Navigation Links
Anemia Drug May Raise Stroke Risk in Kidney Patients
Date:10/31/2009

Use of Aranesp should be reserved for the most seriously ill, experts say

SATURDAY, Oct. 31 (HealthDay News) -- A drug designed to fight anemia appears to double the risk of stroke in patients with diabetes and kidney disease without substantially improving their quality of life, a new study finds.

Darbepoetin alfa, marketed as Aranesp and known as an erythropoiesis-stimulating agent (ESA), is often prescribed for diabetic patients with chronic kidney disease and mild anemia.

"The benefits we assumed we would have by treating anemia were less striking and the risks were more striking," said lead researcher Dr. Marc A. Pfeffer, a professor of medicine in the cardiovascular division of Brigham and Women's Hospital in Boston.

"This provides new data for doctors and patients to make their own risk-benefit assessment," he said. "There was a perception that treating anemia would make people feel so much better that we'll take risks, but the benefit in quality of life was not as great as we thought, and there was a clear doubling of your risk for a stroke."

The report was published in the Oct. 30 online edition of the New England Journal of Medicine to coincide with its scheduled presentation at the annual meeting of the American Society of Nephrology in San Diego.

For the study, Pfeffer's team randomly assigned more than 4,000 patients with diabetes, chronic kidney disease and anemia to receive Aranesp or placebo. During the study, 632 patients receiving Aranesp died or suffered a cardiovascular event, compared to 602 of the patients receiving placebo.

As well, 101 patients taking Aranesp had a fatal or non-fatal stroke compared with 53 of the placebo patients, the researchers found. In addition, patients taking Aranesp reported only a modest improvement in their fatigue, the researchers noted.

In earlier studies, Aranesp and a similar drug, epoetin alfa, marketed as Procrit or Epogen, were linked to increased risk of death in cancer and stroke patients.

Pfeffer believes that people with more severe kidney disease, such as those on dialysis, might still find Aranesp beneficial and the risk acceptable.

"People on dialysis generally feel even worse and generally have even more severe anemia, and this class of therapy has been very helpful to them," he said.

Because the drug was beneficial to these patients, doctors assumed it would help less severely anemic patients, Pfeffer said.

"But this use of ESAs exceeded the data," he said. "Now we have the data, and we will revisit how the drug is used now."

Dr. Phillip Marsden, a professor of medicine at the University of Toronto and author of an accompanying journal editorial, said these findings mean that doctors and patients will have to discuss whether or not to start the medication.

"For most of these patients, the modest improvement in quality of life will not be enough to subject themselves to the increased risk of stroke and death," he said.

ESAs have been used for two decades, Marsden noted. "It is a bit shocking that it took us 20 years to address whether or not these drugs were safe -- and now we know more."

Dr. Ajay Singh, clinical chief of the renal division and director of dialysis at Brigham and Women's Hospital, said this "landmark study" raises the fundamental question of whether epoetin or darbepoetin should routinely be used in treating anemia of chronic kidney disease.

"Earlier studies raised the specter of increased risk with ESA treatment. This study definitively confirms that there is meaningful risk with routine use of ESAs," said Singh, also an associate professor of medicine at Harvard Medical School.

"In my own practice, I will be cautious in using ESAs for most patients with chronic kidney disease, balancing risk with benefits and reserving treatment largely for patients who need frequent blood transfusions or who are candidates for a kidney transplant," he said.

More information

For more information on ESAs, visit the U.S. Food and Drug Administration.



SOURCES: Marc A. Pfeffer, M.D., Ph.D., professor of medicine, cardiovascular division, Brigham and Women's Hospital, Boston; Phillip Marsden, M.D., professor of medicine, University of Toronto, Canada; Ajay Singh, M.D., clinical chief, renal division, director, dialysis, Brigham and Women's Hospital, and associate professor, medicine, Harvard Medical School, Boston; Oct. 30, 2009, New England Journal of Medicine, online


'/>"/>
Copyright©2009 ScoutNews,LLC.
All rights reserved

Related medicine news :

1. Anemia and tropical diseases; Is pharmacogenomics ready for the clinic?
2. Controversial Anemia Drug Doesnt Cut Need for Transfusions
3. Cancer Doctors Across America Stunned at Governments Ruling Restricting Anemia Management Protocols for Cancer Patients, Call Ruling Interference in Practice of Medicine
4. Simpler Anemia Treatment May Help Kidney Patients
5. FDA Issues New Warnings for Anemia Drugs
6. New anemia measure predicts risk of death in dialysis patients
7. FDA Approves MIRCERA(R): First Renal Anemia Treatment with Monthly Maintenance Dosing
8. New Kind of Stem Cells Reverse Sickle Cell Anemia
9. Evidence links anemia drugs with leukemic transformation in patients with primary myelofibrosis
10. Modeling Simulation Predicts Potential Negative Impact on U.S. Blood Supply if ESA Use Limited for Chemotherapy-Induced Anemia
11. FDA Reports New Risks Posed by Anemia Drugs
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/25/2016)... ... June 25, 2016 , ... "With 30 hand-drawn hand gesture animations, ... Christina Austin - CEO of Pixel Film Studios. , ProHand Cartoon’s package transforms ... Final Cut Pro X . Simply select a ProHand generator and drag it above ...
(Date:6/25/2016)... ... June 25, 2016 , ... On Friday, June 10, Van Mitchell, ... at Work award to iHire in recognition of their exemplary accomplishments in worksite health ... annual Maryland Workplace Health & Wellness Symposium at the BWI Marriott in Linthicum Heights. ...
(Date:6/24/2016)... ... June 24, 2016 , ... June 19, 2016 is World ... with chronic pain and the benefits of holistic treatments, Serenity Recovery Center ... with Sickle Cell Disease. , Sickle Cell Disease (SCD) is a disorder of the ...
(Date:6/24/2016)... ... June 24, 2016 , ... Dr. Amanda ... orthodontic treatment. Dr. Cheng has extensive experience with all areas of orthodontics, including ... accelerated osteogenic orthodontics. , Micro-osteoperforation is a revolutionary adjunct to orthodontic treatment. ...
(Date:6/24/2016)... ... June 24, 2016 , ... EB Medicine presented its ... Emergency Medicine conference in Ponte Vedra Beach, FL. The awards honor the outstanding ... Medicine Practice and Pediatric Emergency Medicine Practice. , “With this award, we ...
Breaking Medicine News(10 mins):
(Date:6/23/2016)... 2016 Research and Markets has ... by Type (Organic Chemical (Sugar, Petrochemical, Glycerin), Inorganic Chemical), ... Parenteral) - Global Forecast to 2021" report to ... The global pharmaceutical excipients market is projected to reach ... 6.1% in the forecast period 2016 to 2021. ...
(Date:6/23/2016)... , June 23, 2016 ... CAPR ), a biotechnology company focused on ... today announced that patient enrollment in its ongoing ... Duchenne) has exceeded 50% of its 24-patient target. ... in the third quarter of 2016, and to ...
(Date:6/23/2016)... and INDIANAPOLIS , June 23, 2016 ... Lilly Diabetes Tomorrow,s Leaders Scholarship is any indication, the ... announced today online at www.diabetesscholars.org by the ... diabetes stand in the way of academic and community ... Foundation,s scholarship program since 2012, and continues to advocate ...
Breaking Medicine Technology: