Thai Red Cross To Adopt New Policy Banning Blood Donations From MSM
April 5, 2008
The Thai Red Cross Society plans to adopt a policy that bans blood donations from men who have sex with men, the Bangkok Post reports. TRCS said it recently discovered large amounts of unused donated blood that tested positive for HIV. In-depth interviews and preliminary tests found that most of the blood was donated by MSM who had engaged in risky sex, Soisaang Pikulsod, director of the TRCS’ National Blood Centre, said. Under the new policy, NBS will screen high-risk donors through questionnaires that will ask men to identify whether they are MSM. The questionnaires also will ask women to say whether they have had sex with men from high-prevalence countries. Donor questionnaires and declarations can help reduce the risk of accepting blood from HIV-positive people, according to a study recently published in Transfusion Medicine, Soisaang said.
National Human Rights Commission of Thailand has said it opposes the new policy and will call on the country’s constitutional court to prevent it from being implemented. In addition, the commission this week will discuss the new policy and ways to prevent its implementation with people who are affected by it. Naiyana Supapueng, NHRC commissioner, said the new policy is equivalent to sexual discrimination under the Thai Constitution. The policy should not be a “total rejection” of MSM, Naiyana said, adding, “Taking away people’s rights is not the correct thing to do.”
Soisaang said TRCS “has the right to protect patients who are waiting for blood transfusions to save their lives by screening blood from specific donors that have high-risk sexual behavior.” She added that the new policy is in line with World Health Organization guidelines (Bangkok Post, 3/30).
Reprinted with kind permission from http://www.kaisernetwork.org. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at http://www.kaisernetwork.org/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation© 2007 Advisory Board Company and Kaiser Family Foundation. All rights reserved.
Study Supports New Test To Target Pregnancy Blood Disorder
April 4, 2008
According to a study published on bmj.com,researchers have developed a new test that can identify whether amother and her baby have different blood types. Kristin Finning(International Blood Group Reference Laboratory, NHS) and colleaguesmaintain that the test is accurate, feasible, and couldsignificantly reduce unnecessary treatment.
If a mother’s blood type is Rhesus (Rh) negative and she is carrying ababy whose blood is Rh positive, complications can occur. Blood that isRh positive contains an RhD antigen that passes into the mother’s bloodduring birth. This substance causes the mother to make antibodiesagainst the RhD positive blood.
During a woman’s first pregnancy, there are usually no problems due tothe antibodies. However, if the woman has another RhD positive baby,the antibodies can cross the placenta and invade the baby’s red bloodcells. This results in hemolytic disease - a blood disorder that isserious and can cause death.
The preventive measure for this disorder is to test the blood type ofpregnant women at their first antenatal visit. If the woman is RhDnegative, she is given one or two antiserum injections of anti-RhDimmunoglobulin during the pregnancy. Inefficiencies arise in thissystem, however, because about 38% of RhD negative women are carrying ababy who is also RhD; these women receive an unnecessary treatment ofantiserum injections.
To avoid the occurrence of unnecessary treatments, researchersat the NHS Blood and Transplant Centre in Bristol investigated a newway to predict a baby’s blood group by “typing” its DNA in the plasmaof RhD negative pregnant women.
The researchers took blood samples from 1,997 women at or before the 28week doctor visit and found that the correct RhD phenotype of the babywas predicted by genotyping tests in 96% of cases. Confirmation of thiswas made by testing blood samples retrieved from the umbilical cord atdelivery. Fourteen blood samples (0.8%) resulted in false positiveoutcomes and three blood samples (0.2%) were false negatives.Unobtainable or inconclusive results occurred in 3.4% of cases.
The researchers point out that if the results of the test had been usedas a guide for whether or not a woman would receive the antiserumtreatment, only 2% of women would have received anti-RhD withoutnecessity - compared to 36% who unnecessarily receive the antigenwithout genotyping.
“Our results show that fetuses of RhD negative women could be RHDgenotyped with an acceptable level of accuracy,” write the authors.They also point out the low rate of false positiveresults. “The introduction of fetal genotyping followed by thewithholding of antenatal anti-RhD prophylaxis from mothers with an RhDnegative fetus would result in about 36% of women being saved fromunnecessary exposure to human blood products, inconvenience, anddiscomfort.”
Effect of high throughput RHD typing of fetal DNA in maternalplasma on use of anti-RhD immunoglobulin in RhD negative pregnantwomen: prospective feasibility study
Kirstin Finning, Pete Martin, Joanna Summers, EdwinMassey, Geoff Poole, Geoff Daniels
BMJ. (2008).
doi:10.1136/bmj.39518.463206.25
ClickHere to See Article Online
Written by: Peter M Crosta
Copyright: Medical News Today
Clavis Pharma Starts ELACYT(TM) Phase II Study In Haematology
April 4, 2008
Clavis Pharma (OSE: CLAVIS) announced that it has started recruiting patients to the phase II part of its clinical phase I/II study with ELACYT(TM), within haematological cancers. The phase II part commences after the successful completion of phase I, which demonstrated a good safety profile, as well as clinical activity. The phase II part will evaluate the efficacy and safety of ELACYT in patients with late stage acute myeloid leukaemia (AML). This is a patient group with limited treatment options and short expected survival. Patients will be recruited at 16 major cancer centres in the USA and Europe.
ELACYT is a novel cytotoxic agent, an analogue of cytarabine, a backbone of therapy in acute leukaemia. ELACYT is in development for the treatment of haematological cancers (blood cancers), as well as for solid tumours. In this ongoing phase I/II study 77 patients have been treated to date. Clavis Pharma reports that patients with haematological malignancies have tolerated ELACYT well at doses up to 2500 mg/m2/day both when administered as a short-lasting infusion and as continuous infusion. An international clinical expert group made the recommendation on dose and schedule based on phase I data and the study will continue with ELACYT 2000 mg/m2/day administered by continuous infusion. ELACYT was granted orphan drug designation by the European Commission in September 2007 for the treatment of AML.
The centres recruiting in the phase I part of the study were MD Anderson Cancer Centre (MDACC), Houston, Duke University Hospital, Durham, and University of Texas Health Science Centre (UTHSC), San Antonio, all in the USA and Institute Paoli Calmettes, Marseille, France. All four centres will continue into the phase II part. Over the next weeks additional cancer centres will be opened for recruitment in New York and Cleveland (USA); Oslo (Norway); Paris, Toulouse and Lyon (France); Bologna and Rome (Italy); Berlin, Frankfurt and Münster (Germany); and Manchester (UK).
“At MDACC we are dedicated to quality patient care, innovative research, and developing more effective treatments for all types of leukaemia” says Prof. Hagop Kantarjian, Chairman of the Department of Leukaemia. “There is a strong biological rationale for evaluating ELACYT in leukaemia and the drug has shown real promise against the disease in phase I. We are very pleased to study ELACYT further in our refractory and relapsed AML patients.”
“This phase I/II study in haematological cancers has shown excellent recruitment from day one.” says Geir Christian Melen, CEO of Clavis Pharma. “We are looking forward to continue the study in phase II together with an excellent and enthusiastic investigator team. Furthermore, we are pleased that we are now pursuing 4 individual indications in phase II as part of our clinical development program for Elacyt”.
About Clavis Pharma
Clavis Pharma ASA is an oncology focused pharmaceutical company using its proprietary Lipid Vector Technology (LVT) platform to create New Chemical Entities (NCEs), by significantly improving already established drugs. The improvements are achieved by chemically binding specific unsaturated lipids to existing, and well understood, approved pharmaceuticals. Data generated suggests the resulting patentable NCEs offer improved efficacy and reduced side effects through enhanced pharmacokinetic properties, greater tissue penetration and, in many cases, additional modes of action.
Clavis Pharma’s objective is to develop its drug candidates until significant value has been created and proof of principle in man has been shown. For further clinical development and commercialisation of the products, Clavis Pharma will enter into strategic partnerships with established pharmaceutical or biotech companies. The company’s product portfolio includes three new cancer drugs, of which the first ELACYT(TM), is in Clinical Phase II, the second, CP-4126, is in Clinical Phase I, and the third, CP-4200, is in Preclinical Development. Results indicate that these products have promising potential for several cancer indications within solid tumours and leukaemia.
The shares of Clavis Pharma ASA are listed on the Oslo Stock Exchange (ticker: CLAVIS). Additional information on Clavis Pharma can be found here.
About Leukaemia
Approximately 300,000 new cases of leukaemia are diagnosed globally each year, resulting in around 220,000 deaths. Leukaemia represents a market with high unmet medical needs, which may open for accelerated approval processes to expedite market access for new drugs. It is a segmented market covering a broad variety of disorders. A major clinical concern is the high rate of disease recurrence. The five-year survival for the most common acute leukaemia type, acute myeloid leukaemia (AML), is in the range of 5-10% for treated elderly patients, and approximately 30% for treated younger adults.
About Orphan Drugs
The European Commission grants orphan drug designation to promising products that address life-threatening medical conditions affecting fewer than 230,000 persons in the European Union (EU). The designation allows for the use of the quickest way of placing the medicinal product on the market throughout the EU (known as the “centralised procedure”), regulatory assistance related to the development process and reduced regulatory fees throughout the product’s life. If a product receives marketing approval, the designation will entitle the company to exclusive marketing rights for 10 years following the approval. Orphan Drug Designation provides companies with financial and regulatory incentives to pursue less common diseases. It should be noted that orphan drug designation does not limit a drug to less common diseases. The drug may, in parallel or afterwards, also be developed for other diseases.
Disclaimer
The information contained herein shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of the securities referred to herein in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration, exemption from registration or qualification under the securities laws of any such jurisdiction.
This news release contains forward-looking statements and forecasts based on uncertainty, since they relate to events and depend on circumstances that will occur in the future and which, by their nature, will have an impact on results of operations and the financial condition of Clavis Pharma. There are a number of factors that could cause actual results and developments to differ materially from those expressed or implied by these forward-looking statements. Theses factors include, among other things, risks associated with technological development, the risk that research & development will not yield new products that achieve commercial success, the impact of competition, the ability to close viable and profitable business deals, the risk of non-approval of patents not yet granted and difficulties of obtaining relevant governmental approvals for new products.
No expressed or implied representations or warranties are given concerning Clavis Pharma or the accuracy or completeness of the information or projections provided herein, and no claims shall be made by the recipient hereof by virtue of this Information Memorandum or the information or projections contained herein. Any representations or warranties made to an investor in Clavis Pharma will be subject to separate sale and purchase agreements to be negotiated between the parties.Clavis Pharma(TM) and ELACYT(TM) are registered trademarks of Clavis Pharma ASA.
Clavis Pharma
Contracts Provide Canadians With Access And Choice To Critical Therapies For Hemophilia And Primary Immune Deficiency
April 3, 2008
Baxter Corporation (Canada) is pleased to announce contracts with Canadian Blood Services and Héma-Québec, the two organizations responsible for managing Canada’s blood system. For more than 20 years Baxter has partnered with the organizations managing Canada’s blood collection system to deliver innovative products for Canadians with hemophilia, primary immune deficiency and other rare blood disorders.
“We are pleased to continue our successful relationship with Baxter in supplying Canadians with life-saving therapies,” said Dr. Graham Sher, Chief Executive Officer, Canadian Blood Services, “and we are confident that they will continue to be strong partners for Canadian Blood Services in ensuring a safe, secure, sustainable supply of plasma protein products for Canada.”
Under the new, multi-year agreements, Baxter will supply Canadian Blood Services and Héma-Québec with commercial products, including ADVATE® [Antihemophilic Factor (Recombinant), Plasma/Albumin Free Method (rAHF-PFM)] for the prevention and control of bleeding episodes in people with hemophilia A and the newly launched GAMMAGARD Liquid 10% HUMAN, Intravenous Immune Globulin (IVIG) for the treatment of primary immune deficiency.
Canadian Blood Services and Héma-Québec will distribute these and other important therapies to hospitals across Canada making them available to clinicians and patients.
“This agreement is another link in the long-standing partnership between Baxter and Héma-Québec. This partnership makes it possible for us to continue to offer stable products that meet the industry’s highest standards for quality.” said Dr. Francine Décary, President and Chief Executive Officer of Héma-Québec.
“These contracts are good news for Canadians as they provide both access and choice to those requiring treatment for bleeding disorders and immunological disorders,” said Serge Messerlian, Business Unit Director, BioScience, Baxter Corporation. “In particular, the contracts continue access to ADVATE and GAMMAGARD Liquid, and may help patients lead healthier and more active lives.”
ADVATE is an advanced factor VIII therapy and one of the most studied factor VIII therapies worldwide. It is the only factor VIII therapy made without human or animal blood-derived components approved for use in Canada. In contrast, all other factor VIII therapies available in Canada use human or animal blood-derived components during their manufacturing process. ADVATE was developed by Baxter using recombinant technology to potentially reduce the exposure of patients with hemophilia to blood-borne pathogens.
GAMMAGARD Liquid 10% is the only intravenous immune globulin (IVIG) with three dedicated and effective viral inactivation/removal steps. The therapy’s ready-to-use, sterile preparation eliminates the need for reconstitution. GAMMAGARD Liquid 10% is the latest step in Baxter’s ongoing efforts toward advancing the science of IVIG.
With these contracts, Baxter continues its commitment to providing both the Canadian hemophilia and primary immune deficiency communities a safe and secure supply of products
About Primary Immune Deficiency Disorders
Primary immunodeficiency disorders encompass more than 100 diseases caused by an immune system that does not function correctly. For many people with primary immunodeficiency, the cause is a lack of antibodies usually produced to fight infection. Intravenous immune globulin (IVIG) therapy can help restore immunoglobulin (IgG antibodies) levels to near normal, helping the immune system function properly and prevent infections or fight them when they occur.
About Hemophilia
Hemophilia is a rare genetic bleeding disorder that affects one in 10,000 people. People with hemophilia A are primarily males, although in extremely rare cases women can also be affected. These individuals do not produce adequate amounts of factor VIII, which is necessary to effectively clot blood. Without enough factor VIII, patients can experience spontaneous, uncontrolled internal bleeding that is painful, debilitating and damaging to joints. If untreated, patients with severe hemophilia A have a greatly reduced life expectancy.
About Baxter
As a subsidiary of Baxter International Inc., Baxter Corporation (Canada) applies innovative science to develop specialty therapeutics and medical products that save and sustain patients’ lives. Baxter bioscience, medications delivery and renal products and services are used to treat patients with some of the most challenging medical conditions including cancer, hemophilia, immune deficiencies, infectious diseases, kidney disease and trauma. Learn more about Baxter Corporation (Canada) at http://www.baxter.ca.
This release includes forward-looking statements concerning the contracts between the company and each of Canadian Blood Services and Héma-Québec, including those statements related to the availability and sale of the company’s products including ADVATE and GAMMAGARD Liquid. The statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those in the forward-looking statements: commercial availability of the company’s products including ADVATE and GAMMAGARD Liquid; actual purchases by Canadian Blood Services and Héma-Québec of the company’s products including ADVATE and GAMMAGARD Liquid; actions of regulatory bodies and other governmental authorities; numerous other matters including economic, business, competitive and other risk factors identified in Baxter International Inc.’s most recent filing on Form 10-K and other SEC filings, all of which are available on the company’s website. The company does not undertake any obligation to update its forward-looking statements as a result of new information, future events, changes to assumptions or otherwise and all forward-looking statements speak only as of the time when made.
Baxter International Inc.
Roche Diagnostics Provides Software Upgrade For Its Cobas B 221 Bloodgas Analyzer
April 3, 2008
Roche Diagnostics announced the global launch of an enhanced software (Version 7.0) for its flagship bloodgas analyzer; the cobas b 221 system. The cobas b 221 is a desktop device designed for critical care providing bloodgas analysis, the measurement of the most important electrolytes, as well as Glucose, Lactate, Urea, Bilirubin and hemoglobin derivatives. The new software version is tailored to the demands of critical care clinicians, nurses and POCT co-ordinators. It provides new features for single parameter trending, and the option to define specific parameters panels.
In critical care situations hospitals of all sizes are increasingly reliant on information technology in saving time and coming to rapid therapy decisions. The step from data to actionable healthcare information in this context needs an overview of the trends that a patients’ status follows. For this very reason the upgraded software provides the possibility to graphically display any development on parameters which are measurable on the cobas b 221.
“Roche Decentralized Solutions is dedicated to develop innovative ways to enhance the value of diagnostics in critical care settings,” said Charles Delany, Head of Program, Blood Gas and Electrolytes. “This new version of software is one part of our systematic response to customer requests on how diagnostics can integrate into and improve patient care pathways.”
Up to four parameters can be trended not only in percentage of change, but also against absolute values. This means that a graphical plot can be used to monitor disease progression. Upper and lower critical limits can be user defined for each parameter. Onboard patient trending helps healthcare providers to monitor the progress of their patient’s condition during the course of treatment.
