Navigation Links
For Some on Dialysis, Anemia Drugs Pose Risks
Date:3/2/2010

But experts say not using them would lower people's quality of life,,

TUESDAY, March 2 (HealthDay News) -- Powerful drugs that treat the anemia caused by kidney failure yield mixed results, depending on the severity of the anemia, a new study has shown.

People on dialysis with severe anemia, according to the study, tend to live longer when given high doses of the drugs -- known as erythropoiesis-stimulating agents (ESAs) and marketed as Epogen, Procrit and Aranesp. But it found that the drugs increase the risk for dying prematurely among people with mild anemia.

ESAs, which increase the production of red blood cells, are approved by the U.S. Food and Drug Administration to treat the anemia caused by cancer chemotherapy and AIDS drugs as well as kidney failure. But safety concerns have limited their use, especially among cancer patients.

Over the next few months, the FDA and the U.S. Centers for Medicare and Medicaid Services plan to review the use of ESAs in the treatment of anemic people with kidney disease. The researchers noted that ESAs are the most expensive drugs approved by Medicare for people needing long-term dialysis, with the agency spending about $2 billion a year on them.

"ESAs are the mainstay of treatment in these patients," said study author Dr. Wolfgang C. Winkelmayer, an associate professor of nephrology at Stanford University School of Medicine. "Almost 95 percent of those patients receive them."

By taking ESAs, people on dialysis who are anemic need fewer blood transfusions.

"What we did learn from our study," Winkelmayer said, "is that there is actually a benefit in mortality if you treat aggressively at the low end of hematocrits," which refers to the percent of blood that's made up of red cells.

"These findings clearly justify the use of ESAs beyond just to avoid transfusions, and using ESA might be good practice," he said.

The findings are reported in the March 3 issue of the Journal of the American Medical Association.

For the study, Winkelmayer's team looked at how ESAs were used in about 4,500 dialysis centers across the United States, analyzing data from people treated with ESAs and intravenous iron. They then looked at one-year death rates among the centers' patients.

The researchers found that people with the most severe anemia, with a hematocrit of less than 30 percent, benefited most from aggressive treatment with ESAs, while those with less severe anemia did not. The lower the hematocrit, the more anemic the person.

Less anemic people, those with hematocrits greater than 36 percent, had an 11 percent higher risk for dying if they received aggressive ESA treatment than did similar people whose anemia was treated less aggressively. Among those with hematocrits of 30 percent and 36 percent, aggressive or non-aggressive treatment with ESAs had no effect on mortality, the researchers found.

The findings for treatment with intravenous iron were the same as those for ESAs, Winkelmayer said. Centers that used more aggressive treatment with intravenous iron at low hematocrit had better outcomes, and more aggressive iron use among people with relatively higher hematocrit was associated with more deaths, he noted.

Anemia is a common complication of kidney disease. There are three ESAs sold in the United States to treat anemia: darbepoetin alfa, marketed by Amgen as Aranesp, and epoetin alfa, marketed by Amgen as Epogen and by Johnson & Johnson as Procrit.

ESAs were introduced in 1989, but safety questions have come to light that have brought their use into question. For example, the drugs were promoted as a way to counter the debilitating effects of chemotherapy, but studies have found that the drugs can cause tumors to grow faster, shortening people's lives.

In cancer patients, the drugs are now mostly used as palliative care for terminal patients.

In addition, on Feb. 16, the FDA began requiring doctors to undergo special training before prescribing ESAs for cancer patients.

For people with kidney disease, the FDA says that using ESAs "can increase the risk for stroke, heart attack, heart failure, blood clots and death." The agency last year required the makers of these drugs to place a black-box warning on their labels, alerting doctors to these risks.

Winkelmayer said that not using the drugs would take treatment back to a time when dialysis patients needed many transfusions and had a poorer quality of life. "Not using these drugs is really not an option, in my opinion, but we should be smart about how we use them," he said.

Dr. Ajay K. Singh, an associate professor of medicine at Harvard Medical School and the Brigham and Women's Hospital in Boston, said that "treating anemia of kidney disease is a hot issue this year."

