the 10 mg dose of Lipitor. This analysis, designed and completed following the closure of the five-year Treating to New Targets (TNT) study, was published in the "Journal of the American College of Cardiology."


Intensive Lipitor therapy also provided a significant 30 percent reduction in the need for either repeat coronary bypass surgery or angioplasty, another type of interventional heart surgery, compared with Lipitor 10 mg.


Each year in the U.S., approximately 470,000 bypass surgeries are performed on 270,000 people. Patients in the TNT study who had undergone previous bypass surgery had a much higher likelihood of cardiovascular events than those who did not have prior bypass surgery. This especially high risk population tends to be under-treated with lipid-lowering therapy.


"Patients may be under the impression that once they have had coronary bypass surgery, they are no longer at high risk for heart attacks and strokes," said Dr. Rochelle Chaiken, vice president of Pfizer's global cardiovascular and metabolic medical team. "Although these patients continue to be at an increased risk for major cardiovascular events and repeat heart surgery, statins are considerably underused. This analysis highlights not only the importance of treating, but also treating aggressively with Lipitor 80 mg."


Both doses of Lipitor (80 mg and 10 mg) were well-tolerated in patients with prior coronary bypass surgery, and the safety profile of Lipitor 80 mg was comparable to Lipitor 10 mg, a finding that was consistent with the overall TNT population.


About the TNT Study


The TNT study was an investigator-led trial coordinated by an independent steering committee and funded by Pfizer. The primary endpoint was the reduction of major cardiovascular events, including death from heart disease, non-fatal heart attacks, resuscitated cardiac arrest, and fatal or non-fatal strokes.


The study enrolled 10,001 men and women with coronary heart disease aged 35 years to 75 years in 14 countries and followed them for an average of five years. In this analysis, 4,654 patients who had previous coronary bypass surgery were compared with 5,347 patients who did not. Lipitor 80 mg is not a starting dose.


About Coronary Bypass Surgery


Coronary bypass surgery is a procedure in which damaged sections of the coronary arteries (arteries that bring blood to the heart muscle) are replaced with healthy blood vessel segments. The surgery reroutes, or "bypasses," blood around clogged arteries to improve blood flow and oxygen to the heart.















This procedure is done because arteries that bring blood to the heart muscle can become clogged by plaque (a buildup of fat, cholesterol and other substances). This can slow or stop blood flow through the heart's blood vessels, leading to chest pain or a heart attack. Increasing blood flow to the heart muscle can relieve chest pain and reduce the risk of heart attack.


About Angioplasty


Angioplasty is a type of interventional heart surgery which encompasses a variety of procedures used to treat patients with diseased arteries of the heart, such as:


- Chest pain caused by a build-up of fats and cholesterol.

- Other substances from the blood (referred to as plaque) that can reduce blood flow to a near trickle.

- A heart attack caused by a large blood clot that completely blocks the artery.


Typically, angioplasty is performed by threading a slender balloon-tipped tube - a catheter - from an artery in the groin to a trouble spot in an artery of the heart. The balloon is inflated, compressing the plaque and widening the narrowed coronary artery so that blood can flow more easily. This is often accompanied by inserting an expandable metal stent (a small mesh tube) to keep the artery open.


About Lipitor


Only Lipitor offers these three benefits important in a statin: FDA approval to reduce the risk of heart attacks, strokes and other cardiovascular events in patients with or without heart disease; the ability to reduce "bad" cholesterol (LDL) by 39 percent to 60 percent; and a well-established safety profile across a broad range of patients.


It is the most prescribed cholesterol-lowering therapy in the world, with nearly 151 million patient-years of experience. Lipitor is supported by a 15-year clinical trial program involving more than 400 ongoing and completed trials with more than 80,000 patients.


Important U.S. Prescribing Information


Lipitor is a prescription medication. It is used in patients with multiple risk factors for heart disease such as family history, high blood pressure, age, low HDL ("good" cholesterol) or smoking to reduce the risk of heart attack, stroke, certain kinds of heart surgery, and chest pain.


Lipitor is used in patients with existing coronary heart disease to reduce the risk of heart attack, stroke, certain kinds of heart surgery, hospitalization for heart failure, and chest pain.


Lipitor is also used in patients with type 2 diabetes and at least one other risk factor for heart disease such as high blood pressure, smoking or complications of diabetes, including eye disease and protein in urine, to reduce the risk of heart attack and stroke.


When diet and exercise alone are not enough, Lipitor is used along with a low-fat diet and exercise to lower cholesterol.


Lipitor is not for everyone. It is not for those with liver problems. And it is not for women who are nursing, pregnant or may become pregnant.


Patients taking Lipitor should tell their doctors if they feel any new muscle pain or weakness. This could be a sign of rare but serious muscle side effects. Patients should tell their doctors about all medications they take. This may help avoid serious drug interactions. Doctors should do blood tests to check liver function before and during treatment and may adjust the dose. The most common side effects are gas, constipation, stomach pain and heartburn. They tend to be mild and often go away.


Lipitor

воскресенье, 19 июня 2011 г.

Iron Deficiency In Heart Failure

Iron plays a key role in human homeostasis. It is essential for growth and survival, and is a vital ingredient in numerous processes including erythropoiesis, oxygen transport and storage, oxidative metabolism in the skeletal and heart muscle, synthesis and degradation of lipids, carbohydrates, DNA and RNA. Important though it is, iron metabolism must be precisely controlled because iron is insoluble and excess levels can be toxic.


Iron deficiency is a relatively common nutritional disorder that affects more than one third of the general population, and is often associated with chronic diseases such as inflammatory bowel disease, Parkinson's disease, rheumatoid diseases and renal failure. Until recently, there has been little interest in the linkage between iron deficiency and the natural course of chronic heart failure (CHF) syndrome. Traditionally iron deficiency has been linked with a presence of anaemia in CHF, and its reported prevalence varies from 20 percent to 70 percent. Recent research carried out at the Military Hospital, Medical University of Wroclaw has now demonstrated that iron deficiency must be viewed in a much broader clinical context, as it also affects at least one-third of non-anaemic CHF patients.


The research was led by Doctor Piotr Ponikowski, who said, "Iron deficiency appears to be independent of the severity of CHF symptoms, and occurs irrespective of anaemia. It also seems to be associated with exercise intolerance and leads to a reduced quality of life. Our research shows that it probably constitutes an ominous sign of a poor outcome, independently of the other well-established prognosticators. In light of its high prevalence and clinical consequences, iron deficiency may well be perceived as an attractive therapeutic target in CHF."


Several earlier reports have already shown that, in iron deficient CHF patients, iron repletion can safely improve functional capacity, exercise tolerance and quality of life. Cardiologists should become more aware of the importance of iron deficiency in CHF patients, and be able to evaluate iron status using a combination of simple, clinically relevant parameters of iron metabolism. More studies are needed to evaluate whether correction of iron deficiency in CHF would translate into clinical benefits.


Sources: European Society of Cardiology (ESC), AlphaGalileo Foundation.

суббота, 18 июня 2011 г.

Grant Received By Heart Researchers To Study Asthma

A research grant program that encourages "thinking outside the box" will allow a team of University of Iowa investigators to apply findings from heart research to the study of asthma.



Specifically, the team has received a three-year, $750,000 grant from the Strategic Program for Asthma Research, known as SPAR, to see if an enzyme known to play a role in heart failure might also affect smooth muscle cells in the airway and thus play a role in asthma. The basic science research focuses on CaM kinase II, which has been under scrutiny in other UI research.



"We are taking a fresh look at the role of calcium signaling in asthma, and are applying some ideas and results from the cardiovascular field that have never before been considered in the field of asthma," said study investigator Isabella Grumbach, M.D., Ph.D., assistant professor of internal medicine in the UI Roy J. and Lucille A. Carver College of Medicine.



The study team includes five UI faculty members, four of whom are based in cardiology and have never studied asthma, and only one whose field of expertise is asthma. The team aims to learn more about airway smooth muscle cells.



Grumbach's lab will grow the cells and monitor their response (for example, for inflammation) to the enzyme. She also will supply mouse models to investigate the response of airway smooth muscle cells to CaM kinase II inhibition.



The study will be led by Mark Anderson, M.D., Ph.D., UI professor of internal medicine and molecular physiology and biophysics, who has previously published, and has other studies underway, on CaM kinase II as it relates to heart issues.



Competition for the award was considerable, noted Anderson, with only 17 projects out of 255 applications funded this year.



"This kind of research is meant to help examine 'holes' in the paradigm of current asthma understanding. We're not asking safe, predictable questions, but getting involved because sometimes people from outside a field can help with a paradigm shift," said Anderson, who also holds the Potter-Lambert Chair in Cardiology.



In addition to Grumbach and Anderson, the team includes Joel Kline, M.D., professor of internal medicine; Peter Mohler, Ph.D., associate professor of internal medicine; and Long-Sheng Song, M.D., assistant professor of internal medicine. Anderson, Grumbach, Mohler and Song also are members of the UI Heart and Vascular Center.



Kline is an asthma expert and provided precursor data to help the team apply for the study. Mohler has expertise in helping determine the mechanical and electrical function of cells, while Song brings expertise in measuring calcium responses.



"It's a great partnership, and another example of what can happen when there is a focus on innovative scientific collaboration by generous funders and motivated researchers," Anderson said.







Learn more about SPAR, which is funded by the American Asthma Foundation, at sandlerresearch/.


пятница, 17 июня 2011 г.

Cardiac Risk Estimates Differ For Christian And Muslim Patients

In a study of medical students, more serious cardiac risk estimates were given to Christians and less serious estimates for Muslims despite the patients being otherwise identical in their characteristics and symptoms, according to research in an upcoming issue of Medical Decision Making published by SAGE. Risk assessment, the first step in a medical triage process, determines subsequent treatment.



In the study, led by Jamie Arndt, PhD, of the University of Missouri-Columbia, randomly chosen university medical students were asked to answer questions about their own mortality. Afterward, all the study participants inspected fictitious emergency room admittance forms for Muslim and Christian patients complaining of chest pain, and risk assessments were made for each patient. The participants who had been reminded of their personal mortality rendered more serious cardiac risk estimates for Christians and less serious estimates for Muslims despite the patients being otherwise identical in their characteristics and symptoms.



"We should emphasize that there is no reason to suspect intentional biased judgment on the part of medical students, since research indicates that most prejudicial responses occur without people's intent or awareness," write the authors in the article, noting that none of the study participants identified themselves as Muslim. "Still, psychological motivations provoked by concerns with one's mortality can have far-reaching effects in a health care context. Further research is needed because it is vital that these effects be better understood."







The Medical Decision Making article, "The Psychosocial Effect of Thoughts of Personal Mortality on Cardiac Risk Assessment," written by Jamie Arndt, PhD, Matthew Vess, MA, Cathy R. Cox, MA, Jamie L. Goldenberg, PhD, and Stephen Lagle, BA, is free for a limited time at mdm.sagepub/cgi/rapidpdf/0272989X08323300v1.



Medical Decision Making (MDM), the official journal of the Society for Medical Decision Making, publishes articles designed to improve the health and clinical care of individuals and to assist with health policy development. Presenting theoretical, statistical, and modeling methods from a variety of disciplines, including decision psychology, health economics, clinical epidemiology, and evidence synthesis, the journal promotes understanding of human decision-making processes so that individuals can make more informed and satisfying choices regarding their health. mdm.sagepub/



SAGE is a leading international publisher of journals, books, and electronic media for academic, educational, and professional markets. Since 1965, SAGE has helped inform and educate a global community of scholars, practitioners, researchers, and students spanning a wide range of subject areas including business, humanities, social sciences, and science, technology, and medicine. An independent company, SAGE has principal offices in Los Angeles, London, New Delhi, Singapore and Washington DC. sagepublications/


четверг, 16 июня 2011 г.

Updated Guidelines Include New Research, Advances In Stroke Prevention

Healthy lifestyle choices and emergency room interventions can help prevent first-time strokes, according to revised American Heart Association/American Stroke Association guidelines.


The guidelines, last updated in 2006, will be published in Stroke: Journal of the American Heart Association.


"Between 1999 and 2006, there's been over a 30 percent reduction in stroke death rates in the United States and we think the majority of the reduction is coming from better prevention," said Larry B. Goldstein, M.D., chairman of the statement writing committee and director of the Duke Stroke Center in Durham, N.C.


Prior to this, the incidence of stroke may have been increasing, according to the statement that cites a 39 percent rise in hospitalizations between 1988 and 1997. As the population continues to age, the total number of Americans having a stroke is expected to rise.


More than 77 percent of the 795,000 strokes occurring in Americans each year are first events. The third leading cause of death in the United States after heart disease and cancer, stroke is a significant economic and social burden and one of the major causes of disability in adults.


For the first time, the prevention guidelines address stroke as a broad continuum of related events, including ischemic stroke, non-ischemic stroke and transient ischemic attack (TIA). For prevention, there is often little difference along the stroke spectrum, said Goldstein, who is also a professor of medicine and director of Duke's ASA-Bugher Foundation Center for Stroke Prevention Research.


Accounting for 87 percent of all strokes, ischemic stroke happens when a blood vessel in or leading to the brain is blocked. TIA occurs when the blockage is temporary, but is considered a major risk factor for a later, larger stroke. A blood vessel rupture causes non-ischemic, or bleeding stroke, known as a hemorrhagic stroke.


The new guidelines feature several key prevention updates based on recent research:



-- Those who make healthy lifestyle choices such as not smoking, eating a low-fat diet high in fruits and vegetables, drinking in moderation, exercising regularly and maintaining a normal body weight lower risk of a first stroke as much as 80 percent compared with those who don't make such changes. The preventive benefit increases with each positive change adopted.



-- Emergency room doctors should try to identify patients at high risk for stroke and consider making referrals, conducting screenings or beginning preventive therapy.



-- Although genetic screening for stroke among the general population isn't recommended, it may be appropriate in certain circumstances, depending on family history and other factors.



-- The usefulness of stenting in persons who have a narrowing of a carotid artery in the neck as compared to an operation (endarterectomy) is still uncertain. Because of advances in standard medical therapies (including a change in lifestyle factors, treating high blood pressure and using antiplatelet and cholesterol lowering drugs) the usefulness of either procedure in persons who have not had symptoms is unclear. Doctors must decide whether to perform either procedure on a case-by-case basis.



-- General population screening for carotid artery narrowing isn't recommended.



-- Aspirin doesn't prevent a first stroke in low-risk persons or those with diabetes or asymptomatic peripheral artery disease. However, it's recommended for those whose risk is high enough for the reduction in stroke risk to outweigh the bleeding risks of aspirin.


Co-authors are: Cheryl D. Bushnell, M.D., M.H.S.; Robert J. Adams, M.S., M.D.; Lawrence J. Appel, M.D., M.P.H.; Lynne T. Braun, Ph.D., C.N.P.; Seemant Chaturvedi, M.D.; Mark A. Creager, M.D.; Antonio Culebras, M.D.; Robert H. Eckel, M.D.; Robert G. Hart, M.D.; Judith A. Hinchey, M.D., M.S.; Virginia J. Howard, Ph.D.; Edward C. Jauch, M.D., M.S.; Steven R. Levine, M.D.; James F. Meschia, M.D.; Wesley S. Moore, M.D.; J.V. (Ian) Nixon, M.D.; and Thomas A. Pearson, M.D. Individual author disclosures are on the manuscript.