User defined panels and innovative quality control
In order to provide the user with the option to perfectly tailor the range of tests to everyday needs in a point of care situation, the new software is equipped with panels that can be modified by authorized users. It is possible to define up to four different panels, increasing not only usability but also allowing control over billable parameters for the hospital.
Finally the software means improvement in terms of quality control. “The user will get more rapid information on the QC performance”, said Charles Delany, “The access to QC data is easier, the information is presented more clearly, the time to ready after QC failure is shortened. QC setup is supported by a step by step guidance. This reduces training needs.’”
About Roche
Headquartered in Basel, Switzerland, Roche is one of the world’s leading research-focused healthcare groups in the fields of pharmaceuticals and diagnostics. As the world’s biggest biotech company and an innovator of products and services for the early detection, prevention, diagnosis and treatment of diseases, the Group contributes on a broad range of fronts to improving people’s health and quality of life. Roche is the world leader in in-vitro diagnostics and drugs for cancer and transplantation, and is a market leader in virology. It is also active in other major therapeutic areas such as autoimmune diseases, inflammatory and metabolic disorders and diseases of the central nervous system. In 2007 sales by the Pharmaceuticals Division totalled 36.8 billion Swiss francs, and the Diagnostics Division posted sales of 9.3 billion francs. Roche has R&D agreements and strategic alliances with numerous partners, including majority ownership interests in Genentech and Chugai, and invested over 8 billion Swiss francs in R&D in 2007. Worldwide, the Group employs about 79,000 people.
http://www.roche.com
Proteolix’s Carfilzomib Receives Orphan Drug Designation For Treatment Of Multiple Myeloma
April 3, 2008
Proteolix, Inc., a clinical-stage company engaged in the development of novel pharmaceutical therapies for the treatment of cancer and immunological conditions, announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to carfilzomib, a selective blocker of proteasome activity for the treatment of multiple myeloma. The orphan drug designation encompasses all subsets of multiple myeloma and Waldenstrom’s macroglobulinemia.
“I am very pleased by our receipt of this designation for carfilzomib,” said Susan Molineaux, Ph.D., the Company’s President and CEO. “To date we have been encouraged by carfilzomib’s early-stage clinical results in multiple myeloma, and we continue to believe it has the potential to offer cancer patients a new and effective treatment for their disease.”
The Orphan Drug Act of 1983 allows the FDA to grant orphan drug status to novel drugs or biologics that treat a rare disease or condition affecting fewer than 200,000 patients in the U.S. According to the SEER Database of the National Cancer Institute (2004), the U.S. prevalence of multiple myeloma was 53,712 patients. The Orphan Drug Act provides the drug developer with several financial benefits and incentives related to the orphan drug, including tax credits for clinical research costs, ability to apply for annual grant funding, clinical research trial design assistance, waiver of Prescription Drug User Fee Act (PDUFA) filing fees, and a seven-year period of U.S. marketing exclusivity if the drug is the first of its type approved for the specified indication.
About Multiple Myeloma
Multiple myeloma is cancer of the plasma cell. It begins in the bone marrow, where blood cells are made. The plasma cell is a type of white blood cell that fights infections by making antibodies. Cancerous plasma cells, also called myeloma cells, divide and grow out of control, building up in the marrow and crowding out healthy blood cells. The myeloma cells do not make effective antibodies and instead release abnormal proteins, called M proteins. M proteins can damage the immediate area and travel through the bloodstream and damage other parts of the body. Left untreated, multiple myeloma can cause bone damage, elevated blood calcium, anemia, and predisposition to infection and kidney damage. In 2007, there were an estimated 19,900 new cases diagnosed and 10,790 deaths due to multiple myeloma in the United States. For more information on multiple myeloma go to http://www.cancer.gov/cancertopics/types/myeloma.
About Waldenstrom’s Macroglobulinemia
Waldenstrom’s Macroglobulinemia (WM) is a slow-growing type of non-Hodgkin’s lymphoma that starts in white blood cells called B lymphocytes. WM is also called lymphoplasmacytic lymphoma because it occurs when abnormal lymphoplasmacytic cells multiply out of control, producing large amounts of a protein called monoclonal immunoglobulin M. WM can result in enlargement of the liver and spleen due to anemia and large amounts of immunoglobulin M can lead to hyperviscosity syndrome, in which the blood becomes abnormally thick. Symptoms of this syndrome include visual problems such as blurring or loss of vision and neurological problems including headache, dizziness, or vertigo. WM is a rare cancer with only about 1,500 new cases diagnosed annually in the United States.
About Proteolix
Proteolix, Inc. is a privately-held biopharmaceutical company, headquartered in South San Francisco, and dedicated to discovering, developing and commercializing pharmaceutical therapies that target certain cancers and immunological conditions by inhibiting the proteasome and thereby disrupting protein turnover in cells. Phase 1 clinical studies with carfilzomib, the Company’s lead product, have shown that patients with hematologic malignancies who have relapsed or progressed following multiple therapies can achieve durable anti-tumor responses. Carfilzomib is currently in Phase 2 clinical studies to evaluate its safety and efficacy in multiple myeloma, lymphoma and solid tumor malignancies. Proteolix is also developing a pipeline of next-generation proteasome inhibitors, including an oral proteasome inhibitor and a selective immunoproteasome inhibitor. For more information, please visit the Company’s website at http://www.proteolix.com.
Proteolix, Inc.
http://www.proteolix.com
In Acute Coronary Syndromes Clopidogrel Reloading Worthwhile
April 2, 2008
Many patients who come to the cardiac catheterization laboratory for percutaneous coronary intervention (PCI) are already taking 75mg of clopidogrel daily to prevent unwanted blood clotting. Even so, an additional 600-mg “reloading” dose of clopidogrel significantly improves clinical outcomes without increasing the risk of bleeding - but only in patients with acute coronary syndromes (ACS), according to the Antiplatelet Therapy for Reduction of Myocardial Damage During Angioplasty-RELOAD (ARMYDA-RELOAD) study.
The study was presented in a Late-Breaking Clinical Trials session at the SCAI Annual Scientific Sessions in Partnership with ACC i2 Summit (SCAI-ACCi2) in Chicago. SCAI-ACCi2 is a scientific meeting for practicing cardiovascular interventionalists sponsored by the Society for Cardiovascular Angiography and Interventions (SCAI) in partnership with the American College of Cardiology (ACC).
The ARMYDA-RELOAD study found that clopidogrel reloading reduces the combined risk of death, heart attack or repeat coronary procedure by nearly two-thirds in patients with ACS, although it offers no benefit to those with stable chest pain. Until now, no study has ever specifically examined the effect of clopidogrel reloading on patients with acute coronary syndromes, a condition that encompasses both unstable angina and a form of heart attack known as non-ST-segment-elevation myocardial infarction (NSTEMI). Clopidogrel is used to prevent the formation of blood clots, or thrombi, which could block the coronary artery and cut off blood flow to the heart muscle.
“The implications of the study are self-evident: When a patient with ACS is undergoing PCI and has been taking clopidogrel before, it is a very good idea to give a further loading dose of 600 mg prior to the procedure. This will protect against ischemic complications, without fear of more bleeding,” said Germano Di Sciascio, MD, professor and chairman of cardiology at Campus Biomedico, University of Rome, Italy. “In patients with stable syndromes, ongoing preexisting clopidogrel may supply sufficient anti-platelet effect to safely undergo the procedure.”
For the study, Dr. Di Sciascio and his colleagues recruited a total of 436 patients who had been taking clopidogrel for more than 10 days before PCI. Of these, 167 (38 percent) had ACS. Patients were randomly assigned to receive an additional 600-mg loading dose of clopidogrel four to eight hours before PCI or to receive a placebo. Blood tests confirmed that platelet reactivity was significantly lower in the reload group when compared with the placebo group in patients with ACS.
After 30 days’ follow-up, the overall rates of major adverse cardiac events (MACE) - consisting of death, heart attack, or repeat PCI or bypass surgery - were the same in the two groups: 7 percent in patients who received clopidogrel reloading vs. 9 percent in the placebo group (p=0.70). A similar finding was observed in patients with stable chest pain (8 percent vs. 4 percent, respectively, p=0.23). However, in patients with acute coronary syndromes, clopidogrel reloading significantly reduced the MACE rate (7 percent vs. 18 percent, respectively; odds ratio: 0.36; p=0.035). There was no difference in the rates of bleeding (5 percent in both groups).
Fundamental differences in the cardiovascular conditions that characterize acute and stable chest pain may explain the effectiveness of clopidogrel reloading in patients with ACS, Dr. Di Sciascio said. “Patients with ACS have higher platelet reactivity, higher inflammatory status and more intracoronary thrombus,” he said. “This may make them more prone to benefit from clopidogrel reloading.”
Dr. Di Sciascio presented the results of the “Antiplatelet Therapy for Reduction of Myocardial Damage During Angioplasty-RELOAD” (ARMYDA-RELOAD) study on April 1 at 11:30 a.m. CDT in the Grand Ballroom, S100.
—————————-
—————————-
About SCAI
Headquartered in Washington, DC, the Society for Cardiovascular Angiography and Interventions is a 4,000-member professional organization representing invasive and interventional cardiologists in over 60 nations. SCAI’s mission is to promote excellence in invasive and interventional cardiovascular medicine through physician education and representation, and advancement of quality standards to enhance patient care. SCAI’s annual meeting has become the leading venue for education, discussion, and debate about the latest developments in this dynamic medical specialty.
About ACC
The American College of Cardiology is leading the way to optimal cardiovascular care and disease prevention. The College is a 34,000-member nonprofit medical society and bestows the credential Fellow of the American College of Cardiology upon physicians who meet its stringent qualifications. The College is a leader in the formulation of health policy, standards and guidelines, and is a staunch supporter of cardiovascular research. The ACC provides professional education and operates national registries for the measurement and improvement of quality care.
Source: Kathy Boyd David
Weber Shandwick Worldwide
Blood Thinners Could Be Post-Op Killers
April 1, 2008
Current US guidelines for the prescription of potent anticoagulants by surgeons who perform joint replacement operations could be doing patients more harm than good, according to Dr. Nigel Sharrock and his team from the Hospital for Special Surgery in New York. They argue for a revision of the American College of Chest Physicians’ guidelines, in light of their review showing that the use of powerful anticoagulants to prevent pulmonary embolism may actually lead to more deaths among patients who take these drugs. The paper (1) was published in the March issue of Springer’s journal Clinical Orthopaedics and Related Research.
Anticoagulants are routinely prescribed before and after total hip and knee replacement operations to reduce the risk of thrombosis, and death from pulmonary embolism in particular, as recommended by the Chest Physicians Consensus Statement. During the last decades, deaths from pulmonary embolism have fallen significantly due to a combination of advancements in anesthesia, better surgical techniques and care pre- and post-surgery, as well as a better understanding of how thrombosis develops as a result of surgery. In light of these developments, Sharrock and his team looked at whether the prescription of potent anticoagulants by surgeons who perform joint replacement operations is still warranted, as these drugs also have side effects.
The authors reviewed 20 studies among a total of just over 28,000 patients undergoing joint replacement surgery who were prescribed medication to reduce the risk of thrombosis. They compared the total number of deaths and cases of non-fatal pulmonary embolism between three frequently used prevention protocols worldwide. Patients in group A received potent anticoagulants such as low molecular weight heparin; those in group B received local spinal or epidural anesthesia, pneumatic compression and aspirin; patients in group C were prescribed slow-acting oral anticoagulants such as warfarin.
The lowest number of deaths occurred in patients in group B. Patients in groups A and C were more than twice as likely to have died as those in group B. There was no difference in the number of deaths between groups A and C. Patients in group A were also at 60-70% greater risk of non-fatal pulmonary embolism than those in group B, indicating that pulmonary embolism occurs despite the use of powerful anticoagulants.
Sharrock and colleagues conclude that “the American College of Chest Physicians should reconsider their guidelines to reflect the fact that pulmonary embolism occurs despite the use of potent anticoagulants and may, in fact, expose patients to increased mortality after surgery.” In their view, the current recommendations often result in physicians feeling compelled to prescribe these anticoagulants to avoid potential litigation when, in reality, these drugs could be doing more harm than good.
—————————-
—————————-
Reference
1. Sharrock NE et al (2008). Potent anticoagulants are associated with a higher all-cause mortality rate after hip and knee arthroplasty. Clin Orthop Relat Res; 466:714-721 (DOI 10.1007/s11999-007-0092-4).
Source: Joan Robinson
Springer
New Dawn AC Anaemia Software Simplifies Monitoring And Controlling Patient Progress
April 1, 2008
Physicians who manage individuals with anaemia can boost their productivity and improve patient safety, thanks to comprehensive anaemia management software by 4S Information Systems Ltd.
Known as Dawn Anaemia, the web browser software package is designed to make it easier and less frustrating for clinicians to monitor and control the progress of their anaemia patients. The robust software features a therapy template that medical practitioners can use to manage patients’ treatment and keep them on track. Dawn Anaemia also provides questionnaire tools to improve the recording of patient education and indicates which patients are not meeting goals.
In addition, Dawn Anaemia has a number of administrative-related features to enhance efficiency for health care professionals. It offers a complete appointment system to streamline clinic management. Built-in features, such as bulk messaging and automatic message triggers, make it easier for clinicians to communicate with other health care professionals and patients by email, fax, letter or telephone. The system also allows for instant retrieval of documentation of patient history, education, notes, medications and hemoglobin control.
Dawn Anaemia is ideal for any physician wanting to establish a shared, integrated care solution that links primary and secondary care. The software offers a great deal of convenience, as users can access it using a standard Web browser and print out hardcopies from the central database. Dawn Anaemia can be integrated with other information systems such as laboratory and patient administration.
Anaemia-which is commonly caused by iron and vitamin deficiency as well as chemotherapy treatment for cancer and chronic kidney disease-affects millions of people worldwide. It is one of the most widespread public health concerns, according to the World Health Organization. Sophisticated software such as Dawn Anaemia is an important tool because it helps clinicians establish a safer, more organised way to manage patients with this widespread condition.
Dawn Anaemia is one of a number of software packages developed by 4S Information Systems Ltd., which trades as 4S Dawn Clinical Software. The UK company-established in 1984-is a leader in the clinical software industry and also has products for anticoagulation management, rheumatology patient tracking and hematology patient tracking. Based in North West England near Manchester, 4S Information Systems is being used to benefit thousands of patients worldwide.
To learn more about the features and benefits of the Dawn Anaemia software package, please visit http://www.4s-dawn.com/anaemia.
Dawn Anaemia
HVO Launches Hematology Program In Uganda In Partnership With ASH
March 31, 2008
Health Volunteers Overseas (HVO) and the American Society of Hematology (ASH) are pleased to announce the establishment of the first HVO hematology training program, at Mulago Hospital located in Kampala, Uganda. Mulago Hospital is a 1500-bed facility that serves as Uganda’s national referral, teaching, and research hospital and is affiliated with Makerere University. The overall goal of this program is to improve the hematology training of clinicians, laboratory technicians, technologists, and students.
ASH member Melody Cunningham, MD, will serve as the program director for this site. “Hematology is not a well-developed discipline throughout the country,” stated Dr. Cunningham. “The staff seeking further training in hematology are young, fresh, and genuinely want to advance their programs, both for improved clinical care and academic accomplishment, but also to create a sustainable program that can be passed down.”
HVO will send up to four volunteers a year to fulfill two- to four-week assignments. Volunteers should be ASH members who are board certified/eligible in hematology or hematology/oncology and pediatric or adult hematologists in clinical practice or laboratory research.
Volunteers will provide didactic and hands-on training in both the clinical and laboratory aspects of hematology to undergraduate medical and laboratory students, postgraduates, fellows, and staff. Volunteers will also assist in evaluating postgraduate fellow projects and aid in improving communication between the lab staff and clinicians.
The American Society of Hematology is the world’s largest professional society concerned with the treatment of blood disorders. Since its initial meeting in 1958, ASH has been dedicated to furthering the understanding, diagnosis, treatment, and prevention of disorders affecting the blood, bone marrow, and the immunologic, hemostatic, and vascular systems, by promoting research, clinical care, education, training, and advocacy in hematology. ASH has more than 15,000 members, including more than 3,500 international members from across the globe.
A private, nonprofit membership organization, Health Volunteers Overseas was founded in 1986 to improve global health through education. HVO designs and implements clinical education programs in child health, primary care, trauma and rehabilitation, essential surgical care, oral health, hematology, infectious disease, nursing education, burn management, and wound care. In more than 25 resource-poor nations, volunteers train, mentor, and provide critical professional support to health care providers who care for the neediest populations in the most difficult of circumstances. HVO’s hematology training programs are sponsored by the American Society of Hematology. To learn more about volunteering with HVO, visit the Web site (http://www.hvousa.org) or contact the HVO Program Department at (202) 296-0928.
American Society of Hematology