Another recent study showed minimal benefit but an increased risk of stroke, clotting and cancer-related deaths in diabetic patients with kidney disease who were treated with Aranesp, Singh said. "The FDA plans to convene another public advisory committee, and Medicare is looking to modify the conditions of coverage for ESAs."

"Questions are being asked again about the safety of ESAs," he said.

As for the latest findings, Singh said: "I doubt that this study will change our view of how anemia should be treated in dialysis patients, but it is one more study showing that high dosages of ESAs may be associated with risk under certain circumstances."

More information

The U.S. Food and Drug Administration has more on ESAs.



SOURCES: Wolfgang C. Winkelmayer, M.D., Sc.D., associate professor, nephrology, Stanford University School of Medicine, Stanford, Calif.; Ajay K. Singh, M.D., associate professor, medicine, Harvard Medical School, and renal division, Brigham & Women's Hospital, Boston; March 3, 2010, Journal of the American Medical Association


'/>"/>
Copyright©2010 ScoutNews,LLC.
All rights reserved

Related medicine news :

1. For People on Dialysis, Too Thin Can Be Risky
2. FDA Tightens Controls on Anemia Drugs
3. Anemia drug not helpful for kidney disease patients
4. Anemia Drugs May Cause Deadly Blood Clots
5. Drugs to treat anemia in cancer patients linked to thromboembolism
6. Will New Anemia Drug Top Current Treatments?
7. Anemia Drug May Raise Stroke Risk in Kidney Patients
8. Large Study of Anemia Treatment in Chronic Kidney Disease Patients Not on Dialysis Published in the New England Journal of Medicine Failed to Meet Primary Efficacy Endpoints
9. Replication at DNA damage sites highlights Fanconi anemia and breast cancer proteins
10. How to confirm the causes of iron deficiency anemia in young women
11. Anemia associated with greater risk of death in heart disease patients
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/25/2016)... , ... June 25, 2016 , ... Austin residents seeking ... American College of Mohs Surgery and to Dr. Russell Peckham for medical and surgical ... effective treatment for skin cancer. The selective fellowship in Mohs Micrographic Surgery completed by ...
(Date:6/25/2016)... , ... June 25, 2016 , ... "With 30 hand-drawn ... specific project," said Christina Austin - CEO of Pixel Film Studios. , ProHand ... all within Final Cut Pro X . Simply select a ProHand generator and ...
(Date:6/25/2016)... ... June 25, 2016 , ... As a lifelong Southern ... Laude and his M.D from the David Geffen School of Medicine at UCLA. He ... Los Angeles to complete his fellowship in hematology/oncology at the UCLA-Olive View-Cedars Sinai program ...
(Date:6/25/2016)... , ... June 25, 2016 , ... On Friday, June ... a Bronze Wellness at Work award to iHire in recognition of their exemplary accomplishments ... of the 7th annual Maryland Workplace Health & Wellness Symposium at the BWI Marriott ...
(Date:6/24/2016)... Los Angeles, CA (PRWEB) , ... June 24, 2016 , ... ... plastic surgery procedures that most people are unfamiliar with. The article goes on to ... known procedures, but also many of these less common operations such as calf and ...
Breaking Medicine News(10 mins):
(Date:6/24/2016)... 24, 2016  Collagen Matrix, Inc., ("Collagen Matrix") ... manufacturing of collagen and mineral based medical devices ... Bill Messer has joined the company ... leverage the growing portfolio of oral surgery, neurosurgery, ... Bill joins the Collagen Matrix executive team as ...
(Date:6/24/2016)... Dublin - ... " Global Markets for Spectroscopy Equipment" report ... This report focuses on the global market of ... applications in various applications. The report deals with spectroscopy ... industries: pharmaceutical and biotechnology, food and beverage, and environmental ...
(Date:6/24/2016)... Dehaier Medical Systems Ltd. (NASDAQ: DHRM ) ... medical devices and wearable sleep respiratory products in ... with Hongyuan Supply Chain Management Co., Ltd. (hereinafter referred ... to develop Dehaier,s new Internet medical technology business. ... Hongyuan Supply Chain,s sales platform to reach Dehaier,s dealers ...
Breaking Medicine Technology: