Navigation Links
Controversial Anemia Drug Doesn't Cut Need for Transfusions
Date:9/5/2007

But it may reduce mortality rates among trauma patients, study finds

WEDNESDAY, Sept. 5 (HealthDay News) -- A drug widely used to treat anemia does not reduce the need for blood transfusions among critically ill patients, but it may reduce mortality in trauma patients.

The drug, epoetin alfa (brand names Epogen and Procrit) has been under regulatory scrutiny because of potentially dangerous side effects.

"Unlike prior studies, this trial found that we didn't reduce blood transfusions, although it still increased hemoglobin levels," said study author Dr. Howard L. Corwin, a professor of medicine and anesthesiology at Dartmouth-Hitchcock Medical Center in Lebanon, N.H. "What we did find, particularly in trauma patients, was a reduction in mortality."

And this mortality benefit was likely due to other mechanisms of action caused by the drug. Once these mechanisms are understood, a whole new range of uses for the drug might be possible, the study authors said.

Overall, however, the drug did not seem to show an overwhelming benefit. "It didn't decrease the need for transfusions, which was the primary endpoint. And, in the majority of patients, which would be medical and surgical non-trauma patients, it did not improve survival," said Dr. Christian Cable, assistant professor of internal medicine at Texas A&M Health Science Center College of Medicine.

The study findings are published in the Sept. 6 issue of the New England Journal of Medicine.

Critically ill patients often develop anemia -- a decrease in the number of healthy red blood cells -- and require blood transfusions. But transfusions involve considerable risks, including death.

"It turns out that for most of the reasons transfusions are given, other than active bleeding, there is little evidence that they actually help and there is good evidence that red-blood-cell transfusions are associated with worse clinical outcomes," Corwin said.

The study authors hypothesized that giving epoetin alfa would reduce the need for transfusions. Epoetin alfa is a genetically engineered version of a natural protein, erythropoietin, which stimulates the bone marrow to make blood cells.

In May, a U.S. Food and Drug Administration advisory panel called for new warnings and additional safety studies on epoetin alfa and other anemia drugs, largely due to dangerous side effects such as the risk of blood clots, strokes, heart attacks and death.

In March, the FDA issued stronger label warnings for the popular drugs, which are also used for patients with chronic kidney failure and cancer.

And on Sept. 11, an FDA advisory panel is scheduled to meet to discuss new evidence on the safety of the drugs, although the panel will be looking at a different group of patients than those involved in this latest study.

For the study, the researchers enrolled 1,460 medical, surgical or trauma patients from 48 to 96 hours after admission to the intensive care unit. Each patient received either epoetin alfa or a placebo weekly for a maximum of three weeks, and all patients were followed for 140 days.

There was no difference in the number of patients who received a transfusion in the placebo or epoetin alfa group, or the number of red-cell units transfused, probably a result of changes in transfusion practice, Corwin said.

Side effects in general were comparable between the two groups, although clotting was higher in the epoetin alfa group. "That shouldn't be forgotten," Corwin said.

However, the concentration of hemoglobin, a protein in red blood cells that carries oxygen to tissues, did increase more in the epoetin alfa group than in the placebo group.

In addition, the mortality rate in patients receiving epoetin alfa was lower than among those receiving a placebo. That effect was most pronounced in trauma patients. "More research is needed to look at the trauma patients and the mechanism for epoetin alfa effect on mortality," Corwin said.

The beneficial mechanism appears to be something other than the drug's ability to enhance red blood cell formation.

"There's some data in animal studies and small clinical studies suggesting that epoetin alfa has a lot of other effects in addition to making blood cells, and we think it's one of these other mechanisms that is causing the mortality benefit," Corwin said.

"There is a whole range of other areas where epoetin alfa may have potential benefits through these other mechanisms," he continued. "This opens up a whole new area of study. There may be benefits in terms of function after strokes or head injury. There needs to be additional work to sort out the mechanisms responsible for this benefit."

More information

To learn more about these anemia drugs, visit the U.S. Food and Drug Administration.



SOURCES: Howard L. Corwin, M.D., professor, medicine and anesthesiology, Dartmouth-Hitchcock Medical Center, Lebanon, N.H.; Christian Cable, M.D., assistant professor, internal medicine, Texas A&M Health Science Center College of Medicine, and specialist, hematologic malignancies, Scott & White Hospital, Temple; Sept. 6, 2007, New England Journal of Medicine


'/>"/>
Copyright©2007 ScoutNews,LLC.
All rights reserved

Related medicine news :

1. Cancer Doctors Okays Controversial Prostate Therapy
2. Controversial deal on public access of the human genome map
3. Controversial Levis jean ad to be withdrawn
4. GMC Gives Controversial Fertility Doctor, A Clean Chit
5. Controversial Theory Says DNA Can Be Pushed To "Dark States"
6. Harvard Begins Controversial Human Stem Cell Cloning Project
7. Controversial Vaccine Raises Fury of the Church
8. The Controversial Stem Cell Transplant Surgery a Failure, Patient died
9. USDA Gives Go-Ahead to Market Controversial Genetically Engineered Rice, LL601
10. Ever-Controversial Mental Health Act To Be Decided Upon
11. Cancer Experts Received Threats for Opposing Controversial Drug
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:8/19/2017)... ... August 18, 2017 , ... ... Act of 2017, legislation that provides for greater public access to over-the-counter (OTC) ... loss to access OTC hearing aids without being seen by a certified and ...
(Date:8/19/2017)... ... August 19, 2017 , ... Praeclarus Press has launched ... illustrations show the diversity of the breastfeeding mothers, using bright colors and ... sizes. These illustrations are also available on tote bags, notepads, smartphone cases, clocks, ...
(Date:8/19/2017)... ... August 19, 2017 , ... Physician Partners of ... location as an interventional pain management physician. He brings a wealth of pain ... migraine headaches, and significant experience in spinal cord stimulation for chronic pain. , ...
(Date:8/18/2017)... ... August 18, 2017 , ... More than 20,000 pairs of ... Congo (DRC) thanks to an ambitious venture that conjoined the passions of an NBA ... support of the Liberty community. These shoes will save lives from the rampant infections ...
(Date:8/18/2017)... ... August 18, 2017 , ... Mediaplanet today ... for active, healthy lifestyles and highlighting the importance of proactive eye and ear ... and shares the latest innovations in hearing aid technology. , In this ...
Breaking Medicine News(10 mins):
(Date:8/17/2017)... 2017 DarioHealth Corp. (NASDAQ: DRIO), a ... and big data solutions, announced today that it ... non-U.S. investors for the sale of shares of ... Company,s newly designated Series B Convertible Preferred Stock ... to conduct a closing with respect to the ...
(Date:8/15/2017)... 15, 2017 AccuGenomics, Inc., a diagnostic company ... announced that the company has provided an AccuKit to ... Carolina at Chapel Hill and to Qura Therapeutics for ... and quantify HIV reservoir and viral expression in human ... HIV Cure Center is a joint initiative between the ...
(Date:8/8/2017)... Israel, Aug. 8, 2017  BioLineRx Ltd. (NASDAQ/TASE: BLRX), ... today reports its financial results for the second quarter ... during the second quarter 2017 and to date: ... clinical development programs for the Company,s lead project, BL-8040: ... pivotal study with BL-8040 as novel stem cell mobilization ...
Breaking Medicine Technology: