Nov 18/2006
High-Dose Anemia Drug May Have Risks - Article from WebMD.
Analysis: Concerns on Amgen Anemia Drug - Article from UPI via Science Daily.
Reversing Anemia Can Threaten Kidney Patients - Article from HealthDay News via Yahoo.
What do you think?
Jessie and Richard
[quote=Jessie St Amour;11158]Nov 18/2006
High-Dose Anemia Drug May Have Risks - Article from WebMD.
Analysis: Concerns on Amgen Anemia Drug - Article from UPI via Science Daily.
Reversing Anemia Can Threaten Kidney Patients - Article from HealthDay News via Yahoo.
What do you think?
Jessie and Richard[/quote]
Not too bad, only if it ain’t beeing managed right. For example, people with high blood pressure getting EPO may be at higher risk…
I think this is definitely something that needs to be given further study. I think it has a lot more to do with the dose amount than rather or not a person has high blood pressure. I believe the articles I read were saying patients didn’t feel much better at the higher dose and it was showing more patients were having problems on the high dose. I think I would question my nephrologist if the hemoglobin got to 13 and he didn’t want to cut back.
The following article was posted at dialysis_support today. Sounds promising:
"Vitamin E-Coated Dialysis Filters Help Fight Anemia in Hemodialysis Patients
For patients on hemodialysis, the use of dialysis filters coated with
vitamin E may provide a simple new approach to the common problem of anemia,
reports a paper presented at the American Society of Nephrology’s 39th Annual
Meeting and Scientific Exposition in San Diego.
Newswise — For patients on hemodialysis, the use of dialysis filters coated
with vitamin E may provide a simple new approach to the common problem of
anemia, reports a paper presented at the American Society of Nephrology’s 39th
Annual Meeting and Scientific Exposition in San Diego.
Dr. Dinna Cruz and colleagues of San Bartolo Hospital in Vicenza, Italy,
analyzed the outcomes of 172 patients in Italian dialysis centers who were
switched from “regular” dialysis filters to new filters coated with vitamin E.
“Vitamin E has long been known for its antioxidant properties, but oral vitamin
E has not been helpful in treating dialysis-related anemia, or low red blood
cell count,” Dr. Cruz explains. “We hoped that these newly invented vitamin
E-containing dialysis filters would have some antioxidant
properties—scavenging
free radicals that may cause damage to cells in the body, including red
blood cells.”
The patients’ red blood cell counts levels increased significantly after the
switch to vitamin E-coated filters and remained increased throughout the
one-year study. By the end of the year, the percentage of hemodialysis patients
who were at target red blood cell counts—that is, without anemia—had
increased from about 50 to 80 percent.
The patients also had a significant reduction in their required dose of the
hormone erythropoietin (EPO). Normally produced by the kidneys, EPO fights
anemia by inducing the bone marrow to make red blood cells and prolonging the
life span of existing red blood cells. By the end of the study year, the
average dose of synthetic EPO had decreased by about 23 percent, especially
important considering the high cost of EPO treatment.
Anemia is one of the most frequent complications of hemodialysis and is a
common cause of death in dialysis-dependent patients. “Many factors contribute
to this anemia, including low levels of EPO, iron and vitamin deficiency,
‘underdialysis,’ and inflammation and oxidant stress,” says Dr. Cruz. The use of
synthetic EPO, along with intravenous iron, has been a major advance in the
treatment of hemodialysis-related anemia, yet low blood counts continue to be
a problem for many dialysis patients.
“We were gratified to see that the use of newer vitamin E-coated filters,
which were designed to reduce oxidative stress, had visible clinical benefits,”
Dr. Cruz concludes. “Our patients’ red blood cell counts improved within the
first six months, and they needed much lower doses of synthetic EPO.” With
further research, vitamin E-coated filters could become a simple and practical
way of reducing a common and important complication of hemodialysis.
The study abstract, “Effect of Vitamine E Coated Filter on Anemia in HD
Patients� (SA-PO026) will be presented as part of a Poster Presentation on the
topic of “Anemia in Dialysis� on Saturday, November 18 from 10:00 am-Noon in
Halls A/B/C of the San Diego Convention Center.
The ASN is a not-for-profit organization of 9,500 physicians and scientists
dedicated to the study of nephrology and committed to providing a forum for
the promulgation of information regarding the latest research and clinical
findings on kidney diseases. ASN’s Renal Week 2006, the largest nephrology
meeting of its kind, will provide a forum for 10,000 nephrologists, to discuss
the
latest findings in renal research and engage in educational sessions relating
advances in the care of patients with kidney and related disorders from
November 14-19 at the San Diego Convention Center in San Diego, CA."
