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PATIENT DEATHS HALT AMGEN TESTING.


Byline: Dawn Yoshitake Daily News Staff Writer

Amgen Inc. said Monday that it has suspended an Epogen clinical trial on dialysis dialysis (dīăl`ĭsĭs), in chemistry, transfer of solute (dissolved solids) across a semipermeable membrane. Strictly speaking, dialysis refers only to the transfer of the solute; transfer of the solvent is called osmosis.  patients with severe heart ailments after the death rate climbed rather than improved.

Epogen, a blood-growth protein, is used to treat patients suffering from anemia while receiving kidney dialysis Dialysis, Kidney Definition

Dialysis treatment replaces the function of the kidneys, which normally serve as the body's natural filtration system.
 treatments. It also is used to increase the red blood cell count red blood cell count,
n the number of red blood cells (erthrocytes) in 1 mm3 of blood; a useful diagnostic tool in the determination of several kinds of anemia. See also mean corpuscular hemoglobin.
 in those patients.

But in its clinical trial, higher doses of Epogen were given to dialysis patients with severe heart disease.

The higher levels of Epogen was designed to increase the level of red blood cells Red blood cells
Cells that carry hemoglobin (the molecule that transports oxygen) and help remove wastes from tissues throughout the body.

Mentioned in: Bone Marrow Transplantation

red blood cells 
, which in turn was expected to improve the cardiac condition of patients, said David Kaye David V. Hope (born 14 October 1964), known professionaly as David Kaye, is a Canadian actor who is better known and revered for his work as a voice actor. Career , spokesman.

The clinical trial, however, found that patients with the higher red blood cell counts had slightly higher death rates.

Of the 634 patients who had a higher red blood cell count and were taking Epogen, 34.8 percent died. Meanwhile, patients who had a red cell count red cell count Erythrocyte count Hematology The number of RBCs per volume of blood, measured in microliters–µL or cubic millimeters–mm3; at birth, the RCC is ↑, which is followed shortly by a ↓ that 'bottoms out' at ± 2 months of  considered normal in dialysis patients had a 28.6 percent death rate among the 631 people in the control group.

``Although the data showed there was an increased rate of death, some doctors said patients do well with the higher (red cell count) levels,'' Kaye said.

David Crossen, an analyst with Montgomery Securities, said the cancellation of the clinical trial will have little effect on Amgen's business.He added the increase in Epogen sales will come from dialysis patients who aren't suffering from severe heart ailments and they represent a larger portion of the patient population.
COPYRIGHT 1996 Daily News
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 1996, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Title Annotation:BUSINESS
Publication:Daily News (Los Angeles, CA)
Geographic Code:1USA
Date:Jun 25, 1996
Words:257
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