Iron is good for you!
Mike Collins
Published at www.nejm.org November 17, 2009 (10.1056/NEJMoa0908355)
Ferric Carboxymaltose in Patients with Heart Failure and Iron
Deficiency
Stefan D. Anker, M.D., Ph.D., Josep Comin Colet, M.D., Gerasimos
Filippatos, M.D., Ronnie Willenheimer, M.D., Kenneth Dickstein, M.D.,
Ph.D., Helmut Drexler, M.D., Thomas F. Lüscher, M.D., Boris Bart,
M.D., Waldemar Banasiak, M.D., Ph.D., Joanna Niegowska, M.D., Bridget-
Anne Kirwan, Ph.D., Claudio Mori, M.D., Barbara von Eisenhart Rothe,
M.D., Stuart J. Pocock, Ph.D., Philip A. Poole-Wilson, M.D., Piotr
Ponikowski, M.D., Ph.D., for the FAIR-HF Trial
Investigators
ABSTRACT
Background Iron deficiency may impair aerobic performance. This study
aimed to determine whether treatment with intravenous iron (ferric
carboxymaltose) would improve symptoms in patients who had heart
failure, reduced left ventricular ejection fraction, and iron
deficiency, either with or without anemia.
Methods We enrolled 459 patients with chronic heart failure of New
York Heart Association (NYHA) functional class II or III, a left
ventricular ejection fraction of 40% or less (for patients with NYHA
class II) or 45% or less (for NYHA class III), iron deficiency
(ferritin level <100 µg per liter or between 100 and 299 µg per liter,
if the transferrin saturation was <20%), and a hemoglobin level of 95
to 135 g per liter. Patients were randomly assigned, in a 2:1 ratio,
to receive 200 mg of intravenous iron (ferric carboxymaltose) or
saline (placebo). The primary end points were the self-reported
Patient Global Assessment and NYHA functional class, both at week 24.
Secondary end points included the distance walked in 6 minutes and the
health-related quality of life.
Results Among the patients receiving ferric carboxymaltose, 50%
reported being much or moderately improved, as compared with 28% of
patients receiving placebo, according to the Patient Global Assessment
(odds ratio for improvement, 2.51; 95% confidence interval [CI], 1.75
to 3.61). Among the patients assigned to ferric carboxymaltose, 47%
had an NYHA functional class I or II at week 24, as compared with 30%
of patients assigned to placebo (odds ratio for improvement by one
class, 2.40; 95% CI, 1.55 to 3.71). Results were similar in patients
with anemia and those without anemia. Significant improvements were
seen with ferric carboxymaltose in the distance on the 6-minute walk
test and quality-of-life assessments. The rates of death, adverse
events, and serious adverse events were similar in the two study
groups.
Conclusions Treatment with intravenous ferric carboxymaltose in
patients with chronic heart failure and iron deficiency, with or
without anemia, improves symptoms, functional capacity, and quality of
life; the side-effect profile is acceptable.
rickh
wrote:
> Published atwww.nejm.orgNovember 17, 2009 (10.1056/NEJMoa0908355)
bwahahaha fighting fire with fire? excellent idea if you were dealing
with
someone who is rational or coherent;-)
you forgot to cross post to a dozen irrelevant NG's, he'll probably
never see it
pretty funny though
ironjustice
bwahahaha fighting fire with fire? excellent idea if you were
dealing with someone who is rational or coherent;-)<<
I'm dealing with someone .. coherent and rational .. when I speak to
some
jrkff like yourself who injects iron filings into someone .. ?
Fkff you dweeeeebs are just toooooo .. stupid .. for .. words ..
"Intravenous administration of ascorbic acid not only facilitates iron
release from storage sites, but also increases iron utilization in the
erythron."
A parallel, comparative study of intravenous iron versus intravenous
ascorbic acid for erythropoietin-hyporesponsive anaemia in
haemodialysis patients with iron overload.
Nephrol Dial Transplant. 1998 Nov;13(11):2867-72. Links
Tarng DC, Huang TP.
Department of Medicine, Veterans General Hospital, Taipei, Taiwan.
BACKGROUND:
Functional iron deficiency may develop and cause erythropoietin
resistance in haemodialysis patients with iron overload.
Controversy remains as to whether intravenous iron medication can
improve this hyporesponsiveness due to decreased iron availability,
or whether iron therapy will aggravate haemosiderosis.
Intravenous administration of ascorbic acid has been shown to
effectively circumvent resistant anaemia associated with iron
overload in a small preliminary study.
To elucidate further the possible mechanisms of this resistance,
a parallel, comparative study was conducted to compare the effects
of intravenous iron and ascorbate therapies in iron-overloaded
haemodialysis patients.
METHODS:
Fifty haemodialysis patients with serum ferritin of > 500 microg/l
were randomly divided into two protocols.
They were further stratified into controls (Control I, n = 11) and
intravenous iron group (IVFE, n = 15) in protocol I; and into
controls (Control II, n = 12) and intravenous ascorbic acid group
(IVAA, n = 12) in protocol II.
Controls had a haematocrit of > 30% and did not receive any adjuvant
therapy.
IVFE and IVAA patients were hyporesponsive to erythropoietin and
functionally iron deficient.
Ferric saccharate (100 mg dose) was administered intravenously
postdialysis on five consecutive dialysis sessions in the first 2
weeks; and ascorbic acid (300 mg dose) thrice a week for 8 weeks.
Red cell and iron metabolism indices were examined before and
following therapy.
RESULTS:
Mean values of haematocrit and transferrin saturation were
significantly lower, and erythropoietin dose was higher in
IVFE and IVAA patients compared to controls.
Intravenous iron therapy neither improved erythropoiesis nor
reduced erythropoietin dose during 12 weeks.
Iron metabolism indices significantly increased at 2 and 6
weeks, but decreased at 12 weeks returning to the baselines.
In contrast, mean haematocrit significantly increased from
25.8+/-0.5 to 30.6+/-0.6% with a concomitant reduction of 20%
in erythropoietin dose after 8 weeks of ascorbate therapy.
Serum ferritin modestly fell but with no statistical significance.
The enhanced erythropoiesis paralleled a rise in transferrin
saturation from 27+/-3 to 48+/-6% and serum iron from 70+/-11 to
107+/-19 microg/dl (P<0.05).
CONCLUSIONS: Short term intravenous iron therapy cannot resolve
the issue of functional iron deficiency in haemodialysis patients
with iron overload.
Intravenous administration of ascorbic acid not only facilitates
iron release from storage sites, but also increases iron utilization
in the erythron.
Our study draws attention to a potential adjuvant therapy, intravenous
ascorbic acid, to treat erythropoietin-hyporesponsive anaemia in iron-
overloaded patients.
PMID: 9829492
> On Nov 17, 5:38 pm, Mike Collins <acridiniumes...@googlemail.com>
> wrote:
>
>
>
>
>
> > Published atwww.nejm.orgNovember17, 2009 (10.1056/NEJMoa0908355)
> pretty funny though- Hide quoted text -
>
> - Show quoted text -
Mike Collins
rickh
> On Nov 17, 5:26 pm, rickh <harrison6...@rogers.com> wrote:
> bwahahaha fighting fire with fire? excellent idea if you were
> dealing with someone who is rational or coherent;-)<<
>
> I'm dealing with someone .. coherent and rational .. when I speak to
> some
> jrkff like yourself who injects iron filings into someone .. ?
Ya that's what I do Tom, how did you know?
Thanks for proving my point.
Thanks for being one of usenets pre-eminent village idiots
ironjustice
wrote:Conclusions Treatment with intravenous ferric carboxymaltose in
patients with chronic heart failure and iron deficiency, with or
without anemia, improves symptoms, functional capacity, and quality of
life; the side-effect profile is acceptable. <<
The SAME 'markers' used for these in OTHER people were found in
FACT ..
The iron INCREASED their DEATH rate.
"The side-effect profile is acceptable"
Oh .. yeah .. sure .. they are ..
IF they were TOLD about recent studies they might not be so INCLINED
to listen to dingbats would they ..
The patients reported "feeling better" / quality of life BUT this
'improvement' / "feeling better" / quality of life .. WOULD come with
a PRICE .. JUST like OTHER patients .. **died**.
Ortho Biotech Products, L.P. Release: Data From Correction Of
Hemoglobin And Outcomes In Renal Insufficiency (CHOIR) Study Presented
At National Kidney Foundation Meeting
CHICAGO, April 20 /PRNewswire/ -- Final data from an investigational
clinical trial, Correction of Hemoglobin and Outcomes in Renal
Insufficiency, referred to as the CHOIR study, were presented today at
the National Kidney Foundation (NKF) 2006 Spring Clinical Meetings.
The
study was conducted to understand whether anemic patients with chronic
kidney disease not on dialysis, treated with PROCRIT(R) (Epoetin alfa)
to an investigational target hemoglobin level of 13.5 grams per
deciliter of blood (g/dL), had improved mortality and specific
cardiovascular outcomes compared to patients treated to a target
hemoglobin level of 11.3 g/dL.
The primary analysis of the composite endpoint showed a statistically
significant higher incidence of composite endpoint events --
consisting
of mortality, stroke, heart attack and hospitalization due to
congestive heart failure -- in the group of patients treated to the
investigational hemoglobin target of 13.5 g/dL, as compared to the
group treated to the hemoglobin target that is consistent with the
current product label, 11.3 g/dL.
The approved labeling for PROCRIT(R) recommends target hemoglobin
levels of 10 to 12 g/dL in anemic patients with chronic kidney disease
not on dialysis. The 2000 National Kidney Foundation guidelines
recommend patients be treated to a target hemoglobin level of 11 to 12
g/dL. "The results of this study reinforce the direction not to exceed
the recommended target hemoglobin of 12 g/dL in anemic patients with
chronic kidney disease," said Ajay Singh, M.D., a principal
investigator of the study, and clinical chief, Renal Division, Brigham
and Women's Hospital, Boston, MA, and associate professor, Harvard
Medical School.
When used according to product labeling, PROCRIT(R) is a safe and
effective treatment for the management of anemia in patients with
chronic kidney disease not on dialysis.
About CHOIR
A total of 1,432 patients in 130 U.S. sites were enrolled in the
study.
The primary endpoint was a composite endpoint. The composite endpoint
was a combination of mortality and cardiovascular outcomes: stroke,
heart attack and hospitalization due to congestive heart failure. Two
hundred and twenty- two composite endpoint events occurred in the
study
up to its termination: 125 events in the 13.5 g/dL arm and 97 events
in
the 11.3 g/dL arm. The difference in the number of composite endpoint
events was statistically significant. One hundred and twenty-eight
patients died during the study and the 90-day study follow-up period:
72 patients in the arm being treated to 13.5 g/dL and 56 patients in
the arm being treated to 11.3 g/dL. However, the difference in the
number of patients who died between the two treatment arms was not
statistically significant. The study investigators did not report an
association between the reported deaths and the use of PROCRIT(R). The
study was terminated in May 2005 upon recommendation of its data
safety
monitoring board. Results of the study have been reported to
regulatory
authorities.
Ortho Biotech Clinical Affairs, L.L.C. sponsored the study. Ajay
Singh,
M.D., clinical chief, Renal Division, Brigham and Women's Hospital,
Boston, MA, and associate professor of Harvard Medical School and
Donal
Reddan, M.D., consultant nephrologist, University College, Galway,
Ireland, and adjunct assistant professor, Duke University, are
principal investigators for the study. Duke Clinical Research
Institute
was the contract research organization.
About Chronic Kidney Disease
Chronic kidney disease is a progressive condition in which the kidneys
are unable to function effectively. More than 20 million Americans --
or one in nine adults -- are estimated to have this condition, and as
many as two-thirds of them develop anemia. As the kidneys' ability to
function decreases, they become unable to help the body produce red
blood cells, which contain oxygen- carrying hemoglobin, resulting in
anemia. Hemoglobin is the main measure doctors use to assess the
severity of anemia. Symptoms of anemia include tiredness, dizziness
and
shortness of breath. PROCRIT(R) helps treat anemia by increasing the
number of red blood cells in the body.
About PROCRIT(R) (Epoetin alfa)
PROCRIT(R) is for the treatment of anemia in chronic kidney disease
patients who are not on dialysis. PROCRIT(R) is available by
prescription only and is injected by a doctor or nurse. PROCRIT(R) has
been prescribed for more than 10 years to treat anemia in patients
with
chronic kidney disease not on dialysis.
Important Safety Information
PROCRIT(R) is not for patients with uncontrolled high blood pressure.
High blood pressure has been noted in patients treated with PROCRIT(R)
and blood pressure should be monitored carefully. Drugs like PROCRIT
(R)
may increase the risk of blood clots and seizures. Loss of response to
PROCRIT(R) could be a sign of a very rare but serious condition. In
studies, the most common side effects were high blood pressure,
headache, joint pain, and nausea.
Please visit http://www.procrit.com for important product information.
About Ortho Biotech Products, L.P.
In 1990, Ortho Biotech Products, L.P. was established in Raritan, N.J.
Since that time, Ortho Biotech and its worldwide affiliates have
earned
a global reputation for researching, manufacturing and marketing
innovative products that enhance patients' health. Ortho Biotech,
located in Bridgewater, N.J., is an established market leader in
Epoetin alfa therapy for anemia management across multiple indications
and focuses its research and marketing efforts in four clinical areas:
oncology, nephrology, immunology and surgery.
Ortho Biotech
CONTACT: Mark Wolfe of Ortho Biotech Products, L.P., Cell
-+1-908-672-4988, Office - +1-908-927-2745, Mwolfe1@xxxxxxxxxxxxx
Web site: http://www.procrit.com/
----------
Parenteral Iron Use: Possible Contribution to Exceeding Target
Hemoglobin in Hemodialysis Patients.
Ibrahim HN, Foley RN, Zhang R, Gilbertson DT, Collins AJ
Clin J Am Soc Nephrol 2009 Feb 11.
BACKGROUND AND OBJECTIVES:
Use of parenteral iron for anemia management in dialysis patients has
greatly
increased.
Exceeding hemoglobin target levels is not without risk, and whether
parenteral
iron administration contributes to exceeding targets has not been
tested.
The authors aimed to determine prevalence of parenteral iron
administration
and its contribution to exceeding hemoglobin target levels.
DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS:
The authors performed a retrospective observational study of 149,292
hemodialysis
patients using Centers for Medicaid & Medicare Services data.
All patients were point prevalent on January 1, 2004; survived
through
June 30, 2004;
had Medicare as primary payer; were treated with erythropoiesis
stimulating agents
(ESAs); and had valid hemoglobin values in April, May, and June,
2004.
RESULTS:
Of the cohort, 58% received parenteral iron; use was more likely
among
men, whites,
younger patients, and patients with end-stage renal disease as a
result of diabetes.
Age > 75 yr, African American and other races, baseline hemoglobin >
12 g/dl,
higher ESA dose, and iron use in months 1 to 4 of the study period
were independently
associated with the risk of exceeding hemoglobin levels of 12, 13,
and
14 g/dl.
Receiving iron in month 4 of the study period showed the highest
probability of exceeding
targets (odds ratios 1.49, 1.43, 1.50 for hemoglobin levels 12, 13,
14
g/dl, respectively).
CONCLUSIONS:
Parenteral iron use is prevalent, and although adequate iron stores
are central to ESA
response, iron use may contribute to exceeding recommended hemoglobin
levels.
Only data from a prospective trial can confirm this association.
Clinical journal of the American Society of Nephrology : CJASN [Clin
J
Am Soc Nephrol]
-----------------------
Who loves ya.
Tom
Jesus Was A Vegetarian!
http://tinyurl.com/634q5a
Man Is A Herbivore!
http://tinyurl.com/4rq595
DEAD PEOPLE WALKING
http://tinyurl.com/zk9fk
> Published atwww.nejm.orgNovember 17, 2009 (10.1056/NEJMoa0908355)
Mike Collins
> On Nov 30, 7:21 am, Mike Collins <acridiniumes...@googlemail.com>
> wrote:Conclusions Treatment with intravenous ferric carboxymaltose in
> patients with chronic heart failure and iron deficiency, with or
> without anemia, improves symptoms, functional capacity, and quality of
> life; the side-effect profile is acceptable. <<
>
> The SAME 'markers' used for these in OTHER people were found in
> FACT ..
>
montored by measuring iron, TIBC/TSAT and ferritin to ensure that
excess EPO os not given both for health reasons and because EPO is
ridiculously expensive. My lab monitors all dialysis patients
according to European guidelines on the treatment of anaemia in
dialysis patients and saves both patient overtreatment and lots of
money.
You however would like to condemn children all over the world to
suffer unnecessarily from a debilitating deficiency disease to please
your religious mania. This would of course condemn you to hell.
http://www.medicalnewstoday.com/articles/19228.php
Iron deficiency is the world's most common preventable nutritional
problem. It has largely been eradicated from developed countries, but
more than 750 million children in the developing world have iron-
deficiency anemia. According to an article by researchers at The
Hospital for Sick Children in Toronto, Canada, published in this
month's issue of the open access global health journal PLoS Medicine,
a simple sachet called "Sprinkles" could be the key to eradicating
this type of anemia.
In developing countries, the standard strategy to try and control iron-
deficiency anemia is the use of an iron supplement (ferrous sulphate)
given to children as a syrup. But children often find the treatment
hard to take, since it has an unpleasant metallic aftertaste, it
leaves a dark stain on their teeth, and it can give them abdominal
discomfort. In contrast, Sprinkles--sachets containing
microencapsulated iron and other micronutrients as a powder that is
sprinkled onto foods--avoids these side effects. When it was tested in
clinical trials in Bangladesh and Ghana, all of the mothers surveyed
found the treatment acceptable.
In the article, Stanley H. Zlotkin and colleagues summarize the
results of seven community-based trials of using Sprinkles in four
different countries. They found that Sprinkles were just as good as
ferrous sulphate at raising the level of hemoglobin in children's
blood (in other words, at treating anemia).
"Each stage in the evolution of the Sprinkles intervention has been
evaluated in a controlled manner," say the authors. "We determined
that the use of encapsulated iron did not appreciably change the taste
or color of the food to which it was added, we showed that the
haemoglobin response in anaemic infants was equivalent to the current
standard of practice, and we documented the acceptability of Sprinkles
among caregivers who used Sprinkles in their homes."
Importantly, the authors have developed a collaborative model to scale
up the intervention for countrywide use, including providing Sprinkles
to the most vulnerable populations in the developing world. In
Mongolia, for example, Sprinkles have been distributed to over 15,000
children in seven districts by a non-governmental organization called
World Vision. The cost was about US$0.03 per sachet. In the project
area, the prevalence of anemia fell from 42% to 24%, and of rickets
from 48% to 33%.
Stanley H. Zlotkin owns the intellectual property rights to Sprinkles,
and the H.J. Heinz Company is supporting the technical development of
Sprinkles on a cost-recovery basis. Any profit from royalty fees on
the technology transfer of Sprinkles is currently donated to The
Hospital for Sick Children Foundation.
"By developing Sprinkles as a cost-effective and simple strategy to
fortify foods in the home," said Professor Zlotkin, "we hope to
improve the nutritional health and well-being of disadvantaged
infants, young children, and pregnant women worldwide, so that they
can meet their genetic potential for growth, health and development."
Citation: Zlotkin S, Schauer C, Christofides A, Sharieff W, Tondeur M,
et al. (2005) Micronutrient sprinkles to control childhood anaemia.
PLoS Med 2 (1): e1.
ironjustice
wrote:You however would like to condemn children all over the world
to
suffer unnecessarily from a debilitating deficiency disease to please
your religious mania. <<
ACTUALLY pal .. it is .. starvation .. you and your ilk are unable to
understand that ..
When someone has no foooood .. they are starving ..
ANY studies done on people who are starving are .. unacceptable .. AS
a 'study group' ..
WHEN you and your ilk USE "young middleclass well nourished Danish
schoolgirls" and say "they have a VERY high rate of iron
deficiency" .. I .. CAN .. and WILL call you a bunch of raving
lunatics ..
I can and DOOOOO supply medical studies which show an INCREASE in
DEATH attributed TO .. your .. and your ILKS .. best laid plans .. IE:
iron supplementation and / or injection ..
YOU bring up some study from somewhere .. PROBABLY FALSIFIED .. and
say "iron deficiency causes stupidity and retardedness" .. but fail to
tell everyone this happens in starving children .. and NOT "Danish
schoolgirls" ..
The ONLY reason the anemia drugs are used is to "keep the hemoglobin
around 13" when even the NIH tells everyone "it might be wise to think
twice around 9" ..
As to whether or not CKD or OVHD or BBHD or is any different from each
other ..
They are not ..
Anemia doesn't kill you ..
YOU guys dooooo ..
"Iron deficiency very uncommon."
N Engl J Med. 2008 Feb 28;358(9):888-99. Links
Severe anemia in Malawian children.
Calis JC, Phiri KS, Faragher EB, Brabin BJ, Bates I, Cuevas LE, de
Haan RJ, Phiri AI, Malange P, Khoka M, Hulshof PJ, van Lieshout L,
Beld MG, Teo YY, Rockett KA, Richardson A, Kwiatkowski DP, Molyneux
ME, van Hensbroek MB.
Malawi-Liverpool-Wellcome Trust Clinical Research Programme, College
of Medicine, Blantyre, Malawi. job.ca...@gmail.com
BACKGROUND:
Severe anemia is a major cause of sickness and death in African
children, yet the causes of anemia in this population have been
inadequately studied.
METHODS:
We conducted a case-control study of 381 preschool children with
severe anemia (hemoglobin concentration, <5.0 g per deciliter) and
757
preschool children without severe anemia in urban and rural settings
in Malawi. Causal factors previously associated with severe anemia
were studied. The data were examined by multivariate analysis and
structural equation modeling. RESULTS:
Bacteremia (adjusted odds ratio, 5.3; 95% confidence interval [CI],
2.6 to 10.9), malaria (adjusted odds ratio, 2.3; 95% CI, 1.6 to 3.3),
hookworm (adjusted odds ratio, 4.8; 95% CI, 2.0 to 11.8), human
immunodeficiency virus infection (adjusted odds ratio, 2.0; 95% CI,
1.0 to 3.8), the G6PD(-202/-376) genetic disorder (adjusted odds
ratio, 2.4; 95% CI, 1.3 to 4.4), vitamin A deficiency (adjusted odds
ratio, 2.8; 95% CI, 1.3 to 5.8), and vitamin B12 deficiency (adjusted
odds ratio, 2.2; 95% CI, 1.4 to 3.6) were associated with severe
anemia.
Folate deficiency, sickle cell disease, and laboratory signs of an
abnormal inflammatory response were uncommon.
Iron deficiency was not prevalent in case patients (adjusted odds
ratio, 0.37; 95% CI, 0.22 to 0.60) and was negatively associated with
bacteremia.
Malaria was associated with severe anemia in the urban site (with
seasonal transmission) but not in the rural site (where malaria was
holoendemic).
Seventy-six percent of hookworm infections were found in children
under 2 years of age.
CONCLUSIONS:
There are multiple causes of severe anemia in Malawian preschool
children, but folate and iron deficiencies are not prominent among
them. Even in the presence of malaria parasites, additional or
alternative causes of severe anemia should be considered. Copyright
2008 Massachusetts Medical Society.
PMID: 18305266 [PubMed - indexed for MEDLINE]
Who loves ya.
Tom
Jesus Was A Vegetarian!
http://tinyurl.com/2r2nkh
Man Is A Herbivore!
http://tinyurl.com/a3cc3
DEAD PEOPLE WALKING
http://tinyurl.com/zk9fk
> On 4 Dec, 19:10, ironjustice <teamtan...@hotmail.com> wrote:> On Nov 30, 7:21 am, Mike Collins <acridiniumes...@googlemail.com>
ironjustice
wrote:
Ferric Carboxymaltose in Patients with Heart Failure and Iron
Deficiency <<
**INCREASED MORTALITY**
"The Normal Hematocrit Cardiac Trial demonstrated **increased
mortality**"
The Normal Hematocrit Cardiac Trial Revisited
Author: Goodkin, David A.
Seminars in Dialysis, Volume 22, Number 5, September/October 2009 ,
pp. 495-502(8)
Blackwell Publishing
Abstract:
The Normal Hematocrit Cardiac Trial (NHCT) was the first large,
randomized study of patients receiving hemodialysis to examine the
outcomes of treating anemia to a target hematocrit range of 42 ± 3%
versus maintaining partial correction in a range of 30 ± 3%.
The results of the NHCT and a meta-analysis adding eight subsequent
trials of normalization of hematocrit/hemoglobin in chronic kidney
disease (CKD) have demonstrated increased thrombovascular events
and mortality associated with the higher targets.
This article expands and clarifies the results of the NHCT, including
data that were edited from the original publication, and highlights
findings from more recent studies in the field.
Paradoxically, none of the randomized trials has reported an
association between higher attained hemoglobin concentration and
mortality within randomized groups.
Mean platelet count did not increase among the patients in the
normal-hematocrit group in the NHCT or in two other large trials,
CREATE and CHOIR.
Exposure to high doses of erythropoietic stimulating agents and/or
intravenous iron could be mediating complications in the CKD
anemia-normalization studies, but post-hoc analyses to probe such
potential associations have yielded conflicting results and are
clearly hindered by the risk of confounding by indication.
The mechanisms underlying the deleterious outcomes associated
with efforts to correct renal anemia fully remain unproven.
Document Type: Research article
DOI: 10.1111/j.1525-139X.2009.00620.x
> Published atwww.nejm.orgNovember 17, 2009 (10.1056/NEJMoa0908355)
ironjustice
wrote:My lab monitors all dialysis patients according to European
guidelines on the treatment of anaemia in
dialysis patients and saves both patient overtreatment and lots of
money. <<
I sure hope you don't use injections ..
You don't inject iron .. do ya .. ?
It seems if you dooooo .. or did .. you might have been killing
people ..
You wouldn't be killing people would you .. ?
" 5% died the in IV iron arm , 2% in the oral iron arm, and 1% in the
placebo arm "
DGDispatch
Intravenous Iron Not Superior to Oral Iron in Chemotherapy-Associated
Anaemia Treated With Darbepoetin Alfa: Presented at ASH
By Betty S. Riggs
NEW ORLEANS -- December 8, 2009 -- In combination with darbepoetin
alfa, treatment with intravenous (IV) iron is not superior to oral
iron in patients with anaemia receiving chemotherapy for nonmyeloid
neoplasms, according to a study presented here at the American Society
of Hematology (ASH) 51st Annual Meeting and Exposition.
The results of the randomised, placebo-controlled study were presented
by David P. Steensma, MD, Department of Hematological Malignancies,
Dana Farber Cancer Institute, Boston, Massachusetts, on December 7.
For the study, patients receiving chemotherapy for a nonmyeloid
neoplasm were randomised to receive either sodium ferric gluconate
complex in sucrose 187.5 mg IV over 90 minutes every 3 weeks, oral
ferrous sulfate 325 mg once daily, or oral placebo once daily.
Patients were excluded if they had nutritional anaemia,
myelodysplastic syndrome, recent surgery or transfusion, an
erythropoiesis-stimulating agent within 3 months, thrombosis within 1
year, or genetic haemochromatosis.
All patients were receiving darbepoetin alfa 500 mcg subcutaneously
every 3 weeks until haemoglobin (Hb) level was >11 g/dL, followed by
300 mcg every 3 weeks as maintenance therapy. Darbepoetin alfa was
held for Hb >13 g/dL until Hb fell to <12 g/dL, then restarted with
25% dose reduction.
Researchers measured blood counts, iron parameters, and quality of
life (QOL) at baseline and at weeks 7 and 16.
The primary endpoint was the proportion of patients achieving Hb
>=12.0 g/dL or a >=2.0 g/dL Hb increment from baseline by the end of
the 16-week study. Secondary endpoints included transfusion
requirements, changes in QOL, changes in iron parameters, and adverse
events (AEs).
Planned enrolment was 582 patients, but the study met an early
stopping rule due to an excess of serious AEs in the IV iron arm.
Of the 502 patients enrolled, 490 were evaluable. Baseline
characteristics were comparable between groups.
With respect to the primary endpoint, 70% of IV iron-treated patients
achieved the Hb response, compared with 67% with oral iron, and 65%
with placebo (P = 0.73 for IV vs placebo).
There were no significant differences in the proportion of patients
requiring red blood cell transfusion between the IV iron (13%), the
oral iron (13%), and the placebo (14%) group (P = .42). There were
also no significant differences in QOL.
In the IV iron arm, 5% of patients died, versus 2% in the oral iron
arm, and 1% in the placebo arm. Grade 3 or higher AEs occurred in 55%
of IV iron patients compared with 45% for oral iron and 47% placebo (P
= .03).
Funding for this study was provided by Amgen.
[Presentation title: A Phase III, Randomized Study of the Effects of
Parenteral Iron, Oral Iron or No Iron Supplementation on the
Erythropoietic Response to Darbepoetin Alfa for Patients With
Chemotherapy-Associated Anemia: A Study of the Mayo Clinic Cancer
Research Consortium (MCCRC). Abstract 630]
Who loves ya.
Tom
Jesus Was A Vegetarian!
http://tinyurl.com/634q5a
Man Is A Herbivore!
http://tinyurl.com/4rq595
DEAD PEOPLE WALKING
http://tinyurl.com/zk9fk
> On 4 Dec, 19:10, ironjustice <teamtan...@hotmail.com> wrote:> On Nov 30, 7:21 am, Mike Collins <acridiniumes...@googlemail.com>
> > wrote:Conclusions Treatment with intravenous ferric carboxymaltose in
> > patients with chronic heart failure and iron deficiency, with or
> > without anemia, improves symptoms, functional capacity, and quality of
> > life; the side-effect profile is acceptable. <<
>
> > The SAME 'markers' used for these in OTHER people were found in
> > FACT ..
>
> We are not talking about patients with CKD - they should always be
> montored by measuring iron, TIBC/TSAT and ferritin to ensure that
> excess EPO os not given both for health reasons and because EPO is
> ridiculously expensive. My lab monitors alldialysispatients
> according to European guidelines on the treatment of anaemia indialysispatients and saves both patient overtreatment and lots of
ironjustice
My lab monitors all dialysis patients according to European
guidelines on the treatment of anaemia in dialysis patients and
saves both patient overtreatment and lots of money. <<
"Nearly twice as likely to have a stroke"
Anaemia drug not helpful for kidney disease patients
Science Centric | 23 December 2009 10:02 GMT
An international study authored by a UT Southwestern Medical Centre
researcher has concluded that the anaemia drug darbepoetin alfa works
no better than a placebo in several other applications previously
thought to be promising.
Darbepoetin alfa is one of a class of drugs used to increase red blood
cells in patients with type 2 diabetes, chronic kidney disease and
anaemia, but in a study of 4,038 patients, it did little to reduce
cardiovascular problems, death or even the need for dialysis.
Patients have used the drug and other similar drugs for at least a
decade to improve the symptoms of anaemia.
'We were disappointed that the drug didn't make a difference,' said Dr
Robert Toto, professor of internal medicine at UT Southwestern and
senior author of the study in The New England Journal of Medicine. 'We
set out doing this trial to prove whether treatment of anaemia would
help our patients.'
Researchers also found that subjects who took the drug were nearly
twice as likely to have a stroke as those who received a placebo - 101
subjects compared with 53.
'This is a surprise,' Dr Toto said. 'Clinicians should not expect that
treatment of anaemia with darbepoetin and other drugs in its class
will reduce their risk of cardiovascular events or prevent their
kidney disease from progressing. If a clinician is treating a patient
for fatigue and other symptoms of anaemia and the symptoms do not
improve, they should consider stopping the drug, because it may expose
the patient to increased risk of stroke.'
Chronic kidney disease, type 2 diabetes and anaemia affect about 1
million people in the U.S., he said. Drugs such as darbepoetin alfa
for treating anaemic patients on dialysis (in the final stage of
kidney disease) were approved in the late 1980s. Soon afterward,
accepted guidelines suggested using the drug with chronic kidney
disease patients not on dialysis in hopes of improving symptoms,
cardiovascular death rates and preventing chronic kidney disease from
progressing to dialysis.
While studies were done in an attempt to determine optimal haemoglobin
levels using such drugs in these patients, no trial was conducted
comparing the drug with a placebo, until TREAT - Trial to Reduce
Cardiovascular Events with Aranesp Therapy.
'From a scientific perspective, TREAT is the most rigourous,' Dr Toto
said. 'It's a randomised, double-blind, placebo-controlled trial.'
From August 2005 until March 2009, researchers from 24 countries gave
subjects with chronic kidney disease, type 2 diabetes or anaemia
either a placebo or darbepoetin alfa. Twenty four subjects were from
UT Southwestern.
Cardiac death or events occurred in 31 percent of the darbepoetin alfa
group and in 29 percent of the placebo group. Kidney disease death or
progression to dialysis occurred in 32 percent of the darbepoetin alfa
group and in 31 percent of the placebo group.
Researchers did find a modest decrease in reported fatigue levels and
a decrease in the need for blood transfusion in subjects taking
darbepoetin alfa.
Source: UT Southwestern Medical Centre
Who loves ya.
Tom
> DEAD PEOPLE WALKINGhttp://tinyurl.com/zk9fk
>
>
>
> > On 4 Dec, 19:10,ironjustice<teamtan...@hotmail.com> wrote:> On Nov 30, 7:21 am, Mike Collins <acridiniumes...@googlemail.com>
> > PLoS Med 2 (1): e1.- Hide quoted text -