"Warning about Procrit, Epogen, and Aranesp
Posted November 17 o6
http://www.fda.gov/medwatch/safety/2006/safety06.htm#erythropoiesis
(http://www.fda.gov/medwatch/safety/2006/safety06.htm#erythropoiesis)
Erythropoiesis Stimulating Agents
Procrit, Epogen, and Aranesp
Audience: Oncologists, Nephrologists, and other healthcare professionals
Indication: Treatment of anemia associated with chronic renal failure,
including patients on dialysis and patients not on dialysis.
[Posted 11/17/2006] FDA notified healthcare professionals of a newly
published clinical study showing that patients treated with an
erythropoiesis-stimulating agent (ESA) and dosed to a target hemoglobin
concentration of 13.5 g/dL
are at a significantly increased risk for serious and life threatening
cardiovascular complications, as compared to use of the ESA to target a
hemoglobin
concentration of 11.3 g/dL. The “Correction of Hemoglobin and Outcomes in
Renal Insufficiency� study, published November 16, 2006 in the New England
Journal of Medicine, reports the adverse cardiovascular complications as a
composite of the occurrence of one of the following events: death, myocardial
infarction, hospitalization for congestive heart failure, or stroke.
The study findings underscore the importance of following the currently
approved prescribing information for Procrit, Epogen, and Aranesp, including the
dosing recommendation that the target hemoglobin not exceed 12 g/dL."
"Hasten down the wireHome | About | Archives | Wiki | FeedbackAnemia or heart problems: take your pick
By Michael Fraase
Thursday, 16 November 2006 08:56PM CST
Section: ESRD
Almost all dialysis patients receive relatively high doses of epoetin (“epo”) as treatment for anemia, one of the complications of end-stage renal disease (permanent kidney failure). A New England Journal of Medicine study released today indicates that these high epo doses may raise the risk of heart problems and death. The study found that kidney failure patients who were not yet on dialysis who received enough epo to almost fully correct their anemia were 34 percent more likely to develop heart problems or die than those whose anemia was treated less aggressively. Dr. Ajay Singh, an associate professor at Harvard Medical School, and the study’s lead researcher, told the New York Times that the study’s results would apply to dialysis patients as well.
This study’s findings are nearly identical to those of a study earlier this year.
Epo sales are big business for pharmaceutical companies and for the dialysis centers that provide the injections. The two companies that make the drug sold more than US$9 billion worth last year and dialysis centers see higher profits with larger epo doses. According to Alex Berenson’s report in the New York Times, “In the first nine months of 2006, Amgen sold $4.9 billion of Aranesp and Epogen, accounting for almost half its revenue. Sales of the two drugs rose almost 15 percent compared with the period in 2005.”
The epo dosage levels in US patients have nearly tripled in the last decade while dosages in European patients has remained lower. Almost 25 percent of US dialysis patients die annually, compared to 15 percent of European patients.
A US Food and Drug Administration (FDA) spokeswoman told the New York Times that the agency would “release a more complete advisory today” with regard to epo dosages.
So, how much epo is too much? The FDA guidelines call for enough epo to reach a target hemoglobin level of 10-12 grams per deciliter of blood (healthy men have hemoglobin levels of at least 14 grams per deciliter). In the general population, treatment is believed to be necessary when hemoglobin levels fall below 10 grams per deciliter. National Kidney Foundation guidelines call for hemoglobin levels of 11-13 grams per deciliter but Amgen sponsored the development of those guidelines.
There doesn’t seem to be much difference between the two guidelines, but the Singh study used an average “low” dose of 11.3 grams and an average “high” dose of 12.6 grams and found a 34 percent greater incidence of death and heart attack in the “high” dosage group. What appears to be minor is in fact a very big deal.
According to the New York Times report, DaVita is especially aggressive with epo dosages: “A paper that will be presented Saturday at the American Society of Nephrology’s annual conference in San Diego found that 37 percent of Davita patients reported hemoglobin levels greater than 14 grams at least once in a nine-month period, an abstract of the paper posted online said.”
This is bad news for dialysis patients. Take smaller doses of epo and feel crappy most of the time or take higher doses and risk heart attack or death.
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[QUOTE=Heather1;11182]The following article was posted at dialysis_support today. Sounds promising:
"Vitamin E-Coated Dialysis Filters Help Fight Anemia in Hemodialysis Patients
For patients on hemodialysis, the use of dialysis filters coated with
vitamin E may provide a simple new approach to the common problem of anemia,
reports a paper presented at the American Society of Nephrology’s 39th Annual
Meeting and Scientific Exposition in San Diego.
