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Drugs used for cancer-associated anemia linked with increased risk of blood clots, death
February 27, 2008Treating anemia with a class of drugs known as erythropoiesis-stimulating agents (ESAs) is associated with an increased risk of venous thromboembolism (blood clots in the deep veins of the legs or in the lungs) and death among patients with cancer, according to an article in the February 27 issue of JAMA.
The ESAs erythropoietin and darbepoetin are widely used to treat anemia in patients with cancer. Some studies have indicated that there may be a higher risk of venous thromboembolism (VTE) with these medications, but it has not been known if there is an associated increased risk of death, according to background information in the article.
Charles L. Bennett, M.D., Ph.D., of the Northwestern University Feinberg School of Medicine, Chicago, and colleagues examined the rate of VTE and death associated with ESA administration for treatment of anemia among patients with cancer by conducting a review of phase 3 trials.
The researchers identified 51 clinical trials with 13,611 patients to examine survival. Analysis of the data indicated that the risk of death was significantly higher for patients with cancer who were treated with ESA vs. the control (placebo) group.
Venous thromboembolism was evaluated for 38 trials that included 8,172 patients. The researchers found that there was a significantly increased risk (57 percent) of VTE among patients treated with ESA (334 events among 4,610 patients treated with ESA vs. 173 events among 3,562 control patients).
"These risks are important given the prevalence of ESA use as a supportive care drug among patients with cancer as well as the dissemination of a series of safety advisories by the Food and Drug Administration (FDA) and ESA manufacturers," the authors write.
"Safety concerns account in large part for changes observed in patterns of use, reimbursement policies, clinical guidelines, and FDA-approved package inserts pertaining to ESAs in the oncology setting. Our findings, in conjunction with basic science reports on erythropoietin and erythropoietin receptors in solid cancers, raise concern about ESA safety for patients with cancer."
JAMA and Archives Journals
The researchers identified 51 clinical trials with 13,611 patients to examine survival. Analysis of the data indicated that the risk of death was significantly higher for patients with cancer who were treated with ESA vs. the control (placebo) group.
Venous thromboembolism was evaluated for 38 trials that included 8,172 patients. The researchers found that there was a significantly increased risk (57 percent) of VTE among patients treated with ESA (334 events among 4,610 patients treated with ESA vs. 173 events among 3,562 control patients).
"These risks are important given the prevalence of ESA use as a supportive care drug among patients with cancer as well as the dissemination of a series of safety advisories by the Food and Drug Administration (FDA) and ESA manufacturers," the authors write.
"Safety concerns account in large part for changes observed in patterns of use, reimbursement policies, clinical guidelines, and FDA-approved package inserts pertaining to ESAs in the oncology setting. Our findings, in conjunction with basic science reports on erythropoietin and erythropoietin receptors in solid cancers, raise concern about ESA safety for patients with cancer."
JAMA and Archives Journals
Venous Thromboembolism Current Events and Venous Thromboembolism News RSSMenopause-cardiology consensus statement on cardiovascular disease and on HRT
A menopause-cardiology consensus statement has called for direct action to prevent cardiovascular disease (CVD) in menopausal women. The statement also concludes that there is little evidence of increased CVD risk in taking HRT.
Drugs to treat anemia in cancer patients linked to thromboembolism
Medications frequently given to cancer patients to reduce their risk of anemia are associated with an increased risk of deep vein thrombosis or pulmonary embolism, according to new research led by Dawn Hershman, M.D, M.S., co-director of the breast cancer program at the Herbert Irving Comprehensive Cancer Center at NewYork-Presbyterian Hospital/Columbia University Medical Center.
Elevated level of certain protein in urine linked to increased risk for blood clots
Preliminary research suggests that higher than normal levels of the protein albumin in urine is associated with an increased risk for blood clots in the deep veins of the legs or lungs (venous thromboembolism; VTE), according to a study in the May 6 issue of JAMA.
New study suggests Rx estrogen delivery through the skin may show safety benefits as opposed to oral delivery
Transdermal delivery of estrogen therapy available by prescription "seems not to alter" the risk of venous thromboembolism (VTE), or blood clotting, in postmenopausal patients when compared to oral delivery, a new study suggests.
Study shows optimal dose management of warfarin improves anticoagulation control
Researchers from Boston University School of Medicine (BUSM) have determined the optimal dose-management strategy to derive maximal benefit from warfarin therapy and improve patient outcomes. Results of the study appear online in the December 2008 issue of the Journal of Thrombosis and Haemostasis.
Research highlights new approaches to prevent blood clots
Blood clotting, or coagulation, is an important process that prevents excessive bleeding when a blood vessel is injured.
Women may stop anticoagulants after blood clots
Women may safely discontinue oral anticoagulants (blood thinners) after 6 months of treatment following a first unprovoked venous blood clot (thromboembolism) if they have no or one risk factor.
Maternal deaths following cesarean delivery can be reduced
Maternal death rates have remained constant in the United States for many decades. Are there any improvements in health care that could reduce these rates further?
New blood clot guidelines for pregnant women
New evidence-based guidelines address the prevention and management of thrombosis in key patient populations and reinforce recommendations related to the routine use of preventive therapies.
Oral HRT more than doubles the risk of blood clots
Hormone replacement therapy (HRT) given in skin patches may cause fewer blood clots than HRT given orally, according to a report published on BMJ.com today.
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