no care
Anyone care to guess WHY there were NO .. deaths .. ?
Where did they hide the bodies .. ?
There HAD to be .. some .. bodies.

The Acord Study seemed to be following the steps of the Procrit study
in which Procrit had 33% increased .. death .. which has led to the
veritable **demise** of .. Amgen .. Procrit was their .. lifeblood.

NOW this Acord Study  is completed .. using another epoetin .. BUT ..
**noone** dies .. NO .. increased .. DEATH .. ?

Same ..  investigational target hemoglobin level of 13.5 grams per
deciliter of blood (g/dL).

The Acord Study compared to the Choir Study.
Choir Study:1,432 patients 72 died at 13.5 g/dL and 56 died at 11.3 g/
dL
Acord Study:172 patients - 0? died at 13.5 g/dL and 0? died at 11.3 g/
dL .. ?
According to calculation:  - 7 died at 13.5 g/dl  and 5 died at 11.3 g/
dl .. ?

This would because of the small study .. and therefore any real
ability to say .. "see" / not enough dead bodies TO count.

Procrit made the mistake of BEING the brunt OF .. a .. large .. study.

<<snip>>
There were no clinically relevant differences in adverse events
between study groups. {Acord Study }
<<snip>>

Two .. people .. not really significant .. multiply that by ..
thousands ..

BUSINESS/FINANCIAL DESK
Heart Risk Seen in Drug For Anemia
November 16, 2006 Health News
By ALEX BERENSON
A new study suggests that high doses of a best-selling drug used to
treat anemia in dialysis and cancer patients may increase the risk of
heart problems.

--------------------------------------------

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 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.

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

http://topics.nytimes.com/top/reference/timestopics/organizations/h/harvard_univ
ersity/index.html?query=EPOETIN%20(DRUG)&field=des&match=exact

The Anaemia CORrection in Diabetes (ACORD) study aims to investigate
the effects of early anaemia correction with subcutaneous NeoRecormon®
(epoetinbeta) on cardiac structure and function in patients with early
diabetic nephropathy. The ACORD study is an international
multicentre,randomised trial in which diabetic patients who are
anaemic (Hb ? 10.5g/dl but less than 13g/dl) are assigned to one of
two treatment groups. The early anaemia correction group start
epoetinbeta therapy immediately to attain a target Hb level of 13-15g/
dl, while the late anaemia correction group only begin treatment once
their Hb has declined below 10.5g/dl, with a target level of 10.5-
11.5g/dl. The results from the ACORD and IRIDIEM trials will provide
additional information regarding the optimal management of anaemia and
risk factors in patients with early diabetic nephropathy. Early
referral and individualised intervention of patients with diabetic
nephropathy is likely to be essential in order to minimise morbidity
and mortality.

<<snip>>
There were no clinically relevant differences in adverse events
between study groups.
<<snip>>

Am J Kidney Dis. 2007 Feb;49(2):194-207. Links
Erratum in:
Am J Kidney Dis. 2007 Apr;49(4):562.
Target level for hemoglobin correction in patients with diabetes and
CKD: primary results of the Anemia Correction in Diabetes (ACORD)
Study.Ritz E, Laville M, Bilous RW, O'Donoghue D, Scherhag A, Burger
U, de Alvaro F; Anemia Correction in Diabetes Study Investigators.
Department of Internal Medicine, University of Heidelberg; Medical
Clinic I, University Hospital Mannheim, Germany. prof.e.ritz@t-
online.de

BACKGROUND:
Patients with diabetes and anemia are at high risk of cardiovascular
disease. The Anemia CORrection in Diabetes (ACORD) Study aimed to
investigate the effect of anemia correction on cardiac structure,
function, and outcomes in patients with diabetes with anemia and early
diabetic nephropathy.
METHODS:
One hundred seventy-two patients with type 1 or 2 diabetes mellitus,
mild to moderate anemia, and stage 1 to 3 chronic kidney disease were
randomly assigned to attain a target hemoglobin (Hb) level of either
13 to 15 g/dL (130 to 150 g/L; group 1) or 10.5 to 11.5 g/dL (105 to
115 g/L; group 2). The primary end point was change in left
ventricular mass index (LVMI). Secondary end points included
echocardiographic variables, renal function, quality of life, and
safety.
RESULTS:
Median Hb level and LVMI were similar in groups 1 and 2 (Hb, 11.9 and
11.7 g/dL [119 and 117 g/L]; LVMI, 113.5 and 112.3 g/m(2),
respectively). At study end, Hb levels were 13.5 g/dL (135 g/L) in
group 1 and 12.1 g/dL (121 g/L) in group 2 (P < 0.001). No significant
differences were observed in median LVMI at month 15 between study
groups (group 1, 112.3 g/m(2); group 2, 116.5 g/m(2)). Multivariate
analysis showed a nonsignificant decrease in LVMI (P = 0.15) in group
1 versus group 2. Anemia correction had no effect on the rate of
decrease in creatinine clearance, but resulted in significantly
improved quality of life in group 1 (P = 0.04). There were no
clinically relevant differences in adverse events between study
groups.
CONCLUSION:
In patients with diabetes with mild to moderate anemia and moderate
left ventricular hypertrophy, correction to an Hb target level of 13
to 15 g/dL (130 to 150 g/L) does not decrease LVMI. However,
normalization of Hb level prevented an additional increase in left
ventricular hypertrophy, was safe, and improved quality of life.

PMID: 17261422 [PubMed - indexed for MEDLINE]

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