Newswise — For patients on hemodialysis, the use of dialysis filters coated
with vitamin E may provide a simple new approach to the common problem of
anemia, reports a paper presented at the American Society of Nephrology’s 39th
Annual Meeting and Scientific Exposition in San Diego.
Dr. Dinna Cruz and colleagues of San Bartolo Hospital in Vicenza, Italy,
analyzed the outcomes of 172 patients in Italian dialysis centers who were
switched from “regular” dialysis filters to new filters coated with vitamin E.
“Vitamin E has long been known for its antioxidant properties, but oral vitamin
E has not been helpful in treating dialysis-related anemia, or low red blood
cell count,” Dr. Cruz explains. “We hoped that these newly invented vitamin
E-containing dialysis filters would have some antioxidant
properties—scavenging
free radicals that may cause damage to cells in the body, including red
blood cells.”
The patients’ red blood cell counts levels increased significantly after the
switch to vitamin E-coated filters and remained increased throughout the
one-year study. By the end of the year, the percentage of hemodialysis patients
who were at target red blood cell counts—that is, without anemia—had
increased from about 50 to 80 percent.
The patients also had a significant reduction in their required dose of the
hormone erythropoietin (EPO). Normally produced by the kidneys, EPO fights
anemia by inducing the bone marrow to make red blood cells and prolonging the
life span of existing red blood cells. By the end of the study year, the
average dose of synthetic EPO had decreased by about 23 percent, especially
important considering the high cost of EPO treatment.
Anemia is one of the most frequent complications of hemodialysis and is a
common cause of death in dialysis-dependent patients. “Many factors contribute
to this anemia, including low levels of EPO, iron and vitamin deficiency,
‘underdialysis,’ and inflammation and oxidant stress,” says Dr. Cruz. The use of
synthetic EPO, along with intravenous iron, has been a major advance in the
treatment of hemodialysis-related anemia, yet low blood counts continue to be
a problem for many dialysis patients.
“We were gratified to see that the use of newer vitamin E-coated filters,
which were designed to reduce oxidative stress, had visible clinical benefits,”
Dr. Cruz concludes. “Our patients’ red blood cell counts improved within the
first six months, and they needed much lower doses of synthetic EPO.” With
further research, vitamin E-coated filters could become a simple and practical
way of reducing a common and important complication of hemodialysis.
The study abstract, “Effect of Vitamine E Coated Filter on Anemia in HD
Patients� (SA-PO026) will be presented as part of a Poster Presentation on the
topic of “Anemia in Dialysis� on Saturday, November 18 from 10:00 am-Noon in
Halls A/B/C of the San Diego Convention Center.
The ASN is a not-for-profit organization of 9,500 physicians and scientists
dedicated to the study of nephrology and committed to providing a forum for
the promulgation of information regarding the latest research and clinical
findings on kidney diseases. ASN’s Renal Week 2006, the largest nephrology
meeting of its kind, will provide a forum for 10,000 nephrologists, to discuss
the
latest findings in renal research and engage in educational sessions relating
advances in the care of patients with kidney and related disorders from
November 14-19 at the San Diego Convention Center in San Diego, CA."[/QUOTE] Thanks for the info my son’s neph wwill be aware of this to-day when we meet … thanks again
http://www.gooznews.com/archives/000543.html
The above is a provocative blog post titled: Amgen, NKF and the Dialysis Killing Fields
That is an interesting blog. The question of whether Hgbs in people on dialysis should be raised to levels that are normal for the general public has been asked pretty much since Epogen came on the market in 1989. It takes large, well-powered studies to detect this–and one of them came out during the deliberations for the first set of DOQI Anemia guidelines in 1996. That study included people with severe heart problems and was ended early due to a higher death rate among people who were brought up to normal. The findings of this most recent study are not new, then, just confirmatory.
It seems logical that folks on dialysis should have the same Hgb levels as folks who are not–but research suggests that this is not the case. I suspect–with no data–that part of the issue may be the fast in-center HD treatments done in the US, with high ultrafiltration rates. During an HD treatment, water can only be removed from the bloodstream (where only 15% of the water in the body resides). When several liters of fluid are pulled off during the “average” 3.5 hour treatment, the blood gets thicker which can cause more problems with access clotting (so can episodes of low blood pressure) and heart issues. So, I have to wonder whether a normal Hgb would not be harmful in a short daily, nocturnal HD, or even a PD patient… I don’t believe this study has been done, nor are the numbers likely big enough (or the interest there) to do it. But you have to wonder.
