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Patterns of Use and Risks Associated With Erythropoiesis-Stimulating Agents Among Medicare Patients
In an article published online on November 10 by the Journal of the National Cancer Institute, Hershman et al. report a large retrospective study in which they used data from Surveillance, Epidemiology, and End Results–Medicare database to assess erythropoiesis-stimulating agent (ESA) usage, blood transfusion, venous thromboembolism (VTE) and overall survival in patients aged 65 years or older diagnosed with colon, non-small cell lung, or breast cancer or with diffuse large B-cell lymphoma between 1991 and 2002, and who received chemotherapy. Among 56,210 patients meeting these criteria, 27% received ESAs (the proportion of patients receiving ESAs increased from 4.8% in 1991 to 45.9% in 2002). The rate of blood transfusion per year remained constant at 22%. VTE developed 14.3% patients who received ESAs and in 9.8% of those who did not(hazard ratio, 1.93; 95% CI, 1.79-2.07). Overall survival was similar in both groups. The authors conclude that "further efforts at monitoring use and long-term toxicity of expensive oncology drugs should be put in place to ensure that for any drug the benefits outweigh the risks in community practice."
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New Scientific Committee
We are pleased to announce that NATA's scientific committee has been entirely renewed. The role of this new committee chaired by Prof. Jean-François Hardy from Montreal, QC, Canada, is threefold: 1)to provide suggestions for the programs of annual symposia and regional meetings; 2) to review and rate abstracts submitted for presentation during annual symposia; and 3)to provide short comments on, and to rate articles for Nataonline. NATA's topics of interest include blood transfusion services/risks of transfusion, transfusion practice, blood conservation strategies, anemia and its management, fluid therapy and oxygen carriers and, finally, hemostasis and thrombosis. To consult the list of NATA scientific committee members, please click on the link above.
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Fibrin Sealants: Their Role in Blood-Sparing Surgery
During the 9th Annual NATA Symposium, a satellite symposium entitled "Fibrin Sealants: Their Role in Blood-Sparing Surgery" addressed the role of topical haemostatic agents in reducing blood loss and transfusion requirements in surgical patients. This symposium, supported by an educational grant from Johnson & Johnson Wound Management, was chaired by Prof. Marcela Contreras and Mr. Peter Earnshaw and featured presentations by Dr. Heidi Doughty and Dr. Dafydd Thomas. To view a podcast of the symposium, please click on the link above.
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Hemoglobin Based Oxygen Carriers: Current Status and Future Directions
On April 28-29, a public workshop entitled "Hemoglobin Based Oxygen Carriers: Current Status and Future Directions" was held in Bethesda, MD, USA. This workshop sponsored by the Food and Drug Administration; the National Heart, Lung and Blood Institute, National Institutes of Health; and the Department of Health and Human Services’ Office of the Secretary and Office of Public Health and Science (OS/OPHS) featured presentations and roundtable discussions led by experts from academic institutions, government, and industry. The objective of the meeting was to discuss the safety of hemoglobin-based oxygen carriers (HBOCs) as related to a variety of potential uses of these investigational products. To consult the agenda, please click on the link above.
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TATM Special Issue on Blood Substitutes
The December 2007 issue of TATM, edited by Dr. Marcos Intaglietta, provides a very comprehensive overview of the current status of oxygen carriers. To access the issue, please click on the link above.
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NATA Membership 2010
To become a NATA member or renew your membership, please click on the link above (you may also contact Stephen Smith at Wiley-Blackwell Publishing Membership Services (+44 1865 476016).
NATA membership includes a one year print and online subscription to Transfusion Alternatives in Transfusion Medicine, a reduced registration fee for the annual NATA symposium and the right to participate in the NATA General Assembly.
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Important Trasylol Safety Information
On November 5, Bayer announced that it will temporarily suspend worldwide marketing of Trasylol (aprotinin injection) until the final results from the Canadian BART trial have been evaluated. The company elected to take this global action following direction from the German BfArM and requests from the FDA, Health Canada and other regulators that Bayer temporarily suspend Trasylol marketing in their respective countries until final BART data were available. The BART trial, a randomized controlled trial in high-risk cardiac surgery patients, was halted after a planned periodic data analysis showed reduced bleeding but also increased all-cause mortality in patients who received aprotinin compared to patients who received either epsilon-aminocaproic acid or tranexamic acid.
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New Guidelines: Diagnosis and Management of Iron Deficiency and Anemia in IBD
New guidelines on Diagnosis and Management of Iron Deficiency and Anemia in Inflammatory Bowel Diseases will be presented on October 29 during the 15th United European Gastroenterology Week. The session, chaired by Prof. Christoph Gasche, will feature presentations on the prevalence and impact of anemia and iron deficiency in IBD (S. Kulnigg, Austria), lessons learned from animal models (B. Oldenburg, the Netherlands), anemia evaluation (A. Dignass, Germany), triggers and targets of anemia therapy (D. Rampton, UK), and treatment of iron deficiency and anemia (G. Van Assche, Belgium). These new guidelines will also be presented by Prof. Gasche during the 9th Annual NATA Symposium in Lisbon.
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Safety of Aprotinin in Cardiac Surgery
Since January, 2006, the US FDA has been conducting a safety review of Trasylol (aprotinin injection). The review was triggered by the results of two published research studies: one that reported an increase in the chance of kidney failure, heart attack and stroke in patients treated with Trasylol compared to those treated with other similar drugs, and the other that reported an increase in kidney dysfunction compared to another drug. On September 21, 2006, FDA held a public meeting of the Cardiovascular and Renal Drugs Advisory Committee to discuss the safety and overall risk-benefit profile for Trasylol. At that meeting, the committee discussed the findings from the two published observational studies, the Bayer worldwide safety review, and the FDA review of its own post-marketing database.
On September 27, 2006, Bayer Pharmaceuticals told FDA that it had conducted an additional safety study of Trasylol. The preliminary findings from this new observational study of patients from a hospital database reported that use of Trasylol may increase the chance for death, serious kidney damage, congestive heart failure and strokes. FDA was not aware of these new data when it held the September 21, 2006, Advisory Committee meeting on Trasylol safety. FDA is actively evaluating these new data and their implications for appropriate use of the drug.
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Late Breaking Session: Reevaluating the Role of Aprotinin in Cardiac Surgery
Following the publication of the study by Mangano et al. in the January 26, 2006 issue of The New England Journal of Medicine, the NATA Board of Directors has decided to organize a late breaking session entitled "Reevaluating the Role of Aprotinin in Cardiac Surgery" during the 7th Annual NATA Symposium. To consult the program of the session, please click on the link above.
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TATM Journal
