ARANESP & Stroke Risk
Ron D
8:46 PM EST October 30, 2009
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A new study raises fresh safety concerns about widely used anemia
medicines, finding that the drug Aranesp nearly doubled the risk of
stroke in people with diabetes and chronic kidney problems who are not
yet sick enough to need dialysis.
The study is the largest ever of these blood-boosting drugs and the only
one that compared them to a dummy treatment. The medicines have become
blockbuster sellers because they lessen the need for transfusions, but
their ability to prevent heart attacks, kidney failure or other problems
have not been proven.
Over the last two years, the federal Food and Drug Administration has
repeatedly strengthened warning labels on Aranesp, Epogen and Procrit as
concerns rose that they may worsen survival in certain cancer patients,
especially at higher doses. Amgen Inc. of Thousand Oaks, Calif., makes
all three drugs, although New Brunswick, N.J.-based Johnson & Johnson
sells Procrit.
The new study tested Aranesp in a different group of patients: 4,038
people with Type 2 diabetes, kidney problems and moderate anemia -
problems that often go hand in hand. The goal was to see if the drug
could prevent heart attacks, heart failure, strokes or the need for
dialysis.
It not only failed to do that, but "we uncovered a risk that I think is
substantial for stroke," said study leader Dr. Marc Pfeffer, a heart
specialist at Brigham and Women's Hospital in Boston. Strokes occurred
in 101 patients given Aranesp and 53 patients given dummy shots. Looked
at another way, the risk of suffering a stroke was about 1 percent per
year in the placebo group and about 2 percent in those given Aranesp.
For many people, "this risk will outweigh its potential benefits," the
study's authors conclude.
Results were published online Friday by the New England Journal of
Medicine and were to be presented at a conference of kidney specialists
in San Diego. Amgen sponsored the study. Pfeffer has consulted for the
company and two authors work for it.
Dr. Roger Perlmutter, Amgen's head of research and development, said the
magnitude of stroke risk "surprised us."
The potential risk of stroke has been listed on Aranesp's label since
the drug was approved in 2001, but "we will definitely update the label"
because of the new study's results, he said.
Aranesp did reduce the need for transfusions - 297 people on the drug
needed them versus 496 of those getting dummy shots. However, there was
only a modest improvement in how fatigued people said they felt in the
Aranesp group.
The study's results may not apply to people already on dialysis, Dr.
Philip Marsden of St. Michael's Hospital and the University of Toronto
in Ontario, Canada, writes in an editorial in the medical journal. For
them, the quality of life improvement from fewer transfusions may be
greater.
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I have stage 3 CKD & my hgb slowly sinks over a 2 1/2 - 3 month period
to below 11.
My hgb is checked every 4 weeks. I don't inject unless below 11 & only
with my Nephrologist blessings. One 100 mcg injection usually bring me
above 11 & closer to 12. My status with my kidney remains stable & I
don't want to risk transfusions. Ron in Fl.
Ron D
ensuing anemia. Ron
mainframetech
> I do NOT have diabetes.. no heart problems. only stage 3 CKD with
> ensuing anemia. Ron
I've had CKD for 3 years now. I keep a table of my lab results
including Red Blood Cell count. The count is always flagged as lower,
but I refuse to do anything about it. A doctor had me try an iron
supplement, but I soon quit that. I found over the 3 years that my
RBC has stayed a little low and that just happens to be where my body
wants it to be. I've had no problems from it. It's like the business
with statins. They get the cholesterol 'optimum' limit lowered so
that more people want to take the statins to lower their cholesterol.
I have big news for many out there. Your cholesterol level is OK the
way it is for 95% of people that are tested. Read "The Cholesterol
Myth" by Uffe Ravnskov, M.D. Her looked into the studies they quoted
to get people to use statins and he found that most of them were faked
or intentionally leaned one way or the other. In one case he actually
found that the summary said people had terribly high cholesterol and
needed statins, and in the detail of the study, it said most people
had no need of statins at all. Go to www.spacedoc.net if you want to
learn about statins from a doctor that had bad experiences with them.
Dr. Duanr Graveline was in the astronaut program, which gives his site
its name. He also wrote "Lipitor: Thief of Memory".
Good Luck,
Chris
Ron D
does not take place. I would be being transfused & want to avoid that &
it's associated risks.
I managed to stay between 11 & 12 on hgb with a dip below to 10.2-10.8
every 2 1/2 to 3 months. One sq injection of 100mcg's of ARANESP brings
me back to the desired 11-12 hgb. If I stabalized at 11 or above I would
not treat either. Ron
mainframetech
Ron D,
Cool. Whatever you decide that works for you. Thew key is that YOU
decided whjat works and not someone with a possible ulterior
motive... :)
My style happens to be to refuse to take anything that I can get
away with not taking. I take regular vitamin D supplements to avoid a
prescription one zealous doctor gave me for 'Zemplar' for a low 'D'
level. Another doctor checked the results and said that worked just
fine. Scratch one very costly drug with side effects.
I had a cardiologist prescribe Plavix for me, and to avoid that
costly drug with side effects I did some research and began taking
2000mg of Omega-3 supplements. Turns out that Omega-3 thins the blood
like Plavix with less side effects. I've had a number of doctors look
over my questionnaire and suggest Plavix for me after seeing that I
take Omega-3, and never realize that it's not needed. That could be
dangerous for anyone not watching what they are trying to give you.
Along these lines I had to drive myself to the hospital a couple
months ago for a kidney stone that was killing me. I got all the
documentation they generated for the less than a day I was there.
They managerd to get 6 doctors to consult on the case, which gave each
one $300 for stopping by. Later I found that many of them had
prescribed drugs for me without saying a thing. I could have had all
sorts of situations where the drugs were bad for me, but they never
asked. They assumed that the hospital record knew everything. Many
of these prescriptions were given to me in the bottle drip I was
getting to help dissolve the kidney stone, so I had no clue or I would
have said something. I'll know better next time.
One of the drugs they thankfully gave me a written prescription
was for 'Levaquin', which is an extremely powerful antibiotic which
many sites recommend only be used as a last resort in very serious
cases. I found that many doctors don't realize that the drug is so
powerful and is used for hospital infections because the maker has
kept them in the dark. More profits I assume. It would have been
indiscriminately given to me if I hadn't looked it up. Kidney Disease
can be badly worsened with antibiotics for some people and I'm one
from past experience. All in all, the hospital and staff seemed to
want to care for me, but weren't interested in checking anything with
me. It's a concern we all should have that almost 100,000 deaths (yes,
deaths) happen each year due to medical mistakes in hospitals.
I just love to rant and rave... :)
Good Luck,
Chris