IMHO, the other issue is quality of life vs. length of life. Folks on dialysis have passionately and articulately described how it feels to have a lower vs. a higher Hgb, and the differences are important. If it were me, I’d want to have the information and weigh for myself the risks of being “overcorrected” vs. feeling too fatigued to work, travel, or have a normal life. I might just choose to risk an early death for a fuller life. Others might or might not.
According to the New York Times report, DaVita is especially aggressive with EPO dosages: “A paper that will be presented Saturday at the American Society of Nephrology’s annual conference in San Diego found that 37 percent of Davita patients reported hemoglobin levels greater than 14 grams at least once in a nine-month period, an abstract of the paper posted online said.”
It is interesting to me that the very first “issue” addressed by Davita Patient Citizens was CMS’s EPO reimbursement policy. Of all the issues of potential concern to dialyzors EPO reimbursement policy struck me as an odd issue with which to launch an advocacy group.
I listened in on the first couple of DPC phone calls and while people had other concerns that they thought needed addressing the decision was already made that EPO reimbursement policy would be the first issue the group addressed. In all of the discussions there was never any mention of possible clinical side effects of high EPO doses and even now looking at the DPC website there is no mention of the recent studies, let alone an apology for advocating for policy changes that may harm dialyzors.
I think the DPC has some explaining to do.
[QUOTE=Bill Peckham;11316]It is interesting to me that the very first “issue” addressed by Davita Patient Citizens was CMS’s EPO reimbursement policy. Of all the issues of potential concern to dialyzors EPO reimbursement policy struck me as an odd issue with which to launch an advocacy group.
I listened in on the first couple of DPC phone calls and while people had other concerns that they thought needed addressing the decision was already made that EPO reimbursement policy would be the first issue the group addressed. In all of the discussions there was never any mention of possible clinical side effects of high EPO doses and even now looking at the DPC website there is no mention of the recent studies, let alone an apology for advocating for policy changes that may harm dialyzors.
I think the DPC has some explaining to do.[/QUOTE]
My family and I listened in on the first couple of DPC tele meetings, too. We were appalled at what we heard! In the first place, we called in to see what this group was about as we couldn’t imagine DaVita organizing an advocacy group for patients. Our family member had been in several different DaVita units and each was dirty, staff inadequately educated and lack of responsiveness to patient concerns. As Bill said, the issue they kept the meeting focused on was higher reimbursement for EPO, a strange choice in light of all the other issues of concern to patients. There was a call-in time and as patients from all over the country brought up their concerns, the patient group leaders cut them off abruptly and told them if they had any problems to take it up with their units. As far as we were concerned, this group is a guize for getting patients to support higher reimbursements. We have read that the group is now totally independent from DaVita, yet it still carries the DaVita name. We would never support this group! This is NOT our idea of patient advocacy.
HI Folks
I’m in a davita and they do push EPO like it a dime a dozen. Saw this today
bobeleanor
Interesting article - my beef with Amgen is that everytime an increase was approved in the composite rate - meaning the rate a company is paid for each dialysis treatment from CMS - Amgen would also increase the cost of EPOGEN, therefore eating up any extra money the company received from the increase - monies I had hoped would be used to update facility equipment, amenities for patients, salaries to retain good staff, etc. I am still not sure this proposed method of payment is the correct way to go, however.
I am worried that bundling will lead to low hematocrits e.g. hematocrits below 33 or to a rollercoaster ride cycle of high and low hematacrits because EPO will be just another cost center and dosing will be conservative.
When Medicare proposes these reimbursement guidelines their goal is an improved quality of life for those on dialysis. Looking only at stroke deaths or EPO costs gives an incomplete picture. Costs and downside risk are only a part of the equation; at this point I have not seen any discussion or comment about the benefits of this reimbursement policy from the point of view of the one on dialysis.
Bundling probably would save money but would the savings be a good value?
Hi Folks
My beef with this whole mess is that if you look at the stocks that every company that has (or almost all) something to do with dialysis are not going broke. I’m all for a company to make $$ but I don’t want hear dialysis company (all companies) saying they are going broke.
The way to save money is to push people into home programs, at least those people deemed fit to handle home dialysis. This has to come from the all the people CMS, etc.
bobeleanor
I don’t think the recent focus on EPO dosing is about provider profits - it is much more about Amgen profits. Here is a alternative scenario about why this has come up now - it’s preemptive. If this could be addressed in the last days of the Republican Congress than maybe it will preempt taking a look at EPO costs under a Democratic Congress.
The Deomcrats are more inclined towards the money saving tactic of negotiating drug prices directly, using CMS’s huge buying power to force discounts.
Tweeking at what hematocrit to taper or stop EPO would not save as much money as negotiating a lower price.