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:6/27/2016)... ... June 27, 2016 , ... TopConsumerReviews.com recently awarded their highest five-star ... , Millions of individuals in the United States and Canada wear eyeglasses. Once considered ... both correct vision and make a fashion statement. Even celebrities use glasses as a ...
(Date:6/26/2016)... ... June 26, 2016 , ... Pixel Film Studios Released ProSlice Levels, a Media ... give their videos a whole new perspective by using the title layers in ... Studios. , ProSlice Levels contains over 30 Different presets to choose from. ...
(Date:6/26/2016)... , ... June 26, 2016 , ... ... once they have been diagnosed with endometriosis. These women need a treatment plan ... require a comprehensive approach that can help for preservation of fertility and ultimately ...
(Date:6/25/2016)... ... June 25, 2016 , ... The temporary closing of Bruton Memorial Library on June ... , brings up a new, often overlooked aspect of head lice: the parasite’s ability to ... is not a common occurrence, but a necessary one in the event that lice have ...
(Date:6/25/2016)... (PRWEB) , ... June 25, 2016 , ... As a ... Magna Cum Laude and his M.D from the David Geffen School of Medicine at ... returned to Los Angeles to complete his fellowship in hematology/oncology at the UCLA-Olive View-Cedars ...
Breaking Medicine News(10 mins):
(Date:6/26/2016)... One of Australia,s successful biotechnology ... a new biotechnology company, Noxopharm Limited [ABN 50 608 966 123] ... to list on the ASX. Noxopharm is a clinic-ready ... a Phase 1 clinical study later this year. ... the biggest problems facing cancer patients - the ability of cancers ...
(Date:6/26/2016)... Jazz Pharmaceuticals plc (Nasdaq: JAZZ ... Antitrust Improvements Act of 1976, as amended ("HSR"), with ... ("Celator"; Nasdaq: CPXX ) expired effective June ... As previously announced on May 31, 2016, Jazz ... under which Jazz Pharmaceuticals has commenced a tender offer ...
(Date:6/26/2016)...  VMS Rehab Systems, Inc. ( www.vmsrehabsystemsinc.com ) reported ... required to build a strong and stable market for ... on the OTC Markets-pink current trading platform. ... are seeing an anomaly in market trading activities that ... the Company, but shareholders and market players as well. ...
Breaking Medicine Technology: