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Home > Archive > Diabetes > April 2006 > Procrit increases death / kidney
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Procrit increases death / kidney
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| ironjustice@aol.com 2006-04-22, 10:52 am |
| 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@gpcus.jnj.com
Web site: http://www.procrit.com/
Who loves ya.
Tom
Jesus Was A Vegetarian!
http://jesuswasavegetarian.7h.com
Man Is A Herbivore!
http://pages.ivillage.com/ironjustice/manisaherbivore
DEAD PEOPLE WALKING
http://pages.ivillage.com/ironjustice/deadpeoplewalking
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| ironjustice@aol.com 2006-04-23, 5:52 pm |
| >>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.<<
'They' .. decided to 'check' .. to 'see' .. IF .. you DIE .. or NOT ..
AGAINST .. the 'recommended' .. label DIRECTIONS .. and .. ? .. what
WAS the .. outcome .. ?
Increased .. deaths ..
NOW .. is that .. stupidity .. ? .. or .. what .. ?
Criminal .. stupidity ..
[vbcol=seagreen]
authorities. <<
Should be reported to more than their own 'inner circle' .. and should
be reported to the friggin cops ..
[vbcol=seagreen]
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. <<
,,
Harvard .. the .. SAME bunch who targeted Shute back in the fifties ..
Shades of Tuskeegee ..
Who loves ya.
Tom
Jesus Was A Vegetarian!
http://jesuswasavegetarian.7h.com
Man Is A Herbivore!
http://pages.ivillage.com/ironjustice/manisaherbivore
DEAD PEOPLE WALKING
http://pages.ivillage.com/ironjustice/deadpeoplewalking
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